Clinical Engineering Handbook
Second Edition
Clinical Engineering
Handbook
Second Edition
Editor-in-Chief
Ernesto Iadanza
IFMBE HTA Division Chair, Adjunct Professor in Clinical Engineering
at the School of Engineering
Università degli Studi di Firenze
Florence, Italy
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Dedication
This Handbook is dedicated to the memory of my first mentor,
Professor ­Silvano Dubini.
Section Editors
Saide Jorge Calil
Department of Biomedical Engineering, Faculty of
Electrical Engineering and Computing, University of
Campinas, Campinas, Brazil
Thomas M. Judd
Clinical Engineering Division, IFMBE, Marietta, GA;
Health & Information Technology & Quality, The
Permanente Journal, Portland, OR; Foundation for Living,
Wellness, and Health, Osprey, FL; Computing Sciences,
Villanova University, Villanova, PA; Quality Assessment,
Improvement and Reporting, Kaiser Permanente Georgia
Region, Atlanta, GA, United States
James O. Wear
Scientific Enterprises, North Little Rock, AR,
United States
Monique Frize
Systems and Computer Engineering, Carleton University,
Ottawa, ON, Canada
Gerald R. Goodman
Health Care Administration, Texas Woman’s University,
Houston, TX, United States
Luca Radice
Medical Device Industries Consulting, Seveso, Italy
Almir Badnjević
Department of Genetics and Bioengineering, Faculty of
Engineering and Natural Sciences, International Burch
University; Medical Device Inspection Laboratory Verlab
Ltd.; Medical Devices Verification Laboratory Verlab Ltd.,
Sarajevo, Bosnia and Herzegovina
Elliot B. Sloane
Foundation for Living, Wellness, and Health, Osprey, FL;
Computing Sciences, Villanova University, Villanova, PA,
United States
Ricardo J. Silva
Computing Sciences, Villanova University, Villanova, PA;
Foundation for Living, Wellness, and Health, Orlando,
FL, United States; Montenegro Institute for Cognitive
Disabilities, Guayaquil, Ecuador
Mladen Poluta
Western Cape Government: Health, Cape Town, South Africa
Leandro Pecchia
School of Engineering, University of Warwick, Coventry,
United Kingdom
Raj M. Ratwani
National Center for Human Factors in Healthcare, MedStar
Health; Georgetown University School of Medicine,
Washington, DC, United States
xxxiii
Contributors
Numbers in paraentheses indicate the pages on which the authors’
contrbutions begin.
Natalie Abts (871) National Center for Human Factors
in Healthcare, MedStar Institute for Innovation,
Washington, DC, United States
Arti Devi Ahluwalia (7) Research Center E. Piaggio and
Department of Information Engineering, University of
Pisa, Pisa, Italy
Hashem O. Al-Fadel (111) Temos Assessors Advisory
Board, Temos International Healthcare Accreditation,
Germany
Martina Andellini (812) HTA Unit, Bambino Gesù
Children’s Hospital, IRCCS, Rome, Italy
Ryan Arnold (858) Drexel University College of Medicine,
Philadelphia, PA, United States
Roberto Ayala (82) Health Technology Excellence
National Center, Mexico City, Mexico
Almir Badnjević (477,478,484,491,498,503,509,514,520,
713,715,722,731,774,780) Department of Genetics and
Bioengineering, Faculty of Engineering and Natural
Sciences, International Burch University; Medical
Device Inspection Laboratory Verlab Ltd.; Devices
Verification Laboratory Verlab Ltd., Sarajevo, Bosnia
and Herzegovina
Matthew F. Baretich (208,349,384,667,674) Baretich
Engineering, Inc., Fort Collins, CO, United States
Paula Berrio (181,186) Clinical Engineering Department,
Hospital Pablo Tobón Uribe, Medellin, Colombia;
COLCINC, Bogota, CO, United States
Li Bin (114) Shanghai Medical Equipment Quality Control
Center, Shanghai, China
J.J.B. Pierre Blais (357) INNOVAL Failure Analysis,
Ottawa, ON, Canada
H. Joseph Blumenthal (887) National Center for Human
Factors in Healthcare, MedStar Health, Washington,
DC, United States
Isis Bonet (33) Computer and Systems Engineering, EIA
University, Envigado, Colombia
Simone Borsci (807,829) Department of Cognitive
Psychology and Ergonomics, Faculty of Behavioural
Management and Social Sciences, University of Twente,
Enschede, The Netherlands; National Institute for
Health Research, London IVD Co-operative, Faculty of
Medicine, Department of Surgery & Cancer, Imperial
College, London; School of Creative Arts, University of
Hertfordshire, Hertfordshire, United Kingdom
Alen Bošnjaković (731,753) Institute of Metrology
of Bosnia and Herzegovina, Sarajevo, Bosnia and
Herzegovina
Russell J. Branaghan (847) Human Systems Engineering
Program, Ira A. Fulton Schools of Engineering, Arizona
State University, Mesa, AZ, United States
Marta Bravi (52) Health Technologies Procurement—
ESTAR, Florence, Italy
Rebecca L. Butler (865) National Center for Human
Factors in Healthcare; Quality and Safety, MedStar
Health; Georgetown University School of Medicine,
Washington, DC, United States
Sam S. Byamukama (161) Mark Biomedical Limited,
Kampala, Uganda
Saide Jorge Calil (61) Department of Biomedical
Engineering, Faculty of Electrical Engineering and
Computing, University of Campinas, Campinas – SP,
Brazil
Javier Enrique Camacho-Cogollo (33) Biomedical
Engineering, EIA University, Envigado, Colombia
Joel R. Canlas (436) Clinical Engineering and Technology
Management
Department,
Beaumont
Services
Company, LLC, Royal Oak, MI, United States
Carole C. Carey (764) C3-Carey Consultants, LLC, Fulton,
MD, United States
Rossana Castaldo (799) School of Engineering, University
of Warwick, Coventry, United Kingdom
Mario Castañeda (178,281) President, HealthiTek, Inc., San
Rafael, CA; Clinical Engineering Division, IFMBE,
Marietta, GA; Health & Information Technology & Quality,
The Permanente Journal, Portland, OR, United States
xxxv
xxxvi Contributors
Noel C. Castro (101) Montenegro Institute for Cognitive
Disabilities, Guayaquil, Ecuador; Department of
Electronics and Circuits, Simon Bolivar University,
Caracas, Venezuela
School of Public Health; Center for TeleHealth and
Biomedical Engineering Department, Texas Children’s
Hospital; Global Clinical Engineering Journal, Houston,
TX, United States
Claudio Cecchini (128) Department of Clinical Engineering,
ASST Valtellina e Alto Lario, Sondrio, Italy
Carol Davis-Smith (393) Carol Davis-Smith & Associates,
LLC, Phoenix, AZ, United States
Emel Çetin (742) Medical Metrology Laboratory, TÜBİTAK
National Metrology Institute, Kocaeli, Turkey
Roxana di Mauro (812) HTA Unit, Bambino Gesù
Children’s Hospital, IRCCS, Rome, Italy
Anthony Chan (321) Biomedical Engineering Technology,
School of Health Sciences, British Columbia Institute
of Technology; School of Biomedical Engineering,
University of British Columbia, Vancouver, BC,
Canada
Licia Di Pietro (7) Research Center E. Piaggio and
Department of Information Engineering, University of
Pisa, Pisa, Italy
Guo Chenchen (114) Clinical Engineering, Children’s
Hospital of Zhejiang University School of Medicine,
Hangzhou, China
Michael Cheng (321,353,357) Biomedical Engineer,
Patient Safety/Education Advocate, Ottawa, ON, Canada
Oriana Ciani (789,795) Center for Research on Health
and Social Care Management, SDA Bocconi, Milan,
Italy; Evidence Synthesis & Modelling for Health
Improvement, University of Exeter Medical School,
Exeter, United Kingdom
Daniel Clark (63) Clinical Engineering, Nottingham
University Hospitals NHS Trust; Faculty of Engineering,
University of Nottingham, Nottingham, United Kingdom
David Dickey (222) Medical Equipment Organization,
Bristol, United Kingdom; Medical Technology
Management, Inc., Clarkston, MI, United States
Hüseyin Okan Durmuş (742) Medical Metrology
Laboratory, TÜBİTAK National Metrology Institute,
Kocaeli, Turkey
Hala Durrah (881) MedStar Health Research Institute and
MedStar National Center for Human Factors in Healthcare,
MedStar Health, Washington, DC, United States
Zijad Džemić (715,722,731) Institute of Metrology
of Bosnia and Herzegovina, Sarajevo, Bosnia and
Herzegovina
Antony Easty (330) Institute of Biomaterials & Biomedical
Engineering (IBBME), University of Toronto, ON,
Canada
J. Tobey Clark (227,281,410) WHO Collaborating Center
for Health Technology Management, Technical Services
Partnership, University of Vermont, Burlington, VT;
Clinical Engineering Division, IFMBE, Marietta, GA;
Health & Information Technology & Quality, The
Permanente Journal, Portland, OR, United States
Jonathan Erskine (321,353) European Health Property
Network, Durham University, Durham, United Kingdom
Theodore Cohen (208,384,543) Clinical Engineering, UC
Davis Health, Fair Oaks, CA, United States
Lourdes Escobar (871) Hospital Universitario Marqués de
Valdecilla, Santander, Spain
Giovanni Conte (52) Health Technologies Procurement—
ESTAR, Florence, Italy
Alice L. Epstein (186,196,308,335,699) Allied Health Risk
Control, CNA; CNA Insurance, Durango, CO, United
States
Todd Cooper (611) True Health Trust, San Diego, CA,
United States
Carlo Federici (789,799) Center for Research on Health
and Social Care Management, SDA Bocconi, Milan,
Italy; School of Engineering, University of Warwick,
Coventry, United Kingdom
Bonacini Daniele, CEO (458) Roadrunnerfoot Engineering
srl, Pregnana Milanese; Politecnico of Milan, Milan,
Italy
Jose Alberto Ferreira Filho (108) Instituto de Engenharia
de Sistemas e Tecnologia da Informação, Universidade
Federal de Itajubá, Itajubá, Minas Gerais, Brazil
Luis Danyau (143) School of Biomedical Engineering,
University of Valparaiso, Valparaiso, Chile
G. Fico (807) IFMBE, HTA Division, Eindhoven, The
Netherlands; Department of Photonics and Biomedical
Engineering, Life Supporting Technologies Research
Group, Universidad Politécnica de Madrid, Madrid,
Spain
Lida Z. David (829) Department of Cognitive Psychology
and Ergonomics, Faculty of Behavioural Management
and Social Sciences, University of Twente, Enschede,
The Netherlands
Yadin David (15,148,166,243,362,550) Biomedical
Engineering Consultants, LLC; University of Texas
Allan Fong (876) National Center for Human Factors in
Healthcare, MedStar Health, Washington, DC, United
States
Contributors xxxvii
William Frank (670) Medical Gas Services, Inc., Webster,
NH, United States
Peter Heimann (236) Healthcare,
Development, Vientiane, Laos
Ella S. Franklin (852) National Center for Human
Factors in Healthcare, MedStar Institute for Innovation,
Washington, DC, United States
Antonio Hernandez (178,243,259,276,281) Consultant on
Healthcare Technology, Washington, DC; University
of Texas School of Public Health, Houston, TX;
PAHO Health Technology Regional Adviser; Health
Technology Consultant, Washington, DC; Clinical
Engineering Division, IFMBE, Marietta, GA; Health
& Information Technology & Quality, The Permanente
Journal, Portland, OR, United States
Monique Frize (329,330) Systems and Computer
Engineering, Carleton University, Ottawa, ON, Canada
Tidimogo Gaamangwe (321,353) Clinical Engineering
Program, Winnipeg Regional Health Authority,
Winnipeg, MB, Canada
Jonathan A. Gaev (428) International Programs, ECRI,
Plymouth Meeting, PA, United States
Beatriz Galeano (181,186) Universidad Pontificia
Bolivariana, Medellín, Colombia; COLCINC, Bogota,
CO, United States
Pedro Galvan (87) Biomedical Engineering Department,
Health Sciences Research Institute, San Lorenzo,
Paraguay
William M. Gentles (72,205,208,268) BT Medical
Technology Consulting; University of Toronto;
Canadian Medical & Biological Engineering Society,
Toronto, ON, Canada
Germán Giles (125) Engineering Department, Medical
Foundation of Mar del Plata, Mar del Plata; National
Technological University - San Nicolas Regional
College, San Nicolás, Buenos Aires, Argentina
Luxembourg
Diógenes Hernández (694) PAHO/WHO, Panama City,
Panama
Laura Herrero-Urigüen (871) Valdecilla Biomedical
Research Institute (IDIVAL), Santander, Spain
Ethan Hertz (736) Clinical Engineering Department, Duke
Health Technology Solutions, Duke University Health
System, Durham, NC, United States
Aaron Zachary Hettinger (876,887) National Center
for Human Factors in Healthcare, MedStar Health;
Georgetown University School of Medicine,
Washington, DC, United States
Rabeh Robert Hijazi (219) Healthcare Technology
Professional, Detroit, MI, United States
Daniel J. Hoffman (887) National Center for Human
Factors in Healthcare, MedStar Health, Washington,
DC, United States
Gerald R. Goodman (377,378,728) Health Care
Administration, Texas Woman’s University, Houston;
Houston Institute of Health Sciences, Texas Women’s
University, TX, United States
Jessica L. Howe (865) National Center for Human
Factors in Healthcare; Quality and Safety, MedStar
Health; Georgetown University School of Medicine,
Washington, DC, United States
Stephen L. Grimes (253,290) Strategic Healthcare
Technology Associates, LLC, Swampscott, MA, United
States
Xia Huiling (114) Clinical Engineering, Inner Mongolia
Autonomous Region People’s Hospital, Hohhot, China
C. Guillermo Avendaño† (143) School of Biomedical
Engineering, University of Valparaiso, Valparaiso, Chile
Lejla Gurbeta Pokvić (478,484,491,498,503,509,514,520,
753,774) Department of Genetics and Bioengineering,
Faculty of Engineering and Natural Sciences, International
Burch University; Medical Device Inspection Laboratory
Verlab Ltd., Sarajevo; Technical Faculty University of
Bihać, Bihać, Bosnia and Herzegovina
Jay W. Hall (436) John D. Dingell VA Hospital-Detroit,
Detroit, MI, United States
Gary H. Harding (186,196,308,335,699) Health Care,
Greener Pastures, Durango, CO, United States
†
Deceased
J.M. Hummel (807) IFMBE, HTA Division; Philips
Research, Royal Philips, Eindhoven, The Netherlands
Bruce Hyndman (657,662) Community Hospital of the
Monterey Peninsula, Monterey, CA, United States
Ernesto Iadanza (1,3,33,42,128,330,832) IFMBE HTA
Division, School of Engineering, University of Florence,
Florence, Italy
Andrea Garcia Ibarra (181,186) Drugs and Health
Technology Department, MoH Colombia, Bogotá,
Colombia
Hiroki Igeta (105) Dept. of Clinical Engineering, Aso
Iizuka Hospital, Iizuka, Japan
Rohit Inamdar (616) Applied Solutions, ECRI Institute,
Plymouth, PA, United States
Andrei Issakov (236) Process Management System, Sarl,
Geneva, Switzerland
xxxviii Contributors
Akhila Iyer (852) National Center for Human Factors
in Healthcare, MedStar Institute for Innovation,
Washington, DC, United States
Jadwiga Jodi Strzelczyk (677) Radiological Sciences
Division, University of Colorado, Health Sciences
Center, Denver, CO, United States
Thomas M. Judd (15,165,166,178,236,243,259,280,
281,290,530,648) Clinical Engineering Division,
IFMBE, Marietta, GA; Health & Information Technology
& Quality, The Permanente Journal, Portland, OR;
Foundation for Living, Wellness, and Health, Osprey,
FL; Computing Sciences, Villanova University,
Villanova, PA; Quality Assessment, Improvement and
Reporting, Kaiser Permanente Georgia Region, Atlanta,
GA, United States
Baki Karaböce (742) Medical Metrology Laboratory,
TÜBİTAK National Metrology Institute, Kocaeli,
Turkey
Marcelo Lencina (125) Engineering Department, Medical
Foundation of Mar del Plata, Mar del Plata; National
Technological University - San Nicolas Regional
College, San Nicolás, Buenos Aires, Argentina
Alessio Luschi (42) Department of Information
Engineering, University of Florence, Florence, Italy
Douglas Magagna (682) Engenhária Clínica Ltda., São
Paulo, Brazil
Lúcio Flávio de Magalhães Brito (682) Engenhária
Clínica Ltda., São Paulo, Brazil
Carmelo De Maria (7) Research Center E. Piaggio and
Department of Information Engineering, University of
Pisa, Pisa, Italy
Ranjana K. Mehta (839) Industrial and Systems
Engineering, Texas A&M University, College Station,
TX, United States
James P. Keller (451) Business Development Director,
Emergo by UL, Austin, TX, United States
Haris Memić (715,722) Department for Legal Metrology,
Institute of Metrology of Bosnia and Herzegovina,
Sarajevo, Bosnia and Herzegovina
Kathryn M. Kellogg (865) National Center for Human
Factors in Healthcare, MedStar Health; Quality and
Safety, MedStar Health; Georgetown University School
of Medicine, Washington, DC, United States
Kristen E. Miller (858,876) National Center for Human
Factors in Healthcare, MedStar Health; Georgetown
University School of Medicine, Washington, DC,
United States
Eben Kermit (390) Biomedical Engineering, Stanford
Health Care, Stanford, CA, United States
Michael B. Mirsky (421) Clinical Engineering Solutions
Yorktown Heights, Yorktown Heights, NY, United States
Baset Khalaf (321) Clinical Engineering, Tshwane
University of Technology, Pretoria, South Africa
Brian Moher (321,353) Health Law & Medical Devices;
Patient Safety, Toronto, ON, Canada
Niranjan D. Khambete (132) Department of Clinical
Engineering, Deenanath Mangeshkar Hospital and
Research Centre, Pune, India
Luis Montesinos (821) School of Engineering and Sciences,
Tecnologico de Monterrey, Mexico City, Mexico
Tracy C. Kim (865) National Center for Human Factors
in Healthcare, MedStar Health; Quality and Safety,
MedStar Health; Georgetown University School of
Medicine, Washington, DC, United States
Gary Klein (858) Shadowbox, LLC, Dayton, OH, United
States
Zheng Kun (114) Clinical Engineering, Children’s Hospital
of Zhejiang University School of Medicine, Hangzhou,
China
Stacie Lafko (847) Human Systems Engineering Program,
Ira A. Fulton Schools of Engineering, Arizona State
University, Mesa, AZ, United States
Andres Diaz Lantada (7) Department of Mechanical
Engineering, Universidad Politécnica de Madrid,
Madrid, Spain
Leo Lehtiniemi (321,353) Health Canada; Methodology
Consultant, Ottawa, ON, Canada
Massimiliano Monti (52) Health Technologies - AOU
Careggi/Meyer—ESTAR, Florence, Italy
Yoon Moonsoo (321) Global Health Department, Public
Health Graduate School, Yonsei University, Seoul,
South Korea
Ed Napke (321,353) Health Canada; World Health
Organization Drug Adverse Event Expert, Queen
Elizaberth Jubilee Medal, Ottawa, ON, Canada
Åke Öberg (446) Linköping University, Linköping, Sweden
Frank R. Painter (393) University of Connecticut, Storrs,
CT, United States
Tadeusz Pałko (137) Institute of Metrology and Biomedical
Engineering, Warsaw Technical University, Warsaw,
Poland
Nicolas Pallikarakis (832) University of Patras, Patras, Greece
W.
David Paperman (362) Clinical Engineering
Consultant, Cut and Shoot, TX, United States
Contributors xxxix
Leandro Pecchia (330,787,799,818,821,832) School of
Engineering, University of Warwick, Coventry, United
Kingdom
Pamela Y. Shuck (436) McLaren Health Care, Flint, MI,
United States
Ledina Picari (151) Medical Devices and Systems Unit,
Ministry of Health of Albania, Tirana, Albania
Ricardo
J.
Silva
(101,527,530,556,611,638,644)
Computing Sciences, Villanova University, Villanova,
PA; Foundation for Living, Wellness, and Health,
Orlando, FL, United States; Montenegro Institute for
Cognitive Disabilities, Guayaquil, Ecuador
Julie Polisena (330,795) Medical Devices & Clinical
Interventions, CADTH; Canadian Agency for Drugs and
Technologies in Health (CADTH), Ottawa, ON, Canada
Hardeep Singh (858) Michael E. DeBakey Veterans Affairs
Medical Center, Baylor College of Medicine, Houston,
TX, United States
Mladen Poluta (156,655) Western Cape Government:
Health, Cape Town, South Africa
Elliot B. Sloane (527,530,556,569,611,638,644,648)
Foundation for Living, Wellness, and Health, Osprey,
FL; Computing Sciences, Villanova University,
Villanova, PA, United States
Davide Piaggio (818,832) School of Engineering,
University of Warwick, Coventry, United Kingdom
Luca Radice (427,469) Medical Device Industries
Consulting, Seveso, Italy
Arjun H. Rao (839) Industrial and Systems Engineering,
Texas A&M University, College Station, TX, United States
Raj M. Ratwani (837,876) National Center for Human Factors
in Healthcare, MedStar Health; Georgetown University
School of Medicine, Washington, DC, United States
Alice Ravizza (7) Department of Mechanical and Aerospace
Engineering, Politecnico di Torino, Torino, Italy
Adrian Richards (140) Biomedical Engineering, The
Women’s and Children’s Health Network, Adelaide,
SA, Australia
Malcolm G. Ridgway (373) Retired Clinical Engineer,
Woodland Hills, CA, United States
Matteo Ritrovato (812) HTA Unit, Bambino Gesù
Children’s Hospital, IRCCS, Rome, Italy
Rossana Rivas (94) Eng. Dep. & Health Technopole
CENGETS, Pontifical Catholic University of Peru
PUCP, Lima, Peru
Stanislao Rizzo (52) Department of Ophthalmology,
University of Florence, Florence, Italy
Peter Smithson (222) Medical Equipment Organization,
Bristol, United Kingdom; Medical Technology
Management, Inc., Clarkston, MI, United States
Ira Soller (421) Scientific and Medical Instrumentation,
SUNY Health Science Center at Brooklyn, Brooklyn,
NY, United States
Lemana Spahić (478,484,491,514) Department of Genetics
and Bioengineering, Faculty of Engineering and Natural
Sciences, International Burch University, Sarajevo,
Bosnia and Herzegovina
Robert T. Ssekitoleko (161) College of Health Sciences,
Makerere University, Kampala; Knowledge for Change
(K4C), Fort Portal, Uganda
Lucy Stein (852) National Center for Human Factors
in Healthcare, MedStar Institute for Innovation,
Washington, DC, United States
Arif Subhan (219) Department of Veterans Affairs, Los
Angeles, CA, United States
David Tacconi (473) CoRehab, Trento, Italy
Elena Rojo (871) Hospital Virtual Valdecilla, Santander,
Spain
Nilgün Tokman (742) Medical Metrology Laboratory,
TÜBİTAK National Metrology Institute, Kocaeli, Turkey
Jiang Ruiyao (114) Clinical Engineering, Shanghai 6th
People’s Hospital, Shanghai, China
Eduardo Toledo (94) Eng. Dep. & Health Technopole
CENGETS, Pontifical Catholic University of Peru
PUCP, Lima, Peru
Farzan Sasangohar (839) Industrial and Systems
Engineering, Texas A&M University, College Station;
Center for Outcomes Research, Houston Methodist
Hospital, Houston, TX, United States
Francesca Satta (52) Health Technologies - AOU Careggi/
Meyer—ESTAR, Florence, Italy
P. Trbovich (330) Institute of Health Policy, Management
and Evaluation, University of Toronto, ON, Canada
Priyanka Upendra (390) Technology Management,
Banner Health, Phoenix, AZ, United States
Peter A. Schilder (707) Saftek Consulting (Pty) Ltd., Cape
Town, South Africa
Luis Vilcahuaman (94) Eng. Dep. & Health Technopole
CENGETS, Pontifical Catholic University of Peru
PUCP, Lima, Peru
Garrett Seeley (402) Biomedical Equipment Technology,
Texas State Technical College, Waco, TX, United States
Jorge Enrique Villamil Gutiérrez (75) Manuela Beltrán
University, Bogotá D.C., Colombia
xl Contributors
Maja Peklić Vitt (715,753) Regulatory and Clinical Affairs
Expert, Freiburg im Breisgau, Germany
Dijana Vuković (780) Faculty of Economics, University of
Bihac, Bihac, Bosnia and Herzegovina
Sam S.B. Wanda (161) Uganda National Association for
Medical and Hospital Engineers, Kampala, Uganda
James O. Wear (289,297,377,416) Scientific Enterprises,
North Little Rock, AR, United States
Danielle L.M. Weldon (887) National Center for Human
Factors in Healthcare, MedStar Health, Washington,
DC, United States
Joseph P. Welsh (648) Foundation for Living, Wellness,
and Health, Osprey, FL; Computing Sciences, Villanova
University, Villanova, PA, United States
Deliya B. Wesley (881) MedStar Health Research Institute and
MedStar National Center for Human Factors in Healthcare,
MedStar Health, Washington, DC, United States
Dinsie Williams (795) Canadian Agency for Drugs and
Technologies in Health (CADTH), Ottawa, ON, Canada
Axel Wirth (253) US Healthcare Industry, Symantec
Corporation
Rachel Wynn (881) MedStar Health Research Institute and
MedStar National Center for Human Factors in Healthcare,
MedStar Health, Washington, DC, United States
Ewa Zalewska (137) Nalecz Institute of Biocybernetics
and Biomedical Engineering PAS, Warsaw, Poland
Raymond Peter Zambuto (166,384) Ashland; CEO
Technology in Medicine, Inc., Holliston, MA, United States
Foreword
The Sustainable Development Goals were launched in
2015 as 17 goals to transform the world. The health-related
one, number 3, on good health and well-being, requires
availability and appropriate use of medical technologies,
which is precisely the scope of this Clinical Engineering
Handbook.
Therefore, it is imperative to be ethical and professional,
and constantly attempt to improve the way all medical technology is managed, to ensure universal health coverage,
support health emergencies and outbreaks, and improve
population well-being. These goals are our professional responsibility and together we can accomplish it. As clinical
engineers, let us continue to strive for it, wherever we live,
wherever we are, for patients all around the world. Fifteen
years ago, the first edition of this outstanding Handbook
was published by Joe Dyro, and exponential developments
in science and technology have impacted the health sector
since then. This second edition, led by Ernesto Iadanza and
multiple global authors, who have much advanced the clinical engineering profession in their own settings, from hospitals and governments, to regional and global organizations,
all around the world, and have reinforced the development
and implementation of each of the facets hereby presented.
The World Health Organization (WHO) has a specific
unit dedicated to medical devices that has collected global
information and developed guidance on policies, regulatory
process, procurement, health technology assessment, computerized maintenance systems, and even lists of essential and
priority medical devices for clinical interventions by disease
areas, searching for an international nomenclature which will
support the global management of medical devices across
healthcare sector stakeholders and produce guidance for all
countries. All of these tools form the standard direction to
support better healthcare technology management and serve
as a basic framework for the compilation of resources presented throughout the various sections of this Handbook.
As can be noted in the Handbook, the role of the clinical engineer has increased in scope and has overcome
challenges globally. However, many challenges remain, especially in low resource settings, and need to be tackled in a
global and interactive manner.
The world of health care is going through multiple revolutions simultaneously as a result of accelerating innovations
in science, technology, and clinical research. Revolutions of
such scale and complexity are unprecedented in human history, and they require professionals to be aware and open
to take coherent advantage of the burgeoning discoveries to
impact people’s health.
While the modern world has many forms of “vertical”
intelligence sectors—organized in academia, government,
industry, patients, and general population—a new challenge
is to provide “horizontal” intelligence that enables the vertical expertise to interact and evolve coherently in a responsible, ethical, and conscious way to aim for a better world.
The disjointed results in medical technology are often
costly, wasteful, stressful, inefficient, and sometimes even
cause adverse events in health care. Clinical engineering attempts to reduce these dysfunctions through a comprehensive program of professional education and specializations
that fill critical gaps in institutional plans and processes.
At the same time that new technologies are extending
diagnostic and therapeutic capabilities from the macro level
down to the molecular and nanoscales of granularity, healthcare services in many countries are expanding dramatically
outward, beyond the traditional hospital-centric model into
homes, gyms, schools, and wearable sensors, as well as
via cellphones, tablets, mobile clinics, teleconsultations,
and portable diagnostic devices to remote, low-resource
regions. This veritable flood of innovations poses significant, often destabilizing challenges for healthcare systems
worldwide, because public expectations escalate easily and
most hospitals and health authorities are not well equipped
to track, evaluate, and incorporate changes of such magnitude, complexity, cost, and functional interdependency.
These changes originate across a wide spectrum of “vertical” scientific, technological, and clinical disciplines that
in many cases do not consider the ultimate impacts of such
changes on the healthcare systems, and systems of systems that ultimately must integrate these innovations successfully and affordably for the benefit of patients and the
­general population.
The current innovation revolutions range across areas
as diverse as biomimetic engineering, electronic medical
records, telehealth technologies, crowd-sourced pandemic
tracking, Big Data, telemedicine, robotics, 3D printing of prosthetics and organ tissue to nano- and molecular
xli
xlii Foreword
e­ ngineering, m
­ iniaturization of lab ­analytics, disaster management, microbiomes, and epigenetics. These innovations
put considerable change pressure on all healthcare systems,
organizationally and individually—from national to local
levels—requiring increased attention to the design and assessment of medical devices, and to the multiple interdependencies that exist between medical devices, clinical and IT
processes, business systems, accreditation standards, staffing
models, scopes of professional practice, and expanding service models oriented toward wellness promotion, the “medical home,” and “care anywhere.”
Clinical engineering is a profession whose purpose is
to understand, manage, and improve the lifecycle of operational complexities of medical devices, systems, and services in a disciplined and skilled manner, building on core
competencies that are augmented over time with specialized
training and project work with diverse stakeholders spanning
the healthcare sector. Clinical engineers increasingly work
across the entire spectrum of employment sectors to improve
the design of medical devices and services, to improve standards and policies, to bring practical clinical experience into
biomedical engineering projects at academic and R&D (research and development) settings, and to provide ongoing
expertise in the integration of healthcare innovations in hospitals, clinics, and decentralized services worldwide.
Through evidence-based understanding of the “system
lifecycle” of medical innovations, clinical engineers can
help to integrate the vertical intelligences of the various
s­ ectors in a more methodical and proactive manner as indicated in the WHO medical devices technical series—from
national policy, regulation, technical standards, professional
education, academic and industry R&D, device and service
design, prototyping, clinical research and trials, technology
assessment, contracting, supply chain and service strategy,
deployment, integration with IT and business systems, operational monitoring, process reengineering, device maintenance and repairs, hazard alerts and recalls, inventory
analysis, and replacement planning. This “lifecycle” intelligence is an essential professional resource for any 21stcentury healthcare innovator, manufacturer, planner, care
provider, or relevant government agency.
Clinical engineering is emerging as a mission-critical
profession for 21st-century health care, helping to orchestrate the diverse technical, clinical, and operational
concerns within a systems orientation that is dynamic, comprehensive, and evolutionary, in keeping with the enormous
promise of the times. This book is a major contribution to
the evolution of the profession itself, and serves as a call to
institutional leaders to look to clinical engineering to expand the professional capabilities that healthcare systems
need worldwide as they grapple with the often overwhelming complexities, always keeping the end-user perspective
of patients, and healthcare workers’ needs globally.
Adriana Velazquez
Senior Advisor on Medical Devices, World Health Organization
Acknowledgments
I thank all the authors for their patience, professionalism,
and friendship shown throughout the long and demanding
process of writing this important Handbook. A very heartfelt thanks to all the section editors, who honor me with
their friendship and have masterfully coordinated the work
of many colleagues.
My special thanks goes to my father, to my children, and
to my beloved better half, Gabriella, who has never spared
her support and her patience throughout these long two
years of writing.
xliii
Introduction
Clinical engineering
The purpose of this second edition of the Clinical Engineering
Handbook is to provide a body of knowledge to all clinical
engineers who intend to practice their profession. The level
of medical equipment complexity and the required skills to
manage it are expanding at a tremendous rate. This is clearly
reflected in the first section of the book, where hot topics
such as open-source medical devices, RFID, and facilities
management are described, together with a long list of success stories about clinical engineers from all over the world.
Worldwide clinical engineering practice
The context of clinical engineering can vary tremendously
from country to country. A highly detailed panorama of
the situation in 21 countries, from all the continents of the
world, is provided in Section 2.
Health technology management
One of the core disciplines in clinical engineering is the
management of healthcare technologies, involving assessment, evaluation, procurement, control, asset management,
maintenance and repair, replacement planning, and more
tasks. Sections 3 and 4 provide the reader with 22 chapters,
which dig into the details of each of these essential processes
and reflect the profound experience of professional leaders
from all over the world. Many tools, techniques, and some
tricks can be found here, ready to be used in daily practice.
Safety
The safety of patients, users, and healthcare structures is
one of the main reasons why clinical engineering simply exists. Preventing and managing the risks related to the use of
medical devices, in particular, is a core activity that requires
the perfect mastery of the techniques, programs, and regulations described in Section 5. Today wireless technologies
are pervasive; numerous devices produce and are receptive to electromagnetic fields, requiring attention to the effects of interference caused by this energy. Key chapters on
e­ lectromagnetic interference in hospitals and a retrospective look at electrical safety round out this section.
Professionalism, education, and ethics
Many aspects of professionalism have been addressed
over the years by some important associations, including
the International Federation for Medical and Biological
Engineering (IFMBE) and the American College of Clinical
Engineering (ACCE). Programs for certification and internship, training, distance education, in-service education, and
ethics are discussed in Section 6.
Medical devices: Design, manufacturing,
evaluation, control, utilization, and
service
Clinical engineers are very much involved in the whole
­lifecycle of a medical device, including its earliest stages,
such as design and manufacturing. Comparative evaluations
influence medical device research and design. Cuttingedge technologies, such as surgical robots, are the result of
choral teamwork involving clinical engineers as core professional figures. Sections 7 and 8 provide the reader with
both a comprehensive picture of the above topics as well
as a detailed description of the utilization and service of
anesthesia machines, cardiovascular techniques and technology, devices inspections, hospital beds, equipment for
intensive care units, devices for imaging, and incubators.
Information technology and mobile apps
Twenty-first-century hospitals are steeped in computer science. Designing the information systems and the integration
and convergence of medical and information technologies
are key roles for clinical engineers today, as opposed to only
a few short years ago. Clinical decision support systems,
very often exploiting artificial intelligence techniques, are
overwhelmingly entering our healthcare structures, sometimes revolutionizing the traditional chain of procurement
xlv
xlvi Introduction
and management. This new scenario implies new aspects
about emerging interoperability standards for apps and the
internet of things. Also, management of these complex interoperable systems poses new challenges for clinical engineers, often involving forensic engineering. All of these
topics are thoroughly addressed in Section 9.
Engineering the clinical environment,
medical device standards, regulations,
and the law
It is critical to ensure a safe and well-run environment in all
the places where medical care is offered to patients. The engineering of physical plants, heating, ventilation, electrical
power, the design and management of medical gas systems,
and disaster planning are just some of the key topics addressed by Section 10. In Section 11, the reader will find an
up-to-date overview of the most important regulations and
laws for both hospital facilities safety and medical device
manufacturing and management, from a global perspective.
Health technology assessment
The World Health Organization defines health technology assessment (HTA) as “the systematic evaluation of
p­ roperties, effects and/or impacts of health technologies
and interventions. It covers both the direct, intended consequences of technologies and interventions and their indirect, unintended consequences.” Mastering these concepts
and tools is vital to “inform policy and decision-making in
health care, especially on how best to allocate limited funds
to health interventions and technologies.”
In Section 12, readers are exposed to many aspects of
HTA that are particularly significant for assessing medical
devices: health economics, early stage HTA, tools such as
multicriteria decision analysis (MCDA), how to teach HTA
to biomedical engineers, and many others.
Introduction to human factors
Section 13 closes this Handbook with an interesting introduction to human factors engineering, a journey through
the physiological and psychological aspects, cognitive ergonomics, safety science and cognitive informatics, which
will enrich the reader’s cultural background with skills and
tools that are rarely covered in normal training courses for
biomedical and clinical engineering.
Ernesto Iadanza
Editor-in-Chief
Florence, Italy
Section 1
Clinical engineering
Ernesto Iadanza
IFMBE HTA Division, School of Engineering, University of Florence, Florence, Italy
Ask any clinical engineer what other work he would have
done if he had not become an engineer. The answer, with
very few exceptions, will always be the same: the doctor!
In the word “clinical” itself the closeness of this professional figure to the patient is inherent. A proximity, even
physical, represents an absolute exception in the vast field
of engineering. The clinical engineer is immersed in the
healthcare environment, without any doubt the most complex environment imaginable, both from the point of view
of the quantity of risks present and from the point of view
of the highly advanced technology present.
Try to compare a hospital to any other production process
(yes, this is what is done in hospitals: producing health!) and
you will immediately realize the very high complexity that
characterizes every healthcare structure. The very presence
of the patient inside the structure introduces a high quantity
of risk factors which must be taken into account for safety
purposes. He is in fact in a condition of vulnerability and
weakness due on the one hand to his health condition and
on the other to the fact that he is in a structure in which he
knows nothing: neither spaces, nor people, nor technology.
The number of electro-medical devices that are nowadays
connected to the patient, physically or not, easily exceeds
two dozen. Minor indecision from the operator can cause
harm to the patient. A minimum breakdown can be very dangerous. On the other hand, accurate planning of the entire
life cycle of a hospital’s technological equipment can make
life easier for operators and can have a fantastic positive impact on patients themselves and on the whole process.
The conductor of this orchestra is the clinical engineer,
who must have the right skills to understand when it is time
to turn to the pianist, when to the drummer, when to the guitarist, and when to all the instrumentalists together. Unlike
what happens in a common musical orchestra, however, the
musicians in this case do not all speak the well-coded language of music, but they can use very different languages. A
medical device manufacturer, a manager, a patient, a doctor,
a technician, and an economist have extremely different cultural and linguistic backgrounds. The clinical engineer has
the hard task of acting as a mediator between such d­ ifferent
cultures, basing his work on the multidisciplinary nature of
his own skills.
The dizzying speed at which healthcare technologies are
progressing complicates things. Today’s hospitals are built
and managed in an extremely different way from what it has
been just 30 years ago. Telecommunications networks and
infrastructure in general have changed dramatically over the
last 20 years. Today’s medicine is very different from that
of just 10 years ago.
All these require that the clinical engineer constantly
renew his skills, his way of working, and even his own language, throughout his professional life.
In this section of the Clinical Engineering Handbook we
wanted to give a “bird’s eye” picture of the above.
The first chapter illustrates the evolution of the profession, describing the high level of complexity of today’s
clinical engineering and underlining that such a high level
of complexity on the scene requires a director and a team
that must work in perfect harmony and with the total ability
to manage complexity.
In the second chapter we face very modern issues such
as the creation of open-source medical devices. This chapter takes the reader to a little-known world, showing how
collaborative design of open-source medical devices can
enhance the access to medical technologies, thanks to a feasible reduction in design, management, maintenance, and
repairing costs.
The third chapter provides a very long list of success
stories from hundreds of clinical engineers from around the
world. The idea was born in Hangzhou China, in October
2015, where the world’s leading experts gathered to devise
a path to promote clinical engineering in the world. On the
occasion of the first Global Clinical Engineering Summit,
we realized how much need there was to let a wide audience
know what clinical engineers do for the benefit of the community. As a result, we collected hundreds of success stories
from 125 different countries! In this chapter many of them
are listed and properly linked.
1
2
SECTION | 1 Clinical engineering
This section provides a complete overview of the use
of RFID (radio-frequency identification) technologies in
the health sector. Two focuses: one showing how computeraided facility management relates to the profession of today’s clinical engineers and the other providing deep insight
into the procurement process management of innovative
medical technologies, close this rich section of the Clinical
Engineering Handbook.
Enjoy the reading!
Chapter 1
Clinical engineering
Ernesto Iadanza
IFMBE HTA Division, School of Engineering, University of Florence, Florence, Italy
Medicine core tasks, such as diagnosis and therapy, have
always been intimately linked to using tools ranging from
stethoscopes to plasters and gauzes. Today’s medicine is
grounded on the use of a huge amount of these tools called
medical devices. The simplest stethoscopes, plasters, and
gauzes are still there, but they are now in the good company of the most cutting-edge technologies. Not a single
activity in today’s modern healthcare setting would be possible without making use of dozens of pieces of equipment,
both hardware and software. This brings a whole new set
of ­exciting possibilities. Nevertheless, such a high level of
complexity on the scene requires a director and a team that
must work in perfect harmony and with the total ability to
manage complexity. To quote Uncle Ben (yes, Spider-Man’s
uncle): “with great power comes great responsibility!”
What is clinical engineering?
Since words are important, a quick online search on the
Online Etymology Dictionary for the word “clinical” brings
us to this result:
clinical (adj.)
1780, “pertaining to hospital patients or hospital care,” from
clinic + -al (2). […]
(Online Etymology Dictionary, 2019)
If we carry on searching for “clinic” on the same dictionary, this is the result:
clinic (n.)
1620s, “bedridden person, one confined to his bed by sickness,” from French clinique (17c.), from Latin clinicus “physician that visits patients in their beds,” from Greek klinike
(techne) “(practice) at the sickbed,” from klinikos “of the
bed,” from kline “bed, couch, that on which one lies,” from
suffixed form of PIE root *klei- “to lean.”
(Online Etymology Dictionary, 2019)
Therefore, the concept of leaning on the patient is
embedded in the actual “clinical engineering” locution.
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00001-8
Copyright © 2020 Elsevier Inc. All rights reserved.
Actually a general and simple definition of clinical engineering could be the application of engineering skills
and methodologies and approach for the benefit of the
patient.
Over the years some organizations have provided their
definition for “clinical engineer,” reflecting their vision.
Among them, the American College of Clinical Engineers
(ACCE) in 1992 provided the following definition:
A Clinical Engineer is a professional who supports and advances patient care by applying engineering and managerial
skills to healthcare technology.
(American College of Clinical Engineering, 2019)
A broader definition was provided at the first Global
Clinical Engineering Summit (Hangzhou, China, October
23, 2015) where 36 representatives from national and international societies convened. As a result of that summit,
a document has been outlined to define the main activities
describing biomedical engineers and clinical engineers. The
clinical engineer was described as
A professional who is qualified by education and/or registration to practice engineering in the health-care environment
where technology is created, deployed, taught, regulated,
managed, or maintained related to health services. Other
related terms used for the CE role in developing countries
include biomedical engineer, and rehabilitation engineer.
(IFMBE/CED Definitions, 2019)
The World Health Organization (WHO) noted in 2018
that it is critical that “trained and qualified medical engineering professionals are required to design, evaluate, regulate, maintain, and manage medical devices, and train on
their safe use in health systems around the world. This role
is referred to as clinical engineering (CE), biomedical engineering (BE), and/or healthcare technology management
(HTM) dependent on regional terminology.” WHO often
uses the term “biomedical engineer” as one who practices
clinical engineering (IFMBE/CED CE-HTM Definitions,
2019).
3
4
SECTION | 1 Clinical engineering
In the first edition of the same book, Joseph D. Bronzino
provided the following list of some typical pursuits, that is
still valid:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Supervision of a hospital clinical engineering department that includes clinical engineers and biomedical
equipment technicians (BMETs)
Prepurchase evaluation and planning for new medical
technology
Design, modification, or repair of sophisticated medical
instruments or systems
Cost-effective management of a medical equipment calibration and repair service
Safety and performance testing of medical equipment
by BMETs
Inspection of all incoming equipment (new and returning repairs)
Establishment of performance benchmarks for all
equipment
Medical equipment inventory control
Coordination of outside services and vendors
Training of medical personnel for the safe and effective
use of medical devices and systems
Clinical application engineering, such as custom modification of medical devices for clinical research or evaluation of new noninvasive monitoring systems
Biomedical computer support
Input to the design of clinical facilities where medical
technology is used [e.g., operating rooms (ORs) or intensive care units]
Development and implementation of documentation
protocols required by external accreditation and licensing agencies (Bronzino, 2004)
On the occasion of the aforementioned first Global
Clinical Engineering Summit (Hangzhou, China, October
23, 2015), a document has been outlined to define the
main activities describing biomedical engineers and clinical engineers. In that document, as described by Iadanza
(2018), there is quite a long list of subtopics of biomedical
engineering, listed as “Application and operation: Clinical
Engineering” and reported here:
•
•
•
•
•
•
•
•
•
•
•
•
Technology management
Quality and regulatory assurance
Education and training
Ethics committee and clinical trials
Disaster preparedness
e-health (telemedicine, m-health)
Wearable sensors/products
Health economics
Health systems engineering
Health technology assessment/evaluation
Health informatics
Service delivery management
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Field service support
Security/privacy/cybersecurity
Forensic engineering/investigation
Manufacturing practices such as QMS (quality management system), GMP (good manufacturing practice)
Medical imaging
Project management
Robotics
Virtual environments
Risk management
EMI (electromagnetic interference)/EMC (electromagnetic compatibility) compliance
Technology innovation strategies
Population- and community-based needs assessment
Engineering asset management
Environmental health
Systems science
This list, far from wanting to be exhaustive of all the
possible topics, gives quite an impressive idea—if read together with the previous one—of how quickly the role of the
clinical engineer is expanding. Today’s clinical engineers
must face a dramatically increased set of scenarios, competences, and skills. Agreeing that this cannot be a task for a
single professional, the clinical engineer is today asked to
be a capable and competent manager of a larger and larger
team of collaborators and professionals.
Fields of knowledge
Section VII in this book treats the subject of education
exhaustively. Here the syllabus of two Master’s Degrees
in Clinical Engineering, designed by the author for the
University of Florence, is just briefly reported. For a better
comprehension it is worth explaining that “first level master” refers to a 1-year program for graduates with a 3-year
degree, while “second level master” refers to a 1-year program for postgraduate candidates holding a 5-year laurea
degree.
First level master in clinical engineering
•
•
•
•
•
•
•
•
•
•
•
•
•
Fundamentals of bioengineering
Fundamentals of clinical engineering
General and organizational models
Audits and technology management
Evaluate technologies and systems
Medical devices, software, and systems
Electrical medical systems
Elements of instrumentation and biomedical technologies
Biomedical instrumentation
Systems diagnostic imaging
Innovative applications
Management tools
Wireless systems
Clinical engineering Chapter | 1
HTM
Service
delivery
management
Education of
others
Risk
management
/safety
Facilities
management
Testing,
evaluation,
modification
Quality
Procurement
HTA
Mobile apps
General
management
CE-IT
Disaster
preparedness
Lean thinking
Models
FIG. 1 Some of the fields of knowledge involving clinical engineering.
Second level master
•
•
•
•
•
•
•
•
•
•
•
•
•
•
General and organizational models
Organization of health systems and regional models
Planning, monitoring, and evaluation of performance
Human resource management
Economic and financial instruments in health care
Project management in health care
Principles and methods of Health Technology Assessment
(HTA)
Methodology, research, and review
Technical, economic, and social aspects
Design, innovation, and sustainability
Legal aspects of clinical engineering
Data management and information
Health information systems
Telematics, telemedicine, and health services in the area
Fig. 1 summarizes just some of the fields in which today’s clinical engineers are involved.
New challenges
As an exercise, let us go back about 15 years and read
again what Bronzino identified as topics for the “Future of
Clinical Engineering” at the end of his chapter “Clinical
Engineering: Evolution of a Discipline” in the first edition
of his book (Bronzino, 2004):
•
•
•
•
Computer support
Telecommunications
Facilities operations
Strategic planning
Well, maybe not surprisingly, nowadays the above list
of topics forms a good part of the core services provided by
clinical engineering departments all over the world, maybe
not in the sense that was conceived back in 2004, but it is.
5
For example, if it is true that computer support in terms
of maintenance does certainly not become a regular part
of clinical engineers’ duties (with some exceptions), it is
also certainly true that there is almost no piece of medical equipment that does not embed a computer, today. In
that sense, clinical engineers are managing the whole life
cycle of these “computers!” Moreover, all kinds of mobile
devices and apps are currently used by healthcare personnel
for managing every aspect of their profession. Managing
such complex processes will be daily bread for the clinical
engineers of tomorrow.
Let us continue our journey back in time and read what
Bronzino said about telecommunications: “Hospitals are
also making increased use of facsimile (fax) transmission.
This equipment allows documents, such as patient charts,
to be sent via telephone line from a remote location and reconstructed at the receiving site in a matter of minutes. […]
Some newer equipment allows pictorial information, such
as patient slides, to be digitally transmitted via a phone
line and then electronically reassembled to produce a video
image” (Bronzino, 2004). Well, knowing what happened
since then puts a smile on our face. Our future readers will
definitely have the same smile reading the description of
today’s virtual/augmented reality applications in surgery,
the current three-dimensional (3D) printing facilities, and
the brand new 5G (fifth-generation) networks. One thing is
sure: safe and powerful telecommunications infrastructures
are today (and will be more and more) as necessary for hospitals as water for human beings.
Similar considerations can be made for facilities
­operations and strategic planning. The modern hospitals
are designed using the most advanced Building Information
Modeling (BIM) tools, providing a 3D virtual model of the
whole structure, including the plants (e.g., medical gasses)
and the embedded technologies. These systems have already
become everyday tools to effectively manage all kinds of
healthcare activities, including clinical engineering services.
New approaches are continuously appearing on the scene
of clinical engineering, a discipline in continuous evolution.
Planning the maintenance based on real evidence (Evidence
Based Maintenance, EBM) has started to become a reality in some facilities (Gonnelli et al., 2018; Iadanza et al.,
2019). The growing availability of big data, the interoperability of systems as well as the rapid diffusion of machine
learning and deep learning techniques will certainly provide
the clinical engineers of the future with new sophisticated
approaches and techniques.
References
American College of Clinical Engineering, 2019. Retrieved from: https://
accenet.org/about/Pages/ClinicalEngineer.aspx.
Bronzino, J.D., 2004. Clinical engineering: evolution of a discipline.
In: Dyro, J.F. (Ed.), Biomedical Engineering, Clinical Engineering
6
SECTION | 1 Clinical engineering
Handbook. Academic Press, ISBN: 9780122265709, pp. 3–7. https://
doi.org/10.1016/B978-012226570-9/50003-X. http://www.sciencedirect.com/science/article/pii/B978012226570950003X.
Gonnelli, V., Satta, F., Frosini, F., Iadanza, E., 2018. Evidence-based approach to medical equipment maintenance monitoring. In: IFMBE
Proceedings, vol. 65. Springer, Singapore.
Iadanza, E., 2018. IFMBE/Clinical Engineering Division projects for the
advancement of the profession of clinical engineering. In: IFMBE
Proceedings, vol. 65. Springer, Singapore.
Iadanza, E., Gonnelli, V., Satta, F., Gherardelli, M., 2019. Evidence-based
medical equipment management: a convenient implementation. Med.
Biol. Eng. Comput. https://doi.org/10.1007/s11517-019-02021-x.
IFMBE/CED CE-HTM Definitions, 2019. Retrieved from: https://ced.ifmbe.org/resources/ce-htm-definitions.html.
IFMBE/CED Definitions, 2019. Retrieved from: http://cedglobal.org/
definitions/.
Online Etymology Dictionary, 2019. Retrieved from: https://www.etymonline.com.
Further reading
Badnjevic, A., Gurbeta, L., Jimenez, E.R., Iadanza, E., 2017. Testing of
mechanical ventilators and infant incubators in healthcare institutions.
Technol. Health Care 25 (2), 237–250.
Biffi Gentili, G., Dori, F., Iadanza, E., 2010. Dual-frequency active RFID
solution for tracking patients in a children’s hospital. Design method,
test procedure, risk analysis, and technical solution. Proc. IEEE 98 (9),
art. no. 5508336, 1656–1662.
Iadanza, E., Marzi, L., Dori, F., Gentili, G.B., Torricelli, M.C., 2007.
Hospital health care offer. A monitoring multidisciplinar approach. In:
IFMBE Proceedings, vol. 14 (1), pp. 3685–3688.
Iadanza, E., Dori, F., Miniati, R., Corrado, E., 2010. Electromagnetic interferences (EMI) from active RFId on critical care equipment. In:
IFMBE Proceedings. 29, pp. 991–994.
Iadanza, E., Baroncelli, L., Manetti, A., Dori, F., Miniati, R., Gentili, G.B.,
2011. An rFId Smart container to perform drugs administration reducing adverse drug events. In: IFMBE Proceedings, vol. 37, pp. 679–682.
Iadanza, E., Chini, M., Marini, F., 2013. Electromagnetic compatibility:
RFID and medical equipment in hospitals. In: IFMBE Proceedings,
vol. 39. IFMBE, pp. 732–735.
Luschi, A., Belardinelli, A., Marzi, L., Frosini, F., Miniati, R., Iadanza,
E., 2014a. Careggi Smart hospital: a mobile app for patients, citizens
and healthcare staff. In: 2014 IEEE-EMBS International Conference
on Biomedical and Health Informatics, BHI 2014, art. no. 6864320.
pp. 125–128.
Luschi, A., Marzi, L., Miniati, R., Iadanza, E., 2014b. A custom decisionsupport information system for structural and technological analysis in
healthcare. In: IFMBE Proceedings, vol. 41, pp. 1350–1353.
Miniati, R., Dori, F., Iadanza, E., Fregonara, M.M., Gentili, G.B., 2011.
Health technology management: a database analysis as support of
technology managers in hospitals. Technol. Health Care 19 (6),
445–454.
Chapter 2
Open-source medical devices:
Healthcare solutions for low-,
middle-, and high-resource
settings
Carmelo De Mariaa, Licia Di Pietroa, Alice Ravizzab, Andres Diaz Lantadac,
Arti Devi Ahluwaliaa
a
Research Center E. Piaggio and Department of Information Engineering, University of Pisa, Pisa, Italy,
Department of Mechanical and Aerospace Engineering, Politecnico di Torino, Torino, Italy, cDepartment of
Mechanical Engineering, Universidad Politécnica de Madrid, Madrid, Spain
b
Increasing the access to medical devices:
The need for alternative strategies for
innovation
Medical technology is one of the pillars of an effective
healthcare system, as recognized by the United Nations
Member States in the 2030 Agenda for Sustainable
Development Goals (SDGs) (UN, 2019), which strives
for the achievement of inclusive and sustainable development, drawn on the principle of “leaving no one behind.”
Furthermore, increasing the access to medical devices
(MDs) has been included by the World Health Organization
(WHO) as one of the six leadership priorities to promote
health throughout the whole lifetime.
However, the overall high costs of MDs create a barrier
for achieving this target. The necessity to guarantee efficacy
of the device and safety for patients, healthcare providers,
bystanders and, in the broader view, the health and thus
the wealth of a country (Lissel et al., 2016) has brought to
strict norms and to control each step of the long life cycle
of a MD (design, prototyping, manufacturing, labeling and
packaging, provision, installation, operation, maintenance,
repair and disposal). This “safety by design” and the quality control determine a higher production cost. It has been
estimated that developing a MD from the idea to the market has a cost of around $31 million for a low-to-moderaterisk device, and around $94 million for high-risk products
(Steinberg et al., 2015).
Removing the charge on a single step could not make
the difference. For example, the WHO estimates that in
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00002-X
Copyright © 2020 Elsevier Inc. All rights reserved.
l­ ow-income countries more than 80% of medical equipment
is donated, but only 10%–30% of these become operational,
given the high operating cost, the lack of personnel, and the
frequent failures due to harsh environment, extreme climate
conditions, humidity, dust, and power instability (Steinberg
et al., 2015; World Health Organization, 2010a,b; Iadanza
and Dyro, 2004; Malkin, 2007; Lustick and Zaman, 2011).
These conditions are usually not taken into account during
the design phase causing more frequent failures and determining a higher request for spare parts, which are expensive
and difficult to find, making maintenance and repairing as
problematic as acquisition (Malkin, 2007).
Developing sustainable medical technologies to make
health care affordable to a larger population, and thus reducing global inequalities, can only be performed taking
into account the cultural, socioeconomic context, and the
­environment-climate constraints in which these will be applied
(Malkin, 2007; Lustick and Zaman, 2011; Douglas, 2011).
However, in many cases patients’ or medical professionals’ needs are considered as a minor part of the decisionmaking process and, under the pressure of marketing and
immediate payback, often clinical needs of rare pathologies
and of low-resource settings are left unattended (Fasterholdt
et al., 2018).
In contrast with the biomedical industry, many product
fields have experienced a paradigm shift from a “close” to
an “open innovation,” by now involving often stakeholders and future users since the beginning of the product development process (Ng and Jee, 2014; Gao and Bernard,
2017).
7
8
SECTION | 1 Clinical engineering
Thanks to the web and the social networking, with the
support of cloud-based design and prototyping (Wu et al.,
2015), this new approach of social product development
has taken place, with the creation of virtual communities
that actively develop innovative solutions (Perilli, 2017;
Sarmah and Rahman, 2017), freely shared on online repositories, such as Thingiverse or GrabCAD, born in the wake
of the “Makers” movement (Gershenfeld, 2005; Rosenfeld
Halverson and Sheridan, 2014).
Indeed, the benefit of collaborative and open-source design, in terms accessibility, sustainability, lower costs, improved performance, and safety, has been widely exploited
in software development (Lessig et al., 2005) and is under
consideration also in the academic research in several fields
from biology to nanotechnology (Oberloier and Pearce,
2018; Mushtaq and Pearce, 2018).
However, more safety and security-sensitive fields, including health care, are still reluctant to taking advantage of
the enormous potentials of open-source and collaborative
approach toward a social development of MDs, although it
has the potential to increase the access to medical technologies, thanks to a feasible reduction in design, management,
maintenance, and repairing costs, due to the open access
to device blueprints (De Maria et al., 2018). In the medical industry, it is crucial to ensure the safety and efficacy
requirements of medical technology and for this reason the
adoption of open resources must follow the standards and
the current regulations (DeMaria et al., 2015). Several examples of healthcare-related technologies have appeared
on the web (Niezen et al., 2016); however only some of
them have been designed to be compliant with MD legislation (GammaCardioSoft S.r.l., 2019; Ferretti et al., 2017;
Arcarisi et al., 2019) (Fig. 1).
Open-source medical devices (OSMDs) and their
boundaries should be adequately defined, to have a real impact on the medical industry and healthcare systems. In the
following sections, a reasoned definition of OSMD is proposed, and the underlying enabling technologies and supporting practices are provided.
Open-source medical device definition
The construction of the OSMDs definition is based on the
currently recognized statement on MD endorsed by WHO
(World Health Organization, 2019) and on the successful examples of the open-source software (Open Source Initiative,
2019) and hardware movements (Open Source Hardware
Association, 2019), and on the principles expressed in the
Kahawa Declaration (Ahluwalia et al., 2018a), a manifesto
for the democratization of medical technologies, signed by
representatives of biomedical engineering (BME) community in Europe and Africa.
Medical device
According to the International Medical Device Regulators
Forum (IMDRF) [ref] and recognized by WHO (World
Health Organization, 2019), “Medical device means any
(A)
HV-board
power
supply
Charging
circuit
Capacitor
Connector
H-bridge
Inner Selector
Internal
discharge
circuit
Connector
Battery
Patient
Outer Selector
High-voltage Board
C-board
power
supply
PSOC
I/O
Control Board
(B)
(C)
FIG. 1 Examples of open-source medical devices: Prosthetic hand (e-NABLE Community, 2019) (A); Device for breast self-examination (Arcarisi
et al., 2019) (B); schematic of an open-source automatic external defibrillator compliant to standards (C) (Ferretti et al., 2017).
Open-source medical devices Chapter | 2
instrument, apparatus, implement, machine, appliance, implant, in vitro reagent, software, material or other similar
or related article: a) intended by the manufacturer to be
used, alone or in combination, for human beings for one or
more of the specific purpose(s) of: diagnosis, prevention,
monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation
for an injury; investigation, replacement, modification, or
support of the anatomy or of a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices; providing information for medical
or diagnostic purposes by means of in vitro examination of
specimens derived from the human body; and b) which does
not achieve its primary intended action in or on the human
body by pharmacological, immunological or metabolic
means, but which may be assisted in its intended function
by such means.”
Consequently, MDs range from contact lenses to bandaids, from pacemakers to implantable heart valves, from surgical instruments to large medical imaging equipment. For
operative purposes, this definition covers also most MDs
worldwide, as defined many regulatory bodies, such as the
EU Parliament (EUR-Lex, 2019), the US Food and Drug
Administration (Food and Drug Administration, 2019), or
the Chinese Food and Drug Administration (Sun, 2012).
Open-source software
The most commonly used definition of open-source software
(currently the open-source definition v.1.9 (Open Source
Initiative, 2019)) derives from the Debian Free Software
Guidelines created by Bruce Perens and the Debian developers (Perens, 1999; Debian, 2019). In short, open-source software is software with accessible source code, hence allowing
peer-review and rapid evolution, complying also with criteria
such as: free distribution, distribution in source and compiled
code, allowance of modifications and derived works, lack of
discrimination against specific persons or groups, lack of discrimination against fields of use, lack of restriction to other
software, lack of product specificity, and technological neutrality. Examples of open-source software licenses include
“GPL,” “BSD,” and “Artistic,” among others.
Open-source hardware
The open-source hardware association (OSHWA) defines
open-source hardware in its Statement of Principles 1.0 and
Definition 1.0 as: “hardware whose design is made publicly available so that anyone can study, modify, distribute,
make, and sell the design or hardware based on that design.
The hardware’s source, the design from which it is made, is
available in the preferred format for making modifications
to it. Ideally, open source hardware uses readily-­available
components and materials, standard processes, open
9
i­nfrastructure, unrestricted content, and open-source design tools to maximize the ability of individuals to make and
use hardware. Open source hardware gives people the freedom to control their technology while sharing knowledge
and encouraging commerce through the open exchange of
designs” (Open Source Hardware Association, 2019).
The definition is based on the previously mentioned
open-source definition for open-source software. However,
as hardware differs from software by requiring the use of
physical resources for the creation of physical goods, it
is important to highlight that these principles and definition of OSHW also state that “persons or companies producing items (“products”) under an OSHW license have
an obligation to make it clear that such products are not
manufactured, sold, warranted, or otherwise sanctioned by
the original designer and also not to make use of any trademarks owned by the original designer.”
Open-source medical devices
Based on these three definitions we have articulated a new
definition for OSMDs, but in a way combines and expands
them, in order to account for very specific and relevant issues present in medical technology development, for the
fact that modern MDs involve hardware and software, and
for adequately incorporating recent trends in data management in collaborative projects (Wilkinson et al., 2016).
Thus, according to our proposed definition, an OSMD is
“a medical device whose design and product development
information are made publicly available so that anyone can
study, modify, distribute, make, and sell the medical devices,
and their related software or hardware, based on the initial
available design and information. The design of the open
source medical device should be shared in a format conceived for enabling validation, verification and modification. Open source medical devices rely on widely available
materials and components, benefit from being designed
according to international safety standards and processes
aimed at guaranteeing patients’ safety, take advantage of
modularity, even being designed as inter-changeable and
inter-operable kits, and rely on open e-infrastructures for
information dissemination and promotion of collaboration.
FAIR (findable, accessible, interoperable, reusable) data
principles are proposed for open source medical devices.
Persons or companies producing and commercializing open
source medical devices are obliged to attribute to the original designers and to make clear that such medical devices
are not manufactured, sold, warranted, or otherwise sanctioned by the original designer.”
Enabling tools and technologies
Design activities normally require the use of computeraided design (CAD) and simulation software tools, as
10 SECTION | 1 Clinical engineering
well as the access to prototyping facilities. In these complete development cycles, the manufacturing and testing
stages help to detect design problems and lead to redesign cycles, as happens with standard product design and
development.
Creating an OSMD requires not only the aforementioned tools but also interdisciplinary interactions between MD designers, healthcare professionals, patients,
citizens, and policy makers. Collaborative research and
development online environments, capable of enabling
collaboration, helping to match medical needs and technological offers, is the specific framework for boosting this process, as the coordination of multiple actors
is crucial to the transformation of an invention into an
economically advantageous and marketable innovation
(Bonaccorsi and Rossi, 2003).
Open-source design and simulation tools
Open-source design software is an appropriate alternative
for dramatically reducing the operational costs for codesign
MDs. FreeCAD (FreeCADweb, 2019) and OpenSCAD
(OpenSCAD, 2019) provide interesting examples of this
open approach to CAD software, successfully used in several
nonmedical open-source projects (Open Source Ecology,
2019). Open options are also available for performing simulations linked to a wide set of engineering problems, for
example, the finite-element modeling open solutions, such
as Code Aster (Code Aster, 2019), or ELMER (CSC, 2019).
Accessible additive manufacturing
Additive manufacturing (well known as 3D printing) has
been identified as appropriate technology for many developing countries: given their increased accuracy and reproducibility, their ability to automatically fabricate functional
or geometrical complex objects, to print with different materials at the same time, 3D printing technologies could be
used to produce and customize MDs (Zadpoor and Malda,
2017).
This “3D printing revolution” in health care can bring
MDs, as surgery tools and orthosis, in low-resources settings, but at the moment the quality control in the production is an issue, even in high-income countries, and it has
to involve different actors, including printers and materials
manufacturers, healthcare providers and lab technicians,
and policy makers.
The widespread of low-cost 3D printers (usually based
on fused deposition modeling technology) has made the
regulation and standardization of this field even more urgent. There are several examples of 3D printed prosthetic
hands, based on open-source files freely downloadable
from the web (NIH, 2019), but their design and/or fabrication are questionable.
Mobile-based technologies
Another great enabler for pursuing the above-mentioned
health priorities is m-health, which relies on the widespread diffusion of smartphones in developing countries.
In LRSs this kind of technology has been exponentially
increasing in the past few years: 28% of people in Kenya
with secondary-level or higher education now own a
smartphone, and 88% of Nairobi medical students do too
(Edgcombe et al., 2016). Many MDs can be substituted by
a smartphone (Kassianos et al., 2015), by the joint use of a
smartphone and 3D printed add-ons (Myung et al., 2014;
Bastawrous et al., 2016).
Electronic rapid prototyping
Open-source electronic rapid prototyping boards have had
a strong influence on product development, providing a
quick path from prototype to production. Platform such
as Arduino (Arduino, 2019) or BeagleBone (Beagleboard,
2019) paved the way to cases of success in the OSMD field,
already on the market, include: open-source electronic kits
for medical signals, such as the solutions by Bitalino (Alves
et al., 2006) and Proto Central Electronics (Withchurch,
2019), open-source ECG systems (GammaCardioSoft S.r.l.,
2019).
Virtual platforms
The relevance of OSMDs has been already put forward
by inspiring projects and has achieved very interesting results demonstrating their transformative potential (see next
section).
Taking examples from open-source software communities and requiring the coordination of a large number
of developers, these collaborative projects usually rely on
well-consolidated versioning systems, such as Git-Hub
(Git-Hub, 2019), and, less frequently, on project management software. Several times these initiatives, projects,
and enlarged communities have their own website for
sharing blueprints, but the upload of CAD files on “general purpose” showcase/repositories such as Thingiverse,
GrabCAD, MyMiniFactory, and YouImagine is also common (Thingiverse, 2019).
In this context, the UBORA e-infrastructure (Ahluwalia
et al., 2018b; UBORA, 2019) promotes and sustains the
open-source development of MD by providing to a structured framework, inspired by MDR 2017/745 and the ISO
standard 13485, for needs identification, risk class and relevant standards identification, project management, and
documentation finalized preparation of the preproduction
device dossier. Each stage is vetted and monitored by experts to ensure that safety criteria are met during the design
process (Fig. 2).
Open-source medical devices Chapter | 2
11
FIG. 2 UBORA e-infrastructure: (A) landing page, and (B) some examples of medical device projects, selected through specific keywords.
The importance of human capital in
OSMDs
The commitment and skills of single developers, as well
as the strength of a supporting community, have revealed
instrumental for the realization of the first OSMDs b­ efore
their economic exploitation could be envisioned. This section describes the importance of human capital in the development of OSMDs and highlights the role universities
in nurturing a new generation of biomedical engineers.
12 SECTION | 1 Clinical engineering
Online communities and initiatives
Perspectives
Inspiring pioneers have devoted themselves to explaining
how to arrange “Do It Yourself” (DIY) labs for prototyping (Pearce, 2014) and detailed in an open-source way
the development of several solutions, such as adaptive
aids for arthritis patients or printable clubfoot bracer for
children (Gallup et al., 2018; Savonen et al., 2019), while
highlighting the potentials of distributed manufacturing
to make MDs reach those who need them most and analyzing the suitable business models for open hardware
(Pearce, 2017).
Inspiring communities, aimed at promoting OSMDs
and sharing of information for improved medical technology and health care, can also be mentioned due to their remarkable growth and international projection, such as the
“Enabling the Future” initiatives, focused on personalized
prostheses designs for children; the “Patient Innovation”
networks, focused on shared information for solving complex pathologies; the “Open Prosthetics” initiative and the
“Open Bionics” environment, both concentrated on lowcost personalized prostheses (Pearce, 2017; e-NABLE
Community, 2019; Oliveira et al., 2019; Open Prosthetics,
2019; Open Bionics, 2019).
Open innovations have the potential to reshape the biomedical industry in the next decade by letting patients, patient
associations, healthcare professionals, and technology developers play more relevant roles in the planning, specification, and conception of innovative healthcare technologies.
The collaborative design, empowered by additive manufacturing technologies already proved technically and economically viable regardless of the size of production series,
will promote the development of patient-specific devices,
including a special focus on rare pathologies, with a shift
from mass production to mass personalization. The needs
of remote and rural populations will be more adequately addressed and answered, thanks to innovative supply chains
that may delocalize the production of OSMDs, placing the
fabrication facilities in the point of care.
However, several challenges need to be faced and
solved in a collaborative way, for supporting the growth of
the OSMD sector. Relevant questions linked to regulation,
privacy, safety, traceability, intellectual property, sustainability, and policy making, among others, still require to be
understood (and their reliability demonstrated to a larger
scale) in this new paradigm of MD development.
In this direction, initiatives such as the UBORA
e-infrastructure and related international and multidis­
ciplinary communities may turn out to be truly transformative resources for supporting the endeavors toward a
well-founded future for BME, which will be more open,
collaborative, and equitable.
Changing the paradigm in biomedical
engineering education
BME requires multidisciplinary collaborations to promote
holistic approaches, so as to more effectively address patients’ needs and to adequately support medical professionals in their daily practice.
In such context, collaborative project/problem-based
teaching-learning methods have been suggested as effective strategies for bridging technical competences with
the development of transversal skills (Dochy et al., 2003;
Mahendru and Mahindru, 2011; Brennan et al., 2013)
and maybe invaluable in the education of BME students
(Ahluwalia et al., 2018b).
The CDIO Initiative (CDIO, 2019) has been considered
among the more relevant international proposals promoting
project-based learning (PBL) methodologies worldwide. It
is focused on the establishment of an innovative educational
framework for producing the “engineers of the future,” by
providing students with an education which emphasizes
engineering fundamentals through “Conceiving-DesigningImplementing-Operating” (CDIO) real-world systems,
processes, and products (Crawley et al., 2007). As regards
BME, CDIO experiences in which students live through the
complete development of MDs, have been recently developed with success, both with undergraduate and graduate
participants (Ahluwalia et al., 2018b; Diaz Lantada et al.,
2015, 2016).
Acknowledgments
This project has received funding from the European Union’s Horizon
2020 research and innovation programme under grant agreement No.
731053.
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United Nation, 2019. Sustainable development goals. Available at: https://
www.un.org/sustainabledevelopment/sustainable-developmentgoals/. (Accessed August 2019).
Wilkinson, M.D., et al., 2016. Comment: the FAIR guiding principles for
scientific data management and stewardship. Sci. Data 3, 1–9. 160018.
Withchurch, A., 2019. Examples of open source medical devices.
Protocentral site in GitHub. (Online) https://github.com/Protocentral/.
(Accessed August 2019).
World Health Organization, 2010a. Medical Devices: Managing the
Mismatch: An Outcome of the Priority Medical Devices Project.
World Health Organization.
World Health Organization, 2010b. Barriers to innovation in the field of
medical devices. Background paper 6. World Health Organization,
Geneva.
World Health Organization, 2019. Medical device definition on WHO
website.
https://www.who.int/medical_devices/definitions/en/.
(Accessed August 2019).
Wu, D., Rosen, D.W., Wang, L., Schaefer, D., 2015. Cloud-based design
and manufacturing: a new paradigm in digital manufacturing and design innovation. Comput. Aided Des. 59, 1–14.
Zadpoor, A.A., Malda, J., 2017. Additive manufacturing of biomaterials,
tissues, and organs. J. Ann. Biomed. Eng. 45, 1.
Further reading
IMDRF, 2012. GHTF/SG1/N071: 2012 Definition of the terms ‘medical
device’ and ‘in vitro diagnostic (ivd) medical device’.
Chapter 3
Clinical engineering success
stories and patient outcomes
based on evidence from 125
countries
Thomas M. Judda, Yadin Davidb,*
a
Clinical Engineering Division, IFMBE, Marietta, GA, United States, bBiomedical Engineering Consultants,
LLC, Houston, TX, United States
Introduction
Health technology (HT) is vital to health; the dependence of
health, rehabilitation, and wellness programs on HT for the
delivery of their services has never been greater. Therefore,
it essential that competent and trained professionals manage in an optimal and safe way for better response to the
burden of diseases and resources. Trained clinical engineers
(CEs) are academically prepared and appropriately responsible for HT life-cycle management, fulfilling a critical role
as members of the healthcare team focusing on availability
and reliability of safe and effective technologies and outcomes. Over the past 50 years growing concerns among CE
professionals about lack of knowledge by government agencies and key stakeholders, coupled with the mute recognition
for their vast contributions to the safe and effective creation
and deployment of HT, led to programs that address these
concerns. Knowledge about and recognition for the professionals of CE community who provide critical services will
help recruit students and future practitioners into this needed
field. Is CE practice important for health, rehabilitation, and
wellness programs and are their contributions recognized?
This paper shares the methodology and the findings identified following a 3-year examination of published evidence.
Following the international congress on CE and HT
management in Hangzhou, China in 2015, a Global CE
Summit took place to determine whether regional issues are
shared across the world and present common international
challenges requiring global strategy for optimal addressing
of the critical issues. After order ranking of the issues that
*
identified at the end of the Global CE Summit, the attending members voted that the (1) lack of understanding of
and recognition for the CE contribution to improvements
in healthcare delivery was a major concern for practitioners
in the field, following by (2) the lack of sufficient education
and training for both those who would like to enter the field
and for ongoing professional development. An action plan
was devised to address these and other issues raised at the
Summit. At the second Global CE Summit in Sao Paulo,
Brazil, in 2017, these challenges were reviewed and confirmed with attendees adopting resolutions seeking to continue to address these concerns. The Summits’ action plans
focused first, on data collection identifying if CE contributions qualify as improvement to world health and wellness
and can it be substantiated through evidence-based records.
Addressing the second issue, an international survey of
Body of Practice (BOP) and Body of Knowledge (BOK)
was initiated and has been now completed.
Methods
Rationale
A task force consisting of senior certified CEs from
International Federation for Medical and Biological
Engineering (IFMBE)/Clinical Engineering Division (CED)
issued a global call for submissions of e­ vidence-supported
case studies of CE contributions to the improvement of
delivery of healthcare services or of patient outcomes. In
addition, literature survey was performed in 2016, and
Editor-in-Chief of Global Clinical Engineering Journal (www.GlobalCE.org).
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00003-1
Copyright © 2020 Elsevier Inc. All rights reserved.
15
16 SECTION |1 Clinical engineering
of both sources, the literature and the submitted studies,
an aggregate volume of 150 responses from 90 countries
was examined and found qualified as e­vidence-based
contributions (see http://global.icehtmc.com/publication/
healthteachnology).
Results were rated and tabulated into categories (innovation, improved access, health systems, HT management,
safety and quality, and e-technology) and incorporated into
document
http://global.icehtmc.com/publication/globalsuccess that was submitted to World Health Organization
(WHO)’s World Health Assembly (WHA) in May 2016.
We expanded our review in 2017, as submissions and publications continued to be collected, to include within our examination review of conference-accepted published data that was
presented and published at IFMBE sponsored events. Our examination methodology identified 250 additional stories from
35 more countries—now raising the total volume over 2 years
to 400 publications from 125 countries (Judd and David, 2018).
These CE success stories point to improved outcomes with
benefit from HT, and present overall demonstration of complex integrated systems that must be effectively managed for
their optimal and safe clinical and business impact to be realized. Clinical outcomes included change in human life quality,
care management decisions support, improving 365 × 24 × 7
readiness, and improving operational efficiency.
innovation, management, accessibility, e-technology applications, safety, and quality outcomes can be identified. To accomplish that a successful project (or submission) was defined as
satisfying two objective measures developed by the sponsors.
These measures included timeliness, cost saving, deployment
or adoption by care providers, impact on services, and overall
projection for success. Each success metric was evaluated using three-point scale against a statement representing the success construct (1 = strongly disagree and 3 = strongly agree).
Definitions
Innovation is the beginning of the technology life
cycle where new ideas offering solutions to current
problems faced by healthcare providers or their patients.
Clinical engineers are well positioned to understand the
current problems and guide different or new approaches
to resolve them. Innovation, in our category, meant to
demonstrate the team approach to solving problems all
the way from a concept and building a prototype and continuing with clinical trials and demonstration of compliance with standards, regulations, and intended outcomes.
Improved Access to services follows the innovation stage
same as safety and quality category, e-technology category, and HTM. Products and applications that are considered in successful deployment were rated high and
included in category count of evidence-based category.
For the present study, we classified the collected database
into six categories with definitions:
Innovation
Through provision of new HT solutions, adaptation of
existing, or a combination to address several issues.
Improved access
Ease in reaching HT-related health services or facilities in
terms of location, time, and ease of approach.
Health systems
Positive impact from more efficient and effective
deployment of HT at national or policy level.
Safety and quality
HT’s positive impact on health services safety or quality
outcomes, or through HT human resource development.
Healthcare technology management
Establishing or improving Healthcare Technology
Management (HTM) methodology resulting in improved
population health or wellness.
e-Technology
Improvements achieved due to deployment of internetbased HT tools.
Measures
During the first Global Clinical Engineering Summit in 2015,
the question was raised whether evidence of successful HT
●
●
●
●
Timeliness refers to whether the project/submission was
implemented in timely manner. This was measured by
the statement “The submission will impact outcomes on
present time.”
The cost measure was evaluated whether the submission
overall costs were within budget constraints and reasonable for the conditions in the region. This was assessed
by statement of “The submission cost objectives can be
met in the region.”
The next two combined into the statements “The submission will be deployed by its intended users” and
“The submission will have positive impact on those who
will adopt it.”
Finally, overall submission success expectations were
assessed with the statement “All things considered, the
submission will be a success.”
Results
Summaries from the six categories of submissions database are described below; from CED’s 2016 HT Resources
(IFMBE Clinical Engineering Division (CED), 2016)
document provided to the WHA, WHO’s May 2017
Third Global Forum on Medical Devices (World Health
Organization Third Global Forum on Medical Devices,
2017); CED’s September 2017 Sao Paulo II ICEHTMC
(IFMBE CED, 2017), and others (Other IFMBE related CE
Papers, n.d.) from 2016 to 2017 IFMBE published sources:
Clinical engineering success stories and patient outcomes Chapter | 3
A new resource summary document of the findings—with links below—demonstrates that benefit
was registered in the six categories from every region
around the world. Overall this review identified evidence from using 400 case studies received from 125
countries where management of medical devices (main
component of HT) made a positive difference over the
past 12 years.
The 2007 WHO WHA Resolution 60.29 urges member
states to create national HT management plans in collaboration with biomedical engineers. WHO further clarified the
definition of these personnel in 2017–18 as part of a global
survey (Other IFMBE related CE Papers, n.d.) (http://www.
who.int/medical_devices/support/en/) in coordination with
IFMBE CED.
“Trained and qualified biomedical engineering professionals are required to design, evaluate, regulate, maintain
and manage medical devices, and train on their safe use in
health systems around the world6.” These occupations have
various names in different countries like clinical engineers,
medical engineers, etc., and related professionals and technicians. (WHO and IFMBE CED surveys have identified
over 800,000 of these global professionals in 2018.)
The case studies—grouped in six categories—aim to formulate national strategies and plans to improve use of HT and
better manage costs. In several countries, this has best been
achieved by developing a HT Unit at Ministry of Health level
with CE leadership. The studies provide clear evidence that
HT is beneficial; at times, presenting complex systems that
must be effectively guided and managed for optimal impact
to be realized.
●
●
●
●
●
●
Innovation
Access
Management
Health systems
e-Technology
Quality and safety
The case studies are actually Health Technology Success
Stories demonstrating, in a limited resource environment,
that it is desirable to include professional HT expertise,
such as clinical engineers, in national decision-making in
order to maximize health systems’ services. Case studies
from the links on the following pages demonstrate these
benefits:
●
Access: The Ministry of Health HT Unit-led project in
Albania that doubled access to critical diagnostic services, for example, computerized tomography (CT)
scanners, magnetic resonance imaging (MRI), and angiography imaging, while reducing equipment downtime
to zero, and significantly reducing cost.
●
●
17
Health systems: Improved coordination between multiple
stakeholders in the National Laboratory and its satellites in
Colombia, led by Ministry of Health and clinical engineers
who partner with experts from academia and industry.
Quality and safety: A clinical engineer-led 122-hospital
program in the Shanghai region that cooperates with official, industry, and academic entities, resulting in improved device user satisfaction, tracking of emerging
technologies, and closer partnerships with industry.
Conclusions
HT is vital to health; the dependence of health, rehabilitation,
and wellness programs on HT for the delivery of their services
has never been greater. Beyond the ongoing healthcare burdens
of population growth, political and economic instability, disease
management, disasters, millions of refugees, accidents, and terror attacks, world healthcare technological systems are facing
enormous challenges to be innovative and optimally managed.
The transition into health programs for the 21st century requires
the employment of trained competent clinical engineering professionals. Disease prevention, treatment, and rehabilitation are
more efficient and effective when health services are provided
with appropriate tools. Along with WHO, the International
Federation of Biological and Medical Engineering (IFMBE)
CED recognizes and emphasizes how important the use of appropriate, integrated, and safe HT is to successful outcomes
for every healthcare delivery systems. In the May 2016 HT resource document that was prepared for the WHA, a recommendation was made: HT must be managed to ensure full clinical
benefit and expected financial return on investment.
It is critical, therefore, that with limited resources, HT must
be professionally managed and its deployment over its life cycle be appropriately guided. This paper describes the extensive
study of published data on the vast contributions by CE that
positively impact patient outcomes. This study shows that every
region of the world including low resource regions face a challenge of improving health services while facing varied levels
of infrastructure and human resources capacity challenges. CEs
play vital roles in all stages of healthcare technology life-cycle
management. From creation to planning and from commissioning to utilization and integration; technology-based systems
must and can be managed for optimal performance. In each of
the life-cycle stages requirements for trained and competent CE
input makes critical difference as shown in the analyzed evidence reviewed here. It is our hope that government agencies
and other interested parties will have better understanding of
CEs role and thus will support their inclusion in the healthcare
team of professionals. It is critical for optimal patient outcomes
to encourage the availability, recognition, and increased participation of clinical engineers as part of the health workforce
in your national healthcare delivery programs (World Health
Organization Third Global Forum on Medical Devices, 2017).
18 SECTION |1 Clinical engineering
A Appendix
TABLE 1 List of innovation-related submissions organized by region submitting it with authors information
and hot links.
Focus area
Innovation: Title, authors, with active links
Afghanistan, Iraq, Libya,
Occupied Palestinian
Territory, Somalia, Sudan,
Syria, and Yemen
Medical devices for emergency kits (NCD Kit), Laura Alejandra Velez, Slim Slama
Australia
Phototherapy to reduce exchange transfusions, Luciano Moccia, Gaston Arnolda, Daniele Trevisanuto
Australia
FREO2 oxygen solutions: The low-pressure oxygen storage system and FREO2 Siphon, Roger Rassool, Jim Black
Australia
BME development of non-electric portable blood/fluid warmer for roadside trauma, Anne-Louise Smith,
Mark McEwen
Bangladesh
Health technology enhancing rural primary care and eHealth, Ahmed Raihan Abir
Brazil
Dynamical orthostatic chair development of a new method of lifting and locomotion for physically disabled
people, Walef Robert Ivo Carvalho
Brazil
A multiband reflectance photometric device for reveal gestational age at birth, Rodney Guimaraes, Zilma Reis
Brazil
Prematurity detection by light, Zilma Reis, Rodney Nascimento Guimarães, Gabriela Luíza Nogueira Vitral,
Maria Albertina Santiago Rego, Ingrid Michelle Fonseca
Brazil
Actions travelling ECG for Telemedicine—A partnership of academic and public service, Kleber Teixeira de
Souza et al.
Brazil
Flow analyzer for blood pump, L.R. Rodrigo, A.M. Marcelo and S. Anderson
Brazil
Principal component analysis usage in biomedical engineering to aid at diagnosing pathologies, E.F.
Esmanhoto
Brazil
Digital storage and system management for video surgery records in a network platform, Benedito
Fernandes De Lima et al.
Brazil
Early stage strategic effectiveness evaluation of high flow nasal therapy (OPTIFLOW®) in the treatment of
acute pediatric respiratory failure, Graziela de Araujo Costa et al.
Brazil
Location of electromedical equipment in closed environment using wi-fi technology, William Knob de
Souza
Brazil
Remote equipment monitoring system, A. Ricardo Maranho
Brazil
Model fitting and simulation of the respiratory control system under incremental exercise and altitude in
healthy subjects, C.A. Sarmiento, A.M. Hernández, L.Y. Serna
Canada
Provincial respiratory outreach program in the Province of British Columbia (BC), Anthony Chan, Esther Khor
Chile
Clinical simulations using actors as a patients as part of a strategic plan to reduce risks associated to a “big
bang” opening of a new hospital in Santiago, Francisco Acevedo
China
A novel automatic method of renal segmentation in GRF estimation, Xu Lei
Colombia
Modeling and simulation of ciprofloxacin pharmacokinetics: Electric circuits approach, J.D. Otálvaro, A.F.
Zuluaga, A.M. Hernández
Colombia
Autoregressive models of electrocardiographic signal contaminated with motion artifacts: Benchmark for
biomedical signal processing studies, F.A. Castaño, A.M. Hernández
Colombia
Parametric modeling of kinetic-kinematic polycentric mechanical knee, A.M. Cárdenas, J. Uribe, A.M.
Hernández
Colombia
Motion artifacts recognition in electrocardiographic signals through artificial neural networks and support
vector machines for personalized health monitoring, A. Castaño, A. Hernández
Colombia
Learning tool for mechanical ventilation during spontaneous breathing test on patients intoxicated with
pesticides, M.B. Salazar Sánchez et al.
Clinical engineering success stories and patient outcomes Chapter | 3
19
TABLE 1 List of innovation-related submissions organized by region submitting it with authors information and
hot links—Cont’d
Focus area
Innovation: Title, authors, with active links
Colombia
Optimization of spectral analysis of electrophysiological recordings of the subthalamic nucleus in
Parkinson’s disease: A retrospective study, S.E. Valderrama-Hincapié et al.
Colombia
Three dimensional reconstruction and airflow simulation in a realistic model of the human respiratory
airways, A.E. Ruiz, J.K. Aristizábal
Colombia
Permanent magnets to enable highly-targeted drug delivery applications: A computational and experimental
study, M. Mercado-M et al.
Colombia
Brain functional connectivity in Parkinson’s disease—EEG resting analysis, J. Carmona, J. Suarez, J. Ochoa
Colombia
Business opportunities in HT Projects, Mario Castañeda
Croatia
Supporting diabetic patients with a remote patient monitoring systems, S. Zulj et al.
Denmark, Norway
Impedance-based monitoring for tissue engineering applications, C. Canali et al.
Ethiopia
Producing oxygen concentrators for low resource settings, Mekdes Seyoum
Global
Development of an innovative regulated affordable uterine balloon tamponade for the management of postpartum hemorrhage, Elizabeth Abu-Haydar, Chris de Villiers
Global
How we drive innovation within medical devices, Kristoffer Gandrup-Marino, UNICEF
Global
A new handheld cordless thermal coagulator, W. Prendiville, S. Rengaswamy, B. Partha, P. Groesbeck,
Wallace Dean, Pickett Tim, Riddle Mike, Juan Felix
Global
Safer medication administration for labor/delivery, Beth Kolko; Bradley Younggren
Global
Enabling and scaling early detection of breast cancer in lmics, Mihir Shah, et al.
Global
Ultralow-cost endoscopy for gastroesophageal cancer screening in low-income countries, Pietro Valdastri,
Joseph Norton, Simone Calo', Beatriz Plaza, Andrew Durkin et al.
Global
Unsupervised electronic stethoscope for childhood pneumonia diagnostic, Mohamed-Rida Benissa, J. Solà,
F. Hugon, P. Starkov, F. Braun, S. Manzano, C. Verjus, A. Gervaix
Global
Field testing a neonatal phototherapy device: a novel approach, Donna Brezinski et al.
Global
Test for management of preeclampsia, Wendy Davis et al.
Global
Device to save postpartum-hemorrhaging women in advanced shock, M Guha et al.
Global
Validity of a device for jaundice screening, Anne Cc Lee et al.
Global
CE-IT innovation: How to make health care right, Mario Castañeda, Tom Judd
Global
WHO priority medical devices, Adriana Velazquez Berumen; Gabriela Jimenez Moyao, Antonio Migliori &
Natalia Rodriguez, Adham Ismael Abdel, Alejandra Velez
Global
Appropriate digital X-ray system with eHealth services, Romain Sahli
Global
Role of biomedical engineer in assessing medical devices, Leandro Pecchia
Global
Challenges in TB diagnostics, Christopher Gilpin
Global
The digital health atlas for inventories and routine registration of digital health investments, Garrett Mehl
Global
Global cooperation on assistive technology: WHO priority assistive products list, Emma Tebbutt
Global
Essential resources for (emergencies and) emergency care, Teri Reynolds and Ian Norton
Global
The role of biomedical engineers, James Goh
Global
Innovative appropriate technologies for low resource settings, Adriana Velazquez
Global
Access to medical devices for universal health coverage and SDGs, Adriana Velazquez
Global
2014: WHO medical device list for Ebola care, Adriana Velazquez
Continued
20 SECTION |1 Clinical engineering
TABLE 1 List of innovation-related submissions organized by region submitting it with authors information and
hot links—Cont’d
Focus area
Innovation: Title, authors, with active links
Global
WHO technical specifications for oxygen concentrators, 2015, Adriana Velazquez
Global
Quick $2 test reveals if you caught a superbug in hospital, Hakho Lee, BME MGH, Boston
India
GANDHI: global affordable need driven health innovations, Prashant Jha
India
Hypothermia alert device: saving newborn lives, Ratul Narain; Gini Morgan
India
Novel technology policy: Integrating service delivery to industry promotion, Jitendar Sharma
India
Preventing apneas of prematurity, Ratul Narain; Gini Morgan
India
Remote monitoring for critical infants, Ratul Narain; Gini Morgan
India
MoH “Andhra Med Tech Zone” administering new medical devices manufacturing park, Jitendar Sharma
India
MoH innovations project, WHO 2GFMD, Jitendar Sharma, 2013
Italy
Current and Future Trends in the HTA of Medical Devices, Oriana Ciani et al.
Italy
HTA of a large tablet system in digital pathology, Daniele Giansanti et al.
Italy
Rapid clinical evaluation of robotic surgery, Stefano Gidaro and Luca Radice, 2016
Macedonia, Haiti, China
CED role in linking global HT innovation and standards: From the research lab to the bedside, Yadin David,
Fred Hosea, Tom Judd
Malaysia
Biomechanics of long-distance cycling of a transtibial amputee, Azman Hamid
Mexico
Semi active hand orthosis, R. Itzel Flores-Luna, Ruben Valenzuela-Montes, David De-Jesus-Cruz, Hanna
Garcia-Guerra, Alvaro Ayala Ruiz, Mariano Garcia del Gállego
Peru
Heavy-metals point of care detection HT to improve care, Herb Voigt, Fred Hosea
Senegal
Oxygen generators type PSA: Solution for the supply of oxygen in Senegal, Awa Ndiaye Ep Diouf
Senegal
Innovative diagnostics for infectious diseases, Catharina Boehme
South Africa
Medical device innovation—Local production of medical devices in Africa: Characterizing the landscape
and assessing feasibility, Mladen Poluta
Tanzania
Maternal child health medical devices: Potential impact of disruptive technology in rural Tanzania, Mbuyita,
Mbaruku et al.
Uganda, India
Cross border learning: Catalyzing medical technology innovation with LMICs, Alexis Steel, Molly Ward
UK
Automating the diagnosis of childhood pneumonia, Elina Naydenova, Climent Casals-Pascual, Thanasis
Tsanas, Maarten De Vos
UNICEF
Medical devices for maternal, neonatal and child care, Paul LaBarre
Uruguay
Clinical engineering driving new public hospital design and construction, Franco Simini, 2016
WHO
WHO HT innovations for low resource countries, Adriana Velazquez
TABLE 2 List of access-related submissions organized by region submitting it with authors information
and hot links.
Focus area
Access: Title, authors, with active links
Africa
Medical devices situation in the Africa Region, Stanislav Kniazkov
Albania
HTM improves high technology diagnostics access, Ledina Picari
Clinical engineering success stories and patient outcomes Chapter | 3
21
TABLE 2 List of management-related submissions organized by region submitting it with authors information
and hot links—Cont’d
Focus area
Access: Title, authors, with active links
Argentina
HT improving provincial access, 2015, German Giles
Australia and Canada
Using telehealth to improve diabetes care, E. Sloane, N. Wickramasinghe, S. Goldberg
Brazil
Evaluation of production capacity, the healthcare coverage and the access of computerized tomography
imaging in the Brazilian Public Health System, Diana Lima et al.
Brazil
Distribution of mammographs by macro-region of Brazil, Ana Claudia Patrocinio
Brazil
The role of clinical engineers for the management of healthcare technologies in a hospital network,
Eduardo Jorge
China
Survey of prolonged mechanical ventilation in intensive care units in mainland China, Li J et al.
Cuba
A telemedicine system to follow-up the evolution of chronic diseases in the community, R.I. GonzalezFernandez et al.
Denmark
The mobile laboratory: Bringing high-quality testing, to the patient, Susanne Andresen
Global
Market dynamics: Supporting country decision-making on medical devices, Ray Cummings
Global
Equipment planning, safety and maintenance: Planning of medical imaging services in rural health centers,
Cari Borrás, Mario Forjaz Secca, Yadin David (part 2)
Global
Surgery: Indispensable interventions are not readily available, Walt Johnson
Global
International atomic energy agency: Roadmap to cancer-free world, Rajiv R Prasad
Global
The importance of laboratory and pathology for a good diagnosis and treatment, need for recognition and
availability, Jagdish Butany
Global
The rise of telehealth, Yadin David et al.
Global
Linear accelerators case studies, Marcos Martins
India
Prioritisation of medical devices and diagnostics in India, Yogita Kumar, Gupta Madhur, Ameel Mohammed
India
Ministry of Health (MoH) mobile medical units, Jitendar Sharma
India
MoH free diagnostics service initiative, Jitendar Sharma
India
MoH national dialysis program, Jitendar Sharma
India
Telemedicine reducing blindness in south India, Niranjan Khambete
Kenya
Improving universal health coverage Kenya PPP example, Gisela Abbam, Farid Fezoua
Mexico
CENETEC—National inventory of high-tech medical equipment as HTM tool for strategy planning, Roberto
Ayala
Mozambique, Tanzania,
Malawi, Togo, DR Congo
Global healthcare telemedicine, Michelangelo Bartolo
Paraguay
Innovative tele-diagnosis technology for universal coverage in remote locations without access to
specialists, Pedro Galvin
Romania
Telemonitoring systems and technologies for independent life of Elderly, S.B. Sebesi
Slovakia
Telemedicine and mHealth system for complex management in T1DM and T2DM patients: Results of
6 months study, Fedor Lehocki, Tomas Bacigal
Sudan, Egypt, Lebanon,
Somalia, Afghanistan and
Iraq
Strengthening health technologies and medical devices management in EMRO, Adham R Ismail
Syria
Hemodialysis in Syria: a BME Approach, Lana Almohamad
WHO
WHO cancer care initiative 2015–2016, Adriana Velazquez et al.
22 SECTION |1 Clinical engineering
TABLE 3 List of management-related submissions organized by region submitting it with authors information
and hot links.
Focus area
Management: Title, authors, with active links
Benin, Burkina Faso,
Burundi, Cameroon, DRC,
Ethiopia, the Gambia,
Ghana, Ivory Coast, Kenya,
Nigeria, South Africa,
Tanzania, Uganda, Zambia
THET NGO and South Africa enhancing 15 African HTM societies, Anna Worm & Mladen Poluta
Australia
In-house Endoscopy support, 2016, Anne-Louise Smith
Bangladesh
Clinical engineering approach to improve healthcare technology management for enhancing healthcare
delivery system in middle income countries, A. Hossain et al.
Benin
Evaluation of medical devices in Benin, Charles Pascal Soroheye, Adjaratou Seidou Maliki, Marc
Myszkowski
Benin
Maintenance management of medical devices in Benin: The case of Papané Hospital, Charles Pascal
Soroheye et al.
Bhutan
Bhutan health technology management (HTM) and HTA 2015, Tashi Penjore
Bosnia and Herzegovina
Testing of dialysis machines in healthcare institutions in Bosnia and Herzegovina, Lejla Gurbeta, Berina
Alic, Zijad Dzemic, Almir Badnjevic
Botswana
Using HTM to improve care delivery, Bonnie Tlhomelang
Brazil
Impact of clinical engineering in primary health care, Priscila Avelar, Renato Garcia, Carlos Alberto Silva
Brazil
Logistics of medical devices for indigenous health care attending in remote sites at Brazilian amazon rain
forest, Ryan Ferriera et al.
Brazil
GETS system on CE-HTM, Jose Bassani
Brazil
Medical device manuals analysis using heuristic evaluation, J.C. Carneiro et al.
Brazil
Proposed calibration of apheresis equipment, A.S. Anderson et al.
Brazil
Maternal fetal simulator, L.R. Rodrigo et al.
Brazil
Evaluation of sphygmomanometers: Comparison between manual and digital measurement, Sousa et al.
Brazil
Hospital maintenance management, A.S. Forte, J.E. Neto
Brazil
Study involving X-ray tube life spam in computed tomography equipment, Petrick Marcellus de Victorio et al.
Brazil
HTA applied to HTM through clinical engineering, Santos
Burkina Faso
The problem of acquisition and maintenance of biomedical equipment in Burkina Faso, Zida Ouambi
Emmanuel
Chile
Activities of clinical engineering in the University of Valparaiso, Guillermo Avendano
Chile
The Chilean navy hospitals 15 years of CE, Francisco Acevedo
China
Preventive maintenance of fetal monitors, LE He-qing
China
The survey of 3 departments in Guangdong Province under new regulations, Yang Shaozhou
China
Impact of national CE certification on health technology, Zhou Dan
Colombia
CE and impact on financial management of the hospital, Paula Berrio
Colombia
Estimation of the optimal maintenance frequency of medical devices: A Monte Carlo simulation approach,
Antonio Miguel Cruz et al.
Colombia
Teaching maintenance of medical devices in simulation centers: A pilot study, Daniel Alejandro Quiroga
Torres et al.
Costa Rica
Clinical engineering—Health technology management (HTM) key areas of challenge and progress in Costa
Rica, Gabriela Murillo
Clinical engineering success stories and patient outcomes Chapter | 3
23
TABLE 3 List of management-related submissions organized by region submitting it with authors information
and hot links—Cont’d
Focus area
Management: Title, authors, with active links
Costa Rica
HTM in Costa Rica, G Murillo, M. Ingeana (part 2)
Cuba
Cuba health technology management, Jorge Castro Medina
Dominica
Health technology management in Dominica, R. Williams
Ecuador
Development of biomedical engineering in the honorable Junta de Beneficencia of Guayaquil, Freddy
Matamoros
El Salvador
Health technology management in El Salvador, Juarez S.
Ethiopia
Managing successful medical device warranty period maintenance, Demeru Yeshitla Desta, Tegbar Yigzaw
Sendeke, Sharon Kibwana, Mihereteab Teshome Tebeje
Ethiopia
Strengthening utility and maintenance of medical devices, Demeru Yeshitla Desta, Sharon Kibwana, Firew
Ayalew, Ismael Cordero
Ghana
CMBES HTM donations study, 2015, Bradley, Yoon, Zahedi, Adusei-poku, Bill Gentles
Global
Medical device ownership models and maintenance contracting approaches, Lisa Smith, Michael Ruffo
Global
The missing link: The role of BMETs throughout the HTM lifecycle, Anna Worm, THET; Ismael Cordero,
Gradian
Global
Global HTM update 2011, Binseng Wang et al.
Global
Global HTM update 2015, T. Judd, S. Calil, A. Hernandez, B. Gentles
Global
IFMBE CED development of e-courses for HTM training 2015–2016, Ernesto Iadanza
Global
Orbis international global HTM training, Ismael Cordero (part 2)
Global
ACCE global HTM seminars, 2013 2GFMD, Antonio Hernandez et al.
Haiti
Using HTM to improve care delivery, Monette Valliere, Jean Chery (part 2)
Italy
Launch of the new WHO Collaborating Centre for Research and Training in CE and HTM, Paolo Lago
Italy
A novel approach to improve the technical maintenance of biomedical equipment, Daniele Bibbo et al.
Jamaica
Health technology management in Jamaica, 2010, Keith Richards
Kenya
MoH ophthalmic equipment support, Philip Anyango, Mary Nguri & Joseph Rugut
Kenya
MoH device hydrocarbon refrigeration training BMETs, J. Rugut
Kosovo
HTM in Kosovo, 2010, Agron Boshnjaku S. Ramiqi S, K. Hashani (part 2)
Kyrgyzstan
HTM in Kyrgyzstan, 2010, Kazbek Agibetov (part 2)
Laos
HTM in Laos, 2GFMD 2013, Thanom Insal
Lebanon
HTM implementation at Saint George Hospital—Lebanon, Riad Farah
Lebanon
Medical devices repair/replacement algorithm model, Riah Farah
Mexico
Decodifying HTM in Mexican private hospitals, Luis Fernandez
Nigeria
Key areas of challenge and progress of CE-HTM in Nigeria, Bukola Esan
Paraguay
Health technology management in Paraguay, Pedro Galvan (part 2)
Peru
Fostering clinical engineering and HTM in developing countries: Alignment and effectiveness in Peruvian
Health Sector, Rossana Rivas
Puerto Rico
Health technology management update in Puerto Rico, Oscar Misla (part 2)
Romania
Prioritization of medical devices for maintenance decisions, S. Taghjpour et al.
Rwanda
Medical device technician training, A. Worm, Mpamije Tonkin, Mol, Kasaro
Continued
24 SECTION |1 Clinical engineering
TABLE 3 List of management-related submissions organized by region submitting it with authors information
and hot links—Cont’d
Focus area
Management: Title, authors, with active links
Saudi Arabia
Creation of health technology technical e-library, Salah Alkhallagi
Senegal
Maintenance of medical devices and quality management in Senegal, Dr. Mamadou Sow, Senegal, WHO
2GFMD
Sierra Leone
Immediate impacts of inventory on procurement, donations, maintenance and use of medical equipment,
Kabia, Johnson, Ministry of Health, WHO 2GFMD, 2013
South Africa
Math model for reliable maintenance of medical equipment, Baset Khalaf 2015 (part 2)
Sub-Sharan Africa
The status of medical equipment in sub-Sahara Africa, Anna Worm, Theogene Namahungu, Harold
Chimphepo, Charles P. Soroheye
Sudan
Health technology management in Sudan, Emad Edin Mohamed Hassan (part 2)
Taiwan
Medical devices troubleshooting, KP Lin
Taiwan
The benefit of in-hospital clinical engineer services for medical devices maintenance, Mei-Fen Chen et al.
Taiwan
Taiwan: An IM strategy for in-house CE department based on equipment service life-cycle model, ChiaHung Chien et al.
Tanzania
Health technology management in Tanzania, Y. Mkwizu and R. Masanja (part 2)
Tanzania, Switzerland
Building management capacities for essential equipment in Tanzania, WHO 2GFMD, 2013, Reinhold
Werlein, Swiss Tropical and Public Health Institute
The Gambia
Medical Research Council HTM Unit, Anna Kah, Ebrima Nyassi
Togo
The governance problem in medical equipment donation projects: Case of Togo, WHO 2GFMD, 2013,
Komi Agbeko Tsolenyanu, NGO Association for Maternal, Neonatal and Child Health
Uganda
Using HT Policy and HTM to improve MoH care delivery, Sitra Mulepo, Kataaha Edward
UK
Apprenticeship model for clinical engineering workforce development, Abdul Basit, Malcolm Birch
USA
Kaiser Permanente Clinical Engineering Staffing Best Practices 2015, Chris Ewing
Zambia
Medical equipment maintenance personnel and training in Zambia; S. Mullally, T. Bbuku, G. Musonda
2012
TABLE 4 List of health systems-related submissions organized by region submitting it with authors information
and hot links.
Focus area
Health systems: Title, authors, with active links
Africa
The potential power of sub-Saharan Africa professional associations for biomedical/clinical engineering
professionals, Anna Worm et al.
Africa—18 countries
The (improved) status of medical equipment in sub-Sahara Africa HTM: A. Worm, L. Jones, T. Namahungu,
H. Chimphepo, P. Soroheye
Albania
Regulation, standards and market surveillance of medical devices and systems in Albania, Ledina Picari
Albania
MoH health technology (HT) unit device legislation, Ledina Picari, 2016
Argentina
Present and future of clinical engineering in Argentina, German Giles, Marcelo Lencina
Asia Pacific
Status of biomedical engineering education in the Asia Pacific, KP Lin et al.
Bangladesh
Biomedical and clinical engineering development, Md Ashrafuzzaman et al.
Bangladesh
Necessity of clinical engineering to regulate the medical devices in middle income countries, Anwar Hossain
Bosnia and Herzegovina
Medical devices in legal metrology framework, Lejla Gurbeta, Almir Badnjeviffi
Clinical engineering success stories and patient outcomes Chapter | 3
25
TABLE 4 List of health systems-related submissions organized by region submitting it with authors information
and hot links—Cont’d
Focus area
Health systems: Title, authors, with active links
Brazil
Analysis of the curriculum of postgraduate courses in clinical engineering in Brazil, Anderson A. Ramos
et al
Brazil
Application of multiparameter method as an assistance to the evaluation of the need for replacement of
medical equipment, M.A. Marciano, E.K. Souza
Brazil
Assistant multi-parametric method to the selection in the process of incorporation of hospital equipment,
M.A. Marciano
Brazil
International standards for medical device and the U.S. Food and Drug Administration, R.G. Fernandes
Brazil
Computed tomography scanners productivity and examinations times, R.P. Santos et al
Brazil
Defibrillators in locations with a high concentration/movement of people in Bauru/Brazil, A.S. de Melo et al.
Brazil
FDA internationalization under the aspect of medical device standards, R.G. Fernandes, S.J. Calil
Brazil
Medical equipment acquisition methodology in public procurement process, J. Martins et al.
Brazil
Cost estimate methodology in procurement processes of Medical Equipment, V. O. Fagundes, R. Zaniboni,
R. Garcia
Brazil
Study of medical device purchasing cycles through temporal series analysis, J.C. Guerrero, J.H. García,
A.M. Hernández
Brazil
RENEM—MoH HT list driving national investment, Murilo Conto
Cameroon
Development of the national healthcare technology policy for Cameroon, J. Riha
Cameroon
Improvement in the use of medical devices and capitalization of investments in the HT sector in Cameroon,
2010, Vincent Ngaleu-Toko
Canada
Clinical engineering/HTM in Canada, Mario Ramirez
Chile
University of Valpariso health technology leadership, Cristian Diaz
China
Clinical engineering in China, Bao Jiali, Zhu Chaoyang
China
HTM as key health planning discipline, Guanxin Gao
Colombia
Integrated model of universities to promote clinical engineering, Nelson Escobar, Javier Camacho, Javier
García, Juan Barreneche, Beatriz Galeano, Mario Castañeda
Colombia
Interuniversity model of cooperation for the development of Clinical Engineering in Colombia, Beatrix
Galeano
Colombia
Methodology design for biomedical technology replacement planning, D.M. Torres-Velez
Colombia
Regional nodes of colombian clinical engineers, Andrea Garcia
Colombia
Identifying the needs in the integration of disciplines in the hospital infrastructure management in
Colombia, M. Madroñal Ortiz, B. Galeano Upegui, N. Escobar Mora, L. Cruz Parra, I. Rios Cuartas
Colombia
HT regulation, policy, management, 2015, Andrea García Ibarra, Rojas Morales (part 2)
Colombia
Clinical Engineering for non-engineers: acquisition of medical equipment, 2011, Tatiana Molina
Cuba
Trading barriers in the medical devices industry. Are these barriers hindering the development of this sector
in Cuba? Y. Chaveco Salabarria, J.C. Rubio Romero, R.M. Guerra Bretaña
Czech Republic
Hospital based HTA—Implementation for the Czech Republic, Ivana Kubátová, Veronika Matloffiová
Ethiopia
Using HT policy and HTM to improve care delivery, Mulugeta Mideksa, 2015
EU (28 member states),
EFTA/EEA: Norway,
Liechtenstein, Iceland,
Turkey, Switzerland
The regulation of medical devices in the European Union, Carlo Pettinelli
Continued
26 SECTION |1 Clinical engineering
TABLE 4 List of health systems-related submissions organized by region submitting it with authors information
and hot links—Cont’d
Focus area
Health systems: Title, authors, with active links
Ghana
Clinical engineering in Ghana, Nicholas Adjabu
Ghana, Canada
CMBES donations project, 2015, Nicolas Adjabu, John Zienna, Bill Gentles
Global
IFMBE/CED and global CE-HTM evidence based results, Yadin David, Ernesto Iadanza
Global
IFMBE/CED role in global BME/CE recognition, James Goh, Ernesto Iadanza
Global
Global CE-HTM success stories, Yadin David, Tom Judd
Global
Technical characterization of appropriate medical equipment, Maurice Page, Matthieu Gani, Mélanie
Amrouche, Robin Walz, Cathy Blanc-Gonnet and Barbara Comte
Global
MSF medical equipment framework, Gabriela Jimenez Moyao, Oscar Rodriguez, Tom Lauwaert, Jean
Claude Tewa, Belgium; Benoit Pierre Ligot, Paul Damien Chateau, MSF, France; Hugues Gaertner, MSF,
Spain; Malcom Townsend, MSF, Switzerland; Lizette Van De Kamp, Sean King, MSF, Netherlands
Global
Assessment of medical devices in low-income settings, L. Pecchia, N. Pallikarakis
Global
The AHWP playbook for implementation of a health technology regulatory framework, an overview, Ms.
Joanna Koh et al.
Global
Global atlas of medical devices, Adriana Velazquez
Global
Medical devices for universal health coverage and sustainable development, Marie-Paule Kieny
Global
The book, human resources for medical devices, the role of the biomedical engineer, Adriana Velazquez
Global
National medical equipment policies and planning for universal health coverage, Roberto Ayala
Global
Improving medical equipment donations: Contribution of NGO Humatem, Cathy Blanc-Gonnet
Global
Health technology management initiatives, Ernesto Iadanza
Global
Health technology assessment of innovative medical devices, Iñaki Gutiérrez-Ibarluzea
Global
IFMBE/clinical engineering division projects for the advancement of the profession of clinical engineering,
Ernesto Iadanza
Global
The importance of technical specifications, Adriana Velazquez
Global
The role of HTM to the universal health coverage, P. Galvan et al.
Global
2009 WHO database of biomedical/clinical engineering teaching units and associations worldwide, Saide Calil
Global
Global HT disaster preparedness, Yadin David, Fred Hosea (part 2)
Global
Latin American and Caribbean health technology training, 2013, Antonio Hernandez
Global
Role of IFMBE in medical equipment in developing countries, Worm, Linnenbank
Global
The importance of establishing a national policy for infrastructure, Africa Health, Andrei Issakov
Global
Need for undergraduate clinical engineering education, 2015, Herb Voigt
Global
MAKING IT WORK: Managing medical equipment in low-resource settings video, THET
Global
The role of HTM in WHO, to support access to medical devices for Universal Health Coverage and
achievement of SDGs, Adriana Velazquez (part 2, part 3)
Global
IFMBE HTA division filling the gap between HTA and HTM, Leandro Pecchia
Global
Global health technology equity: How emerging CE-HTM leaders can help, Antonio Hernandez, Tom Judd
Greece
Medical equipment management, Nicolas Pallikarakis, Institute of Biomedical Technology, Greece
India
Generic specifications for medical equipment in developing countries, S.B. Sinha, A.R. Gammie and P.J. Mellon
India
MoH HTM via public private partnership, 2015, Jitendar Sharma
Clinical engineering success stories and patient outcomes Chapter | 3
27
TABLE 4 List of health systems-related submissions organized by region submitting it with authors information
and hot links—Cont’d
Focus area
Health systems: Title, authors, with active links
India, Indonesia, Thailand
South East Asia regional perspective, Madhur Gupta
Indonesia
Development of biomedical engineering education in Indonesia, Cholid Badri
Italy
The Italian Clinical Engineers Association: A success story, Stefano Bergamasco, Paolo Lago, Lorenzo
Leogrande, Umberto Nocco
Italy
Assessing the impact of a CIS/PACS technology for a cardiology department using QFD methodology,
Alessio Luschi, Laura Caltagirone, Claudio Mondovecchio, Roberto Miniati, Ernesto Iadanza
Italy
Model national CE society and impact on legislation, Paolo Lago, Lorenzo Leogrande
Japan
Roles of clinical engineering in medical device development, Hiroki Igeta et al.
Japan
The business operations of CEs, roles and certifications, Jun Yoshioka
Kenya
Using HTM to improve MoH care delivery, Philip Anyango Amoko (part 2)
Kyrgyzstan, Albania
HT characteristics of countries in the WHO European region, Tifenn Humbert
Latin America
The status of biomedical engineering (BME) programs in Latin America, Martha Zequera Díaz, A.P. Koch
Mexico
Health technology project value chain, Andrade Bravo Ignacio
Mexico
Opportunities of the Mexican biomedical engineering society to influence and adopt clinical engineering in
Mexico, Elliot Vernet
Mexico
CENETEC-MoH HT unit creates nation-wide HTM capacity, Roberto Ayala
Mexico
HTA, HT regulation, HTM to improve care delivery, Cardenas, de Alba, Orencio, Moreno (part 2)
Moldova
Medical devices management strategy in the Republic of Moldova, V. Sontea, S. Morgoci, Gh. Turcanu, C. Pislaru
Nigeria
Using HT policy and HTM to improve care delivery, Bukola Esan
Peru
Improving emergency preparedness through hybrid interactive training, T. Clark, R. Rivas, Y. David
Peru
A comprehensive system for HTM, L. Vilcahuaman, M. Cordova, J. Kalafatovich, R. Rivas
Peru
MoH and National Institute of Health HT Unit care improvement strategies, Rossana Rivas, Luis
Vilcahuaman
Peru
Collaborative HT partnerships to improve care delivery 2015, Rossana Rivas
Portugal
Technology decision-making process: MRI purchase in Portugal, Maria Maia
Romania
Knowledge about materio-vigilance in Cluj-Napoca, Romania, Simona Maria Mirel
Rwanda, Benin,
Cameroon, Guinea,
Nigeria, Sierra Leone
The odyssey of an HTM expert, Mboule, Cameroon
Sierra Leone, Canada
Sierra Leone/Canada: Transnational donations of medical equipment, Dinsie Williams, Jillian Kohler,
University of Toronto
Singapore
Global BME education programs, 2016, Siew-Lok Toh
South Africa
Health technology management in the African Continent, Mladen Poluta
Suriname
Using HTM to improve care delivery, Gillian Jie
Taiwan
Intern programs of biomedical engineering education, Kangping Lin; Tsai, Chenglun
Taiwan
BME/clinical engineering (CE) role for policy implementation of medical equipment regarding post-market
surveillance in health systems, KP Lin (part 2)
Taiwan
Accreditation of BME/CE in Taiwan, KP Lin (part 2)
Turkey
MoH HT unit product tracking/surveillance/pricing and country-wide HTM data, Ugur Cunedioglu, Bilal Beceren
Continued
28 SECTION |1 Clinical engineering
TABLE 4 List of health systems-related submissions organized by region submitting it with authors information
and hot links—Cont’d
Focus area
Health systems: Title, authors, with active links
Turkey
HTM improving country-wide care delivery, Bilal Beceren
UK
Crisis, what crisis? How clinical engineers will solve the billion dollar healthcare funding gap, Daniel Clark
UK, Global
Tropical health education trust (THET) partnerships, A. Worm and Schofield
Vietnam
Survey of personnel who are operating, repairing and maintaining medical equipment in some hospitals in
Vietnam, 2013, Tam
WHO
WHO HT indicators for MoH, 2009, Joachim Nagel et al.
WHO
WHO and international labor organization discussions 2015–2017, Adriana Velazquez
WHO AMRO
Development and initiatives of medical devices in the Americas, Alexandre Lemgruber
WHO EMRO
Strengthening medical devices regulation in the Eastern Mediterranean region of WHO, Adham R. Ismail
TABLE 5 List of e-technology-related submissions organized by region submitting it with authors information
and hot links.
Focus area
e-Technology: Title, authors, with active links
Brazil
Telerradiology network in Amazonas rainforest, Leonardo Melo, Alessandro Melo
Brazil
Telecommunication innovation in mobile health units, Leonardo Melo, Alessandro Melo
Brazil
Business intelligence application in health management, O.B. Souto et al.
Brazil
Geocoding dengue cases for spatial analysis, J.L.S. Lustosa et al.
Brazil
Integration of the trans-operative information with the patient's electronic record, E.K. Souza, M.A.
Marciano
Brazil
Dental Chair Unit Clinical Engineering management, G.L.O. da Fonseca, F.S. Rosa, R. Garcia
Bulgaria, Greece
Re-engineering a medical devices management software system: The web approach, 2014, Malataras,
Bliznakov et al.
China
Mobile control of risk factors of NCDs, Bao Jiali, Zhu Chaoyang, Bao Jiaming, Zheng Xiuxiu
China
Mutual recognition research of medical imaging remote intelligent quality control technology, JingXin
Colombia
Networking from colombian clinical engineers, Andrea Rocio Garcia Ibarra
Colombia
Introducing IHE (integrating the healthcare enterprise) into Colombia and Latin America, 2015, Vladimir
Quintero
Georgia
Becoming of ubiquitous sensors for ubiquitous health care, S. Dadunashvili
Global
Medical device service procedures mobile application, Jean Ngoie, Kelsea Tomaino
Global
Use of CMMS (computerized medical equipment management system) in low resource countries, Bill
Gentles, Claudio Meirovich, Martin Raab, Jitendra Sharma
Global
Clinical and ICT (information and communication technologies) cybersecurity overview and cases, Elliot
Sloane
Global
Integrated health solutions to deliver value-based health care, Frederic Noel
Global
Conquering the leprosy last mile: the role of mobile-phones, Phillip Olla
Global
Appropriate CMMS systems—Potential for health systems development, Mr. Martin Raab, David Huser,
Alexandre Vanobbhergen
Clinical engineering success stories and patient outcomes Chapter | 3
TABLE 5 List of e-technology-related submissions organized by region submitting it with authors information
and hot links—Cont’d
Focus area
e-Technology: Title, authors, with active links
Global
Clinical engineering, eHealth, and ICT global overview, Elliot Sloane
Global
Decision support systems: An all-around approach to healthcare management,
Ernesto Iadanza
Global
Developments in global clinical engineering-information technology, Tom Judd, Ricardo Silva
Global
Total cost of ownership, Elliot Sloane
Global
ICT training for health technology, Elliot Sloane
Global
CE: From devices to systems, Roberto Miniati, Ernesto Iadanza, Fabrizio Dori, Italy
Global
On-line HTM training in Latin America, Tobey Clark et al. 2015
Global
Using clinical engineering CMMS to improve care delivery, Bill Gentles
Global
Trends on information technology and health technology, Antonio Hernandez, 2015
Global
Medical device and ICT convergence, Elliot Sloane
Greece
Web-based medical equipment management system, Nicolas Pallikarakis, Panayiotis Malataras, Aris
Dermitzakis
Haiti
Evidence-based maternal child health care enabled by health technology, Tom Judd, Lee Jacobs, Brian
Birch, and Matt Jansen
India
Using near-patient data in HTM, Tracy Rausch, Yatin Mehta MD
India
Designing MoH HTM IT systems in developing countries, Jitendar Sharma, Prabhat Arora
India, USA
Using integrated clinical environment (ICE) data for HTM (India pilot), Tracy Rausch, Tom Judd
Italy
SILAM: Integrating laboratory IS within the Liguria region EHR, 2014, A. Tagliati et al.
Japan
Study on medical equipment location systems that use RFID technology, Manabu Kawabe, Yasuyuki Miwa,
Takashi Kano
Nigeria
Developing an appropriate and affordable expert system for medical diagnosis in developing countries,
2015, K.I. Nkuma-Udah et al. (part 2)
Portugal
End-to-end QoS-based admission control via virtual sensor nodes, Carlos Abreu et al.
Romania
Development of wireless biomedical data transmission and real time monitoring system, C.M. Fort, S.
Gergely, A.O. Berar
Saudi Arabia, North
Macedonia, Global
Digital hospital 21st century: you certainly can't manage it if you don't understand it, WHO 2GFMD,
2013, Elliot Sloane, Tom Judd, Paul Sherman, Joseph Welch
Slovakia
Electronic categorization of medical devices in Slovakia, Dr. Jadud, Ministry of Health
South Africa
Medical internet of things and embedded intelligence in health care, Abdelbaset Khalaf
South Africa
Wireless body sensor network and ECG android app eHealth. Abdelbaset Khalaf
Spain, France
Integrating an EHR graphical user interface into nanoelectronic-based biosensor technology, Ana Maria
Quintero et al.
Uruguay
CAMACUA: Low cost real time risk alert and location system for healthcare
environments, I. Decia et al.
USA
Assessing risk in the Kaiser Permanente CE program, C. Davis-Smith, F. Painter, M. Baretich
USA
Medical device cybersecurity, Steve Grimes, HIMSS 2016
USA
Biomedical device integration into an electronic health record, Michael Fraai
Venezuela, Ecuador
Intelligent system for identification of patients in health care, Ricardo Silva (part 2)
29
30 SECTION |1 Clinical engineering
TABLE 6 List of quality and safety-related submissions organized by region submitting
it with authors information and hot links.
Focus area
Quality and safety: Title, authors, with active links
Australia
Medical air mis-connections, Anne-Louise Smith, Mark McEwen, 2016
Brazil
An observational study of the high incidence of false and nuisance alarms in an intensive care unit, L.G.
Vaz, G.C. Vivas
Brazil
Evaluation of waste disposal inadequate management from health services, Larissa Teixeira de Oliveira,
Ana Claudia Patrocínio
Brazil
Improving health technology assessment in cold chain by applying clinical and industrial engineering,
LFM Brito et al.
Brazil
Improving operational reliability in medical washer disinfector with the use of FMEA tool: A quality
improvement report, Marcelo Espinheira et al.
Brazil
Medical devices proactive surveillance—Trends and impact from field and enforcement actions in Brazil,
M.G. Vincente
Brazil
Structuring the radiological report, D.M. Rocha et al.
Brazil
Development of an ubiquitous management platform in air compressors used in primary health care, I.L.
Santos, F.S. Rosa, R. Garcia
Brazil
The clinical engineering in hospital accreditation case study: Radiology clinic, R.A.M. Sá et al.
Brazil
Clinical engineering/health technology regulation, evaluation and training to improve care delivery,
Murilo Conto, Zeev Katz (part 2)
China
A hospital-based dynamic warning system medical consumables regarding adverse event management,
Sun-Lv-Feng
China
Case study and management improvement of medical devices, Jing-ying Gao, Lei Wei, Yin-chun Lu
China
Survey and analysis of current state of ventilator alarms in ICU, Lin, Zheng Kun
China
Shanghai region medical equipment quality and safety, Li Bin
China
Design of a web-based medical equipment management system for CE, 2015, Liu Shenglin, Zhang Qiang,
Wu Hanxi, Zhang Xutian, Wang Guohong
Colombia
MoH health technology management regulations, Andrea Garcia-Ibarra
Dominican Republic
Medical-surgical vacuum and anesthetic residue extraction policy in the Dominican Republic, Diogenes
Hernandez
Germany
Technological surveillance and integrity monitoring of infusion systems, D. Grosse-Wentrup, U.M.
Hoelscher
Global
A pneumonia prevention system, Peter Young; Maryanne Mariyaselam
Global
Global professional credentialing project, Yadin David, Mario Medvedec, Jim Wear
Global
Adoption of medical-technologies in infrastructure-poor environments, Gisela Abbam, Vikram
Damodaran, Sally Lee
Global
Hospital integrated networks risk management—Issues and recommendations, Yadin David (part 2)
Global
Skill development for growth in emerging markets, Gisela Abbam, Marut Setia
Global
Clinical engineering risk management, Frank Painter
Global
CE certification globally to improve care delivery, Jim Wear, Mario Medvedec
Global
Human factors engineering book—Global resource, Tony Easty et al.
Global
Global training partnerships, Shauna Mullally
Global
Promoting the image of biomedical engineers and improving safety, Michael Cheng
Global
Managing the medical equipment lifecycle resource, THET, Anna Worm
Clinical engineering success stories and patient outcomes Chapter | 3
31
TABLE 6 List of quality and safety-related submissions organized by region submitting
it with authors information and hot links—Cont’d
Focus area
Quality and safety: Title, authors, with active links
Global
Medical equipment maintenance book, 2013, Binseng Wang
Global
Profile of biomedical engineering education in Latin America, SJ Calil et al.
Global
Preventable adverse events: How to? Yadin David
Global
Medical device risk management from a human factors perspective, Tony Easty
Global
Medical devices vigilance and the European Union Regulations, Nicolas Pallikarakis
Italy
A new digital era of clinical and biomedical process, Giulia and Stefano Marchesi
Italy, Egypt
A new approach for preventive maintenance prioritization of medical equipment, Neven Saleh et al.
Japan
The role of policymakers for health technologies, Dr. Masato Mugitani
Jordan
Implementation of six sigma on case study at the directorate of BME in the Jordanian MoH, 2012, Adnan
Al-Bashir, Akram Al-Tawarah
Kenya
Roadmap to validation and verification of Intravenous Devices in Kenya, Bintiomar Tsala, Abdulatif Ali,
Abel Onyango
Kuwait
Safe care: An initiative for regulations in Kuwait, WHO 2GFMD, 2013, Ms. Hanan Al-awadhi, Association
for Biomedical Engineers
Mexico
Impact of state CE directorate, Ignacio Macias, 2016
Mozambique, Portugal
Training program in Central Hospital of Maputo (2011–2016), Mario Forjaz Secca
Papua New Guinea
Improving pediatric and neonatal care in rural district hospitals in the highlands of Papua New Guinea: A
quality improvement approach, M. Saavu, Trevor Duke, Sens Matai
Samoa, Fiji
User care of medical equipment, Nehal Kapadia, Sunema Talapusi
Saudi Arabia
Unifying efforts against counterfeiting medical devices, Nazeeh Alothmany
Taiwan
Actions of medical device post-market surveillance, K.P. Lin, Y.-T. Hung, Shiu-Huei Yeh
USA
Application of quality, risk and asset management principles to clinical engineering, Binseng Wang
(part 2)
Cape Verde, Senegal, The
Gambia, Guinea Bissau,
Guinea, Sierra Leone,
Liberia, Mali, Ivory Coast,
Ghana, Togo, Benin,
Burkina Faso, Nigeria, Niger
The West African health organization, biomedical engineering curriculum, Bobo-Dioulasso et al. (part 2)
References
IFMBE CED, 2017. 2nd international clinical engineering and health technology management congress (II ICEHTMC) proceedings. http://cedglobal.org/
icehtmc2017-proceedings/.
IFMBE Clinical Engineering Division (CED), 2016. Health technologies resource. http://cedglobal.org/global-ce-success-stories/.
Judd, T., David, Y., 2018. Making a difference—global health technology success stories: overview of over 400 submissions from 125 countries. Global Clin Eng
J 1 (1), 24–49. https://doi.org/10.31354/globalce.v1i1.43.
Other IFMBE related CE Papers, TBD at CEDGlobal.org.
World Health Organization Third Global Forum on Medical Devices, 2017. http://www.who.int/medical_devices/global_forum/3rd_gfmd/en/.
Links
AWHP www.ahwp.info; Asian Harmonization Working Party—30 countries, 3/17 Regulatory Authorities.
HTAi, https://www.htai.org/.
32 SECTION |1 Clinical engineering
IFMBE, CED, HTA, http://ifmbe.org/. http://cedglobal.org/. http://htad.
ifmbe.org/.
PATH, https://www.path.org/. (Belgium, China, DRC, Ethiopia, Ghana,
India, Kenya, Malawi, Mozambique, Myanmar, Peru, Senegal, RSA,
Switzerland, Tanzania, Uganda, Ukraine, Vietnam, and Zambia).
WHO AMRO, http://www.who.int/about/regions/amro/en/.
WHO Assistive Devices-GATE, https://mednet-communities.net/gate/.
WHO Digital Health, http://www.who.int/medical_devices/global_forum/
Thedigitalhealthaltas.pdf.
WHO Emergency, www.who.int/medical_devices/global_forum/Essentialresourcesemergencycare.pdf.
WHO EMRO, http://www.emro.who.int.
WHO HQ, http://www.who.int/medical_devices/en/.
WHO NCD Kit Refugees, http://www.who.int/medical_devices/global_
forum/NCDkitrefugees.pdf.
Chapter 4
RFID technology in health care
Javier Enrique Camacho-Cogolloa, Isis Bonetb, Ernesto Iadanzac
a
Biomedical Engineering, EIA University, Envigado, Colombia, bComputer and Systems Engineering, EIA
University, Envigado, Colombia, cIFMBE HTA Division, School of Engineering, University of Florence,
Florence, Italy
A brief introduction
Radio-frequency identification (RFID) is a technology that
allows to store and retrieve a huge amount of data through
electromagnetic transmission using radio-frequency (RF)
devices and a strategically installed technological structure (Seol et al., 2017). RFID technology uses radio waves
and has the capacity to identify thousands of tagged items
per second via wireless transmission (Yazici, 2014). More
recently, the healthcare sector is taking advantage of information technologies to improve the health delivery,
the patient safety, and to save costs. The use of bar codes
has spread very much among hospitals, but the limitations of this technology are causing many concerns. For
this reason the healthcare industry and most hospitals
are searching for other new alternatives (Coustasse et al.,
2013). Currently bar codes and associated technology are
being replaced with RFID tags and readers in hospitals, to
manage healthcare products and to improve operations’
efficiency, reduce the inventory level, and achieve substantial saving (Chan et al., 2012). Nowadays, the RFID
technology is applied to real-time traceability, communication, identification, location of assets, medical devices and
people, preventing counterfeiting of drugs, saving nurse
time in locating medical equipment or tools, identifying
under- or overutilization of medical equipment, reducing
medical errors in laboratory tests, managing blood distribution, improving security of a hospital or treatment center,
and scanning information from implanted device (Yazici,
2014; Fosso Wamba et al., 2013).
The RFID technology has increased its penetration
in various industry fields and the healthcare sector is an
emerging market. In fact, the maturing of applications such
as the real-time locating system (RTLS) for patient tracking, medical staff and asset, will likely lead the RFID market to a high growth over the coming years. This market
was valued at USD 16.95 Billion in 2016 and is expected to
grow at a CAGR of 7.7% between 2017 and 2023 {Markets,
2018; RFID Market, 2023}.
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00004-3
Copyright © 2020 Elsevier Inc. All rights reserved.
This chapter addresses the RFID technology describing
firstly the history, the components, and the technical configuration. The most important application in the healthcare
field is described in the second part and finally the trends,
futures applications, and the last technologies in RF that are
bringing innovation and opportunities in health care.
A brief history of RFID
The first usage RFID technology was found during World
War II for the identification of “Friends or Foe” military
aircrafts (Stockman, 1948). The early exploration was in
the 1950s, when the invention of the transistor produced
theoretical and electronics experiments for the exploration
of RFID techniques with several researches. In the 1960s,
the first commercial systems were launched with the equipment used as antitheft device. These systems were used for
detecting the presence or absence of a tag and were used
in retail stores attached to high-value items and clothing.
This proved to be an effective antitheft measure and was
the first and most widespread commercial use of this kind
technology. In the 1970s, there was a huge interest in RFID
from researchers and developers; the applications were
extended into various areas. An active location estimator
system called GPS was firstly introduced for the military
application.
The GPS system has become a pervasive technology for
tracking and navigation purposes, providing accurate location estimation for outdoor tracking, but it does not work
indoor applications (Shukri and Kamarudin, 2017). In the
1980s, tracking systems using RFID became widespread
in new applications, such as: toll roads, rail applications,
access control, and animal tagging. With integrated circuit
development and size reduction down to the microwaves,
the developments continued and RFID tags were reduced
to a single integrated device. In 2006, there were over 350
patents registered with the US Patent Office related to RFID
and its applications (Roberts, 2006). A Google Patents
search for “RFID” in 2019 shows about 299.000 results!
33
34 SECTION | 1 Clinical engineering
RFID technology
There are different configurations of electromagnetic transmission using a RF device for several applications, but a
RFID system will typically include the following components (Kumari et al., 2015; Roberts, 2006):
•
•
•
RFID device (tag)
Tag reader with an antenna and transceiver
Host system or connection to an enterprise system
(a) Tag: this component is used to store the information.
Each RFID tag contains an electronic integrated circuit
chip and an antenna encapsulated together in a suitable
packaging. A tag is attached to an object with a unique
identification number and memory that stores additional
data about its manufacturer, product type, and other related environmental information (Seol et al., 2017).
Commercially, the tags are available in a wide variety of
sizes, shapes, and protective housings. Typically, tags are
encapsulated in credit card sized packages, for example,
to build access cards. Others are for use in harsh environments such as container tracking applications. The smallest devices commercially available measure 0.4 × 0.4 mm
and are thinner than a sheet of paper (Roberts, 2006).
(b) Reader or interrogator: this component is used to collect all the information stored in a tag. RFID reader
consists of a decoder to decode the information from a
tag. Antenna is used for transmitting and receiving the
RF waves carrying information from tag to reader and
vice versa. RFID reader is able to read or/and write data
to tags by reading nearby tag IDs and mapping this ID
to an object via external database or service; the reader
can therefore sense and monitor the existence of a corresponding object (Seol et al., 2017). The readers typically
have two interfaces. A RF interface that communicates
with the tags in their read range in order to retrieve tags’
identities. A communication interface for communicating with the servers, generally IEEE 802.11 or 802.3
(Bouet and dos Santos, 2008). There currently exist systems which combine RFID and wireless sensor network
(WSN) applied directly on healthcare environments.
Nodes are in this case equipped with RFID tags and incorporate an identification code to their readings. There
exist solutions using different WSN technologies, such
as IEEE 802.15.4, ZigBee, and even Wi-Fi or Bluetooth
(Adame et al., 2018).
(c) Software: it is used to manage the received data and operations of reader and tag. Indeed, software manages the
information in a database; it can also contain the details
of tags and readers. All the information is sent to a host
computer or RFID middleware to ensure communication between the RFID infrastructure and the different
intra- and interorganizational systems (Fosso Wamba
et al., 2013).
In general, RFID tags are classified into three categories: passive, semi-passive, and active.
(a) Passive tag: these tags have no internal power supply;
they are activated when they come within the range of a
RFID reader. These tags communicate with the reader by
backscattering the carrier signal received from a reader
using an electromagnetic resonance structure. Thus the
tag activates and reflects back the information stored
on the chip, through backscattering the carrier signal
received from a reader (Bouet and dos Santos, 2008).
Passive tags have a smaller size, are lighter, and are
low cost with unlimited life. Despite this, passive tags
have very limited functionalities, for example, they cannot transmit radio waves of its own, and its information
storage capacity and computing capability are limited;
they also have short read ranges (0.6–3 m) (Chetouane,
2015). Their performance is reduced in electromagnetically “noisy” environments and they require high-power
readers (Kumari et al., 2015; Roberts, 2006).
(b) Active tag: these tags are powered with an embedded
battery and thus are always active. These tags can communicate with the reader at any time. They provide read/
write facilities with higher read range, approximately
90 m (Chetouane, 2015; Kumari et al., 2015). They are
bulky and more expensive than passive tags due to the
embedded battery. The use of a battery places a limit on
the life of the device, although with current battery technology this may be as much as 10 years (Roberts, 2006).
An active tag can also have additional functionalities
such as memory, sensors, and a cryptography module
(Bouet and dos Santos, 2008).
(c) Semi-passive tag: these tags have a battery that is used
only to energize the internal circuitry. Unlike the active
tag, they use the electromagnetic field generated by the
reader for communication. Battery remains inactive until activated by a signal from a reader. This mechanism
saves battery power and increases the life of the tag
(Kumari et al., 2015).
The tags durability generally depends on the battery used.
Usually lithium and magnesium oxide batteries are used.
New-generation tags are powered by paper batteries and ultrafine batteries as the current integrated circuitry needs lower
currents (Kumari et al., 2015). To establish communication
between RFID readers and tags, an antennas network system is required. There are several types of antennas for RFID
systems: linear, circular, wide band, narrow band, single, and
dual polarized antennas. Antennas are usually selected according to their beam width (Chetouane, 2015).
RFID systems use different frequency bands for communication purpose and each frequency has some advantages and disadvantages. No single frequency is ideal for
all applications (Kumari et al., 2015). Generally, legislation and regulation by individual governments manage the
RFID technology in health care Chapter | 4
f­ requency allocations. Internationally, there are differences
in frequencies allocated for RFID applications although
standardization through ISO and similar organizations is assisting in compatibility. For example, Europe uses 868 MHz
for ultrahigh frequency (UHF) and the US uses 915 MHz
(Roberts, 2006).
Some common frequency bands used by RFID devices
are given in the following (Roberts, 2006):
(a) Low-frequency (LF) band (100–500 kHz): LF passive
tags have an effective range of approximately 30 cm.
However, the limited read range and slow data read
speed limits its applications and usability. The common
application is used for access control, animal identification, inventory control, and car immobilizer.
(b) High-frequency (HF) band (850–950 MHz): The popular frequency is in the spectrum of 13.56 MHz (Bibi
et al., 2017; Kumari et al., 2015). The most important
characteristic is the long read range (around 1 m), high
reading speed, line of sight required, and expensive cost.
Typical applications are focused on railway vehicle
monitoring, toll collection systems, pallet and container
tracking, and vehicle tracking.
(c) UHF band (850–960 MHz): it is most popularly used
for supply chain, logistics, and distributions because
of its better read range (3–5 m), faster data identification/transfer, and good anticollision capability
(Kumari et al., 2015). UHF tags have a better read
range and improved data transfer than in the previous frequency bands, but are impaired by water and
metals (Bibi et al., 2017). A newer technology using
an ultrawide band (UWB) is also gaining recognition
for future RFID applications. UWB spectrum covers
3.1–10.6 GHz region and advantages include high data
35
rate, long read range, low average radiated power,
easy RF circuitry, less interference as compared to
other available bands (Kumari et al., 2015; Maalek
and Sadeghpour, 2016).
RFID applications
The strategic and effective use of technology information
and software in the healthcare sector is a critical goal for
the sustainability healthcare system. The clinical engineering and information technologies offer new opportunities
for healthcare transformation through the implementation
of reengineering process, saving costs, minimizing unproductive data entry, guaranteeing real-time access of clinicians to patient data for improving decision-making (Bliven
et al., 2016; Ishida et al., 2014). No doubt the strategic
implementation of RFID technology can improve patient
identification, tracking, and tracing within the healthcare
value chain. The technology offers new ways and tools for
reducing errors in patient care, including the management
of allergies, preventing and controlling adverse drug events
and medical devices unintended effects, patient-medication
mismatches, and medication dosage errors (Aboelmaged
and Hashem, 2018; Fosso Wamba et al., 2013). All these
new capabilities enabled by RFID technology and it correct
uses facilitate new value creation in healthcare service and
encourage better management of critical healthcare assets
by enabling real-time identification, tracking, and tracing.
In the literature, good examples are found where the RFID
technology can enable caregivers to monitor all the patient
blood collection and transfusion process, by identifying
blood bags from the collection point to the healthcare facility (Table 1).
TABLE 1 Application RFID systems in health care.
Application
Description
Author
Patient traceability
Traceability application from arrival until discharged, considering prescribed and
administered pharmaceuticals. The significant benefit is to reduce the occurrence of
adverse events.
Martinez Perez
et al. (2012)
Patient—assets tracking
and ensuring hand
hygiene compliance
Three cases where hospitals are using this solution to track patients from registered
to discharged. Prevent the transmission and spread of infections. Identify, track and
match medication accurately and in real time.
Fosso Wamba
et al. (2013)
Patient traceability
The RFID system is integrated with HIS for increase the workflow efficiency by
reduction the waiting time patient.
Kim et al. (2010)
Risk management
Prevent adverse events promptly detecting potentially dangerous conditions and
obtaining a more comprehensive vision of the patient status.
Zappia et al.
(2014)
Patient traceability and
evaluation
Provides control of patients inside a hospital while the patients wearing a wristband
equipped with different vital sign sensors and an RF transmitter.
Adame et al.
(2018)
Continued
36 SECTION | 1 Clinical engineering
TABLE 1 Application RFID systems in health care—cont’d
Application
Description
Author
Patient evaluation
Support caregivers to assess the health condition of the monitored patients by
interpreting their daily routine in an assisted living.
Shukri and
Kamarudin (2017)
Patient diagnostic
Detects body movement by measuring changes in Wi-Fi signal strength allowing an
unobtrusive way of measuring sleep quality.
Ammae et al.
(2018)
Dosimetry control
This system was developed based on a smartphone, using NFC tag technology
dosimeters and commercial integrated circuit. Reader unit is not necessary to carry
out dose measurements, only the NFC tag and a smartphone.
Carvajal et al.
(2017)
Risk management
Prevent five types of medication errors: wrong patient, wrong medication, wrong
time, wrong dose, and wrong route. The phone works as a reader and interface to the
system, can easily be carried, and delivers real-time alerts.
Alabdulhafith and
Sampalli (2014)
Asset tracking
For reduces equipment losses and improves asset management in hospitals. Improve
equipment utilization and staff productivity. Ensure the availability of medical
equipment at the place when needed. Enhance the maintenance.
Qu et al. (2011)
and Tsai et al.
(2019)
Patient safety
One of the most important factors that directly affect the
quality of health care is patient safety. Nowadays, minimizing the impact of adverse events and improving the
patient safety are the most important challenges for health
professionals. Health care is currently facing challenges of
improving patient safety and reducing operational costs,
which are unfortunately often caused by human and systematic errors (Martinez Perez et al., 2012). Most errors
in clinical reasoning are not due to incompetence or inadequate knowledge but to frailty of human thinking under
conditions of complexity, uncertainty, and pressure of time
(Scott, 2009). A medication error is any error that occurs at
any point in the medication use process and is considered
an important cause of patient morbidity and mortality. It has
been estimated by the Institute of Medicine that medication
errors cause 1 out of 131 outpatient and 1 out of 854 inpatient deaths (Wittich et al., 2014). The IOM estimated that
between 44,000 and 98,000 deaths per year were related to
medical errors occurring in hospitals, showing the desperate
need to improve patient safety and wellness experienced in
US hospital (Institute of Medicine Committee on Quality of
Health Care in America, 2000).
Information technologies offer new opportunities for
the healthcare sector. The deployment of RFID technology
is likely to transform the hospitals. This includes real-time
access of clinicians to patient data for improved decisionmaking, improving clinical trials which foster personalized
medicine, helping to reduce medical errors, improving patient safety, facilitating the continuity of care, improving
the patient-physician communication, and reducing the
administrative overhead (Fosso Wamba et al., 2013). More
precisely, RFID-enabled patient management covers the
following applications: accurate patient identification for
medication safety, critical information to the patient, uncooperative outpatients tracking and tracing, elimination of
wrong procedures for patient surgery, RFID-driven medical
record, infant hospitals identification to avoid mismatching,
tracking and tracing of infants in hospitals, smart patient
identification for blood transfusion, patient identification to
avoid wrong drug doses, patient flow monitoring in hospitals (Fosso Wamba et al., 2013).
One of the main concerns in maintaining a high level of
safety in healthcare environments is to closely follow the
patients throughout their stay in a hospital, that is, from their
arrival until they are discharged, considering prescribed, and
administered pharmaceuticals. This process is known as patient traceability and is one of the means that can contribute
to guarantee the patient safety (Martinez Perez et al., 2012).
The significant benefit to be gained by tracing patients is
reducing the occurrence of adverse events. Currently there
are projects concerning RFID application in a healthcare
environment for patient tracking and medication.
In Spain, a research presents the development of a computerized system using RFID technology to obtain patient
and medication traceability in the emergency service of the
Coruña Hospital (Martinez Perez et al., 2012). The technology allowed to minimize and prevent adverse events caused
by the act of medical assistance. The systems based on
RFID technology to perform various tasks: (1) locating and
identifying the patient within 1–4 m; (2) identifying unitary
doses of medication; and (3) assuring the correct association between the patient and the medication prescribed by
the doctor. The global system consists of two traceability
subsystems, one focused on patients and the other devoted
to medication. Two different types of RFID tags were used,
active tag for patients (Aeroscout WI-FI tags) and passive
(1800 Philips size 15 × 15 mm) in the case of medication,
RFID technology in health care Chapter | 4
the system locates a patient in a specific area and correctly
identifies the unitary dose of medication prescribed by the
doctor.
Fosso Wamba et al. (2013) describe three cases of best
practices using RFID systems. The first one is in England,
in the Royal Wolverhampton Hospitals National Health
Service Trust. This hospital has used an RFID system to
manage three different functions throughout its facility:
tracking the movements of patients and staff members, managing the locations of tagged assets, and ensuring hand hygiene compliance. The hospital is using this solution to track
patients from registered, moved through various wards, and
then discharged. The second one is in Toronto University
Health Network, Canada. They are currently testing a realtime RFID-enabled location system in order to prevent the
transmission and spread of new infections, and to control
any existing infections, by tracking equipment, patients,
and employees. The last case is the University Hospital
of Jena, Germany. This hospital is using the technology in
combination with a SAP NetWeaver platform to identify,
track, and match medication accurately and in real-time
from the hospital pharmacy to the patients (Fosso Wamba
et al., 2013). Certainly, this leads to increased service quality and improved treatment process and safety of patients.
The Seoul National University Bundang Hospital, in
Korea, has been evaluating the RFID technology within the
hospital information system (HIS) to improve the workflow management. The hospital has developed an RFID
(433 MHz) real-time tracking system to monitor patients
at the room level and implemented an automatic workflow
management by integrating RFID system with HIS. After
implementation of the RFID system, the waiting time of patients in the health promotion center decreased significantly
(from 5.4 to 4.3 min: 20% decrease). The RFID system integrated with HIS increases workflow efficiency by reducing the waiting time during the workflow process; it also
provides valuable real-time data for physicians and staff
regarding workflow efficiency (Kim et al., 2010).
A support clinical risk management using RFID systems
in a hospital is an example for detecting adverse events in
patient in Italy. The support clinical risk management take
advantage of the complex event processing (CEP) technologies to extract hidden information from RFID tags. The
solution prevents adverse events promptly by detecting potentially dangerous conditions and obtaining a more comprehensive vision of the patient status. The system identifies
potentially dangerous conditions as complex events through
identification and analysis of events produced in the patient
identification and tracking domain with events produced in
the drug administration control domain. Events produced
by two different RFID appliances have been integrated to
obtain new meaningful information about the status of the
patient. A hierarchy of events by adopting essential CEP
principles is modeled for the system. The lowest level
37
events are the representation of RFID messages while the
highest level events describe potentially dangerous patient
conditions (Zappia et al., 2014).
RFID technology trends
Internet of things
Smart health care offers to achieve high effectiveness in
healthcare infrastructures and medical systems and promises
to reduce their costs. In this context, Internet of things (IoT)
is the main front end for the Smart technologies (Adame
et al., 2018). IoT is considered as the new revolution of the
Internet; it is a priority in multidisciplinary research topic
in healthcare industry. With the launch of multiple wearable devices and smartphones, the various IoT systems
are changing and evolving the typical old ­healthcare system into a smarter and more personalized one (Papa et al.,
2018). Several studies propose to migrate healthcare services from hospital-centered model to person-centered
model with the support of IoT. Farahani et al. (2018) propose a holistic multilayer IoT ecosystem for eHealth that is
driven by three layers including edge devices, fog nodes,
and cloud computing. IoT has been evolving from RFID
and WSN technologies to more advanced integration with
Internet services, cloud computing, cyber-physical systems,
and interconnections between software and hardware devices (Farahani et al., 2018). More precisely, the integration
of RFID and WSNs offers a low cost, autonomous, centralized, performance, and extensible infrastructure for the
identification and tracking of both patients and medical devices (Adame et al., 2018). In the recent years, the research
on RFID technology has moved toward hybrid monitoring
systems for health care based on IoT.
One of them is CUIDATS, a solution which integrates
RFID and WSN technologies in a single platform providing location, status, tracking of patients which has been
deployed and evaluated with a high degree of success in
Hospital Asepeyo Sant Cugat del Vallès, in Spain (Adame
et al., 2018). This RFID solution has the ability to monitors
patients’ vital signs and activates alarms. CUIDATS provides control of patients inside a hospital while the patients
are wearing a wristband equipped with different vital sign
sensors and an RF transmitter. In this system, the RFID
readers are fully integrated with RF beacons in a single device, thus creating a WSN mesh responsible for retransmitting the gathered data to the CUIDATS server. In addition,
the whole system may be easily integrated with the HIS,
so that the complexity of the mesh network is alleviated
whereas the general usability of the platform is increased.
Nowadays, most researches are focusing on passive localization systems as device-free localization (DFL) as well
as on RF tomography. The DFL is one of the emerging applications of WSN that uses static RF sensor nodes to track
38 SECTION | 1 Clinical engineering
and locate stationary and moving entities without the need
to carry any radio devices (Ruan et al., 2018). In a DFL
system, the object to be tracked requires no device to carry
and participates actively to the localization process. The
concept of DFL system works on the criteria that the presence and motion of human body changes the pattern of RF
signals. This change is specially observed in 2.4 GHz band
which is required for various IEEE standards like 802.11b
and 802.11g. The presence and movements of human body
inside monitored area of WSNs perform the task of extracting the useful information from the changes in the received
signal strength indicator (RSSI) (Pirzada et al., 2014). DFL
is a highly effective human presence detecting technology,
and that received much attention in a wide range of applications including patient tracking.
Shukri and Kamarudin (2017) present a care scenario
in an assisted living for elderly people; the DFL system
supports the caretakers to assess the health condition of the
monitored patient by interpreting his/her daily routine. If
the daily routine of the patient is abnormal, he or she might
be sick and should be visited soon for closer examination
(Shukri and Kamarudin, 2017).
Another application is using Wi-Fi-enabled devices for
detecting body movements by measuring changes in Wi-Fi
signal strength allowing an unobtrusive way of measuring
sleep quality (Ammae et al., 2018). This method allows detection of movements without any sensors connected to the
patient, using devices that are equipped with commercially
available Wi-Fi modules. This approach is based on the fact
that Wi-Fi signals are affected (absorbed and reflected) by
the human body because water makes up most of the human
body. When a human body is present between a signal transmitter and a receiver, the energy of the signal is partially
absorbed by the body when the signal penetrates the body.
Also, the signal is partially reflected by the surface of the
human body. The volume of the body that occludes the line
of sight between the transmitter and receiver changes when
the posture of the body changes. In addition, because the
angle of the signal reflection also changes due to the posture
change, the signal propagation path from the transmitter to
the receiver also changes and consequently the strength of
the received signal changes. These effects, caused by the
presence of a human body between transmitter and receiver,
then allow to detect body movements by detecting changes
in signal strength (Ammae et al., 2018).
This system uses Wi-Fi RSSIs via Wi-Fi enabled devices which can be easily obtained from smartphones and
tablet PCs. One device measures the signal strength of a
signal transmitted from the opposite device, and detects the
changes in that signal strength that occurs when the user
rolls over in his/her sleep. For this experiment, Ammae et al.
(2018) have used Raspberry Pi devices as Wi-Fi-enabled
devices, with one device broadcasting UDP packets to a receiving device at a rate of approximately 350 Hz.
Near-field communication
Near-field communication (NFC) has become an interesting
research area for researchers due to its growing and promising applications in several fields and brings innovation
opportunities to mobile communications and for tracking
proposes. As mentioned by Coskun et al., it is a short-range
half duplex communication protocol, which provides easy
and secure communication between various devices. It indicates some features for characterizing NFC technology
given in the following (Coskun et al., 2013):
(1) NFC is distinct from far-field RF communication that
is used in personal area and longer-range wireless networks. NFC relies on inductive coupling between transmitting and receiving devices.
(2) The communication occurs between two compatible devices within few centimeters with 13.56 MHz operating
frequency. There exist three NFC devices: mobile, tag,
and reader.
(3) NFC technology operates in three different operating
modes: reader/writer, pee-to-peer, and card emulation
modes where communication occurs between an NFC
mobile on one side, and an NFC tag, an NFC mobile,
and an NFC reader on the other side, respectively.
Two examples of quality and safety improvement for patients using NFC are described in the following:
A good example of the application of NFC technology
has been described and evaluated in a dosimetry control in
radiotherapy treatments. A dosimetric system was developed based on a smartphone, using NFC tag technology
dosimeters and commercial integrated circuits. A sensor
module is connected to the NFC tag configured as a reader
unit (Carvajal et al., 2017). An Android application has
been designed to use an NFC-enabled smartphone. A good
characteristic of this system is that the whole reader unit is
not obliged to have on board some dose measurement hardware, but only the NFC tag and a smartphone. Moreover,
the system performance showed very good agreement with
4.75 ± 0.15 mV/Gy average sensitivity.
Another example is an NFC-enabled smartphone application system for checking the five rights (see below) of
medication administration. This solutions is much more reliable than printed barcodes (Alabdulhafith and Sampalli,
2014). The system was designed to prevent five types of
medication errors: wrong patient, wrong medication, wrong
time, wrong dose, and wrong route. The phone works as
a reader and interface to the system. It can easily be carried, and delivers real-time alerts. The smartphone application alerts the nurse prior to administering the medication to
the patient. The application also provides the nurse with an
option that allows him/her to alert the physician who prescribed the medication and the pharmacist who dispensed it
(Alabdulhafith and Sampalli, 2014).
RFID technology in health care Chapter | 4
Asset tracking
Effective equipment management in hospitals is critical to
deliver high-quality care as well as to reduce healthcare
costs. Nevertheless, the hospitals spend millions of dollars
on lost, misplaced, and stolen equipment every year. Benefits
from RFID-enabled hospital equipment tracking has been
discussed in the literature (Coustasse et al., 2013; Qu et al.,
2011; Yazici, 2014). Qu et al. (2011) have classified these
benefits into three groups: (1) reduction of equipment losses
and improvement of asset management in hospitals, (2) improvement of equipment utilization and staff productivity
by ensuring the availability of equipment when needed and
reducing the time staff spends in locating equipment and
managing inventory, and (3) ensuring the availability of
medical equipment at the place where it is needed, which
prevents nursing staff from diverting their time and focusing away from patient care. Qu et al. (2011) describe several examples for the implementation of RFID for tracking
assets: (1) three hospitals in Bon Secours Health System
installed active RFID systems to track about 12,000 pieces
of mobile equipment and they saved at least $203,000 in the
first year and saved nurses 30 min per shift by eliminating
equipment searches and (2) the Wayne Memorial Hospital
in North Carolina tracks about 1300 medical devices saving
about $303,000 by improving infusion pump utilization.
A model to identify and quantify the benefits of RFID
from reducing equipment shrinkage and staff time spent
in searching for equipment and increasing equipment utilization in hospitals was developed using a Markov chain
(Qu et al., 2011). This model demonstrates that an RFIDenabled equipment tracking system could significantly increase equipment utilization.
Recently, an RFID system was implemented in hospital
settings to track the location of medical equipment, guaranteeing this features: quick access and effective control and
enhanced maintenance (Tsai et al., 2019). It allows technical personnel to access the system through a smartphone
app, thereby reducing time spent searching for equipment.
A log tool can be used for statistical analysis in a range
of time frames, giving managers reference for future purchasing and maintenance decisions. The system was developed using Sony smartphones with Android 4.4 operating
system; SQLite is used for database development to ensure
cross-platform and multiple language support.
A new asset tracking system that integrates a classical
tracking solution with the Bluetooth low-energy (BLE)
technology is taking importance in several fields. This is because, in the last years, smartphones have become popular
and widely used for mobility, friendly user interfaces, communication interfaces, with increasing computing power.
Modern BLE tags do not require any specific configuration
to interact with smartphones. These tags may be used to
track persons or high-value assets. The power is supplied by
39
a 3 V battery that assures a long life, estimated in 2.5 years.
The sole task that they perform is the periodic transmission
of their code (beacon mode) so that a smartphone may listen
to it (Bisio et al., 2016).
A new software and hardware system integrated into
ambulance services as a solution for tracking personnel, assets, consumables, and drugs (PACD) was developed using
RFID and BLE technologies (Utku et al., 2016). This system is a complete solution, based on a centralized database,
which reduces manual paper documentation and frees the
personnel to better focus on the patient. The presence and
amounts of the PACD are automatically monitored, warning
about their depletion, nonpresence, or maintenance dates.
This system is a good example for tracking the maintenance
and expiration dates related to the PACD inside an ambulance to provide good quality interventions, by generating warnings over missing or outdated PACDs. With these
features, the solution eliminates personnel errors that can
cause adverse effects to a remote patient during the medical
intervention. A commercial BLE-based item used for identification was the iBeacon (a trademark of Apple Inc.), a
system that is gradually becoming more common in health
care (Varsamou and Antonakopoulos, 2014). An iBeacon is
a low-energy consuming device that periodically broadcasts
a unique identification number. Any device with BLE capability that comes within the iBeacon transmission range can
identify the iBeacon and launch a predefined application.
Thus, devices can detect proximity to specific locations and
perform location-aware activities (Utku et al., 2016).
Hospital supply chain
Hospital material management has been identified as one of
the key cost containment level to cope with steadily increasing healthcare costs in industrialized countries (Volland
et al., 2017). The increase in cost of supplies and services
is outpacing the increase in revenues at many hospitals
(Rosales et al., 2015). In fact, more than 30% of hospital
costs are linked to logistics activities. To reduce these costs,
RFID technology has emerged as a solution (Coustasse
et al., 2013).
It is nowadays quite commonly finding in hospitals using RFID system for the management of consignments and
high-value products. These systems are suitable for traceability and replenishment processes. RFID-enabled cabinets
have been presented as an alternative for the replenishment
of consignment and high-value medical devices, medical
gases cylinders, surgical equipment, and prosthetic ancillaries in complex operating rooms, cardiac catheterization
laboratories, and interventional radiology departments by
enabling the tracking of items from reception to consumption (Bendavid and Boeck, 2011; Meiller et al., 2011).
Furthermore, the clinical engineering department can
propose and implement novel project focused on i­ mproving
40 SECTION | 1 Clinical engineering
the healthcare delivery and making reengineering using the
RFID technology. A case study in the linens division of
Central Sterilization Services Department at a Singaporean
hospital is a good example for the application of the RFIDenabled process reengineering in health care (Kumar and
Rahman, 2014). They focused on the process reengineering in the supply chain using an RFID system to provide
clear visibility in linen inventory control. For the case study,
the current active RFID systems were operating within the
UHF region at 868 MHz and the linens department uses a
special tag. Particularly, this tag is waterproof, dry cleaning
chemical proof, provided with high mechanical resistance,
resistant to heat (−25–150°C) and pressure (45 bar). Kumar
and Rahman (2014) conclude that the RFID technology
supports the supply chain process and reduces environmental hazards costs at the healthcare facilities. The healthcare
supply chain can be significantly enhanced by the end-toend traceability of medical products.
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41
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Further reading
Biffi Gentili, G., Dori, F., Iadanza, E., 2010. Dual-frequency active RFID
solution for tracking patients in a children’s hospital. Design method,
test procedure, risk analysis, and technical solution. Proc. IEEE 98 (9),
1656–1662. art. no. 5508336.
Iadanza, E., Dori, F., 2009. Custom active RFId solution for children tracking and identifying in a resuscitation ward. In: Proceedings of the 31st
Annual International Conference of the IEEE Engineering in Medicine
and Biology Society: Engineering the Future of Biomedicine, EMBC
2009, Art. No. 5333497, pp. 5223–5226.
Iadanza, E., Dori, F., Miniati, R., Corrado, E., 2010. Electromagnetic interferences (EMI) from active RFId on critical care equipment. IFMBE
Proc. 29, 991–994.
Iadanza, E., Baroncelli, L., Manetti, A., Dori, F., Miniati, R., Gentili, G.B.,
2011. An rFId smart container to perform drugs administration reducing adverse drug events. IFMBE Proc. 37, 679–682.
Iadanza, E., Gaudio, F., Marini, F., 2013a. The diagnostic-therapeutic
process. Workflow analysis and risk management with IT tools. In:
Proceedings of the Annual International Conference of the IEEE
Engineering in Medicine and Biology Society, EMBS, Art. No.
6610612. pp. 4763–4766.
Iadanza, E., Chini, M., Marini, F., 2013b. Electromagnetic compatibility:
RFID and medical equipment in hospitals. IFMBE Proc. 39, 732–735.
Luschi, A., Marzi, L., Miniati, R., Iadanza, E., 2014. A custom decisionsupport information system for structural and technological analysis in
healthcare. IFMBE Proc. 41, 1350–1353.
Luschi, A., Miniati, R., Iadanza, E., 2015. A web based integrated healthcare facility management system. IFMBE Proc. 45, 633–636.
Chapter 5
Computer-aided facilities
management in health care
Ernesto Iadanzaa, Alessio Luschib
a
IFMBE HTA Division, School of Engineering, University of Florence, Florence, Italy, bDepartment of
Information Engineering, University of Florence, Florence, Italy
The organization of modern hospitals is intimately related
to a big amount of data that needs to be organized. Hospitals
must comply with a large amount of requirements in order to
fulfill their clinical and medical duties. These requirements
are set by national and international institutions which compel structures to respect strict parameters in order to have
minimal hygienic, qualitative, and organizational standards
granted.
Clinical Engineering Services and Technical Departments
must deal with these problems every day and find solutions
to fully satisfy all sorts of technological, structural, and
organizational needs for such a complex structure as a
hospital. Different technical tools have been developed
through the years to monitor the hospital by measuring
quantitative, architectonical, technological, and peoplerelated parameters.
Many of these systems are based on special hospital
dedicated Database Management Systems (DBMS) and
Building Information Modeling (BIM) systems. By using
databases, all sorts of data can be stored and then aggregated in different ways to answer a wide range of queries.
Computer-Aided Facility Management (CAFM) systems
can be seen as decision-support tools based on Integrated
Healthcare Facility Management Models (IHFMM) which
provide indexes on those processes that can affect the performance of the healthcare structure. These tools can be
very useful for the top-management for performance and
risk evaluations, business management and development.
Workplace management systems (WMS) are solutions
designed to manage real estate facilities, allowing users to
assess, analyze, and reorganize the company assets in order to preserve their value, improve their effectiveness and
respond to multiple needs. They provide access to stored
information regardless of the workplace: data and plans can
be acquired through web services, using a common browser
over an Internet or intranet network. The level of detail of
the analysis can be a homogeneous functional area (rooms
42
grouped together by destination of use (DU) or any other
level of aggregation) or a single room: in the first case, users
have an overall view which may be useful for wide range
analysis, while the latter case offers a full-scale examination to know details and supplies for specific spaces of the
premise.
This chapter presents several CAFM systems, developed
through the last 20 years by a team of health engineers and
informatics of the Department of Information Engineering,
with external consulting by architects of the Department of
Architecture. These systems have been designed within research agreements and professional collaborations with the
hospital campus of the “Azienda Ospedaliero Universitaria
Careggi” (AOUC) in Florence and the hospital campus of
the “Azienda Ospedaliero Universitaria Pisana” (AOUP) in
Pisa. Both the structures are now using the developed tools
on a daily basis for managing their premises.
They are based on the everything-inside-DWG approach: the systems manage and analyze digital plans of
hospital buildings, coded on specific layers, and save the
information on a core MS SQL Server database linked to
the Hospital Information System (HIS).
The main core application has its own CAD drivers which allow directly driving CAD software, such as
Autodesk AutoCAD, and make automation straight on the
DWG files, saving the information inside the map itself
by using the XData extension for every CAD object. This
approach lets the users manipulate the DWG files directly
from the main application and, moreover, rebuild the information about hospital’s inner organization, destinations of
use, and environmental comforts with nothing but only the
DWG maps, allowing a great level of redundancy in case
of data loss.
Both the systems can output quantitative, qualitative,
and graphical reports. The link between the core database and other existing databases allows the system to be
used as a central control cockpit. Outputs can be used by
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00005-5
Copyright © 2020 Elsevier Inc. All rights reserved.
Computer-aided facilities management in health care Chapter | 5
t­op-management as a decision-support tool in order to improve hospital’s structure and organization and to reduce
the major workflow risks. Furthermore, the CAFM systems
have many plug-ins which contribute to complete analysis
and management of the healthcare facilities, and which will
be highlighted later throughout this chapter.
The everything-inside-DWG approach
The core-engine software drives CAD maps to implement
an approach that could be called “everything inside DWG”:
all data are stored inside the maps through the Extended
Data (XData) properties of the AutoCAD Polylines. The
drawings are self-sufficient and the information can be always rebuilt using nothing but the CAD files. An MS SQL
Server database that contains support tables is still used to
perform queries and aggregations on the data.
The XData propriety allows heterogeneous types of data
to be stored inside the DWG file, directly linked to CAD
objects. Integer or floating number, strings, timestamps, binary data or any other types of data can be stored in the
DWG file in this way.
Data is collected through on-site surveys and interviews
with the personnel. Spaces are classified by their usage and
by customer expectations in terms of environmental comfort. Survey information is then entered into the system and
linked to the DWG AcadPolyline objects which outline the
perimeter of a room which must be previously drawn by
the user. Polyline color is used as a parameter to identify
the DU. It is associated with the intensity of care for each
destination. The software has a module to make multiple
selections on the DWG file and to give to selected polylines
an RGB color associated with each of the 42 available destinations of use coming from the database.
DUs can be freely edited by managers and users according to the hospital’s organization and needs, so the initial
set can be widened or narrowed during the time. Each DU
is subcategorized in classes to allow a more detailed complexity of the surveys. For example, the outpatient clinics
DU groups heterogeneous areas, which must be differently
treated both from an architectural and an engineering point
of view (Cardiology OC, Pulmonary OC, General OC, etc.).
Classes allow the user to specify these parameters for each
hospital environment narrowing down the level of observation. They can also be added, removed, and edited by the
user.
Another main function of these systems is the ability
to build a complete register of all the spaces throughout
the healthcare facility. This allows every room to have its
unique code. They are therefore uniquely identified for every possible activity (cleaning, maintenance, inventory).
The code is automatically generated by the system according to the premise, the building and the floor of the room,
letting the user immediately know the position of the room.
43
Moreover, users can freely aggregate several rooms up
to four different groups according to the hospital’s inner organization (Departments, Operative Units, Activity Areas,
and Cleaning Classes). Other aggregating groups may also
be added to highlight different aggregations typical of the
analyzed premise.
The whole information in each file is always extracted
by the software itself and inserted in a MS SQL Server support table linked via ActiveX Data Objects (ADO) in order
to assure redundancy backup functionality.
Web viewer
One of the main criticalities of a CAFM system is the
usability of the application because it is accessed by
heterogeneous users with different formation and for
different scopes (top-management, engineers, nurses,
physicians, technicians, external companies). In order to
face such a complex scenario, these systems offer a webviewer engine installed on a facility’s web-server that allows accessing (and sometimes also to edit) the available
information.
Maps are displayed by using automatically generated
SVG polygons drawn from the room’s coordinates stored in
the core databases. The coordinates are fed into the database
via a dedicated command which allows all the semantic and
geometrical (X) data to be copied into tables and then be
accessed from the web-viewer application.
W3C HTML5-compliant SVG format can be rendered
by any web browser with no need for third-party plug-ins.
The application allows users to visualize the last updated
map of the requested floor of a building in real time by using
a RESTful architecture. JavaScript and other libraries and
frameworks such as jQuery, D3.js and Bootstrap are used
on client-side, with AJAX calls to invoke Web Application
Programming Interfaces (APIs) which reside on the central
web-server with Microsoft Internet Information Services
(IIS), developed within Microsoft .NET 4.5 Framework.
The engine also provides the basic functions of a CAD engine such as multiselection, panning, zooming, text placement, and scaling (Fig. 1).
Users can access information stored in the main database or in other linked databases according to the privileges
associated with their usernames. Usually, the links between
the databases are made by using the unique code register so
that heterogeneous information can be aggregated together
with just a simple one-to-many link.
Structural data (surfaces, heights, and beds), organizational data (name and contacts of the staff, organizational
heterogeneous subgroups such as Department, Operative
Units, and so on), technical data (medical devices location),
plant and architectural data (air treatment units, frames,
lights, accessibility for disabled people, assets) are all available for the end user (Figs. 2 and 3).
FIG. 1 Example of multiselection inside the web-viewer.
FIG. 2 Single selection of a room with a set of technical and architectural information shown.
FIG. 3 List of all the assets installed in the selected room. This information comes from a linked asset database within the hospital structure.
Computer-aided facilities management in health care Chapter | 5
Search engine
Due to the great amount of data stored inside the databases the CAFM relies on, a web-search engine is
required to perform free-text queries according to unpredictable user’s needs. The developed engine is integrated within the web-viewer via external web-service,
but it is also provided with a dedicated web-application
to perform more detailed searches, which can be even
narrowed by using advanced searching filters to refine
the search (Fig. 4).
FIG. 4 Example of a free-text query performed against the CAFM database.
FIG. 5 Different GUI for the web-viewer application.
45
Queries can be performed by using common syntax
and special ASCII characters to perform inclusion, exclusion, and perfect searches. Moreover, a fuzzy dictionary
and Google’s APIs are also used, so that a “Did you mean”
functionality is also available.
Dynamic reporting function allows users to make custom reports with different levels of aggregation.
Besides, additional modules can be installed alongside
the main one to manage different data and procedures, such
as housekeeping management, fire evacuation, energy management, and bed management (Fig. 5).
46 SECTION | 1 Clinical engineering
Sanitation management
This module is a vertical application which relies on existing space and rooms’ information already stored in the main
CAFM database. It allows a logged user (usually the Nurse
Coordinator or Managerial Staff whosoever) to request suspension, reactivation, and extension of the cleaning service
for a given room within a given time period. Besides, extraordinary cleanings, cleaning class variation, or disinfection can also be requested (Fig. 6).
The Sanitation Manager is able to confirm or not confirm all the received requests (Fig. 7). Once an edit is validated, it is marked as active in the database. This means the
room would change its cleaning cost within the time span of
the specific request. For example, a temporary suspension
of cleaning service will result in a lower maintenance cost
for that given room because the sanitation service will not
be paid for that unit for that time span. On the opposite side,
an extraordinary cleaning or a disinfection service will raise
the maintenance cost due to extra off-schedule cleanings.
FIG. 6 Example of a request of disinfection for a room within a Stroke Unit.
FIG. 7 Confirmation and validation of a disinfection request for a room within a Stroke Unit.
Computer-aided facilities management in health care Chapter | 5
All these changes which occur during the year vary the
overall cost of a room. Top-management can continuously
monitor this parameter by using this module, assessing the
performance of the staff and knowing exactly the daily price
per unit/room.
Fire evacuation
Prevention and protection in the working environment are
crucial and all the events which may cause damages to
people (and to devices) must be identified, evaluated and
eventually corrected. Healthcare facilities have a lot of technologies and procedures which involve combustible and
oxidizing materials as well as ignition sources (MRI, CT,
PET, thermos-ablation, etc.).
Active fire protection aims to prevent the ignition and
possibly to extinguishing the fire in its early stage. Instead,
passive fire protection aims to evacuate the on-fire building
in the safest possible way once the active protection fails.
These are the two main aspects of fire prevention.
During the evacuation, the simultaneous presence of
heterogeneous people, with different speeds and spatial
knowledge, and spatial layout may lead to congestion issue.
This module uses a custom-developed algorithm to
evaluate the safest evacuation path in case of fire, according
to typology of user, speed, initial ignition, fire propagation,
and congestion.
Dijkstra’s algorithm is used to evaluate the shortest path
between two points (the room which must be evacuated and
the emergency exit) by implementing an adjacency matrix among all the nodes which have to be traveled from
the starting to the exiting point. The weight of every single
connection represents the length of the path and the arrows
between two different nodes indicate if the path can be traveled only toward or even backward. The process is then iterated among all the possible ending nodes (emergency exits)
and the shortest path among all the shortest paths to each
exit is then chosen (Fig. 8).
It is crucial that a sensor system is installed on every
node (a room or a portion of an alley) to monitor how a
possible fire is evolving during the evacuation, and that it
can communicate with the CAFM system. Sensors measure
parameters such as temperature, humidity, air pressure, and
smoke density. If one of these measurements overcomes a
FIG. 8 Interconnected weighted graph used to evaluate the shortest path.
47
threshold safety value, the related node will not be considered safe anymore and it will be excluded from the graph
just before the algorithm recalculates. Therefore, the safest path might not be the shortest if one of the nodes has
become unusable, but anyway it will be the shortest path
among all the available safe nodes.
During this phase people inside the hospital must be
safely evacuated, regardless of the reason, they were in
(physician, nurse, technicians, patients, visitors). However,
while internal staff knows the structure and how to move
through, patients usually cannot walk properly and may
need additional help during the evacuation according to
their illness: this may imply the transportation of vital support systems and a subsequent decrease of evacuation speed
which must be taken into account to evaluate the average
speed of evacuation for a given department or unit.
Information about the destination of use and activity for
single rooms, together with the expected number of persons
(deduced from the number of beds, the time of the day, and
the scheduled visit program) are taken from the hospital
CAFM system which this module is related to.
The output is an escaping path drawn directly on the
SVG map within the web-viewer which highlights in real
time the shortest safest exiting route once a fire event is
placed. Referring to Fig. 9 the escaping route for the given
room leads to the central emergency exit which is not the
closest one (that would be the stairs in the upper left corner), but it is the safest in relation to the simulated fire
event.
Energy management
This vertical application to the main CAFM system allows
assessing and aggregating previously collected data, outputting performance indicators about the energy consumption
and savings in order to cut the cost of energy supply and
maintenance within a healthcare facility.
Firstly, every room is associated with an Energy Class
which defines its energy consumption according to legislative standards specific for the destination of use. These
links are made inside the database acting as guiding rules to
evaluate the overall energy consumption.
The process of evaluation is quite simple: sensors monitor environmental parameters such as temperature, humidity, and air circulation, then input real-time values to the
database via JSON or XML formats through Web API, and
finally the system matches them with maximum and minimum threshold standards related to the destination of use
the area is associated with.
RESTful architecture is mandatory in order to allow the
application to be fully integrable with any third-party sensors management system.
Once the data have been collected and stored inside the
hospital’s CAFM system, the main requirement is to have
48 SECTION | 1 Clinical engineering
FIG. 9 Shortest safest route with a fire event in place.
FIG. 10 Matching between theorical and actual environmental parameters.
an efficient managing system in order to update and monitor the parameters and to query a single room or a set of
rooms with given attributes (i.e., all the rooms with at least
one parameter—or a given parameter—outside the threshold range).
The comparison between the theoretical values and the
real ones is output on a dedicated window of the application
with simple graphic feedbacks about the compliance to the
environmental standards (Fig. 10).
If the collected parameter range is all inside the theorical one, the icon will be a green check mark; if it is partially
inside the theorical one, the icon will be a yellow warning
sign; finally, if it is all outside the theorical one, the icon
will be a red uncheck mark.
The system also allows a granted user to override an
actual value for a given date. A granted user can override
a parameter (or all of them) without editing its value: this
makes the real collected valued compliant to the theorical
Computer-aided facilities management in health care Chapter | 5
49
4 - OPHTALMOLOGY
4_028 - Warehouse
5 - Office/Teaching/Corridors/Other (CZ - Common Zones)
Summer Temperature [°C]
28
Real Maximum
Theoretical Min.
22/04/2018
10/04/2018
Real Minimum
09/04/2018
07/04/2018
Real Average
08/04/2018
06/04/2018
27
26
25
24
23
22
21
20
Theoretical Max.
FIG. 11 Report showing the time evolution of minimum, medium, and maximum values for each parameter of a given room.
range even if the values would not be. This functionality allows a logged user with administration privileges, such the
Energy Manager, to validate a parameter which differs from
the theorical one, but still with a consistent time-evolution
and a known reason of incompatibility.
The system also outputs a detailed report about the
summary of the compliance of a room, a homogeneous
­functional area or the hospital itself, together with the time
evolution of the minimum, medium, and maximum values
of each energy parameter (Fig. 11).
Bed management
The last module for the analyzed CAFM system is about
the bed management of a hospital, properly called Bed
Management Information System (BMIS). It has been designed to efficiently provide a proper allocation of beds inside hospitals to reduce the diversions (transfer of patients
in other ward or hospital) and the number of outliers (patients admitted in the not-right ward). The algorithm analyzes the interaction among patients, admission status, and
personnel in order to reduce the length of stay (LOS) and
the cost of care for hospitals. The application is obviously
linked to the CAFM system to gather information about the
number of beds and their location.
Every department has its own bed cycle, which must be
minimized in order to provide an efficient bed management.
Bed cycle is defined as the time which takes between two successive discharges of two different patients for the same bed.
All the operations and procedures which take place between a discharge request and its effective implementation
must be fully organized (notification, cleaning, assignment,
and transportation). This implies that every single actor
(nurses, physicians, and housekeeping staff) knows exactly
what and how to do (Fig. 12).
Five user typologies are identified, each one with a dedicated panel of the application: nurse, housekeeping staff,
ward physician, Emergency Department physician, and bed
manager.
A typical process which intercourses between a discharge and an admission starts with nurses who notify the
housekeeping staff to begin the cleaning operation for a
given bed once the patient is discharged. Then the housekeeping staff notifies back to the system the availability of
the bed once the cleanings have concluded. Meanwhile,
ward physicians feed the system with predicted LOS of
the patient according to Diagnosis-Related Groups (DRG)
standards. Finally, ED physicians access the system to easily visualize the current number of available beds, and then
make decisions about the transfer of a patient.
Fig. 13 shows a possible scenario for the bed status in
a Cardiology Department. Red rows identify occupied beds,
yellow ones are for free but not yet cleaned beds, and the
green ones represent available beds. The pie chart on the right
recaps the bed availability for the analyzed ward while on
the top header there are shortcuts for the Elective Patients
list section, the Waiting Lists, the Bed Availability, and the
Critical Operative Units (wards with more than 85% of occupied beds). The panel represents an actual status-quo of the
bed’s availability throughout the departments, with real-time
information refreshing as the actors interact with the system.
The described systems are just some examples of the
many tools that the authors have designed and implemented
in real healthcare settings in a research that started about
20 years ago. The common denominator has always been
taking the most of the available data to provide the decision makers (whether clinical engineers, hospital engineers,
managers, or health staff) with evidence. Because evidencebased management can only be grounded on all the available data and the right tools to exploit it.
50 SECTION | 1 Clinical engineering
FIG. 12 Bed cycle diagram.
BM Service
Home page
Bed Manager
Beds status
Elective
patients
Waiting
lists
Beds
availability
Beds occupancy 21%
Select operative unit
79%
Cardiology
Room number Bed number Room gender
01C
0101C
FM
02C
0102C
02C
0202C
F
05C
0105C
M
05C
0205C
M
06C
0106C
M
06C
0206C
M
06C
0306C
M
06C
0406C
M
F
Home > Beds status
FIG. 13 Bed status for the Cardiology Department.
21%
Critical
operative units
Computer-aided facilities management in health care Chapter | 5
Acknowledgments
All the above-presented tools have been possible thanks to the valuable work of so many collaborators and students that it would be impossible to name them all one by one. A heartfelt thanks to all our
students of the present and the past.
Further reading
Biffi Gentili, G., Dori, F., Iadanza, E., 2010. Dual-frequency active RFID
solution for tracking patients in a children’s hospital. Design method,
test procedure, risk analysis, and technical solution. Proc. IEEE 98 (9),
1656–1662. art. no. 5508336.
Ho, S.P., et al., 2013. Enhancing knowledge sharing management using BIM
technology in construction. Sci. World J. 2013. Article ID 170498.
Iadanza, E., Baroncelli, L., Manetti, A., Dori, F., Miniati, R., Gentili, G.B.,
2011. An RFId smart container to perform drugs administration reducing adverse drug events. IFMBE Proc. 37, 679–682.
Iadanza, E., Chini, M., Marini, F., 2013a. Electromagnetic compatibility:
RFID and medical equipment in hospitals. In: IFMBE Proceedings.
vol. 39 IFMBE, pp. 732–735.
Iadanza, E., Dori, F., 2009. Custom active RFId solution for children tracking and identifying in a resuscitation ward. In: Proceedings of the 31st
Annual International Conference of the IEEE Engineering in Medicine
and Biology Society: Engineering the Future of Biomedicine, EMBC
2009, pp. 5223–5226. art. no. 5333497.
Iadanza, E., Dori, F., Biffi Gentili, G., Calani, G., Marini, E., Sladoievich,
E., Surace, A., 2007. A hospital structural and technological performance indicators set. IFMBE Proc. 16 (1), 752–755.
Iadanza, E., Dori, F., Miniati, R., Corrado, E., 2010. Electromagnetic interferences (EMI) from active RFId on critical care equipment. IFMBE
Proc. 29, 991–994.
Iadanza, E., Gaudio, F., Marini, F., 2013b. The diagnostic-therapeutic
process. Workflow analysis and risk management with IT tools. In:
Proceedings of the Annual International Conference of the IEEE
Engineering in Medicine and Biology Society, EMBS, pp. 4763–4766.
art. no. 6610612.
Iadanza, E., Luschi, A., Ancora, A., 2019. Bed management in hospital
systems. IFMBE Proc. 68 (3), 313–316.
Iadanza, E., Luschi, A., Gusinu, R., Terzaghi, F., 2020. Designing a healthcare computer aided facility management system: a new approach.
IFMBE Proc. 73, 407–411.
51
Iadanza, E., Luschi, A., Merli, T., Terzaghi, F., 2019. Navigation algorithm for the evacuation of hospitalized patients. IFMBE Proc. 68 (3),
317–320.
Iadanza, E., Ottaviani, L., Guidi, G., Luschi, A., Terzaghi, F., 2014.
License: web application for monitoring and controlling hospitals’ status with respect to legislative standards. IFMBE Proc. 41, 1887–1890.
Iadanza, E., Turillazzi, B., Terzaghi, F., Marzi, L., Giuntini, A., Sebastian,
R., 2015. The streamer European project. Case study: Careggi Hospital
in Florence. IFMBE Proc. 45, 649–652.
Lavy, S., Shohet, I.M., 2007. Computer-aided healthcare facility management. J. Comput. Civil Eng. 21 (5), 363–372.
Linehan, M., Andress, B., 2013. Medical equipment and BIM. Advancing
the planning process with building information modeling. Health
Facility Manag. 26 (11), 21–24.
Luschi, A., Di Franco, R., Turillazzi, B., Iadanza, E., 2020. System for
monitoring environmental parameters in a hospital facility. IFMBE
Proc. 73, 413–416.
Luschi, A., Marzi, L., Miniati, R., Iadanza, E., 2014. A custom decisionsupport information system for structural and technological analysis in
healthcare. IFMBE Proc. 41, 1350–1353.
Luschi, A., Miniati, R., Iadanza, E., 2015. A web based integrated healthcare facility management system. IFMBE Proc. 45, 633–636.
Luschi, A., Monti, M., Iadanza, E., 2015. Assisted reproductive technology center design with quality function deployment approach. IFMBE
Proc. 51, 1587–1590.
Meirovich, C., Mann, P., 2017. Codebook for planning, procurement,
testing and commissioning. In: Proceedings of 3rd Global Forum on
Medical Devices.
Muresan, F., et al., 2006. Specific features of GIS database for hospital
management. An example for Bihor county. Geogr. Techn. 1 (1),
133–138.
Naves Givisiez, G.H., 2001. Hospital demand: using GIS and spatial analysis for estimation. In: Anais da XXIV IUSSP General Conference.
vol. 1. pp. 1–33.
Rodriguez, E., et al., 2003. A new proposal of quality indicators for clinical engineering. In: Proceedings of the 25th Annual International
Conference of the IEEE Engineering in Medicine and Biology Society.
vol. 4, pp. 3598–3601.
Zappia, I., Ciofi, L., Paganelli, F., Iadanza, E., Gherardelli, M., Giuli, D.,
2014. A distributed approach to Complex Event Processing in RFIDenabled hospitals. In: 2014 Euro Med Telco Conference (EMTC),
12–15 November 2014, pp. 1–6.
Chapter 6
Public procurement of
innovative medical technology:
Femtosecond and excimer
laser platform for ophthalmic
surgery
Francesca Sattaa, Massimiliano Montia, Marta Bravib, Giovanni Conteb,
Stanislao Rizzoc
a
Health Technologies - AOU Careggi/Meyer—ESTAR, Florence, Italy, bHealth Technologies Procurement—
ESTAR, Florence, Italy, cDepartment of Ophthalmology, University of Florence, Florence, Italy
Introduction
In the past few years, ophthalmic surgery has made much
progress by combining the most advanced laser techniques
with standard procedures for cataract, corneal graft, and the
correction of refractive defects such as myopia, hypermetropia, astigmatism, and presbyopia.
The use of the modern femtosecond laser that emits
femtosecond impulses (one millionth of a billionth of a
second) in the infrared wavelength allows the replacement
of the classic blades, since it cuts tissues at the required
depth with a precision which is taken in a few microns, that
is the dimensions of a single cell. It can be considered as a
“blade of invisible light.” The Careggi University Hospital
in Florence (Italy) planned a heavy investment in laser
systems to enhance the quality of care. Between 2015 and
2018 it has undertaken all the necessary steps for public
procurement of three different laser systems for different
clinical needs.
Epidemiology of cataracts
Four people out of 10 between the age of 55 and 64 and 8
people out of 10 over 70 years of age suffer from cataract.
In 2016, about 560,000 interventions have been carried out
in Italy. Today, the standard intervention is a manual surgical intervention performed with a scalpel and an ultrasound
phaco-emulsificator device, to replace the opaque lens with
an artificial and non-cloudy lens.
52
The femto-laser surgery for cataract provides various benefits in terms of precision and risk reduction associated with the intervention. The device makes a very
slight and replicable incision in the cornea, creates a
perfectly symmetrical circular opening in the anterior
capsule containing the cloudy lens (cataract), and finally
crumbles the nucleus of the cataract into little fragments.
The technique reduces the energy required for phacoemulsification and results thus in less mechanical and
thermal stress compared to traditional intervention, reducing risks of complications and improving the visual
recovery.
Innovation concerns not only the surgical technique but
also the intraocular lens (IOL) that replaces the natural lens.
Laser surgery mainly addresses the implantation of hightechnology IOLs.
Corneal graft
Laser-assisted cornea surgery allows customizing every single procedure, reducing the risk of graft failure
by limiting the necessity of the full-thickness perforating
keratoplasty.
More specifically, femto-laser permits carrying out
lamellar grafts (anterior, posterior, or endothelial that
leave the receiving patient’s healthy cornea layers intact
replacing only the pathological tissue) with more precision and reproducibility than with manual surgery. It
is also possible to carry out corneal cuts with specific
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00006-7
Copyright © 2020 Elsevier Inc. All rights reserved.
Public procurement of innovative medical technology Chapter | 6
p­ rofiles for every piece of tissue, of both the donor and
the recipient, to facilitate the graft survival, reduce (or
even eliminate) the corneal sutures, and accelerate the
visual recovery.
Furthermore, in some cases (e.g., in keratoconus, a
corneal alteration that may cause high astigmatism), it
is possible to implant in the defective cornea some very
thin micro-prostheses that serve to stabilize and regulate the corneal shape (intracorneal rings) and in several cases are useful to avoid a corneal graft with all its
consequences.
Sight defects
About 10 million Italians have bad eyesight, usually corrected using glasses and contact lenses. Many people, however, badly tolerate glasses or contact lenses and look for a
refractive surgery solution that provides a permanent correction of sight problems.
Only in 2016, about 3.8 million refractive procedures
have been carried out worldwide and it is expected that in
2021 the number will rise to about 5 million.
Laser-assisted surgical techniques are deeply applied in
corneal procedures as follows:
Photo refractive keratectomy (PRK) uses the vaporizing effect of the excimer laser for remodeling
the curve of the corneal surface. It is the pioneering
technique.
Laser-assisted in situ keratomileusis (LASIK) similarly
to PRK shapes the corneal curvature through excimer
laser, but also acts on a deeper layer of the cornea than
PRK, dislocating temporarily and partially a corneal lamella (corneal flap), created by the plasma cavitation
cut of the femtosecond laser.
The new femtosecond lasers have allowed important
surgical innovations.
In the first instance, the correction of myopia and
astigmatism with the small-incision lenticule extraction
(SMILE) technique represents a conceptual breakthrough in
the refractive surgery field. In fact, while the standard techniques (PRK and LASIK) model the corneal shape through
vaporization (excimer laser), the SMILE technique creates
a very thin, customized intracorneal refractive lamella that
is equal and opposite to the refractive error that is supposed
to be corrected, and then it is removed through a very small
peripheral corneal incision.
The second innovation is the presbyopia correction using
the Presbyond technique, also called laser blended vision.
Based on LASIK (carried out with a combined procedure:
femto-laser + excimer laser), it combines the precision and
safety of cornea refractive surgery with the advantages of a
deeper focus at all distances.
53
National and regional background in
public procurement
The Directive 2004/18/EC of the European Parliament
and of the Council repealed and replaced at present by the
Directive 2014/24/EC has highlighted that centralized purchasing techniques constitute a useful tool to increase competition and streamline public purchasing.
Moreover, the Italian Legislative Decree no. 50/2016,
also called “Code of Public Contracts”, identifies the central
purchasing bodies as contracting authorities or contracting
entities that provide centralized commissioning activities,
performing activities related to
(1) acquisition of supplies or services intended for contracting stations;
(2) awarding of contracts or conclusion of framework
agreements for works, supplies, or services intended
for contracting authorities.
The central purchasing bodies, therefore, have a fundamental role in the supply cycle of the administrations,
providing greater guarantees in terms of quality of public
spending, transparency, and prevention of corruption.
With Law n. 40/2005, the Tuscany Region has setup
ESTAR, a regional health service body with public juridical personality and administrative, organizational, accounting, managerial, and technical autonomy, through which
the Region implements its intervention strategies in the regional health service.
ESTAR operates as the central office of the health
service of the Tuscany Region on behalf of the health
companies and the hospital-university companies. It is
therefore subject to all national and regional provisions
governing the purchases of the companies themselves.
ESTAR is responsible for the procurement of goods
and services required by the local health authorities
and contributes to the definition of strategies for purchasing those goods and services. Thus ESTAR defines
needs in close cooperation and in line with the regional
indications about appropriateness of use and economic-­
financial compatibility.
The annual planning of the contractual activity aims
to rationalize purchases and optimize costs and ensuring regional levels of aggregation of needs and equity
of care.
ESTAR includes a specific department for managing
tender procedures to acquire goods and services. It is divided into specific structures dealing with different product
categories. It
-
prepares the tender specifications, that is disciplinary, technical and performance specifications, scores,
quantities, starting bid and penalties in case of
noncompliance;
54 SECTION | 1 Clinical engineering
-
-
-
manages electronically the tender procedure through
regional telematic platforms and other e-procurement
tools;
carries out all publications on the GUCE (Official
Gazette of the European Union), on the GURI (Official
Gazette of the Italian Republic), on the newspapers,
and on the platform of the “Osservatorio dei Contratti
Pubblici Regione Toscana”;
takes care of all communications with economic operators, providing the clarifications and the support necessary to guarantee the continuity of the administrative
activity;
coordinates the activities of juries and team of experts,
also ensuring logistical and administrative support for
the related activities;
prepares all deliberative acts (calling for competition,
awards, appointing juries and teams of experts)
takes care of all the obligations included those imposed
by ANAC (National Anti-Corruption Authority);
choices between best suitable agreements (framework
os basic) according to the operational needs of the recipient administrations; and
obtains the maximum administrative efficiency and
economy by aggregation of acquisition procedures, so to
obtain competitive offers, achieve transparency in small
contracts, reduce logistics costs, reduce the need for urgent procedures.
Tender project
In the first months of 2015 University Hospital of Careggi
started assessment on acquisition of ophtalmic laser systems. Once a preliminary budget evaluation was performed and a previsional budget allocated, Careggi
Hospital started to collaborate with ESTAR to design a
tender. From the analysis of the University Hospital of
Careggi requests, comes up immediately the need to nominate a team of experts in charge of drawing up the technical specifications and other documents useful to call the
tender procedure.
The team members were appointed in January 2016 and
included a clinical engineer with extensive experience in
health technology assessment and acquisition, an ophthalmic surgeon experienced in laser-supported techniques, and
a manager of the acquisition department of ESTAR.
The team was invited to evaluate if a supply of laser
platforms could be of interest also to other health authorities of the Tuscany Region.
Identification of appropriate technologies for femtosecond laser systems is determined by the prevailing clinical
indication.
The three alternatives are:
The tender procedure takes place entirely on an electronic platform including all communications to and
from economic operators, according to the following
steps:
1. femtosecond laser for cataract surgery complete with
diagnostic station;
2. refractive suite combined system of excimer laser (for
refractive surgery) and femtosecond laser complete with
diagnostic station; and
3. femtosecond laser for cataract and corneal surgery complete with the diagnostic station.
First phase:
- Publication of documents of competition on GUCES
/GURI …;
- Answer to clarification requests by economic operators interested in participation.
Second phase:
- Opening and examination of the administrative documentation to admit tenders;
- Appointment of juries responsible for the assessment of the admitted offers, composed of technical
and clinical professionals;
- Opening and examination of the technical documentation produced by the company;
- Coordination of the equipment tests;
- Supporting juries in assigning scores.
Third phase:
- Opening of economic offers and provisional awards
for each lot;
- Verification of anomaly offers;
- Pubblication of the final award;
- Contract stipulation.
Once the appropriate technologies have been determined, all the accessories, consumable materials, and any
additional accessories necessary to ensure continuity and
stable correct and safe use of the different laser systems
must be carefully assessed.
In fact, it was found that the use of disposable consumable materials, the so-called eye-laser interfaces (one
needed for each eye in surgery), and the presence of a technician specialized in the use of the system to support the
surgical team during each surgery is indispensable for the
use of the systems.
A quantitative and financial evaluation is necessary, as
these aspects have significant importance in the economic
framework.
It is also necessary to contractualize these aspects together with the laser system to guarantee their supply
throughout the duration of the contract so that their price is
established together with the price of the system.
Therefore, the overall economic framework must
be determined not only by the acquisition price of the
system but also by considering this along with the number of i­nterfaces needed in a certain period and with
Public procurement of innovative medical technology Chapter | 6
the number of t­echnicians (expressed in days). An
estimation of the Life Cycle Cost (LCC) is therefore
determined.
Methods of acquisition and economic framework
To assess the methods of acquisition of a system, its technological complexity, its degree of technological innovation,
its deterioration over time, and the types of resources provided by the healthcare companies must all be taken into
account.
Femtosecond laser systems are of high technological
complexity with frequent innovation.
It must be remembered that, in addition to the normal
maintenance activity (corrective and preventive), the calibration activity is of fundamental importance since no errors are allowed, as they are potentially very dangerous to
the eye.
Considering that in the national (Italian) market it is
not possible to entrust the maintenance and calibration activities to third parties, that is, to companies other than
the supplier, and that technological innovation can lead to
obsolescence of the laser systems, the most suitable acquisition mode is believed to be a 3-year lease with “inclusive
service,” in which the unit is rented for 3 years with comprehensive maintenance, estimating the required number
of interfaces and technicians on the basis of the surgical
activity foreseeable by the ophthalmology clinic of AOU
Careggi.
As there are resources (assigned by the Tuscany Region
to AOU Careggi) of the Ministry of Health (ex art. 20) by
which it is necessary to make a purchase (it is not possible
to hire), it was decided to diversify the mode of acquisition:
two laser systems in 3-year lease “inclusive service” (with
eventual renewal for another 2 years), and the purchase of a
third laser system with a warranty of 24 months, 3 years of
subsequent full-risk maintenance, and supply of interfaces
and key operators.
The so-designed economic framework guarantees the
availability of the three laser systems for 5 years with definite prices and costs.
It should be noted, for example, that the price of the interfaces, once fixed by the tender, will not change for the
duration of the contract (5 years).
Given the high cost of the technician, it was decided to
proceed in this way: a technician is hired for the first year
only and contextual training is provided (by the supplier
company) to employed health workers to become technicians certified to operate independently.
This request, we believe unique in its kind, has the dual
purpose of cutting down the costs of the technicians and
professionally grow health workers already employed in the
Tuscany Region.
55
The team of experts forecasted the amount of equipment for possible future request of other regional Health
Authorities considering the initial evaluation of the
University Hospital of Careggi. They proposed three distinct and separate lots with different contract types:
Lot 1: A 3-year operating lease of n. 3 femtosecond laser
systems for cataract surgery complete with the diagnostic station.
Lot 2: A 3-year operating lease of n. 3 systems refractive suite—combined excimer laser system (for refractive surgery) and femto-laser (for corneal and refractive
surgery) complete with the diagnostic station.
Lot 3: Purchase (with full-risk maintenance of 36 months
post warranty + interfaces 36 months + key operator
for 12 months) of n. 3 femtosecond laser systems for
cataract and corneal surgery complete with diagnostic
station.
This quantitative remodulation obliged ESTAR to
carry out a specific assessment on the type of procedure to
be used It opted for the signing of a “convention,” which
allows the healthcare companies possibly involved to perform subsequent accessions, in the period of relative contractual validity with the times and methods they consider
most useful.
With the choice of this contract, it was decided not only
to allow the administrations to meet with often unforeseen
and complex needs but also to provide and address strategic use of specific technologies, influencing companies
to assess their operational scenarios, and specific health
services.
To manage the future needs, the agreement allows signing three contracts for each lot. For Lot 1 and Lot 2 each
contract signed can be renewed for another 24 months and
eventually extended for another 6 months. It takes 6 months
to complete this phase.
Drafting of technical specifications
The guiding idea for the drafting of specifications was to
indicate a few technical characteristics of the laser, a list of
all possible clinical treatments (surgical treatment options),
a list of obligatory accessories (operating bed, system of
acquisition, etc.), and an indication of the presence of a
calibration system, a control and alarm system, consumable
materials (i.e., interfaces), the working days of the technician, and of the technician trainees.
The specifications were deliberately simple and
complete.
An evaluation table/grid with scores serves guide the
technical offer toward qualifying solutions for the user
health company.
The lots and their specifications are as follows:
56 SECTION | 1 Clinical engineering
Lot 1—Femtosecond laser
system for cataract surgery
complete with diagnostic station
Femtosecond laser
Wavelength 1040 nm or in any case
suitable for the execution of required
treatments
High pulse rate and in any case
suitable for the execution of required
treatments
Pulse duration: 220–500 fs and in
any case suitable for the execution of
required treatments
Required treatments
Crystalline surgery:
• Anterior capsulotomy
• Fragmentation of the lens
• Primary and secondary corneal
incisions
• Arcuate corneal incisions
Femtosecond laser equipped with the
following accessories/options:
•
•
•
•
•
Lot 2—Refractive suite—combined excimer
laser system (for refractive surgery) and
femto laser (for corneal and refractive
surgery) complete with diagnostic station
Lot 3—Femtosecond laser
system for cataract and corneal
surgery complete with diagnostic
station
Excimer laser
Wavelength 193 nm (indicative value)
Spot diameter <1 mm
High pulse rate
Flying spot technology
Eye tracking technology (eye movement tracking
option)
Femtosecond laser
Wavelength 1040 nm or in any case
suitable for the execution of required
treatments
High pulse rate and in any case suitable
for the execution of required treatments
Pulse duration: 220–500 fs and in
any case suitable for the execution of
required treatments
Required treatments
•
•
•
•
PTK
PRK
LASEK
i-LASIK or femto LASIK
Excimer laser equipped with the following
accessories/options:
•
•
•
•
•
Integrated operating microscope
Integrated camera
Surgical fumes suction system
Workstation
Laser management software
Integrated operating microscope
Integrated camera
Intraoperative OCT
Workstation
Laser management software
Required treatments
Crystalline surgery:
- Anterior capsulotomy
- Fragmentation of the lens
- Primary and secondary corneal
incisions
- Arcuate corneal incisions
Corneal surgery:
• Execution of curved keratotomies
• Creation of corneal flaps
• Creation of pockets and corneal
channels at varying depths for
insertion of intrastromal rings and
refractive inserts
• Corneal cutting with customizable
profile for preparation of donor flap
and receiving bed for lamellar and
perforating keratoplasty
Femtosecond laser equipped with the
following accessories/options:
•
•
•
•
•
Femtosecond corneal surgical laser
Wavelength 1040 nm (indicative value)
High pulse rate
Pulse duration: 220–500 fs (indicative value)
Required treatments
• Corneal flap
• Pockets and channels for inserting intrastromal
rings and refractive inserts
• Corneal doors and pockets at variable depths for
intrastromal treatments with excimer laser
• Lamellar and perforating keratoplasty (for
corneal transplants)
Mandatory accessories/options
•
•
•
•
•
Integrated operating microscope
Integrated camera
Intraoperative OCT
Workstation
Laser management software
Integrated operating microscope
Integrated camera
Intraoperative OCT
Workstation
Laser management software
Public procurement of innovative medical technology Chapter | 6
57
Lot 2—Refractive suite—combined excimer
laser system (for refractive surgery) and
femto laser (for corneal and refractive
surgery) complete with diagnostic station
Lot 3—Femtosecond laser
system for cataract and corneal
surgery complete with diagnostic
station
Minimum system configuration
Surgical bed with ergonomic design
and easily cleanable.
Data and image acquisition,
management and recording
system with the possibility of
archiving on physical media and/or
export data.
Remote planning system completed
with treatment planning software.
UPS to ensure continuity of laser
operation.
Minimum system configuration
Adjustable surgical bed with ergonomic design
and easily cleanable
Data and image acquisition,
management, and recording system
with the possibility of archiving on physical media
and/or export data.
Remote planning system complete with treatment
planning software.
UPS to ensure continuity of laser
operation.
Minimum system configuration
Surgical bed with ergonomic design and
easily cleanable.
Data and image acquisition,
management and recording
system with the possibility of
archiving on physical media and/or
export data.
Remote planning system
completed with treatment planning
software.
UPS to ensure continuity of laser
operation.
Calibration system for laser
source
• Equipped with suitable control and
calibration systems and calibration
controls
Control and alarms systems
for laser source
Calibration system for both laser sources
• Equipped with suitable calibration systems and
calibration controls
Control and alarms systems
for both laser sources
Calibration system for laser
source
• Equipped with suitable control and
calibration systems and calibration
controls
Control and alarms systems
for laser source
Lot 1—Femtosecond laser
system for cataract surgery
complete with diagnostic station
• Equipped with suitable control systems and
proper alarms
• Equipped with suitable control
systems and proper alarms
• Equipped with suitable
control systems and proper
alarms
Disposable and single-use
consumables
Interfaces for cataract treatment
Disposable and single-use consumables
Interfaces for corneal applications
Disposable and single-use
consumables
Interfaces for cataract
treatment
Interfaces for cornea
treatment
Other services
Key operator presence during
operating sessions
Training project for healthcare
professionals employed by AOU
Careggi with a final qualification
certificate as key operator
Other services
Key operator presence during operating sessions
Training project for healthcare professionals
employed by AOU Careggi with a final
qualification certificate as key operator
Other services
Key operator presence during operating
sessions
Training project for healthcare
professionals employed by
AOU Careggi with a final
qualification certificate as
key operator
Bidding assessment criterion and drafting
of the evaluation table/grid
Given the context and the high technological content of the
systems and following Estar’s practice for health technologies, the assessment criterion is the best price-quality ratio
on separate lots (each lot is competing for itself, so that the
best economical technical solution is guaranteed for each
system in the tender and the competition is widened).
For the two lots with more mature technology: 50 points
can be attributed to the quality and 50 points to the price,
to encourage economic operators to present technical solutions at lower prices.
Weighting: price: 50% and quality: 50%.
For the lot with the most innovative technology: 70
points for quality and 30 points for price, to encourage
economic operators to present more innovative technical
solutions.
Weighting: price: 70% and quality: 30%.
For the evaluation table/grid, seven criteria for two lots
and eight criteria for one lot were used, with scores ranging
from 5 to 10, in a specific case 20 points.
58 SECTION | 1 Clinical engineering
The qualifying criteria for the envisaged technical solution for all the lots are as follows:
Quality criteria
Price criteria
Rating
Max quality rating
50
1
Job workflow in supporting Surgeon: easy to use of planning
and image guided system
10
2
Hardware integration of the overall system
5
3
Calibration system
8
4
Control and alarm system
7
5
Key operator
training program for
hospital employee
Timeline and number of hours for
training and retraining
5
Level (with certification) achieved by
hospital employee
5
Capability to configure and use the
laser system in clinical practice (some
or all possible clinical case)
10
6
Key operator
qualification and
experience
7
Price
50
Max rating
Price rating was calculated with the following formula:
Ci ( per Ai ≤ Athreshold ) = X ∗ Ai / Athreshold
( Ai − Athreshold ) / 
Ci ( per Ai > Athreshold ) = X + (1.00 − X ) ∗ 

( Amax − Athreshold ) 
where Ci = coefficient of the i-tender, Ai = % discount
of the i-tender, Athreshold = arithmetic average of % discount of the bids, Amax = max % discount of the bids, and
X = 0.90.
Each lot was awarded to a tender who obtained the highest score in the sum of the points attributed to the elements
of a qualitative nature and to the elements of a quantitative
nature (max 100).
Tender publication
Upon completion of the technical investigation and therefore of the technical specifications by the team of expert, all
the administrative documentation of the tender procedure
has been prepared:
-
induction procedure;
calls for tenders to be published;
disciplinary, with the scores to be assigned when evaluating offers;
specifications with the technical specifications and penalties to be applied in case of default;
models of economic offers;
100
-
other documents accompanying the procedure; and
carrying out the entire tender procedure on a specific
­electronic platform, taking care of all the consequent
requirements.
With the stipulation of the 2-year agreement, the procedure managed by ESTAR as a regional purchasing center
ends and it allows all the health authorities of the Tuscany
Region (included Careggi Hospital), benefit from an immediate contractual instrument to obtain supplies but also from
a particularly innovative technology capable of providing
high-level health services.
Tenders assessment
The jury comprised two ophthalmic surgeons and one clinical engineer.
The tender assessment was complex either from a technical point of view or to understand only from documents
how difficult could be the use of these types of equipment
during surgical activity. For this reason, the jury decided
that it was necessary to organize clinical trials. Due to the
volume of equipment, transportation, and installation requirements and also risk assessment for the use of a laser
source it was a challenging task. The jury had to choose
which of the three lots help them better in their task.
Lots n. 2 and 3 were too heavy and an operating room
was not available with adequate dimensions. Therefore, the
jury opted for lot 1 with 1-day clinical trials on multiple
surgical session of each laser equipment.
Public procurement of innovative medical technology Chapter | 6
Organization of clinical trials was complicated but
made it possible to carry out a more in-depth evaluation of
both the purely technical aspects of the machines and the
workflow.
CLINICAL TRIAL OF FEMTOSECOND LASER.
The difficulty in organizing clinical trial was mainly due
to logistics such as
•
•
•
equipment weight and path to access the operating rooms
assembly and installation procedures
room suitability for laser use
•
•
•
interference with scheduled room activity
availability of key operators
disassembly and transport procedures
From a clinical point of view, the surgeons identified
suitable patients and acquired informed consents.
During clinical trial particularly noncritical issues were
raised by one patient who refused surgery despite being previously informed. Once he came into the operating room and
he saw the equipment he became scared and upset refusing
to lay down on the operating bed. The main problem was
the laser harm upon his head that aroused claustrophobia.
The experience underlined how important is ergonomics
and usability in medical equipment.
The jury’s work lasted 10 months with also stuck phases.
Some of them were due to the lack in the jury composition of an
ICT (information and communication technology) expert that
could be very helpfull to evaluate crucial aspects of tenders as
data flow from diagnostic/planning station to laser equipment.
Further we can see that these lapses generate problems
during the installation phase considering that the two elements have to be in different buildings.
Opening of financial offers
The financial offers received from the economic operators
confirm that if a broad competition is ensured the outcome
of a tender can be of high quality with a high discount on
prices for optimum use of public funds.
Lot
Procurement
Quantity
Estimated
value (VAT
not included)
1
3-year operating lease + 1 year key
operator + 3 years patient interface
3
€ 3,578,400.00
€ 1,757,700.00
3
50.88%
2
3-year operating lease + 1 year key
operator + 3 years patient interface
3
€ 6,261,600.00
€ 4,341,915.00
4
30.66%
3
Purchase + 3 year full-risk
maintenance contract + 1 year key
operator + 3 years patient interface
3
€ 2,221,200.00
€ 2,197,655.28
1
1.06%
Financial aspects were really important taking into consideration the Italian reimbursement system. In Italy, the general conditions of the reimbursement system are established
on a national level and implemented at a regional level by
governmental bodies.
Reimbursements are made with prespecified rates
(DRG—diagnosis-related groups) on a standardized nomenclature of procedures (ICD9). Some treatments that can
be performed with laser systems do not have an established
reimbursement rate, others have low rates compatible only
with an acquisition price lower than the medium price on
the market, especially in lot 1.
59
Value of the
contract (VAT
not included)
Num. of
economic
operators
Max
discount
It was possible to sign the first contract in July 2018 for
lot 1 and 2 and in September for lot 3 by Careggi Hospital.
Another regional hospital decided to use the convention
and order the platform in lot 2 at the end of 2018.
Conclusions
The procedure gave an excellent result in terms of quality of
equipment and awarded prices but the total time to achieve
the result is quite long.
The timeline in the following image shows that it takes
almost 4 years from the request of the first hospital.
60 SECTION | 1 Clinical engineering
A very good investment planning has to be in place to bear
long total times but the return in terms of money savings is
high.
After the first contract signed by Careggi Hospital other
requests arrived from other regional health authorities.
Postaward contract management
The experience of the Tuscany Region is significant because it created a contractual structure which incentivizes
­suppliers to innovate and allows innovations to be introduced during the lifetime of the contract.
When planning such complex acquisitions and, moreover, aggregating the needs of extended geographical areas,
the total time needed to get the solution up and running
is rather long. In fact, in addition to the total tender management time, we also need to add the time required for
installation.
During the installation, emerged technical problems
could probably be addressed during the tender design
phase. For example, the verification of the load of the floors
could be carried out during the tender and not post awarding, surely shortening the total supply times. So the tender
is not a one-off process but must be strongly coordinated
with the health facility concerned.
Furthermore, the aspects related to the data flow would
have the deserved deeper analysis already from the drafting
of the specifications and then also during the assessment.
Some critical issues emerged only ex post that is during the
assessment, since ICT professionals were not involved from
the beginning. It underlines how important it is to select the
right professionals for a successful tender, all the more for
long-duration tenders.
Further reading
Directive 2014/24/EU of the European Parliament and of the Council of
26 February 2014 on public procurement and repealing Directive
2004/18/EC.
Legislative Decree 2016/50 Code of Public Procurement.
Femtosecond Laser-Assisted Cataract Surgery (FLACS) for the Treatment
of Age-Related Cataract Version 1.4 October 2018 Eunethta.
Section 2
Worldwide clinical engineering
practice
Saide Jorge Calil
Department of Biomedical Engineering, Faculty of Electrical Engineering and Computing,
University of Campinas, Campinas – SP, Brazil
This chapter gathers several reports showing the situation of
the clinical engineering (CE) profession in countries around
the world. Basically, for each country presented here, the
history of the CE, the present situation, the difficulties faced
by the professionals, the type of activities, and the certification system are described.
Differently from other traditional professions like civil
engineering, mechanical engineering, electrical engineering, and so on, CE still has to show most healthcare administrators what it can do for them. While in almost every
country people understand and know the type of activities
developed by such traditional professions, CE is scarcely
known and develops different activities according to the
country.
The articles presented in this chapter show the significant differences between CE activities among several
countries. To exemplify such differences one can start
with the name defining such professional; whereas in the
American continent (North, Central, and South), it is called
Clinical Engineer, in most European countries, it is called
Biomedical Engineer. While in Japan, clinical engineers
deal directly with patients [hemodialysis, ECG signals,
etc.], this activity is totally forbidden in western countries
and is developed only by medical doctors or nurses.
In some countries CE is thriving while in others there
are discussions to define a new model for the profession,
and still others dove into deep frustration due to the lack
of recognition by the healthcare personnel as well as the
government. While in some countries, most of the clinical maintenance activities are developed by external service, some still maintain internal maintenance groups,
and others have a mixed model. Even the way CE was
originated in countries is different. In the Unites States,
for instance, CE was developed with the concept of patient
safety while in Brazil with the concept of medical equipment maintenance.
Indeed, one of the major complaints of professionals
working in the CE area is the lack of recognition of the
healthcare team. To worsen this problem, in several countries some maintenance groups, having as unique activity
the repair of medical devices, call themselves “Clinical
Engineering Group,” which makes the healthcare team to
think this is what CEs were trained for.
CE certification system, where there is one, follows a
different format. While in some countries there is a strict
procedure for CE certification, others just require a membership in a local CE society.
One of the biggest hurdles for the profession is the lack
of a basic set of knowledge required to define what is the
clinical engineering. Due to the different demands by the
country’s healthcare system for CE, and as a consequence,
different types of activities practiced by them, training
courses aim at different set of knowledge to attend such
demands. Exemplifying, if risk management is not yet an
identified demand of the healthcare system in the country,
this subject is not taught by the CE training courses, or even
known by their teachers. Hence, not knowing such subject
CEs will hardly press or propose the health system/unit to
develop a risk management program.
A serious issue found by reading the articles here is
that to become a clinical engineer, some countries require a
graduation background while others are happy with a technical background where these professionals also call themselves “clinical engineers.”
However, it has to be understood that CE is quite a
new profession and new technologies are arriving to the
­healthcare area every week. The number of new kinds of
knowledges needed by the clinical engineers to develop
their activities from the 1970s till today had grown four
times and is still growing. Taking the example of civil engineering where it is required to have specialists to build different type of structures (bridges, buildings, roads, etc.), the
61
62 SECTION | 2 Worldwide clinical engineering practice
growing number of different demands from the healthcare
area, and as a consequence different types of technological
and managing knowledge required to the clinical engineer,
will also need specialists within the CE area in the very near
future, if not now.
On the other hand, almost all the reports in the articles
show CE professionals struggling to improve the recognition of the profession and are aware and optimist that
despite the required endeavor, things are slowly getting
better.
Chapter 7
Clinical engineering in the
United Kingdom
Daniel Clark
Clinical Engineering, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom; Faculty of
Engineering, University of Nottingham, Nottingham, United Kingdom
Introduction
Modern health care is ever more dominated by technology: technology has a role in hospitals and in community
settings; in acute episodes and chronic care; and indeed,
technology can be used to prevent people becoming
unwell in the first place and help us all live longer and
healthier lives. New technologies have the potential to
revolutionize the way we manage health and well-being
now and in the future. Research and development into
new healthcare technology; the application of this technology in clinical settings and managing it to ensure it
continues to work safely and effectively once deployed,
requires the skills and experience of clinical engineers.
The profession has grown from early days supporting
pioneering research to being a vital resource supporting
most healthcare provision in the UK. Despite this success, clinical engineering teams remain largely unsung
heroes and need to continue to progress the profession’s
profile and gain further recognition for its value to health
care.
What is in a name?
Well, that which we call a rose, by any other word might
smell as sweet but a profession finds it hard to define its
identity and raise its profile when it cannot agree on its own
name. Over the years many terms have been used in the
UK to describe the functions of the application of engineering to health and well-being: bioengineering, biomedical
engineering, clinical engineering, medical equipment management (MES), electro-biomedical engineering (EBME),
medical equipment servicing units (MESU), rehabilitation
engineering, clinical instrumentation, biomechanics, and
medical engineering amongst many others. The debate has
not so much raged as bubbled along but today in the UK
there is relatively broad agreement that two terms encompass the field:
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00007-9
Copyright © 2020 Elsevier Inc. All rights reserved.
●
●
Biomedical engineering. The overarching term for engineers who use traditional engineering expertise to
analyze and solve problems in biology and medicine,
provides an overall enhancement in health care. It encompasses a range of subspecialties including biomechanics (including prosthetic devices and artificial
organs); bioinstrumentation (including imaging system,
sensors, and monitoring systems); biomaterials (including tissue engineering and regenerative medicine); systems physiology and physiological modeling.
Clinical engineering. A separate but linked discipline, sometimes seen as a subspecialty of biomedical engineering, with
a direct focus on the adoption, application, and management
of healthcare technology in the clinical environment (and in
the UK, predominantly in the hospital setting).
Of course, there is a dependency between and across
these areas and even a degree of overlap. Moreover, the
nature of these rapidly evolving fields makes definitions
difficult but these two broad terms help describe the disciplines. And old habits, of course, die hard: the terms EBME,
MESU, and others will still be heard in many hospitals
across the UK. In general, biomedical engineering tends to
the work at the more research and development end of the
product lifecycle; clinical engineering at the more adopt,
implement, and improve end. In general, biomedical engineers tend to work in academia, research facilities, and industry; clinical engineers in hospitals and other healthcare
settings. But in all cases, engineering principles, good communications, multidisciplinary working, and a desire to improve the health and well-being of people is common.
This chapter concentrates on clinical engineering in the
UK and covers the early development of the field; the organization and management of clinical engineering services and
the current range of services provided within the National
Health Service (NHS); the standards and regulations in place
covering clinical engineering services and the workforce delivering these services, their training and registration.
63
64 SECTION | 2 Worldwide clinical engineering practice
Early years
The application of technology to health care is not new. One of
the earliest examples of medical device technology is a prosthetic toe that dates from about 1000 BCE (Before Common
Era) and is currently on display in the Cairo Museum in Egypt.
It is made from cartonnage, a sort of papier maché made using linen, glue, and plaster and demonstrates the engineering
ingenuity of the time, though the Egyptians probably did not
refer to the creator as a clinical engineer. Indeed, the first reported use of the term was not until much more recent times
when cardiologist Cesar Caceres first coined the term (Landoll
and Caceres, 1969) in 1969. A decade earlier, in 1959, a
group of engineers, physicists, and physicians met at the
Second International Conference of Medical and Biological
Engineering, in the United Nations Educational, Scientific and
Cultural Organization (UNESCO) Building, Paris to create
an organization then entitled the International Federation for
Medical Electronics and Biological Engineering (IFMBE). At
that time there were few national biomedical engineering societies, and certainly not one for the UK, so individual workers in the discipline joined as Associates of the Federation.
Later, as national societies were formed, these societies became affiliates of the Federation.
The following year, the conference was held in London
and served as the catalyst for the formation of a society to
serve the needs of biomedical engineers in the UK and the biological engineering society (BES) was established in 1960.
The name of the society reflected the aim of representing
the widest possible group of multidisciplinary professionals working in the application of engineering to biological
systems. In 1963, the BES was one of the first national societies to affiliate with the IFMBE and provided a focus for
biomedical engineering activity in the UK. In 1995 the BES
merged with the Hospital Physicists’ Association (HPA) to
form what is now the Institute of Physics and Engineering
in Medicine (IPEM) to create a single professional body
representing the interests of physicists and engineers in
medicine. In part this merger was a pragmatic marriage creating a larger and more resilient new institution to better
support its professions; in part it reflected a general coming
together of these teams at local level in hospitals across the
NHS; but mostly this was an opportunity to integrate education, training, research, and methods of service delivery.
The first hospital-based departments dedicated to engineering started to appear in the early 1970s. Before that, engineers employed in healthcare applications tended to be based
in academic research facilities; within clinical departments in
support of specific research programs or within medical physics departments in larger hospitals. The UK developed significant research strengths in biomedical engineering during this
time developing many healthcare technologies in worldwide
use today. Specific examples of these pioneers of biomedical
engineering include (IPEM, n.d.): Sir Godfrey Hounsfield:
an electrical engineer who was awarded the Nobel Prize for
developing X-ray computed tomography (CT) scanning; Sir
Peter Mansfield: this Nobel Prize winner played a pivotal role
in the development of the medical imaging using magnetic
resonance imaging (MRI) and functional MRI; Professor Peter
Wells CBE (Commander of the Order of the British Empire):
awarded the Royal Medal in 2013, also known as the Queen’s
Medal, for his pioneering work in medical ultrasound.
Organization of services and management
arrangements
During the same period there was an increasing dependency
on medical equipment in healthcare provision and by the
late 1960s and early 1970s, hospitals were becoming aware
of the need to manage this equipment. Responsibility for
medical equipment generally rested with the local Hospital
Engineering Department (which would now be called the
Estates Department) but there was the recognition that these
teams—who managed fixed plant and nonmedical equipment—had neither the systems nor capacity to address the
growing issue. Significant debate followed as to the best way
to address the issue with two schools of thought prevailing:
(1) that Hospital Engineering Departments should continue
to manage all equipment, including medical equipment,
and should be expanded and developed to facilitate this and
(2) that biomedical engineers (including the newly termed
Clinical Engineers) should establish new teams within existing Medical Physics Departments. In general, the larger hospitals that already had bioengineering activity usually based
around research tended to develop services within Medical
Physics Departments whereas the smaller hospitals tended to
develop services within existing hospital engineers (estates)
departments. This division is still apparent today with some
hospitals, generally the major teaching hospitals, running engineering or scientifically led services usually out of medical
physics and clinical engineering departments while the majority, generally smaller district general hospitals provide technically led services managed through estates departments.
Clinical engineering services in the UK
Over the years, the development of different management
arrangements in different hospitals led to a range of service
provisions across the NHS: it is probably true to say that no
two hospitals provide exactly the same services. It is therefore convenient to describe UK-based clinical engineering
services initially in high-level terms. Fig. 1 describes the elements that a healthcare provider (hospital) should have in
place to safely and effectively manage healthcare technology.
This can be broadly grouped into three themes: healthcare
technology management; healthcare technology innovation;
and healthcare technology applications all of which require
systems of governance to ensure patient safety.
Clinical engineering in the United Kingdom Chapter | 7
65
FIG. 1 Range of clinical engineering services.
Healthcare technology governance
The paramount responsibility of the clinical engineering
service is to ensure good governance of technology, ensuring the organization is compliant with national regulations
and standards, and ultimately that patients are kept safe.
The exact mechanism through which this is delivered will
vary depending on the size of the hospital and the clinical
engineering service but will include systems to respond to
external and internal safety alerts; services to support investigations into clinical incidents involving medical devices;
system to monitor, review interpret and implement relevant
legislation, regulations, standards, and best practice guidance and support for corporate, hospital-wide groups developing healthcare technology strategy and policy.
Healthcare technology management
Modern health care is hugely dependent on the availability and management of the medical equipment which is,
perhaps, the core function of clinical engineers. Clinical
engineers will be influential in, and indeed sometimes
responsible for, medical equipment resourcing: managing, or being involved in, the acquisition of new medical
equipment; ensuring the needs of the patients are met; ensuring that the equipment is appropriately evaluated before
a­ cquisition; ensuring that equipment is compliant to appropriate legal and regulatory standards and that when delivered to site that the equipment is safe and working correctly
before it is used on patients. Increasingly, clinical engineers
will also manage the availability of equipment through central stores or libraries, ensuring the right equipment is available at the right time and in the right condition.
Medical equipment servicing ensures that the essential
performance and safety of the equipment is maintained over
its lifetime helping to support optimum clinical care for patients. Clinical engineering servicing teams maintain most
medical equipment and place contracts with external servicing agents where appropriate. Servicing tasks will include
acceptance checks to ensure equipment is safe and working
correctly when first delivered, preventative maintenance to
ensure equipment continues to perform as the manufacturer
intended and repairs. Often, servicing teams are grouped
by equipment portfolio which, depending on the size and
nature of the hospital might include: general medical equipment; theaters and anesthetics, renal; critical care; radiotherapy and radiology.
A key element to healthcare technology management
is maintaining and developing records. Good inventory
­management is not only essential to manage the current equipment base but provides valuable insight for
66 SECTION | 2 Worldwide clinical engineering practice
r­eplacement programs and financial management of vital hospital assets. Most clinical engineering departments
use one of a number of commercially available inventory
systems (databases) but, unfortunately, there is a lack of
consistency and standardization as to how these inventories are used leading to difficulties in national reporting
and benchmarking.
Healthcare technology innovation
While genuine ‘blue sky’ research (like that of Hounsfield,
Mansfield, and Wells) is rare within NHS clinical engineering services these days, Clinical Engineers nonetheless make significant contributions to medical technology
innovations in various ways. Some departments still run
engineering and instrumentation groups that provide a
bespoke technical solution to clinical research projects.
Operational pressures and finances have made these services hard to sustain. The 2017 changes to the medical
devices regulations (MDR2017/745, Regulation (EU)
2017/745 of the European Parliament and of the Council,
n.d.) in Europe might, perhaps counterintuitively, present an opportunity for these services because well run
NHS clinical engineering teams designing devices or elements of devices under appropriate quality systems will
become more attractive to NHS clinical research projects
than outsourcing to commercial or academic partners.
While the number of centers designing and developing
new devices is small, most departments will be facilitating clinical research by supporting the introduction of
new and novel technologies as part of clinical research
projects.
Health technology assessment (HTA) is a developing
role for clinical engineers. Traditionally, clinical engineers
have not been active in this relatively new discipline but
increasingly their skills and experiences are being recognized as valuable in this area. Moreover, as the focus
of healthcare systems becomes more and more centered
on financial sustainability, the role of new technologies
to support more cost-effective health care is being highlighted. Clinical engineers, with their knowledge of technology, their systems-based methods, and their analytical
skills are being seen more and more as key workers in this
developing field.
Healthcare technology applications
Clinical engineers play both a direct and indirect role in the
applications of healthcare technology. Directly, some clinical engineers will be routinely supporting clinical services
by providing technical and scientific input into clinics and
procedures. This often overlaps with what is traditionally
referred to in the UK as physiological measurement and includes services such as audiology, ophthalmology, electro-
diagnostics, clinical neurophysiology, human performance
(gait analysis), and critical care technology. In some hospitals, these technical and scientific services are provided by
staff employed directly with the clinical team, in others by
staff in dedicated teams within medical physics services and
in some centers by clinical engineering teams. Howsoever
this service is provided, the staff tend to be based locally
within the clinical areas and work directly with clinical staff
and patients.
Another area of direct clinical support that can involve
clinical engineers is nonionizing radiation. It is perhaps
more common in the UK for these services—which include
lasers, microwaves, ultrasound, ultraviolet, thermometry,
and diathermy— to be provided by the radiation physics
teams.
More generally, whenever new technology is introduced into the healthcare system, clinical engineering
teams are involved in supporting clinical teams and ensure they optimize its performance. This can take the form
of assessing the technology and working with the clinical
teams to get the configurations correct, through to helping redesign the clinical pathway to account for the new
technologies capabilities. Ordinarily, once the clinical service is established, the clinical engineer reduces or ends
their involvement and the routine service is provided by
the clinical teams.
Rehabilitation engineering
A specific mention needs to be made to rehabilitation engineering. Sometimes this service is provided by the clinical engineering team but more often this is a standalone
department, usually based with the multidisciplinary rehabilitation team that also includes physiotherapists, occupational therapist, speech and language therapist, and
mobility teams. Rehabilitation engineers have very similar training and skills to clinical engineers but dedicate
their service toward assessing and responding to the needs
of people with disabilities. They provide standard and
customer-made assistive technology including specialist
seating; wheelchairs; artificial limbs; electronic communicators; and robotic aids.
Indirectly, clinical engineers support the application
of technology by providing medical devices training and
competency management which can range from fairly
small training and assessment centers on a limited number of medical devices through to full proficiency management covering most equipment used in the hospital across
all staff groups. Increasingly, the NHS inspection bodies
(see below) are looking for evidence that clinical staff are
competent to use the equipment in their areas. Clinical
engineers, with their extensive experience of equipment
types, are well placed to manage systems to train and assess competency.
Clinical engineering in the United Kingdom Chapter | 7
Managing standards, regulations, and
performance
Regulations
At time of writing, the UK medical devices market was regulated, in common with the rest of Europe, under three principle Directives: the Medical Devices Directive (EC 93/42/
EEC); the Active Implantable Medical Devices Directive
(EC 90/385/EEC), and the In-Vitro Diagnostic Medical
Devices Directive (EC 98/79/EC). The UK Competent
Authority—the Medicines and Healthcare products
Regulatory Agency (MHRA)—acts as the regulator for the
medical devices industry. The MHRA ensures that manufacturers meet UK legislation (MHRA, n.d.) by monitoring
incidents, approving of clinical trials and clinical investigations, auditing of UK notified bodies, maintaining the register of manufacturers of class I medical devices, and taking
compliance and enforcement action where necessary. The
MHRA also produce guidance intended primarily for people working in hospitals and community-based organizations that are responsible for the management of reusable
medical devices, to help them set up and develop systems
that promote the use of the medical devices for safe and
effective health care (Managing Medical Devices, 2014).
This guidance document (and its predecessors, Managing
Medical Devices, 2006; DB 2005(03), 2005) form the basis
of all clinical engineering services in the UK, outlining the
principles, systems, and practices required for safe and effective management of medical devices. This guidance also
influences the inspection bodies in the UK with respect to
medical devices management.
Changes to the European legislative framework for medical devices are being implemented with the current three
Directives becoming two new Regulations: Regulation on
Medical Devices (EU 2017/745) and Regulation on In vitro
Diagnostic Medical Devices (EU 2017/746) with transition
periods of 3 years (until 2020) and 5 years (until 2022), respectively. Clinical engineering departments are likely to
have to adapt their services to meet these newer requirements but again, guidance from the MHRA is expected.
Additionally, of course, at the time of writing, the UK is
planning to leave the European Union and as such the legislative framework is now uncertain. The expectation is that
the UK will continue to follow the EU regulations under
a mutual recognition agreement but the future here is still
unclear.
UK (NHS) healthcare inspection regimes
The vast majority of health, well-being, and social care
services provided to people in the UK is delivered by the
NHS. A single system is in place across England and Wales,
with slightly different approaches in Scotland and Northern
67
Ireland, but all essential an NHS provision. Additionally,
there are a few smaller private and charity-based providers. All these services are subject to a single regulatory system and the principal regulatory body for all health service
providers is the Care Quality Commission (CQC), an independent regulator of health and adult social care. The CQC
make sure that health and social care services provide people with safe, effective, compassionate, high-quality care,
and support care services to improve. They register care
providers (a care provider must be registered in order to
provide its services); inspect and rate services (Outstanding,
Good, Requires Improvement, or Inadequate); take action
to protect people (by issuing improvement notices for care
providers where required or even by removing their right
to provide services), and publish their findings. There is no
national body with specific responsibility for inspection or
regulation of clinical engineering services. Rather, these
services are assessed, by the CQC, in terms of the support
they provide to the clinical teams they serve. The CQC use
available standards and best practice guidance when inspecting; in the case of clinical engineering, this tends to be
the guidance produced by the MHRA (Managing Medical
Devices, 2014). Although clinical engineering services are
only a tiny fraction of everything that the CQC has to inspect, they tend to get a higher profile than their size might
suggest because almost every patient episode will involve
one or more medical device which can lead the inspector to
ask questions about the clinical engineering teams.
From April 2016 a second inspection body also took effect across the UK healthcare system. NHS Improvement
(NHSi) is responsible for overseeing NHS organizations and
offers the support these providers need to give patients consistently safe, high quality, compassionate care within local
health systems that are financially sustainable. By holding
providers to account and, where necessary, intervening,
NHSi help the NHS to meet its short-term challenges and
secure its future. While not strictly a regulator and without the powers to stop organizations from providing care
services, they nonetheless hold significant influence over
funding and their inspections, therefore, carry great weight.
Like the CQC, NHSi does not specifically inspect clinical
engineering services but again, because the impact of our
services is so wide across all clinical teams, our roles can
have a disproportionately large effect on any inspection.
Quality systems
It is increasingly common for UK clinical engineering departments to operate within a quality management systems
(QMS) with ISO 9001 being the primary standard. The
quality management establishes the framework for how a
service manages its key processes and helps ensure processes meet recognized standards, clarifying objectives and
avoiding damaging and expensive mistakes. In the absence
68 SECTION | 2 Worldwide clinical engineering practice
of a national inspection body for clinical engineering services, operating a QMS also enables departments to demonstrate their adherence to MHRA and other relevant guidance
when inspected by the more generic CQC or NHSi inspectorate. Departments that manufacturer devices (which are
relatively rare in the NHS) or are active in supporting design
and development of medical devices also tend to be covered
by ISO 13484.
Benchmarking
Benchmarking can be an important part of performance
management enabling different services to compare their
processes and performance metrics to industry bests and to
best practices from other departments. The diverse range
and size of clinical engineering departments in the UK can
make this challenging but the NHS National Performance
Advisory Group (NPAG) support a number of benchmarking activities across many clinical engineering departments.
This is not a requirement under any national regulatory or directive but supports best practice and service improvement.
Workforce
Career and training pathways
Clinical engineering comes under the umbrella term of
healthcare science within the NHS. A career and training pathway for healthcare science is managed nationally through NHS Health Education England. Fig. 2
below shows the stages of this pathway generalized for
all healthcare science professions (NHS Health Education
England, 2018). The intention is that individuals can enter
at one of three points as indicated on the diagram (dependent on academic qualification and experience) but can also
travel up through the pathway supported by workplace and
academic training programs. In theory, an individual can
enter at the lowest point on the diagram and work themselves up to consult level.
At the “Entry” Level, an individual might come directly
from school or college or be appointed into a clinical engineering team from another career but without relevant
qualifications or experience. Staff at this point would generally be referred to as Assistant Clinical Technologists or
Associate Clinical Technologists. Their roles would vary
depending on the department size and scope of service but
might include a technical support function; basic user and
technical maintenance; general workshop support roles.
Clinical engineering assistants work toward vocational
qualifications, often apprenticeships are used as a training
route. They might also be trained through a higher-level
apprenticeship, foundation degree or diploma. A national
learning and development framework is being developed by
Health Education England. Once implemented, the modular framework will provide a national learning structure for
assistants and associates with vocational awards and qualifications. However, this is not yet available for clinical engineering assistants and Associates.
At the “Direct entry” level, an individual might come
via progression from the clinical engineering assistant or
associate route or might come directly from college with
appropriate qualifications. Individuals might also be appointed from other careers provided they have relevant
experience. Generically, this stage of the career pathway
is termed the healthcare science practitioner, but within
clinical engineering they are generally referred to as
Clinical Engineering Technologists [or sometimes Clinical
Engineering Technicians (EngTech)].
Healthcare science practitioners are now trained through
NHS approved and accredited BSc honors degrees through
the Practitioner Training Program (PTP) in various themes
of healthcare science. Offered by a number of universities
across England, the programs include academic learning
and work-based training. The 50+ week work-based training element, supported by curricula, is spread over 3 years,
involving broad scientific training in the first 2 years with
an increasing focus on a chosen specialism during year 3.
The PTP scheme is still maturing and is not generally well
adopted within clinical engineering services.
At the “Graduate direct entry” level, an individual
usually comes post-university degree and would join the
Scientist Training Program (STP). This is a 3-year program of work-based learning, underpinned by a university
accredited master’s degree. Trainees are employed by an
NHS hospital for the duration of the program and will be
required to spend time in a range of settings, before specializing in the last 2 years of the program. Within clinical engineering, these specialisms cover Device Risk Management
and Governance; Clinical Measurement; Design and
Development; and Rehabilitation Engineering. The STP
national recruitment process is managed by the National
School of Healthcare Science. Generically, this stage of the
career pathway is termed the trainee clinical scientist, but
within clinical engineering they are generally referred to
as trainee clinical engineers. Upon successful completion
of the STP staff would become clinical engineers and be
expected to join the nation register (see state registration
below).
Beyond this level, a further national training scheme
is also available: the Higher Specialist Scientific Training
(HSST). This is a 5-year program available to registered
and experienced clinical scientists (including clinical engineers) who wish to train and become eligible to apply for
consultant clinical scientist (including clinical engineer)
posts. The program is equivalent to the standards of training undertaken by medical postgraduate trainees. Staff can
join the program either as a direct entry (apply for a new
post) or as an in-service entry (nominated by their current
employer).
Clinical engineering in the United Kingdom Chapter | 7
Clinical academic career
Consultant clinical scientist
Higher Specialist
Scientist Training
(HSST)
Graduate direct entry
Scientist Training
Programme (STP)
MSc Clinical
science and work
based programme
69
Statutory
regulation
(clinical scientist)
Clinical
scientist
Accredited
Expert Scientific
Practice
Potential equivalence and progression route
Direct entry
Practitioner Training
Programme (PTP)
integrated BSC
(Hons) Healthcare
Science and
statutory regulation
Biomedical
scientist or
accredited
voluntary
registration
Accredited
Specialist
Scientific
Practice
Healthcare science
practitioner
Potential equivalence and progression route
Entry
Learning and
development
framework
Accredited
voluntary
registration
You can enter healthcare science at
any of these levels
Healthcare science
associates and
assistants
Accredited
Additional
Scientific
Practice
Source: www.dh.gov.uk
FIG. 2 Healthcare science career and training pathway.
Profile
The number of staff and the roles they undertake will vary
widely across clinical engineering departments depending
on their size, the type, and size of the hospital they support, and the range of services they are involved with. The
following is therefore merely indicative of what a typical
department might look like, should such a thing exist.
Clinical engineers
Generally, few in numbers—many departments will have
one or two engineers and even larger departments rarely
have more than 10—clinical engineers will work across
all aspects of clinical engineering services. They provide
support and leadership roles for most clinical engineering
activities, being responsible for service delivery, practice,
and policy. They often have hospital-wide responsibility for
medical devices governance and patient safety. Additionally,
they often play lead roles in healthcare technology innovation, either directly through their own research or by facilitating technology-led research programs in hospitals.
Clinical engineering technologists
The largest staff group, clinical engineering technologists
are generally the mainstay of a clinical engineering department, predominantly working in the healthcare technology
management field, and in servicing workshops, in particular. Some staff technologists, of course, will also be involved with the application of technology—particularly in
clinical support roles—and others will support research and
innovation activities.
70 SECTION | 2 Worldwide clinical engineering practice
Assistant clinical engineering technologist
Often seen as an entry-level role or apprenticeship, assistant technologists are an increasing staff group with clinical engineering services. Most departments try to have a
small number of these roles to help future workforce requirements. However, assistant technologists provide a very
useful role in themselves, often supporting the servicing
functions of the department.
Equipment library staff
Staff supporting equipment library functions in hospitals
can be porters, assistant technologists, and supervisors.
This very operational role not only involves the logistics
side of ensuring equipment provision across the hospital
but usually also includes basic user and technical servicing
elements, particularly equipment cleaning, inspection, and
battery management.
Nurses
Clinical engineering services often provide training and
competency management support for clinical users of medical equipment. This role might be delivered by engineers,
technologists or nurses. Nurses bring clinical credibility
and understanding to the role and when supported by a
technical department can often enhance the service quality
considerably.
Administration
By the nature of their activities, clinical engineering departments have a significant need for good administration systems and business support staff. Often, this team
is the essential glue that holds services together providing
financial support, procurement, stock management, and
record-keeping.
Health technology assessment analysts
A growing role for clinical engineering HTA is making an
increasing impact on health technology provision. Specialist
HTA analysts remain rare in UK clinical engineering services but are likely to increase in the future.
Managers
Most clinical engineering services are managed by clinical
engineers or clinical engineering technologists. It is rare
that a department would have a dedicated, nontechnical
manager. However, larger departments often employ business managers to help with the increasing financial and contractual arrangements.
Clinical engineering certification
There is no Clinical Engineering Certification scheme currently in operation in the UK. For a period in the 1980s and
1990s, attempts were made to introduce a scheme along the
lines of the successful national certification schemes in the
United States and Canada. However, the UK scheme never
gained traction, perhaps because it tried to cover too broad
a field that included clinical engineering and rehabilitation
engineering, perhaps because the profession at that time
was diverse and did not coalesce around the scheme or perhaps because of the higher profile and status of the generic
Charter Engineer run through the Engineering Council.
Whatever the reasons, by 1998 the attempt to introduce a
Clinical Engineering Certification was abandoned.
In the UK, the Engineering Council is charged with
maintaining the register of professional engineers who
are referred to as chartered engineers (CEng) and use the
designator letters CEng. IPEM holds a license to assess
CEng candidates for registration under the auspices of the
Engineering Council. This also extends to EngTech and incorporated engineer (IEng) candidates.
State registration
The Health and Care Professions Council (HCPC) is the
UK regulator with responsibility for maintaining the registered of healthcare professionals who meet defined standards for their training, professional skills, behavior, and
health. The HCPC replaced the Council for Professions
Supplementary to Medicine (CPSM) in 2002 and currently
regulates 16 professions (it does not regulate doctors, dentists, or nurses). In 2000, the profession of Clinical Scientist
was formally included in this register under the Professions
Supplementary to Medicines act of 1960. The term clinical
scientists (which is a protected title and can only be used by
professionals on the registered) is a broad group of professions and includes clinical engineers. The primary aim of
the HCPC is to protect the public by ensuring that professionals, including clinical engineers, achieve and maintain
appropriate standards for their training, professional skills,
behavior, and health. All clinical scientists, including clinical engineers, working in the UK health service must be
registered. Loss of registration means that person may no
longer work in the public sector.
The register of clinical technologists (RCT)
The RCT was formed in 2000 (as the Voluntary Register
of Clinical Technologists) with the aim of protecting the
public by advocating statutory, professional regulation for
clinical technologists. However, a new approach to regulation, namely accredited registers, has been established by
the UK government in preference to statutory registers and
in 2012 the Health and Social Care Act extended the role
of the Professional Standards Authority (PSA) to include
accrediting registers of people working in health and care
occupations not regulated by statute.
Clinical engineering in the United Kingdom Chapter | 7
The RCT has been accredited by the PSA under its
Accredited Registers program since September 2015. In order to obtain accreditation, an organization must show they
have met the PSA’s specific, demanding standards relating
to governance, standards for registrants (including education and training), and management of the register, by way
of a rigorous application process. Organizations are then reaccredited each year provided they can show they are still
meeting the PSA standards.
Conclusion
Clinical engineering in the UK has matured as a profession from its early days supporting academic research to
being an essential service supporting healthcare provision
right across the NHS. Early achievements in biomedical research, adoption of quality-based service delivery, recognition of national training schemes, and state registration have
all helped to confirm the sense of identity and gain professional acceptance in the UK healthcare market. However,
UK clinical engineering cannot rest on its laurels. It needs
71
to continue to raise its profile, to continue to develop its
services and to continue to support the changing and increasing demands of an ever more technology-dependent
healthcare system.
References
DB 2005(03), 2005. Guidance on the Safe and Effective Use of Batteries
and Chargers for Medical Devices.
IPEM,WebPage:https://www.ipem.ac.uk/AboutIPEM/GovernanceofIPEM/
History.aspx.
Landoll, J.R., Caceres, C.A., 1969. Automation of data acquisition in patient testing. Proc. IEEE 57 (11), 1941–1953.
Managing Medical Devices, 2006. Guidance for Healthcare and Social
Services Organisations DB 2006(05).
Managing Medical Devices, 2014. Guidance for Healthcare and Social
Services Organisations.
MHRA,https://www.gov.uk/government/organisations/medicines-andhealthcare-products-regulatory-agency.
NHS Health Education England, 2018. Careers in Healthcare Science,
NHSCB09.
Regulation (EU) 2017/745 of the European Parliament and of the Council.
Chapter 8
Clinical engineering in Canada
William M. Gentles
BT Medical Technology Consulting, Toronto, ON, Canada
Introduction
Demographics
Canada is a country with a population of 36.7 million (as
of 2017) distributed over an area of approximately 10 million km2 (including land and fresh water). That results in
a population density of 3.67 inhabitants/km2 although the
population is not distributed uniformly throughout Canada’s
territory. The majority of the population lives in a fairly narrow band within 160 km (100 miles) of the US border. In
2015, the infant mortality rate was 4.9 per 1000 live births.
Canada’s infant mortality rate is higher than most other developed countries except the United States. This high infant
mortality rate is an indicator of inequalities in access to health
care, which are most evident in indigenous populations. The
territory of Nunavut in the far north of Canada has an infant mortality rate of 18.5 per 1000 live births. The average
life expectancy of those born today in Canada is 82 years.
Canada is experiencing an ageing population. According to
Statistics Canada (2017), 15.7% of the Canadian population,
nearly one person in six, was 65 or older as of July 1, 2014.
This proportion has been rising steadily since the mid-1960s
because fertility rates have been below the replacement level
and life expectancy has been increasing. This is presenting a
growing challenge to the healthcare system, as the h­ ealthcare
needs of an elderly population include many unique challenges. There is a growing trend to deliver health care in the
home, as it better meets the needs of elderly patients, and is
much cheaper than hospital care. The technologies to support home health care are developing rapidly, and require
clinical engineering departments to learn how to service this
technology effectively.
Education of clinical engineers and clinical
engineering technologists
In most hospital clinical engineering departments in Canada
the technical staff is a mix of engineers and technologists.
The ratio of technologists to engineers is typically around
72
10:1. Technologists are usually educated in community colleges (or CEGEPs in the province of Quebec). The duration of this postsecondary education is typically 3 years.
Many technologists in Canadian hospitals have a college or
CEGEP diploma in electronics technology, although there
are now a limited number of college programs offering diplomas in biomedical engineering technology.
There are a limited number of universities offering
degrees in clinical engineering or health technology management. Such clinical engineering programs typically
include internships where the student works in a hospital
environment. The number of educational programs is too
many to list here, but may be found listed on the website of
the Canadian Medical and Biological Engineering Society
(CMBES, 2014) (http://cmbes.ca/schools).
The Canadian medical and biological engineering
society
The national society for clinical and biomedical engineering in Canada is the CMBES (www.cmbes.ca). This society
was founded in 1965 by Dr. Jack Hopps. The first annual
CMBES conference was held in 1966 in Ottawa. In 1977
the society hosted the first Clinical Engineering Conference
in Montreal. By 1982, the CMBES conference had become
an annual event, which incorporated clinical engineering as
one of the main tracks, the other being devoted to research
and academic topics. The CMBES secretariat is managed by
a Society Management Group called “The Willow Group”
which is based in Ottawa. They provide administrative support, manage the society website, and assist in organizing
the annual conference.
Over successive years, a number of regional clinical
engineering societies were formed to provide learning and
networking opportunities for clinical engineers. These included the Atlantic Canada Clinical Engineering Society
(http://accesociety.org/), l’Association des physiciens et ingénieurs biomédicaux du Québec (www.apibq.ca), and the
Clinical Engineering Society of Ontario (www.ceso.on.ca).
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00008-0
Copyright © 2020 Elsevier Inc. All rights reserved.
Clinical engineering in Canada Chapter | 8
Canadian clinical engineers also participate actively
in international groups such as AAMI (Association for
the Advancement of Medical Instrumentation), ACCE
(American College of Clinical Engineering), and IFMBE
(International Federation of Medical and Biological
Engineering).
The present status of clinical engineering in
Canada
Health care is a provincial responsibility in Canada, and
each of the 10 provinces and 3 territories has a slightly different approach to the way health care is organized. There
is a growing trend to organize health systems regionally
within a province, with the number of regions determined
by the population and size of the province. For example,
the province of British Columbia, on Canada’s west coast,
has a population of 4.8 million and a total area (including freshwater) of 944,735 km2. The province has five regional health authorities. Clinical engineering services are
also regionalized into four regions, with a similar management structure in each region. The total number of clinical
­engineering staff (including engineers, technologists, and
administrative staff) in the province is about 350. On a per
capita basis, this is about 1 clinical engineering staff for every 14,000 people in the province. In the 2015–16 fiscal
year there were 12,274 staffed hospital beds in the province
(Canadian Institute for Health Information, 2017), so 1 clinical engineering staff for every 35 hospital beds. Another indicator is the number of devices per staff member. In British
Columbia there are 135,000 devices in the province-wide
CMMS (computerized maintenance management system).
This translates into an average of 385 devices per clinical
engineering staff member.
Other provinces are expected to have similar indicators,
although the data is not readily available.
Certification of clinical engineers
There has been a certification program for clinical engineers in Canada since 1979. The program fell dormant for several years, but was revived in 2005. The
certification program is administered by the Healthcare
Technology Certification Commission (http://accenet.org/CECertification/Pages/Default.aspx) and the
Canadian Board of Examiners for Clinical Engineering
Certification. The prerequisite in Canada to become a
certified clinical engineer is that you must be registered
as a Professional Engineer (P. Eng.) within a provincial
engineering association. The reason for this is that the
title “Engineer” is protected by law, and can only be used
by persons who are registered as Professional Engineers
with one of the provincial Professional Engineering
Associations. As of March 2017, there were 24 certified
73
clinical engineers in Canada. Candidates wishing to become certified must apply to the Healthcare Technology
Certification Commission. If their application is accepted,
they take the same written examination as all candidates
in the United States; however questions specific to US
codes and standards are not marked. If they pass the written examination, they are then required to take an oral examination with one question that is specific to Canadian
Codes and Standards. The oral examination is administered by the Canadian Board of Examiners, and usually
takes place during the CMBES annual conference. For
candidates who pass the oral examination, a recommendation for certification is sent by the Canadian Board of
Examiners to the Healthcare Technology Certification
Commission, who issues the certificate.
Clinical engineering standards of practice for
Canada
In 1998 the first Clinical Engineering Standards of
Practice for Canada (CESOP) was published by CMBES.
Updated editions were published in 2007 and 2014. The
standards were developed and revised by committees
consisting of experienced members of the clinical engineering community from across the country. Each edition was presented to the membership of CMBES, and
was adopted after a vote of approval by the membership.
The latest edition is structured according to guidelines
from the International Standards Organization (ISO/
IEC, 1994). The major sections are Service Management
and Service Provision. There has been a trend for clinical engineering services in Canada to use the Standards
of Practice as the basis of a Departmental Policy and
Procedure Manual.
The document is also used as the basis of a peer-review
program in which a clinical engineering department or service can apply for an external review of their department or
service by a team of their peers with expertise in the field
of clinical engineering. The peer-review program is voluntary and has been offered by CMBES since 2000 and as
of 2017, eight reviews have been conducted. The rationale
for developing a Standard of Practice and a peer-review
program was the recognition that Accreditation Canada,
the Hospital Accreditation body, had little expertise in
evaluating clinical engineering services in hospitals. Since
the development of the Standards of Practice, we have
shared these standards with Accreditation Canada, and
they have incorporated references to our standards and our
peer-review process in their Accreditation questionnaires
that they send out to a hospital prior to an Accreditation
review.
This is strong evidence that a Standard of Practice
document is a valuable tool for raising the profile of the
profession.
74 SECTION | 2 Worldwide clinical engineering practice
The peer-review process
The peer-review process is voluntary, and operated by
CMBES on a cost recovery basis. Services requesting a review are only charged for the expenses of the surveyors.
The surveyors volunteer their time. It is generally acknowledged that surveyors learn a great deal from participating in
a survey, and so there is mutual benefit. Consequently, we
have had no shortage of potential surveyors volunteering to
participate in a survey.
The first step that a clinical engineering service must
take to initiate a survey is to submit a written request to
the CMBES peer-review committee. They are then sent a
presurvey questionnaire, and a request for other documents
such as the policy and procedure manual and an organizational chart. The peer-review committee decides if the request is eligible for peer-review and informs the requestor.
The scope of the review is confirmed including all sites,
locations, and proposed dates for the survey.
The peer-review committee then recruits a team of three
to five surveyors that includes at least one technologist and
one engineer, with experience relevant to the hospital being
surveyed.
The following activities take place during the site visit
which lasts from three to five days (there may be several
sites included in the survey):
●
●
●
●
●
An introductory meeting with the service manager to review the itinerary and the organization of the service.
A meeting with the senior administration representative
that the service manager reports to.
A tour of the clinical engineering facilities.
An audit of service documentation including completeness and accuracy of device service history, scheduled
maintenance compliance, and completeness and accuracy of device inventory information.
Meetings with as many service customers as possible.
This is an important part of the survey. These take place
in private to allow a frank discussion of the strengths
and weaknesses of the service.
●
●
A private meeting of the surveyors on the last day of the
survey to allow them to collect their thoughts and identify key issues, and prepare a synopsis for service staff.
A wrap up meeting with the service manager and service
staff to discuss the preliminary findings. This discussion
is of a positive and supportive nature, and fairly brief.
The following are the activities that happen after the survey has been completed:
●
●
Findings are summarized in a written report that the service manager can present to the senior administrator.
A postsurvey questionnaire is sent to the site asking for
feedback and suggestions to improve the peer-review
program.
Conclusions
Clinical engineering in Canada has a long history. It has benefitted from a single-payer health system, where all clinical
engineers work ultimately for the same boss, the Canadian
taxpayer. As a result, there is a sense that we are all on the
same team, and there is a willingness to work together to
share best practices and other information. This has led to
the strengthening of the profession and recognition of its
importance by federal regulators, and Accreditation Canada.
References
Canadian Institute for Health Information, 2017. Canadian MIS database
(CMDB), 2015–2016, CMDB hospital beds staffed and in operation,
2015–2016. https://www.cihi.ca/en. (Accessed February 8, 2018).
CMBES, Clinical Engineering Standards of Practice for Canada, 2014.
Available at: http://cmbes.ca/publications-a-references. (Accessed
February 8, 2018).
ISO/IEC, 1994. Code of good practice for standardization. ISO/IEC
GUIDE 59:1994 (E). https://www.iso.org/standard/23390.html.
(Accessed February 8, 2018).
Statistics Canada, 2017. Canada at a Glance. Available at: http://www.
statcan.gc.ca/pub/12-581-x/12-581-x2017000-eng.htm.
(Accessed
February 11, 2018).
Chapter 9
Clinical Engineering in
Colombia
Jorge Enrique Villamil Gutiérrez
Manuela Beltrán University, Bogotá D.C., Colombia
This chapter aims to inform about the state of development of
clinical engineering that in Colombia should be understood
as a group of specialized activities related to the engineering
and administration of the resources required to provide health
services, carried out by professionals of various branches [architects, engineers (civil, electrical, mechanical, industrial,
and systems)], which in recent years has focused preferentially on graduates of the bioengineering or biomedical engineering programs. It begins with a brief description of the
characteristics of the country, its population, and how it is
organized administratively, an aspect that is directly related
to the authorities, institutions, and health organizations and
consequently to the provision of health services to the population, aspect in which the clinical engineering activities are
developed. Then the health and social security system, and
the most important aspects related to technology management, the quality system, the habilitation of health institutions
and the topics related to the policies through which it seeks to
improve the patient safety through better health services are
briefly described. The subject of the training of the engineers
is also briefly described. In Colombia, the professional degree of biomedical engineering is offered by several universities located in different cities of the country. This information
is presented in Tables 1–3 that indicate the universities and
the type of programs they offer and since when the said program has been approved by the National Education Ministry.
The distribution of engineers in the different departments of
the country is presented in Table 3. There is also a description
of activities that engineers must perform in the health institutions in which they are working and that has been incorporated into the country's legislation. At the end of the chapter,
a brief section is included related to the organizations that
group the industry and the suppliers of medical equipment
and devices and supplies for health.
Clinical engineering in Colombia
During the last 25 years, the clinical engineering in
Colombia has undergone intense transformation as a result
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00009-2
Copyright © 2020 Elsevier Inc. All rights reserved.
of the changes that have occurred in national and international spheres. The national environment highlights the reforms that the national government has made to the health
and social protection system and the legislation that regulates it, which has obliged the health institutions and organizations to implement modifications to the physical health
infrastructures, the equipment, the human resources, and
the administrative and financial procedures required to meet
the guidelines of the legislation. It is in this environment
where biomedical engineers have responsibilities and bring
their expertise and knowledge, which are essential to have
a good quality health system in the country. In the international arena, the advance of knowledge in all the disciplines
stands out, highlighting those related to medical procedures where the development of equipment for diagnosis,
treatment, and rehabilitation and their associated devices
and systems have transformed the professional practice of
medicine, engineering, and other disciplines involved in the
achievement of a healthy population.
Administrative organization of the
Colombian health and social security
system
Colombia is a country located in the northwestern corner
of South America, with an area of 2,070,408 km2 of which
1,141,748 km2 correspond to the continental surface and
928,660 km2 correspond to the maritime areas. It has a population estimated at 49,500,000 inhabitants and administratively is organized into 32 departments, 1101 municipalities,
5 districts, and 20 small towns jurisdictions (Colombia.
National Department of Statistics (DANE), 2018). In the
capital of each department there is a health directorate,
which depends on the governor of the department. In each
municipality there is a secretary of health, who depends on
the mayor of the municipality. Depending on the level of
economic development and the population, there are health
institutions (public and private) that must comply with the
75
76 SECTION | 2 Worldwide clinical engineering practice
TABLE 1 Summary of health institutions (IPS) by district
or department—Private and public sectors, Colombia
2017.
Department or district
Number of IPS
Private
Public
Amazonas
2
1
Antioquia
305
123
Arauca
16
4
Atlantico
192
26
Bogotá D.C
731
7
Bolívar
106
43
Boyacá
72
105
Caldas
73
29
Caqueta
21
6
Casanare
35
5
Cauca
59
20
Cesar
60
28
Choco
22
6
Cordoba
112
31
Guajira
22
16
Cundinamarca
86
52
Guaviare
5
2
Huila
47
40
Magdalena
76
34
Meta
68
15
Nariño
66
68
Norte de Santander
96
16
Putumayo
21
10
Quindio
47
14
Risaralda
42
16
San Andres y Providencia
2
1
Santander
146
83
Sucre
81
27
Tolima
72
50
Valle del Cauca
298
52
Vaupes
1
1
Total
2982
931
Source: Colombia. Ministry of Health and Social Protection. Direction of
Provision of Services and Primare Care. Registro Especial de Prestadores e
Servicios de Salud—RESP [Online], 2017. https://prestadores.minsalud.gov.
co/habilitacion/ [Consulted 31 October 2017].
policy and social security guidelines defined by the national
government to provide the health services to the population.
The head of the health sector in Colombia is the Ministry
of Health and Social Protection that has the responsibility
to draw up the health policies of the country, following the
guidelines defined by the national government. There is a
group of institutions attached to the ministry, among which
the following stand out: The Institute of Food and Drug
Monitoring (INVIMA), whose mission is to protect and promote the health of the population by managing the risks associated with the consumption and use of food, medicines,
medical devices, and other products subject to health surveillance (INVIMA, 2011). The National Superintendence
of Health (SUPERSALUD), which has the mission of protecting the rights of users of the General System of Social
Security in Health through inspection, monitoring, control,
and exercise of the jurisdictional and conciliation function
in a transparent and timely manner (Colombia. National
Superintendence of Health, 2017); the National Institute
of Health (INS), which is a public entity of scientific and
technical nature in public health, of national coverage,
that contributes to the protection of health in Colombia
through the management of knowledge, the monitoring
of the health status of the population, and the provision of
goods and services of interest for public health (Colombia.
National Institute of Health, n.d.), and the Institute for
Technological Assessment in Health (IETS) (2017), a nonprofit, mixed participation, and private corporation with
its own assets, whose members are the Ministry of Health
and Social Protection, the Food and Drug Monitoring
Institute—INVIMA, the National Institute of Health—INS,
the Administrative Department of Science, Technology, and
Innovation (COLCIENCIAS), the Colombian Association
of Faculties of Medicine (ASCOFAME), and the Colombian
Association of Scientific Societies. These are all central
level institutions that work coordinately with the departmental and municipal health authorities and the network of
public and private hospitals in the whole country (Colombia.
Institute of Technological Assessment of Health, n.d.).
The health and social security system is organized in
two regimes as follows: a contributory regime, in which the
workers of the legally constituted companies paid a percentage of their salary to a health promoter company (EPS) in
which they are registered to cover the health services they
could demand in hospitals that are identified in the health
system as health service providers (IPS) contracted by the
EPS. A subsidized regime protects the population with the
least economic resources, which lacks formal employment.
The state pays the EPS for the health services that may be
required by such population, which is provided by IPS (hospitals) with which the EPS has contracts. The Ministry of
Health and Social Protection estimated that by the end of
2017, the health and social protection system has covered
97% of the country’s population, being the mentioned as an
Clinical Engineering in Colombia Chapter | 9
TABLE 2 Colombian universities with biomedical engineering programs (2017).
University
Program
Year
City
Andes University
Biomedical Engineering
6/04/2011
Bogotá D.C.
Andes University
MSc in Biomedical Engineering
24/10/2012
Bogotá D.C.
Antioquia School of Engineering EIA
Biomedical Engineering
21/03/1998
Medellín
Antioquia School of Engineering EIA
MSc in Biomedical Engineering
21/03/1998
Envigado
Antonio Nariño University
Biomedical Engineering
21/03/1998
Bogotá D.C.
Antonio Nariño University
Biomedical Engineering
21/03/1998
Cartagena
Antonio Nariño University
Biomedical Engineering
21/03/1998
Pereira
Antonio Nariño University
Biomedical Engineering
21/03/1998
Popayán
Bucaramanga Autonomous University
Biomedical Engineering
30/07/2015
Bucaramanga
ECCI University
Biomedical Engineering
5/12/2003
Bogotá D.C.
Julio Garavito School of Engineering
Biomedical Engineering
23/02/2011
Bogotá D.C.
Manizales Autonomous University
Biomedical Engineering
27/11/2003
Manizales
Manuela Beltrán University
Biomedical Engineering
18/09/1998
Bogotá D.C.
Manuela Beltrán University
Biomedical Engineering
4/12/2008
Bucaramanga
Metropolitan Technological Institute
Biomedical Engineering
15/01/2008
Medellín
Metropolitan Technological Institute
MSc in Biomedical Engineering
11/04/2015
Medellín
Nueva Granada Military University
Biomedical Engineering
20/05/2016
Cajica
National University of Colombia
MSc in Biomedical Engineering
23/04/2007
Bogotá D.C.
Occidente Autonomous University
Biomedical Engineering
6/04/2001
Cali
Pontifical University Bolivariana
Specialization in Biomedical Engineering
21/03/1998
Medellín
Reformed University Corporation
Biomedical Engineering
22/07/2014
Barranquilla
Source: Labor Laboratory for Education Observatorio Laboral para la Educación [Online], 2017. http://bi.mineducacion.gov.co:8380/eportal/web/menobservatorio-laboral/instituciones-de-educacion-superior-ies1?p_auth=K9ISCW3o&p_p_id=com_ideasoft_o3_portlets_O3ControlPortlet_WAR_o3portal_
INSTANCE_P9ct&p_p_lifecycle=1&p_p_state=normal&p_p_mode=view&p_p [Consulted 30 September 2017].
TABLE 3 Colombia. National distribution of the biomedical technicians and engineers graduated between 2001 and
2014.
Level of vocational training
Colombian
region or city
Professional
technicians
Technologists
Engineers
Engineers with
specialization
MSc Engineers
PhD
Engineers
Bogotá D.C.
484
138
869
126
58
0
Antioquia
0
837
646
13
0
0
Atlántico
0
22
0
0
0
0
Bolívar
0
0
4
0
0
0
Caldas
0
0
69
0
0
0
Cauca
0
0
58
0
0
0
Córdoba
0
1
0
0
0
0
77
78 SECTION | 2 Worldwide clinical engineering practice
TABLE 3 Colombia. National distribution of the biomedical technicians and engineers graduated between 2001 and
2014—cont’d
Level of vocational training
Colombian
region or city
Professional
technicians
Technologists
Engineers
Engineers with
specialization
MSc Engineers
PhD
Engineers
Huila
0
0
1
0
0
0
Magdalena
0
2
0
0
0
0
Putumayo
0
0
1
0
0
0
Santander
0
0
226
0
0
0
Valle
0
0
358
126
0
0
Total
484
1000
2232
265
58
0
Percentage (%)
12%
25%
55%
7%
1%
0%
Source: Labor Laboratory for Education Observatorio Laboral para la Educación [Online], 2017. http://bi.mineducacion.gov.co:8380/eportal/web/menobservatorio-laboral/instituciones-de-educacion-superior-ies1?p_auth=K9ISCW3o&p_p_id=com_ideasoft_o3_portlets_O3ControlPortlet_WAR_o3portal_
INSTANCE_P9ct&p_p_lifecycle=1&p_p_state=normal&p_p_mode=view&p_p [Consulted 30 September 2017].
outstanding achievement. The distribution of hospitals and
health institutions in the country depends on the population
that inhabits the municipalities and departments and their
degree of economic development. The departments, municipalities, and districts with the highest development income
have more health institutions of different complexity which
is classified into three levels as follows.
First level complexity institutions provide basic health
services. They have a staff of general doctors and nurses to
provide the services. They offer education and prevention
programs to the community. They provide basic emergency
services, external consultation, and clinical laboratory services, and also basic hospitalization is available, but lack
surgery services. In the second level complexity hospitals,
there are availability of medical specialists. There are surgery services and basic care hospitalization with diagnostic
support in images and clinical laboratory. In the hospitals of
the third level of complexity, located generally in the capitals of the departments, there are medical specialists and
subspecialists, have advanced technologies of images and
clinical laboratory, and have hospitalization services of high
complexity (intensive and intermediate care and surgical
and obstetrical services). The private health resources are
distributed in the whole country. It is common to find institutions of different complexity whose resources are considered a component of the health service delivery networks
that the national government is promoting.
Table 1 shows how the institutions are distributed to
provide health services (IPS) (hospitals, health centers, and
post centers) in the country. They are disaggregated by department or district, differentiating into the private sector
and the public sector. In the private sector there are medical and dental offices, laboratories, foundations, and hospitals (IPS) owned by stock companies, which operate in the
­ unicipalities and cities. In the public sector, the institutions
m
accounted are from health posts, health centers, municipal,
departmental, and district hospitals, and specialized centers.
Educational sector
Colombian universities that offer biomedical
engineering programs
Until the 1990s, Colombia lacked educational institutions
in which biomedical engineers were trained. There were
only some electronic engineering programs in which there
was an emphasis on electromedicine. Training in biomedical engineering or electromedicine was limited to very few
university programs. The professionals in the hospital were
formed as engineers in the universities of the country. Few
technicians and engineers, linked to hospital institutions
of the public sector, were trained by the National Hospital
Fund, a public entity attached to the Ministry of Health,
which was liquidated in December 1993, as a consequence
of the political and administrative decentralization process
that took place in the country. In the 1990s, the educational
sector started programs of bioengineering and biomedical
engineering. During the last 20 years, several universities
and technological institutes of the country have launched
undergraduate programs and master’s degrees in biomedical
engineering, which seeks to form engineers and technicians
capable of responding to the challenges of incorporating
adequate technological alternatives to provide timely and
good quality health services to the population, despite the
limitations of resources of the local environment. Table 2
presents disaggregated information, organized alphabetically, highlighting the universities that developed biomedical engineering programs, the type of programs that are
Clinical Engineering in Colombia Chapter | 9
offered, the year in which the programs has been officially
registered by the educational authorities and the city in
which the programs are performed.
Table 3 presents an aggregate showing how the biomedical engineers and technicians, who have graduated
from the above universities between 2001 and 2014, whose
training is formally registered with the Ministry of National
Education, are distributed in different regions of the country.
Professional registration of biomedical engineers
Engineers who obtain their professional degree from
higher education institutions must apply for professional
registration in the National Professional Engineering
Council (COPNIA). As a result of the professional registration before COPNIA, it issues the professional card that
legally authorizes the exercise of the profession, since it is
required to contract or hold positions in the various organizations of the sector. Those who work performing maintenance activities for medical equipment and devices must
register also with INVIMA. No other certifications are required to validate the exercise of the biomedical engineering in Colombia. Certifications such as the one granted by
the ACCE of “Certified Clinical Engineer” are voluntary,
that is, engineers who want to be recognized by said association apply it, but they do not have legal effects in the
country. It is a certification that gives prestige to those who
obtain it.
Health technology management
In the subject of management of health technologies, it is
important to highlight some points that are related to the
Mandatory System of Quality Assurance of the Care of
Health of the General System of Social Security in Health
(SOGCS), which has four fundamental components: (a) the
unified enabling system; (b) the audit for the improvement
of the quality of health care; (c) the unique system of accreditation, and (d) the information system for quality.
The habilitation system determines the basic capabilities
of technological and scientific capacity, the requirements
of patrimonial and financial sufficiency, and the technical
and administrative conditions, so that the institutions of the
health system can operate.
This has a direct influence on activities such as maintenance of equipment and facilities, the technology acquisition processes, the postmarket surveillance of equipment
and devices, topics that are briefly described below.
Maintenance
As a result of the process of political, administrative, and
fiscal decentralization in the country, maintenance is an
activity regulated by law (Decree 1769 of 1994), whose
79
realization depends on each hospital, a situation that has
not yielded the best results in many hospitals due to the
lack of hiring and technical experience of the human resource of the hospitals, involved in these processes, aspect in which the Ministry of Health and Social Security
is working, seeking to standardize the conditions that
must be demanded by the hospitals in this type of contracts. Another result of the decentralization is the appearance of companies that offer technical services of diverse
nature and that many hospitals use to cover their needs.
Maintenance, leasing of equipment, metrology services,
and consultancies to enable or accredit health services or
implement technosurveillance programs, performed by
engineers with expertise in the health sector, are now common in the country.
The maintenance of the medical equipment implies
that the hospital’s engineering departments require to
manage the activity through an annual maintenance plan
whose budget corresponds to 5% of the total annual budget of each hospital (IPS) that has the status of institutional, because it must be signed by the hospital’s general
manager or director, the chief engineer, and the tax auditor. This requirement seeks to ensure that the institutions
define the maintenance priorities that must be carried out,
that these priorities have the approval of the management,
and that the budget is invested as planned. The maintenance plan is mandatory in the public hospitals and also
in the private hospitals, whose contracting of health services with the state represents more than 30% of their total annual income. The maintenance plan must cover the
resources related with the medical equipment, the physical infrastructure, the engineering systems and facilities
[electrical, hydraulic, and mechanical (steam, air conditioning, fire protection, communications, and informatics)], and furniture for administrative use, but excluded
from it are the investments required for the acquisition
or renewal of medical equipment and the remodeling or
construction of buildings with their facilities, which must
be carried out exclusively in the institutions of the public
sector, through projects properly planned, approved, and
financed with investment resources of the national budget. The annual maintenance plans must be properly informed to the departmental health authorities and to the
National Superintendence of Health (Colombia. Ministry
of Health and Social Protection, 1994; Colombia. National
Superintendence of Health, 1997).
Carrying out maintenance activities requires, by law,
that they be documented. Maintenance plans, inventory,
maintenance records (preventive, corrective), resumes
(maintenance history), and metrological control of those
equipment that require it are nowadays the requirements
that must be met (demonstrated) by hospitals (IPS) so that
the health authorities authorize the provision of services to
the population through the habilitation process.
80 SECTION | 2 Worldwide clinical engineering practice
Procurement of technologies
The procurement of technologies for health also requires
that health institutions incorporate and implement new procedures. Public IPSs must have biennial plans to carry out
technology acquisition processes, which must be conform
to the planning and institutional strengthening priorities
that have been approved. The equipment that is acquired
must have sanitary registers issued by INVIMA, and the
marketers must demonstrate that this equipment is new and
have been authorized for sale in the international market.
Also, that they have been legally imported into the country.
All these, looking for procurement processes, are more appropriate to the local reality. The Ministry of Health and
Social Protection has been working on documents that provide guidelines that should be included in procurement processes so that the acquired goods are appropriate for the
provision of health services.
Recently (2016, 2017), on the initiative of the Directorate
of Medicines and Health Technology—Medical Devices—
Biomedical Equipment, of the Health and Social Protection
Ministry, and with the cooperation of hospital groups, organized into regional nodes (Bogotá, Valle, Santander, and
Antioquia), a cooperation initiative is being developed to
exchange experiences on issues related to the management
of health technologies (processes of acquisition, reception and commissioning of equipment and facilities, maintenance and contracting methods, criteria for training for
the use and maintenance of equipment, obsolescence of
technologies, and classification and analysis of suppliers,
among other topics) to enrich the technical management
processes of the country's health sector. It is expected that
as a result of the cooperation efforts, in the medium term,
the management of medical technologies in the country, a
task that is not easy given the diversity of institutions and
regions, can be improved significantly.
Technosurveillance and patient security
programs
The quality control and safety of medical equipment and
devices in Colombia is an issue that has been developed
gradually by the national government. It is estimated by
the INVIMA that in 1985 only 5% of medical equipment
and devices that were marketed in the country had Sanitary
Registry, situation that by 2005 had improved achieving
100% of medical devices marketed in the country, of national manufacture or imported, had the Sanitary Registry.
The Sanitary Registry is a requirement that gained importance when the national government published the Decree
4725 of 2005 through which the Ministry of Health and
Social Protection, with the support of the National Institute
for Drug and Food Surveillance, INVIMA, designs a technosurveillance program to identify adverse incidents not
described, quantify the risk, and propose and carry out
public health measures to reduce their incidence and keep
informed the health authorities at the national level, other
health professionals, users, and the population in general.
The national technosurveillance program was conceived
as a postmarket strategy through which the security information related to the use of medical devices imported or
manufactured in the country is identified, evaluated, managed, and communicated, in order to take the measures
that are necessary to protect the health of the population
(INVIMA, 2018).
The technosurveillance plan has evolved since its inception. Decree 4725 of 2005 gave life and defined the Ministry
of Social Protection and INVIMA as responsible for designing and implementing the said plan and defined basic
concepts related to adverse events, risk levels, and classification of medical equipment and devices according to risk,
initiating what has been defined as passive technosurveillance, as it is spontaneous and voluntary. Then by resolution
No. 4816 of 2008, the technovigilance plan is regulated, the
responsibilities of the institutions and authorities involved
are defined and articulated with the Mandatory System of
Quality Assurance of Health Care of the General System
of Social Security in Health and with the Public Health
Surveillance System to initiate an active technosurveillance
process on those equipment and devices that pose a high
risk to public health; for this purpose the classic signaling
model for the administration of technosurveillance reports
is implemented by the European Medicines Agency, which
involves indicators of disproportionality defined by specialized agencies in the United Kingdom and the Netherlands
(Colombia. Ministry of Social Protection, 2005; Colombia.
Ministry of Health and Social Protection, 2008.
The technosurveillance program of Colombia has been
structured around five systems: (a) the system of search and
capture of reports; (b) a system of consolidation of information and databases; (c) a system of information analysis and
signal search; (d) a signal management system and sanitary
measures, and (e) a communication and training system
(INVIMA, 2018).
Accreditation of health institutions
The accreditation of health institutions is a process that
dates back to 2002, when the national government saw
the need to regulate the System of Quality Assurance
in Health, of which the Single Accreditation System is
a fundamental component. The regulation of this component has been basic for the development of the quality system. The model of an accrediting entity has been
changed to that of several accrediting entities, making the
requirements for accreditation more demanding. It is required that these entities be accredited by the International
Clinical Engineering in Colombia Chapter | 9
Society for Quality in Health Care (ISQUA). Currently,
the governing body of the Single System of Accreditation
in Health is the Ministry of Health and Social Protection,
with the support of an Advisory Board on issues of management, evaluation, and improvement of health quality
and receives information online through the Accreditation
Special Registry (REAS) (Colombia. Ministry of Health
and Social Security, 2014).
Professional and industrial associations
In the Colombian health sector, it is necessary to highlight
two groups of initiatives that have been developed to promote
the professional improvement of biomedical engineers graduated from various universities and those related to the companies that produce or market specialized goods and services
for the sector. In the first group stands out the Colombian
Association of Bioengineering and Medical Electronics
(ABIOIN) whose foundation was promoted by Eng. Isnardo
Torres in Bucaramanga, Santander at 1993 and the Colombian
Association of Biomedical Engineering (ACIB), founded by
biomedical engineers of different universities.
From the point of view of industry and commerce, the
most important organizations are the National Association
of Industrialists (ANDI) and the National Federation of
Merchants (FENALCO). ANDI, as an economic group, is
organized by chambers, which in the health sector are four,
namely: (a) the Health Sector Chamber (CSS), made up of
a group of hospitals (IPS), to highlight its importance in
the national macroeconomic environment; (b) the Chamber
of Medical Devices and Supplies for Health (CDMIS); (c)
the Chamber of Pharmaceutical Industry (CIF), and (d)
the Chamber of Industrial and Medical Gases (CGIM),
through which ANDI seeks to contribute to the stability and
development of the sector, through working jointly with
government entities, control authorities, associations, and
international organizations. The chamber works with its associated companies on major issues and challenges such as
access to technology and innovation, pricing policies that
promote free competition, good corporate ethical practices,
dispute resolution mechanisms, good manufacture practices, flow of resources from the health sector, and adherence to international semantic standards (GMDN). ANDI
highlights that the medical devices sector in Colombia recorded in 2016 imports of about 1.106 million dollars and
exports of 84 million dollars, which positions the country
as the third largest market for medical devices in Latin
America, after Brazil and Mexico.
81
References
Colombia. Institute of Technological Assessment of Health IETS, (Online)
http://www.iets.org.co/quienes-somos/Paginas/Qu%C3%A9-es-elIETS.aspx. [Consulted 15 December 2017].
Colombia. Ministry of Health and Social Protection, 1994. Minsalud. (Online)
https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/
DE/DIJ/decreto-1769-de-1994.pdf. [Consulted 15 December 2017].
Colombia. Ministry of Health and Social Protection, 2008. INVIMA.
(Online) https://www.invima.gov.co/images/pdf/Prensa/publicaciones/Resolucion-4816.pdf. [Consulted 15 December 2017].
Colombia. Ministry of Health and Social Security, 2014. Minsalud. (Online)
https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/
DE/CA/abc-suas.pdf. [Consulted 15 December 2017].
Colombia. Ministry of Social Protection, 2005. Minsalud. (Online) http://
www.who.int/medical_devices/survey_resources/health_technology_
national_policy_colombia.pdf. [Consulted 20 December 2017].
Colombia. National Department of Statistics (DANE), 2018. DANE.
(Online) https://geoportal.dane.gov.co/v2/?page=elementoDivipola.
[Consulted 15 January 2018].
Colombia. National Institute of Health, Instituto Nacional de Salud.
(Online)
http://www.ins.gov.co/conocenos/objeto-y-funciones.
[Consulted 15 December 2017].
Colombia. National Superintendence of Health, 1997. (Online) https://
docs.supersalud.gov.co/PortalWeb/Juridica/OtraNormativa/
CIR02997.pdf. [Consulted 20 December 2017].
Colombia. National Superintendence of Health, 2017. Superintendencia
Nacional de Salud. (Online) www.supersalud.gov.co/es-co/
superintendencia/nuestra-entidad/misión-y-visión.
Instituto de Evaluación de Tecnologias en Salud-IETS, 2017. IETS. (Online)
http://www.iets.org.co/quienes-somos/Paginas/Qu%C3%A9-es-elIETS.aspx.
INVIMA, 2011. INVIMA. (Online) https://www.invima.gov.co/nuestraentidad/mision-y-vision.html. [Consulted 2017].
INVIMA, 2018. INVIMA. (Online) https://www.invima.gov.co/
images/pdf/tecnovigilancia/presentaciones/EVOLUCION_
TECNOVIGILANCIA_29_01_2018_II.pdf. [Consulted 04 February
2018].
Further reading
Colombia. Ministry of Health and Social Protection. Direction of Provision
of Services and Primare Care, 2017. Registro Especial de Prestadores
e Servicios de Salud—RESP. (Online) https://prestadores.minsalud.
gov.co/habilitacion/. [Consulted 31 October 2017].
Labor Laboratory for Education, 2017. Observatorio Laboral para la
Educación. (Online) http://bi.mineducacion.gov.co:8380/eportal/
web/men-observatorio-laboral/instituciones-de-educacion-superior-ies1?p_auth=K9ISCW3o&p_p_id=com_ideasoft_o3_portlets_O3ControlPortlet_WAR_o3portal_INSTANCE_P9ct&p_p_
lifecycle=1&p_p_state=normal&p_p_mode=view&p_p. [Consulted
30 September 2017].
Chapter 10
Clinical engineering in Mexico
Roberto Ayala
Health Technology Excellence National Center, Mexico City, Mexico
Mexico is proudly one of the first countries in the LatinAmerican and Caribbean region to develop clinical engineering (CE) programs, going back as far as early 1970s, and
being recognized as such by their regional peers. Nowadays
the CE practice has presence in all sectors that provide health
care in Mexico, and has one of the first Ministry of Health’s
agency dedicated to advance CE and health technology management (HTM). But there is still much work to be done,
like having national policies on HTM and CE practice. In
the this chapter the author discusses the HTM problem in
Mexico, the work done by biomedical engineers in hospitals,
how is the educational ground for CE, the achievements by
CE professionals and the challenges ahead.
Health technology management problems
in Mexico
One challenge for every health system around the globe is to
warrant the proper management of their health technology,
including medical equipment, as commanded by the World
Health Organization in the WHA60.29 resolution (World
Health Organization, 2017a). Unfortunately, medical equipment does not always cover its purpose to help solve health
problems due to malpractices in HTM and Mexico is no
exception.
According to a diagnosis made by CENETEC (National
Center for Health Technology Excellence) (CENETEC,
2017c), which we talk about it in length further, there are
three main problems regarding medical equipment in health
facilities:
●
●
●
Medical equipment in inappropriate state, inoperative,
and/or insecure, due to lack of maintenance and/or operative capacity.
Inadequate planning and management of medical
equipment.
Lack of knowledge and inadequate formation of personnel in charge of medical equipment management.
As a result around 10%–30% of medical equipment installed in the country is not able to produce the results that
are expected from them.
82
In order to achieve the goal of an effective access to
medical technology, with efficacy and safety, for every patient who needs it, it is imperative to improve its management, and in Mexico a biomedical engineer with specialty
in CE is a suitable professional for the task.
Biomedical/clinical engineering
in Mexican hospitals
The National Health System in Mexico, as of 2017, has
more than 33,989 establishments for medical care, divided into three attention levels: primary care (first level),
hospitals (second level), and specialty care (third level)
(Fig. 1).
Mexico’s health system is a segmented one and is composed of several sectors, each with administrative and legal
autonomy, thus having particular operative policies, including those for managing medical equipment (Fig. 2).
The first biomedical engineering (BME) department in a
Mexican hospital, doing CE tasks, was founded in a public
hospital in 1977. In the private sector the first BME department was set in 1984. Since then, at the time of publishing
this article, every health sector and at least 29 of the 32 states
that composed the Mexican Republic had at least one BME
department doing CE tasks. The social sector that provides
health care to the working class, Instituto Mexicano del
Seguro Social, has established a policy (Instituto Mexicano
del Seguro Social, 2017) to have BME departments in each
of their high specialty hospitals (UMAE, High Speciality
Medical Unit) and in each of their 32 state delegations.
In all of the 12 national health institutes (high specialty
healthcare organizations) there is a BME department and
according to the Ministry of Health database of resources
(Dirección General de Información en Salud, 2017b), there
is a register of 112 BME departments in public hospitals
across the country. There is no accurate data because an official and updated census of BME departments in Mexico
has not been made, but the coverage on all the health establishments in Mexico is believed to be less than 20%, this being the biggest challenge of the CE practice in the country.
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00010-9
Copyright © 2020 Elsevier Inc. All rights reserved.
Clinical engineering in Mexico Chapter | 10
83
FIG. 1 Number of healthcare establishments in Mexico (Dirección General de Información en Salud, 2017a).
FIG. 2 Health sectors in Mexico.
According to a survey conducted by CENETEC in 2014
(CENETEC, 2017d), in 19 public hospitals, the following
results came regarding the participation of biomedical/clinical engineers in HTM processes:
●
●
62% of BME departments participate in planning processes for medical equipment; 23% don’t have any involvement at all.
62% participate in the incorporation process for medical
equipment.
●
●
●
69% have an inventory of the medical equipment.
77% have a medical equipment maintenance program.
54% have involvement in the disposal procedure of
medical equipment.
Typically the highest position a biomedical/clinical engineer in a hospital department can hold is Chief
of Department, but there are cases where a professional
in the field has had charges such as Operations Manager,
Technology Manager, Subdirector, and even as a hospital
84 SECTION | 2 Worldwide clinical engineering practice
General Director (at least two documented cases), among
other high organizational positions.
The number of personnel in a BME/CE department varies much, in a range of 2–25 persons. There is no normative
or regulatory requirement to have BME department in hospitals, although there are two Official Mexican Normatives
(NOM) that refer to the role of biomedical engineers; one for
electrical installations, in the chapter of hospital installations
(CENETEC, 2017a) and the other regarding medical device
alerts, known as techno-vigilance (CENETEC, 2017b).
The CE departments in Mexico are looking to strength
their HTM responsibilities by incorporating procedures
such as quality assurance, medical equipment metrology,
techno-vigilance, and interoperability, among other modern
trends. It should also to be noted that some clinical engineers have responsibilities in telemedicine/telehealth programs of some public health providers.
(ANUIES) (Asociación Nacional de Universidades e
Instituciones de Educación Superior, 2019). Fig. 3 shows
the distribution of students per state, Mexico City being the
highest in concentration.
Although the academic programs are very similar to
those for BME program, some institutions name their bachelor degree different, with equivalents such as bioengineering, medical bioengineering, electromedical engineering,
and biomedical systems engineering. CE is identified as
a specialty in the BME academic programs, but not all refer it as such. In 2017 the first master’s degree in CE was
launched, in the Southeast State of Yucatan. There are also
several independent companies offering CE/HTM courses
all year long, in both classroom and virtual modalities.
BME associations in Mexico
In 1978 the first national BME society, Sociedad Mexicana
de Ingeniería Biomédica A.C., SOMIB (Sociedad Mexicana
de Ingeniería Biomédica A.C., 2019), was founded, recognized internationally by institutions like the IFMBE
(International Federation of Medical and Biological
Engineering), AAMI (Association for the Advancement of
Medical Instrumentation), and ACCE (American College
of Clinical Engineering), and have done until 2019 42 congresses. The Society includes a CE committee.
In 2015 a BME professional college, Colegio de
Ingenieros Biomédicos de México A.C. (Colegio de
Ingenieros Biomédicos de México A.C., 2017), was founded
that requires its members to have concluded their professional
studies. This association does include a CE commission.
Biomedical/clinical engineering
education in Mexico
The first BME bachelor programs in Mexico were established in 1973, in Mexico City, by two universities,
Universidad Iberoamericana and Universidad Autónoma
Metropolitana Unidad Iztapalapa. In 1981 it began the BME
bachelor program in the Instituto Politécnico Nacional. The
first generation released just a couple of dozen professionals.
By 2018, more than 11,000 Mexicans were studying BME
bachelor program in 49 universities throughout the country, 57% male and 43% female, according to the National
Association of Universities and High Education Institutes
2500
8
7
2000
6
5
1500
4
1000
3
2
500
FIG. 3 Number of BME students by state.
Students number
ZAC
VER
YUC
TLA
TAM
TAB
SLP
SON
SIN
Qroo
PUE
Universities number
QRO
NL
OAX
NAY
CDMX
MOR
JAL
MICH
GTO
HGO
GRO
DGO
ED OMEX
COL
COAH
CHIA
CHIH
BCS
CAM
BC
0
AGS
1
0
Clinical engineering in Mexico Chapter | 10
FIG. 4 Infographics made by CENETEC about HTM.
85
86 SECTION | 2 Worldwide clinical engineering practice
Achievements of CE in Mexico
One important achievement of the BME/CE profession in
Mexico was the creation of the CENETEC (Centro Nacional
de Excelencia Tecnológica en Salud, 2017) (Fig. 4). Founded
in 2004 as part of Mexico’s Ministry of Health structure,
by the internationally recognized and CE certified Adriana
Velázquez, MsC, to support and advance health technology assessment (HTA) and HTM for the National Health
System, it soon began to generate services and tools in those
areas, such as the following:
●
●
●
●
●
Guidelines and recommendations for HTM processes.
Technical specifications charts for medical equipment.
Courses and workshops for CE/HTM education.
Participation in workgroups for medical equipment
normatives.
Participation in validation process for federal financing
of medical equipment.
In 2009 CENETEC became a Collaboration Center for
WHO and PAHO (Panamerican Health Organization) for
HTA and HTM functions, and has been recognized by international institutions like ACCE, HTAi (Health Technology
Assessment International), and IFMBE, among others.
In 2008 a Mexican biomedical/clinical engineer took
position at the Medical Devices Coordination Group for
the World Health Organization: Adriana Velázquez, MSc/
CCE, once again proving her commitment for the betterment of health technologies assessment and management.
Since then, a vast production of resources has been offered,
from HTA/HTM publications, guidelines, and statistics to
the organization of global forums regarding all topics about
medical devices (World Health Organization, 2017b).
Challenges for CE in Mexico
As mentioned earlier, there is still a worrisome shortage
of BME/CE departments in Mexican hospitals, both public and private. Even though it is clear that there are sufficient professional offers, with the growth of educational
instances with BME programs, and the recognized need for
them in health organizations, some issues should be solved
to make the match and those include a better payment and
the opportunity to prove that these professionals can do
more than just medical equipment repair. For that reasons,
and to strength the profession, there should be a normative and regulatory framework for CE practice in both
public and private institutions.
There is also a need to make sure that BME bachelor
programs include appropriate CE and HTM courses, with
proper educational resources and based on Mexico’s particular problematic regarding HTM in the National Health
System.
Regardless, Mexico’s CE and HTM experience has recorded an important progress and is keeping a steady pace,
looking not to be a region leader of sorts but to keep contributing for a better, safer, and good-quality health care.
References
Asociación Nacional de Universidades e Instituciones de Educación
Superior, 2019. Anuarios Esatdísticos de Educación Superior. http://
www.anuies.mx/iinformacion-y-servicios/informacion-estadisticade-educacion-superior/anuario-estadistico-de-educacion-superior.
(Accessed August 30, 2019).
CENETEC, 2017a. Norma Oficial Mexicana NOM-001-SEDE 2012,
Instalaciones Eléctricas. http://www.cenetec.salud.gob.mx/descargas/equipoMedico/normas/NOM_001_SEDE_2012.pdf. (Accessed
August 30, 2017).
CENETEC, 2017b. Norma Oficial Mexicana NOM-240-SSA3-2012,
Tecnovigilancia. http://www.cenetec.salud.gob.mx/descargas/equipoMedico/normas/NOM_240_SSA1_2012.pdf. (Accessed August 30, 2017).
CENETEC, 2017c. Programa de Acción Específico. p. 19, http://www.
cenetec.salud.gob.mx/descargas/PAES/PEDM.pdf. (Accessed August
30, 2017).
CENETEC, 2017d. Estado de la Gestión de Equipo Médico. http://www.
cenetec.salud.gob.mx/descargas/equipoMedico/SS-CENETEC_IB_
Gto.pdf. (Accessed August 30, 2017).
Centro Nacional de Excelencia Tecnológica en Salud, 2017. http://www.
cenetec.salud.gob.mx/. (Accessed August 30, 2017).
Colegio de Ingenieros Biomédicos de México A.C, 2017. http://cib.org.
mx/. (Accessed August 30, 2017).
Dirección General de Información en Salud, 2017a. Datos abiertosRecursos en salud. http://www.dgis.salud.gob.mx/contenidos/basesdedatos/da_recursos_gobmx.html. (Accessed August 30, 2017).
Dirección General de Información en Salud, 2017b. Clave Única de
Establecimientos de Salud (CLUES). http://www.dgis.salud.gob.mx/
contenidos/sinais/subsistema_clues.html. (Accessed August 30, 2017).
Instituto Mexicano del Seguro Social, 2017. Manual de Organización
de las Unidades Médicas de Alta Especialidad. http://www.imss.
gob.mx/sites/all/statics/pdf/manualesynormas/0500-002-001_0.pdf.
(Accessed August 30, 2017).
Sociedad Mexicana de Ingeniería Biomédica A.C, 2019. http://www.
somib.org.mx/index.html. (Accessed August 30, 2017).
World Health Organization, 2017a. World Health Assembly Resolution
WHA60.29. http://www.who.int/medical_devices/policies/resolution_
wha60_r29-sp.pdf. (Accessed August 30, 2017).
World Health Organization, 2017b. Medical devices. http://www.who.int/
medical_devices/en/. (Accessed August 30, 2017).
Chapter 11
Clinical engineering in
Paraguay
Pedro Galvan
Biomedical Engineering Department, Health Sciences Research Institute, San Lorenzo, Paraguay
Healthcare technology (HCT) development plays an essential role today in promoting health and developing health
systems and services. Clinical engineers must be able to
work with patients and with a range of professional staff, including technicians and clinicians, and with medical device
providers. They have to keep up-to-date with fast-­moving
scientific and medical research in the field and be able to
develop laboratory, design, workshop, and management
skills. Traditionally, in developing countries, nonfunctional
equipment and facilities impede the adequate delivery of
appropriate health services. Furthermore, a proper health
technology management (HTM), which includes HCT
policy, sufficient financial resources, adequate human resources, and a comprehensive maintenance system, is crucial to guaranteeing the development of a sustainable health
service.
This chapter provides an overview of the clinical engineering practice in Paraguay and its impact on the care HCT
management system for the public health sector. A feasible
and sustainable HCT model is included in the management
plan, which is based on a development of the healthcare
infrastructure in the last decade. The HCT management
(HCTM) plan focuses on issues such as HCT policy, financial resources, human resource development, and maintenance system to promote a sustainable clinical engineering
practice in the country in the framework of an adequate
health service delivery policy. Together, a well-structured
and organized HCTM with the experiences made in this
field can help to establish a comprehensive clinical engineering practice in healthcare systems.
Introduction
One of the results of globalization and efforts to improve
healthcare systems worldwide has been the recognition that
increasingly complex healthcare technology (HCT) plays a
vitally important role in all health systems.
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00011-0
Copyright © 2020 Elsevier Inc. All rights reserved.
In the last decade, the majority of countries in the
Americas, including Paraguay, has been reforming their
health systems and services to promote equity in health
and universal access to health services through improved
HCTM. Improved HCTM will result in increased efficiency
in the allocation, use, and maintenance of resources; improved effectiveness and quality of care; ensured financial
sustainability, and encouraging community participation
and intersectoral action (PAHO, 2001).
In Latin America and the Caribbean, there are approximately 50% of the medical devices in public hospitals out of
service or is functioning at a level that is out of compliance
with manufacturer safety specifications.
The problem of malfunctioning equipment is complex
and it involves issues such as the capital and recurrent cost
of equipment; the low level of development of maintenance
systems; the lack of standardization; the donation of medical equipment; weak after-sale support service; uncoordinated processes for infrastructure development; a lack of
technical capacity; and a shortage of professional and technical staff in public sector hospitals.
In Paraguay, the hospital infrastructure lists 1207 hospitals with 6966 hospital beds. Of these hospitals, 68.6%
are located in the public sector and comprise 62.2% of the
hospitals beds.
The state of the physical and technological infrastructure in the health sector is similar to that in Latin America.
A survey of HCT maintenance practices taken in 18 regions
in the country (Galvan and Isaacs, 1999) showed that 48.9%
of existing medical equipment and devices were out of service or malfunctioning, mainly due to a lack of managerial
capacity and a shortage of professional and technical maintenance staff.
Finally, as in most developing countries, technology development plays an essential role in promoting health and in
developing health systems and services. A well-conceived
and well-implemented biomedical or clinical ­engineering
87
88 SECTION | 2 Worldwide clinical engineering practice
service can make an important contribution to health technology assessment (HTA), to the proper distribution of
resources, to the selection of cost-effective technology, to
greater efficiency and more effective services, to quality assurance in HCT, and to the facilitation of decision-making
regarding HCT policy in hospitals and other healthcare services. This chapter expands the information about the status
of clinical engineering in Paraguay and its contribution in
improving regulation and the appropriate use and maintenance of HCT.
Healthcare infrastructure
As in most developing countries, technological development
in the healthcare system of Paraguay has been based on the
transfer of technologies designed for developed countries
(PAHO, 2001). In many cases, this technology transfer was
incomplete, as it was not contextualized (organizational,
economic, social, and cultural settings) to the country.
In the past two decades, some of the common problems
in the healthcare system were the following:
•
•
•
•
•
•
•
Scarcity of many basic technologies
Excessive and indiscriminate use of expensive HCT
Lack of policies and standards to regulate the introduction and use of HCT
Underdevelopment of support technologies
Inequalities in access to available HCT
Scarce human and financial resources
A shortage of professional and technical staff [i.e., clinical engineers (CEs) and biomedical equipment technicians (BMETs)]
Problems such as a lack of HCT policies and standards; uncoordinated donor programs; shortages of, and inadequately
qualified, human resources; and suboptimal managerial capacities are consequences of scarce resources, institutional
weaknesses, and insufficient capacity to absorb and maintain
new technology in the country (Galvan and Isaacs, 1999).
Regarding the field of HCT and physical infrastructures
management, it is common to find that medical devices and
facilities are frequently out of service or malfunctioning
(Galvan and Isaacs, 1999) for various reasons, such as the
following:
•
•
•
•
•
•
Lack of infrastructure, equipment, and human resources
for maintenance
Lack of resource planning and management
Low efficiency and weak after-sale support service
Low levels of standardization, leading to a high degree
of diversity of medical devices and physical plant
Inadequate training of medical device operators and
maintenance technicians
Lack of managerial and financial capacity to improve
HCT maintenance
Survey reports (Galvan and Isaacs, 1999) showed that
only 51.1% of basic medical devices of selected health facilities, 10 of the secondary care hospitals (second referral
level), and 48 of primary care hospitals (first referral level),
were in proper working condition. This situation is a direct
consequence of the absence of a maintenance program and
shortage of, as well as inadequate training, maintenance
technicians. For performing maintenance in the selected
hospitals, only BMETs (13%) and self-taught technicians (87%) were available but no clinical or biomedical
engineers.
Sustainable clinical engineering practice
A sustainable and strengthened organization and structure
of clinical engineering services in the healthcare centers is
of vital importance and implies a challenge for all stakeholders and decision makers (particularly for HCT, as its
rate of change has increased considerably faster, in recent
years, outpacing the evolution in the management and organization of national health care).
To develop a comprehensive clinical engineering practice in Paraguay, the Biomedical Engineering and Imaging
Department of the “Instituto de Investigaciones en Ciencias
de la Salud-UNA” (Health Sciences Research Institute) proposed a feasible and sustainable strategy based on survey
results (Galvan and Isaacs, 1996, 1997), with the key focus on HCT policy, financing, and human resource development, as well as maintenance system development. The
final outcome will only be as successful and strong as the
quality of effort and skill applied to the key issues.
HCT policy
In December 1994, the Summit of the Americas reaffirmed
the interest of the governments of the region in promoting
reforms in their health systems that would guarantee equal
access to basic health services. The summit charged Pan
American Health Organization (PAHO), the International
Development Bank (IDB), and the World Bank with organizing a special meeting on health sector in the Americas
(PAHO, 2001).
In this regard, and within the framework of transformation of the health sector, the Ministry of Health of Paraguay
has been working since 1994 (Vidovich et al., 1998) on the
reorganization of health systems, including health technology, to achieve a higher level of equity, quality, efficiency,
and universal access to health care.
In the last decade, decisions on new construction, the
purchase, or replacement of HCT, and the approval of new
applications were made through specialists like physicians
and nurses but without participation of clinical or biomedical engineers. Consequently, in most cases, it is common to
find that for complex HCT, what was chosen was what was
Clinical engineering in Paraguay Chapter | 11
technically possible instead of what is really necessary and
useful for each health service (PAHO, 2001). This unsatisfactory situation contributed to inadequate procurement
and operational strategies and impacted adversely on the
­healthcare system.
In order to improve the overall situation, in particular
HCTM and HTA issues, the Ministry of Health defined a
strategy (Galvan, 2001) wherein a basic health technology
policy (HTP) is an integral part of its overall national health
policy and development plans (i.e., contingency, short-,
mid-, and long-term plans).
One essential part of the strategy is the assumed health
technology development framework, which includes two
important components:
1. HTA (PAHO, 2001)
2. Health technology management (HTM)
In order to guarantee ownership and sustainability of the
HTM policy, the Ministry of Health includes all national
stakeholders in the formulation and implementation of the
policy. In this regard, it created alliances with the following:
•
•
•
•
Health sciences research institutes (basic and applied)
Scientific organizations and universities
Multilateral organizations
International agencies
In addition, in April 1996, a meeting of ministers of
health of MERCOSUR (the commercial alliance among
Argentina, Brazil, Paraguay, and Uruguay) was held to address quality and HCT.
Since 1997, MERCOSUR has started a technical subgroup 11, which is in charge of promoting HCT and HTA
issues, among other things. In this regard, the technical subgroup is working on multilateral cooperation, facilitating
cooperation with international agencies and networks (e.g.,
PAHO/WHO, HTAi, RedETSA, EUnetHTA, INAHTA,
CCOHTA, etc.), identifying relevant groups and national
institutions in HCTM and HTA fields, and emphasizing that
the clinical engineer is pivotal in the proper implementation
of such issues.
More recently, the Ministry of Health of Paraguay began creating a critical mass of personnel trained in HTA
methodology and practice (Galvan et al., 2017) who have
appropriate access to national and international information
sources.
To establish an appropriate HCT system and its management, the Ministry of Health created an HCTM Department
with three specific objectives:
•
•
Strengthening policy and programs in clinical engineering, maintenance, technology management, and
regulation
Optimal use of the resources assigned to the clinical engineering and maintenance programs
•
89
Improvement in quality, efficiency, and safety of the operation of equipment, utilities, and physical plant, adapting to economic realities
The HCTM Department has implemented the divisions
of planning, procurement, and management to achieve the
specific objectives and to guarantee health services delivery
with equity, quality, efficacy, and safety, and to protect the
HCT investment.
A short evaluation report (Galvan et al., 2017) showed
that the impact of the implementation of the HCT development plan was focused on acceptable improvement of the
healthcare referral system, giving access to curative services with appropriate technology to deliver a basic package of essential diagnosis, treatment, and rehabilitation,
with increased delegation of responsibilities at the district
level.
Furthermore, viewed from a practical perspective, this
preliminary country analysis showed that, over the implementation period of HCTM, the evidence gathered demonstrates that 90% of the contingency plan of the HTP for
the period 2013–17 has been achieved with the general improvement in the state of HCT. In general, improvement of
planning system focusing on an appropriate HCT system
and its management was reached at the Ministry of Health
through the implementation of the HCT development plans.
Telemedicine
Through technological innovations based on information
and communication technologies (ICT), advantageous telemedicine systems can be developed to improve the health
care of remote populations that do not have access to specialist physicians (Basogain et al., 2010). In the context
of universal coverage and the efficient use of available resources in public health which should be directed toward
greater equity in the provision of services, greater concern
for the effectiveness and usefulness of health technologies,
there is a favorable opportunity to develop telemedicine
toward an integrated ecosystem to improve health care in
remote locations without access to specialists. Telemedicine
activities require knowledge of telecommunications technology, networking technology, and medical device technology. In this sense, clinical and biomedical engineers can
expand their horizons to a more diverse application of their
engineering and management skills.
In Paraguay, the first telemedicine experience was
made in 2000 at the Biomedical Engineering and Imaging
Department (Galvan et al., 2008) with a live pregnancy
echography transmission from the gynecology rooms at the
Regional Hospital of Fuerte Olimpo (800 km north from
Asuncion) to the Ministry of Health in the capital city of
Asuncion, utilizing satellite transmission. But, the connection with remote rural communities was not attempted u­ ntil
90 SECTION | 2 Worldwide clinical engineering practice
FIG. 1 National telemedicine network of the Ministry of Public Health.
2008, when sufficient experience had accumulated with
­ultrasound, electrocardiography, and nuclear medicine image transmission at the Biomedical Engineering Department
with the available internet services.
The National Telemedicine Program of the Ministry of
Public Health (MoH), the first nationwide telemedicine program implemented in 2013 in Paraguay, as shown in Fig. 1,
focused on tele-electrocardiography, tele-­tomography, teleechography, and tele-­electroencephalography, is the result
of a collaborative pilot project between the Biomedical
Engineering Department at the Health Sciences Research
Institute of the National University of Asunción (IICS-UNA)
and the University of the Basque Country (UPV/EHU).
The telemedicine experience in Paraguay (Galvan et al.,
2017) between 2013 and 2017 shows that technological innovation in public hospitals through telediagnosis can facilitate the universal coverage of diagnostic services at a
relatively low cost, the economic sustainability of the public
telediagnosis system, and the development of systems resilient in rural and isolated communities of the country, where
these are not available.
Financial resources
According to World Bank reports (World Bank, 1996), it
is recommended that up to US$12 per capita is required to
comply with current healthcare demands. The reality of the
developing countries demonstrates that such targets are difficult to achieve and that they must make tremendous efforts
to comply and meet their healthcare demands (Heimann
et al., 2001).
In the case of Paraguay, the per capita spending on health
in 2015 was US$317.00, and the public spending was 7.8%
of the gross domestic product (GDP) (Ministry of Public
Health, Dirección de Economía de la Salud, 2017).
The poor financial resources for public health are mirrored in the area of HCT, with <5% of the overall national
health budget dedicated to upkeep and maintenance.
Consequently, the financial needs far exceed the resources available. In order to improve the available financial resources, a process of decentralization with increased
delegation of responsibilities at the district level could prove
to be one of the key responses.
Human resource development
A sustainable and strengthened HCTM can be achieved
only if an appropriate human resource development plan is
included in the HTP. To establish an appropriate HCT system and its management, human resource availability based
on clinical engineers, BMETs, managers, and secretaries as
staff members is required.
Clinical engineering in Paraguay Chapter | 11
91
TABLE 1 Task distribution by job classes (Bauld, 1987).
Job
Task
BMET
Clinical engineer
Manager
In-service training
✶
✶
✶
Equipment evaluation
✶
✶
✶
Periodic inspection
✶
✶
✶
Preacquisition planning
Repair
✶
Design services
✶
✶
Rounds
✶
✶
Parts ordering
✶
✶
Data analysis
✶
✶
Such qualified staff should perform activities as listed in
Table 1 (Bauld, 1987). Task distribution by job classes and
the total work effort by all of the staff must be included to
account for productivity.
The clinical engineer is the manager of a Clinical or
Biomedical Engineering Department. The department will
be responsible for technology management and at least part
of the safety management program. With this variety of responsibilities, several different job roles are required, and
each of these may have different educational requirements.
In Paraguay, the main problem with HCTM in the 1980s
and 1990s was defined as inadequately qualified human resources and suboptimal managerial capacity. Survey reports
(Galvan and Isaacs, 1999) showed that, regarding human
resources, the main institutional weaknesses were focused
on the following for upkeep and maintenance of HCT:
•
•
•
•
•
Secretary
The absence of a clinical or biomedical engineer to manage the Clinical Engineering Department
Shortage of technical staff (2.5% CE, 13% low-qualified
BMET, and 84.5% self-taught)
Inadequate training of maintenance technicians
Low managerial capacity
Lack of staff in new technical areas
To improve the HCTM and, in particular, human resource development, a training strategy for BMET and CE
was defined. Additionally, another key goal of professional
development will be the formation of certification programs
for CEs and BMET, with the cooperation and support of the
American College of Clinical Engineering (ACCE).
To overcome the critical situation of scarce qualified
staff for HTM in the country, the Biomedical Engineering
Department of the Health Science Research Institute (IICS/
National University of Asuncion) has played an essential
✶
✶
✶
✶
✶
role for the development and implementation of the education program for clinical engineers, BMETs, and master in
biomedical engineering.
Regarding the training of BMETs, since 2008 a 2-year
polyvalent basic training program was instituted at the
National Institute of Health of the Ministry of Health. Such
qualified staff has received a further 1-year training on medical electronics of biomedical equipment to enable them to
fulfill their roles. Thus, today it is estimated that more than
60 licensed BMETs are working in the hospital field.
The clinical engineering (CE) training program includes
a 5-year polyvalent training at the National University of
Asunción (Polytechnics Faculty). Furthermore, a 1-year
training practicum at hospitals (in Clinical Engineering
Departments) or in industry is necessary to enable the
clinical engineers to fulfill their roles. Education of clinical engineers started in Paraguay in 2000. Thus, today it is
estimated that more than 65 specialized professionals are
working in the field of clinical engineering.
In addition to the clinical engineering and BMET training program, since 2011 exist a Master Course Program in
Biomedical Engineering developed between the Basque
Country University (Europe) and the National University of
Asuncion (Paraguay) with 60 European Credit Transfer System
(ECTS). Thus, today it is estimated more than 15 masters working in the field of research, academy, and clinical engineering.
After fulfilling the education and training program the
BMET, CE, and Master in Biomedical Engineering get a
5-year valid license from the Ministry of Public Health
for registration and permission to work as health staff at
the hospitals and health research centers. Today, there are
more than 200 clinical technicians working in hospitals, and
service companies in Paraguay (32.5% CE, 30% qualified
BMET, and 37.5% self-taught).
92 SECTION | 2 Worldwide clinical engineering practice
Regular, continuous training courses for staff and clinical equipment users should be implemented, and career
opportunities should be explored. Furthermore, specialized courses have been designed and instituted for specific
topics, for example, X-ray, CT scanners, lab analyzers,
surgery equipment, and ventilators in the annual training program of the Ministry of Health with the cooperation and support of the Senior Experten Service (SES) of
Germany.
Moreover, managerial skills are also required at the administrative level (private and public sector) to comply with
the needs of a maintenance system and future advances and
developments in HCT.
HCT maintenance
A full clinical engineering service should cover the entire
life cycle of a medical device within a quality assurance
system. Maintenance infrastructure should be designed
and established at all hospitals and reference centers that
have at least 100 beds. Then, in general, at this level there
are operating theaters, intensive care units, radiology departments, maternity services, and functional laboratories,
all of which need in-house maintenance services. The
list of duties includes maintaining the inventory, device
records, and schedule of maintenance, safety checks, and
calibrations.
In Paraguay, the maintenance system situation is similar
to that in Latin America. Survey reports (Galvan and Isaacs,
1999) showed that 48.9% of the existing medical equipment and devices of selected hospitals were out of service
or malfunctioning, and that one of the main reasons for this
situation was lack of infrastructure, tools, equipment, and
information systems for maintenance.
To overcome this situation and to improve the HCT
maintenance system in the country, the Ministry of Health
has designed, and is seeking financial resources to implement, an HCTM Network for national hospitals as well
as all regional/district hospitals as reference centers. The
HCTM Network comprises a central workshop, located in
Asuncion; three regional workshops distributed according
to the demand of the involved hospitals in main provincial
towns; and three mobile workshops to maintain hospitals in
rural and remote areas.
According to the assigned capabilities, the HCTM
network should cover up to 85% (depending on volume
of complex repair) of the daily scope of maintenance activities. Further, the more complex repair and maintenance
work (15%) should be performed by private services (i.e.,
manufacturers and agents). However, to achieve an acceptable level of efficiency in the HCTM system, a good collaboration should exist among the administration, hospital
managers, and workshop personnel.
Paraguayan Society of Biomedical
Engineering
The society was established in 2014 and now has 55 members. The majority (38) are clinical engineers and 17 students of clinical engineering. Thus, today it is estimated that
28 professionals found jobs in the private sector (medical
device providers, CE services) and 10 are working in public
hospitals. Eight members are working in the field of CE
education and 4 members in CE research.
Recommendations
Clinical engineering services should be installed close to the
problem areas in a sustainable and cost-effective manner.
This implies that such departments must have competent
human resources (CEs and BMETs), adequate infrastructure, sufficient financial resources, and adequate management for the scope of responsibilities. Furthermore, such
CE services would not be available at rural and remote levels, given the lack of critical mass of HCT. In Paraguay, the
majority of rural and remote hospitals have between 5 and
20 beds, with a lack of critical mass of HCT. To compensate for the absence of such CE services in rural and remote
areas, the use of mobile workshops incorporated into the
clinical engineering maintenance system is recommended.
In order to achieve a well-organized and well-­structured
clinical engineering service, an HCTM plan developed
according to the criteria of the Joint Commission for
Accreditation of Healthcare Organizations (JCAHO) called
“equipment management” (EM) should be established to
comply with the HCTM’s mission and vision.
Conclusion
Clinical engineering practice in Paraguay does not differ
significantly from the practice made in other Latin America
countries. Proper HCTM, including performing maintenance, is crucial for adequate health service delivery. But
local settings differ from region to region in the same country, and appropriate solutions are not easy to find.
In order to guarantee health service delivery with equity,
quality, efficacy, and safety and to protect the physical plant
investment, governments need to improve the availability
and management of HCT at hospitals in rural and remote
areas for the more deprived population.
Sustainable maintenance systems at an affordable cost
contribute substantially toward improving the health system. The establishment of an adequate HCT policy, improvement of financial resources, investment in local human
resources, and alliances with relevant groups and national
institutions to create common positions to solve problems
are of vital importance to guarantee a sustainable system.
Clinical engineering in Paraguay Chapter | 11
World experiences show that in-house maintenance services at the local, regional, or national level can save the
scarce financial resources if driven by a clinical engineering
concept and cost-effective considerations.
Investment in continuing education courses for clinical
engineers and BMETs is important but is only beneficial if
the other key components like sufficient financial resources,
adequate infrastructure, and appropriate supply of spare
parts are available.
In conclusion, well-structured and well-organized
Clinical Engineering Departments to manage and maintain
HCT are absolutely necessary at healthcare facilities where
a critical mass of HCT and utilities is available.
References
Basogain, X., Cane, V., Galván, P., Cabral, M., Olabe, M.A., Gómez, M.A.,
et al., 2010. Epidemiological surveillance using information technologies in Paraguay. Biomed. Instrum. Technol. (2), 159–165.
Bauld, T., 1987. Productivity: standard terminology and definitions. J.
Clin. Eng. 12 (2), 139.
Galvan, P., 2001. Technology Development in Health Systems and
Services in Paraguay. Instituto de Investigaciones en Ciencias de la
Salud, Asunción.
Galvan, P., Isaacs, J., 1996. Evaluación del Estado de los Equipos y Sus
Respectivos Programas de Mantenimiento en las 5 Regiones Sanitarias
del Proyecto BID “Reforma de la Atención Primaria de Salud”. Pan
American Health Organization/World Health Organization (PAHO/
WHO), Asunción.
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Galvan, P., Isaacs, J., 1997. Evaluación del Estado de los Equipos y sus
respectivos Programas de Mantenimiento en las 6 Regiones Sanitarias
del Proyecto BIRF “Salud Materna y Desarrollo Integraldel Niño/a”.
Pan American Health Organization/World Health Organization
(PAHO/WHO), Asunción.
Galvan, P., Isaacs, J., 1999. Evaluación del estado de los equipos y sus
respectivos programas de mantenimientoen 11 Regiones Sanitarias
de Paraguay. Instituto de Investigaciones en Ciencias de la Salud,
Asunción.
Galvan, P., Cabral, M.B., Cane, V., 2008. Implementation of a
Telemedicine/Telehealth system at the Institute of Research in Health
Sciences. Mem. Inst. Investig. Cienc. Salud 1817-46204 (1), 20–27.
Galvan, P., Velázquez, M., Benítez, G., Ortellado, J., Rivas, R., Barrios, A.,
et al., 2017. Impacto en la salud pública del sistema de telediagnóstico
implementado en hospitales regionales y distritales del Paraguay. Rev.
Panam. Salud Pública 40 (4), 250–255.
Heimann, P., Porter, D., Schmitt, R., et al., 2001. Sustainable health care
technology management systems for the public health sector in developing countries. Medizintechnik 1, 22.
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Planificación y Evaluación, Dirección de Economía de la Salud,
2017.
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WHO), 2001. Developing Health Technology Assessment in Latin
America and the Caribbean. Pan American Health Organization/World
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del Paraguay. Pan American Health Organization/World Health
Organization (PAHO/WHO), Asunción.
World Bank, 1996. Health Report. Washington, DC.
Chapter 12
Clinical engineering in Peru:
Looking for a healthcare
technology management
model
Luis Vilcahuaman, Rossana Rivas, Eduardo Toledo
Eng. Dep. & Health Technopole CENGETS, Pontifical Catholic University of Peru PUCP, Lima, Peru
This chapter describes how clinical engineering needs to
be redefined in the face of a complex problem about the
state of medical equipment. Due to additional deficiencies
in hospital infrastructure and equipment, the clinical engineer is in need of interacting in a broader context than
only medical equipment. The current premise is not only to
guarantee the operability of medical equipment, but to support in reaching appropriate technological environments for
functional, cost-effective and safe clinical services. Given
this perspective, a holistic vision is required. The step of
managing medical devices to manage healthcare technology is essential. Likewise, the health sector is eager for new
management models. A reengineering in the organizational
strategy is proposed for the integrated management of the
various types of healthcare technology. Consider senior
management as a vice-ministry or directorate of science and
technology, as well as a reengineering in the organization
of hospitals in order to have a greater capacity for design
and healthcare technology management. For this is considered the intervention of not only the clinical engineer, but
also the coordinated intervention of biomedical engineers,
hospital engineers, medical physicists, hospital architects,
among other healthcare technology specialists. This chapter analyzes the technology in the Peruvian health system
and proposes processes and organizational models for the
healthcare technology management aimed at guaranteeing
better quality in the care of health services.
Peruvian healthcare system
In 2015, Peru had a population of 31 million inhabitants.
By regions, the population was concentrated mainly on
the coast (57.3%), followed by the highland (28.4%) and
94
the jungle (14.3%). It is estimated that by 2020 Peru will
have a population of 37 million. According to the Survey of
Demography and Health 2015 (INEI, 2016), 29.2% of the
population are under 15 years of age; 62.2% are between
15 and 64 years old, and those above 65 represent 8.6%.
It is estimated that by 2025 young people will remain at
approximately 8 million (24%), and the population above
60 will increase from 3 to 4.3 million (from 10% to 13%).
These data show that the population according to age is
changing. However, despite the increase in the adult population, the young population will continue to represent
a high percentage (demographic bonus). Aspects related
to mortality and fertility have influenced this population
change, among which the following stand out: (a) decrease
in the infant mortality rate, which went from 21 per thousand live births (LB), in 2008, to 16.6 per thousand LB, in
2015; (b) the crude death rate, which remained from 2008
(5.5 deaths per thousand) to 2015 (5.7 per thousand) without major changes; (c) the global fertility rate, which went
from 2.41 children per woman, in 2008, to 2.2, in 2015;
and (d) the increase in life expectancy at birth, which went
from 75.0 years in women and 70.0 years in men, in 2008, to
77.8 years in women and 72.5 in men, in 2015.
In Peru there are subsystems of public, private, and
mixed health. The first seeks to express the logic of citizens’ right to health, the second is based on market logic,
and the third is social security (Essalud), public entity of
private law. The Ministry of Health (MoH) (MINSA), in
its role as National Health Authority, governs the system.
In the course of decentralization, 25 regional governments
were formed, which, after receiving a series of competencies and functions in transfer, began to administer the state
health services in their respective areas, although under the
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00012-2
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Clinical engineering in Peru: Looking for a healthcare technology management model Chapter | 12
political guidelines and regulations issued by the MoH. For
its administration, each regional government organized its
Regional Directorate of Health (Diresa). On the other hand,
employees of companies and their beneficiaries can choose
to receive Essalud services (traditional mode), through its
own network of services distributed nationwide, or join an
EPS (private mode), which provides them the attention of
less complexity (simple layer) through contracted private
services and toward Essalud the attention of greater complexity. The three military institutes and the national police each have their own network of services. Additionally,
it operates a network of mixed services, which is state
owned but operates as private. It is an informal modality of
­public-private partnership implemented by the Metropolitan
Municipality of Lima, a practice that has spread to different cities in the country (Solidarity Hospitals). Likewise,
there are multiple health services run by philanthropic organizations and churches that receive financing from their
promoters and nongovernmental cooperation. According to
the Medical College of Peru (CMP), “The Peruvian health
system is the product of the superposition of various organizational structures from different health arenas, tributaries
of diverse conceptions and carriers of varied interests, cultural patterns, forms of financing and government models,
of management and provision; accumulated as geological
strata, some of them coming from the colonial world. Its
structure is the expression of diverse ideological currents
and political orientations, usually discontinuous, disconnected and even contradictory, in which high levels of inequality and inefficiency persist” (Lazo-Gonzales et al.,
2016).
According to Peruvian MoH the principal goals in 2017
are (MINSA-1, 2017): (a) achieving an efficient management of the health system services and (b) to have a modern and interconnected health infrastructure. On the other
hand, MoH states that the gap in access to health services is
due to some of the following factors: (i) human resources,
(ii) infrastructural and equipment limitations, (iii) health
investment weaknesses, and (iv) user’s dissatisfaction with
the quality of the health service keeps high, among others.
Peruvian government defined the next 3 years for investment
in infrastructure. Interventions are mainly aimed at the following priorities: (I) access to basic public services in water and sanitation; (II) citizen security and anti-­corruption;
(III) quality public education; (IV) health services oriented
to people; and (V) infrastructure for development and productivity (Rivas et al., 2017).
Regarding the achievement of results from health technology projects, the initiatives of e-health and telemedicine projects in Peru and other countries of the region have
shown successful results although there are still relevant difficulties to design sustainable telemedicine programs due to
the lack of health policies. In addition, the lack of measurement of the scope and the exact assessment of the r­esults
95
of the National Health Programs are additional factors to
be considered on the analysis of the situation of Peru and
the countries of the region (Vilcahuaman and Rivas, 2017).
About education for health technology, currently, Peru
has three biomedical engineering programs (undergraduate studies) that include clinical engineering courses, and
at least two other programs in progress, two master’s programs related to biomedical engineering, as well as clinical engineering courses, including a diploma course (1 year
of study) of clinical engineering and healthcare technology
management, a diploma (1 year of study) of architecture
and hospital engineering, in addition to recurrent courses
and events organized by more than six universities or professional entities related to the health sector. Particularly,
the programs of the Pontifical Catholic University of Peru
(PUCP) include the participation of students in international
events organized by National Biomedical Engineering
Societies or by partner universities or by the Regional
Council of Biomedical Engineering for Latin America
(CORAL), in addition visits to representative hospitals of
the countries visited.
Situational status of infrastructure and
equipment in hospitals
According to MoH in 2005 (MINSA-2, 2005), “the hospital infrastructure presents an acceptable state of conservation in 69%, the degree of conservation of equipment and
furniture is only 59% operative. It is necessary to implement strategies that lead to increase the management capacity of hospitals and their sustainability over time, through
the implementation of adequate technology management
in each of the hospitals, in order to improve and optimize
the attention of the health services.” The cost of not having
technology management in hospitals is already being paid,
due to the cost of inefficiency and the waste of economic
resources derived from the lack and ineffectiveness of technology decisions.
For 2016, a study by the Congress of the Republic (CR,
2016) says the following about the situational status of infrastructure and equipment in hospitals: “The health sector presents difficulties in terms of hospital infrastructure,
among them the poor state of infrastructure and equipment, irregular supply and quality of medicines, deficiencies in management, poor capacity and training of staff
and serious shortages of financial resources. In addition,
the Geophysical Institute of Peru warned that the capital
Lima could be affected by an earthquake of 8 degrees (or
more). The result would be a large number of uninhabitable hospitals due to their antiquity and poor infrastructure, causing the collapse of the health system by not
having the capacity to attend to the 600 thousand injured
that, at least, would leave this telluric movement according to the INDECI.” Faced with this risk of collapse of
96 SECTION | 2 Worldwide clinical engineering practice
various hospitals due to seismic or natural phenomena, the
Peruvian government enacted Supreme Decrees in 2017
declaring emergency health systems, authorizing measures that allow investments to be made for the reinforcement and maintenance of hospital infrastructure, among
other necessary resources.
According to the Peruvian General Comptroller in its
report at the end of 2016 (CGR, 2016), 79% of hospitals in
the country lack the minimum equipment required. Being
consistent with this evidence, the change proposed for the
health sector should be initiated as soon as possible (Rivas
et al., 2017).
Review about health technology
The World Health Organization (WHO) defines hospitals
in the following terms (WHO-1, 2018): “These are health
facilities that have an organized group of doctors and other
professionals, as well as having inpatient and outpatient facilities, and they offer their services 24 hours a day, 7 days
a week. They offer a wide variety of care for acute, convalescent and terminal cases using diagnostic and healing
services. Hospitals need to be organized around the needs of
their population, work closely with other social and health
services, as well as contribute to strengthening primary care
and public health services to sustainably contribute to universal health coverage.”
On the other hand, according to the WHO, Health
Technology (WHO-2, 2018) is the application of knowledge and skills organized in the form of devices, medicines,
vaccines, procedures, and systems developed to solve a
problem of health and improve the quality of life. The incorporation of these in the health system and its use requires
an appropriate technology management system, based on
well-known methods and procedures such as the life cycle,
health technology evaluation, norms, codes and regulations,
as well as policies that promote it. Fig. 1 shows the different types of technology. It must be emphasized that these
interact together and therefore constitute a platform or technological environment for each clinical service or health
initiative.
In a health facility, in each clinical service and in general, in each health intervention, all these technologies together, interrelated, constitute a platform or technological
environment, such that they require specialized management to ensure their functionality. However, the model of
technology management in the Peruvian health system
follows the old model, it consists of a maintenance or engineering office exclusively oriented to guarantee the operation of medical and hospital equipment in a way unlinked
from functionality of the clinical service. This unit is dependent on the general services office, which in turn belongs
to the administrative branch of the hospital. The result is
that there is no formal entity responsible for the ­technology,
Technologies for healthcare
Environmental health
People’s health
Individual health services
Community health services
Protection
technologies
Prevention
technologies
Promotion
technologies
Clinical technologies
Pharmaceuticals &
others consumable
products
Medical
epuipment/
devices
Clinical procedures
Support technologies
Organization &
management
systems
Information &
communication
Technologies
Infrastructure, plant, facilities,
hospital equipment, emergency
vehicles, waste management
Telemedicine, e-Health, tele-Health, movil Health, home based Health
FIG. 1 Different types of health technology working together in each clinical service or hospital. (Modified of PAHO/WHO Pan American Health
Organization/World Health Organization. Healthcare technologies assessment in Latin America and the Caribbean, 2000.)
Clinical engineering in Peru: Looking for a healthcare technology management model Chapter | 12
which implies that there is no engineering, which in turn
obviously discourages any outstanding engineer. When reviewing the history of this old model, it is observed that it
never worked correctly, either due to deficiencies in hospital management or lack of resources. Likewise, health management does not contemplate the management of health
technology, so the problem of the deplorable state of infrastructure, systems and hospital, and medical equipment
is not formally addressed. In summary, the health system
has considered the repair of equipment and leaves aside the
development and direction of its technology, making the
premises, criteria, updates, norms, and modern regulations
on health technology not reception, do not apply and therefore, they do not benefit the patient or the health personnel.
One possible explanation for this situation is that the old
model is based purely on the “technical” approach and not
on the “technological.” The difference can be found in any
dictionary, the technical is oriented to the skill, in this case
to repair equipment. However, the orientation to technology
implies a scientific knowledge of by means, very necessary
to design and direct the development of technology in the
health system and in hospitals. Thus, the current management system has only focused on technological aspect of
maintenance of equipment, whose objective is operability,
but does not contemplate the technological functionality of
clinical services, which is what doctors and patients expect
to have for a health service with quality. It is not enough
to have an operative device, if the rest of the technological
components are not equally operative, and what is more,
not only is it required that all the technological components
be operative, tangible, and nontangible, but also that they
work in an integrated and interrelated way to achieve the
real functionality of the clinical service (Vilcahuaman and
Rivas, 2017).
Resolution WHA 60.29 of the World Health Assembly
(WHA, 2007) recognizes that health technology is the indispensable means by which health facilities offer effective
and efficient prevention, diagnosis, treatment, and rehabilitation services, aimed at achieving the internationally
agreed development goals related to health, including those
contained in the Millennium Declaration. It also urges
member states to create units for the appropriate management of health technology. It is necessary to highlight that
in Peru, laws, regulations, and other official documents on
health, the concept of technology is absent, which explains
its reduced attention and therefore the precariousness of
the technological aspect in hospitals (infrastructure, energy
system, hospital equipment, biomedical equipment, ICT’s,
clinical procedures, organization, etc.). It is proposed to
move from maintenance management or equipment management to healthcare technology management, where
hospitals have the capacity to develop and manage their
own technology. In this sense, for example, Brazil (MS,
2018) and Mexico (UVM, 2014) are incorporating in their
97
health sector and the hospital network, general directorates of science and technology, as well as departments of
biomedical engineering and other related, with the purpose
of guaranteeing an appropriate technological environment
and applying specific technologies according to the type
of hospital or clinical service, and even to carry out joint
work with health professionals for the clinical cases that
require it.
Technology management model for a
modern health system
The medical branch is the raison d’etre and main pillar of
the health system. However, the quality of healthcare services also includes the administrative branch and technology as defined above. The latter recently recognized as
such, is more complex than just considering its operatibility,
it requires a real capacity for technological development in
the health system, able to address its highly dynamic evolution, which makes it necessary to have the ability to design
clinical services and ensure the integrated functionality of
the technological environment. These premises can be conveniently served from a unit specialized in technology still
to be created in the health system and within health facilities, that is, it is necessary to start the task of implementing a technology branch with responsibility, functions, and
processes of a health technology management system (Silva
and Lara-Estrella, 2004). The cost of not having it is already
being paid (HNCH, 2005) and in the absence of appropriate
technology decisions, inefficiencies and waste of resources
are generated, the cost of which is higher than having these
units. Health’s trends and goals demand to change the traditional concept related to hospitals role and health staff’s
profile, the achievement of high-value results depends on
a number of factors, including the understanding of the
science-technology-ethics link; this synergy is part of the
core of the level of quality and efficiency expected by the
population from the health system (Vilcahuaman and Rivas,
2017).
Public-Private Partnerships (PPP) in the Peruvian
health system
Public-private partnerships (PPP’s) have begun to be applied in Peru, with promising results and will surely continue to improve over time. At the moment, the construction
of infrastructure and the operation of hospital and biomedical equipment (gray coat) have been emphasized, which is
a good start. However, to align with the international premises on technology and quality of health services, it is necessary to consider the technological development of hospitals
and the integrality of technological components at the time
of patient care. That is, even though PPPs are a viable option, it does not mean that the technological development
98 SECTION | 2 Worldwide clinical engineering practice
of the hospital is guaranteed and that all the technological
components (as defined by WHO) are functional in a coherent manner for a good quality of care. Therefore, it is
required that the health system and hospitals have adequate
capacity to manage their own technology, that is, they have
a branch of health technology in their organizational structure. The “gray coat” and even the “green coat” suggest a
wide variety of options for PPPs, however, hospitals should
not stop but having control of their own technology for the
fulfillment of their mission and health service objectives
(Vilcahuaman and Rivas, 2017; MINSA-3, 2009).
Healthcare technology management system and
clinical engineering
Raising a new management model to address the technological aspect will be a long process. Naturally, some hospitals will continue to try to make the old model work just to
maintain equipment. However, there is great interest from
several hospitals to address this problem frontally and there
is a willingness to establish a new model, more holistic,
more focused on the functionality of clinical services, more
integrating all aspects related to technology, with greater
support to the development of hospital clinical and administrative activities, greater control of costs and risks in the use
of technology, greater interaction and connectivity among
the technological components, better interaction with
health professionals, and especially guaranteeing the quality of the technological platform required for the provision
of health services. That is, this model follows the approach
provided by Silva and Lara-Estrella (2004), which establishes the need to create a branch of the organization oriented to the joint management of all technological aspects
in health, including in a hospital as well as in the health
system in general. As an advance in this process, several
Peruvian hospitals have created health technology management units or biomedical engineering units or clinical engineering units in order to improve or expand the functions of
the maintenance offices, despite not yet having a national
policy in this regard. Next, we propose the mission and vision of these new units in the process of incorporation, as
well as their main processes.
Mission and vision of a healthcare technology
management system or branch of technology
Mission: To guarantee the functionality of the technological
environment of the clinical services, including the telemedicine clinical services, taking into account the different types
of health technology, based on high levels of clinical effectiveness, efficiency in the use of resources, safety in the
application of technology, and the control of costs derived
from the use of technology, with its main processes: planning, acquisition, management of technological assets, risk
management, human resources development, and research
applied to the continuous improvement of the hospital’s
technological environment.
Vision: Within the framework of the mission and institutional vision of the health system and the hospital,
contribute to the management of the technological evolution of health care, oriented to an appropriately specialized and high-quality care for the ascribed population,
with leadership in the excellence of the technological
environment.
Main processes of a healthcare technology
management system
The effectiveness, productivity, and sustainability of
healthcare technology management system require previously the design and the implementation of Health
Technology Policies for the country; according to the
WHO, two principal aspects are promoted by the government: (a) the interaction between academia-­industrygovernment, and (b) the definition of governmental
mechanisms to raise the visibility of the scientific and
technological activity in the countries of the region.
Health and technology in health are complex issues that
require matrix conceptions to approach them conveniently
(Vilcahuaman and Rivas, 2017; Ziken International
Consultants & WHO, 2005). Thus, different types of
health technology require different approaches, however,
their incorporation and use in the health system follows
the following processes (Fig. 2).
a. Technology planning: Situational status analysis, preparation of plans in the current and future context, as well
as planning investments, hospital design, and hospital
facilities.
b. Technology acquisition: Analysis of needs, assessment
of appropriate technology, application of current regulations, and functional installation.
c. Management of technological assets: Functionality and
operability of installed technological resources, preventive and corrective maintenance of the technological
environment.
d. Management of technological risks: Hazard identification and risk assessment, technosurveillance: metrological verification, infection control, quality control, and
evaluation of adverse events.
e. Development of human resources in technology:
Hospital architecture, hospital engineering, biomedical
engineering, medical physics, biomedical technicians,
and others.
f. Applied research and project management: Research to
solve problems and for the technological development
of the health system, based on working together with
health professionals and administrators.
Clinical engineering in Peru: Looking for a healthcare technology management model Chapter | 12
99
5. Human resources development
3. Technological
assets
management
Inputs
1.
Technology
planning
2.
Technology
acquisition
Outputs
4. Technological
risk management
6. Applied research & projects management
FIG. 2 Main processes of an integrated healthcare technology management HTM system for hospitals (Vilcahuaman and Rivas, 2017).
To modernize the health sector, as well as to provide and
guarantee a high quality of health services, it is necessary
to strengthen the management capacity of the technology
in the health system and hospital network, which implies
improving the ability to design technological environments
and the ability to properly direct and supervise the technological development of hospitals. This requires a long process of change or reengineering of the management model,
being the breaking point, the approach of the policies and
programs that we propose below:
1. Creation of health technology management units (technology branch): creation and strengthening of units responsible for health technology in hospitals, with the
capacity to manage their own technology, which implies
having a greater capacity to design services clinical, in
addition to directing and supervising their technological
development within the framework of their life cycle,
with efficiency in the use of resources, promotion of
clinical effectiveness, reduction of technological risks
and biosecurity, in addition to control of associated
costs. All this driven by an integrated healthcare technology management system. It is about strengthening
the capacity of hospitals and at the same time promoting
better PPP contracts.
2. Recovery program for the current technological environment of hospitals: it mainly includes support
technologies (infrastructure, energy systems, hospital
equipment, information and communication systems,
and the organization itself) and clinical technologies (medical procedures, medical devices, drugs, and
medical materials). These tasks involve considering the
r­ edesign or complementation of the design of the hospitals as well as their clinical services from master plans
of investments for a short- and long-term horizon. In this
regard, various initiatives have been created to generate
greater public investment in health such as the National
System of Public Investment (SNIP and others similar
investments), “Works for Taxes,” National Program of
Investments in Health, etc. PPPs are also options to promote in this recovery program.
3. Update program health technical standards NTS (Norma
Técnica en Salud) in hospital design and hospital management: Updating of existing standards and development
of new hospital design standards according to resolution
level and geographical area, aimed at the comprehensive
modernization of hospital technology: infrastructure, energy systems, hospital equipment (electromechanical),
ICTs, biomedical equipment, organization, clinical procedures, prevention technologies, protection, and promotion technologies; as well as the promotion of new PPP
contracts, in particular those of “gray coat,” such that
they are more integrated in order to guarantee the technological functionality of the clinical services, together with
professional and institutional actors linked to the sector.
4. Education and Training of human resources: Peru has
a large deficit of professionals and technicians specialized in addressing aspects of health technology. Clinical
engineers, biomedical engineers, medical physicists,
hospital architects, hospital engineers, and others
are required. At this point, the MoH needs to recognize the technological aspect as a basis to perform its
role in health and generate the appropriate policies to
strengthen the capacity of technology management
100 SECTION | 2 Worldwide clinical engineering practice
in the sector. In particular, the PUCP has defined the
profile of the clinical engineer in the described context:
“The clinical engineer is a professional for design and
management, who supports and promotes the well-­
being of the patient in order to ensure the optimal use of
technological resources, through the application of their
engineering and management skills in the management
of technology, in clinical procedures and contributions
in the design of clinical services, thus promoting better clinical effectiveness, greater efficiency in the use of
technological resources, greater safety, better control of
costs and, therefore, greater quality in the attention of
health services. The clinical engineer leads the technological intelligence in public and private organizations
of health services, clinical research, and technology
regulation. Promotes the creation of companies, startup
companies and patents.” It should be noted that the need
for the clinical engineer to be involved in the design
of clinical services arises from the requirement to recover the current state of the infrastructure from having
a better interlocutor between clinical work and hospital architecture and engineering. In this sense, an additional requirement for the clinical engineer is the need
to have the applied research capacity in order to solve
the innumerable clinical-technological issues that health
services require, which would lead hospitals to better
development technological, leaving aside the stagnation
typically observed in the current health system.
Conclusions and recommendations
The poor state of the infrastructure, energy systems, medical and hospital equipment, information systems and organization, especially in public sector hospitals, has sensitized
authorities and health professionals in the search for alternatives, whether conventional- or even-type leapfrogging or
design thinking out of the box. The process of change will
be long despite the starting point being explicit recognition that in health technology, there is a big problem. In this
way Peruvian government realizes health technology is key
to solve the serious problem of quality of health services in
Peru. The next step is to define feasible alternatives for the
health sector, the authorities begin to be available to define
technology policy also to recognize that the academia is a
strong partner for the formation of human resources and to
propose strategies. In this process, a holistic vision applied to
health technology is pertinent as well as the interaction with
the various countries and international entities whose experience and methods serve as lessons learned. If we add to this
the ethics applied to the use of technology and research, we
will have considered the fundamental factors of the process.
References
CGR General Comptroller of the Republic, 2016. Report: Operative Health
Control 2016, Lima.
CR Congress of the Republic, 2016. The public hospital infrastructure in
Peru. Research report 27/2016–2017. Department of Parliamentary
Research and Documentation. CR.
HNCH National Hospital Cayetano Heredia, 2005. 300,000 Soles (US$
120,000) Saved the Hospital in 2004. Agenda Hospitalaria Magazine.
INEI, 2016. Encuesta Demográfica y de Salud Familiar ENDES. Instituto
Nacional de Estadística e Informática.
Lazo-Gonzales, O., Mayor-Rabanal, J., Espinosa-Henao, O., 2016. The
Health System in Peru—Situation and Challenges. Medical College
of Peru CMP.
MINSA-1 Ministry of Health, 2017. Minister of Health P. García.
Presentation to the Health Commission of the Congress of the
Republic.
MINSA-2 Ministry of Health, 2005. Physical and Functional Diagnosis
of Infrastructure, Equipment and Maintenance of Hospitals of the
Ministry of Health. Ministerial Resolution MINSA N°. 608-2005.
MINSA-3 Ministry of Health, 2009. Hospital Management Model. Work
Document. General Directorate of Persons Health DGSP-MINSA.
MS Ministério da Saúde do Brasil, 2018. Secretaria de Ciência, Tecnologia
e Insumos Estratégicos. http://u.saude.gov.br/index.php/o-ministerio/
principal/secretarias/sctie.
Rivas, R., Clark, T., Voigt, H., 2017. Fostering Clinical Engineering and
Health Technology Management in Developing Countries: Alignment
and Effectiveness in Peruvian Health Sector. IFMBE, IUPESM,
ACCE, IOMP, ICEHTM.
Silva, R., Lara-Estrella, L., 2004. Chapter 26: Clinical engineering in
Venezuela. In: Dyro, J. (Ed.), Clinical Engineering Handbook. A
Biomedical Engineering Series, Elsevier.
UVM Universidad del Valle de México, 2014. Nearly 12,000 biomedical
engineers are required per year in Mexico and only 800 are being produced. Of 1120 public hospitals of 2nd and 3rd level in Mexico, only
73 have a Biomedical Engineering Department. Public Opinion Center
of the Universidad del Valle de México. http://laureate-comunicacion.
com/prensa/cop-biome/.
Vilcahuaman, L., Rivas, R., 2017. Healthcare Technology Management
Systems—Towards a New Organizational Model for Health Services.
Elsevier.
WHA World Health Assembly, 2007. Health Technologies. Resolution
WHA60.29. http://www.who.int/healthsystems/WHA60_29.pdf?ua=1.
WHO-1 World Health Organization, 2018. Hospital Definition. http://
www.who.int/hospitals/en/.
WHO-2 World Health Organization, 2018. Health Technology. http://www.
who.int/health-technology-assessment/about/healthtechnology/en/.
Ziken International Consultants & WHO, 2005. How organize a system of
healthcare technology management. How to manage series for healthcare technology.
Further reading
PAHO/WHO Pan American Health Organization/World Health
Organization, 2000. Healthcare Technologies Assessment in Latin
America and the Caribbean.
Chapter 13
Clinical engineering in
Venezuela
Ricardo J. Silvaa,b, Noel C. Castrob,c
a
Foundation for Living, Wellness, and Health, Orlando, FL, United States, bMontenegro Institute for Cognitive
Disabilities, Guayaquil, Ecuador, cDepartment of Electronics and Circuits, Simon Bolivar University, Caracas,
Venezuela
The present chapter is an update to the Clinical Engineering
Handbook chapter about Clinical Engineering in Venezuela
(Silva and Lara-Estrella, 2004) and is written in honor of
Prof. Luis Lara-Estrella who has since passed away. This
new version recovers and updates the historical background
from that chapter updates all health-related information and
reorganizes the content, according to the systems model developed by Dr. Roemer (Kleczkowski et al., 1984).
The Bolivarian Republic of Venezuela
The Bolivarian Republic of Venezuela (916,446 km2) is organized into 23 states and a district capital. According to
the latest data available from the Global Health Observatory
(Table 1), Venezuela counts with a population of 31,108,000,
93.5% of whom live in urban areas (Moya, 2017).
According to the Constitution of the Bolivarian
Republic of Venezuela (Asamblea Nacional Constituyente,
1999), health care is a fundamental social right, and the
government has the obligation to guarantee it (Article
83). In order to do this, there is a National Public Health
System, controlled by the Ministry of Health and Social
Development, based on the principles of free service, universality, integrity, equity, social integration, and solidarity
(Article 84). Finally, the constitution states that financial
support for the National Public Health System is a responsibility of the state (Article 85) and that everyone has the
right to social security as a public, nonlucrative service that
warrants health and protection against different contingencies (Article 86).
There are 296 public hospitals; 214 of which are integrated into the National Public Health System and the rest
are integrated into several different public organizations.
There are 344 private hospitals, of which 29 are nonprofit
organizations. By the year 2000, there were 40,675 hospitalization beds integrated into the National Public Health
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00013-4
Copyright © 2020 Elsevier Inc. All rights reserved.
System (17.6 beds per 10,000 inhabitants), with more than
50% of those in the five most developed states.
Historical perspective
The first attempts at organizing clinical engineering-related
activities were begun during the 1960s when the Centro
Nacional de Mantenimiento (National Maintenance Center)
was created within the Ministry of Health with a grant from
WHO-PAHO (VEN 24/U.N.D.P/P.A.H.O.-4862) (Lara
Estrella, 1992). This center was a pioneer in the development of maintenance standards and guidelines for hospital
engineering in Latin America. Although it was a good start,
the economic welfare of the nation was about to change,
and these initiatives were short-lived.
During the 1970s, Venezuela had an impressive economic boom; oil prices were high, and the government
had money to spare. The money seemed limitless, and everything could be acquired new. Major investment projects
were begun, new hospitals were built, new equipment was
bought, everything was overpriced, and there was a lack of
government control to avoid excess. At this time it was felt
that there was no need for maintenance. Therefore, maintenance organizations were dismantled and clinical engineering was considered unnecessary. The National Maintenance
Center was the basis for what later became known as the
Dirección General de Mantenimiento de Infraestructura
Física y Equipos (DIFE) (General Direction for Physical
Plant and Equipment). DIFE’s functions were planning, construction, and maintenance of the physical plant and equipment for all of the institutions within the Ministry of Health.
In 1987, in conjunction with DIFE, the Fundación para el
Mantenimiento de la Infraestructura Médico-Asistencial para
la Salud Pública (FIMA) (Foundation for Maintenance of
Medical Infrastructure for Public Health), was created. FIMA
was created with the aim of organizing and ­optimizing the
101
102 SECTION | 2 Worldwide clinical engineering practice
TABLE 1 World Health Organization, Global Health
Observatory, latest data for Venezuela (2017) (Moya, 2017).
Total population (2015)
31,108,000
Gross national income per capita (PPP
international $, 2013)
17
Life expectancy at birth m/f (years, 2015)
70/78
Probability of dying between 15 and
60 years m/f (per 1000 population, 2015)
208/103
Total expenditure on health per capita (Intl $,
2014)
923
Total expenditure on health as % of GDP
(2014)
5.3
response time for the maintenance of medical infrastructure
and equipment. The headquarters were located in Caracas,
but FIMA had offices in each of the 23 states. FIMA was
a civil nonprofit organization, overseen by the Ministry of
Health, with direct income from the central government
(Lara Estrella, 1992). Both FIMA and DIFE were centralized
structures in charge of all of the technological responsibilities
for the whole country. The area of competence for the first
one was hospitals, while that of the second was small clinics
and ambulatory care units. These organizations selected and
acquired technology, determined technical specifications,
provided maintenance, installed equipment, and supervised
service contracts. This proved to be a great failure because
acquired equipment did not necessarily respond to a real
technological need; response time for repair of damaged and
defective equipment was high and preventive maintenance
was almost nonexistent. Moreover, customer (hospital clinical personnel) satisfaction was very low.
Since 1976, clinical engineering has been studied at
the Simon Bolivar University (USB) as part of the bioengineering studies program; however, it was not until 1996
that clinical engineering activities were established in a
Venezuelan hospital. Clinical engineering is commonly
associated with the management of medical equipment,
while hospital engineering concerns with the physical
plant. In Venezuela, this distinction of activities was impossible because many of the equipment-related problems
are the direct result of physical plant problems and vice
versa. Therefore, in 1997, Mijares and Lara-Estrella redefined clinical engineering for Venezuela as “the sum of
all the engineering and management processes that, as a
whole, allows the optimization of the hospital’s technological aspects, guaranteeing an overall efficient technological
management, with high availability and to the satisfaction of physicians, paramedics, and patients” (Seminario
and Lara-Estrella, 1997). In 1996, the Master of Science
program in Biomedical Engineering was established
­
within USB and the Unidad de Gestión de Tecnología en
Salud (UGTS) (Health Technology Management Group)
was created to provide research and funding for clinical
­engineering-related activities. That same year, a technical
assistance agreement was signed between the USB and the
J.M. de Los Ríos Children’s Hospital. The objective of the
project was to endow the institution with an integral technological management system through the establishment
of a clinical engineering department that allowed effective
management of all technology available in the institution
(Seminario and Lara-Estrella, 1997). The project was begun in March 1996 and lasted for 10 months. A new organizational structure that considered the technological
aspects was proposed. Consequently, the clinical engineering department, structured at a staff level, modified the traditional organization of the hospital to include the Clinical
Engineering Department at an executive level.
Many Clinical Engineering projects followed the implementation at the Children’s Hospital. After2 years, in
1998, Centro Médico Loira, a private hospital in the city of
Caracas, requested the establishment of a clinical engineering department. This project was significant since Clinical
hospitality was incorporated for the first time as part of a
Clinical Engineering Department. Clinical Hospitality was
defined as the management of infrastructure and accommodation in order to increase customer (patients, medical
doctors, and staff) satisfaction, within a clinical/hospital environment. This concept proved to be a significant improvement in clinical engineering management since customer
satisfaction became an essential managerial component.
In 1999, a project was begun to establish a clinical engineering department within Dr. Carlos Arvelo Military
Hospital, the head hospital for Military Health Service
(SM). This project incorporated training of clinical engineering staff for the other military hospitals and introduced
the concept of clinical engineering networking and coordination at a national level. That project was renewed in
two opportunities and allowed for the constitution of the
Clinical Engineering Division at SM.
That same year (1999), the Ministry of Health decided
to change their Technology Management Practices and
Procedures, and a New Technology Management General
Direction (TMGD) was created within the Ministry. FIMA
and DIFE were integrated, and their technological, and some
human, resources were incorporated into this new structure.
TMGD is responsible for policy manager and supervisor of
Good Clinical Engineering Practice and operative processes
at the national level. TMGD is also responsible for establishing and controlling usefulness, accessibility, and quality of new technology introduced into the country, and for
supervising regional activities. However, the operation of
technology needs assessment, maintenance, and operative
procedures will be managed locally by clinical engineering
departments created in every hospital.
Clinical engineering in Venezuela Chapter | 13
In 2001, the Venezuelan Social Services Institute (IVSS),
established the central maintenance direction (DGE) for
Medical Technologies, with similar responsibilities to those
of the TMGD. With all these major clinical engineering
structures in place, UGTS at USB devoted to the creation of
a new Clinical Engineering Specialization Program. Also,
in 2001 a new National System for Science Technology and
Innovation was developed via specific Law (Nacional A,
2010). This law defines science technology and innovation
as a matter of public interest and in its fourth article promotes technology transfer from research institutes to private and public industries. Besides that, it creates a national
fund for that purpose and requires large industries to invest
a minimum of 0.5% of their gross income into activities
related to this law.
Based on the spirit of the law the National Center for
Technology Innovation (CENIT) was created. CENIT’s
mission is to contribute with the strengthening and development of science, technology, education, production
and social appropriation of technology, through the conformation of a network of research development and innovation, articulated with the National System for Science
Technology and Innovation. CENIT partnered up with
UGTS in 2006, in order to develop technology for the automation of Health Institutes. CENIT was aiming to develop
dedicated computer systems for specific applications. The
result was Medicar, a sturdy movable device, with its own
uninterruptible power supply (UPS), a local information
storage unit, a convenient Man-Machine Interface (MMI),
and wireless communication to a broad area network
(Silva, 2010).
Venezuelan Ministry of Science and Technology partnered up with the Ministry of Health to define an electronic medical record (EMR) system for the Venezuelan
Health Sector. The Ministry of Health developed a
Standardized Basic Clinical Record, to serve as a base
for the EMR. The Standardized Basic Clinical Record includes many categories that are not usual in other EMR.
For example, geographic and ethnic origins of ancestral
indigenous groups, the relation of the patient with various
government organizations, specific obligatory report for
various contagious deceases and others. The team decided
to create a new software-based over Care2X platform. The
new software was called Sinapsis, being this an acronym
for National Public Health System for Social Inclusion
(Sistema Nacional Publico de Salud para la Inclusión
Social) (Silva, 2010).
Sinapsis Software was presented to the public January 12,
2009, during the transference of the Venesat-1, Venezuela’s
first communication satellite from the Chinese Space
Agency, which launched the satellite, to the Venezuelan
Space Agency. Sinapsis was used as a mean of interconsultation between MD. Huascar Tejera, who was in a rural ambulatory at San Francisco de Guayos, on the Orinoco Delta
103
and MD. Francisco Gonzales a Pediatric Dermatologist at
Universidad Central de Venezuela, University Hospital in
Caracas.
Clinical engineering in Venezuela
In order to understand the organization of Clinical
Engineering in Venezuela and in order to compare it with
other health systems, the Roemer’s Model is utilized
(Kleczkowski et al., 1984). Roemer’s Model divides health
system into five components: (1) systems organization, (2)
how services are delivered, (3) programs and their management, (4) sources of economic support, and (5) production
of resources that support the system.
Systems organization
According to the Constitution of the Bolivarian Republic
of Venezuela (Asamblea Nacional Constituyente, 1999), the
National Public Health System is based on the principles
of free service, universality, integrity, equity, social integration, and solidarity (article 84). Venezuela’s health services
system is a mixture of public or government sector, private
sector, and voluntary or charitable services. The government’s role in health is that of major care provider through
large public-sector programs such as the Ministry of Public
Health (MPPS), The Venezuelan Social Security Institute
(IVSS), SM, and other area-specific government providers. Under the late Hugo Chavez, Venezuela developed a
primary public healthcare system for the poor, The Barrio
Adentro Foundation, working in what are called missions
set up in the poorest areas (Venezuela Gaceta Oficial, 2006).
How services are delivered
The Venezuelan MPPS counts with three Deputy Ministries.
The Office of the Deputy Minister of Health Resources is in
charge of: Planning, formulating, coordinating, and evaluating policies, strategies, plans, programs, and projects at
the national level, aimed at ensuring the production, maintenance and supply of equipment, medicines, and other resources and inputs to the establishments that make up the
National Public Health System.
Programs and their management
Management of the Venezuelan health services system,
which includes planning, administration, legislation, and
regulation, is the responsibility of the MPPS, although, the
IVSS, SM, and even the Missions have certain autonomy to
determine health provision and services.
Clinical Engineering provision and management is
under the supervision of the Foundation of Buildings and
Hospital Equipment (FUNDEEH), created in 2006 (Salud
104 SECTION | 2 Worldwide clinical engineering practice
MdPPpl, 2006). Institutional Mission: Support the promotion, planning, maintenance, and construction of buildings
of the National Public Health System; the coordination,
management, financing, administration, execution, and
supervision of Projects related to equipment and Health
Services Network. FUNDEEH was assigned by the MPPS
with the responsibility to “establish Clinical Engineering
units in all hospitals.” The IVSS has a central maintenance
direction (DGE) and the SM has a Clinical Engineering
Direction (DIG).
The Barrio Adentro Foundation has the autonomy to
manage resources allocated for the provision of human
resources and adequate infrastructure for health facilities,
the Barrio Adentro I, II Mission and Integral Dental Care,
as well as the development of other projects and special
programs, with the participation of qualified personnel, applying the principles of efficiency, efficiency, transparency,
and speed in the processes; reflecting the values of respect,
honesty, responsibility, solidarity, social justice, teamwork,
to contribute to the sustainability of health services and improve health quality of life of the entire Venezuelan population (Venezuela Gaceta Oficial, 2006).
Sources of economic support
Financial support for the National Public Health System is
a responsibility of the state (article 85), and everyone has
the right to social security as public, no lucrative service
that warrants health and protection against different contingencies (article 86) (Asamblea Nacional Constituyente,
1999). However, Economic support depends on the type of
health services organizations—those in the public, the private, and the voluntary or charitable sectors—influence the
ways in which health services are financed. In the case of
The Barrio Adentro Foundation this is largely supported by
PDVSA. Venezuela’s public petroleum corporation.
Production of resources that support the system
In addition to financial support, the provision of health services requires resources, such as a trained workforce. Due
to the experience accumulated at the USB, a project for the
creation of a Graduate Program in Clinical Engineering was
carried out. This Graduate Program was accredited by the
National Universities Council (CNU) (Gaceta Oficial No.
38.508, August 25, 2006). The Specialization Program was
structured with subjects that conformed to the professional
profile required in Venezuela. The curriculum is structured in three components: basic (principles of biophysics and bioengineering, principles of clinical engineering,
and medical bases of bioengineering); specialized (medical equipment management, management of physical plant
and facilities, networks and communications, and clinical
hospitality); management (hospital security, maintenance
management, organizational design, and business administration). Clinical Engineering Specialization has received
a multiplicity of students from public institutions and also
international students from Mexico and Colombia.
References
Asamblea Nacional Constituyente, 1999. Constitución de la República
Bolivariana de Venezuela. Gaceta Oficial de la República de Venezuela.
Kleczkowski, B.M., Roemer, M.I., van der Werff, A., 1984. National
Health Systems and Their Reorientation Towards Health for All:
Guidelines for Policy-Making. World Health Organization, Geneva.
Lara Estrella, L., 1992. El Mantenimiento como parte Integrante de la
Gerencia y Gestión Tecnológica en el Ámbito Hospitalario. GBBAUSB. Senado de la República de Venezuela, Comisión de Asuntos
Sociales, Caracas.
Moya, D.J.G., 2017. Venezuela (Bolivarian Republic of) [Online]. Available
from: http://www.who.int/countries/ven/en/. (cited 11 October 2017).
Nacional A, 2010. Ley Orgánica de Ciencia, Tecnología e Innovación.
Gaceta Oficial.
Salud MdPPpl, 2006. Fundación de Edificaciones y Equipamiento
Hospitalario (FUNDEEH). Gaceta Oficial.
Seminario, R.M., Lara-Estrella, L.O., 1997. Establishment of a clinical engineering department in a Venezuelan national reference hospital. J.
Clin. Eng. 22 (4), 239–248.
Silva, R., 2010. Venezuela makes medical IT a national priority. Biomed.
Instrum. Technol. 44 (5), 409–413.
Silva, R., Lara-Estrella, L., 2004. Clinical engineering in Venezuela. In:
Dyro, J.F. (Ed.), Clinical Engineering Handbook. Elsevier Academic
Press, Burlington, pp. 89–91.
Venezuela Gaceta Oficial, 2006. Decreto Presidencial No. 4382. Gaceta
Oficial.
Chapter 14
Clinical engineering in Japan
Hiroki Igeta
Dept. of Clinical Engineering, Aso Iizuka Hospital, Iizuka, Japan
Overview
Clinical engineer is a national qualification in Japan and it is
a very unique system in that qualified clinical engineers not
only manage and maintain medical equipment but can also
operate it. In order to become a clinical engineer, it is necessary to take and pass the national examination after receiving 3 or 4 years of education at a designated university or
college. After passing the examination, a clinical engineer
license is issued and it allows the performance of maintenance, management, and operation of life support management equipment under the direction of a physician. Many
license holders work for medical institutions, but some also
belong to medical equipment manufacturers, dealers, and
education or research institutions such as universities.
History
In the past, medical doctors and nurses were responsible for
operating and managing medical equipment. However, in
the 1970s and 1980s, the development and advancement of
medical equipment were remarkable and the equipment became complicated. The burden of physicians and nurses has
also increased. In addition, cases of medical devices being
operated by unqualified service representatives of manufacturers and unqualified hospital staff also occurred and subsequently became a social problem (Kawasaki, 2017, 2018).
These factors have resulted in an increase in the demand for
medical professions specialized in advanced medical equipment, especially in life support management equipment such
as hemodialysis equipment, heart-lung machines, respirators, and the like. In May 1987, the Clinical Engineers Act
was enacted introducing a new national license in the medical field and the role of the Clinical Engineer was socially
recognized (Japanese Ministry of Health and Welfare, 1987).
National Certification (License) System
There are about 20 national licenses for medical professions in
Japan, such as medical doctors, dentists, pharmacists, nurses,
medical radiology technicians, physical therapists, etc.
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00014-6
Copyright © 2020 Elsevier Inc. All rights reserved.
The clinical engineer is also one of them (Japanese Ministry
of Health, 2017). As mentioned earlier, clinical engineer is
a relatively new national license, and under the Clinical
Engineers Act (Act No. 60 of 1987), clinical engineers can
do their job by receiving the license from the Minister of
Health, Labour and Welfare. Until June 2017, the licenses
have been issued to more than 41,500 people in total (Japan
Association for Clinical Engineers, 2017).
In order to acquire a national license, it is necessary to
take and pass the national examination. In order to qualify
for taking the national examination, it is necessary to acquire the knowledge and skills that are necessary for being
a clinical engineer in colleges and universities designated
by the government for 3–4 years. Most clinical engineers
receive education at a college or a university that specializes
in training clinical engineers for 3–4 years and are qualified
to take the examination. The passing rate of the national
examination is around 80% (Japan Association for Clinical
Engineers, 2017). The outline of the conditions to be qualified to take the examination is shown below.
1. Those who acquired the necessary knowledge and skills
to be a clinical engineer for 3 years or more at a designated college or university.
2. Those who studied related subjects for more than 2 years
at a university, etc., and acquired knowledge and skills
necessary to be a clinical engineer for more than 1 year
at a designated college or university.
3. Those who studied related subjects for 2 years or more
at a university, etc., and acquired knowledge and skills
necessary to be a clinical engineer for more than 1 year
at a designated college or university.
4. Those who completed the subjects designated by the
Minister of Health, Labour and Welfare at a university
and acquired the necessary knowledge and skills to be a
clinical engineer.
5. Those who have obtained equivalent education in a foreign country or who received a license equivalent to a
Japanese clinical engineer in a foreign country, and have
been approved by the Minister of Health, Labour and
Welfare.
105
106 SECTION | 2 Worldwide clinical engineering practice
Those who pass the national examination need to register on the name list of clinical engineers at the Ministry
of Health, Labour and Welfare by application, so that their
license can be issued by the Minister of Health, Labour and
Welfare, and it will be possible for them to work as a clinical engineer.
Training and education
There are 79 designated universities and colleges which
have clinical engineering courses in Japan (as of May 2017)
(Editorial Department of Clinical Engineering, 2017). At
these universities and colleges, it is necessary to educate
in accordance with the contents specified by the ordinance
for clinical engineering training institutions (Ministry of
Education, Ministry of Health and Welfare Ordinance No.
2, 1988) (Japanese Ministry of Education and Ministry of
Health and Welfare, 1988). Essential educational contents
set by the ordinance are as shown in the table (Table 1)
(Japanese Ministry of Education and Ministry of Health and
Welfare, 1988), and each university and college builds and
provides educational programs in accordance with these
contents. Practical clinical training in hospitals is also mandatory in the specialized fields.
i­nspection of life support management equipment (including connection of the tip of the life support equipment to
the body or removal from the body) under the direction of
a physician using the name of “Clinical Engineer” with a
license from the Minister of Health, Labour and Welfare”
(Japanese Ministry of Health and Welfare, 1987).
For detailed work content, the guidelines are indicated
separately. Regarding the guidelines, “The Guidelines
for Clinical Engineer” was indicated by the Ministry of
Health, Labour and Welfare in September 1988, but a fundamental review was done in 2010, at which time “The
Clinical Engineer Basic Operation Guide 2010” was enacted as new guidelines and “The Guidelines for Clinical
Engineer” were abolished accordingly (Japanese Ministry
of Health and Welfare, 1988; Clinical Engineering Joint
Committee, 2010).
The new guidelines concretely show the scope of work
performed by clinical engineers and contain information
about the interpretation of the law and general medical
practice. Furthermore, detailed business scopes are shown
for certain fields in which clinical engineers are mainly involved and have responsibilities. Those fields are shown below (Clinical Engineering Joint Committee, 2010).
●
Business scope
●
According to the Clinical Engineers Act (Act No. 60 of
1987), the clinical engineer is defined as “a person engaged as a profession in the operation, maintenance, and
●
●
●
●
●
●
TABLE 1 Essential education contents.
●
Contents
Basic fields
The Foundation of Scientific Thinking
Humanity and Life
Specialized basic
fields
Structure and Function of the Human
Body
Basic Medicine
Basic Science and Engineering
Basic Medical Information Technology
and System Engineering
Specialized fields
●
Medical Bioengineering
Medical Instrument Science
Biomedical Technology
Medical Safety Management
Clinical Medicine
Practical Clinical Training
Respiratory treatment
Perfusion (cardiopulmonary bypass)
Blood purification including hemodialysis
Operation room
Intensive care
Cardiovascular catheter
Hyperbaric oxygen therapy
Cardiac implantable electronic devices such as pacemakers, ICDs
Medical equipment management
Endoscope
Japanese clinical engineers perform not only maintenance and management of medical equipment but also
operating it and involving the patients’ care during the operation. For example, during hemodialysis therapy, Japanese
clinical engineers have responsibilities for water quality
management, preparing the dialysis fluid, priming the circuit, puncturing the shunt, measuring the blood pressure,
injecting the drug into the circuit, taking the blood from the
circuit for blood examination, returning the blood to the
patients, etc. Another example is respiratory care. Japanese
clinical engineer can perform endotracheal suction on the
patients under ventilator control. As explained, Japanese
clinical engineers have a clinician side too. Therefore, the
guideline shows detailed business scopes for clinical engineers on clinical procedures in the related fields too.
In addition, radiation-related equipment and MRI are
generally operated by radiology technicians in Japan, and
a very limited number of clinical engineers are involved in
management of this equipment.
Clinical engineering in Japan Chapter | 14
Japan Association for Clinical Engineers
Japan Association for Clinical Engineer (JACE) is a professional organization. JACE was established in February 1990,
3 years after the license system was enacted. JACE is now
acting as a Public Interest Incorporated Association after
gaining the approval of the Cabinet Office in March 2002.
The objective of JACE is to contribute to the promotion and
development of the nation’s medical care and welfare through
the elevation of the professional ethics of clinical engineers,
the enhancement of their professional knowledge and skills,
and the improvement of the reliability of ­equipment-based
medical care and welfare, including life-support systems
(Japan Association for Clinical Engineers, 2002).
Until present (June 2018), clinical engineer licenses
have been issued to more than 41,500 people in total and
about 26,000 of them are actually working in medical institutions such as hospitals and clinics (as of 2016) (Japanese
Ministry of Health, 2017; Japan Association for Clinical
Engineers, 2017). About 18,700 clinical engineers are
members of JACE (as of November 2016).
JACE issues many types of guidelines for clinical engineers in specific fields and also holds academic conferences
and expos every year with more than 500 presentations and
usually 3000–5000 members attending.
JACE has more than 40 committees for professional activities, education, examination, certification, international
activities, etc. Under these committees, many activities are
being performed. One of the remarkable activities is a certification system. JACE provides various types of further education courses. Some of the courses are related to JACE’s
original certifications. These certificates guarantee to impart higher knowledge and skills for successful applicants.
In addition, many clinical engineers join other academic
societies depending on their specialties. Some of these societies also provide further education courses and sometimes
original certifications to guarantee higher knowledge and
skills in the specific fields.
Future of clinical engineers in Japan
Japan has serious social problems such as a declining birth
rate, an aging population, and a declining population.
Accordingly, while the number of hospitals is decreasing
(Japanese Ministry of Health, 2017), in contrast, the demand
for clinical engineers is expected to be stable for a while due
to the background of the advancement of medical technology and the like. However, with about 2000 new clinical
107
engineers licensed each year, from a long-term perspective,
it is unclear whether future jobs can be secured. JACE continues to expand clinical engineers’ fields and opportunities
(e.g., medical device development, etc.) through its various
activities. JACE is also trying to stipulate the roles that clinical engineers play in the reimbursement system. In Japan,
medical expenses are reimbursed to medial institutions by
the national health insurance system, and the fees and scope
of the covered areas and conditions are clearly shown on
the Medical Fee Points List determined by the government.
Medical institutions need to follow the list and it has great
effects on their management. JACE will continue making
efforts to increase the number of clinical engineer-specific
criteria covered by the medical reimbursement system in
order to encourage an increasing demand for clinical engineers whose employment will lead to a rising standard
of medical safety. Moreover, international efforts will be
strengthened in the future, such as assisting with the introduction of the Japanese clinical engineering system in developing countries where clinical engineering systems are
not complete.
References
Clinical Engineering Joint Committee, 2010. The Clinical Engineer Basic
Operation Guide 2010.
Editorial Department of Clinical Engineering, 2017. List of designated
universities and colleges. Clin. Eng. 28 (7), 578–582.
Japan Association for Clinical Engineers, 2002. Articles of Incorporation.
Japan Association for Clinical Engineers, 2017. Commemorative
Publication for the 15th Anniversary of Foundation of Japan
Association for Clinical Engineers as a Public Interest Incorporated
Association and 30th Anniversary of Promulgation of Clinical
Engineers Act.
Japanese Ministry of Education and Ministry of Health and Welfare, 1988.
Ordinance for Clinical Engineering Training Institutions (Ministry of
Education, Ministry of Health and Welfare Ordinance No. 2, 1988).
Japanese Ministry of Health, 2017. Labour and Welfare (2017)—Health
and Medical Services-Annual Health, Labour and Welfare Report.
Japanese Ministry of Health and Welfare, 1987. Clinical Engineers Act
(Act No. 60 of 1987).
Japanese Ministry of Health and Welfare, 1988. The Guidelines for
Clinical Engineer (Ministry of Health and Welfare Health Policy
Bureau, Medical Division Notification No. 57, 1988).
Kawasaki, T., 2017. What clinical engineers should be. J. Jpn. Assoc. Clin.
Eng. 61, 9–21.
Kawasaki, T., 2018. Developments in the role of clinical engineers in blood
purification therapy. Blood Purif. 46, 136–142.
Chapter 15
Clinical engineering in Brazil
Jose Alberto Ferreira Filho
Instituto de Engenharia de Sistemas e Tecnologia da Informação, Universidade Federal de Itajubá, Itajubá,
Minas Gerais, Brazil
The beginning
The year 1982 was quite important for the Clinical
Engineering in Brazil. On May 17 of that year, the
President of the Brazilian National Council for Scientific
and Technological Development (CNPq—Conselho
Nacional de Desenvolvimento Científico e Tecnológico, in
Portuguese), Dr. Lynaldo de Cavalcanti Albuquerque created a task force to “examine and propose measures to guide
CNPq in the area of biomedical instrumentation,” according to Executive Resolution CNPq 077/82 (Brasil, 1983;
Moreno, 2010). The task force identified serious problems
in the management of medical equipment, especially in
procurement phases. Basic issues such as the need to provide installation and maintenance manuals were identified,
added to the routine supply of spare parts and accessories,
operational training and equipment maintenance, price policies, and greater clarity regarding maintenance contracts
(Moreno, 2010).
That same year, CNPq also created the project
“Evaluation and Prospects” in order to assess the state of
research and training of human resources based on the
national needs of the 1980s. Within this scope, the area
of Biomedical Engineering was led by Dr. Wang Binseng
who issued a report that highlighted the need for professional training to support the development of health services, considering the precarious situation of the country’s
­medical-hospital equipment (Wang, 1983). These two actions reflected the Federal Government’s recognition of the
importance of medical equipment management.
In October 1982 the consolidation of Clinical Engineering
in Brazil was another decisive and relevant factor. The
Rector of the University of Campinas (UNICAMP), Dr.
José Aristodemo Pinotti, created the Center for Biomedical
Engineering (CEB) and appointed Dr. Wang Binseng as its
first director (UNICAMP, 1982). The Center was conceived
with the objective of conducting biomedical engineering research and advising on the acquisition and maintenance of
medical equipment. The organization’s mission went well
108
beyond the walls of UNICAMP and became an important
training center for clinical engineers as well as for development methodologies in the area. Thus, it can be said that
Clinical Engineering in Brazil came into formal existence
from the moment the CEB at the UNICAMP was created.
In 1989, the Interregional Meeting on Manpower
Development and Training for Healthcare Equipment
Management, Maintenance, and Repair (WHO, 1989) took
place in the city of Campinas. The event was attended by
professionals from various countries and “focused its attention on the problem of the management of healthcare
equipment, namely the development and training of the
manpower for equipment management.” The meeting was
recorded with precision and depth and would come to serve
as a basis for future actions in Brazil.
Up until 1991 Clinical Engineering in Brazil did not undergo many great advances. Few hospitals had even minimal
Clinical Engineering and there were no training programs
for medical equipment engineers and technicians (Wang
and Calil, 1991). However, in July 1991, the Ministry of
Health published SNAS Ordinance No. 101, constituting an execution plan called the Dental-Medical-Hospital
Equipment Program—PROEQUIPO. PROEQUIPO recognized the need to foster clinical engineering in Brazil and
supported the implementation of five courses, as well as
defining the duties of a clinical engineer, and establishing a
curriculum with a workload of 1920 h, of which 640 h were
supervised. Based on this action, it was possible to provide
quality training to a significant number of clinical engineers
who went to work in important Brazilian hospitals. With the
results obtained in PROEQUIPO, Clinical Engineering was
enabled to reach new levels and was finally able to solidify
its position in the national health system.
From 1990 on, specific events on the topic of Clinical
Engineering have become more constant and featured
international speakers, helping to consolidate the area.
For example, in 1994 the First Symposium on Clinical
Engineering in the city of São Paulo was organized by the
National Service for Commercial Learning (SENAC). This
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Clinical engineering in Brazil Chapter | 15
109
event was a­ ttended by national and foreign speakers. An
interesting fact is that the event folder already announced
the graduation of the first 135 clinical engineers for the
program supported by the Ministry of Health. New courses
were opened and numerous professionals were trained in
the area. The market responded well to the newly coined
Clinical Engineering professional and today the main
Brazilian hospitals have a Clinical Engineering department.
All this progress created the conditions for the foundation of the Brazilian Association of Clinical Engineering
(ABECLIN) in 2003. The creation of ABECLIN was yet
another sign that Brazil had already reached an advanced
level of maturity in the management of medical technology and possessed a number of professionals working in
the labor market.
Other occurrences that happened in parallel to the development of Clinical Engineering also added to the momentum of the area. In 1962, the Brazilian Medical Devices
Manufacturers Association (ABIMO) began its activities
with 25 manufacturing members. Another event worth
mentioning was the creation of the Brazilian Society of
Biomedical Engineering (SBEB) in 1975. In 1990 Brazil
adopted a series of safety and performance standards for
medical equipment—IEC 601-1—and is able to qualify
several laboratories for medical equipment tests with the
National Institute of Metrology, Quality, and Technology
(INMETRO). The adoption of the IEC 601-1 standard series generated a great amount of knowledge in the areas of
safety and performance of medical equipment, both in terms
of maintenance and equipment design levels. In 1999 the
Brazilian Health Regulatory Agency (ANVISA) was created, acting in an important role to guide regulatory actions
in the areas of products for health and quality of health services. The creation of ANVISA was an important landmark
for Clinical Engineering since health products (including
medical equipment) began to have a specific treatment from
a regulatory point of view.
job openings come about annually. From 2011 to 2016,
2119 students entered the course, while 514 completed
it in the same period. The title “Biomedical Engineer” is
recognized by the Federal Council of Engineering and
Agriculture (CONFEA), being given to these professionals all the necessary attributions for the development of the
activities of Clinical Engineering. Interestingly enough,
Clinical Engineering was not granted this same status with
CONFEA. The major challenge for biomedical engineering
courses is to train qualified professionals who truly understand Clinical Engineering. To validate the quality of these
professionals in Clinical Engineering, Brazil does not yet
have a certification system.
Some master’s and doctoral courses have specific areas
for Clinical Engineering. Studies of great importance are
developed in these courses, with publications at the national
and international levels.
Clinical Engineering services today are organized in
two basic forms:
Clinical engineering today
Since 2003, Santa Casa Porto Alegre’s Clinical
Engineering Department has also coordinated a regular
course of Specialization in Clinical Engineering with 16 vacancies. The classes cover both theoretical materials along
with practical application within the hospital environment.
The outsourcing of Clinical Engineering services has
become increasingly more commonplace in recent years.
Today there are many qualified companies in the area
which are able to service dozens of hospitals. Some of the
companies are comprised of former students of the Clinical
Engineering courses. These companies are important in assisting public hospitals, which largely work with outsourced
companies. This model has shown good results both in the
quality of services rendered and pricing. Usually hospitals
hire a clinical engineer to coordinate and oversee the services provided by the outsourced company. For example,
Nearing its fourth decade, Clinical Engineering in Brazil
has evolved in many significant ways. Much of this advance
has occurred because of the investment in human resources
training. But still, many challenges need to be overcome.
The process of training human resources continued after the investments of the Ministry of Health. Currently,
the main form of training revolves around specialization
courses in Clinical Engineering, which are designed for
professionals with undergraduate degrees, classifying the
program as a postgraduate. With a shorter workload than
a master’s degree, there is no need to defend a dissertation.
One may or may not have a supervised internship.
Over the last decade, 21 Biomedical Engineering undergraduate courses have been created in Brazil. 2190
(a) With their own engineering and technical teams; and
(b) Outsourced teams.
One example of a hospital with its own team is the
Brotherhood of Santa Casa de Misericórida in Porto Alegre,
which currently operates seven hospitals. The team to serve
at the hospital is made up of
(a) Five engineers specialized in clinical engineering:
three electrical engineers;
one mechanical engineer;
one electronic engineer.
(b) Other professionals:
four medical physicians;
24 electronic technicians;
one electromechanical technician;
four maintenance assistants;
one administrative assistant;
two information technology technicians.
110 SECTION | 2 Worldwide clinical engineering practice
the Brazilian Hospital Services Company (EBSERH) has a
network of 39 federal university hospitals and in most cases
adopts the model of a clinical engineer in the company’s
staff with the other Clinical Engineering services contracted
through public bidding processes. Under Brazilian law
these contracts can last up to 60 months. Below are some
examples of contracted services:
(a) keep records and equipment history, as well as its organization, traceability, and updating;
(b) support the receiving and acceptance of equipment;
(c) perform corrective maintenance (repair) of equipment;
(d) perform preventive maintenance procedures, calibration, electrical safety test; functional tests, and departmental rounds;
(e) perform management of service through dedicated
clinical engineering management software;
(f) support the creation of management indicators to monitor equipment, management, and follow-up activities;
(g) support the planning, selection, and acquisition of new
equipment;
(h) support technical and economic feasibility studies for
the incorporation of new technologies, and to review
and update opinions regarding medical equipment;
(i) support quality processes (ONA, ISO, Joint
Commission, etc.), technovigilance, and risk
management;
(j) prepare an annual training plan and coordinate with
management.
Challenges
It can be said that Clinical Engineering services in
Brazil have advanced significantly, including the area
of ­
scientific production. However, several hospitals
still suffer from the same problems that existed in the
1980s, such as maintenance-free equipment and acquisitions without proper planning. One substantial hurdle
to overcome now is to have quality Clinical Engineering
throughout the country.
Undoubtedly, accreditation in Clinical Engineering is an
important topic to be implemented considering the number
of professionals that are currently being placed on the market with typical assignments of a clinical engineer.
Conclusions
Over the past 40 years, Brazil has taken great strides in
Clinical Engineering through considerable investment in
personnel training. Recognition is due to United States
clinical engineers who made great contributions to this
process. Nonetheless, there is still much to be done in
order to ensure that the gains seen technologically can
reach to even most remote regions of Brazil’s vast territorial expanse.
References
Brasil, 1983. Ministério da Ciência e Tecnologia. In: Conselho Nacional
de Desenvolvimento Científico e Tecnológico. Grupo de Trabalho na
Área de Instrumentação Biomédica. A instrumentação biomédica e o
problema da engenharia de manutenção nos hospitais, Brasília.
Moreno, A., 2010. 40 anos de história da gestão da manutenção de equipamentos biomédicos nos hospitais públicos do Rio de Janeiro.
Wang, B., Calil, S.J., 1991. Clinical engineering in Brazil: current status.
J. Clin. Eng. 16 (2), 129.
WHO, 1989. Manpower Development for Health Care Technical Service.
World Health Organization.
Chapter 16
Clinical engineering updates in
the Middle East
Hashem O. Al-Fadel
Temos Assessors Advisory Board, Temos International Healthcare Accreditation, Germany
During the past decade, its estimated that half of medical
technology existing was not here before that. This adds
more burden on clinical engineering (CE) support and
more for continuing education and training. The Middle
East depends mostly on imported medical technologies,
similar to many developing countries in the world. This in
turn creates many challenges to support such technologies
that may be different from other countries. CE in Middle
Eastern countries mostly emphasizes on maintenance functions and is viewed as such by hospital management and
governance bodies. In this chapter, the current status of CE
will be briefly reviewed in some countries. The author got
experience or knowledge with such as Jordan, Kingdom of
Saudi Arabia (KSA), United Arab Emirates (UAE), Egypt,
Lebanon, and Turkey. History of CE, present status, challenges, and recommendations will be provided, including
some of the main issues in the selected countries.
History of CE in the Middle East
The start of CE in the Middle East, particularly in the Arab
part, can go back to the late 1970s and early 1980s when
high flux of medical equipment and technologies started to
come to hospitals in the region. During that period, aids from
the developed countries have shed some lights on the education and support of such technologies. For example, the first
biomedical education was started at the Cairo University
and during that period with the initiation of Biomedical
Engineering education. Project “Hope,” based in the United
States started to help Egypt to support medical equipment
maintenance programs in some hospitals and to assist the
support of the biomedical engineering education already
existing at that time. In the Gulf countries, since they had
abundant of financial resources at that time, hospitals are
very well equipped and thus required even more support
than the other Middle Eastern countries. Therefore, these
countries were able to attract qualified clinical ­engineers
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Copyright © 2020 Elsevier Inc. All rights reserved.
from western countries as well as other countries. In Jordan,
Lebanon, Egypt, and Turkey, since they have enough qualified technical staff, they managed the support of their equipment without the need to hire experienced expatriates.
Present status
The present status of CE will be described briefly for the
selected countries chosen based on the experience of the
author in these countries within the past two decades.
Jordan
The country is presently in the midst of a troubled region;
in the north is Syria and in the east is Iraq as this in turn
resulted in a huge influx of refugees to the country. This has
added huge pressure on the economy and as such it affected
the healthcare services in the country with less acquired
technology and a consequent addition of more pressure on
the CE support in the country. Currently, there is a shortage
of CE professionals in the country as most of the qualified
staff will seek work in the Gulf Cooperation Council (GCC)
countries and other developed countries due to low salaries
and limited resources. Even though the maintenance support of health technology is less demanding compared to
a decade ago due to technology and digital advancement,
most support is provided by equipment suppliers and is less
dependent on in-house support.
Regarding the regulatory part, this is done by Jordan
FDA, making sure all new technologies meet certain standards as it is required by the exporting countries. This,
however, has helped to elevate some of the challenges the
country was facing if compared to a decade or two ago. Still
there are many challenges facing Jordan for the acquisition
and support of medical equipment and devices, which are
similar to other Middle Eastern countries and will be explained later in the chapter for the whole region.
111
112 SECTION | 2 Worldwide clinical engineering practice
Kingdom of Saudi Arabia
Lebanon
KSA is the biggest importing country in the region for medical equipment and technologies due to huge demand and
availability of resources (Medical devices fact book). This,
however, creates huge demand for CE support.
The country presently is experiencing shortage of financial resources due to the decline in oil prices and as such
there is a national-wide restructuring to adopt to the current
situation. KSA had historically depended on foreign trained
clinical engineers particularly during the past decades.
Presently, the Kingdom has many qualified clinical engineers who studied in western countries as well inside the
country and today, it currently depends much less on expatriate clinical engineers. With the start of Saudi FDA in the
past 10 years, the regulation of medical devices’ import has
helped to reduce many of the challenges facing the proper
acquisition of medical technologies. However, there are still
many challenges facing CE in KSA similarly to other countries to be addressed later on.
Similar to Jordan, Lebanon is presently in the midst of a
troubled region from north, south, and east.
This resulted in a huge influx of refugees in the country
which has added a huge pressure on the economy, affecting the healthcare services in the country. All this lead to
a big reduction on acquisition of medical technologies and
again adding more pressure to the CE support in the country. Similar to Jordan currently, there is a shortage of CE
professionals in the country, as most of the qualified staff
will seek work in the GCC countries and other developed
countries, seeking more income and opportunities.
On the regulatory part, this is done by ministry of health,
making sure all new technologies meet certain standards as
required by the exporting countries.
United Arab Emirates
UAE could be considered the second largest importing
country per capita in Medical Technology in the Middle
East after Saudi Arabia (Medical devices fact book). With
many similarities to that in KSA for the present status, including pressure on financial resources. It differs that it
depends mostly on expatriates’ clinical engineers to support the medical technology. Due to more openness of UAE
for trade and investments than other countries, many of the
manufacturers and equipment exporters have regional offices in Dubai to support the whole region. This, however,
is helping the country to provide more support as compared
to other regional countries.
Egypt
Even though Egypt is one of the first countries in the
Middle East to address the CE support as well to have education and training in this field, it is presently experiencing
many challenges in supporting medical technologies and
may even more than the countries described here. This is
mainly due to the post-Arab spring, the instability of the
region, the brain draining of many qualified clinical engineers to work in other countries and with most the recent
depreciation of the Egyptian pound and with the severe
shortage of hard currencies and financial resources in the
country.
On the regulatory part, this is done by Drug Policy and
Planning Center of Ministry of Health, making sure all new
technologies meet certain standards as required by the exporting countries which is a new trend compared to more
than a decade ago.
Turkey
Turkey is one of the biggest Middle Eastern countries in
the region with very big market for healthcare technology.
The country heavily emphasizes on medical tourism from
European and Arab countries and possesses a good healthcare
infrastructure within the region. Since it is within or closer to
Europe, the support of medical technology is more matured
as compared to the other countries described in this chapter.
However, the instability of the region, particularly to the south
border with Syria and Iraq, has added pressure on the financial resources for the country and, therefore, the private sector
seems to have more support to CE than the public sector due to
generation of financial resources from medical tourism.
On the regulation side, the Turkish Medicines and
Medical Devices Agency affiliated with MOH is the official
regulatory agency (Medical devices in Turkey).
Common challenges
The challenges facing CE in the region includes the
following:
1. Shortage of financial resources and less emphasis
on technology support from the time of purchasing.
Although this may vary from one country to other, it can
be found more in the private sector than public due to
the recent economic pressure.
2. Qualified and trained engineers in some countries are
limited in numbers due to either brain draining such as
in Jordan, Egypt, and Lebanon or less trained local staff
in some Gulf countries as compared to expatriates especially with the exodus of many expatriates from some
countries in the region.
3. Adequate support from some vendors, or even from manufacturers, is often not provided. For example, a vendor
might not be prompt in solving equipment ­problems or experience long delays in providing the spare parts needed.
Clinical engineering updates in the Middle East Chapter | 16
4. Difficulty to find well-qualified engineers.
5. There is no national or regional health technology assessment (HTA) system to standardize equipment acquisition in such a case, you may find many equipment
available without use and or many hospitals have similar
high-tech equipment that are not fully utilized.
6. Sustainability in governmental CE support in relation to
HTA programs is not maintained and consequently there
is no long-term policy of support to address equipment
advancement and support.
7. Education and training at local universities for CE do not
address the local needs in many of the current programs.
Many of the old problems and concerns raised in the past
have been reduced as compared to early 2000 due to digitization and maturity of information technology (Alfadel,
2004).
Societies, accreditations, and education
1. BME Society in Egypt started in 1989 and was available and active in the late 20th century; currently it lacks
sustainability.
2. BME Club (society) in KSA started in 1992 and currently there are more chapters in a number of exiting
associations.
3. BME Society in Jordan started in 2005.
4. KSA, Jordan, Egypt, and Lebanon have local accreditation programs.
5. Support from the WHO, World Bank, and USAID can
be found from one agency or more in some middle
eastern countries such as Jordan, Lebanon, Egypt, and
Turkey.
6. Mandatory International hospital accreditation in UAE.
7. All these mentioned countries have programs for biomedical engineering education in local universities.
Recommendations
The following are some recommendations for CE status in
the region:
1. To work on forming a network of cooperation at high
level for HTA for medical devices with cooperation with
HTA international agencies.
113
2. To strengthen and activate the currently available biomedical associations or societies with collaboration between them across different countries as possible.
3. Due to shortage of financial resources, the associations
or societies need to prepare strategic plans and to prioritize the requirements due to financial limitations.
4. Regulatory associations in KSA FDA, Jordan FDA as
well as associations from other countries can collaborate
and to include chapters for CE and possibly implement
certificate of needs.
5. To emphasize on CE certification or accreditations and
possibly to form a regional certification independent
organization.
6. To continue holding regional CE conferences and workshops and to look for solution to the most pressing
problems in the CE field for the region. Though this has
started to take place, but concept papers and recommendations that could come out need to be distributed to all
stakeholders for follow-up and implementation.
7. More integration of CE and information technology
would help greatly to automate the operation and increase the productivity (Institute of Medicine).
References
Alfadel, H., 2004. Clinical engineering in the Middle East. In: Clinical
Engineering Handbook, pp. 97–98.
Further reading
Alfadel, H, Health Technology Assessment, Perspective of Medical devices for Arab Countries, Hospital Built.
Institute of Medicine, 2001. Crossing the Quality Chasm: A New Health
System for the 21st Century. IOM.
Magazine Issue 2, 2009.
Medical Devices Fact Book, https://store.bmiresearch.com/worldwidemedical-devices-market-factbook-2016.html.
Medical Devices Regulation Turkey, http://titck.gov.tr/TibbiCihaz.
Chapter 17
Clinical engineering
development in China
Li Bina, Zheng Kunb, Xia Huilingc, Jiang Ruiyaod, Guo Chenchenb
a
Shanghai Medical Equipment Quality Control Center, Shanghai, China, bClinical Engineering, Children’s
Hospital of Zhejiang University School of Medicine, Hangzhou, China, cClinical Engineering, Inner Mongolia
Autonomous Region People's Hospital, Hohhot, China, dClinical Engineering, Shanghai 6th People’s Hospital,
Shanghai, China
Development review of Chinese clinical
engineering
The main development stages of clinical
engineering in China
Dr. Cesar Caceres coined the term clinical engineering
(CE) in the 1960s, and Chinese clinical engineering began in the 1970s, as more and more medical devices began
to be applied in hospitals and engineers and technicians
began to work in hospitals. Zhejiang University was the
first university in China to initiate an academic program
for biomedical engineering in 1977. In 1978, some medical colleges also began to establish biomedical engineering
education programs, which opened up professional education in this field.
Clinical engineering in China has gone through four
stages of development. The first stage focused on maintenance and supply. From the 1970s and in particular
from the late 1980s, many hospitals established clinical
engineering departments. In 1992, the Chinese College
of Clinical Engineering was formally established. During
this stage, the main responsibility for the hospital clinical
engineering department was medical device procurement
and maintenance. Some clinical engineering technicians
received very good training from manufacturers. The maintenance of medical equipment played an important role in
technical support for the hospitals. The US-based Project
Health Opportunity for People Everywhere (HOPE) foundation and the former Zhejiang Medical University (now
the Zhijiang University School of Medicine) opened a
clinical engineering program in 1984. HOPE also cooperated with the Children’s Hospital affiliated with Zhejiang
Medical University to establish the first national NICU,
114
and in a­ ddition established an emergency ICU (EICU)
in ­cooperation with an ­affiliated second hospital. During
this period, HOPE dispatched clinical engineers to apply
advanced medical equipment technology management
and support the collaborated programs. Concepts and
methods including project management (PM) were introduced to the CE community of Zhejiang and Shanghai.
The second stage of development featured the adoption of
quality and risk management. Since the late 1990s, quality control methodology has been introduced into Chinese
hospitals. Some hospitals started inspection and quality
control for medical equipment. Developed regions in
China began to implement systematic quality control programs with preventive maintenance and continuous quality improvement. In 2005, the Shanghai Municipal Health
Bureau established the first medical equipment management quality control center (MDMQCC) in China. The
quality control center was attached to the Shanghai No. 6
People’s Hospital. From 2005, many areas in China successively established medical equipment quality control
centers, and organized professional teams to carry out
regional medical equipment management with quality
control. The third stage of development featured technology convergence and integration. After entering the 21st
century, IT technology began to develop at a rapid speed,
and new technologies such as medical digital technology, network technology, and mobile technology were
continuously developed and integrated. Promotion of the
diversified development of technology integration and
the convergence of clinical engineering technology and
information technology was witnessed and quickly developed. The current fourth stage of development features
systematic medical technology service and management.
In recent years, the international medical community has
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Copyright © 2020 Elsevier Inc. All rights reserved.
Clinical engineering development in China Chapter | 17
made great progress and development in value-based
health care and the role of clinical engineering has been
recognized and a­ ppreciated gradually. The World Health
Organization (WHO) points out that health technology is
essential for the proper functioning of health systems and
that medical devices are especially important in disease
­prevention, diagnosis, quality, and rehabilitation. Medical
devices are not only used as a material basis in hospitals, but also as an important part of medical technology.
The functions of the clinical engineering department are
also gradually transforming into technical management
and technical services. Some leading clinical engineering
departments in China are actively exploring participation
of the management of medical technology at the C-suite
level.
Establishment and development of the Chinese
Medical Association and Clinical Engineering
The Chinese Society of Clinical Engineering (CSCE) of
the Chinese Medical Association was formerly a medical
instrument professional committee affiliated with the China
Biomedical Engineering Society. On October 11, 1993, the
CSCE of the Chinese Medical Association was formally
established. As a formal independent professional organization, its members are mainly clinical engineers from
domestic medical institutions and healthcare delivery organizations (HDOs) at all levels, as well as experts and professor from universities. The main missions of the Society are:
to carry out academic and technical exchanges at home and
abroad; to edit and publish science and technology books
and periodicals; to carry out clinical engineering continuing education and technical training; and to recommend and
commend outstanding scientific and technological achievements, best practices, and talents.
The CSCE has experienced four periods of development. (1) During the start-up period (1993–2002), it
started the Society journal, actively organized seminars
and academic conferences, and continuously expanded the
influence of the Society, actively promoting the establishment of 12 branches of clinical engineering associations
in medical associations of provinces, municipalities, and
autonomous regions. (2) During the construction period
(2003–09), the Society entered a stage of rapid and standardized development. In this construction period, CSCE
actively promoted the transformation of the CE discipline
toward medical equipment quality control and quality assurance, supplies management and logistics, information
technology, and clinical engineering. (3) During the development period (2009–13), the Society entered a stage of
rapid development and prosperity, increasing the membership, establishing the Youth Research and Development
Fund, and launching the outstanding clinical engineers
115
and the “Ten National Top Clinical Engineers” youth selection activities. It also c­ arried out the selection of key
disciplines, and through role models, promoted the overall construction of the discipline and enhanced the understanding and affirmation of the discipline of clinical
engineering. (4) During the new transition period (2014
to present), the Society entered a transformational adjustment, standardized various academic exchange activities, and consolidated the CSCE foundation. It also
organized and published the white paper “China Clinical
Engineering Development Research Report,” translated
nine books of the WHO Medical Device Technical Series
and 10 national textbooks for biomedical engineering
and clinical engineering through the People’s Health
Publishing House, selected some outstanding engineers to
participate in international clinical engineering exchange
activities, and held the first international conference for
clinical engineering and medical technology management
(ICEHTMC) in Hangzhou, hence contributing to the development of international clinical engineering.
The development of clinical engineering chapters
of the Medical Association in various provinces
and cities in recent years
With the development of medical technology and China’s
reform and opening up in the 1980s, Chinese hospitals
introduced more advanced medical equipment. More and
more professional clinical engineers and technicians also
entered the hospital to engage in the management and
maintenance of medical devices. In order to strengthen the
professional management of medical equipment in hospitals, some regions, including Anhui, Xinjiang, Liaoning,
Yunnan, Shandong, Chongqing, and other provinces and
cities, successively established medical device management branches or clinical engineering chapters within the
provincial Medical Association. When the Chinese Society
of Clinical Engineering was established in October 1993,
only six provinces and cities established clinical engineering chapters of the Medical Association; after that point, the
branch organizations already established in each province
were generally unified into clinical engineering chapters of
the Medical Association. The following list shows the establishment of clinical engineering chapters of the Medical
Association in each province (Table 1).
Judging from the establishment times of various a­ reas,
the number of clinical engineering chapters established in
various regions after the turn of the 21st century increased,
showing the momentum of rapid CE development. After
25 years of development, 20 provinces and cities have established chapters, which includes about 64.5% of the total provinces and p­ rovince-level municipalities (excluding
Hong Kong, Taiwan, and Macao).
116 SECTION | 2 Worldwide clinical engineering practice
TABLE 1 The list for the establishment of clinical engineering chapters of the Medical Association of each province and
province-level municipality.
Names of provincial and
municipal branch
Date of
establishment
Duration
Remark
1
Anhui Clinical Engineering Chapter
of Medical Association
July 1, 1985
5
Formerly the Medical Device Branch
2
Xinjiang Clinical Engineering
Chapter of Medical Association
July 1, 1990
4
3
Yunnan Clinical Engineering Chapter
of Medical Association
August 20, 1990
7
Formerly the Medical Device
Association
4
Liaoning Clinical Engineering
Chapter of Medical Association
March 13, 1992
7
Formerly medical equipment
management and maintenance
5
Shandong Clinical Engineering
Chapter of Medical Association
June 11, 1992
4
Formerly the Medical Device
Professional Committee
6
Chongqing Clinical Engineering
Chapter of Medical Association
January 1, 1993
5
Formerly the Medical Device
Association, Renamed to Clinical
Engineering Chapter of Medical
Association in 2014
7
Zhejiang Clinical Engineering
Chapter of Medical Association
August 1, 1994
6
8
Shanxi Clinical Engineering Chapter
of Medical Association
August 1 1996
5
9
Jilin Clinical Engineering Chapter of
Medical Association
August 6, 1997
6
10
Hubei Clinical Engineering Chapter
of Medical Association
October 28, 1999
5
11
Neimenggu Clinical Engineering
Chapter of Medical Association
August 1, 2001
3
12
Shanghai Clinical Engineering
Chapter of Medical Association
September 2, 2004
5
13
Sichuan Clinical Engineering Chapter
of Medical Association
August 1, 2005
4
14
Jiangsu Clinical Engineering Chapter
of Medical Association
October 15, 2008
4
15
Heilongjiang Clinical Engineering
Chapter of Medical Association
May 30, 2008
3
16
Henan Clinical Engineering Chapter
of Medical Association
January 1, 2011
3
17
Guangdong Clinical Engineering
Chapter of Medical Association
December 24, 2011
2
18
Beijing Clinical Engineering Chapter
of Medical Association
December 21, 2013
2
19
Hunan Clinical Engineering Chapter
of Medical Association
January 11, 2014
2
20
Hebei Clinical Engineering Chapter
of Medical Association
December 5, 2014
2
No.
Clinical engineering development in China Chapter | 17
Some major achievements of the Chinese
Society of Clinical Engineering in recent
years
Forming professional consensus
In 2012, the writing of a white paper on clinical
engineering development (published in
November 2015) was initiated
In 2012, in order to achieve the goals of establishing a safe
medical system and professional clinical engineering, promoting consensus, and facilitating the practice, entrusted by
the Hospital Management Research Institute of the Ministry
of Health, the Chinese Society of Clinical Engineering cooperated with the Clinical Engineering Research Base of the
Hospital Management Research Institute of the Ministry of
Health and some medical device companies to begin this project. Based on the investigation and survey of the status quo and
challenges of clinical engineering in China, this white paper
elaborated the following topics: clinical engineering development overview, medical device industry development and
medical technology advancement, medical equipment maintenance program, medical device quality and risk and logistics
engineering management, clinical engineering and technology management, clinical engineering and informatics, human resources, and discipline construction. Furthermore, the
white paper systematically summarized the achievements and
experience of clinical engineering construction, and analyzed
the clinical engineering development trends, put forward opinions and suggestions for clinical engineering development,
provided a reference for health authorities to make relevant
decisions in clinical engineering, and provided norm guidance
and consideration for all levels of medical institutions in formulating their clinical engineering programs.
Completion of “Entering Twenty Years of
Clinical Engineering” in 2013
Since the Chinese Society of Clinical Engineering was established in 1993, clinical engineers and professionals from
generation to generation have carried forward the spirit of
hard work and kept pace with the times, and have made
many remarkable achievements in academic organization,
the education system, scientific research, academic exchange, and technology applications. The CSCE has played
a very positive role in promoting the reform and development of clinical engineering in China. In 2013, on the occasion of the 20th anniversary of the establishment of the
Chinese Society of Clinical Engineering, the Society selected experts and scholars at all levels to write “Entering
Twenty Years of Clinical Engineering,” which addressed
the following topics: development history review, organization construction and management, academic activities and
achievements, government decision support, talent training
117
and awards, exchanges and cooperation with international
and Hong Kong and Taiwan regions, development outlooks,
local CE chapter introduction, etc. It explained in detail
the development history of the Society, milestones of the
Society, and the outstanding colleagues, giving recognition
and a comprehensive and objective record of the activities
of the Society in different periods and its role as a bridge
and link in the Chinese clinical engineering community.
This book invigorated the spirit of CE professionals and has
far-reaching significance for realizing the new take-off of
clinical engineering disciplines.
Working out the “Biomedical engineering
Textbook”
Assigned by the National Health Commission and organized
by the People’s Medical Publishing House, 10 textbooks
were composed on the 13th Five-Year Plan of the National
Health Commission of the People’s Republic of China for
the first round of the biomedical engineering specialty (clinical engineering direction) in universities and colleges. This
project was sponsored by the People’s Medical Publishing
House, the Chinese Society of Clinical Engineering, and
China Medical Device Magazine. It includes the introduction of clinical engineering management, medical equipment principles and clinical applications, medical materials
and supplies, medical device technology assessment, digital
medical equipment introduction, medical equipment maintenance, medical equipment quality testing and calibration,
clinical engineering technology evaluation, medical device
technology horizon scanning, and introduction to clinical
engineering research. This series of textbooks was officially
published in August 2017. From more than 50 hospitals and
colleges across the country, nearly 70 textbook review committee members, editors, deputy editors, and representatives
participated in the preparation work. This compilation of
biomedical engineering planning textbooks represents the
first time that People’s Medical Publishing House relied on
the CE academy. This was also the standardization process
for the body of knowledge (BOK) of clinical engineering
disciplines, which is of great significance in the development of clinical engineering.
Chinese translation of nine books of the WHO
Medical Device Technical Series released in
November 2015
Medical devices are important parts of health technology
and are essential for the effective operation of healthcare
delivery. They play a vital role in the prevention, diagnosis,
and treatment of diseases and the rehabilitation of patients.
The WHO medical device technical series is a set of books
for the global health system coauthored by experts from the
WHO and other member states. It includes all important issues related to medical devices, such as medical device
118 SECTION | 2 Worldwide clinical engineering practice
regulation, research, management, action plans, tools, and
guidelines to enhance the rational use of medical devices.
The Chinese translation by CSCE was a project sponsored by
the Hospital Management Research Institute of the National
Health Commission of the People’s Republic of China. In
2016, CSCE’s Chinese translation version was approved by
the WHO publishing house. The Chinese translation of the
first nine publications in the WHO medical device technology
series was completed in September 2017 and published by
the People’s Medical Publishing House. During the publishing ceremony, the WHO Medical Devices Coordinator Ms.
Adriana Velazquez Berumen was invited to be present and
give a speech. The Chinese translation of the other 10 books in
the WHO medical device series was also launched in March
2018. The series of books is aligned with the formulation
of national technical strategies related to the “development,
learning, research, management, and use” of medical devices,
and provides guidance to medical and health practitioners as
well as the medical device industry, and promotes the integration of medical device supervision and international standards.
Conducting academic exchange activities
Regularly host the National Clinical
Engineering Academic Annual Congress
The Chinese Society of Clinical Engineering adheres to
the purpose of its father organization, namely the Chinese
Medical Association, strengthening academic exchanges
through Academic Conference, Clinical Engineer Salon,
Clinical Engineering Experts High-Level Forum, Youth
Committee Annual Conference Academic Conference and
CE Forum of China International Medical Equipment Fair
(CMEF). Since 1993, the National Clinical Engineering
Academic Annual Congress has been held in Beijing,
Shanghai, Nanjing, Wuhan, Kunming, and Hangzhou, etc.,
every 1 or 2 years. So far, 16 national clinical engineering
academic conferences have been held. The annual conference is large scale and highly attended, including a main
forum and five to eight special subforums. The congress
invites many domestic and foreign experts from clinical
engineering, information technology professionals, and
hospital administration to attend and deliver academic reports. Nearly 1000 people from 31 provinces, cities, and
regions attend the conference, and more than 100 domestic
and foreign industry experts and engineers are gathered to
give insightful academic speeches. They focus on the frontiers of clinical engineering and digital medicine and the
development trends of healthcare technology. The conference normally receives 300–500 papers, covering dozens
of provinces and cities nationwide. A lot of stakeholders
in the clinical engineering community from all over the
­country come to attend the congress, to discuss together, to
exchange academic ideas and views, to enlighten each other
and learn from each other, and to network and constantly
inspire original innovation. It is believed that all the conferences hosted by CSCE play a vital role in facilitating the
development and progress of the CE profession.
Organized Clinical Engineering White Paper
Road Show in various provinces and cities
across the country
In order to popularize the core concepts in the field of clinical engineering and to build consensus, the Chinese Society
of Clinical Engineering, the China International Medical
Exchange Foundation, and various local clinical engineering
chapters have co-organized clinical engineering management
training in most provinces/municipalities across the country since 2016. Based on the China Clinical Engineering
Development Report, the medical device technology series
issued by the WHO, and the National 13th Five-Year Plan
Teaching Materials (10 volumes) for clinical engineering academic education, this Road Show taught the core concepts
and introduced the international and domestic advanced management experience and technical guidelines in the field of
clinical engineering to the heads of the clinical engineering
departments of the national secondary and tertiary hospitals. The seasoned and experienced 26 instructors chosen by
CSCE formed a strong lecturer group to conduct the training.
Each training course was cosponsored and organized by local
provincial or municipality clinical engineering associations.
The number of attendees in each training course was about
100–300, and the training lasted about 2 days and 12 h. Up
to now, 23 training courses have taken place in 23 provinces/
municipalities. The number of participants was about 4500 in
total and the total number of training hours was 276 h.
Co-organized “Flying Over the Hump” Health
Technology Management (HTM) training series
Cosponsored by the China Biomedical Engineering Society
and/or the China Association of Medical Equipment, CSCE
hosted the “Flying Over the Hump—2015 HTM China Tour”
medical technology management training, launched in 10
cities, namely Chongqing, Guangzhou, Jinan, Wenzhou,
Harbin, Shanghai, Urumqi, Wuhan, Nanjing, and Beijing in
May, July, and September 2015. Some guest speakers from
the United States were invited, including experts from nongovernmental organizations, American College of Clinical
Engineering (ACCE), AAMI, ECRI, etc., to introduce international experience and best practices of medical technology management, to discuss how to help hospital equipment
and consumables managers to have a more ­forward-looking
vision, and strategic and more effective ­
management
methods. It covers medical device management strategy,
­planning and budgeting, procurement, efficient operation,
equipment maintenance, and financial management. The
Clinical engineering development in China Chapter | 17
“Flying Over the Hump” course was aimed at the practice
improvement in terms of hospital medical technology management. From the whole life-cycle management concept of
medical devices, the recognized best practice program has
established a complete management system for all aspects
of medical equipment from planning and procurement to
final decommission. At the same time, it gave a large number of guiding principles and methods with operability, as
well as best practice cases sharing under the actual operation of American medical institutions, further improving
the medical technology management level of middle and
senior managers, and promoting hospitals to improve overall operational efficiency and increase patient safety. Health
Technology Management (HTM)/CE professionals play
an important role in ensuring the continuous and effective
supply of medical services, while reducing the incidence of
medical device adverse events and benefiting patients.
Actively promoting the participation of clinical
engineering personnel in acquisition and
implementation of major national research and
development projects
In 2016–17, the National Ministry of Science and
Technology issued the National Key R&D Program
Application Guide, and the Chinese Society of Clinical
Engineering actively responded. Union Hospital ­affiliated
with College of Huazhong University of Science and
Technology, the Sixth People’s Hospital affiliated with
Shanghai Jiaotong University, the Ruijin Hospital affiliated
with Shanghai Jiaotong University, the General Hospital
of the People’s Liberation Army and the First Affiliated
Hospital of Zhejiang University worked together, organizing medical workers to participate in the demonstration and evaluation of innovative products in the “Digital
Diagnostic Equipment” guide of the Ministry of Science
and Technology. During the project application process,
Shanghai, Beijing, Wuhan, Zhengzhou Chongqing and
Zhejiang, along with other national CE counterparts, communicated and collaborated; after the successful writing
of the application materials, the formulation of the budget,
the preparation of the report materials, the online application materials submission, and the two rounds of evaluation, many projects led by CE were finally approved. For
example, the project for comprehensive evaluation of medical magnetic resonance products, construction and application of stereotactic radiotherapy equipment, research and
practice of positron-emission tomography (PET)-computed
tomography (PET-CT) comprehensive evaluation system
and training system, based on the comprehensive evaluation and training of medical ultrasound imaging systems in
hospitals of different levels, and research on an endoscope
comprehensive evaluation system and training system, in
119
total were awarded more than 30 million RMBs funding by
the Ministry of Science and Technology’s key research and
development plan “Digital Diagnostic Equipment R&D.”
Clinical engineers actively participated in the declaration
and implementation of major national research and development projects. With more than 2 years of continuous efforts, the CE profession achieved breakthroughs in national
major scientific research project bidding in clinical engineering disciplines, and this also demonstrated our scientific and technological research capabilities.
Professional training and continuing
education
There are two types of certification programs for clinical engineers, namely the Certified Clinical Engineer
(CCE) Program for senior-level clinical engineers and the
Registered Engineer Certification Program for entry-level
clinical engineers, respectively.
CCE certification program
Strengthening international academic exchanges and letting
the voice of Chinese clinical engineers reverberate in the
international academic arena have always been important
endeavors of CSCE. Since 2005, the International CCE
training course along with the CCE certification program
have been launched and sponsored by CSCE. The program
recognizes those who demonstrate the required CE competency. The BOK of the CCE certification program consists
of comprehensive CE knowledge fields, namely medical
equipment management, technology assessment and risk
management, project management, department management, CE-IT integration, training, etc., supplemented by
professional skills. So far, eight sessions were successfully
held consecutively in 2005, 2007, 2008, 2010, 2011, 2012,
2014, and 2016. The clinical engineer certification exam is
divided into an English written test and an oral test (from
the beginning of 2012, compliance with medical device
regulations in Chinese was added as a part of the oral test).
The exam questions adopt a similar pattern to the CCE certification exam in the United States, and the participants
are required to answer in English, with the exception of
part of the oral exam using Chinese pertinent to medical
device regulation compliance. Dr. David Yadin, founder of
the ACCE, and Professor William Hyman from Texas A&M
University, Professor James Wear, and other experts were
invited as examiners. More than 600 clinical engineers in
total from major hospitals in the country participated in the
clinical engineer certification exams, of which 273 passed
both written and oral exams and received their certificates
as CCEs. This program has improved the overall level of
Chinese clinical engineers. Its establishment helps to ­better
120 SECTION | 2 Worldwide clinical engineering practice
FIG. 1 The distribution of CCE personnel: 273 clinical engineers from 24 provinces, municipalities, and autonomous regions have passed the certification.
establish and enhance the position of clinical engineer in
the hospital, and is conducive to career growth for clinical
engineers (Fig. 1).
Registered engineer certification program
Continuing education in clinical engineering is partly based
on two levels of qualification certification, and it provides
training in professional skills and equipment management
for all levels of personnel to achieve lifelong continuing
education. In addition to the abovementioned CCE program, there is a certification program for entry-level CEs,
namely the Registered Engineer Certification Program. This
program is targeted to help practitioners with their daily
technical work. The certified registered engineer should
demonstrate that he or she possesses the required BOK and
competency for the profession. This program is administered
at the provincial or regional level with CSCE and/or CCCE’s
oversight. The registered engineer is similar to the resident
physician: it is the professional qualification for clinical engineering practitioners with needed continuing education.
The candidates include CE technicians, junior clinical engineers, medical device industry field engineers, and related
CE senior students. The certification contents are based on
basic knowledge, basic theory, basic skills (three basics) and
relevant medical equipment principles, maintenance, quality
inspection, etc. The Chinese Society of Clinical Engineering
issued the “Management Guidance for Clinical Engineering
Registered Engineer Certification” and the “Registration
Procedures for Registered Engineer Skills Test Bases,”
which state guidance and process in terms of general rules,
organization management, application procedures, written
examination, hands-on skill examination, appeal, continuing education needed, etc. The Association developed a
specific website for the CE certification program, set up the
Registration Certification Examination Platform, and established the Registration Certification Examination Question
Bank. So far, during 2012–16, three sessions were held, and
in total 147 people from 10 different regions and provinces
got their certificates; the general pass rate is about 50%. The
program is not only conducive to establishing and improving
the status of clinical engineering personnel in the hospital,
but also beneficial to the management and sustainable development of clinical engineering personnel, and is conducive
to promoting the accelerated construction of clinical engineering disciplines in China.
Joint training courses for EMBA, HTM, and
hospital operation management in conjunction
with Peking University and Tongji University
In 2011, the leading group of the Chinese Society of Clinical
Engineering initiated a training course with the collaboration of academia such as Peking University and Tongji
University. This training course focused on high-quality
training for senior managers and clinical engineers. It aims
to expand the vision and management skills of senior clinical engineers and promote their career growth.
(1) Organized a senior seminar titled “Purchasing and
Logistics Management.” In order to improve the procurement management, negotiation skills and logistics
management capabilities of clinical engineering personnel, the Association and Johnson & Johnson jointly
held a course titled the “Advanced Training Course on
Purchasing and Logistics Management.” Mr. Zhang
Zhonghao, a senior logistics manager and lecturer
with rich teaching and practical experience, was invited as the main speaker. In 2011, three such sessions
were held in Weihai, Chongqing, and Hangzhou, respectively. The training course was warmly welcomed
in the CE community. The seminar was held for two
consecutive years and the trainees reached 300 people
in total.
Clinical engineering development in China Chapter | 17
(2) Held the “Hospital Operations Management” (HOM)
seminar. The Association jointly organized the HOM
Program with the EMBA Center of Shanghai Tongji
University and Johnson & Johnson, mainly for the
directors of clinical engineering departments. It is an
executive training program and specially designed
for senior engineers and device management talents
in hospitals to enhance their management philosophy
and capability. The courses include: establishment
of hospital quality management system and quality
control tools and methods, calculation and control of
hospital operating costs, hospital financial, technical
management related to hospital operations, and hospital safety management. All the courses are divided
into three models, which are to be finished in 8 days
total within a duration of 10 months. Since 2011, the
program has been held for five consecutive years and it
has trained more than 500 people in the field of clinical
engineering.
(3) Held the “Hospital Management Excellence in
Operational Leadership” seminar. The Association
has teamed up with the Peking University’s Guanghua
School of Management’s EDP Center and Philips to
launch a high-end training program for hospital excellent operational leadership. It aims to help improve
HOM in China, improve efficiency, and enhance performance. In all, 56 people have obtained the certificates of completion issued by the Peking University
after they completed the course.
Talent selection
Medical equipment troubleshooting and quality
control skill competition
With the steady advancement of the country’s comprehensive medical reform, medical safety has become a focus
and has been pushed to a higher level with new and more
stringent requirements for medical equipment safety and effectiveness. This has brought new challenges for medical
equipment management in terms of safety and effectiveness
for all hospitals. As a regional collaborated CE initiative
aiming at enhancing the maintenance capability of medical equipment, the provincial CE associations of Shanghai,
Jiangsu, Zhejiang, and Anhui provinces have pioneered
the competition program annually since 2012. It has been
extremely welcomed by all the front-line engineers and
technicians and prevailed quickly in the whole country.
The competition has emphasized “multiparty cooperation,
equipment hands-on skills, teamwork” with the objective of
improving practical ability for clinical engineers and technicians. It delivers the spirit of “friendship first, competition
second.” The competition consists of three major sessions,
121
namely, typical case study review competition session,
theoretical knowledge competition session, and hands-on
practice of troubleshooting and quality control competition
session. Best teams and individuals are awarded afterwards.
Starting in 2012, more than six competitions were successfully held in the East China region of Shanghai, Suzhou,
Nanjing, Weihai, etc. with annually chosen equipment,
namely, ventilator, patient monitor, ultrasound, DR, endoscopy, and dialysis machines, respectively. This project
started in the East China area and soon spread nationwide.
In 2018, the first National Clinical Engineer Skills
Competition organized by the Chinese Society of Clinical
Engineering was held in October and November. Eight
different medical equipment devices were chosen for
the competition and 48 teams consisting of 240 clinical
engineers and technicians from more than 20 provinces
participated in this event. These 48 teams were selected
and organized based on regional competition. The eight
medical equipment devices were dialysis machine, ultrasound, DR, ventilator, patient monitor, defibrillator, infusion pump, and digestive endoscopy. It is believed that the
overall technical and medical equipment service capability of engineering personnel in various regions will be improved through this competition.
The awarding for the national key clinical
engineering disciplines in 2011
In order to further strengthen the construction of clinical
engineering disciplines and promote the development of
clinical engineering disciplines in China, CSCE organized
the evaluation and recognition of key disciplines of clinical engineering on a national scale in 2011. In April 2011,
CSCE developed the Key Discipline Evaluation Standards
with reference to the evaluation criteria of other key disciplines, of which 41 were common standards for subject
management, talent team, scientific research, and academic
achievements; 62 were individual standards, mainly divided
into two aspects: infrastructure and technical services performance. If the self-assessment of the applicator is more
than 850 points, the application materials can be submitted by the local clinical engineering chapter of the Medical
Association and submitted to the CSCE. CSCE conducted
an on-site survey for evaluation and identification afterwards. A total of 21 hospital clinical engineering departments in the country submitted the application materials.
Six hospital clinical engineering departments among these
21 applicators were finally awarded as national key clinical engineering disciplines, namely, the 301-army hospital,
the Inner Mongolia Autonomous Region People’s Hospital,
Wuhan Union Hospital, Nanjing Military Region Nanjing
Hospital, Shanghai Sixth People’s Hospital and Jiangsu
Provincial People’s Hospital. This event has achieved four
122 SECTION | 2 Worldwide clinical engineering practice
positive effects: first, to build a group of clinical engineering disciplines at a leading national level; second, to train
a group of young and middle-aged clinical engineering
experts and academic leaders; third, to produce a number
of high-level clinical engineering scientific and technological achievements; and the fourth is to identify some best
practices of clinical engineering disciplines. The evaluation
and recognition of key disciplines in clinical engineering
is a milestone in the construction of clinical engineering
disciplines and it bears significance for clinical engineering development in China. It will further promote the continuous advancement and innovation of clinical engineering
disciplines, and continuously improve the performance of
clinical engineering in the whole country and benefit patient
care ultimately.
National outstanding youth of clinical
engineering selection review
In order to honor, encourage, and commend outstanding
young talents in the clinical engineering community and
strengthen the pool of clinical engineering reserve talents,
CSCE held the “Top Ten Outstanding Youths” selection in
2010 and 2012. The event has received wide attention and
praise from the CE community and health workers at large.
After the recommendation of various provinces and cities,
qualification examination, network publicity, committee
voting, and the Standing Committee review, there were finally 21 outstanding young people selected as national outstanding youth of clinical engineering.
“China Medical Equipment Excellent Engineer”
selection review
In 2011, the “China Medical Equipment Excellent
Engineer” selection event was held in Taiyuan. After the online voting, CSCE conducted screening, on-site interviewing and inspection, as well as finally voting and scoring;
10 “excellent engineers” were selected, and presented with
a trophy and certificate at the academic annual meeting in
October. The selection activities have received very positive responses at all levels of medical institutions across the
country, enabling hospital administrators to have a new and
good understanding for clinical engineering. At the same
time, it also encouraged the work enthusiasm of clinical engineering professionals.
The “China Medical Equipment Excellent Engineer”
along with the later add-on for best CE team Selection
Program are cosponsored by the Chinese Society of
Clinical Engineering, Chinese College of Clinical
Engineers, Clinical Engineering Branch, Chinese Society
of Biomedical Engineering, Clinical Engineering Branch,
Chinese Association of Research Hospitals, Clinical
Engineering Branch, Chinese Association of Nonpublic
Hospitals, People’s Medical Publishing House, China
Medical Equipment magazine, and others. The program
aims to improve the equipment service and management
level of clinical engineering professionals, strengthen the
operation and maintenance, quality control and scientific
research capabilities of clinical engineers, and accelerate
the construction of clinical engineering disciplines. Since
2010, the event has been successfully held for eight sessions, and about 600 outstanding clinical engineering
professionals have been selected from more than 2000
applicants covering more than 30 provinces across the
country. Among them, there are more than 100 top 10 in
the country, 48 in research/management, and 34 excellent
hospital teams. From 2014 to 2017, they were ­co-organized
by the Southwest Hospital of the Third Military Medical
University, the Xiangya Hospital of Central South University,
the Biomedical Instrument Professional Committee of the
Hubei Biomedical Engineering Society, and the Southern
Hospital of Southern Medical University. The ninth “China
Medical Equipment Excellent Engineer” selection event
was co-organized by the Fujian Medical Association
Clinical Engineering Branch, Fujian Provincial Hospital,
and the Second Hospital of Nanping City, Fujian Province.
The final contest was held in Jianyang, Fujian on September
15, 2018. “China Medical Equipment Excellent Engineer”
has become one of the most recognized professional awards
in the CE community. The event organizers commended
the winners at the “International Clinical Engineering Day”
global celebration event and awarded the honorary certificates; the “People’s Health News” published the results of
the selection; the provincial and municipal health departments also issued various encouragement policies to recommend and to commend the awarded persons in the form of
a recommendation to join the CE society, presentations of
awards at conferences, media reports, and providing opportunities for further professional training, and so forth.
Other noted events
After-sales service satisfaction survey
Shanghai MDMQCC was set up by Shanghai MOH in 2005,
which is affiliated with Shanghai Sixth People’s Hospital.
The MDMQCC is responsible for supervising MD management of 120 top hospitals in Shanghai. It is one of the first
MDMQCCs in China.
From 2008, Shanghai MDMQCC started an investigation of after-sale service quality of MD manufacturers
in Shanghai. The survey covered 15 categories and more
than 50 brands of medical equipment after-sales service.
According to the satisfaction survey results of each manufacturer’s service, MDMQCC makes annual rankings and
awards for MD manufacturers. The project has continued
Clinical engineering development in China Chapter | 17
for 11 years and has won National Hospital Technology
Innovation awards in 2011. At present, the project has been
extended to more than 20 provinces in China, and has made
outstanding contributions in improving the quality of MD
after-sales service.
Participate in the publication of the “Safety
Management Regulations for Clinical Use of
Medical Devices (Trial)”
The Chinese Society of Clinical Engineering actively participated in the discussion on the formulation of policies
related to medical device management by the Ministry of
Health.
In August 2010, after the Ministry of Health issued
the Medical Device Safety Management Regulations
(Trial), the Chinese Society of Clinical Engineering recommended eight experts to participate in the edit of the
“Interpretation of the Safety Management Regulations
for Clinical Use of Medical Devices (Trial)” by the management of the Ministry of Health Medical Services
Supervision Department and the Ministry of Health
Hospital Management, to provide technical support and
operational guidance for the administrators of grassroots
health administrative departments, medical institutions,
medical device administrators, users, and maintainers to
understand and grasp the distant and regulatory provisions
of the Code more accurately. In October 2010, the Medical
Management Division of the National Health Commission
launched a special spot check on rational clinical use and
safety management of medical devices. Seven experts from
the Chinese Medical Society and Clinical Engineering
participated in the investigation of the clinical safety management of medical devices in 30 hospitals in Beijing,
Shanghai, Guangdong, Hubei, Liaoning, and Zhejiang,
where they analyzed the problems found in the inspection
and suggested countermeasures and suggestions.
Participation in the preparation of the national
medical device management quality control
center
By the end of 2017, 14 provinces and ­m unicipalities
in China had established provincial and municipal
MDMQCCs, which respectively initiated quality control of medical equipment management in the region.
At present, under the leadership of the National Health
and Family Planning Hospital Management Research
Institute, 14 medical equipment quality control centers
of various provinces and cities actively participated in
the drafting of relevant quality control center management norms, and preparations for the establishment of a
national-level MDMQCC.
123
International exchanges
Successfully held the first international clinical
engineering and HTM academic congress
(ICEHTMC) in Hanghzou in 2015
As one of the main coorganizers, CSCE put forth great efforts to make the first ICEHTMC a success.
Collaborated programs with ECRI
(4) Training courses for medical devices relevant to adverse events investigation have been conducted once
a year since 2013, and nearly 500 HTM professionals
attended these courses.
(5) Chinese translation of ECRI Health Device Journal
was published on the CSCE website and the Journal of
China Medical Device during 2011–13.
American subject matter experts who attended
our annual CE Congress or CMEF CE Forum and
shared their best practice and knowledge
Many subject matter experts including Yadin David,
Malcolm Ridgway, William Hyman, Binseng Wang, James
Wear, Jeff Lerner, Elliot Sloane, Samantha Jacques, Kevin
Bennet, Steve Grimes, Mario Castaneda, Tobey Clark,
Anthony Montagnolo, Robert Stiefel, Tom Judd, Andrew
Currie, Jennifer Jackson, Ilir Kullolli, and Alan Lipschultz
visited us at our annual congress or other relevant events.
Participated in the AAMI and ACCE conferences
in the United States in 2017
On June 9–12, 2017, a CSCE expert delegation (hereinafter
referred to as the visiting group) went to the United States
to attend the AAMI Annual Meeting and conduct local hospital visits and exchanges. The participants in this international exchange were: Professor Li Bin, the vice chairman
of CSCE; Professor Zheng Kun, vice chairman of CSCE
and head of foreign affairs division; Prof. Xia Huilin, deputy Secretary-General of CSCE; and Zhang Yue, Academic
Department of the Chinese Medical Association. This was
the first time that the CSCE sent a delegation to participate in the AAMI academic activities. The visiting activities enabled us to have a comprehensive understanding of
the overall development level of clinical engineering in the
United States, and have deeper contacts and exchanges with
mainstream academic groups such as AAMI, ECRI, ACCE,
etc., and have further contacts with more American clinical engineering experts and scholars. It also enabled these
organizations and personnel to understand Chinese clinical
engineering and CSCE better.
124 SECTION | 2 Worldwide clinical engineering practice
Further reading
David, Y., Dan, Z., Hyman, W., Kun, Z., 2011. Clinical engineering development in China. J. Clin. Eng., 68–71.
David, Y., Qiang, Z., Dan, Z., Mingchen, P., Kun, Z., Bin, L., Shenglin, L.,
Huiling, X., 2014. Quality and safety should be the objective for inhouse clinical engineering. China Med. Dev. 8, 1–4. 57.
Huiling, X., 2013. Walking Into the 20 Years of Clinical Engineering.
China City Press, Beijing.
Qiang, Z., Guanxing, G., Dan, Z., 2015. The White Paper on Chinese
Clinical Engineering. Hubei Scientific & Technology Publishing
House, Wu Han.
Wang, B., 2011. Medical Equipment Maintenance: Management and
Oversight. Morgan & Claypool Publishers.
WHO Medical Device Technical Series, 2017. Human Resources for
Medical Devices. World Health Organization.
Yuanhai, J., Mingchen, P., 2009. Clinical Engineering Technology.
Scientific & Technology Publishing House, Beijing.
Chapter 18
Clinical engineering in
Argentina
Germán Giles, Marcelo Lencina
Engineering Department, Medical Foundation of Mar del Plata, Mar del Plata, Buenos Aires, Argentina;
National Technological University - San Nicolas Regional College, San Nicolás, Buenos Aires, Argentina
History
In the 1970s, some Provincial Ministries of Health started
the so-called “Electromedical Departments,” mostly integrated by engineers and technicians with a background
in electronics. Their tasks included repairing X-ray equipment, patient monitors, and electrosurgical units. During
the 1980s, they managed to develop preventive maintenance
programs, guidelines for equipment purchases with appropriate specifications, and control over third-party companies repairing equipment.
Years later, some universities created courses in electromedicine; but bioengineering was the first bachelor degree
in the country, designed by Universidad Nacional de Entre
Ríos in 1986, and then other universities followed them.
So, biomedical engineering professionals started a new
and more complex era of health technologies management
(HTM) around the country. Some of them, decided to become involved in clinical engineering areas.
The Argentine Bioengineering Society (SABI)
(Argentinean Bioengineering Society (SABI), n.d.) was
created in 1979, and near the end of the 1980s, together
with the Brazilian and Mexican Bioengineering Societies,
began to reflect upon the idea of creating a Latin American
Organization. In addition, they aimed to facilitate the communication among societies, laboratories, industries, universities, and groups in Latin America and the Caribbean
region. With those objectives in mind, the Latin American
Regional Council on Biomedical Engineering (CORAL)
(CORAL History, n.d.) was created.
The first CORAL meeting took place in Cordoba,
Argentina in 1990, in the framework of the VII SABI
Congress, with the participation of Chilean, Mexican,
Venezuelan, and Uruguayan representatives. This meeting
was promoted and convened by Robert N. Nerem (IFMBE
President), Charles J. Robinson (IEEE/EMBS President),
and Maximo Valentinuzzi (IEEE/EMBS Region 9 representative and IFMBE Developing Countries Committee—DCC
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00018-3
Copyright © 2020 Elsevier Inc. All rights reserved.
Latin American member), at the same time that the IEEE/
EMBS were negotiating the incorporation as a member of
the International Federation of Medicine and Biological
Engineering (IFMBE) (IFMBE, n.d.).
The first Argentinean Clinical Engineering Conference
took place in the framework of the XII SABI Congress on
April 1999 in Buenos Aires, giving way to creation of the
CE chapter.
Present
Regulations
The development and evolution of medical devices intensified the professionals’ need to seek strategies on how
to use/handle them properly, from both the Public and
Private sectors. The National Regulatory Health Institution,
called A.N.M.A.T. (Argentinean National Administration
for Medicine, Food and Technology, n.d.), dependent on
the National Ministry of Health (Argentinean National
Ministry of Health, n.d.), represents a big advancement
for healthcare technology stakeholders. Their guidelines
and resolutions help CE Departments to purchase medical
technologies, as part of assuring patient safety and quality
control. Using the Universal Medical Device Nomenclature
System (UMDNS) (n.d.) for medical devices registry;
A.N.M.A.T. authorize and audit manufacturers, distributors, import agents, and storage places for medical devices
across the country. Their Techno-Surveillance program;
collects, evaluates, and organizes information from users,
when adverse events occur, after their authorization and
during commercialization. Every medical institution acquiring medical devices must require from providers, the
valid A.N.M.A.T. registry number or its certification, before
a purchasing process begins.
The advancement of regulatory frameworks such as the
National Law No. 26.906: “Traceability Regime and Verification
of the Technical Aptitude of Health Medical Products in use”
125
126 SECTION | 2 Worldwide clinical engineering practice
(Argentinean National Ministry of Justice, n.d.), as well as other
laws and provincial decrees, ensures a safer environment in
Healthcare Institutions. The purpose of the law is to establish the
traceability regime for active medical products, the metrological
traceability thereof, and the creation of Biomedical Technology
Departments throughout the national territory.
Education
About 11 universities offer biomedical or bioengineering graduate programs (Human Resources for Medical
Devices—The Role of Biomedical Engineers, n.d.), some
with postgraduate course offers in clinical engineering.
The titles granted after 5-year academic programs are
“bioengineer” or “biomedical engineer.” They all include
in their curricula, specific contents on clinical engineering.
Currently, there are more than 1500 biomedical engineers and bioengineers working in different specialty areas.
Clinical engineers both in the public and the private sector
has a great demand, mainly due to the continuous technological advancements applied to medicine.
Pre and postgraduate programs are offered, just in some
of those universities.
A Healthcare Technology Management International
Certification is being evaluated, in line with other countries
and latest developments.
Patient safety and committees
Resolutions PAHO/WHO CD42.R10-2000 (PAHO/WHO
Resolution CD42.R10-2000, n.d.) and WHO 60.29-2007
(World Health Organization Resolution 60.29-2007, n.d.)
had high impact on the development and strengthening of the
CE professionals involved in the purchase and maintenance
of medical devices. Guided by National Ministry of Health—
National Quality Program (Argentina Health National
Quality Program, n.d.), some Healthcare Technology
Departments started to contribute through different internal
committees to develop guidelines and processes to reduce
accidents or adverse events with patients. The role of CE
and HTM Departments is to regularly train on equipment
use, check device performance based on National Laws and
Guidelines, and provide advice on purchases.
A few institutions across the country have an
Accreditation or Certification like ISO or Joint Commission
International; others are guided or certified by the
International Society for Quality in Health Care (ISQua)
(International Society for Quality in Health Care, n.d.) or
their institutional members.
Health IT status. Use of social networks
Argentina is in an advanced stage of electronic health records (EHRs) adoption in a unified way. Some provinces
and various private health institutions, have been working for many years on this task. But there is no legislation
with clear guidelines and projects to implement this on a
national scale. International standards and experiences on
this matter are followed by a few players while this issue is
solved. Many of them have started their own development,
but as continuous technological changes need to be applied,
shared work with healthcare software providers has become frequent. In Argentina, unlike in other countries, CE
Departments are independent from Information Technology
(IT) Departments. They just work together to achieve some
IT goals, to provide more information collected from medical devices, being it shown in the EHR’s.
The Argentinean Ministry of Health works with public
and private stakeholders to promote the use of standards
and interoperability of data, around the country (National
Interoperability Health Network, n.d.).
On the other hand, the use of social networks is a good
tool to share information among clinical engineers about
providers, laws, guidelines, recommendations, experiences,
and international developments on this and other related
fields.
Clinical engineering internships
In the Provinces of Córdoba, Corrientes, San Juan, Tucumán,
and the Autonomous City of Buenos Aires, the system of
residencies in clinical engineering has been implemented.
This consists of a biomedical engineer or another specialist
developing activities with weekly hourly load for 3 years
in the Engineering Department, overseen and guided by an
instructor. Theoretical training is provided by the university,
since this system is backed up in conjunction with the respective Ministry of Health. During this period the resident
earns a salary similar to the professionals of the hospital and
equal in terms of employment benefits. Selection is carried
out through public competition since there are very few positions available—one or two—in each province.
As an example, the Province of Buenos Aires implemented Clinical Engineering Departments in 18 hospitals,
by means of an agreement with the National Technological
University. The department activities are carried out by
graduates and undergraduate students, who perform tasks
within the hospital every weekday in an office assigned for
that purpose, and with the support of the university structure.
At the end, biomedical engineers earn a degree, awarded
by the Ministry of Health and the University, certifying the
latter, the specialization in clinical engineering.
Societies
As stated above, since 1999 the Argentinian Society for
Bioengineering (SABI) has the Clinical Engineering chapter written down on its statute. Relaunched at 2017 SABI
Clinical engineering in Argentina Chapter | 18
Congress, the CE chapter updates topics through the SABI
website, promoting CE education, healthcare technologies
management initiatives, Government sensitization about
CE roles and needs, around Argentina.
Other objectives include coordinating similar strategies
of work among colleagues of all Provinces, sharing information on suppliers and technical documentation (virtual
library), obtaining up-to-date information on changes and/
or modifications to international standards on the subject.
Provided that these actions were taken, it has been of great
value; since the realities of the 24 provinces are very different due to their geographical features (the vast expanse of
territory) and unique socioeconomic situations.
SABI is working with other scientific societies like the
Argentinian Cardiology Society and the Medical Physics
Society to share knowledge, experiences, research, and development. Additionally, there has been an increase in relations with international Associations and Societies related
to clinical engineering.
Future
If we consider the continuous development of clinical engineering field during the last 15–20 years, we could say that
the CE future in our country is encouraging.
This assertion is based on the following facts:
●
●
●
●
More Provincial Ministries of Health are incorporating Biomedical Technologies Offices in their organizational charts, as well as assigned biomedical and clinical
engineers.
In Argentina the control of professional activities should
be done by the state, but this role has been delegated to
the professional colleges by law. Nowadays, these colleges are regulating the biomedical engineering activities and their professional fees (Buenos Aires Engineers
College, n.d.).
New graduates from universities are entering the labor
market every year.
The continue effort in maintaining and incorporating
new regulations and processes from all healthcare stakeholders, both the public or private sectors, is giving good
results in terms of user/patient safety.
127
Conclusions and recommendations
Like other Latin American countries, Clinical Engineering
Departments in Argentina, sequentially suffer the country’s
critical economic situation and currency devaluation, making daily work a difficult issue. Stakeholders understand
this and readapt core goals, prioritizing patient welfare. As
explained, many advancements have been achieved in the
CE-HTM fields during last years, so we are very optimistic
to continue implementing the newest medical and life sciences technologies, sharing knowledge with colleagues and
encouraging Ministries of Health to count on clinical and
biomedical engineers, technicians, and healthcare technology managers to fulfill their goals.
References
Argentina Health National Quality Program n.d. www.argentina.gob.ar/
salud/calidadatencionmedica.
Argentinean Bioengineering Society (SABI) n.d. www.sabi.org.ar.
Argentinean National Administration for Medicine, Food and Technology
n.d. www.argentina.gob.ar/anmat.
Argentinean National Ministry of Health n.d. www.argentina.gob.ar/salud/.
Argentinean National Ministry of Justice. n.d. National Law No.
26.906
http://servicios.infoleg.gob.ar/infolegInternet/anexos/220000-224999/224109/norma.htm.
Buenos Aires Engineers College, n.d. Res. No. 1258 www.colegioingenieros.org.ar.
CORAL History n.d. http://www.mobecomm.com/docs/pubs/BMES_in_
Latin_America.pdf.
Human Resources for Medical Devices—The Role of Biomedical
Engineers n.d. https://www.who.int/medical_devices/publications/
hr_med_dev_bio-engineers/en/.
IFMBE n.d. www.2016.ifmbe.org.
International Society for Quality in Health Care n.d. https://www.
isqua.org/.
National Interoperability Health Network n.d. https://www.boletinoficial.
gob.ar/#!DetalleNorma/200811/20190128.
PAHO/WHO Resolution CD42.R10-2000 n.d. http://iris.paho.org/xmlui/
bitstream/handle/123456789/1427/CD42.R10en.pdf?sequence=1&is
Allowed=y.
Universal Medical Device Nomenclature System (UMDNS) n.d. www.
ecri.org.
World Health Organization Resolution 60.29-2007 n.d. https://www.who.
int/healthsystems/WHA60_29.pdf.
Chapter 19
Clinical engineering in Italy
Claudio Cecchinia, Ernesto Iadanzab
a
Department of Clinical Engineering, ASST Valtellina e Alto Lario, Sondrio, Italy, bIFMBE HTA Division,
School of Engineering, University of Florence, Florence, Italy
History summary and academic
qualification
It is important to provide the reader with a brief historical summary of the development of clinical engineering in
Italy, over the past years. It dates back to the end of the
1980s in Trieste (northeast part of Italy, in the Friuli Venezia
Giulia region) with the first specialization program in clinical engineering at the University of Trieste.
In other universities, clinical engineering was taught
inside other engineering programs (mostly electronics
and mechanics) with biomedical curricula. It is the case of
the University of Florence, the Politecnico di Milano, and
the University of Bologna, to cite some. At the end of the
1990s, the Italian legal framework started to include some
guidelines about the rules and the standards to be applied to
hospitals. The figure of the “manager of the electro-medical
equipment” has been defined as well—even if not explicitly. This is an important fact to be underlined since before
this moment this professional did not exist and the technical
office was in charge of everything.
This is one of the main reasons why the Italian Association
of Clinical Engineers (AIIC) was founded in 1993 and the
figure of the clinical engineer slowly started to gain importance in the hospitals and in all the medical facilities.
Another important aspect to be considered concerns the
academic qualification and the labor market. Even the academia had to change its offer due to the growing importance
of the figure of the clinical engineer. To the programs in
electronics and mechanical engineering with biomedical
curricula, new degrees, and master programs in bioengineering have been added. Nowadays these programs are
more often referred to as “Biomedical Engineering.”
The employment opportunities related to biomedical engineering are related to three main sectors:
1. Academia—R&D.
2. Health care—both in public and private hospitals.
3. Industry—R&D, product specialist and vendors, servicing, and maintenance.
128
The distribution of the employment rate of graduated
people in the abovementioned sectors is 1% in universities,
5% in health care, and industry sector (factory 10%; sales
60%; and maintenance 14%). These estimations come from
the field knowledge and from the experience of the authors
in the world of clinical engineering (Table 1).
The market of medical devices in Italy
As indicated by the 2016 report from Italian Association of
Electro-Medical Industries (ANIE), the market of medical
devices kept on growing in the last years. Another relevant
information is related to the concentration of this growth in
a few regions.
The analysis and the interpretation of these data lead to
conclude that the structure of those companies operating in
high-investing regions is directly proportional to the market
(higher number of qualified employees) (Fig. 1).
Table 2 shows the number of engineers working in public healthcare structures, independently from their qualification as clinical engineers or other. The whole number of
engineers is 764 (with a high disproportion between men,
654, and women, 110).
The up-to-date situation of the Clinical
Engineering in Italy
The main activities of today’s clinical engineers include
medical devices procurement, management, maintenance,
investment and disposal, health technology assessment
(HTA), risk management, patient safety, and more.
A study conducted in 2018 by the AIIC, although based
just on its 1716 members, gives a good idea about the distribution of the profession in the whole country. There is a substantially equal distribution between the three geographical
areas, north (37%), center (30%), and south (33%). Almost
half of them work in a healthcare structure (53%) while the
others are employed as service providers (47%). It is also
worth considering how the gender balance is changing: in
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00019-5
Copyright © 2020 Elsevier Inc. All rights reserved.
Clinical engineering in Italy Chapter | 19
TABLE 1 Medical device sector in Italy.
Medical devices sector (data in M€)
Import
2013
2014
2015
6538.9
6878.6
7290.6
5.2
6.0
Annual variation (%)
2017/2013 variation (%)
Export
11.5
6128.7
Annual variation (%)
6439.7
6958.2
5.1
8.1
2017/2013 variation (%)
13.5
Balance
−410.2
−438.9
−332.4
Manufacturing
7111.1
7269.1
7962.1
2.2
9.5
Annual variation (%)
2017/2013 variation (%)
Internal market
12.0
9051.3
Annual variation (%)
9267.5
9869.8
2.4
6.5
2017/2013 variation (%)
Public demand
9.0
6891.9
Annual variation (%)
7137.4
7324.1
3.6
2.6
2017/2013 variation (%)
Private demand
6.3
2159.3
Annual variation (%)
2017/2013 variation (%)
2130.1
2545.7
−1.4
19.5
17.9
Source: Report ANIE 2016, Table 1, page 9 (translated).
FIG. 1 Medical device companies in Italy per region. Source: Report ANIE 2016, GRAPH 3, page 18 (adapted and translated).
129
130 SECTION | 2 Worldwide clinical engineering practice
TABLE 2 Healthcare personnel in 2017.
Male
Female
Total
Health care
140.760
290.732
431.492
Doctors and dentists
56.259
44.841
101.100
Doctors
56.199
44.825
101.024
Dentists
60
16
76
Other graduated personnel
6.557
9.675
16.232
Vets
3.859
931
4.790
Pharmacists
535
2.022
2.557
Biologists
591
2.404
2.995
Chemists
109
94
203
Physicists
234
284
518
Psychologists
1.229
3.940
5.169
Manager of the health
professions
137
224
361
Health Technician
12.007
20.026
32.033
Rehabilitation
3.475
15.520
18.995
Supervision and inspection
5.425
3.916
9.341
Nursing staff
56.900
196.530
253.430
Operators 1^ category
55.499
192.657
248.156
Operators 2^ category
1.401
3.873
5.274
Professional role
1.028
250
1.278
Lawyers
80
96
176
Engineers
654
110
764
Architects
78
25
103
Geologists
–
1
1
Religious assistants
216
18
234
Source: Italian Ministry of Health (translated) http://www.salute.gov.it/imgs/C_17_pubblicazioni_2870_ulterioriallegati_ulterioreallegato_0_alleg.xlsx.
the age range over 50, about 90% of the clinical engineers
are men, in the age range below 40, there are more women
than men.
With the Italian Law n. 3 January 1, 2018, it is set at the
Order of Engineers, a Certified National List of Biomedical
and Clinical Engineers. Although the subscription to this
list is on a voluntary basis, the certification is regulated by
a specific inter-ministerial regulation yet to be published.
The National Council of Engineers [Consiglio Nazionale
Ingegneri (CNI)], in the meantime, has set up a certification
program named CertING, ISO/IEC 17024 compliant, that
will be the first step for the professionals to enter this certified national list.
The criteria for this certification are largely based on
the work carried out by those local order of engineers who
have set up biomedical/clinical engineering commissions.
Two representatives of these local commissions (the authors
among them) have been meeting more than once each year
in Milan, on the occasion of purposely created coordination
meetings, to create two documents that defined competencies and tasks of biomedical and clinical engineers.
The Clinical Engineering Division of the International
Federation for Medical and Biological Engineering
(IFMBE/CED), chaired by Ernesto Iadanza in the period
2015–18, has done its part in advancing clinical engineering in Italy by having many contacts and participations
Clinical engineering in Italy Chapter | 19
in Italian events and conferences in the last years. To further confirm this, the third edition of the International
Conference of Clinical Engineering and Health Technology
Management (ICEHTMC, 2019, http://www.icehtmc.com)
was held in Rome in October 2019, in combination with the
Global Clinical Engineering Day (October 21).
There is no doubt that today Italy is having a big impact
on the worldwide clinical engineering, for example, also
exporting at European Union (EU) level its coding system
for medical devices. Very good signals arrive from academia, with more and more students choosing this path and
with excellent figures in their placement after graduation.
Nevertheless, there is still a lot to do—both on the legislative level and on the organizational level—before seeing a
clinical engineer sitting at all the tables of healthcare top
managers.
131
And this, considering the amount of technology in today’s healthcare structures, is not a matter of “if” but actually of “when” and “how.”
Further reading
AIIC Identikit 2018, http://www.panoramasanita.it/2018/05/11/primoidentikit-dellingegneria-clinica-e-biomedica-in-italia-1716-professionisti-in-tutta-italia/.
ASSOBIOMEDICA “Produzione, ricerca innovazione nel settore dei dispositivi medici in Italia-Sintesi del rapporto 2016”.
I quaderni di Quotidiano Sanità.it 10, “Le politiche di acquisto dei dispositivi medici, La strada migliore per coniugare sostenibilità ed
innovazione”.
Italian Ministry of Health, http://www.salute.gov.it/imgs/C_17_pubblicazioni_2870_ulterioriallegati_ulterioreallegato_0_alleg.xlsx.
Chapter 20
Clinical engineering in India
Niranjan D. Khambete
Department of Clinical Engineering, Deenanath Mangeshkar Hospital and Research Centre, Pune, India
Introduction
Advanced medical technology has revolutionized modern
medical practice making it possible to effectively deliver
high quality and safe health care to patients. Effectiveness
of healthcare delivery is closely linked to the efficient management of this medical technology and clinical engineers
(CEs), who manages the medical technology, play a key role
along with other clinical professionals in this h­ ealthcare delivery process. Therefore, for any country, it is essential to
ensure that sufficient efforts are directed toward developing
and strengthening of the CE profession.
This chapter begins by outlining the current form of
healthcare delivery systems in India and the current situation of healthcare technology management (HTM). It then
goes on to describe historical as well as recent initiatives
aimed at development of the CE profession in India. It provides details regarding training avenues for CEs and their
professional activities and concludes with some suggestions
for further development of this profession in the country.
Healthcare delivery systems in India
India is the second most populated country in the world
and in order to cater to the healthcare needs of such a
large population, it needs to have an effective and safe
healthcare delivery system. In its current form, the country’s healthcare delivery system has evolved into a mix of
government-funded network of healthcare organizations
­
and a large number of charitable and corporate healthcare
organizations. Highly qualified and well-trained clinical
professionals are indeed a strength of these organizations
and by acquiring advanced medical technology they have
brought its benefits to a large number of patients.
Initiatives such as the establishment of National
Accreditation Board for Hospitals and Healthcare Systems in
2006 and passing of Clinical Establishment Act by the Indian
Parliament in 2010 have provided a suitable framework for
quality enhancement and regulation of the h­ ealthcare delivery systems. Furthermore, various activities of the advisory
bodies such as National Health Systems Resource Center,
132
have initiated policy-level changes for increasing the effectiveness of healthcare delivery in the country (National
Accreditation Board for Hospitals and Healthcare Systems,
2015; National Health Systems Resource Centre, n.d.).
Concerns regarding current state of
healthcare technology management
In spite of the strengths mentioned above, one aspect that
seems to have received less attention from the leaders and
policymakers of healthcare system is the need to have effective systems for management of medical technology. This is
evident from the literature and media reports published in
recent years.
A survey aimed at reviewing the status of medical equipment in one of the largest public hospitals in South India
reported that out of 3790 pieces of medical equipment,
30% were found to be “out of service.” This situation was
attributed to the absence of efficient procedures for equipment and vendor management, suboptimal user training and
insufficient efforts toward carrying out preventive maintenance (APAC-VHS/Shiva Consultants, 2011). Another pilot
survey of medical equipment safety conducted in Central
India revealed that out of 41 clinicians surveyed, 39 reported
that they had witnessed medical equipment-related patient
safety incidents. These incidents involved various types of
medical equipment such as electrosurgery units, motorized
operation tables, patient monitors, surgical lamps, suction
pumps, and infusion pumps (Khambete et al., 2010, 2012).
Reports of serious injuries and death due to malfunction
of neonatal intensive care equipment such as baby incubators and warmers have appeared in media at an alarmingly
high rate. A study of these reports revealed that 15 such cases
from eight different states of India were reported in the media between 2003 and 2011, and burn injuries and death due
to fire were reported in 13 of them (Indian Express, 2009;
The Hindu, 2008; Khambete and Sable, 2012). Concerns
regarding the safety of medical X-ray equipment have also
been raised more than once in newspaper reports (The
Hindu, 2008; India Today, 2012; Sonawane et al., 2010).
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00020-1
Copyright © 2020 Elsevier Inc. All rights reserved.
Clinical engineering in India Chapter | 20
A few reports have also highlighted issues related to medical device regulation and periodic medical device checks
and raised concerns over suboptimal maintenance of medical equipment in public hospitals (The Hindu, 2012; Maya,
2013; Nagarajan, 2015). These reports, though anecdotal in
nature, cannot be ignored as they do point at major gaps in
the management and safe use of medical technology.
Efforts have been underway historically as well as in recent years to address these issues by encouraging discussion
among stakeholders and emphasizing the need to promote
CE profession. An account of these early efforts is presented below followed by details of more recent initiatives.
Early efforts in establishing clinical
engineering
As reported by Mehta JC in 2000, efforts to establish clinical engineering profession in India were initiated as early as
1969 (Mehta, 2000). Subsequently, in the year 1970, senior
medical professionals working at Post Graduate Institute of
Medical Education and Research (PGIMER), Chandigarh,
India, along with the Ministry of Health, Government of
India, took an initiative in forming a working group to identify the engineering needs in hospitals. These findings were
implemented in PGIMER by establishing preventive maintenance protocols for the medical equipment.
Bio-Medical Engineering Society of India (BMESI) was
also established in the 1960s with a mission to encourage
interaction between scientist, engineers, and clinicians and
thus, promote research and development in all aspects of
Biomedical Engineering. A similar initiative in Bangalore
led to the formation of Clinical Engineering Society of
India in 1997. However, in spite of achieving an initial
breakthrough in bringing interdisciplinary professionals on
a common platform, it appears that these societies could
create limited impact on development of CE profession in
India. As a consequence, the CE profession and HTM practices seem to have lagged behind other developments in the
healthcare system.
Recent efforts for revival of clinical
engineering
These media reports highlighting the limitations in HTM
practices and raising concerns about medical equipment
safety have led to a feeling of urgency among professionals
for reviving and strengthening the CE profession in India.
Many conferences, workshops, and focus group meetings
have been organized in recent past, building up consensus
to speedily act and overcome these limitations through concerted action. Inputs from international experts have been
sought during these events and participation of leaders of
healthcare systems and health policymakers have been
133
e­ nsured to achieve maximum impact. The following overview of these initiatives highlights their key points.
Advanced Clinical Engineering Workshop
(ACEW—India, 2009)
The Advanced Clinical Engineering Workshop (ACEW—
India, 2009), was organized in October 2009 by Sree Chitra
Tirunal Institute for Medical Sciences and Technology at
Trivandrum, Kerala, India and can be considered as the first
major event in recent past for revival of interest in CE profession. The faculty to this Workshop included five experienced CEs from the United States of America along with
senior clinicians and hospital managers from leading hospitals of India. CEs, teaching faculty, hospital managers, and
students were the participants in this Workshop. The sessions covered all the important topics related to HTM with a
special emphasis on training and competency requirements
for certification of CEs, use of information technology in
modern HTM practices and adverse event investigation.
After a long time gap, this workshop provided a valuable
opportunity to CE professionals from India to interact with
those from abroad and compare their practices. Participants
from distinct disciplines such as engineering, medicine, and
management used this platform to exchange their experiences and share their concerns about the current CE practices in the country leading to a clear consensus that urgent
action was needed to strengthen the CE profession in India.
International Clinical Engineering Workshop
(ICEW—India, 2011)
In order to sustain the momentum generated by ACEWIndia (2009), second ICEW-India (2011) was organized
jointly by the College of Engineering, Pune and Sree Chitra
Tirunal Institute for Medical Sciences and Technology in
Pune in February 2011. Active involvement of CEs and
medical device experts from the UK was the main feature
of this event. A talk by the Senior Advisor to World Health
Organization, Geneva, on Medical Devices and Healthcare
Technology, was another important highlight of this
Workshop. It also received formal endorsements from some
of the country’s leading healthcare organizations, namely
the Armed Forces Medical College, Fortis Healthcare Ltd,
Max Healthcare Institute, and Deenanath Mangeshkar
Hospital and Research Center.
“Medical Device Safety” was the central theme of this
Workshop and keeping in line with this theme, a low priced
Asian edition of the book titled “Medical Devices: Use
and Safety” by Jacobson and Murray (2011), was released
during the inaugural session of this Workshop. The eminent personalities invited to the inaugural session mainly
included clinicians occupying offices of high authority in
134 SECTION | 2 Worldwide clinical engineering practice
renowned healthcare organizations. The purpose behind
giving them prominence was to attract their attention to the
current status of CE profession in India and seek their involvement in its development. The experts equivocally acknowledged that there was a need to employ trained and
certified CEs in hospitals to reduce medical device safety
incidents. They also emphasized the need for setting up a
National Certification Body for CEs in India and assured
help and complete support to this initiative.
Impact of these workshops and follow-up
activities
The talks and discussions on good HTM Practices and
medical equipment safety, which took place at the two main
events described above seemed to generate significant interest among other medical professionals. Their impact
in spreading this message beyond the cities was evident
from an invitation to conduct a similar workshop for staff
of Government Medical College, in Latur, a small town in
the state of Maharashtra. Taking a cue from this invitation,
two 1-day “Regional Clinical Engineering Workshops”
(RCEWs) were organized in Latur and Mumbai in May and
June of 2011, respectively.
These RCEWs also provided an opportunity to the
Workshop’s faculty members in gaining insight into challenges faced in implementing HTM practices in places located away from the major cities. The discussions at these
RCEWs also led to the preparation of a report recommending establishment of “Department of Clinical Engineering”
with full academic status in each of the Medical Colleges
run by the state of Maharashtra. This report was presented
to the Health Education Ministry of the state government
for further consideration.
Clinical engineering conclave—2012
In order to further strengthen advocacy in support of CE
profession, a roundtable meeting of experts was called
in February 2012 at King Edward Memorial Hospital,
Mumbai. The invitees included individuals in leadership
positions in public health sectors, experts in senior positions
in charitable and private healthcare sectors, representatives
of medical equipment procurement agencies, accreditation bodies (National Accreditation Board for Hospitals
& Healthcare Providers, NABH), Medical Council of
India, Army Medical Corps, and academic institutions.
International experts from the UK and from WHO were
special invitees and they shared their experiences and gave
valuable suggestions. The action points that emerged from
these discussions identified the need for:
●
An Adverse Event Reporting System, initially in selected hospitals and then at the national level.
●
●
●
Systematic surveys on existing HTM practices in different healthcare sectors and identifying the gaps.
Formation of a professional body for CEs and
Biomedical Equipment Technicians (BMETs) and certification requirements.
Continued advocacy at various levels of government for
policies on HTM and medical device safety.
Medical Equipment Safety Workshop
Series—2013 and 2014
Medical Equipment Safety Workshop Series—India, 2013
and 2014 was a continuation of efforts toward engaging
healthcare authorities and professionals with problems related to medical equipment safety and initiate necessary
changes. This initiative involved conducting 1-day seminar
on Medical Equipment Safety in about 20 medical colleges
and renowned hospitals across the country. During these
seminars, information on the current situation of medical
equipment safety practices was also sought from the participants through a questionnaire.
Achieving sustainability in the long run
These renewed efforts in the form of Workshops and consultation meetings helped in achieving the first step toward
creating an overall awareness regarding the need for good
HTM practices, safe use of medical devices and development of the CE profession in India. It was also an important
step forward in acknowledging that there were substantial
challenges associated with the management of healthcare
technology, the availability of clinical engineers and their
training and establishing effective medical device incident
reporting in the country.
Training of clinical engineers: Barriers
and opportunities
Almost throughout India, it is an established norm to provide engineering and medical education in separate educational institutions. This perhaps has led to the creation of a
knowledge barrier between these two professions. On the
one hand, healthcare systems, which are led by medical
professionals, have been rapidly adopting modern medical
technology, but on the other hand, realization for its effective management also requires a strong back up of highly
trained in-house CE professionals and this has been coming
up only lately.
Thus, in the absence of significant demand for formally
trained CE professionals, the education and training avenues
for them have taken a long time to come up. Undergraduate
and postgraduate programs in Biomedical Engineering
have remained focused on biomedical engineering research
Clinical engineering in India Chapter | 20
rather than CE training because the ‘engineering’ institutions offering these opportunities have remained distant
from the clinical environment.
High-level academic and training of
Clinical Engineers
In order to address the need for a formal high-level academic
as well as training program for CEs in the country, in 2008,
three premier academic institutes, namely, Indian Institute
of Technology Madras, Christian Medical College Vellore
and Sree Chitra Tirunal Institute for Medical Sciences
and Technology Trivandrum, jointly launched Masters in
Technology program in Clinical Engineering, the first of its
kind in the country.
In addition to conventional academic courses in Biomedical
Engineering, two unique training modules in the form of
“Clinical Attachment” and “Clinical Engineering Internship”
were introduced into the curriculum. This provided students
ample time to immerse themselves in the clinical environment
and thus, understand important practical aspects of patient
care. They could closely interact with the clinical professionals in various clinical departments as well as get involved in
the management of medical equipment through all stages of
its life cycle from procurement to disposal. They also got a
unique opportunity to identify “unmet clinical needs” and
propose innovative technology-oriented solutions.
Training avenues for Biomedical Equipment
Technicians
Training for Biomedical Equipment Technicians has been
made available by many institutions across the country in
private as well as public sector. These training programs include hands-on repair and maintenance of most commonly
used medical equipment. These programs have been either
short courses up to 6-month duration or 3-year state government recognized Diploma in Engineering Courses with
specialization in Medical Electronics. Organizations such as
HLL (formerly Hindustan Latex Limited) Lifecare Limited,
Trivandrum, Center for Advanced Computing, Mohali,
Center for Development of Imaging Technology, Trivandrum,
and Kerala Institute of Medical Sciences, Trivandrum have
been offering certificate courses of 6 months to 1-year duration. Some Universities offer an M.Sc. (Biomedical
Instrumentation) which allow successful candidates to take
up positions as senior BMETs or even CEs in hospitals.
Clinical engineering professional
activities
Clinical engineering community in India has remained professionally unorganized. On the other hand, recent widespread use of social media through smartphones has made
135
it possible for them to unite on such platforms. One such
platform is FORCE Biomedical, which has been recently
registered with the government as nonprofit organization
and has about 1000 members. Similarly, CEs and BMETs
have formed informal social media groups, which they use
for exchanging technical information.
Future of clinical engineering in India
Clinical engineering profession in India has been slow in
gaining recognition for all these years. However, recent
initiatives have provided momentum for its growth and in
order to sustain this growth, innovative approaches need to
be adopted.
One such approach could be providing CE exposure to
undergraduate engineering students by offering them long
term, that is, up to 6 months, internships in hospitals. These
internships would be compulsory and made part of their engineering curriculum. This would open up an opportunity
for these young engineers to gain the first-hand experience
of clinical medicine and witness how advances in technology have revolutionized today’s medical practice.
Regulation of CE profession through Certification by
a statutory body such as the Clinical Engineering Council
of India would help in ensuring that quality of this profession is maintained. A system for assessment of knowledge
and competency levels of existing CEs and BMETs working in hospitals will have to be worked out. In the same
way formal periodic assessments by this body would help in
achieving continuous professional development. These efforts will lead to ensuring that only best and competent CE
professionals remain in service.
Conclusion
The crucial role of CEs in providing effective and safe
health care is acknowledged world over, especially when
modern medicine continues to increasingly depend on use
of advanced medical technology. Clinical engineers are capable of addressing multiple issues in relation to the use of
advanced medical technology, thus can effectively complement the efforts of clinical professionals in providing highest standards of care.
In India, in spite of having highly trained clinical professionals, less attention is being directed toward the needs
of education, training, credentialing, and continuing professional development of CEs. This is perhaps reflected in the
appearance of multiple media reports on equipment associated with patient safety incidents. It is obvious that urgent steps need to be taken toward developing a strong CE
Profession in the country.
Recent renewed efforts described in this chapter have
helped in creating awareness and triggered interest among
the authorities in the healthcare systems by closely i­ nvolving
136 SECTION | 2 Worldwide clinical engineering practice
them in various events. These efforts need to be sustained
if the required change has to happen in near future. Many
more avenues for education and training of the CEs to the
highest and internationally accepted standards are needed
to satisfy the need of the country. A policy-level change is
warranted at the highest level of governance to trigger this
process.
References
APAC-VHS/Shiva Consultants, 2011. Utilisation of medical equipment
in public health facilities in Tamil Nadu: a pilot study. Unpublished
Report.
India Today, 2012. AERB’s sloppiness leads to flouting of radiation norms.
Kartikeya Sharma, New Delhi, September 10, 2012. http://indiatoday.
intoday.in/story/radiation-norms-aerb-diagnostic-units/1/216718.
html. (Accessed October 3, 2012).
Indian Express, 2009. Five infants burnt alive as incubator catches fire.
http://www.indianexpress.com/news/five-infants-burnt-alive-as-incubator-catche/417449/. (Accessed January 10, 2010).
Jacobson, Murray, A., 2011. Medical Devices: Use and Safety, Elsevier,
India.
Khambete, N., and Sable, S., 2012. Neonatal incubators: are new born babies really safe? IFMBE Proceedings 2013; 39. World Congress on
Medical Physics and Biomedical Engineering, Beijing.
Khambete, N., Kelkar-Khambete, A., Desurkar, V., Murray, A., 2010
.Safety of medical equipment: a review of hospital safety testing in
the Indian City of Pune, In: Appropriate Healthcare Technologies for
Developing Countries, Institution of Engineering and Technology,
London, pp 1–4.
Khambete, N., Kelkar-Khambete, A., Desurkar, V., Murray, A., 2012.
Safety testing of medical equipment in hospitals and its implications
for patient care in India. World Congress in Medical Physics and
Biomedical Engineering, Beijing.
Maya, 2013. Life-saving machines in medical colleges get no check-up.
The Hindu, http://www.thehindu.com/todays-paper/lifesavingmachines-in-medical-colleges-get-no-checkup/article5337476.ece.
(Accessed November 2, 2019).
Mehta, J., 2000. Why are our hospitals sick?. The Tribune, https://www.
tribuneindia.com/2000/20000308/health.htm#4. (Accessed November
2, 2019).
Nagarajan, R., 2015. 30-63% of Rs 10,000 crore medical devices faulty.
The Times of India. https://timesofindia.indiatimes.com/india/3063-of-Rs-10000-crore-medical-devicesfaulty/articleshow/46037018.
cms. (Accessed November 2, 2019).
National Accreditation Board for Hospitals and Healthcare Systems, 2015.
Accreditation Standards for Hospitals, fourth ed.
National Health Systems Resource Centre. NHRC Introductory Brochure. n.d.
http://nhsrcindia.org/sites/default/files/NHSRC_Introductory_Brochure.
pdf (Accessed November 2, 2019).
Sonawane, U., Singh, M., Sunil Kumar, J.V., Kulkarni, A., Shirva, V.K.,
Pradhan, A.S., 2010. Radiological safety status and quality assurance
audit of medical X-ray diagnostic installations in India. J. Med. Phys.
35 (4), 229–234.
The Hindu, 2008. Dismal state of medical X-ray safety. http://www.­thehindu.
com/thehindu/seta/2008/06/05/stories/2008060550081400.htm.
(Accessed October 3, 2012).
The Hindu, 2008. Two tragic deaths in two incubators. http://www.thehindu.com/2008/03/13/stories/2008031360440100.htm. (Accessed
January 10, 2010).
The Hindu, 2012. Editorial. Regulating hospitals is healthy. http://www.
thehindu.com/opinion/editorial/regulatinghospitals-is-healthy/article2889880.ece. (Accessed November 2, 2019).
Chapter 21
Clinical engineering in Poland
Ewa Zalewskaa, Tadeusz Pałkob
a
Nalecz Institute of Biocybernetics and Biomedical Engineering PAS, Warsaw, Poland, bInstitute of Metrology
and Biomedical Engineering, Warsaw Technical University, Warsaw, Poland
Development of clinical engineering in
Poland
Clinical (also named medical) engineering and medical
physics in Poland have the common roots in the Radium
Institute established in Warsaw in 1932, thanks to the initiative of Maria Skłodowska-Curie, the Nobel Laureate in
1903 and 1911. The assistant and collaborator of Maria
Skłodowska-Curie, Prof. Cezary Pawłowski has founded in
1934 the Physics Department of the Radium Institute and
organized first courses on medical physics and biomedical
engineering. After the World War II, in 1946 graduate studies were started at the Warsaw University of Technology, as
the world’s first regular academic courses in electromedical
engineering, organized by Prof. Pawłowski. Later on, Prof.
Pawłowski, Prof. Juliusz Keller, and Prof. S. Nowosielski
started the multidisciplinary program of the study, which
consisted of electrical engineering, basic knowledge in
medicine, and radiology. The graduates have started collaboration with medical doctors in clinics as well as in the
construction of medical equipment.
In the early 1960s, the first medical engineering laboratories in medical clinics were organized. The engineers
and technicians were responsible not only for service,
maintenance of medical equipment but also took part in
the diagnostic examinations supporting the physicians. The
first engineers at that time were Józef Cywiński, Andrzej
Karliński, Tadeusz Pałko, and Jerzy Kopeć who have organized technical teams in clinics.
In 1993, Prof. Pałko, the formal representative for Ministry of Health qualified, was invited to
Massachusetts, Boston, USA by the American College
of Clinical Engineering (ACCE) and WHO on Advanced
Clinical Engineering Workshop to Wentworth Institute of
Technology (WIT), and for three hospital visits: in Albany,
NY, USA; in Charleston University, SC, USA; and in
Stony Brook University, NY, USA. Results of the workshop were discussed and analyzed in several meetings in
the Committee for BME of Association of Polish Electrical
Engineers (SEP; Stowarzyszenie Elektryków Polskich in
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00021-3
Copyright © 2020 Elsevier Inc. All rights reserved.
Polish) that contributes to the development of medical engineering association in Poland.
During years of activity in this field, the group of specialists was growing and in 1965 the Polish Society of
Medical Physics was founded. The organizer was Prof.
Oskar Chomicki who later on became the president of the
International Organization for Medical Physics (IOMP).
The society has its own journal since 1966. Firstly, Postepy
Fizyki Medycznej (in Polish) and since 1995—Polish
Journal of Medical Physics and Engineering. This society
was a common assemble of medical physicists and engineers up to 1999 when the Polish Society of Biomedical
Engineering was founded. In parallel to the activity of the
Polish Society of Medical Physics, the medical electronic
group was established in Electronics Section of SEP (organized by Prof. Keller) in 1971 and then was transformed
into the Committee of Biomedical Engineering of SEP in
1977. This committee was affiliated to the International
Federation of Medical and Biological Engineering (IFMBE)
in 1985 as Polish Scientific and Technical Committee for
Biomedical Engineering of SEP in which medical engineering education and its clinical application are analyzed
among other things.
Education
Education in BME started in 1946 at Warsaw University
of Technology, and is still continuing till today. It has
been later modified and developed at several universities.
Actually, 16 high schools offer education in this field and
more than 20 are working in this area. Until the academic
year of 2005–2006, education in BME was a speciality for
the existing fields of studies, such as electronics, mechanics, materials engineering, automatics or mechatronics.
The development of new medical technologies required
a new approach to BME education. The program of education has been changed several times and finally a new
field of studies has been established, called “Biomedical
Engineering”. The BME teaching meets legal regulations
including national standards for academic teaching set out
137
138 SECTION | 2 Worldwide clinical engineering practice
by the Ministry of Science and Higher Education and according to the guidelines of the Bologna Process (including the Educational Credits Transfer System). The quality
of education is assured by the accreditation of universities
and their study program together with the standardization
of program minimum enables the mobility of students between universities. The current program offers the first degree (engineer), the second degree (MSc), and third degree
study (PhD).
Specialization in medical engineering—
The postgraduate education
The regulation of Minister of Health has in 2002 introduced the specialization in medical engineering as a profession in clinical environment (for engineers and medical
physicists), similar to that in medical education system.
The postgraduate education program in medical engineering, as well as medical procedure using technical means,
is being implemented under the auspices of the Ministry
of Health, the Medical Center of Postgraduate Education,
and the National Consultant in the field of medical engineering. The postgraduate study takes 2–3 years, including practice in various clinics. Institutions providing
the training are accredited by the State Commission for
Accreditation and should have appropriate facilities
for training, experiment, and competent staff as well as
adequate medical equipment. The aims of medical engineering’s specializations are to provide the practical
experience, extend the trainees’ knowledge, and maintain
research awareness. The candidates for this specialization
are obliged to have MSc degree in one of the following
fields: BME, automatics and robotics, mechanics, electronics and telecommunications, electrical engineering,
computer science, and to be employed at least 1 year in
clinical environment. The training comprises 1700 working hours. Study structure consists of lectures (700 h),
laboratories and seminars (200 h), and practical trainings
in hospitals (23 weeks = 800 h). The training program contains 10 modules: (1) basic medical knowledge, (2) biomechanics and rehabilitation engineering, (3) fundamentals
of medical electronics, (4) radiological devices and radiation protection, (5) automatics, robotics, and healthcare
telematics, (6) signal processing, modeling, and medical
informatics, (7) electrography, intensive care instrumentation, and laboratory equipment, (8) computed tomography
[X-ray computed tomogram (XCT), magnetic resonance
imaging (MRI), single photon emission computed tomography (SPECT), positron emission tomography (PET)],
and ultrasound sonography (USG), (9) biomaterials and
artificial organs, and (10) clinical engineering regulatory
and organization issues.
The current state of specialization/
certification
The education in BME field has produced up until now
4000 graduated engineers. Some of them have started working in hospitals to complete 1-year practice necessary to begin specialization course. There are 10 persons nominated
by the Minister of Health as specialists to serve as a staff to
lead the specialization courses.
The program of planning to realize the specialization in medical engineering area at Warsaw University of
Technology was modified by using e-Learning platform
(lectures, seminars, and some practical training). Two
academic years of the specialization course are divided
into four 16-week long semesters. Each semester consists
of eight working meetings (Saturday and Sunday) with
2 weeks of examination session (two meetings). The course
is completed by a State Exam (The State Examination
Commission) consisting of a practical and theoretical part
authorized by the Medical Examination Center. The graduate obtains the diploma granting the title of specialist in
Medical Engineering area. Professional competence gained
during postgraduate education entitles to work in a clinic as
a medical engineer or clinical resident.
In 2017, new regulations related to the specialization in
health care were released by the Ministry of Health, namely:
the Act from February 24, 2017 on obtaining a title of specialist
in fields applicable to health care [Journal of Laws (JL)—from
March 20, 2017, item 599] and Regulation of the Minister of
Health from June 13, 2017 on specialization in fields applicable to health care (JL from June 29, 2017, item 217).
CE authorities
There is a very important role of the national consultant in
medical engineering at the Ministry of Health that coordinates this activity. The regulation of the Ministry of Health
introduced also the formal positions for medical engineers
as consultants, i.e., national consultant and regional consultants. The consultants have several duties and permissions
such as carry out supervision of the postgraduate education,
perform tasks asked for opinion, advice for state administration, take part in the work of the commission for the
implementation of health policies, control of the quality of
medical equipment in health care, opinions on the evaluation of human resources with respect to medical engineers,
and to give an opinion in the field of medical devices.
Following this, in 2012 we have started new journal,
Inzynier, fizyk medyczny in Polish (Engineer, Medical
Physicist) dedicated to medical engineers and physicists, as
well to physicians working in hospitals, who deals mainly
with practical procedures and problems such as safety of
Clinical engineering in Poland Chapter | 21
medical equipment, introduction of new technologies, and
postgraduate education in medical engineering.
In conclusion, it should be underlined that the main purpose of introducing specialization of medical engineering
as a profession in clinical environment is to improve the
quality of health care in hospitals. Structure of education
program of medical engineering specialization in Poland
has been prepared according to medical needs, Bologna
Declaration, IFMBE recommendations, and practical
possibilities.
Further reading
Ministry of Science and Higher Education, 2007. Educational Standards
for Higher Education, No 49 Biomedical Engineering (in Polish).
139
Palko, T., Golnik, N., 2005. Quality assurance in the Polish higher education system and the influence of the Bologna Process. In: BIOMEDEA
II Conference, April 15–17. International Centre of Biocybernetics,
Polish Academy of Sciences, Warsaw. http://www.ibibwaw.pl/
Biomedea.
Palko, T., Golnik, N., Pawlicki, G., Pawlowski, Z., 2002. Education on
biomedical engineering in Warsaw University of Technology. Polish J.
Med. Phys. Eng. 8 (2), 121–127.
Wasilewska-Radwanska, M., Palko, T., 2011. Medical physics and engineering education and training. Pt. 1, In: Tabakov, S., et al. (Eds.),
Actual State of Medical Physics and Biomedical Engineering
Education in Poland. Abdus Salam International Centre for Theoretical
Physics, ICTP, Trieste, ISBN: 92-95003-44-6, pp. 159–165.
Zalewska, E., Palko, T., Pawlicki, G., 2014. Medical engineering in Poland.
In: Lackovićand, I., Vasić, D. (Eds.), IFMBE Proceedings. vol. 45.
Springer International Publishing Switzerland 2015, pp. 967–969.
Chapter 22
Clinical engineering in Australia
Adrian Richards
Biomedical Engineering, The Women’s and Children’s Health Network, Adelaide, SA, Australia
The practice of clinical engineering (CE) within Australia
has a long, respected history and is seen by other h­ ealthcare
professionals as being a significant contributor to the delivery of patient care. With responsibility being primarily
centered around health technology management (HTM),
CE practitioners are typically well educated and demonstrate a level of skill and independence that comes from the
country’s isolation from the major manufacturers of health
technology. With the size of the country and its sparse population, there is also often a degree of isolation from their
own peers.
The birth and growth of the profession
CE, be it under many different titles, can trace its history
back to the late1960s when medical professionals were
starting to introduce a range of new technologies into their
practice, which required technical support for their continuing operation. Engineers and technicians were employed
by individual clinical departments within large hospitals to
either be responsible for the operation and maintenance of
what was seen as highly complex electronic equipment or
developing new technologies in conjunction with their medical colleagues. Often there were significant attachments
or links with university departments, perhaps medicine or
physiology.
People working within this newly emerging profession may typically have had an education in electronics,
with others having mechanical skills from a background
in a range of trade-based vocations. Clinical departments
typically determined the mix of support essential to keep
their new equipment functioning and what they required in
terms of development or modification equipment. As this
technology became more mainstream, CE staff tended to
migrate out of what was their home clinical department
and into a consolidated service that provided support to a
broader clinical audience within their hospital. In the early
1970s, a significant number of large hospitals within the
capital cities contained a CE department, however, it may
well have been known as Medical Electronics or something
similar.
140
At the same time, concerns were growing over the risks
to patient safety that this plethora of electrically powered
equipment posed to patients to whom it was attached. There
are outstanding examples during the time of landmark research being undertaken in areas such as the determination of electrical current thresholds for cardiac fibrillation.
Australia’s long history of significant involvement in the
development of electrical safety standards, both local and
international, was also triggered at this point; an outstanding legacy that remains intact to this day.
In the March 1971 edition of Ladies Home Journal,
USA-based consumer and political activist Ralph Nader
described his view on the number of accidental deaths by
electrocution that were occurring in healthcare facilities in
the United States. This article provided an added catalyst to
the electrical safety movement, CE had arrived, remaining a
growth industry within the country for many decades.
The environment
To fully appreciate how CE evolved and how it came to
be practiced, the healthcare environment in which it is delivered must be understood. In Australia, the delivery of
hospital-based health services takes place predominantly in
government-owned and operated hospitals. These have been
funded since 1984, at least partially, by a tax that is levied
on the wages of all Australians within a system known as
Medicare. Under this scheme comprehensive hospital care
is provided to everyone with minimal out of pocket expenses, but no choice of treating practitioner.
There is a private healthcare system that runs in parallel
with the public one for people who wish to choose their doctor and not be subjected to the often-lengthy waiting lists in
the public system. These private facilities may be owned by
either profit-making or not-for-profit organizations, perhaps
a religious order. However, around 70% of all hospital beds
within Australia fall into the government-run category, a sector that provides an even greater proportion of tertiary hospital
services. Public hospitals are typically associated with universities which provide training on their behalf for medical, nursing, and allied health under and postgraduate students.
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00022-5
Copyright © 2020 Elsevier Inc. All rights reserved.
Clinical engineering in Australia Chapter | 22
This publicly funded system results in the major proportion of CE practice taking place in large, government, and
tertiary teaching hospitals. There are relatively few private
hospitals that provide the same levels of service or house
equivalent levels of technology. A typical tertiary hospital within a capital city may comprise 300–700 beds, but
the widely distributed population in the regional areas of
Australia see this also range down to small country towns
with a basic facility of only a few dozen beds, many hundreds of kilometers distant from a sizable city. This certainly poses challenges for the delivery of CE services.
The clinical engineering role and function
CE departments most commonly perform a HTM function.
They will have substantial involvement in equipment planning, purchasing, and commissioning. This then extends
to management of technologies during their working life,
meaning that repair and routine testing becomes a day to
day staple activity. The management of hazards and recalls
is integral to this often-involving liaison with the Australia’s
medical device regulatory agency, the Therapeutic Goods
Administration.
Effective performance of these functions is facilitated
by the widespread use of comprehensive asset management
databases and all CE departments will have a system in
place. The activities of the USA-based not-for-profit ECRI
Institute are well known and highly regarded. A limited
number of CE departments will play a role in medical device research and development, perhaps via close affiliation with a university. However, the healthcare system, in
general, is under great financial pressure and this can transfer directly down to CE operations, driving departments toward their service provision being based more around core
services with research not being considered in that category. Very much consistent with global trends, the merging
of Biomedical and Information Technologies is relentless
and the way that this is handled is very much a local issue. It is fair to say that many CE departments struggle
with managing this phenomenon, but there are also other
examples that excel.
The governance structures into which CE Departments
exist vary from state to state, city to city, and hospital to
hospital. There is one of Australia’s eight states and territories that run a centralized, statewide service, while others
have departments in hospitals that run autonomously and
hybrids also exist in between these two extremes. There
is no consensus on which model produces the best outcomes, every variation on the theme has its advantages and
disadvantages.
The larger of the privately run hospitals may directly
employ CE staff, but they may also source services from
the third party contracted providers. There are a small
number of these independent providers that operate
141
n­ ationally and a greater number that will offer services
locally within a capital city or a region. The large vendors of medical technology will employ their own technical support staff, but it is debatable as to whether these
would be classified as CE as their roles are very focused
and product-specific.
Australia has a strong collection of standards, both locally developed and harmonized international publications
that provide the framework for service delivery. In particular, the joint Australian and New Zealand standard AS/
NZS 3551 entitled “Technical Management Programs for
Medical Devices,” voluntary in its application is upheld as
the defining document and referenced by hospital accreditation authorities. The legislated requirements are very little
when it comes to CE practice and regulation of medical devices and are exclusively around their sale and use and does
not extend to their service, support, or management.
The workforce
CE practitioners are a mix of professionally and technically
qualified staff that work side by side in close collaboration
as in many cases their academic background being transparent. Those that are professionally qualified, considered to be
the holders a 4-year university degree, tend to find their way
into positions of management as well as fulfilling roles that
focus on technology planning and assessment, specifying,
procuring, or involved in the more consultative application
of their skills and experience. It is estimated that approximately 30% of the total workforce fall into this category,
with the balance being technical staff who provide highly
skilled, hands-on expertise. The academic qualifications of
this group comprise mainly vocational level, or “Associate
Degree” style of awards complemented with substantial on
the job training.
Universities in almost all Australian capital cities offer undergraduate degree programs in biomedical engineering, but these do not have a CE focus. They tend to
provide more generalist programs that may have some
medical device content, but equally may specialize in
biomechanics, rehabilitation engineering or some of the
other biomedical engineering subdisciplines. The majority of these will have a basis in electronic or electrical engineering, but the focus of some may also see them with
a mechanical engineering core. Similarly, there ­exists a
healthy offering of postgraduate and research ­options,
which takes the focus even further away from CE. At the
technical level, there is a serious lack of specific clinical or biomedical engineering course options limited
to only two or three within the whole country. This has
been identified as a gap, with most workers within this
vocational category studying electronic engineering,
developing their CE skill over time with on the job or
vendor-provided training.
142 SECTION | 2 Worldwide clinical engineering practice
Due to the remote nature of Australia from the medical device manufacturing centers in the United States and
Europe (virtually no medical manufacturing industry within
Australia), CE practitioners have always tended to develop
high levels of skills resulting in the ability to support technology with a degree of independence. There is little in the
way of real-time vendor factory support, and while the vendors or their agents have a good depth of product support,
they also rely on factory backup that can often have significant delays.
In terms of professional formation and development on
the completion of academic studies, this is an area that is
not well provided anywhere within the country. There is a
distinct lack of internship style of opportunities or formal
mentoring that results in challenging conditions for recent
graduates that are seeking employment with little practical
experience.
Other groups exist to provide development and networking opportunities for clinical engineers and other
like-minded people. There are Societies for Medical and
Biological Engineering (SMBE) in most states with membership requirements that provide membership for many
different clinically related professions, including clinicians,
managers, and vendor representatives. These groups have
existed in most states of Australia for more than 50 years
since the very genesis of the profession. There are also other
organizations either based or with a presence, in Australia,
with the Australasian College of Physical Scientists and
Engineers in Medicine (ACPSEM) and the Institute of
Electrical and Electronics Engineers (IEEE) with its
Engineering in Medicine and Biology Society (EMBS) being the most prominent.
Professional association
There is little doubt within the Australian CE profession
that there are challenges to be faced. It is a simple fact
that the merging of BME and information technologies
(IT) is set to continue. The boundaries of responsibility will need to be defined, the CE skill set must diversify and working collaboratively must become the norm.
Educational programs are beginning to acknowledge this
with course content expanding appropriately. The CE
services that embrace this and make the most of the opportunities that it presents will be the ones that prosper
and grow.
The question of whether CE should be registered to
practice is a debate that is on the horizon, but the serious
discussion is yet to be had. The voluntary nature of existing registration systems results in having little uptake.
Legislation requirements will almost certainly be statebased with there being little hope of a consistent approach
across the country emerging. The movement toward legislation could possibly be employer-driven, but there are no
real signs of this happening and with governments being the
largest employer of CE, the landscape is not set to change
any time soon.
Early career and ongoing development opportunities
have room to grow. The availability of internship programs
would enable the profession to take a step forward and assist with producing the next generation of work-ready CE.
This applies at both the technical and professional levels,
but in a healthcare system that is under financial pressure,
the focus is all too often on the “here and now” rather than
the future.
Challenges aside, the CE profession will continue to
work side by side with other professionals on the ­healthcare
team and add measurable value to the provision of care. The
inherent rewards that come from playing an active role in
patient care, treatment, and diagnosis will always remain
strong and continue to set CE apart.
Many people working within the CE workforce seek opportunities for professional development. The primary professional body for the provision of this is Engineers Australia.
This is a multidisciplinary organization that represents all
engineering disciplines, maintaining the specialized bodies
of knowledge by way of a series of colleges.
Amongst its 100,000 members, less than 500 are members of the biomedical college, however despite the small
number they are considered to be active and progressive.
College membership is open to people qualified at all academic levels, not restricted to those with professional degrees. There are no requirements for entry into a college
beyond one’s academic qualification, with biomedical college membership not requiring a specific biomedical qualification or examination, simply the need is to be practicing
in the field.
Engineers Australia also has a range of high-level activities and responsibilities that include the accreditation
of engineering courses and the entering into international
accords that facilitate global recognition of engineering
qualifications. Engineers Australia hosts a national register of engineers, the National Engineering Register which
individuals can use as a form of recognition, but it is not
required for practice within any Australian jurisdiction.
Members of the biomedical college are internationally affiliated with the International Federation for Medical and
Biological Engineering (IFMBE).
The college provides professional development for the
full range of biomedical engineering subdisciplines through
a series of committees. The National Committee for CE
caters to the needs of clinical engineers. As part of its provision of continuing professional development, the college
convenes a National Annual Conference that has broad biomedical engineering coverage, including CE.
The future
Chapter 23
Clinical engineering in Chile
C. Guillermo Avendaño†, Luis Danyau
School of Biomedical Engineering, University of Valparaiso, Valparaiso, Chile
Introduction
This paper aims to provide background information on the
development of clinical engineering (CE) activity in Chile,
considering facts or historical milestones, the education and
training of professional and technical personnel, as well as
the impact they have had on the current situation of health in
Chile; in which there are specialists formed in the practical
and theoretical aspects of the specialty, as well as the contribution of the knowledge acquired through international linking. The historical milestones related to the implementation
of modern technology and its correlation with the growing
competencies of the professionals who select, acquire, install, maintain, and evaluate their performance are analyzed.
Historical analysis
For analysis purposes, we define some phases of the incorporation of technology in the health sector in Chile:
(1) First phase (1940–60): Initial incorporation of technology in the field of health, corresponding to the global
emergence of biomedical equipment, parallel to the
development of electronics in the world. In this period,
some diagnostic devices are used, such as electrocardiographs, electroencephalographs, audiometers, X-ray
equipment, and other therapeutic devices such as stimulators and diathermy equipment, as well as clinical laboratory equipment and sterilization technology.
(2) Second phase (1970–80): Massive incorporation of
computer technology occurs worldwide. In this phase
there is a great diversity of technology in all specialties
with a preponderance of electronics, especially digital
and big development of diagnostic imaging.
Regrettably, this world development does not have an
equivalent correlate in Chile, except in some private or
military health institutions, due to the period of the military dictatorship, when there was a drastic reduction in
public health budgets in all fields and the stagnation of
the development of technology applied to health.
†
Deceased
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00023-7
Copyright © 2004 Elsevier Inc. All rights reserved.
(3) Third phase (1990–2000): The application of multitechnology in health care was the most important
achievements of science and technology in all fields
of knowledge (precision mechanics, computer science,
electronics, physics quantum, biotechnology, materials
sciences, etc.). This forced the authorities in Chile to
make high disbursements (PAHO, 2017a) both to overcome the comparative lag generated in the two previous decades, and to incorporate the latest technological
achievements.
This situation brought as a consequence greater demand
for specialization, resources, and knowledge of any era.
The importance of biomedical engineering, clinical engineering, and the need to professionalize technological
management in the world of health care was discovered.
(4) Fourth phase (2000–to date): This is the current stage,
characterized by the incorporation of multimodal technology and optimization in the management of technology. CE appears as a discipline of study in the academy
and also of systematic application in some health institutions. The study and the evaluation of the technologies
in health HTA (health technology assessment), the first
attempts of certification of devices, and the accreditation of institutions begin. This phase in Chile is also
characterized by the construction of new public hospitals (MINSAL, 2017), at a level never seen in its history.
The previous situation
As in other countries, the initial activity of what is now
known as CE was initially developed with the following
characteristics:
(a) It was carried out in a predominantly empirical way and
by professionals not trained in the concepts and methodologies of CE.
(b) It was developed without strategic planning by national
or regional authorities.
(c) The work is carried out by personnel close to the specialty (such as electronic, mechanical, or industrial en143
144 SECTION | 2 Worldwide clinical engineering practice
gineers), but without specific knowledge of biomedical
engineering or CE application methodologies.
(d) The issue of equipment, its management, and everything
related to these devices were considered “medical issue,” especially regarding the acquisition of equipment
and systems.
(e) The calibration, maintenance, and other activities related
to medical equipment were performed in a deregulated
manner and without institutional certification. There
was no preventive maintenance and less predictive.
(f) There was no correct allocation of financial resources,
maintenance budgets were always lower than the minimum required for a basic condition of availability.
(g) The existence of a CE unit or department in the hospitals
was not conceived, but an emergency repair workshop
and a person in charge of contacting the suppliers maintained the equipment they supplied.
One of the adverse consequences of this situation is the
phenomenon of having many damaged equipment, equipment purchased but not installed, technologies that become
obsolete due to lack of use and in general a condition of
waste that makes evident the need to have people specialized in all aspects of technology management.
In this context, the first university career in biomedical
engineering emerged, with a strong CE component that began in 2000 in Chile at the University of Valparaíso and
was followed at 6 years by the University of Concepción
with a curricular orientation of much less interest in the CE
(Carrera de Ingeniería Civil Biomédica U de Concepción,
2017).
Global CE in Chile before 2000
The CE developed in Chile is generally subrogated, that is,
awarded to the companies that supply biomedical equipment, this phenomenon was more intense in the past than
at present, since there was not enough competent personnel
to achieve the initial intervention in subjects related to biomedical equipment, management, and evaluation.
The performance of the professional and technical staff
was based on the policy of solving problems with commonsense prioritization or prioritization of greater urgency, this
is known as hospital jargon, such as work of “firefighters,” that is, extinguishing fires to the extent that occur, in
such a way that the culture installed in the Maintenance
Departments or General Services of the hospitals was to act
by remedying problems as they appeared and with the criterion of acting immediately on the most critical, leaving
aside less urgent tasks.
The aforementioned prioritization eliminated the
planned management, for that reason there was no preventive and less predictive maintenance, only corrective intervention in case of failures or disqualification of the devices
for some technical or lack of consumable supplies reason.
In this context, hospital safety was unknown as a global
concept and no planned or organized measures were implemented to establish a culture of risk prevention and hospital
safety.
CE situation at the start of the career in the University
of Valparaíso
The development of teaching in CE was facilitated in
Chile due to the existence of training and development
niches, some sponsored by the Ministry of Health and others of a private nature.
Favorable conditions also occurred due to the existence
of some specialists with high experience (concentrated in
central regions of the country, most of them trained in foreign countries and with outstanding work experience).
Another contributing factor was the existence of other
universities interested and involved in the subject of biomedical equipment of different magnitude. Like the
University of Chile, the University of Santiago, Chile
(USACH), Universidad Católica de Chile (UC), and Arturo
Prat University of Iquique.
Also the international organizations IFMBE (International
Federation of Medical and Biological Engineering), IEEE
(Institute of Electrical and Electronics Engineers), ACCE,
CORAL (Compact Reprocessing Facility for Advanced
Fuels in Lead Cells), WHO (World Health Organization),
PAHO (Pan American Health Organization), UNESCO
(United Nations Educational, Scientific and Cultural
Organization), and ECRI (Emergency Care Research
Institute) were interested in supporting and helping Chile.
In this context, more interinstitutional relations were developed with other universities, ministries, consulting companies, medical equipment companies, and service.
Hospital safety situation
An aspect of first importance in the training of clinical engineers, at the University of Valparaíso, is the study of hospital safety, understanding this topic as the theoretical and
practical study of all aspects of functionality and the operation of the systems at the service of the patient, excluding
the architectural aspects, that is to say, those related to the
prevention of catastrophes incorporated into the design and
construction of health institutions are not studied, that is,
earthquakes, tsunamis, river floods, avalanches, cyclones,
and others, all of which is outside the study of the clinical
engineer because it is not his competence.
Hospital safety training
The topics that are included in the training of clinical engineers are biosecurity and prevention of intrahospital infections, safe handling of medical gases, radiosafety and
radiological protection, electromedical safety, electromagnetic safety, technological measures against fires, and safety
in the handling of hospital waste.
Clinical engineering in Chile Chapter | 23
It has managed to create a safety culture to impact the
world of health, so that the combination of direct teaching
in the subject, the implementation of dissemination events,
and the implementation of measures by graduates who are
included in the hospital world, has allowed to improve behaviors and reduce events, which is notorious in terms of
better management of hospital waste (Castillo and Brulé,
2010) and the growing implementation of electromedical
safety in the country (NCH 2893/14. OF2004, 2004).
Current situation of CE professionals, activities,
safety programs provided by them,
and positive and negative effects
The group of professionals trained academically in CE
have been gradually incorporated into work in hospitals,
regulatory bodies, and entities dependent on the Ministry of
Health, so that in general terms their competences are a positive contribution for the management of technologies, for the
certification processes, and to have an impact on the effectiveness of investments in technologies in general, however
these activities are not coordinated by any central entity in
charge of planning and making work more efficient.
These limitations result in the fact that the CE in Chile
is a very uneven activity between entities that have professionals, financial resources, and instruments and those
that continue working with the old style of responding to
emergencies and not being able to plan and organize their
activity. On the other hand, the ignorance of the theory of
the CE causes nonexistence of some fundamental activities,
for example, the studies of the availability and reliability of
the technologies that are acquired and incorporated into the
medical and surgical practice.
Chile does not have a college of clinical engineers that
has to do with professional ethics, the improvement of
performance conditions, and the monitoring of the professional relevance of those who carry out activities considered as CE. We only have a National Society of Biomedical
Engineering (SOCHIB) that has a more scientific than a
professional or union sense.
In summary, the contrast between the health centers of
any level that have specialists in CE and those that do not
have them is very noticeable.
The performance of professionals trained in CE is hampered by the fact that there are no technicians trained in
institutions who provide specific content related to biomedical technology, there are only training schools for
electronic, mechanical, and electrical technicians, who in
practice learn by doing and its theoretical deficiencies are
the main limitation for the optimization of the processes in
the world of health.
A consequence of this situation is the fact that many biomedical engineers are performing tasks that should be done
by senior technicians.
145
Fortunately, high demand of professionals trained in CE
has allowed the incorporation of practically all university
graduates into the hospital and technology management
world, without the necessary allocation of jobs, specified
and regulated in the professional ranks of the Ministry
of Health. Efforts are being made to legislate this in the
Chilean Parliament to position the biomedical engineers
(as clinical engineers) with full authority and with a law
that will give them jobs, in each and every health centers
of certain level of importance. Another shortage detected
and highly necessary is to be able to have forms of updating
in new methodologies, that is, it is necessary to carry out
refresher courses for the professional personnel who work
in management activities, regulation, and hospital design. It
would be highly convenient for the concurrence of international entities to conduct courses in Chile and diploma with
specific themes of the modern CE.
Current needs for knowledge, regulations,
and support for CE professionals,
and certification programs
In the current situation of development of the CE in Chile,
it is necessary to install the concept of strategic planning
and even more to achieve the systemic organization of the
technological implementation related to health.
It is necessary to link academic programs with government programs such as National Normalization Institute
(INN) (2017) and certification activities of the Institute of
Public Health (ISP) (2017), and Chilean Commission of
Atomic Energy CCHEN (2017).
Also, specialists in CE are included in the work teams of
the organizations dedicated to the certification of hospitals
and the planning of new hospitals.
As previously stated, it is necessary to create conditions
for certification through international organizations that
grant it and thus raise the professional level of Chilean clinical engineers and optimize the results of their management
in the field of public and private health.
Type of CE structure in the country (centralized
or individual CE centers)
In Chile there are CE activities in most of the hospital institutions exercised by professionals with different levels of
training, most of them with practical experience and basic
theoretical training, while the minority has a university education in this field, on the other hand the Ministry of Health
has a body called ISP is in charge of the national regulation
of devices and equipment. This body and the INN are in
charge of the technological surveillance related to the certification and compliance of the application of standards.
There are also two semiautonomous entities that are responsible for training and execution of projects. One is the
146 SECTION | 2 Worldwide clinical engineering practice
Center for Hospital Technology (CTH) (2017) dependent
on the University of Valparaíso that collaborates with the
implementation of equipment in new hospitals, technical
investment, purchasing, planning, training in electromedical safety, training courses for medical and paramedical
personnel in hospital technology issues and everything
related to training for technology user personnel. The
other body is the National Commission ETESA (Empresa
de Transmision Electrica SA) (ETESA, Comisión de
Evaluación de Evaluación de Tecnologías de Salud, 2017),
Health Technology Assessment Group, entity in charge of
carrying out HTA studies of critical devices; its function is
currently oriented toward economic studies and does not
have enough personnel or technological resources to make
technical clinical studies of the devices that evaluate their
efficacy.
Between 1990 and 2000, Training and Technology
Management Center in the city of Temuco, under the
Ministry of Health (MINSAL) with support of the German
project PROINGSAL carried out training activities for all
technical personnel in various specialties; currently it is
deactivated.
Level of complexity of the service provided
by CE (IT, security programs, education, cost
control, forensic, etc.)
Currently the dominant activity in the world of the CE in
Chile is the management of technology in its most primary
forms, however eventually higher competencies are required for tasks of greater importance.
Among the most relevant is the need to provide adequate
maintenance to medical equipment of greater criticality
and more abundant in the hospital setting. To this end, a
National Maintenance Plan has been created for the first
time, focusing on public hospital teams belonging to the national network of the MINSAL (PAHO, 2017b). This plan
has been discussed by the professionals involved in CE of
the aforementioned network during the two last years and
finally in 2017 has been legally sanctioned. The triggering
factor of this important milestone has been the high demand
for the organization and execution of maintenance policies
produced by the large number of new hospitals (21 finished,
21 under construction, and 16 in tender) (Plan Nacional De
Inversiones Minsal Chile, 2017) that have been installed
throughout the Chilean geography.
Corresponding to the above, there is the need to
strengthen the tasks of device certification, which has been
initiated with great interest by the current government and
MINSAL, which through the ISP has created a department
to initiate these activities on a scheduled basis and with certain human and financial resources.
Finally, in this area, we have an incipient activity of technological vigilance in which some clinical engineers participate, with the mission of organizing a national network
that allows registering all types of adverse events caused
by the deficient technology and creating an instance of registration, inventorial, and feedback to manufacturers, with
the purpose of correcting design, improving manufacturing
methods, and ultimately reducing the incidence of adverse
events that would affect patients and health workers.
The expectations of the general society and the
professionals of the CE for the future
The topics that have been discussed (III Jornadas Chilenas
de Ingeniería Biomédica, 2017) among the professionals,
who currently work in the field of the CE, have in summary to consider the future development of the following
activities:
●
●
●
●
●
●
●
●
●
Transversal standardization of health and technology
applied to it.
Education and training at all levels, professionals, technicians, and especially paramedical personnel who use
the equipment.
Creation of institutions of continuous training and updating of professionals.
Total organization of technology management activities,
such as inventories, nomenclatures, acquisitions, bids,
and technology safe withdrawal protocols.
Maintenance with high productivity and reliability.
Development of a transparent and viable policy in relation to hospital safety.
Optimization of the relationship between the incorporation of technology and an adequate development of
hospital infrastructure.
Intensive and extensive incorporation of ICT (information and communication technology) and growth of telemedicine applications.
Development of own biomedical technology
applications.
References
Carrera de Ingeniería Civil Biomédica U de Concepción, 2017. http://
www.ing.udec.cl/Carrera/ingenieria-civil-biomedica. (Accessed 28
November 2017).
Castillo, C., Brulé, R., 2010. Guía de Seguridad Hospitalaria contra
Incendios para el Diseño de Establecimientos Hospitalarios Edit.
Universidad de Valparaíso, Valparaíso.
CCHEN Comision chilena de Energia Nuclear, 2017. http://www.cchen.
cl/. (Accessed 28 November 2017).
CTH. Centro de Tecnologías Hospitalarias, 2017. http://www.cthchile.
com/web/. (Accessed 05 December 2017).
Clinical engineering in Chile Chapter | 23
ETESA, Comisión de Evaluación de Evaluación de Tecnologías de Salud,
2017. http://web.minsal.cl/etesa-comision-nacional/. (Accessed 05
December 2017).
III Jornadas Chilenas de Ingeniería Biomédica, 2017. http://www.jcib.cl/.
(Accessed 05 December 2017).
INN, Instituto Nacional de Normalización, 2017. http://repositorio.conicyt.
cl/handle/10533/111644?show=full. (Accessed 30 November 2017).
ISP Instituto de Salud Pública, 2017. http://www.ispch.cl/. (Accessed 28
November 2017).
MINSAL, 2017. Plan Nacional de Inversiones Hospitalarias: Gobierno asegura cumplimiento de compromiso presidencial. http://web.minsal.cl/plannacional-de-inversiones-hospitalarias-gobierno-asegura-cumplimientode-compromiso-presidencial/. (Accessed 28 November 2017).
NCH 2893/14. OF2004, 2004. Equipos electro-médicos: -parte 1- requisitos generales de seguridad—norma colateral 4: sistemas electromédicos programables Santiago.
147
PAHO, 2017a. Diseño e implementación de una metodología de evaluación, seguimiento y acompañamiento de la reforma de la salud de
Chile. http://www.paho.org/chi/images/DOC_WORD/reporte%2520v
f%2520octubre%25202011.doc%3Fua%3D1&sa=U&ved=2ahUKE
wjYmLXo1OvlAhXJ7nMBHc2HBOYQFjAAegQIAxAB&usg=AO
vVaw3IXLaFdR_QQnZGsMSyM3f2. (Accessed 23 November 2017).
PAHO, 2017b. Redes integrales de servicios, el desafio de los hospitales Representación de la OPS/OMS en Chile, PAHO OMS. http://
www1.paho.org/chi/images/PDFs/redes_integrales_de_servicios.pdf.
(Accessed 05 December 2017).
Plan Nacional De Inversiones Minsal Chile, 2017. http://plandeinversionesensalud.minsal.cl/. (Accessed 05 December 2017).
Chapter 24
Clinical engineering in the
United States
Yadin David
Biomedical Engineering Consultants, LLC, Houston, TX, United States; University of Texas School of Public
Health, Houston, TX, United States
Introduction
Health technology (HT) is vital to health; the dependence
of health, rehabilitation, and wellness programs on HT
for the delivery of their services has never been greater.
Therefore, it is essential that competent and trained professionals manage it in an optimal and safe way for better
response to the burden of diseases, prevention, and the
limited available resources. Trained clinical engineers
(CEs) are academically prepared and appropriately responsible for HT life-cycle management, fulfilling a
critical role as members of the healthcare team focusing
on availability and reliability of safe and effective technologies, and thus care outcomes. Over the past 50 years,
growing concerns among practicing professionals and
the public about lack of knowledge on technology safety
and risk management by government agencies and key
stakeholders, coupled with the lack of technology introduction planning and commissioning contributed to the
realization that safe and effective creation and deployment of HT must be led through policies and programs
that address these concerns. This facilitated the creation
of new engineering discipline that focuses on the development of technological solutions to problems encountered
in the clinical environment where patient care has been
provided. In addition, the need for life cycle management
of these new technological tools promoted the need for
professionals with clinically applied knowledge and technological expertise. National societies in the field of clinical engineering began to expand their membership and
to recruit members with prime example, which was the
creation of the American College of Clinical Engineering
(ACCE) in the United States in 1990 (American College
of Clinical Engineering (ACCE), 2019), in response to
148
the call, a year earlier, for new professional society dedicated to the interests of CEs.
Professional evolution
Early technology-related practitioners in the clinical environment were mostly electrical and mechanical e­ ngineers
who saw the need for the continuous calibration and assembly of medical products at the time (mid 1960s) and
were interested to assist the operation of these early products which did not function well without engineering
­support. At the same time, cardiac invasive procedures,
such as open-heart surgeries and cardiac catheterization
procedures, depended on technological tools that were
new to the hospital environments (Ridgeway, 2004). There
were no academic programs that prepared engineers for
practice in the clinical environment of the technologically
evolving hospitals. Perhaps the published Expose by Ralph
Nader about the Danger in Our Hospitals in 1971 created
the momentum for more rapid deployment of engineers in
the clinical environment in order to more safely manage
patient care technology (Ralph Nader, 1971). The captioned bolded print was too much for the public to ignore
“Too many hospitals are hazardous electrical horror chambers, says America’s leading safety crusader. At least 1200
­people a year are electrocuted and many more are killed or
injured in needless electrical accidents in hospitals. Here’s
a report on the danger—and what must be done about it by
the hospitals themselves, by the makers of medical equipment, by the government and concerned citizens.” While
the debate about the accuracy and causation are being debated even today, this public exposure contributed to the
birth of the clinical engineering field in the United States
and perhaps worldwide.
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00024-9
Copyright © 2020 Elsevier Inc. All rights reserved.
Clinical engineering in the United States Chapter | 24
The state of the profession
Today’s knowledge about and recognition for the professionals of CE community practicing in the United States
has grown significantly since the early days. In addition to
ACCE organization, other associations such as Association
of the Advancement of Medical Instrumentation (AAMI)
(2019), IEEE Engineering in Medicine and Biology
(EMBS) (2019), American Society of Hospital Care
Engineering (ASHE) (2019), and Biomedical Engineering
Society (BES) (University of Connecticut, n.d.) are present
much more than others, in the US clinical engineering field.
With only a few academic programs available for preparing engineers for practice in the clinical environment
the growth of practitioners is mostly accomplished by technologists who gain knowledge and experience to advance
their career and through professional conversion of practitioners from other engineering and management fields
(University of Connecticut, n.d.). Regardless of the limited
academic opportunities to enter the filed, the professional
credentialing and certification program (ACCE Healthcare
Technology Certification Commission, 2018) of CEs led by
ACCE and other associations around the world is gaining
recognition and acceptance by employers.
The practice of CE in the United States includes distribution of competencies in subject areas that resembled
results of national survey of Body of Knowledge conducted
in 2015 (Subhan, 2017) showing work categories:
• Technology management
33%
• Service delivery management
17%
• General management
11%
• Risk management/Safety
11%
• Education of others
11%
• IT/Telecom
8%
• Product development, evaluation,
testing, and modification
5%
• Facilities management
5%
• Others
1%
(due to rounding the total is over 100%).
At present, CE practice in the United States focuses on
HT life cycle management where industrial engineering and
business field methodologies are useful resources. However,
future career development will be highly dependent on the
preparation of CE skills and competencies that lead to the
ability to guide achievement of better patient outcomes,
higher care quality, and safer risk management when technological tools are employed. Job outlook predication by
the US Department of Labor is positive with 7% growth
between 2006 and 2026 (US Department of Labor, n.d.). If
one looks at the introduction of artificial intelligence (AI),
149
robotics, telehealth, virtual reality, and image-guided tools
and health technologies system integration—it should be a
surprise that future CE practice will continue to evolve and
grow.
Summary
HT is vital to health; the dependence of health, rehabilitation, and wellness programs on HT for the delivery of
their services has never been greater. Beyond the ongoing
­healthcare burdens of population growth, political and economic instability, disease management, disasters, society
mobility, accidents, and terror attacks, healthcare technological systems are facing enormous challenges to be innovative and optimally managed. The transition into health
programs for the 21st century requires the employment
of trained competent clinical engineering professionals.
Disease prevention, treatment, and rehabilitation are more
efficient and effective when health services are provided
with appropriate tools. At present, CEs in the United States
are beginning to be recognized for their important contribution and ability to guide the use of appropriate, integrated,
and safe HTs, which is essential for the successful care
outcomes of every healthcare delivery systems. However,
CEs preparation is still lacking uniformed preparation and
requirements for practice that must include clinical knowledge, engineering training, and systems expertise.
It is critical, therefore, that with the limited resources,
HT must be professionally managed and its deployment
over its life cycle be appropriately guided. Study shows
(Judd and David, 2018) that every region of the world including low resource regions face a challenge of improving
health services while facing varied levels of infrastructure
and human resources capacity challenges. CEs play vital
roles in all stages of healthcare technology life cycle management. From creation to planning, and from commissioning to utilization and integration; technology-based systems
must and can be managed for optimal performance. In each
of the life cycle stages, the requirements for trained and
competent CE input make critical difference. It is our hope
that government agencies, healthcare providers, industry,
and other interested parties will have better understanding of CEs role and thus will support their inclusion in the
healthcare team of professionals. It is critical for optimal
patient outcomes to encourage the availability, recognition, and increased participation of CEs as part of the health
workforce in the national healthcare delivery programs.
References
ACCE Healthcare Technology Certification Commission, 2018. https://accenet.org/CECertification/Pages/Default.aspx. (last visited November
5, 2019).
American College of Clinical Engineering (ACCE), 2019. https://accenet.
org/about/Pages/History.aspx. (last visited March 1, 2019).
150 SECTION | 2 Worldwide clinical engineering practice
American Society of Health Care Engineering of the American Hospital
Association (ASHE), 2019. http://www.ashe.org/about/index.shtml.
(last visited March 1, 2019).
Association for the Advancement of Medical Instrumentation (AAMI),
2019. https://www.aami.org/. (last visited march 10, 2019).
IEEE/Engineering in Medicine and Biology (EMBS), 2019. https://www.
embs.org/. (Last visited March 5, 2019).
Judd, T., David, Y., 2018. Making a difference—global health technology
success stories: overview of over 400 submissions from 125 countries. Glob. Clin. Eng. J. 1 (1). https://www.globalce.org/index.php/
GlobalCE. (last visited March 10, 2019).
Ralph Nader, A., 1971. Expose: danger in our hospitals. Ladies Home J.
http://kami.camp9.org/Resources/Pictures/Ralph-naders-most-shockingexpose%5B1%5D.pdf. (last visited March 1, 2019).
Ridgeway, M.G., 2004. The great debate of electrical safety—in retrospect.
In: Clinical Engineering Handbook. Series in Biomedical Engineering,
Academic Press. (Chapter 65).
Subhan, A., 2017. 2015 American College of Clinical Engineering Body of
Knowledge survey results. J. Clin. Eng. 42 (3), 105–106. https://journals.
lww.com/jcejournal/Citation/2017/07000/2015_American_College_
of_Clinical_Engineering_Body.4.aspx. (last visited October 1,
2018).
University of Connecticut. Clinical Engineering Internship, https://www.
bme.uconn.edu/clinical-engineering/.
US Department of Labor, Bureau of Labor Statistics, Occupational
Outlook Handbook, https://www.bls.gov/ooh/architecture-andengineering/biomedical-engineers.htm (last visited November 5,
2019).
Chapter 25
Clinical engineering in Albania
Ledina Picari
Medical Devices and Systems Unit, Ministry of Health of Albania, Tirana, Albania
This is a brief summary of the organization and functioning of the clinical engineering in Albania. The issues addressed in this chapter include Albania’s healthcare system
infrastructure and organization, the role and responsibilities
of the organizational structures, regulatory framework of
medical devices, maintenance policies, clinical engineering
education, and activities at hospitals and other issues related
to the health technology management in Albania.
Demographics and geography
Albania is a country in Southeastern Europe, located in
the Southwestern part of the Balkan Peninsula.
Albania spans 28748 km2 with a population of almost
2.9 million according to the 2016 census data.
Coastlines: Adriatic and Ionian seas.
Neighbors: Kosovo, Italy, Greece, North Macedonia,
and Montenegro.
Tirana is the capital, with almost 1million people.
Language: Albanian, a separate branch of IndoEuropean symbolic tree of world languages.
History
The first independent Albanian state was established in 1912.
After World War II, the Communist Party came to power.
Albania experienced the most severe dictatorial regime compared to other countries of the Communist Camp. Therefore,
it has had significantly more turbulent progress along the path
of economic and structural transition than most of the other
ex-communist European countries. Today Albania has established a constitutional democracy. It is a member of NATO
and is in the process of becoming a member of the European
Union (EU). This commitment is a key factor c­ontributing
to regional stability and further cooperation between the
Republic of Albania and the European Union. Due to radical
changes, there has been two major disruptions: the disruption
of effective working of the existing health infrastructure, particularly a loss of qualified staff because of migration, and the
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00025-0
Copyright © 2020 Elsevier Inc. All rights reserved.
disruption of a number of early initiatives in economic reform,
specifically, the initiatives in the field of healthcare reform and
development. Despite these difficulties, the Ministry of Health
has continuously strived to develop programs and policies to
redevelop and realign the healthcare system into a more effective structure and more responsive to population needs.
Albania’s healthcare system
Healthcare facilities
●
●
●
●
●
413 primary healthcare centers
5 university hospitals
11 regional hospitals
23 district hospitals
10 polyclinics in Tirana
Organization and budget allocation
Albania’s healthcare system, before 1990, was completely
public. It is still very centralized and the central government
controls almost all aspects of the system. Primary health care
covers all population through family doctors. The referral system is organized into three hospital levels: district, regional,
and tertiary. Problems related to this system are mainly due
to the concentration of the “best doctors in capital” and the
lack of trust in the expertise in primary health care and small
hospitals. The “Fund” is the only Insurance Health Institute in
the country financing health services. To support the access
to health care, Albania is using the universal healthcare system. Almost all the healthcare providers work as government
employees and the government acts as the single payer for all
health services. Aiming to provide the healthcare coverage for
all population, the system is under pressure due to rising costs.
The private sector covered initially pharmaceutical, dental,
and diagnostic services but in the last 5 years, four private
hospitals have covered almost all healthcare services. Big investments (medical devices and buildings) are mainly planned
and procured by the Ministry of Health (MoH). Running costs
are managed by hospitals upon the approval of MoH.
151
152 SECTION | 2 Worldwide clinical engineering practice
Budget allocaon (mln USD)
6
5
4
3
2
1
0
1994
New MD
2000
2004
Consumable MD
2011
2017
Maintenance cost
FIG. 1 Health technology budget allocation.
documentation, and training. The progress in the integration process to European Union, the government priorities,
and the new competence in biomedical engineering in the
decision-making levels have brought to light the need for a
great reform in this field. The last 15 years have achieved
more than what was achieved in the last 50 years and these
achievements were because of the strong aspiration of the
country to join the European Union, the technical and financial supports provided by the international experts and
institutions, and the strong commitment of the new clinical
engineers.
Medical devices and systems unit at MoH
In the last 5 years, the government policy has encouraged private-public partnership (PPP) mainly in:
-
laundry and food services
dialysis
sterilization of the medical instruments (used in surgery
departments)
checkup age 40–70
laboratory services
For the past 15 years, millions of Euros were invested in new
medical devices. This has contributed to increased cost efficiency
and better access to health care. Total health expenditure in 2017
exceeded the highest historical value of 3% of GDP from public
funding, which was around US$470 million and 2.3% of GDP
from private funding. Investments in health technology followed
the same trend (Fig. 1).
Health technology management
After the collapse of the communism in 1990, Albania
emerged as a poor country with a poor healthcare system.
There were a limited number of medical devices (MDs)
mainly imported from China and other ex-communist
countries. Very old analog technology was in use in hospitals providing poor diagnosis and healthcare treatment.
For several years, loads of hospital medical devices were
donated by various countries and organizations. Some of
them were never put to work; some were out of service soon
after installation because of the lack of spare parts and consumables or lack of user’s competence. From 2000 on, the
Albanian government has paid more attention in procuring
new medical devices, several new hospitals were built and
other hospitals were renovated. Even though new, modern
devices were procured every year and new medical facilities were build or renovated, the importance of the health
technology management throughout the medical device life
cycle was not the focus of the healthcare reforms because
of low awareness of the high-level decision makers. There
were no proper standardized routines for planning, procurement, installation, acceptance testing, maintenance, repair,
Structural organization at Ministry of Health of Albania did
not have any department or unit for medical devices before
2010.
There was one electronic engineer in the Department
of Procurement and Investment as procurement specialist
dealing mainly with the preparation of technical specifications for medical devices and the evaluation of bids to define
technical compliance. In 2007, the Ministry of Health developed the National Strategy for Management of Medical
Devices. This document was used for strategic, long-term
decisions regarding the management of medical devices in
compliance with the European Medical Device Directives.
In 2009, a biomedical engineer was employed at the
Hospital Department, a health policy department of MoH.
Main tasks included:
-
defining priorities and planning the supply of hospitals
with medical devices,
preparing technical specifications,
participation in the evaluation committees,
distribution of medical devices, donated by various philanthropic associations, based on hospital needs,
designing regulatory documents for medical devices.
Due to continuous increasing investments in health
technology and the need for planning, prioritizing, evaluation, and regulation design, in 2010, the first dedicated
Management and Standardization of Health Technologies
Unit, later Medical Devices and Systems Unit (Unit) was
established, having for the first time, in high levels of public
healthcare sector, a decision-making unit with a high competence in this area. The head of the unit was a biomedical
engineer.
Duties and responsibilities
The unit was responsible for the overall supervision and
monitoring of medical devices in the healthcare sector. Its
mission was to increase patient and user safety when medical devices are used. The unit was directly involved in legal
framework preparation and its implementation:
Clinical engineering in Albania Chapter | 25
-
-
-
Design of laws and sublaws, orders of the Minister,
policy documents, recommendations, and guidelines regarding the use, management, and maintenance of medical devices as part of policy-making process.
Preparation and/or approval of technical specifications,
for medical devices aiming the standardization of the
health technology used in public hospitals in the country.
Wholesale and retail distribution authorization provision for economic operators.
Management and participation in the process of the adverse event reporting process.
Monitoring of legislation and guidelines for implementation of national policies on medical devices.
Preparation of the process for medical device recalls or
limitations in their use when incidents related to safety
are encountered.
Participation in working groups for health technology
budget planning.
Participation in procurement procedures when high and
sophisticated technology is procured centrally (CTs,
MRIs, etc.) at MoH.
Participation in working groups of the Ministry of
European Integration regarding European legislation approximation for medical devices, customer protection,
and market surveillance, leading the process in this field
on behalf of MoH.
Representation in international organization, e.g., WHO,
World Bank, etc., for medical device-related issues.
Clinical engineering structures
District(small) hospitals do not have any in-house clinical
engineer. There is a technician (electric, mechanical, or IT)
performing the duties. Due to the government priority for
the informatization of the healthcare systems in Albania,
in regional hospitals, clinical engineering and information
technology departments were integrated and are part of the
same unit. These units are composed of two to four technical
staff. Since there is a lack of clinical engineers in Albania,
the information technologist, in some hospitals, performs
the clinical engineer duties and responsibilities.These inhouse structures of clinical engineering in regional hospitals
can only perform simple repairs and everyday safety routine
for medical devices. The replacement of spare parts, updates, and maintenance of big and complex medical devices
are provided by third-party contractors. The biggest hospital in the country, “Mother Theresa” University Hospital of
Tirana, with around 1200 beds, has a unit of clinical engineering (CE) composed of the head of the unit, four clinical
engineers, four information technologists, and five technicians. When problems arise, each of the three levels of hospitals (district, regional, and tertiary), address the problem
to the Biomedical National Center (Centre).The center is a
153
small workshop with a bunch of engineers and t­echnicians.
It existed since 1960s, taking care of small repairs mainly
analog devices. It was thought as a reference center when
the CE unit of each hospital was unable to fix the problem.
Because of the lack of continuous training and complexity of
modern devices, the center did lose importance and was unable to manage the process and answer the increasing need
for technical support.
Actual legislation
The Law 89/2014 “For Medical Devices,” the first law for
medical devices in Albania:
-
regulates the circulation of medical devices in Albanian
market;
improves the safety of the patients and users;
defines the legal responsibilities of the responsible
structures;
defines the role and functioning of the State Agency for
Drugs and Medical Devices.
The Law 89/2014 “For Medical Devices” and three
sub-laws: The Decision of Council of Ministers (DCM)
No. 508 date 10.06.2015, Technical regulation “On
Essential Requirements, conformity evaluation and CE
marking of active implantable medical devices”, DCM
No. 731 date 02.09.2015, Technical regulation “On
Essential Requirements, conformity evaluation, classification and CE marking of medical devices” and DCM No.
189 date 09.03.2016, Technical regulation “On Essential
Requirements, conformity evaluation, CE marking of in-­
vitro medical devices”, prepared by the unit in collaboration with the law department, approximate the three
European directives:
-
Directive 93/42/EEC concerning medical devices.
Directive 98/79/EEC on in vitro diagnostic medical
devices.
Directive 90/385/EEC on active implantable medical
devices.
To complete the legal framework, three orders of
the Minister were prepared as well: “For the authorization of the wholesales traders of medical devices” (No.
86/2015), “On procedures and rules for the registration
of medical devices” (No. 360/2016), and “On the inspection of medical devices” (No. 150/2017), starting for the
first time the market surveillance for medical devices.
The unit was directly involved in these regulatory documents preparation.
Harmonized standards
All the European standards referred by European Directives
for MD were adopted by Albanian Standards Institute. Head
154 SECTION | 2 Worldwide clinical engineering practice
of unit of MoH is the head of the Technical Committee
205 (Non-active MD); another biomedical engineer is the
head of the Technical Committee 140 (in vitro diagnostic
MD). Since there is no domestic production, the focus is
to guarantee the quality of the imported MD and market
surveillance.
The implementation of the regulations made possible
for the first time the following:
-
Only medical devices bearing CE mark are placed on
the Albanian market.
Database of the economic operators trading medical devices in Albania was created.
The registration of the medical devices placed on the
Albanian market is a continuing process.
Market surveillance as part of the national action
plan for consumer protection 2014–2020 has started.
Head of the unit was a member of the governmental
working group for the Consumer Protection Strategy
design.
has drastically reduced, increasing patients' access to diagnostic imaging services.
This policy has provided the following outcomes:
-
improvement in the service
lower price: from approx. 12% (of the purchase price) to
8% annually
standardization of prices and procedures
shorter downtimes
better partnership with distributors
no more gaps between contracts
better budget planning from both sides (hospital and
­service provider)
efficient use of public funds
better planning
budget guaranteed due to fixed price
open procedure for international participation to avoid
speculation of a monopoly situation
Safety and adverse events
Maintenance of medical devices
Before 2014, the maintenance of medical devices was
managed by each hospital. No standard procurements and
maintenance procedures even for the same devices were applied and no standard terms and conditions were used in
binding contracts. Due to the increase in the investments in
high and sophisticated technology, in-house engineers and
technicians were unable to repair and maintain them and
the hospitals were facing higher costs due to the frequent
interventions, difficult relationships with the service providers and long waiting times for the patients and delay in
the diagnosis. Because of the lack of management policies,
the big and complex devices were very often out of service. The long downtimes were related to long procedures
for public procurements of spare parts and service company
selection. Gradually the private companies increased in
number and competencies. Since Albania is a small country,
usually, manufacturers assign “country authorized distributors” for repairs and maintenance. Being a small market,
often only one company was authorized for each brand,
creating a monopoly situation and providing a very highcost service. In order to gain and preserve the status, the
distributors are obliged to systematically train their engineers ensuring higher competencies compared to the public
staff where training programs for continuing education are
not available. This situation led to a new policy: the procurement of the maintenance services for CT scans, MRIs,
angiographers, etc., was organized centrally by the Ministry
of Health. The actions taken were the centralization of the
procedures, negotiation with the country authorized distributors and manufacturers regarding the price and contract
terms and conditions. Thanks to this policy, the downtime
No proper system for the registration of human errors is in
place. Although some efforts have been made, no proper
analyses for the evaluation of the malfunctions and adverse
events associated with medical devices are performed.
Development of human resources dealing with
medical devices
The lack of knowledge and competence was identified as
one of the problems during the life-cycle management of the
medical devices. Not many educational and training programs
for the people dealing with medical devices in health centers,
hospitals, or other health institutions have been organized.
University program in Biomedical/Clinical
Engineering
In order to ensure a long-term solution in having qualified clinical engineers, negotiations with the Ministry of
Education and Tirana Polytechnic University were undertaken to establish a Biomedical/Clinical Engineering
Programs at the Engineering School. A master's program in
clinical engineering was completed in 2014. In all 10 students graduated and some of them are working with medical devices in the private and public sector. Even though
there is a great need for qualified people, they have struggled to find a job at any public hospitals and some of them
are not working with medical devices. Still, the system is
suffering from the lack of awareness of the need for qualified people. Often other professionals are hired instead of
clinical engineers in hospitals to take care of health techno­
logy. Low salary in the public sector is another obstacle for
hiring qualified engineers and technicians.
Clinical engineering in Albania Chapter | 25
Education at hospital level
The staff working with medical devices in hospitals do have
a diploma in biomedical, clinical, electronics, information
technology, electrical, or mechanical engineering. Most of
them have some knowledge mainly due to the experience
gained by working with medical devices. Not many possibilities to attend training courses have been made available.
Medical device information system as an
important tool of management
The number of medical devices being used in hospitals and
healthcare organizations continues to grow demanding the
setup of a medical devices information system for proper
management. There have been several local attempts by
the hospitals to list all the medical devices in use. Several
various programs were created. It was difficult to make
these systems compatible with each other and the information was impossible to be merged into a central national
list. Ministry of Health intervened and registered all the
medical devices of the public hospitals in a central system
administered by commercial software.
In 2014, the Ministry of Health of Albania started the informatization reform in health care. This process has improved the
access to the system and health service delivery. Key projects
were the introduction of the personal health card, nationwide
electronic health records, e-prescription, hospital management
information system, e-signature and e-examination, administration of medical drugs, registration system, management of
human resource, and medical assets system. Clinical engineers
are being charged to extend their scope as communicators,
problem solvers, and experts in integrating high technology
systems. With medical devices becoming more software-based
and connected to networks, the role and responsibilities of CE
have increased, demanding new skills and competencies in order to make the technology connected. The Telemedicine and
e-Health Program are operating in 18 hospitals. Telemedicine
center is merged with Biomedical National Center to create
and to put in operation a remote care program for tele-trauma,
tele-stroke, tele-radiology, etc. These achievements and other
smaller complementary successes in the last years were attained as a result of the commitment of the local staff and the
foreign experts who have assisted the Albanian health sector
with their knowledge and financial support through various international bilateral and regional projects. World Bank, WHO,
USAID, Italian Cooperation Agency, JICA, etc., projects have
brought the best of international experiences to Albania and
have supported successfully the local attempts in the development of healthcare technologies.
Albanian Society of Biomedical Engineering
Albanian Society of Biomedical Engineering was founded
in 2005. The mission was to promote the role and i­ mportance
of biomedical engineering in health care, to represent the
155
professional interests of biomedical and clinical engineers,
and to promote the safe use of the technology by establishing standards of practice in clinical engineering. Since
there is a small community of people involved in health
technology in Albania and due to the lack of economic
and political stability, challenges have been faced over the
years to get full recognition. As the awareness to recognize
the important role of biomedical and clinical engineering
in health care is increasing internationally, the collaboration of Albanian Society of Biomedical Engineering with
other international societies and organizations and the involvement of its members in international forums are playing a crucial role in strengthening this organization and its
contributions in healthcare delivery.
Clinical engineering challenges in Albania
The challenges facing clinical engineering in Albania are
as follows:
Raising awareness of the importance of biomedical and
clinical engineering within the health system.
Establishing national health technology assessment
in order to support management, clinical, and policy
decisions.
Establishing collaboration and partnerships with
­healthcare providers, industry, patient’s societies, and
scientific and technical organizations.
Implementation of national regulations and strengthening of the human resources.
Development of the university programs in biomedical and
clinical engineering and training programs for a high professional profile.
Enhance patient safety in healthcare delivery.
Strengthening market surveillance for medical devices to ensure regulatory compliance and public health protection.
Further reading
Calil, S.J., 2016. The evolution of clinical engineering: history and the role
of technology in health care. In: Clinical Engineering, From Devices
to Systems.
Council of Ministers of Albania, 2017. National plan for European integration, 2016-2020. Decision of the Council of Ministers of Albania, No. 42.
Hernandez, A., Judd, T., 2017. ACCE Webinar: Global Health Technology
Equity: How Emerging CE-HTM Leaders Can Help.
Ministry of Health of Albania, 2007. National Policy for Management of
Medical Devices.
Statistics Institute of Albania, 2007. Population of Albania, www.instat.gov.al.
Velazquez, A., 2017. World Health Organization, The role of health technology management in WHO, to support access to medical devices for
Universal Health Coverage and achievement of SDGs.
World Health Organization, Sixtieth World Health Assembly, WHO
Resolutions: WHA60.29, Health technologies. http://158.232.12.119/
health systems/WHA60_29.pdf.
Yadin, D., 2013. Second WHO Global Forum on Medical Devices, Global
Perspectives on Clinical Engineering Trends, Geneva, Switzerland.
Chapter 26
Clinical engineering in
South Africa
Mladen Poluta
Western Cape Government: Health, Cape Town, South Africa
Contextual introduction
-
-
-
-
Clinical engineering has been practiced in South Africa
for almost 50 years.
Almost all clinical engineering practitioners (CEPs) are
engineering technicians, the major reason being that the
focus is primarily on medical equipment management
and maintenance for which limited expertise at the level
of a professional graduate engineer is required.
CEPs are not regarded as health professionals (they do not
have a health sciences background) and have not received
the recognition that many CEPs believe they have earned.
Health professionals with defined roles relating to
healthcare technology include medical physicists
(­
generally engaged in radiation oncology), clinical
technologists (operating life-support and other complex
healthcare technology with seven areas of specialization: cardiology, pulmonology, critical care, nephrology,
perfusion, neurophysiology, and reproductive biology)
and radiographers (operating medical imaging equipment and systems).
Healthcare technology management (HTM) is considered to be a multidisciplinary endeavor and although
CEPs are widely involved in various aspects thereof,
many HTM practitioners are health professionals (typically nurses or radiographers).
There is close collaboration between clinical- and hospital engineering practitioners in the private healthcare
sector, much less so in the public sector.
●
●
Notable developments in 1970s:
●
●
●
●
1970s: growth of CE in public healthcare sector
1980s: growth of CE in medical device industry (mainly
multinationals active in South Africa)
156
Technical workshops established in the large academic
hospitals built at the time; these workshops later split
into Medical Equipment and Hospital Engineering
Workshops.
Formation of SAACET (SA Association of Clinical
Engineering Technicians).
Notable developments in 1980s:
●
●
●
●
●
Brief history
Clinical engineering (CE) in South Africa can best be understood in terms of the following phases:
1990s: growth of CE in private healthcare sector
2000s: active involvement of National Department of
Health (NDoH) in CE/HTM-related matters
●
●
CE practitioners appointed by medical equipment suppliers to provide technical-, sales-, and user support to
customers in both public and private healthcare sectors.
Change in name from SAACET to SAACE (SA
Association of Clinical Engineering) with new constitution and bylaws; establishment of additional regional
branches and a national secretariat.
SAACE represented at the 1988 Annual General
Meeting of the International Certification Commission
(ICC).
Establishment of the South African Board of Examiners
for Clinical Engineering (SABECE) to oversee certification of clinical engineers and CE technicians (equivalent to BMETs).
Establishment of a CE specialization option within the
National Higher Diploma for Electrical Engineering
at the Technikon Pretoria (3-year program with four
semesters for formal study and two for practical
training).
New regulations announced for “electronic products
emitting some form of radiation” and licensing control
of import and sale of related medical devices.
SAAAMI (Southern African Association for the
Advancement of Medical Instrumentation) established
and first Congress held.
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00026-2
Copyright © 2020 Elsevier Inc. All rights reserved.
Clinical engineering in South Africa Chapter | 26 157
Notable developments in the 1990s:
●
●
●
●
●
●
●
●
●
●
SAAAMI dissolved in favor of the Professional
Alliance for Technology in Health (PATH), intended
to stimulate and facilitate interdisciplinary HT-related
activities in Southern Africa; PATH participation at
Medic Africa 1992 in Zimbabwe; interim committee
established to investigate and report back on the feasibility of establishing an African organization using the
PATH model.
Vitalink Program at the South African Medical Research
Council (SAMRC) proposes a regional CE training
scheme for the sub-Saharan Region, with a core group
comprising countries with existing training facilities (at
that time Kenya, South Africa, and Swaziland) and satellites in other participating countries.
Visit to South Africa by ICC President Bill Betts in
1993; meetings held with stakeholders on CE certification and related issues.
MRC/PATH/IFMBE/WHO Workshop on Healthcare
Technology in sub-Saharan Africa (SSA) in 1994;
Meeting Statement submitted to 44th Session of WHO
Regional Committee for Africa, leading to the first
WHO-AFRO Resolution (AFR/RC44/R15) addressing
health technologies specifically, and highlighting the
importance of health technology policies and plans, and
related training and information support.
Democratic transition in 1994 with the emergence of a
unified public sector health system; healthcare declared
a provincial competency with responsibility for related
decision-making and allocation of resources.
At a meeting convened by WHO during Medic Africa
in 1995, the Constitution of the African Federation for
Technology in Health (AFTH) presented and office
bearers elected; AFTH a new regional structure modeled
on PATH with secretariat based at SAMRC.
With the rapid expansion of the private healthcare sector, increasing recognition of the importance of in-house
CE capability.
Voluntary Severance Package offered to public servants
as part of a government downsizing process has the unintended consequence of significantly reducing the capacity of many CE departments as many senior, skilled
CE practitioners leave the service.
National Steering Committee on Education and Training
for Medical Equipment Maintenance and Management
(MEM&M) appointed by the NDoH to conduct a situational analysis; report compiled and submitted.
Private healthcare sector shows preference for taking
graduates from generic engineering programs and providing in-house/on-the-job training related to medical
equipment management and maintenance, with strong
links to hospital engineering under a Technical Services
umbrella.
●
●
●
●
Establishment of Clinical Engineering Association of
South Africa (CEASA), a new professional association
for CEPs; constitution and bylaws adopted—see Annex.
Establishment of Postgraduate Diploma in HTM program at the University of Cape Town, with the first intake in 1999.
Advanced HTM Workshop, organized by WHO/AFTH/
ACCE/NDoH/SAMRC in association with the IFMBE/
IFHE, held in 1999 with the theme Planning, Funding
and Management of Healthcare Technology and
Required Infrastructure to Achieve Optimal Outcomes.
Formation of Council for Health Services Accreditation
of Southern Africa (COHSASA), offering a service
similar to that provided by Joint Commission (JCAHO);
standards related to HTM/CE drafted and piloted.
Notable developments in the 2000s:
●
●
●
●
●
●
●
●
Release of NDoH Framework for Health Technology
Policies outlining a proposed National Health
Technology System comprising four subsystems:
one each for Planning, Assessment, Acquisition, and
Utilization (including maintenance).
National Health Technology Strategy drafted and accepted by the National Health Council.
Health Technology Scoping Study commissioned by
NDoH; includes an audit of CE capacity in the public
sector and related staffing norms.
Occupation Specific Dispensation (OSD) instituted
in public sector, offering improved remuneration for
selected professions deemed to represent “scarce
skills”; CE technicians (as a category of “Industrial
Technicians”) included on understanding that professional registration was forthcoming; required that all applicants for CE posts be registered with the Engineering
Council of South Africa (ECSA)—see Annex.
ECSA requested by NDoH to establish professional
registration for CE specifically (CE not recognized as a
branch of engineering under Engineering Profession of
South Africa Act); steering committee formed with representation from NDoH as client stakeholder, CEASA,
public and private healthcare sectors, academia, and industry; generic CE practitioner profiles compiled.
Qualification standard prepared and approved for a “specified scope” category of Medical Equipment Maintainer
(MEM) that provided for registration of persons who
cannot register in a professional category but would be
recognized by ECSA as a Candidate CE Technician.
Ministerial Advisory Committee on Health Technology
established, with subcommittee on CE capacitation and
capacity-building.
Inaugural joint conference of the South African
Federation of Hospital Engineering (SAFHE) and
CEASA held in 2005.
158 SECTION | 2 Worldwide clinical engineering practice
●
Participation by CEASA in 2006 WHO/ACCE
Advanced CE Workshop, held in Cape Town at time of
IFHE World Congress.
Clinical engineering structures
These differ fundamentally between the public and private
sectors. The major private sector hospital groups all have
a distributed structure with a national head office; hospitals generally have an on-site technical services department
covering both clinical- and hospital engineering and systems and processes are highly standardized with integrated
management and governance.
By contrast, CE services in the public sector—besides
being separate from hospital engineering services—are
disjointed and nonstandardized, due in part to healthcare
service delivery being a provincial rather than a national
(federal) competency.
The large academic (central) hospitals—associated with
university faculties of health sciences—have their own CE
departments and these generally have a responsibility to
that one institution only, functioning as independent entities. Regional and district hospitals, primary healthcare facilities, and specialized services rely on a central provincial
workshop that may have satellite workshops, depending on
the geographical spread and/or workload associated with
facilities served.
Provinces differ in their maintenance strategy, with
some seeing the benefit of capacitated in-house services
while others have outsourced all or most of their maintenance workload, leaving them open to potential risk (both
operational and financial).
Current situation
The last 10 years have seen little or no progress on important issues highlighted above; these include recommendations impacting on CE as contained in the NDoH’s
Framework for Health Technology Policies, its Draft Health
Technology Management Policy and the National Health
Technology Strategy. Without determined leadership and
stakeholder buy-in it is difficult, if not impossible, to ensure
a standardized and adequately capacitated CE service in the
public sector nationally.
The situation is exacerbated by a significant shortage
of filled CE technician posts, due in part to an outflow of
skills to other sectors in pursuit of better opportunities and
improved remuneration and/or working conditions. Efforts
to mitigate these shortages have included sending cohorts of
sponsored students to Cuba to participate in a customized
CE program as part of an overarching bilateral partnership
between our two countries. Even so, the public healthcare
sector lacks a pipeline of new CE practitioners with the
r­ equisite practical/technical skills often lacking in graduates
from existing programs.
Consideration is being given to the implementation of the
MEM qualification at Technical and Vocational Education and
Training (TVET) colleges; it is hoped that the MEM practitioners will bridge the gap between Technical Assistants and CE
Technicians and prove to be the “workhorses” required for a
cost effective and sustainable maintenance capability. With
the MEM qualification in place, a structured career path will
be available for CEP’s extending from Technical Assistant to
MEM to CE Technician, CE Technologist and CE Engineer
(the last three recognized as engineering professionals).
Added to this, the possibility of using CE certification
as the qualifying criterion for professional registration with
ECSA is being explored; this option is supported by the current interest in global CE certification and the related initiative of the IFMBE’s Clinical Engineering Division (CED)
and other stakeholders.
CEASA remains active with branches convening regular meetings at which speakers present on new technologies
or topics of current interest; these meetings are occasionally held jointly with the SAFHE and are intended to meet
the dual needs of continuing professional education (CPD)
and professional networking. The 2-yearly joint CEASA/
SAFHE Congress continues to be a great success, and has
been complemented in recent years by conferences with
CE/HTM themes—cohosted by CEASA and IFMBE’s
CED—at the annual Africa Health Exhibition.
Finally, new medical device regulations under the recently established South African Health Products Regulatory
Authority (SAHPRA) are likely to impact on CE in at least
two respects: (i) the need for accreditation of maintenance
services (personnel and their working environments) and
(ii) improved monitoring and assessment of medical devicerelated adverse events linked to patient safety.
Conclusion
As described above, CE in South Africa has a proud tradition and remains vibrant and active, contributing to the
enabling environment for healthcare delivery in both public
and private sectors. However, CE will be unable to fulfill its
important role in the proposed national health system under
National Health Insurance if CE-related capability is not assured; this will require concerted and sustained effort by all
stakeholders and partners, not only to meet current challenges or those anticipated in the medium-term but indeed
with an eye on the health system of the future. This, in turn,
will necessitate revising current bodies of knowledge and
practice for CE. Linkages and partnerships with stakeholders such as the IFMBE, WHO, and CE colleagues in other
countries and regions (notably the African Region) will be
essential on this important journey.
Clinical engineering in South Africa Chapter | 26 159
Annex
●
Clinical engineering education
The Tshwane University of Technology (TUT) offers
qualifications from national diploma to BTech (Bachelor of
Technology) and postgraduate degrees (MTech, DTech). The
study program in CE falls under Electrical Engineering and
has been the major provider of CE practitioners in the country.
The number of diploma students peaked in 2004 at 85, many
of these with bursaries from the NDoH; since then the number
has been in the range 30–50, with some students pursuing the
BTech program. Workshops in medical equipment maintenance and health technology management have been offered
to targeted external groups. TUT also has research facilities
and interests in the areas of eHealth and assistive devices, with
postgraduate students from a number of African countries.
The University of Cape Town offers a range of
­career-building opportunities, from short courses to formal qualifications. The flagship qualification has been the
Postgraduate Diploma in HTM program based on a mixedmodality, block-release format with content covering both
healthcare infrastructure and technology, and transversal
topics such as project management, airborne infection control and health informatics/eHealth. The HTM program,
now complemented by Masters and PhD programs in biomedical engineering and an MPhil in Health Innovation,
has received students from more than 10 countries in the
African region (most of these employed in the respective
Ministries of Health).
The University of South Africa (UNISA) offers a
3-year diploma on a distance learning basis, leading to a
formal qualification in CE (as for TUT, this is a specialization within Electrical Engineering); 1 year is spent in the
healthcare industry in a monitored learnership.
Professional registration/Engineering Council of
South Africa
CEPs registering with ECSA receive recognition that
they meet the minimum requirements expected of a competent engineering practitioner in the generic categories of Professional Engineer, Professional Engineering
Technologist, Professional Certificated Engineer, or
Professional Engineering Technician.
The ECSA Steering Committee on CE, in a submission in 2007 outlining the rationale for registration of CEPs
stated, inter alia, the following:
●
It is important to note that persons wishing to be registered in the specified category of Clinical Engineering
will be required, in the first instance, to already be registered in a generic professional category and thereafter
be assessed as being competent to practise in the field of
Clinical Engineering.
The title relating to registration as a Clinical Engineering
Practitioner is not intended be an “add on” to a professional title. It will stand alone and be used independently of any other registration title. Thus whether one
be registered as a Professional Engineer, Technologist
or Technician the single descriptor will be used for all
three, i.e. Registered Clinical Engineering Practitioner.
ECSA is aligned with the International Engineering
Alliance (IEA) with respect to Graduate Attributes and
Professional Competencies—see http://www.ieagreements.org. The IEA is a global not-for-profit organization
with members from 36 jurisdictions within 27 countries,
with international accords and agreements governing the
recognition of engineering educational qualifications and
professional competence; these enable IEA members to establish and enforce internationally benchmarked standards
for engineering education and expected competence for engineering practice.
Clinical Engineering Society of South Africa
CEASA replaced SAACE (SA Association for Clinical
Engineering) as the national mouthpiece and home for
CEPs—see https://www.ceasa.org.za/. Individual paid-up
membership in 2017 totaled almost 500. CEASA’s objectives include the following:
●
●
●
●
●
to encourage and promote the personal and professional
development of all our members;
to reinforce and elevate the CE profession as seen by all
healthcare professionals;
to strive for continued CE excellence and partnership
within all healthcare provision environments;
to represent all CEPs in engaging with the ECSA;
to foster and establish international links and cooperation surrounding all aspects of CE.
CE is defined in the CEASA Constitution as “the maintenance, management, support, development and quality
assurance of healthcare technology as part of safe, costeffective and sustainable healthcare delivery”.
Acknowledgments
Material for this chapter has been drawn from many local sources,
most of them unpublished; documents and reflections from the following clinical engineering stalwarts are acknowledged:
●
●
Jurgen (Heinz) Muller, an early president of SAACE and the first
editor of its newsletter, who worked tirelessly to put CE on a professional footing and sought to build bridges with organizations,
institutions, and colleagues outside of South Africa.
Gerard Locke, also SAACE president, who contributed in many
ways over an extended period but notably in advocacy for inhouse clinical engineering departments in the private healthcare
sector by highlighting the importance of patient safety.
160 SECTION | 2 Worldwide clinical engineering practice
●
●
●
Tom Cooper, an engineering technologist who served as the interface between the clinical engineering community and the
Engineering Council of South Africa, contributing passionately to
the complex discussion around professional registration of clinical
engineering practitioners.
Rob Dickinson, generously shared his vast knowledge of medical
devices and related experiences, his guidance and insights inspiring students, and CEPs in many resource-scarce settings.
Johan van Roon, who initiated and convened the clinical engineering program at Technikon Pretoria (now Tshwane University
of Technology) and made valuable contributions both to formal education and to advancing professionalism within clinical
engineering.
(Note: Heinz Muller’s whereabouts are unknown while Gerard
Locke, Tom Cooper, and Rob Dickinson are all deceased. There
are many others—too many to mention here—who have made major contributions to the growth and presence of CE on the South
African stage; their contributions should be acknowledged in an
appropriate forum.)
Chapter 27
Clinical engineering in Uganda
Robert T. Ssekitolekoa,b, Sam S. Byamukamac, Sam S.B. Wandad
a
College of Health Sciences, Makerere University, Kampala, Uganda, bKnowledge for Change (K4C), Fort
Portal, Uganda, cMark Biomedical Limited, Kampala, Uganda, dUganda National Association for Medical
and Hospital Engineers, Kampala, Uganda
Introduction
History of clinical engineering in Uganda
Clinical engineering is commonly understood as biomedical engineering in Uganda. This is a relatively new field in
the country with local formal education having started in
2007. For many years, hospital equipment including medical devices were managed by engineers and technicians
trained in either electrical or mechanical engineering. These
were mentored on-job and attended various short courses
to develop skill sets that were tailored to specific equipment. With a population of over 43 million people, Uganda
has 2 National Referral Hospitals (Mulago and Butabika),
14 Regional Referral Hospitals (RRHs) and a total of 155
hospitals (public and private), which consist of 65 public
(government-owned), 63 private-not-for-profit (PFNFP),
and 27 private hospitals.a The RRHs have a catchment
population of approximately 3 million people and an average capacity of 400 beds. The average capacity of a general
hospital is 135 beds. As shown in Fig. 1, in the public health
sector Biomedical Engineers and Biomedical Technicians
employed starting at the level of RRHs and above. There
are currently over 100 degree graduates of Biomedical
Engineering in the country and over 200 diploma holders.
In 2016 the Government of Uganda introduced in the public
service for the first time a scheme of service for Biomedical
Engineers and Technicians complete with job descriptions
and salary scales, effectively marking a formal Government
recognition of biomedical engineering. Previously, professional Biomedical Engineers and Technicians who worked
in the public hospitals were mainly funded by implementing partners such as United States Agency for International
Development (USAID) and Japan Intentional Cooperation
Agency (JICA) among others.
The field of clinical engineering in Uganda started taking
shape in the 1980s following one of the WHO World Health
Assembly which passed a resolution urging ­member countries to adopt health technical services to cater for service
engineers and technicians who would carry out maintenance
repair medical devices in hospitals. Over the years, clinical engineering services in Uganda have been undertaken
through team efforts of artisans, technicians, engineers in
fields of plumbing, electrical, and mechanical. With the increasingly complex equipment and the constant high rates
of broken equipment, local stakeholders with support with
international collaborators saw the need to establish at RRHs
what became known as Regional Referral Workshops. The
engineering units had a mobile transportation vehicle and
were tasked to provide technical services to the hospitals
and lower-level health facilities (health centers) in their respective geographical regions composed of several districts.
These workshops had about five personnel including electricians, plumbers, mechanics, and carpenters with no one having a formal education background in clinical or biomedical
engineering. A number of these technicians attended short
courses on specific equipment that improved their skill sets
but the majority of the learning was on-job where the more
senior people mentored the junior ones. The electricians
were generally the people directly in charge of managing
medical devices, but the limited human resources meant that
all the other technicians had to help out from time to time.
The creation of the Uganda National Association for
Medical and Hospital Engineers (UNAMHE) in 1993 helped
to provide a platform for the health-sector engineers and
technicians to network together and share experiences. Later
on UNAMHE joined efforts with its counterpart professional body in the East African Community, the Association
of Medical Engineering Kenya (AMEK) in furthering the
coming together as colleagues to improve knowledge and
exchange of skills. One of the key events in the early stages
a. https://health.go.ug/hospitals.
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00027-4
Copyright © 2020 Elsevier Inc. All rights reserved.
161
162 SECTION | 2 Worldwide clinical engineering practice
FIG. 1 Levels and structures of the health system in Uganda.
of this regional collaboration was the convening in 2006 of
the East African round of the Advanced HTM Workshop series that were being conducted in various parts of the globe
by a team of experts from the American College of Clinical
Engineering (ACCE) supported by WHO. The year 2008 was
marked by the onset of the biennial East African Regional
Conference Healthcare Conference and Exhibition (EARC)
which rotates among member countries of the regional bloc.
This helped engineers and technicians to share regional
best practices and do some benchmarking through site visits. The regional collaboration also motivated the formation
national associations in the rest of the neighboring countries, namely Rwanda Association of Medical Engineering
(RAME), Association of Medical Engineers and Technicians
Tanzania (AMETT), and in Burundi, Association Burundaise
d’Ingénierie Biomédicale et Hospitalière (ABIB). During
the third regional conference (EARC 2012) a regional body
Federation of the East African Healthcare Engineering
Association (FEAHEA) was formed made up of the national
bodies from the five member states Burundi, Kenya, Rwanda,
Tanzania, and Uganda. There is now more widespread collaboration and improved access to more experienced personnel in the field. For example, on various occasions nominated
members from the East African national associations have
been granted sponsored access by the Clinical Engineering
Association of South Africa (CEASA) and the South Africa
Federation of Hospital Engineering (SAFHE) at their flagship
biennial conference and exhibition. And in 2018 Uganda’s
UNAMHE gained affiliation to the International Federation
for Medical and Biological Engineering (IFMBE) alongside
Benin, Ethiopia, Ghana, and Kenya, bringing the number of
affiliations from Africa to seven given that at that time only
Nigeria and South Africa were the only existing IFMBE
members on the continent.
Over the years several implementing partners including Danish International Development Agency (DANIDA),
USAID, and JICA among others have greatly contributed
to the improvement of medical equipment management in
the country. Some, such as DANIDA, Amalthea Trust, and
Knowledge for change (K4C) have paid key attention to supporting training programs, while others have concentrated
on other activities such as donating equipment, sponsoring
short courses, and so on The introduction of in-country formal biomedical engineering education at diploma and degree levels has helped greatly in improving the caliber of
engineers and technicians employed in some of the RRHs,
private hospitals as well as medical device vendors. The
Health Infrastructure Division of the Ministry of Health has
greatly improved in the monitoring of the medical equipment management in public hospitals and effective 2018
it has been elevated to the level of a department as a way
to support and strengthen its role. This remarkable step of
transformation has seen the introduction of biomedical engineering positions in the hierarchy of the Ministry of Health
headquarters for the first time in the history of the country.
Principal biomedical engineer and senior biomedical engineer among others will greatly improve the field. Meanwhile
the National Advisory Committee on Medical Equipment
Clinical engineering in Uganda Chapter | 27
(NACME)b continues to participate actively in matters of
health technology policy formulation and guidelines.
163
of Salford—United Kingdom, Leeds University—United
Kingdom, Queen Mary University of London, and many
more. The focus of the curricula is mainly about instrumentation, taking into account the current great need in the
country but also putting great emphasis on local innovations. As of 2019 the country had 4 people with doctorates
in biomedical engineering, with a further 5 in training, with
over 10 others about to complete their masters level training in different universities around the world. These are expected to boot teaching and research capacity of the local
universities and other related institutions.
Clinical engineering training
Formal biomedical engineering education in Uganda started
in 2007 when a 3-year diploma level program was launched
at the Ernest Cook Ultrasound Research and Education
Institute (ECUREI), a private institution attached to Mengo
Hospital—Kampala. The Ministry of Health in collaboration with implementing partners supported Kyambogo
University to start in 2010 a 2-year diploma program for
biomedical technicians. In 2011, the first biomedical engineering degree program in East Africa was started at
Makerere University Kampala. Later other teaching institutions in Kenya, Tanzania, and Rwanda also started
Biomedical Engineering training at different levels. As of
July 2019, there were 27 institutions training biomedical
engineers and technicians in East Africa at diploma and
bachelors degree level with 7 of them located in Uganda
(Table 1). The certificate programs typically run for 2 years,
diploma programs 2 or 3 years, and degree programs are
typically of 4 years duration.
The local training has been supported by international
partners. For example Mbarara University of Science and
Technology (MUST) has collaborations with Pennsylvania
State University—United States, University of Netherlands
and University of Strathclyde—United Kingdom;
Kyambogo partners with the Amalthea Trust Foundation—
United Kingdom and Fontys University of Applied
Sciences—The Netherlands; and Makerere University
collaborates with Duke University—United States, Case
Western Reserve University—United States, University
Current status of medical equipment
Different interventions including efforts by local and international stakeholders have improved the status of medical
equipment in a number of hospitals across the country. By
2019 at least 5 of the 14 RRHs employ degree-holding biomedical engineers as in-charges of the Regional Workshops.
Biomedical technicians are also employed either directly by
the hospitals, implementing partners or vendors. Partners
such as AIHA are supporting efforts to develop a calibration center that would help to meet the demands in that area.
Recently, the management of equipment has been boosted
by the introduction of a locally developed electronic inventory management database, which has been adopted by the
Health Infrastructure Department (HID) at the Ministry of
Health. All the RRHs update inventories are also stored at
the HID. A scale to tell the condition of medical equipment
was introduced by JICA in the early 2000s. This scale shows
the equipment in different categories as shown in Fig. 2.
The condition of equipment in public hospitals changes
considerably. Whereas on average over 30% of equipment
TABLE 1 Biomedical training institutions in Uganda.
Graduated students to date
Currently enrolled students
Institution
Bachelors level
Diploma level
Bachelors level
Makerere University
114
–
104
Kyambogo University
0
200
140
60
Ernest Cook Ultrasound Research and
Education Institute (ECUREI)
8
56
38
28
Bugema University
–
2
10
Mbarara University of Science and
Technology (MUST)
0
–
78
St. Francis School of Health Sciences
–
0
9
Vine Paramedical
–
0
1
b. https://www.who.int/medical_devices/survey_resources/health_technology_national_policy_uganda.pdf.
Diploma level
164 SECTION | 2 Worldwide clinical engineering practice
(A)
(B)
Condition key
U: Unknown status
A: Good in use
C: In use but needs repair
E: Out of use/repairable
B: Good/not in use
D: In use but needs replacement
F: Out of use /replacement
FIG. 2 Condition of equipment taken at two different public Regional Referral Hospitals in July 2018. (A) and (B) illustrate that the status of equipment
can be different even in very similar hospitals. (A) A much lower percentage of equipment in good condition and in use when compared to (B).
are out of use due to reasons such as lack of knowledge for
proper use, missing spares among others, it is not uncommon to see much better performing status. Some of the factors that improve the overall equipment status include new
equipment to the hospitals among many more.
UNAMHE launched in 2017 a biennial Uganda National
Biomedical Engineering Conference (UNBEC) as a forum
to encourage stakeholders in academia, industry, and hospital personal to come together periodically (once every odd
year) and share best practices. This is complemented by the
East African Regional Healthcare Engineering Conference
(EARC) that rotates every 2 years among member states of
the East African Community. Through events such as these,
a number of practicing biomedical engineers and technicians have been able to improve their skills.
Regulations and policy
The NACME was set up in 1989 and initially tasked to prepare
a policy to guide the health sector on acquisition and management of medical equipment. The first Standard List of Medical
Equipment for the various levels of health facilities was issued
in 1989. The National Medical Equipment Policy was thereafter developed in 1991 and this development assisted both government and implementing partners to rationalize procurement
and management of medical equipment. This policy was subsequently reviewed in 2000 and 2003 to accommodate the everchanging medical technology. The fourth and the latest edition
of Medical Equipment Policy and Guidelines were developed
in 2009 and this is what informing practices around medical
­devices, with the standard lists tagged with the corresponding
generic technical specifications of all the listed equipment.
The Uganda National Bureau of Standards (UNBS) is
mandated to develop and promote standardization, quality
assurance, laboratory testing, and metrology to enhance the
competitiveness of the local industry, strengthen Uganda’s
economy and promote quality, safety, and fair trade.c This
body works with NACME to ensure that devices meet the required standards. The National Drug Authority plays the role
of verifying medical device imports at all ports of entry into
the country as well as licensing importers and vendors. At the
Ministry of Health itself, besides introducing various brand
new positions in its hierarchy as mentioned above, the new
restructuring has also created new senior level positions such
as Assistant Commissioner, Standards and Accreditation and
Assistant Commissioner, Inspection and Compliance.
The future
The status of medical devices in Ugandan hospitals is
steadily improving as a result of the growing investment by
different stakeholders. The caliber of trained staff coupled
with recognition of the biomedical engineering profession
by the Government and other implementing partners means
that in future patients’ access to equipment in good working
condition can improve furthermore. Also, the placement approach that is increasingly being adopted by vendors with
regard to highly expensive medical equipment is helping to
rapidly increase access to high-end technology. Through
this scheme, the hospitals only pay for consumables while
the servicing and repairing of equipment itself remain the
responsibility of the vendor. A growing number of researchers in some of the universities and related institutions are
collecting baseline data on the condition and performance of
medical equipment and are publishing findings in ­reputable
scientific journals. This is very effective and it means that
with time it will become easier to find contextualized information that can be referenced to improve systems and
enable policy-makers to make better-informed decisions.
c. http://www.mtic.go.ug/index.php?option=com_content&view=article
&id=33&Itemid=181.
Section 3
Healthcare technology
management
Thomas M. Judd
Clinical Engineering Division, IFMBE, Marietta, GA, United States
What a joy to watch our profession grow!
Having had the privilege of editing this Healthcare
Technology Management (Clinical Engineering—CEHTM) Section in 2004 and now again in 2019, I have a great
perspective on how far our profession has come around the
world. I see advancement in the scope of CE-HTM in higherincome countries (HIC) as evidenced by many chapters in
this section not only on comprehensive lifecycle management of medical equipment, but also in the emergence of
CE-HTM aspects of digital medicine and our rightful place
in its innovation, deployment, and support.
Moreover, I also see increasing depth of CE-HTM in
low- and middle-income countries (LMIC). The late great
CE Robert Morris was quick to say if you cannot measure
IT, you cannot manage IT. The “IT” is CE-HTM and the
World Health Organization (WHO) Medical Device Unit,
led by CE colleague Adriana Velazquez, has taken the lead
in defining CE-HTM, creating appropriate performance
­indicators, and measuring the strength of CE-HTM around
the world. The 2017–18 WHO CE-HTM surveys showed
over 800,000 practitioners in 130 countries. There are
several ongoing initiatives with WHO along with global,
regional, and country CE-HTM societies to define the presence of CE-HTM in the world’s other 100 countries, and to
increase its impact and strength everywhere. This section
joins Worldwide CE in Section 2 to view several of these
initiatives, and tell their stories.
Join us for the ongoing and ever-expanding CE-HTM
role in health care. You will be left with some great new
questions as well as a lot of current and planned solutions.
165
Chapter 28
Introduction to medical
technology management
practices
Yadin Davida, Thomas M. Juddb, Raymond Peter Zambutoc
a
Center for TeleHealth and Biomedical Engineering Department, Texas Children’s Hospital, Houston, TX,
United States, bQuality Assessment, Improvement and Reporting, Kaiser Permanente Georgia Region, Atlanta,
GA, United States, cCEO Technology in Medicine, Inc., Holliston, MA, United States
The quest of every society is to continuously improve the
quality of its members’ lives, through promotion of health,
prevention of disease, and access to an efficient healthcare
delivery system. Many different methods and strategies for
pursuing efficient delivery systems have been tried, and others will be experimented with in the future, but it is evident
that we have not yet found the optimal approach. Health
care ranges from the fight against diseases to the maintenance of physical and mental functioning, and its delivery
largely depends on technology, especially medical technology. Therefore, medical technology management is one of
the most important segments of the healthcare system, and
it is the segment that carries the best potential for clinical
engineers (CEs) to demonstrate their unique expertise and
leadership excellence.
Medical technology contributes to the advancement of
health care in many ways. It contributes to screening of
abnormalities and their risks. It contributes to the diagnosis of clinical signs that identify the nature or the cause or
the extent of the pathology. It contributes to treatment in
the restoration, improvement, and replacement of bodily
function as well as preventing further deterioration or pain
sensation. It contributes to rehabilitation by restoring, replacing, improving, or maintaining physical or mental function impairment. Technology is expected to reduce the risk
of a disease, shorten illness duration, improve the quality
and accuracy of care, increase access to care, and replace
or limit the decay of a person’s functions so and return that
person to a state of quality life. In addition, technology is
expected to contain cost, to enhance healthy behavior, and
to reduce intervention risks. In summary, acquisition of
medical technology is accomplished primarily for the following five reasons:
166
1. To improve diagnostic, therapeutic, or rehabilitation
efficiency
2. To increase the health system’s cost effectiveness or
reimbursement
3. To reduce risk exposure and eliminate errors
4. To attract high-quality professionals
5. To expand the service area or to better serve the beneficiary base
Healthcare delivery systems around the world are going
through major transformations. While knowledge is continuously being created and disseminated at an accelerating rate, the allocation of resources for implementation of
preferred solutions is lagging behind, creating a gap that
could overwhelm the system if left unchecked. This chapter
addresses technology management practices that close this
gap by achieving an efficient and effective methodology for
the assessment and deployment of medical technology.
Technologies in general and medical technology in particular play a significant role in the healthcare transformation. To ensure that technology is safe and effective, there is
a need to understand adequately the potential of technology
and the importance of its associated management methodology and tools. Without such management methodology and
tools, technology function and patient outcomes will be impaired. Forward-looking managers recognize that properly
constructed medical technology management methodologies and tools provide objectives and guideline protocols
for efficient practice and decision-making processes in the
following stages in the technology life cycle:
●
●
●
Strategic technology planning
Technology assessment
Technology acquisition and implementation
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00028-6
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Introduction to medical technology management practices Chapter | 28
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Technology risk management and quality improvement
(QI)
Technology utilization and servicing
Technology value or cost/benefit ratio analysis
The management of assessment and deployment of
safe and effective medical technology lags behind both the
knowledge and practice patterns of management in general.
In the highly complex environment of the healthcare delivery system, the challenge to invest in management methods
and practices has diminished such that the consequences
of medical technology decisions are inadequately factored
into the larger strategy. While this varies from one patient
population to another and from one hospital type to another,
these management tools, where they are used, have a direct impact on patient care outcomes, hospital operations,
and financial efficiency. Only by applying these tools and
methodologies can the system optimize the development of
medical technology and the facilities that house it.
There are three types of managers: those who make
things happen, those who watch things happen, and those
who wonder what happened. This chapter describes the
managerial tools that can facilitate the transformation of a
“watcher” into a “maker.”
Strategic medical technology planning
The healthcare delivery system is going through a transition
that is driven by four major forces: budget, structure, technology, and social expectations. The impact of any one or combination of these forces may change from time to time, as does
their relative significance, creating a result that is the subject
of public debate. It is clear, however, that health care is being
subjected to mounting pressure by the needs to (1) identify its
goals; (2) select and define priorities; (3) allocate resources
more effectively; and (4) achieve system-wide integration.
The healthcare delivery system presents a complex environment wherein policies, facilities, technologies, drugs, information, and a full range of human interventions interact. It is
in this clinical environment that patients in various conditions,
skilled staff, contract labor, and a wide variety of technologies
converge. The dynamics of this swirling environment, as they
relate to medical technology management, include leadership,
resources, competencies, risk exposure, regulations, rate of
change, and the ability to demonstrate impact on outcomes.
Care providers are faced with the ubiquitous presence
of medical technology at the vortex of changing provider
and patient roles compounded by system accessibility
and integration challenges. Society demands, in addition
to user competency, improved quality of care, reduction
in error rates, and containment of expenditures. Without
a systematic approach, this scenario often leaves hospitals
without a clear direction for meeting these expectations.
Short-term cost pressures can drive hospital decisions that
conflict with the other factors.
167
One apparent solution that would bring a sense of order and reason to this volatile environment is to seek ways
for hospitals to more effectively manage their available
technology resources and to do more with less available
capital by only selecting “appropriate” technologies that
have longer and more reliable life cycles. Proven technologies that fit well into their budgets and operations can
be supported and relied upon to provide safe and effective care. Healthcare delivery organizations have begun to
combine strategic technology planning with other technology management activities in programs that effectively
integrate decisions about adoption of newer technologies
with the hospital’s existing technology base—a process
that has resulted in better care outcomes at higher efficiencies. Well-integrated medical technology programs will
steer hospitals through these transition times by improving
performance, eliminating preventable errors, and reducing
operational costs.
The scope of technology to be managed
Technology, as defined by David and Judd (1993), means
merely the use of “tools,” that is, the involvement of any agent
that assists in the performance of a task. In this context, the
technology that has been developed for, and deployed in, the
healthcare delivery system ranges from the “smart” facilities within which care is being provided to the products that
are used in and around the provision of healthcare services.
Technology “tools” have been introduced at an increasing rate
during the past 100 years and include the use of techniques,
instruments, materials, systems, facilities, and information.
Of all the factors and resources that will shape the future of
the health of humankind, the one that most often stretches the
imagination is medical technology. However, medical technology is often blamed for contributing to the escalation of
healthcare costs without receiving recognition for improving access to the system and the quality and efficiency of the
system.
The past decade has shown a trend toward increased legislation in support of more regulations in health care. These
and other pressures will require technology managers to be
familiar with the regulations and to be able to manage a program that demonstrates compliance with these requirements
throughout the life cycle of the technology. If you subscribe
to the saying, “You cannot manage what you do not measure,
and you cannot measure what you do not define,” then the
need for the development of a systematic and comprehensive planning process for technology adoption is obvious. In
terms of defining the scope of technology to be managed, the
healthcare organization must develop a rationale for adoption. Without this most basic tool, the process becomes increasingly randomized overtime until no consistent system
of management can survive. One example of a ranking of
rationale for technology adoption is the following list:
168 SECTION |3 Healthcare technology management
Clinical necessity
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Contribute to meeting/exceeding standard of care
Positively impact care quality or level
Impact life quality
Improve intervention’s accuracy, specificity, reliability,
and/or safety
Reduce disease longevity/length of stay
their interaction with budgeting processes require a unique
set of skills and technical management expertise that is consistent with the characteristics of a mature clinical engineering professional. This expertise facilitates the integration of
clinical objectives with management and technical threads
that permeate the organization. This aspect of the planning
process must include the following elements:
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Operational support
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More effective care/protocol/decision-making
Impact operational efficiency and effectiveness
Impact development or current service offering
Impact liability exposure, contribute to reduction in
errors
Increase compliance with regulations
Reduce dependence on user skill level
Impact supporting departments
Increase utilization rate and reduce maintenance load
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Market preference
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Impact access to care
Increase customers’ convenience and/or satisfaction
Impact organization or service image
Improve return on investment (ROI) or revenue stream
Lower the cost of adoption and ownership
Impact market share
In order for the planning process to maximize the value
it adds, it must include standard elements of analysis and
must be somewhat predictive in several areas where trends
may change over the course of implementation of the plan.
The planning process must include the following elements:
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Strategic planning process
The strategic planning process is the road map for the introduction and development of technology and services, and
their related policies into the core business of the hospital to
maximize the value outputs of the program. The outputs of
this process are measured as changes in cost, quality, performance efficiency, or quality of life. The road map is an
important guideline because it identifies a common vision
for timely response to fundamental needs. The following
key components must be present in the plan to ensure the
optimal allocation of funds needed:
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Regional planning, coordination, and technology
assessment
Strategic technology planning and priority setting
Budget development and approval processes
Technology management and service planning
Technology acquisition
Technology audit and risk management
A technology strategic plan is derived from, and supports,
well-defined clinical objectives. The ability to contribute to
this process and the development of these components and
Creation of a plan to support the facility’s vision and
communicate its process to staff
Periodic review of the alignment between the vision and
strategy
Identification of areas/topics where changes are needed
Determination of priorities and creation of a plan to
meet the objectives
Inclusion in the plan of the details of specific expectations from information technology, medical technology,
and building spaces—transforming experts’ knowledge
into service strategy
Delineation of clinical goals for road map planning,
interaction with operations and capital budgeting processes, acquisition and deployment timing, equipment
asset management, and monitoring and evaluation
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Assess changing clinical goals. The clinical goals are updated annually. For a given year, key hospital participants,
through the strategic planning process, determine the clinical services that the hospital should be offering in its referral
area. These must be projected with accuracy at the outset.
Take into account healthcare trends, demographic and
market-share data, and space and facilities plans.
Analyze the facility’s strengths and weaknesses, goals
and objectives, and opportunities and threats.
Conduct an audit of the existing technology base, including its condition, life expectancy, and utilization
rate.
Audit and project the costs of healthcare providers using
the existing technology, considering turnover of personnel as well as technology.
Integrate assessment and prioritization of new and
emerging technologies.
Ensure strong compliance with and support of anticipated technological and utilization standards.
Review technological trends and their operations impact.
If all of these areas are considered, the outcome of this
process will be the following:
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A coherent plan that supports the objectives outlined in
the organization’s vision for the coming year
Introduction to medical technology management practices Chapter | 28
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A predictable level of technology that is capable of
meeting requirements for a standard level of operation
in the referral area
Offerings of better and more efficacious and consistent
healthcare services
Effective use of limited resources and provision for
growth of the organization’s intellectual property
A strategic technology plan that helps technology managers to match available technical abilities (both existing and new) with clinical requirements and financial
capability
A definition for the level of service expected
Priorities in budgeting for technological adoption and
acquisitions
To accomplish this goal, CEs and technology managers must understand why their institutions’ values and mission are as they are; must pursue knowledge and collect
information that supports their institutions’ strategic plans;
and must be able to translate their operations according to
the strategic planning process utilizing the often limited resources allocated to them. Although a technology manager
might not be assigned to develop an institution’s overall
strategic plan, he or she must understand and be ready to
offer logical and informative input to the hospital management. The CE will be prepared to provide this input in the
following ways:
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By committing to a professional involvement with, and
understanding of, all the hospital services
By understanding technology assessment methodology
and equipment life-cycle functions
By determining the ways in which the hospital’s technological deployment is best evaluated
By articulating justifications and provisions for adoption of new technologies or enhancement of existing
ones
By assisting in providing a review of emerging technological innovations and in determining the impact that
they can have in the hospital. (A good rapport with the
research and development industry facilitates this.)
By visiting the sites of technology development—research or manufacturing—as well as the exhibit areas at
major scientific and medical meetings, because tomorrow’s clinical devices are in the research laboratories
today
By being familiar with the institution and its equipment
users’ ability to assimilate new technology
The past decade has seen a trend toward increased customer expectations, legislation, and regulation in health
care. These developments and financial pressures require
that additional or replacement medical technology be
well anticipated and justified. Proper planning will provide the rationale for sound technology adoption. Today’s
169
­ arketplace demands cost effectiveness, competitiveness,
m
and flexibility from every hospital if it is to survive and
grow. Such demands require that the effective CE be able
to articulate the differences among factors such as clinical
necessity, code compliance, management support, market
preference, and arbitrary decision.
Technology assessment
As medical technology continues to evolve, so does its impact on patient outcomes, hospital operations, and financial
resources. The ability to manage this continual evolution
and its subsequent implications has become a major challenge in all healthcare organizations. To be successful, it
must be an integral part of hospital operations that address
the needs of the patient, and it must smoothly mesh people and technology. The manager who commands knowledge about the organization’s culture, the equipment users’
needs, the existing environment within which equipment
will be applied, equipment engineering, and emerging technological capabilities will be successful at implementing
and managing technological changes.
In the technology assessment phase, the clinical engineering professional needs to wear two hats in order to lead
the team and to contribute to the decision-making process.
The team should incorporate representatives of equipment
users, equipment maintainers, physicians, purchasing or reimbursement managers, administration, and other members
from the institution, as applicable.
Technology audit
With a coherent clinical strategic plan in place, the hospital
can conduct a credible audit. Each major clinical service or
product line must be analyzed to determine how well the
existing technology base supports it and supports the conditions of that technology. A Medical Technology Advisory
Committee (MTAC), consisting of hospital management,
physicians from major specialties, nurses, program managers, and CEs should be appointed to conduct this analysis.
The key steps that should be taken during the audit are as
follows:
1. Develop a hospital-wide complete inventory (i.e., quantity and quality of equipment included), and compare
the existing technology base against known and evolving standard-of-care information, patient-outcome data,
and known equipment problems
2. Collect and review information on technology utilization and assess appropriate use, opportunities for improvement, and reduction of risk level
3. Review technology users’ (physicians, nurses, technologists, and support staff) educational needs as they relate
to the application and servicing of medical equipment
170 SECTION |3 Healthcare technology management
4. Determine appropriate credentialing of users for competence in the application of new technologies, assess
needs, determine whether requirements are being met,
and assess risks involved (credentialing committees
will be the primary group to match clinician skills with
evolving clinical treatment procedures or protocols)
5. Keep current with published clinical protocols and
practice guidelines using available healthcare standards
directories
6. Utilize clinical outcomes data for quality assurance and
risk management program feedback
The audit will allow the gathering of information about
the existing technology base and will enhance the capability of the MTAC to assess the need for new and emerging
technologies as well as the impact of these technologies on
their major clinical services. In this assessment, the following issues should be considered:
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Needs
Value of the technology
Technical validity
Ability to assimilate the technology
Ability to integrate with existing technological platforms
Medical staff satisfaction
Impact on staffing and delivery of care
Impact on facilities
Impact on standards of care and quality
Economic considerations (e.g., reimbursement, l­ ife-cycle
costs)
The committee will then set priorities for equipment
replacement and implementation of new and emerging
technologies, which, over a period of several years, will
guide the acquisitions that provide the desired service developments or enhancements. Priorities will be set based
on the need, risk, cost (acquisition, operational, and maintenance), utilization, and fit with the clinical strategic
plan.
Budget strategies
All of the information collected above will bear on the developing of budget strategies. Strategic technology planning requires a 3–5-year long-range capital spending plan.
The MTAC, as appropriate, will provide key information regarding capital budget requests and make recommendations
to the capital budget committee (CBC) each year. There is a
threefold purpose for the capital budgeting process:
1. To develop procedures to solicit and review technology
requests
2. To coordinate capital expenditures with available
resources
3. To determine optimal financing methods for acquisition
The MTAC should review the final capital budget listing
in order to recommend when the items should be purchased
during the next year and, if possible, to determine if there
should be centralized, coordinated acquisition processes
planned for similar items from different departments.
Long-term capital equipment budgets are derived from
the analysis of replacement life cycles, organization financial conditions, annual operations support costs (including
service, upgrades, and repairs), and true needs justification
coupled with a 3-year budget cycle. Each item of equipment
listed on the budget is highlighted as either a replacement
or a new requirement for an existing or new program. The
replacement life cycle is modified from standard tables by
factors such as average duty cycles and utilization and escalating repair and service history. Economic justifications
for clinical services revolve around a “make or buy” decision—whether the service should be performed by the clinical services in-house or should just be purchased from the
commercial market. The needs justification usually centers
on the capabilities of the clinical staff.
Prerequisites for medical technology
assessment
Medical technology has a major strategic factor in positioning the hospital and its perception in the competitive environment of healthcare providers. Numerous dazzling new
biomedical devices and systems are continuously being
introduced. They are being introduced at a time when the
pressure on hospitals to contain expenditures is mounting.
Therefore, forecasting the deployment of medical technology and the capacity to continuously evaluate its impact on
the hospital require that the hospital be willing to make the
commitment and to provide the support such a program. An
in-house “champion” is needed in order to provide the leadership that continuously and objectively plans. This figure
might use additional in-house or independent expertise as
needed. To focus the function of this program in large, academically affiliated, and government hospitals, the position
of a chief technology officer (CTO) is becoming justifiable.
While executives have traditionally relied on members of
their staffs to produce objective analyses of the hospital’s
technological needs, they nevertheless are too often subjected to the biases of various interest groups, including
marketing and vendor appeals. More than one executive has
made a purchasing decision for biomedical technology only
to discover later that some needed or expected features were
not included with the installation or that those features were
not yet approved for delivery. These features have come to
be known as “futureware” or “vaporware.” Or, alternatively,
it may be discovered that the installation has not been adequately planned, ending therefore as a disturbing, unscheduled, expensive, and long undertaking.
Introduction to medical technology management practices Chapter | 28
Most hospitals that will be providers of quality care will
be conducting technology assessment activities in order to
be able to project needs for new assets and to efficiently
manage existing assets within the limits of the available
resources. In order to be effective, an interdisciplinary approach and a cooperative attitude are required because the
task is complex. The ability to integrate information from
disciplines such as clinical, technical, financial, administrative, and facilities in a timely and objective manner is critical to the success of the assessment.
Medical technology includes medical and surgical
procedures, drugs, equipment and facilities, and the organizational and supportive systems within which care is
provided. This definition focuses on equipment, systems,
facilities, and procedures (but not drugs). There are considered to be two tiers of investigation in medical technology
assessment, given that it is the evaluation of the effectiveness of equipment, systems, and procedures in treating or
preventing disease or injury:
1. Primary: clinical safety and effectiveness in terms of
physical indicators of patient care outcome.
2. Secondary: synthesizing the results of clinical impact to
project financial outcome and reimbursement decisions
for payers.
This chapter also emphasizes medical equipment management as an essential element of medical technology
management, including the notion of the skills to forecast
medical equipment changes and the impact of those changes
on the hospital market position. While most consideration is
usually given to capital asset management (see Chapter 35)
when it comes to medical equipment, one should not exclude
the accessories, supplies, and disposables from the medical
equipment management program. Another often-overlooked
factor in medical equipment management is the impact of
the maturity of the technology on education and training as
well as on servicing. Equipment that is highly innovative,
in development or in clinical trials, will have a far different
learning curve for users as well as maintainers than equipment based on more mature technologies.
As mentioned earlier, technology assessment is a function
of technology planning that begins with the assessment of the
hospital’s existing technology base. Technology assessment
is, rather than an equipment comparison, a major, new function of a clinical engineering department. It is important that
CEs be well prepared for the challenge. They must have a full
understanding of the missions of their particular hospitals, a
familiarity with the healthcare delivery system, and the cooperation of the hospital administration and the medical staff.
To maximize their effectiveness, CEs need access to database
services and libraries; the ability to visit scientific and clinical
exhibits; the capability to establish an industrial network; and
a relationship with peers throughout the country.
The need for clinical engineering involvement in such a
program is evident when one considers the problems typically encountered:
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Recently purchased equipment, or its functions, is
underused.
Users experience problems with equipment.
Maintenance costs are excessive.
The facility is unable to comply with the standards or
guidelines (e.g., JCAHO requirements) for equipment
management.
A high percent of equipment awaits repair.
Training is inefficient because of a shortage of allied
health professionals.
A deeper look at these symptoms using a proper technology assessment analysis likely would reveal the following:
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Technology assessment program
Increasingly more hospitals are faced with capital or equipment requests that are much larger than the capital budget.
The most difficult decision, then, is the one that matches
clinical needs with financial capability. In that process,
the following questions are often asked: How can a hospital avoid costly technology mistakes? How can a hospital
wisely target capital dollars for technology? How can a hospital avoid medical staff conflicts as they relate to technology? How can a hospital control equipment-related risks?
How can a hospital maximize the useful life of the equipment or systems while minimizing the cost of ownership?
171
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The lack of a central clearinghouse to collect, index, and
monitor all technology-related information for future
planning purposes
The absence of procedures for identifying emerging
technologies for potential acquisition
The lack of a systematic plan for conducting technology assessment, and thus an inability to maximize
the benefits from deployment of available technology
The inability to benefit from the organization’s own previous experience with a particular type of technology
The random replacement of medical technologies, rather
than a systematic plan based on a set of well-developed
criteria
The failure to integrate technology acquisition into the
strategic and capital planning of the hospital
The following scenario suggests one way to address
these problems and symptoms.
To address these issues, efforts to develop a technology
assessment plan are initiated with the following objectives:
1. To accumulate information on medical equipment
2. To facilitate systematic planning
3. To create an administrative structure supporting the assessment program and its methodology
172 SECTION |3 Healthcare technology management
4. To monitor the replacement of outdated technology
5. To improve the capital budget process by focusing on
long-term needs relative to the acquisition of medical
equipment
This program, and specifically the collection of up to
date, pertinent information, requires the expenditures of
certain resources and active participation in a network of
colleagues who practice in this field. Membership in organizations and societies that provide such information should
be considered, as should subscriptions to computerized databases and printed sources.
The Director of Clinical Engineering (DCE) chairs the
MTAC, while another CE from the same department serves
as the committee’s designated technical coordinator for a
specific task force. Once the committee accepts a request
from an individual user, it identifies other users who might
have an interest in that equipment or system, and it authorizes the technical coordinator to assemble a task force consisting of users who the committee has identified. This task
force then serves as an ad hoc committee that is responsible
for the establishment of performance criteria that will be
used during the assessment of the equipment described on
a request for review (RR) form. During any specific period,
there might be multiple task forces, each focusing on a specific equipment protocol.
The task force coordinator cooperates with the material
management department in conducting a market survey, in
obtaining the specified equipment for evaluation purposes,
and in scheduling vendor-provided in-service training. The
scheduling of the in-service training for the users can be
highly frustrating at times, as the shortage of allied health
professionals reduces availability for training while increasing the need for training due to higher staff turnover rate. It
is highly recommended, therefore, that this activity be well
coordinated with the users’ group training coordinator.
After establishment of a task force, the committee’s
technical coordinator analyzes the evaluation objectives and
devises appropriate technical tests, in accordance with recommendations from the taskforce. Only equipment that has
successfully passed technical tests will proceed to a clinical
trial. During the clinical trials, the clinical coordinator collects and then reports to the task force the summary of experiences gained. The technical coordinator then combines
the results from the technical tests and the clinical trials into
a summary report and prepares the task force’s recommendations for MTAC approval. In these roles, the CE serves
as the technical coordinator and as the clinical coordinator bridging the gap between the clinical and the technical
needs of the hospital.
The technology assessment process begins with a department or individual filling out two forms: (1) an RR form
(Fig. 1) and (2) a capital asset request (CAR) form. These
forms are submitted to the hospital’s product standards
committee, which determines whether an assessment process is to be initiated, and the priority for its completion. It
also determines whether a previously established standard
for this equipment already exists.
In the RR form, the originator delineates the rationale
for acquiring the medical device. For example, the way
the item will improve patient care; generate cost savings,
support the quality of service; and provide ease of use, as
well as who the primary user will be. In the CAR form, the
originator describes the item, estimates its cost, and offers
some justification for its purchase. The CAR is then routed
to the capital budget office for review. During this process,
the optimal financing method for acquisition is determined.
If funding is secured, the CAR is routed to the materials
management department where, together with the RR, it
will be processed.
The rationale for having the RR accompany the CAR is
to ensure that pricing information is included as part of the
assessment process. The CAR is the device by which the
purchasing department sends product requests for bid. Any
RR that is received without a CAR, or any CAR involving
medical equipment that is received without a RR is returned
to the originator without action. Both forms are then sent to
the clinical engineering department, where a full-time employee designated as a coordinator reviews and prioritizes
various requests for the committee to review.
Both forms must be sent to the MTAC if the item requested is not currently used by the hospital or if it does
not conform to previously adopted hospital standards. The
committee has the authority to recommend either acceptance or rejection of any request, based on a consensus of its
members. If the request is approved by the MTAC, then the
requested technology or equipment will be evaluated using
technical and performance standards. Upon completion of
the review, a recommendation is returned to the hospital’s
product standards committee, which reviews the results of
the technology assessment, determines whether the particular product is suitable as a hospital standard, and decides
whether it should be purchased. If approved, the request to
purchase will be reviewed by the CBC to determine whether
the required expenditure fits within the available financial
resources of the institution, and whether or when it might
be feasible to make the purchase. To ensure coordination
of the technology assessment program, the chairman of the
MTAC also serves as a permanent member of the hospital’s
CBC. Accordingly, there is a planned integration between
technology assessment and budget decisions.
As a footnote to this example, it is important that those
involved in the process understand fully the way that standards are developed, the way they are used and modified,
and, most significantly, the effect of these activities on the
entire spectrum of health-related matters. Some standards
address, for example, protection of the power distribution
Introduction to medical technology management practices Chapter | 28
173
FIG. 1 Request for review (RR) form.
system in the healthcare facility; protection of individuals
from radiation sources, such as lasers and X-rays; and protection of the environment from hazardous substances (see
Chapter 116). The practicing professional should fully appreciate the intent of standards in general and should participate in their development and use.
Technology assessment and clinical
engineering
Clinical engineering departments are at the threshold of
a revolution toward the comprehensive management of
all ­healthcare technology. Increasing pressures for greater
a­ ttention to the quality, fiscal containment, and risk mitigation and error reduction should be matched with skillful and
competent management focusing on the characteristics of
healthcare technology. A well-organized program will have
a significant impact on the hospital’s bottom line, which
is a highly desirable outcome in today’s financial climate.
Hospitals and vendors that operate with organized asset management programs are already benefiting from the involvement of clinical engineering professionals. The role of CEs
is threaded throughout the program as it relates to medical
equipment and systems. CEs contribute to, and participate in,
every phase of the equipment life cycle, from the capital budget planning, the equipment evaluation, and the performance
174 SECTION |3 Healthcare technology management
validation, to the acceptance testing, user training, inventory
control, repair and maintenance services, and incident investigation. Their involvement improves the planning for the
new (and the management of the existing) equipment inventory, thus impacting integration, quality, finance, and risk.
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Device evaluation
One of the best methods of ensuring that the contribution a
technology makes is valuable to the hospital is to analyze carefully each medical device in preparation for its assimilation
into the hospital operations. This process of equipment evaluation provides information that can be used to screen unacceptable performance, by either the vendor or the equipment,
before it becomes a problem for the hospital (see Chapter 33).
The evaluation process consists of technical, clinical, financial, and operational aspects. These aspects were evaluated earlier, as described in the MTAC function; however,
the emphasis here is on the CE’s responsibility. It is assumed
that in order to fulfill these duties, the CE is familiar with
the emerging and evolving technologies and can translate
the clinical needs of the users into an effective and comprehensive bid specification document. The document should
be clear, facilitating a competitive bidding environment and
comparison of vendors and their wares. This document sets
the whole equipment evaluation and selection into motion.
Validation criteria for key elements, such as system configuration, extent of facility preparation and operation disturbance, performance requirements, users and maintainers
training, warranty, documentation, delivery schedule, and
implementation plan, should be spelled out. Cost of service
support and price for future upgrades need to be locked.
After the vendor has responded to the informal request
or the request for proposal (RFP) information, the clinical
engineering department will be responsible for evaluating
the technical responses, while the materials management
department evaluates the financial responses.
In translating clinical needs into a specification list, key
features or “must have” attributes of the desired device are
identified. In practice, clinical engineering and materials
management develop a “must have” list and an “extras” list.
The “extras” list contains features that could tip the decision
in favor of one vendor, all other factors being equal. These
specification lists are sent to the vendor and are effective in
a self-elimination process that results in a time savings for
the hospital.
Once the “must have” attributes have been satisfied, the
remaining “candidate” devices are evaluated technically
and the “extras” are considered. This is accomplished by
assigning a weighing factor, for example, 0–5, to denote the
relative importance of each of the desired attributes. The
relative ability of each device to meet the defined requirements is then rated. Consider the following examples of
attributes:
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Accuracy and repeatability
Ease of use
Reliability
Expected user’s skill level
Serviceability and warranty
Performance
Compatibility and interchangeability
Ability to be upgraded
Safety
Cost
Each of these attributes is important, but some are more
important than others. In assigning the weighing factors,
the CE must take into account the relative importance of
each of these attributes. He or she should create a bidding
environment that will enable a direct comparison of vendors. Therefore, the RFP should provide details of delivery
training and installation, a detailed description of the “must
haves” and the “extras,” and the cost of service and upgrades,
as well as identifying recourse for vendor deficiencies.
The performance of the acceptance testing accomplishes
the following:
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Verifies by incoming inspection that each medical device
received is capable of performing its designed function
Obtains baseline measures that can be used later to resolve specified problems
Assures compliance with the equipment management
program, the relevant factors of which include:
Verification that the chosen vendor has delivered a complete system with all of the accessories and other needed
supplies
Documentation of full compliance with terms that were
prescribed in the conditions of sale and agreed upon
when the bid was awarded
Initiation of an asset control record by the clinical engineering department
This last item is the point where the equipment enters
into the equipment maintenance program, the warranty
period is initiated (if applicable), and testing criteria are
documented.
The review of each of the vendors’ responses, the performance of comparative tests and value analysis, and the
performance of acceptance testing are the steps that will
reduce procurement costs and problems. They will prevent
problems such as dissatisfaction, cost overrun, postimplementation surprises, unplanned service costs, slow resolution or delayed response, prolonged startup, performance
gaps, overcharges, and unauthorized promises.
Existing inventory utilization should be monitored periodically. The utilization level can be measured and compared with the budgeted level. The utilization rate of existing
inventory is a good indicator in justifying additional capital
requests.
Introduction to medical technology management practices Chapter | 28
Risk reduction
Significant progress in controlling risk has been achieved
with the early implementation of an equipment management program. With the development of the dynamic
equipment risk factors and associated failure analysis techniques, proactive techniques to contain risk can now be
implemented (see Chapter 55). These techniques should be
used for assessing new equipment as well as for the management of existing inventory. Error avoidance and lessons
learned from analysis of near-miss events are useful tools
for further reduction of potential risk (see Chapter 54).
An organization may have a variety of objectives, such
as profit, growth, and the performance of a public service.
However, a fundamental management commitment to
minimizing the adverse effect of accidental loss to an organization is the founding principle of a risk management
program. Risk management is the process of making and
carrying out decisions that will minimize adverse incidents.
Such a program requires development of criteria, identification of problems, and action to reduce those problems.
The medical technology management program participates in the organization effort early on and throughout the
equipment life cycle by assessing equipment performance.
Impact of risk and quality is monitored prior to purchase
decision; during installation, maintenance, and repair; and
as indicators for disposition or replacement. Faulty design,
poor manufacturing, lack of compatibility with existing
technology, and mismatch with users’ skills or needs can be
corrected during the equipment selection and incoming inspection. On the other hand, incorrect operating procedures,
the lack of a (or an inadequate) maintenance program, or
faulty repair work can be corrected by failure analysis and
corrective action based on the information collection and
an evaluation system that has been described in the JCAHO
Plant, Technology, and Safety Management publication.
The collection of equipment failure analysis information
over several years indicates that equipment risk factor is dynamic. The dynamic equipment risk factor is a modification
of a static factor that is assigned to a medical device when it
first enters the equipment management program. This static
factor is being modified, continuously, over its life cycle by
risk factors that derive from information collected about the
equipment performance experiences.
Periodically, a summary report of significant equipmentrelated performance is prepared. The report’s data comprise
elements that show
1. The ratio of completed to scheduled inspections.
2. The number and percentage of devices that fail to pass
the prescribed inspection.
3. The number and percentage of devices for which a user’s complaint was registered, even if no problem was
found.
175
4. The number and percentage of devices that show physical damage.
5. Devices that were involved in an unusual event, that is,
an accident. Each element is counted as an event, and
thresholds above which unsafe conditions may exist can
be determined.
Each individual device has its own history and thus
its own risk level. The failure elements report allows the
structured progression from considering an isolated device
performance to clustering equipment users’ behavior and
their interaction with the devices. In essence, this change is
a translation of an equipment repair service into a technology management function that aids the hospital in selecting
better equipment, establishing more effective users training
that is proportional to measured risk, scheduling maintenance more efficiently, and prioritizing capital replacement.
The trending of this information overtime will guide the annual review of the effectiveness of the clinical engineering
program.
The program should be complemented with a professional communication between the CE and the various
manufacturers. It will result in the availability of better and
safer products, less complex operation and maintenance
instructions, more effective in-service training, and rapid
resolution when action is needed.
A well-managed equipment program provides a systematic approach to controlling technology-related risks in all
of its phases, from the needs analysis to equipment disposition. Equipment-related data elements provide qualitative
criteria for evaluating equipment and users performance in
relation to equipment use. Through the development of a
failure analysis program, continuous improvement in equipment performance and simultaneous reduction of risk potential in the clinical environment is achievable.
Technical asset management
An accountable, systematic approach will assure that costeffective, efficacious, safe, and appropriate equipment is
available to meet the demands of quality patient care. Such
an approach requires that resources committed to the acquisition and the management of medical equipment will be
monitored. It is assumed that the financial group manages
cost accounting. The medical equipment management program’s purpose is to ensure that a process is dedicated to the
management of technology.
The MTAC provides a comprehensive and integrated
approach to the analysis, implementation, and management
of new or additional medical technology. It will turn a fragmented and unpredictable decision-making process into a
new technique that is well conceived and that supports the
hospital’s mission. Bold action is required in order to achieve
this, including gathering knowledge regarding the trends in
176 SECTION |3 Healthcare technology management
medical technology; the development of decision criteria and
analytical techniques; the interaction with budget strategies
and financial alternatives; the implementation of the capital
assets management program; the determination of facility design and long-range services impacts; and the coordination of
technology and assets information into hospital operations.
This technique will fill many gaps in database reports that are
critical to effective operation and hospital performance. Once
it becomes integrated, this process may impact a broad range
of parameters, including monthly profit and loss, employee
productivity, cost accounting, departmental utilization, the
effect of physicians’ practice patterns on resources, use of
hospital resources in relation to patient outcome, analysis of
charges, comparative data from other hospitals, profitability
forecasts, and procedures pricing.
Asset management
The attributes of ideal asset management are demonstrated
through the continuous availability of robust and reliable
equipment and systems at the lowest possible life-cycle
cost, whenever and wherever needed (see Chapter 35). Asset
management attributes are outlined below.
1. Acquisition and equipment life cycle
(a) Involvement in the process of determining the need
for equipment (both short- and long-term needs)
(b) Preparation of bid specifications and supporting
negotiation
(c) Careful and detailed prepurchase evaluation and
selection
(d) Development and performance of acceptance testing
(e) Technical support over the equipment’s life cycle
(f) Recommendations for, and assistance in, its disposition by replacement, refurbishment, upgrade, or declared obsolescence
2. Technical support
(a) Establishment of complete equipment inventory
with control records, files containing operating and
service manuals, and testing and quality-assurance
indicators
(b) Incoming equipment acceptance testing and application of a control-number tag
(c) Hazard and recall notification and incidents handling
system
(d) Periodic, as well as preventive, maintenance of all
equipment, performed by either hospital personnel
or outside vendors
(e) Equipment repair, including management and integration of service vendor activities
(f) Day-to-day assistance to equipment users promoting
improvement in clinical use of equipment (e.g., periodic “equipment rounds” in the diagnostic-imaging
department)
3. Information and Training
(a) Dissemination of users of manuals and other labels
(b) Processing and tracking hazard and recall data
(c) Initial and ongoing training of all clinical personnel
in the safe and effective use of patient care equipment on at least an annual basis
(d) Investigation of incidents, prompt reporting as appropriate, equipment-related incidents, hazards, and
problems. Methods to avoid learned errors should be
discussed during staff training
4. Monitoring and evaluation
(a) Development of, implementation of, and participation in quality assurance and risk management
activities
(b) Periodic assessment of the equipment management
program’s effectiveness with the combination of objective and subjective data
(c) Ensuring of effective communication and feedback
between relevant personnel in the hospital (e.g.,
clinical staff, purchasing, clinical engineering, hospital administration, and equipment vendors). It is
important to focus all service-related communication between hospital departments and vendors in
the clinical engineering department
5. Documentation of program activities described above
to meet regulatory, accreditation, and problem solving
requirements and to minimize liability
A clinical engineering program, through outstanding
performance in equipment management, will win the support of the hospital and will be asked to be involved in the
full range of technology management activities, including:
●
●
●
●
●
An equipment control program that encompasses routine
performance testing, inspection, periodic and preventive
maintenance, on-demand repair services, incidents investigation, and actions on recalls and hazards
Multidisciplinary involvement in equipment acquisition and replacement decisions; development of new
services; and planning of new construction and major
renovations, including intensive participation by clinical engineering, materials management, and finance
departments
Training programs for all users of patient care equipment
QI, as it relates to technology use
Technology-related risk management
Clinical engineering needs
Because medical assets, the technology, the information,
and their interaction with users are mission critical, professional management review is expected to guide this process.
Clinical engineering professionals have the skills and the
Introduction to medical technology management practices Chapter | 28
competency to provide this service. However, an effective
program requires that administrative and clinical personnel
have a clear vision of the program deliverables and ROI.
The deliverables must be well documented and periodically
reported, highlighting changes in medical assets characteristics and performance, clinical engineering personnel
development and turnover rate, risk mitigation results, cost
containment achieved, customer satisfaction, and participation in scientific publications.
To deliver all of these items, a clinical engineering program requires strong and capable leadership, commitment
of budget for personnel, test equipment, and appropriate space. Clinical engineering leadership must be able to
identify the needs for a quality program and to determine
the impact if the expected level of fiscal support is not obtained. To accomplish this, workload and budget allocations per unit of service must be developed and established
for the organization and for clinical engineering functions.
Because medical assets management consists of a variety of
tasks, individual impact and alternatives should be studied
and presented to management.
A successful clinical engineering program is largely dependent on adequate budgetary support for training, administrative overhead, subscription to technical services, and
access to supplies. Strong relationships with peers in other
organizations, including professional societies and vendors,
177
should be encouraged, and information technologies such
as computer hardware and software programs are necessary.
Within the organization, there should be a demonstration of strong support for the clinical engineering program
through clear and immediate communications and involvement of members of the program in space and equipment
planning, purchasing decisions, and service contract review. Organizations that have adopted this approach have
harvested the benefits of planting and nourishing the seeds
of optimal medical technology management.
Reference
David, Y., Judd, T.M., 1993. Medical Technology Management.
Biophysical Measurement Series. SpaceLabs Medical, Redmond, WA.
Further Information
Andrade, J.D., 1994. Medical and Biological Engineering in the Future of
Health Care. University of Utah Press, Salt Lake City, UT.
Bronzino, J.D., 1992. Management of Medical Technology: A Primer for
Clinical Engineers. Butterworth-Heineman, Boston, MA.
Bronzino, J.D., Smith, V.H., Wade, M.L., 1991. Medical Technology and
Society: An Interdisciplinary Perspective. MIT Press, Cambridge,
MA.
Reisner, S.J., 1978. Medicine and the Reign of Technology. Cambridge
University Press, New York.
Chapter 29
Good management practices
(GMP) for medical equipment/
leadership
Thomas M. Judda,b, Mario Castañedac, Antonio Hernandezd
a
Clinical Engineering Division, IFMBE, Marietta, GA, United States, bHealth & Information Technology &
Quality, The Permanente Journal, Portland, OR, United States, cPresident, HealthiTek, Inc., San Rafael, CA,
United States, dConsultant on Healthcare Technology, Washington, DC, United States
Situation
Assessment
Clinical engineering (CE) and health technology management (HTM) play a critical role in worldwide management
of health technologies (HT). With increasing reliance by
developing countries on HT, enhanced recognition of this
role by health leaders in 194 World Health Organization
(WHO) member states will be vital in coming years. The
global CE-HTM community must be prepared to ensure
strong medical device management practices to meet these
expectations.
CE-HTM global practitioners
Background
WHO’s 2007 Resolution on HT stated that “Health technologies (WHO Medical Device Unit, n.d.)—defined as
the application of organized knowledge and skills in the
form of (medical) devices, medicines, vaccines, procedures and systems developed to solve a health problem
and improve quality of life—equip healthcare providers
with tools are indispensable for effective and efficient
prevention, diagnosis, treatment and rehabilitation and attainment of internationally agreed health-related development goals, including those contained in the Millennium
Declaration …” WHO then noted (Clinical EngineeringHTM, n.d.) critically that “trained and qualified biomedical engineering professionals are required to design,
evaluate, regulate, maintain and manage medical devices,
and train on their safe use in health systems around the
world.” And that “this area is often referred to as CE
(WHO, n.d.-a) or HTM.”
178
In 2017–18, WHO conducted surveys of CE-HTM professionals (WHO, n.d.-c), and found over 800,000 practitioners
reported globally—with the data concentrated from 130
countries (IFMBE Clinical Engineering Division (CED),
2018). HT (and medical devices) must be managed to ensure full clinical benefit and expected financial return on
investment (ROI) (IFMBE Clinical Engineering Division
(CED), 2018).
CE-HTM success stories
A 2018 study, with active links, shows 400 case studies
from 125 countries where management of medical devices
made a positive difference over the past 12 years (IFMBE
Clinical Engineering Division (CED), 2018). This CE success story project has been developed by the global CE
Society/Federation, called IFMBE (IFMBE = International
Federation for Medical and Biological Engineering, n.d.)
Clinical Engineering Division (CED) (IFMBE Clinical
Engineering Division, n.d.).
Global CE day
IFMBE CED also began celebrating Global CE Day
(GCED) on October 21, 2015 that has become an annual
event around the world focusing recognition on the many
contributions CEs make every day.
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00029-8
Copyright © 2020 Elsevier Inc. All rights reserved.
Good management practices (GMP) for medical equipment/leadership Chapter | 29 179
In 2016, GCED held programs in 20 countries and had
70,000 social media hits; in 2018, GCED expanded to celebrations in over 40 countries and had nearly 320,000 social media
touches! Including streaming video, see http://global.icehtmc.
com/ for videos and other materials from these events.
Key parameters to measure GMP
External—as identified by WHO (WHO Medical Device
Unit, n.d.) and IFMBE CED (IFMBE Clinical Engineering
Division (CED), 2018; IFMBE Clinical Engineering
Division, n.d.)
1. Recognition of CE-HTM at health leader level, for example, HT unit for Ministry of Health (MOH) (IFMBE
Clinical Engineering Division (CED), 2018; IFMBE
Clinical Engineering Division, n.d.)
2. Patient clinical outcomes linked to HT and CE-HTM
(IFMBE Clinical Engineering Division (CED), 2018;
IFMBE Clinical Engineering Division, n.d.)
3. Patient safety measures linked to HT and CE-HTM
(IFMBE Clinical Engineering Division (CED), 2018;
IFMBE Clinical Engineering Division, n.d.)
4. CE-HTM and digital medicine, aka eHealth (WHO
Medical Device Unit, n.d.; IFMBE Clinical Engineering
Division (CED), 2018; IFMBE Clinical Engineering
Division, n.d.)
5. Financial ROI of CE-HTM (IFMBE Clinical Engineering
Division (CED), 2018; IFMBE Clinical Engineering
Division, n.d.)
6. HT regulation and CE-HTM (WHO Medical Device
Unit, n.d.; IFMBE Clinical Engineering Division (CED),
2018; IFMBE Clinical Engineering Division, n.d.)
7. Innovation of HT processes (IFMBE Clinical
Engineering Division (CED), 2018; IFMBE Clinical
Engineering Division, n.d.)
8. CE-HTM links to healthcare organization accreditation
(IFMBE Clinical Engineering Division (CED), 2018;
IFMBE Clinical Engineering Division, n.d.)
Internal—as identified by WHO (WHO Medical Device
Unit, n.d.) and IFMBE CED (IFMBE Clinical Engineering
Division (CED), 2018; IFMBE Clinical Engineering
Division, n.d.)
9. Body of practice/body of knowledge (IFMBE Clinical
Engineering Division (CED), 2018; IFMBE Clinical
Engineering Division, n.d.)
a. WHO Biomedical Engineering Human Resources
Book, 2017 (WHO Medical Device Unit, n.d.)
b. Education and training (IFMBE Clinical Engineering
Division (CED), 2018; IFMBE Clinical Engineering
Division, n.d.)
c. Education
accreditation
(IFMBE
Clinical
Engineering Division (CED), 2018; IFMBE Clinical
Engineering Division, n.d.)
10. Professional certification/registration (IFMBE Clinical
Engineering Division (CED), 2018; IFMBE Clinical
Engineering Division, n.d.)
11. CE-HTM organizational models (IFMBE Clinical
Engineering Division (CED), 2018; IFMBE Clinical
Engineering Division, n.d.)
a. Public hospitals
b. Private hospitals
12. Medical device design (IFMBE Clinical Engineering
Division (CED), 2018; IFMBE Clinical Engineering
Division, n.d.)
a. for low resource settings
b. for LMIC (WHO Medical Device Unit, n.d.) (lowand-middle-income countries) settings
13. CE-HTM publications (IFMBE Clinical Engineering
Division (CED), 2018; IFMBE Clinical Engineering
Division, n.d.)
a. Global CE journal
b. Other notable global healthcare journals
14. National/regional CE professional societies (IFMBE
Clinical Engineering Division (CED), 2018; IFMBE
Clinical Engineering Division, n.d.)
a. Partnering with other healthcare leadership-related
organizations
15. WHO HT tools (WHO Medical Device Unit, n.d.)
a. Evidence-based cancer treatment and HT
b. Evidence-based maternal child health and HT
c. Other
16. CE and HT assessment (IFMBE Clinical Engineering
Division (CED), 2018; IFMBE Clinical Engineering
Division, n.d.)
Recommendation(s)
IFMBE CED has gathered evidence with WHO about
these external and internal parameters for measuring GMP
for medical equipment leadership. The best organizations
make use of as many of these parameters as possible to
demonstrate CE-HTM optimal l­ eadership. In 2019, IFMBE
CED, in coordination with WHO (Clinical EngineeringHTM, n.d.), plans to partner with our global healthcare
colleagues to take the collection of these evidence-based
CE success stories to MOH leaders in 175 countries. The
success story case studies have six categories—­including
access, innovation, health systems, management,
e-­technology, and quality and safety—and together demonstrate potential solutions to many healthcare challenges
around the world.
180 SECTION | 3 Healthcare technology management
References
Clinical Engineering-HTM, n.d. http://www.who.int/medical_devices/
support/en/.
IFMBE = International Federation for Medical and Biological Engineering,
n.d. http://ifmbe.org/.
IFMBE Clinical Engineering Division, n.d. http://cedglobal.org/; CED
Board and Collaborators, and 2018-2021 CED Projects, http://cedglobal.org/organization-and-teams/.
IFMBE Clinical Engineering Division (CED), 2018. Global CE success
stories. Glob. Clin. Eng. J. 1 (1). https://globalce.org/index.php/
GlobalCE.
WHO, n.d.-a. http://www.who.int/medical_devices/management_use/en/.
WHO,
n.d.-c.
http://www.who.int/medical_devices/BME_Global_
Survey_Update_27Agu18.xlsx?ua=1.
WHO Medical Device Unit, n.d. http://www.who.int/medical_devices/
definitions/en/ and http://www.who.int/medical_devices/resolution_
wha60_29-en1.pdf?ua=1.
Further reading
WHO, n.d.-b. https://extranet.who.int/dataform/survey/index/sid/155764.
Chapter 30
Healthcare strategic planning using
technology assessment
Paula Berrioa, Andrea Garcia Ibarrab, Beatriz Galeanoc
a
Clinical Engineering Department, Hospital Pablo Tobón Uribe, Medellin, Colombia, bDrugs and Health Technology Department, MoH Colombia,
Bogotá, Colombia, cUniversidad Pontificia Bolivariana, Medellín, Colombia
The beginning of the healthcare technology cycle is the
assessment of the clinical needs and planning of technological resources. These directly impact care services and
therefore patients. This work needs the clinical engineers
participation, because it requires knowledge of biomedical
technology and understanding clinical procedures and impact on the organization , to help to weigh the relevance of
resources allocation. Typically, the list of needs is usually
long with a lot of requirements, and is not possible to have
all, because of the resources constrain, so it is necessary
to prioritize according to institutional strategic plans, annual operating plans, the evaluation of obsolete technology
which requires replacement and particular goals identified
by an interdisciplinary teamwork with nurse and physians
chiefs of healthcare services and managers.
Organizational strategic plan
Organizational strategic planning is the deliberate and systematic decision- making process, developed to anticipate
the organization against the internal and external changes
that can affect it an guarantee the continuity of the operation. this planning is that it is projected in the long term, at
least in terms of its effects and consequences for the institution, because it is not advisable to subject the company to
constant changes without having periods of stabilization and
measurement of the results of the decisions taken. However,
these periods can be up to 1 year in case the sector or conditions outside the company are highly changing. Another
characteristic of planning is oriented toward the relationship
between the company and its environment, for which a detailed analysis of them must be done and finally, it includes
the company as a whole and includes all its resources to
obtain the synergic effect of all the capacity and potential of
the company to accomplishes the goals defined in the plan.
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00030-4
Copyright © 2020 Elsevier Inc. All rights reserved.
The stages of organizational strategic planning are
●
●
●
●
●
●
determination of business objectives, based on the mission and vision;
external environmental analysis;
internal organizational analysis;
formulation of strategic alternatives and choice of
strategy;
preparation of strategic planning;
implementation of tactical and operational plans.
Once the strategic planning of the organization is done,
one of the most important parts is the Implementation of
tactical and operational plans, which must include the
­healthcare technology strategic planning as a fundamental part of the healthcare services: “The health system that
consisted mainly of the doctor ‘on horseback and with
errors’ is gone forever, replaced by a technologically sophisticated clinical staff that operates mainly in ‘modern’
hospitals designed to accommodate the new medical technology” (Yadin and Judd, 2000).
We can then say that the strategic planning of the
technology is a developed process that allows generating a plan that contains the needs of incorporation and
management of technology, in accordance with the organizational strategy. To do this, you must know the organizational planning and clinical planning as part of the
process inputs.
The strategic planning of the technology is important
insofar as it allows to generate in an orderly manner a plan
for the incorporation of technology and its management,
based on the needs of the organization, the impact, and the
limitations of existing resources. In turn, it allows the management to know in advance the needs, the prioritization
criteria, and guarantee the flow of resources to comply with
the execution of the plan (see Fig. 1).
181
182 SECTION | 3 Healthcare technology management
Services growing and services opening
Technology
incorporation
strategic
planning
Technology replacement planning
Regulation
Technology surveillance and HTA
FIG. 1 Healthcare technology strategic planning inputs.
From the perspective of risk management, it is also critical to carry out the strategic planning of incorporation and
management of technology in the institutions providing
healthcare services, since the dependence of the same for
the provision of services generates risks that must be mitigated, such as:
●
●
●
●
Risks for people due to nonavailability of technology, nonsatisfaction of healthcare needs or inadequate
functioning, related to nonplanning of incorporation or
maintenance of technology.
Financial risks for the institution related to unbudgeted
resources flow or lost profit due to the failure or need to
replace a technology.
Risk of legal breach by changing regulations related to
the renewal or acquisition of technology.
Risks to the image of the institution due to the materialization of risks with people and legal breaches.
Inputs for strategic planning
To ensure the coherence of the technology necessary for the
provision of the services projected by the institution, its incorporation must be carefully planned, taking into account
the following inputs: The first two elements mentioned in
the figure constitute basic inputs for planning and have traditionally been taken into account. Technological surveillance and technology evaluation are part of the trends and
practices that strengthen planning and ensure that all sources
of technology incorporation needs are covered. Regulation
is necessary to review previous to the strategic planning to
include new devices or changes needed to accomplished law.
Growth of services and opening of new
services
As mentioned above, the strategic planning of the technology must be consistent with the strategic planning of the
clinical services that follow the general decisions of the
organization.
This is how it is necessary to know in detail the growth
and expansion projects of the areas, as well as the projects
to open new services. Once these projects are known, one
should inquire about the detail of the clinical services that
are to be provided and the technology required for this and
proceed to generate the first component of the planning,
which is the list of technologies to be acquired for this concept, with the initial costs associated with its implementation, such as the cost of infrastructure, support services,
connectivity, supplies, consumables, training, and finetuning necessary for proper operation and safety of patients
and users. When carrying out this activity, the legal requirements related to the opening of new services and growth of
services must be taken into account.
Technology planned replacement needs
Within the needs of incorporation of technology, the definition and prioritization of needs depend mainly on the area
of clinical engineering, which is the planning of needs for
technology renewal as well.
For this, it is necessary to perform an audit of the documentation related to the medical equipment, that is to say,
the equipment identifiers, as well as the physical status of
each. It is important to include obsolete computers associated with medical equipment because the obsolesce of
operative systems, software, hardware and safety issues
(cybersecurity). Subsequently, the prioritization of technology needs must be carried out through the quantitative and/
or qualitative methodology established in the institution.
Subsequently, the list of technologies that must be renewed
in the next period of time and the costs associated with said
renewal must be defined. This list constitutes the second input of the strategic planning of technology incorporation.
Regulations
It is necessary, when carrying out the process of construction of the strategic technology plan, to review the state of
the art of the regulations related to the management of technology and infrastructure.
This in order to determine any necessary variations,
which may lead to acquisition or renewal of technology for
compliance. Once this review is done, a list of associated
costs should be constructed.
Technology surveillance and healthcare
technology assessment
Among the elements necessary for a complete strategic
planning, it is the survey of trends and innovation in medical device/biomedical technology. This is in order to complement or improve the lists of technology required for the
expansion, opening of services, or renewal of technology.
Healthcare strategic planning using technology assessment Chapter | 30
However, the search alone does not allow the appropriate
determination of the relevance of these trends and new technology to the needs of the sector, and of the institution.
This is the reason why it is necessary to make use of the
evaluation of healthcare technology assessment (HTA), as a
tool to ensure appropriateness.
HTA—noted in the International HTA Glossary as an
official collaboration between the International Network of
Agencies for Health Technology Assessment (INAHTA),
Health Technology Assessment International (HTAi), and
other partner organizations—is defined as:
The systematic evaluation of the properties and effects of a
health technology, addressing the direct and intended effects
of this technology, as well as its indirect and unintended consequences, and aimed primarily at informing decision-making
regarding health technologies (INAHTA et al., 2018).
HTA is conducted by interdisciplinary groups that use explicit
analytical frameworks drawing on a variety of methods.
Taking into account the dynamics of the health sector
and the technology related to health care, which is constantly evolving to meet these needs and since its inception
in the middle of the 1970s, HTA has emerged as a crucial
tool in the decision-making process performed by the different stakeholders inside a specific healthcare system. This
tool contributes to the challenge of incorporating technology according to the needs of the health system and the organizations that comprise it.
HTA allows the review of technologies and yields as a
result the evidence of the value and relevance of the same
for the health system and all stakeholders. According to the
World Health Organization, the ultimate purpose of HTA
and healthcare quality initiatives are improvement of health
at individual and population.
In order to be useful, HTA must deliver timely and
relevant information that takes into account the actual requirements of the healthcare system. At the same time, it
promotes those innovations that provide value for money
and disinvest in ineffective and obsolete technologies and
interventions, protecting the basic principles of equity and
choice.
As part of its evolution, HTA has changed from an efficacy to effectiveness perspective, besides the incorporation
of principles such as evidence-based medicine (EBM), cost
effectiveness, and patient centered services.
Around the world, HTA is provided by government agencies,
private institutions, nonprofit organizations, and the academia.
In the case of developing countries, it is more adequate-to consider the public sector mixed with nonprofit organizations to be
the best providers of HTA. In order to strengthen HTA’s progress
in the Latin American region, on 2011, Argentina, Peru, Bolivia,
Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, México,
Paraguay, and Uruguay agreed on the creation of REDETSA
183
as the network to support decision-making on incorporation,
dissemination, and use of technologies, looking at the contexts
of health systems at country level and expanding their access
to equity. This initiative was supported by the Pan-American
Health Organization (PAHO) and HTAi (Vilcahuamán and
Rivas, 2017).
The context demands a network between the countries
of the region in order to improve the sustainability of the
efforts and the results expected by the permanent exchange
of information, the discussions of best practices, and joint
efforts to improve capacity building on research and critical
appraisal.
On the other hand, HTA is increasingly used in
European countries to inform decision- and policy-making
in the healthcare sector. Several countries have integrated
HTA into policy, governance, reimbursement, or regulatory processes. Therefore, the European Union (EU) and
Member States in 2004 expressed the need for a sustainable
European network for HTA. EUnetHTA was established
to respond to this need. The European Commission and
Member States co-funded a 3-year project (2006–08) with
the aim to develop a sustainable network and information
resources to inform health policy (EUnetHTA, 2008).
The technology evaluation process then incorporates the
following stages (Fig. 2):
Based on the analysis of the information collected, the
following questions should be answered, definitions in:
(1) current use of the technology (implementation level);
(2) description and technical characteristics of the
technology;
(3) safety;
(4) effectiveness;
(5) costs, economic evaluation;
(6) ethical aspects;
(7) organizational aspects;
(8) social aspects;
(9) legal aspects (Buse et al., 2002).
WHO defines the following trends in HTA (WHO
Workshop, Bangkok, September 2010):
(a) greater emphasis on cost-effectiveness and economic
impacts;
(b) rapid reviews/checklists;
(c) using surrogate endpoints;
(d) using evidence from real-world practice (registries, surveillance, and databases);
(e) qualitative research (narrative synthesis);
(f) tailoring HTA methods to particular types of technology;
(g) looking at contexts;
(h) international collaboration in HTA methods;
(i) reports;
(j) including patients’ views;
(k) including needs for training (procedures and devices).
184 SECTION | 3 Healthcare technology management
Policy question
The policy question reflects the context in which the assessment was carried out
HTA protocol
Define how the whole assessment is going to be carried out.
Background information
The background information helps translate the policy question into a research question. information about the
target condition, the target group, and the technology to be assessed.
Research question(s)
specifying the policy question in terms of safety, efficacy, effectiveness, psychological, social, ethical,
organizational, professional, and economic aspects.
Answer the questions
Discussionj of methods and results
Conclusions and recommendations
HTA report publication, dissemination
Use of HTA
FIG. 2 HTA process.
Considering the gaps related to policies, regulation, access to information, and alignment, developing countries
are closer to the trends (a), (b), (d), (f), (g), and (k). The
recommendation is to have a clear picture of medium- and
long-term investment taking into account the financial impact on the organization.
Construction of healthcare strategic
planning report
Once every input had been studied and developed the list
of healthcare technologies with costs of implementation associated, it is necessary to do a priorization of the list based
on a risk as positive or negative impact on the organization with the acquisition of the technology. The quantity of
technologies included in the final version of the healthcare
technology strategic planning report will be determined by
the impact magnitude and the resources available in the institution for this purpose (Fig. 3).
Technology
planned
replacement
needs
Growth of
services and
opening of
new services
and HTA
Regulation
Budged
risk magnitude
Healthcare technology
strategic planning
FIG. 3 Healthcare technology strategic planning priorization.
Healthcare strategic planning using technology assessment Chapter | 30
References
Buse, R., Orvain, J., Velasco, M., Perleth, M., Drummond, M., Gürtner, F., y
otros., 2002. Best practice in undertaking and reporting health technology assessments. Int. J. Technol. Assess. Health Care 18(2), 361–422.
EUnetHTA, 2008. EUnetHTA Handbook on HTA Capacity Building.
Catalan Agency for Health Technology Assessment and Research,
Barcelona.
185
INAHTA, HTAi, and others, 2018. Health technology assessment (HTA).
Obtained from http://htaglossary.net/health+technology+assessment+
%28HTA%29.
Vilcahuamán, L., Rivas, R., 2017. Healthcare Technology Management
Systems Towards a New Organizational Model for Health Services.
Elsevier Inc.
Yadin, D., Judd, T.M., 2000. The Biomedical Engineering Handbook. CRC
Press LLC, En J. Bronzino.
Chapter 31
Technology evaluation/US
and global perspectives
Gary H. Hardinga, Alice L. Epsteinb, Andrea Garcia Ibarrac, Paula Berrioc,
Beatriz Galeanoc
a
Health Care, Greener Pastures, Durango, CO, United States, bAllied Health Risk Control, CNA, Durango,
CO, United States, cDrugs and Health Technology Department, MoH Colombia, Bogotá, Colombia
Technology evaluation is the review of those devices or supplies for particular clinical need(s), not merely the review of
devices or supplies. If the technology selected does not meet
the clinical needs of the patient or cannot be successfully
used by those who are responsible for direct patient care,
then needed or optimum procedures could be impossible to
provide. Participation by clinical engineers in the evaluation of technology can directly contribute to and affect the
quality of patient care and patient outcomes and financial
situation of the facility. The extent of training required to
effectively participate in the process and the workloads of
various departments required to contribute will need to be
analyzed. The impact of new or reengineered technologies
varies from the time the technology is introduced through
its obsolescence. Technology evaluation is most often associated with complex devices, but clinical engineers should
be aware that what appear to be simple, noncomplex devices should be subject to the same technology evaluation
processes; otherwise, there can be dramatic and negative
impacts. If the technology overlaps the utility of existing
equipment or is rapidly made obsolete by other technology expected to be introduced onto the commercial market,
there can be a substantial negative financial impact. If user
and service support are not considered, frequent training
and retraining in correct use of the technology and mitigation of accidents, as well as constant downtime for repair or
maintenance, can result.
Examples of newer medical technologies include:
●
●
●
●
●
●
Gamifying patient compliance
Genomic-based treatments and precision medicine
Medical three-dimensional (3D) printing
Medications with digestible sensors
Near-artificial intelligence
Real-time tissue diagnosis, for example, surgical vaporized smoke analysis for malignancies
186
●
●
Virtual reality
Wearable data analysis
Clinical engineering’s contribution to careful and complete evaluation of technology can ensure that the introduction of new technology fulfills the medical goals of
the organization in the present and, to the extent possible
through forecasting, in the future. Examining ways in which
technology would integrate system wide into the organization, or what alternatives there are or might be in the near
future, can help to control costs, thereby improving the organization’s financial situation. Determining whether and
how technology can be rapidly assimilated by clinical staff
and whether service expectations are within reason and acceptability can reduce training requirements, accidents, and
downtime.
This chapter will discuss many of the critical aspects
of technology evaluation. While the process can be identified by many names (e.g., value analysis process) and the
features vary somewhat from process to process, the goals
of the technology evaluation process should be the same.
Evaluation of technology is a team effort. Members of the
clinical staff, administrative management, facilities management, and many others should (and do) participate in
this process. As with all team efforts, there will have to be
concessions because of such things as cost and user limitations. While there are many acceptable and necessary
reasons to make concessions, clinical engineers must be
careful to identify and to evaluate requested concessions
that do the following:
●
●
●
●
Impact patient and/or staff safety
Are not truly required, as the limitation is perceived and
not real
Have potentially severe utility or financial implications
Fail to meet laws, regulations, or acceptable practice
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00031-6
Copyright © 2020 Elsevier Inc. All rights reserved.
Technology evaluation/US and global perspectives Chapter | 31
Evaluating technology can be a challenging and rewarding experience for the clinical engineer—one in which others can learn from the engineer, and the engineer can learn
from others.
Strategic technology planning
Where does (or should) an organization start in the technology evaluation process? Because of the importance of
technology to the overall patient care and financial goals of
the organization and the risks of haphazard acquisition, the
first step in technology evaluation should be development
and implementation of a strategic technology planning program (or process, depending on the size and resources of
the organization). The main purpose of strategic technology
planning is to gain a complete understanding of the existing
technology-related equipment and services within the organization and the expected progression of and changes in
services that can be forecast with intent to provide a base on
which to consider and time acquisition of future technology.
The clinical engineer has the primary responsibility for
identifying existing technology within the organization. This
duty often takes the form of the clinical engineering inventory, although it is not uncommon to supplement this with
inventories from specialty departments such as radiology
and clinical laboratory, and from capital equipment financial
bases, for example, accounting. For the purposes of strategic
technology planning, a complete tabulation of current technology should be developed and should include not only the
name and manufacturer, but also the age and expected useful
lifetime. Other information (e.g., location in the facility and
progressive annual costs to use and maintain) can be useful
as well, although more detailed information can be acquired
later in the process as specific technologies are considered.
The importance of this tabulation is primarily to assist in determining the status of current technology within the organization that may or may not be in actual clinical use, vendors
that have supplied technology, and technology approaching
obsolescence and need for replacement.
An inventory and overview of technology-related clinical services delivered by the organization is typically the responsibility of administrative management. It might include
departmental administrators and/or clinicians. It is important
that an overview of current technology-related services be
compiled so that (1) future requests for new services can be
compared against services already provided; and (2) future
requests for new technology acquisition can be examined
for ability to meet current needs and to expand utilization in
areas other than that of the requester. For example, it would
be unwise to purchase a new surgical laser for one department when there was an existing, acceptable surgical laser in
use by another department that was underutilized. It would
be important to know that a request for new service by one
medical specialty is a service already provided by a d­ ifferent
187
medical specialty, or that a technology requested for one
procedure could be used in many more. Technology relating
to imaging illustrates this point.
In order to ensure that the strategic technology planning
process is supported, it is important to seek participation by
affected parties. It is not essential that all parties be represented in a strategic technology planning and acquisition
committee, but some mechanism(s) to ensure that the voices
of affected parties are heard and that rationales for decisions
are distributed to these parties must be provided. There will
be difficult, and often political, decisions about replacement,
supplementation, and introduction of technology that be
necessary to make. In today’s economy, financial resources
are limited and must be distributed carefully. Unrealistic requests may be made; powerful participants may not understand the relative importance of their need or desire versus
the relative importance of another participant’s need outside
their expertise. One value of the strategic technology planning process is that participants can be advised of all of the
needs and the rationales for decisions. Experience shows
that these highly trained and motivated participants typically
endorse decisions or offer constructive alternatives when
provided with valid information. Organizations might want
to consider utilizing independent consultants for initial process development and periodic participation in lieu of developing their own structure for strategic technology planning.
Technology and alternatives
Once the strategic technology planning program has been
instituted and identification of technologies for consideration for acquisition occurs, the process of technology
evaluation can proceed. The first step in the process is to
identify and assess the requested technology and alternative
technologies already in use within the organization or available commercially that could meet the identified clinical
need. This process will formalize the following:
1. Identification and detailing of the clinical procedure(s)
for which the requester intends use of the technology
2. Collection of information about the specific technology
being requested
3. Identification of other clinical procedures for which the
technology could be used
4. Collection of information about alternative technologies
that could be used for the same clinical procedures
5. Comparison of the requested and alternative technologies to the existing technologies within the organization
6. Determination of the risks and hazards associated with
the use of the requested and alternative technologies
7. Examination of the clinical efficacy of the requested and
alternative technologies
8. Performance of a conceptual needs analysis based on all
of this information
188 SECTION | 3 Healthcare technology management
Clinical procedures
It is typical for there to be an official or unofficial clinical
sponsor or advocate for acquisition of the technology. The
sponsor should provide a narrative and supporting literature
(e.g., authoritative published reviews of the procedures and
use of the technology) for the technology being requested.
The narrative should provide the sponsor’s understanding
of the clinical procedures for which the technology may
be used now and in the future; their analysis of the clinical
literature that clearly supports the use of the technology in
these clinical procedures; the technology they are currently
using or could use to perform these clinical procedures; and
their reasons why the specific technology should be acquired.
Complete copies of authoritative published reviews are desirable. A review is an article that examines experience derived
from many studies; these reviews often can save those who
are responsible for making decisions from having to seek out,
select, obtain, and read volumes of separate articles—all of
which may have individual limitations in their performance
and application. Reviews often provide detailed bibliographies that provide additional references in one place and also
provide the reviewer with an idea of how well established and
analyzed the technology is. For example, if no reviews exist,
or only three articles exist in the world, or all articles are foreign based, the reviewer could gather important information
on which additional questions to ask.
The sponsor also might be aware of, or might seek out,
information about other clinical procedures for which current technology, requested technology, and alternative
technology may be used. Resources that are readily available for the sponsor in this endeavor include peer-reviewed
literature, the medical director and medical staff, and the
manufacturer(s) of the technologies.
Comparing requested and alternative
technologies
The clinical engineer is well prepared to direct the effort to
collect information about the requested technology and alternative technologies. A literature search should be performed
emphasizing the specific technologies and include related
medical literature, as well as engineering, financial, and governmental databases. Resources that identify manufacturers of
the technologies should be consulted (e.g., group purchasing
lists of acceptable equipment, ECRI Institute’s Sourcebase,
MD Buyline Medical Equipment Information Catalog).
Requests for information should be made of each manufacturer of the requested and alternative technologies,
emphasizing that the manufacturer should provide all information, for example, brochures, user manuals, sales
and marketing documents, support documents, and published articles that the manufacturer believes the organization should consult before making a decision about the
t­echnology acquisition. Organizations could specifically
ask each manufacturer to provide a comparison of their
product to that of its competitors. Such a comparison should
be readily available or easily compiled, as it is important
for sales and marketing professionals to differentiate their
product from those of competitors. It is convenient at this
time to request data that the manufacturer either submitted
to the Food and Drug Administration (FDA) or identified to
the FDA as available to support the manufacturers’ contention that the technology is safe and effective for its intended
purposes, as well as a compilation of the clinical procedures
that the manufacturer identifies as an intended purpose of
the device. In new or developing technologies, it is worthwhile to ask specifically which clinical procedures normally encountered within the medical specialties for which
the technology is used are not currently within the intended
purposes of the technology.
Comparing owned vs requested or alternative
technologies
Once information about possible clinical procedures and
technologies has been received, and before any other extensive investment of time or money, the information should be
reviewed and compared against comparable information on
technology that is already owned. All affected parties should
be consulted, and their viewpoints should be considered.
While much of the discussion might have occurred as part
of the strategic technology planning process, this effort provides an opportunity for parties to become aware of the latest information about requested and alternative technologies
and how they could impact on, or be utilized by, all parties.
Identification of potentially unacceptable financial impact
or equipment compatibility issues could arise. Participants
from other medical specialties can identify an opportunity
and interest in supporting and using the technology if, for
example, necessary options for their specialty are purchased;
this can be particularly important to the original sponsor if
the sponsor’s utilization projections are marginal. A rational
decision to forgo acquisition of the requested or alternative
technology, to use or upgrade existing technology, or to proceed with the process as existent or modified can be made.
Risks, hazards, and clinical efficacy
It is important to remember a basic premise in health care:
first, do no harm. In order to meet this basic premise, potential risk must be identified. While adverse clinical events
occur, and some might be inevitable given the complex nature of medicine, unnecessary complications and accidents
should be avoided when possible. It is imperative that risks
be minimized and eliminated where possible through the
proactive identification of risks and hazards to identify
whether and how they can be mitigated.
Technology evaluation/US and global perspectives Chapter | 31
Process
Most engineers are familiar with standard design engineering practices, such as failure modes and effects analysis
(FMEA). One can consider technology risk and hazard analysis to be analogous to a system-wide process applied to the
technology rather than the device. The points are the same:
●
●
●
eliminate unnecessary failure modes;
guard against those that cannot be eliminated for some
reason;
warn about those that cannot be eliminated and where
guarding alone is insufficient to mitigate the risk or
hazard.
Elimination of risk or hazard could mean redesigning a
feature of the product while in device design. In technology
evaluation, elimination could mean discontinuing consideration of a product from a specific manufacturer. Similarly,
while in device design, a fail-safe limit switch may be provided to guard against the potential for limb entrapment; in
technology evaluation, however, the guard might be accepting products only from vendors who have a commercially
available system that has been in place in other facilities
for some time, without resultant adverse occurrences.
Furthermore, while a caution label could serve as the warning in device design, alerting medical staff to limitations in
use of each of the technologies under consideration could
be an analogous technology evaluation warning. Hence, it
is important that a systematic, unbiased process of risk, and
hazard identification and mitigation be used for technology
evaluation.
Financial risk
Risk, for the purposes of technology evaluation, means not
only the risk of physical injury or facility damage typically
recognized, by clinical engineers, but also financial risks
that the technology may pose as well, for example, underutilization, unacceptable dedication of financial resources,
loss of clinical specialists, increase in liability premiums or
potential losses, or adverse publicity. While addressing certain risks would be beyond the clinical engineers capability
or control, they can ensure that a participant in the process
who can address them is responsible to identify and review
risks and their extent. While any aspect of technology evaluation can be a “make or break” item, more often decisions
are based on a comparison of many aspects, with financial
risk being significant.
Resources
The United States FDA Center for Devices and Radiological
Health (CDRH), the governmental agency that we often
think of as being responsible for ensuring the safety and
189
e­ fficacy of medical products, has not aggressively engaged
in technology evaluation as it related to patient safety as
demonstrated by the number of patient and staff injuries
caused by medical devices. While physicians and other
medical specialists often believe that if a product has gone
through the FDA process it is safe and effective, the reality
is that for many device types, and in many cases, the FDA
approval/clearance process does not ensure safety and efficacy. Due in large part to human and financial resource
limitations primarily imposed by Congress, the FDA often relies on the product manufacturer to determine safety
and efficacy. In the 510(k) premarket clearance process,
the FDA often does not even require the manufacturer to
provide the data on which the manufacturer made its determination that the product was safe and effective. Hence,
potential purchasers of technology cannot, and should not,
rely on a manufacturer or a technology having received the
FDA clearance to market the technology as any indication
that the product is safe and effective. Greater assurance
is provided if that product has gone through the premarket approval (PMA) process, usually reserved for class III,
complicated, or other technologies identified in the past as
particularly problematic.
The FDA process can be abused by manufacturers, distributors, and others as a means, for example, to avoid cost,
dissemination of information, or appearance of acceptance
of responsibility to determine safety and efficacy. For example, a large manufacturer who held and still holds major market share in injection and blood-collection needle products
did not perform unbiased, statistically significant clinical
studies prior to, or for years after, placing its safety products in the market to determine that these safety products
actually reduced the occurrence of accidental needle sticks.
Instead, the manufacturer made it a de facto responsibility
of each organization to determine on its own whether the
safety products were “safe and effective.”a CDRH cleared
such products from this and other manufacturers again and
again, for years, without review of safety data or even requesting that the data be provided to them.
While organizations should request this information
from the manufacturer and should examine the FDA and/
or CDRH databases,b a healthy degree of skepticism in
findings, or the lack thereof, could be warranted. If the
manufacturer did not submit clinical data to the CDRH and
does not provide this data in response to the request by the
a. This manufacturer introduced a safety-needle product in 1988. However,
it was not until Younger et al. (1992), the Centers for Disease Control and
Prevention (1996), and Mendelsohn (1998) performed studies that clinical
safety and efficacy of safety devices were evaluated.
b. The CDRH website has databases relating to registration of the
manufacturer, listing of devices, 510(k)s, PMAs, and occurrence reports, which can be accessed at http://www.fda.gov/MedicalDevices/
MedicalDeviceRegulationsandGuidelines/Databases/default.htm.
190 SECTION | 3 Healthcare technology management
o­ rganization, it is difficult to offer a valid reason to continue to consider that device. It is reasonable to expect that
the manufacturer is most knowledgeable (i.e., expert) about
the product and its safety and efficacy. If a manufacturer
cannot, does not, or will not provide substantiating information that is convincing, it is reasonable to exclude that
manufacturer’s technology. If a manufacturer transfers the
responsibility for determining safety and efficacy to the organization, it is reasonable to exclude that manufacturer’s
technology from further consideration. Document the situation so it can be conveyed to the clinical sponsor in an unbiased, straightforward manner.
There are other governmental and private agencies that
can offer information on technology evaluation. For example, the Agency for Healthcare Research and Quality
(AHRQ) performs technology assessments on behalf of the
Center for Medicare & Medicaid Services (CMS) for the
purpose of CMS determining whether Medicare/Medicaid
will provide financial reimbursement for application of the
technology. The AHRQ has performed a number of technology assessments since 1990.c AHRQ states that it (or
its evidence-based practice centers) uses state-of-the-art
methodologies for assessing the clinical utility of medical
interventions. Reportedly, their assessments are based on a
systematic review of the literature, along with appropriate
qualitative and quantitative methods of synthesizing data
from multiple studies. While useful information can be
gained from studies performed by, or on behalf of, AHRQ
and CMS, it is important to differentiate the interests and
motivation of the organization from the interests and motivation of a governmental agency impacting on government
spending. If third-party or Medicare reimbursement is an
important financial aspect of the technology acquisition,
and the technology is not covered, this would be important
information to acquire, document, and distribute.
The International Network of Agencies for Health
Technology Assessment (INAHTA) currently includes 50
member agencies from countries around the world. It offers
a database of technology assessments, a technology assessment checklist, and links to member technology assessment sites.d If a technology under consideration is new or
“cutting edge” technology in the United States, experience
gained by use in other countries can be obtained by accessing INAHTA information.
Private agencies, such as ECRI Institute and MDISS
(Medical Device Innovation, Safety & Security Consortium),
can offer technology assessment information of varying
detail. While this information is typically fee based (e.g.,
cost per report and cost per annual subscription), it can be
a wise investment if the resource provides specific, detailed
information about the requested or alternative technologies
under consideration that is correct and unbiased. In some
instances, fees cover telephone consultation with agency
experts to whom specific questions can be addressed. Onsite and comprehensive consulting services also can be useful, especially where organizational expertise does not exist
or where organizational internal dynamics challenge the
ability for the system to operate properly otherwise.
Local, regional, national, and international organizations of clinical engineers can provide a mechanism for obtaining advice from peers who may have encountered the
same technology evaluation issue.
c. A list of, and access to, these reports can be found at http://www.ahrq.
gov/research/findings/ta/index.html.
d. Go to http://www.inahta.org/hta-tools-resources/database/.
e. It is important to recognize that mitigation may not mean elimination of
the risk, but, for example, implementation of risk control actions or purchasing insurance to cover the risk.
Conceptual needs analysis
The purpose of the conceptual needs analysis is to capture
and synthesize clinical procedure and technology information that is pertinent to decision making. That is, it is not
typically reasonable to provide participants with a package
of original articles, manufacturers’ brochures, or technology assessments. A small, experienced taskforce should
preview the information and present only the information
that is necessary to do the following:
1. Educate the participants
2. Inform participants why preliminary procedures, technologies, or even specific vendors have been excluded
from further consideration
3. Briefly identify aspects that are similar to all technologies under consideration
4. Identify in greater detail specific aspects that are dissimilar and that are important to decision-making
5. Identify known risks and hazards and methods to successfully mitigate theme
6. Detail the clinical efficacy of the technologies
Some organizations may direct this task force to make
specific recommendations based on their analysis of these
considerations.
The preliminary analysis should be provided to all participants in anticipation of their individual or collective (i.e.,
committee) review. Ample time for participants to examine
and consider the information must be provided. Participants
may pose new questions that will have to be explored.
Collective review allows an opportunity for discussion and
the back and forth consideration of important items, be they
financial, technical, or administrative. The desired outcome
of the conceptual needs analysis is to determine whether existing, requested, or alternative technologies should receive
Technology evaluation/US and global perspectives Chapter | 31
further consideration. If the outcome is not to proceed, it is
important to document the reasons for discontinuing pursuit; this may be especially important when the issue was
related to replacing existing equipment that is nearing obsolescence. Documenting the decision can simplify future
consideration if and when it arises; this is not to say future
consideration will be avoided or result in the same outcome,
since reasons for discontinuing pursuit may have been overcome at a later date. It can help the organization’s litigation
position if there are valid reasons for discontinuing pursuit
and if an incident occurs with the current equipment.
Several other important decisions can be made at this
juncture:
●
●
●
●
Which top three to five vendors should be considered
further?
Should the technology receive further evaluation of only
the preliminary clinical procedures that were identified,
or should a broader or narrower application be pursued?
Are there other issues (e.g., potential physical location,
staffing, volume of disposables, and medical professional certification) that must be considered and how
critical are they to ultimate acquisition and safe introduction of the technology?
How well does the technology fit into the current user
environment? Can the technology be expected to fit
easily, safely, and reliably into current experience and
practices of clinical users, service support professionals,
and the patient population without undue resistance or
extraordinary requirements for training? Is there a feature of the product that allows it to interface with other
equipment and is that feature compatible with existing
facility equipment?
Assuming that a decision is made to pursue the technology further, the next step involves determining desired
specifications and starting the bid process. This technology evaluation model assumes that desired specifications
have been identified and that a reasonable bid process has
been achieved. The remaining discussion assumes that the
bid process was performed and that it resulted in a further reduction of vendors and identification of a more detailed compilation of device features and options, service
support offerings, acquisition alternatives, and training
requirements.
Testing laboratory and engineering
evaluation
The most desirable next step is to have the remaining vendor products brought into the facility for further engineering
and user evaluation. If possible, the technology or a representative sample thereof (e.g., a single patient monitor)
should be delivered by each vendor to the facility. In some
cases, where the equipment is extremely large or costly, or
191
requires special utilities or facilities, this may not be possible. In such cases, the testing laboratory and engineering
evaluation should be performed either at the manufacturer’s
location or in a representative installation at a time when the
technology is not expected to be in use. It is important that
those who are responsible for the laboratory and engineering
evaluation receive adequate training from the manufacturer
prior to the actual evaluation. It is also essential—especially
when the testing of equipment is performed in a representative installation—to advise the vendor of tests that are expected to be performed prior to their performance, in order
to allow the vendor to identify tests that could be potentially
destructive to the equipment or harmful to staff. Laboratory
and engineering evaluation prior to introduction of the technology serves several purposes. Of primary importance is
the keeping of potentially unsafe equipment out of clinical
areas. It is important to examine the quality, features, performance, possible failures, and service requirements of the
equipment as well.
Incoming inspection
Technology entering a facility on a trial or evaluation basis should be subjected to full incoming inspection testing.
Because the clinical engineering components of the evaluation are significant, the tests performed during incoming
inspection of a trial/evaluation device should be even more
comprehensive. Clinical engineers are expected to gain information that will allow decision makers to differentiate
and decide among competing products. While incoming
inspection of a purchased product can focus in part on verifying that operation specifications are met, incoming inspection of a trial/evaluation product could justifiably focus on
determining the full range of operation and the comparability of operation from one trial/evaluation product to another.
Clinical engineers have a multitude of incoming inspection checklists available,f including the manufacturers’
recommendations on how to examine electrical and mechanical safety of the products. Most address classic aspects
of electrical and mechanical safety through inspection and
testing. All accessories required for proper operation should
be present, as should the operators’ manuals and technical
service manuals and schematics. Some manufacturers might
attempt to limit this information, but the information is important to understanding exactly how the product works and
the limitations that are inherent. User/operations and service manuals, like the product and options, can be returned
to the manufacturer if their product is not selected, thereby
avoiding cost to the manufacturer or release of information
that the manufacturer considers proprietary and sensitive.
f. Inspection resources are available through organizations such as
AAMI and ACCE. One example is the ECRI Inspection and Preventive
Maintenance Manual.
192 SECTION | 3 Healthcare technology management
Proper operation of the equipment as specified in the
performance specifications in the manufacturer’s literature should be confirmed. However, if possible, clinical
engineering should develop and perform tests that are specifically intended to differentiate competing products in important areas. Tests that differentiate equipment but that are
not clinically significant or not significant in any other way
(e.g., safety wise or financially) should be avoided.
The clinical engineer should note whether the product
has been evaluated in any manner by nationally recognized
testing entities; for example, Underwriters Laboratories
(UL), Canadian Standards Association (CSA), or City of
Los Angeles. The clinical engineer should acquire and peruse all applicable standards that address the technology
under evaluation. Further, it should be noted whether the
product does or does not comply with the governmental
labeling and performance requirements; for example, use
on physician prescription only and OSHA-compliant for reducing accidental needle sticks.
Gaining the experience of others
Clinical engineers should require the manufacturer to provide references, including customers who currently utilize
the product. They should contact these referrals directly,
to discuss the experience with the product and the vendor. Clinical engineers should contact their counterpart(s)
within the referral organization(s) to seek their input on
their experiences, whenever possible. If available to them,
clinical engineers should contact others not included in the
manufacturer’s reference list who have experience with the
product. Such lists might be available through group purchasing organizations, professional societies, and shared
service organizations. Clinical engineers should be willing
to contact representatives from other organizations who
have noted use of the product in, for example, the medical literature. When gaining the experience of others, however, it is important to remember to compare, to the extent
possible, “oranges to oranges.” Experience with a product
that might be years older than the product under evaluation
can result in misinformation if the clinical engineer is not
careful. Similarly, comparing a vendor’s historical performance to its current performance might not be appropriate,
in either a positive or a negative way. The clinical engineer
should examine the information and its limitations, with an
emphasis on determining exactly what can be said and supported with regard to positive and negative aspects of the
experience of others.
Technology and the facility
Will the facility be a good fit for the technology? The clinical engineer has the user’s manual, the service manual,
the schematics, and, most importantly, the product. Most
c­ linical engineers have a working knowledge of the physical facilities in which the product can be used and of the
utilities necessary to support the technology. Certainly, there
might be other engineering professionals who have greater
expertise and responsibility for the facilities and utilities,
however, laboratory and engineering evaluation of the products is a perfect opportunity for clinical engineers to examine and discuss, with their internal counterparts who are
responsible for the facility, what the perceived needs are for
the product. For example, there might be particular power
or shielding requirements. There might be particular water,
gas, or other requirements. Systems (e.g., fire suppression
systems to protect the physical product) might be required.
The device might be too large to fit into the facility, or it
might be too heavy for the support structure. The facilities
engineer should be invited to participate in the laboratory
and engineering evaluation. More than one strong alliance
between clinical engineers and facilities engineers has been
created by clinical engineers recognizing the facilities engineer’s expertise and encouraging participation.
Technology and information systems
Some medical devices provide information logging and
control features. Electronic health records (EHRs), robotic
control systems, and feedback control that interface of individual medical devices into facility- or department-wide
information systems will expand. The Internet of things
(IoT) has numerous applications in new technologies and
medical devices including remote monitoring, smart sensors, and medical device integration. Clinical engineers are
rarely responsible for information systems, but in a good
position to interact and cooperate with information systems
engineers. Challenges which can benefit from mutual and
joint analysis include EHR integration, data security, data
management, device patches and upgrades, and technology
interconnections.
Documentation, including the EHR, printers, and electronic storage systems, is often a major part of the analysis
in incident investigation and litigation. Ensuring that a technology is evaluated properly to determine the advantages
and/or disadvantages of a particular technology under consideration requires the participation of the proper information system specialist in the technology evaluation process.
Maintenance and service requirements
The clinical engineer can examine and perform
manufacturer-­
identified maintenance and service procedures to determine human and financial resources that are
required. The ease of disassembly and the need for special
tools can be examined. The clinical engineer can evaluate
whether special training is required and whether the manufacturer can and will provide such training. But there are
Technology evaluation/US and global perspectives Chapter | 31
other ­issues that might be more difficult to evaluate. For
example, how reliable is the product? What are the expected
maintenance and service requirements? While the results
of manufacturer testing and experience in the field can be
requested, the actual applicability of laboratory-simulated
testing of a component might have no relationship to the
reliability of the system in actual clinical use. The clinical
engineer can request that the manufacturer provides a complete list of spare parts recommended by the manufacturer.
The actual service experience of organizations that use the
same technology should be examined as well.
It is important to remember that some issues relating
to maintenance and service can be transferred to others
(e.g., the manufacturer or a shared service) by contract.
Contractual elements could include provisions for the
manufacturer to guarantee replacement parts availability,
defined service response time and up time, the provision of
“loaner” equipment, and training.
Laboratory evaluation by clinicians
Clinical evaluation of the product is an important part of the
technology evaluation process. But clinicians should first
evaluate the product in the testing laboratory before allowing it to be placed into the clinical environment. While there
is an obvious safety aspect to testing laboratory evaluation,
laboratory (i.e., simulated use) evaluation of the technology by clinicians offers an opportunity for clinicians to be
trained in the use of the product, to be advised of limitations
or differences noted by clinical engineering review, and to
systematically examine the operation and human factors aspects of the product without the interference of a patient’s
clinical need. Human factors with the interference of clinical need of a patient will be examined during the clinical
evaluation. If simulated use identifies a shortcoming prior
to acceptance, the clinical engineer should not allow a product to progress to the clinical evaluation phase, where an
accident might ensue (e.g., from a defeated alarm that staff
thought was active).
Laboratory evaluation of the product by a clinician offers
an opportunity for the collaboration and development of a
relationship between clinical staff and clinical engineering
staff. It can offer an opportunity to identify special training needs and requisite warnings that clinical staff who are
responsible for the clinical evaluation should receive prior
to initiation of the process. Current clinical practice on the
existing product in use might not be recommended, or could
even be hazardous, if used with the technology under evaluation. Staff needs to know, prior to use of the product, that
a change in practice not only can make the product more
attractive to them, but also that it can enhance patient and/
or staff safety. Including clinicians in the testing laboratory
evaluation of the product can facilitate the inclusion of the
clinical engineer in the clinical evaluation of the p­ roduct.
193
Such inclusion can have a number of benefits, including
verification of testing laboratory findings, identification
of new issues, and strengthening of the engineer/clinician
relationship. The results of the testing laboratory evaluation should be compiled, and a recommendation provided
regarding whether and how to proceed further. The results
might eliminate a product from further consideration. The
recommendation might identify previously unidentified
needs or costs. It should provide details of training and
warnings that clinical staff who are responsible for clinical evaluation should receive prior to actual clinical use of
the product. It might also identify additional questions to be
answered prior to proceeding further.
Clinical evaluation
Assuming that selection of the product has not been eliminated by previous processes, it is important to assess the
product in the area of expected use by representative expected users. Just as certain device design and facility limitations could have precluded the introduction of a product
into the facility for laboratory testing, so too, for various
reasons, examining the product within the organization on
a trial/evaluation basis might be impossible. In such instances, clinical evaluation could be limited to simulated
clinical use, observation of clinical use by others, or use
on volunteers, if performed within the confines of laws and
regulations. In some cases, there might be special clinical
trial requirements for Institutional Review Board (IRB) approval of a protocol in order for the technology to be used
on a patient or volunteer.
Clinical evaluation has many of the same features (e.g.,
confirming operations) as the testing laboratory and engineering evaluation of the product. Clinical evaluation
extends testing laboratory and engineering evaluation by
interjecting the clinical environment, including the patient, the clinical user, and the facility. Clinical evaluation
includes examining the performance, ease of use, human
factors, and safety aspects of the product, but also should
emphasize examining the differences between or among
competing products. Clinical engineering can participate
in the clinical evaluation process as an observer/recorder;
although it is not paramount that the observer be a clinical engineer; it is paramount that an impartial observer/
recorder participate. Often, a user does not realize exactly
how they are using, or misusing, a product at the actual
time in question. The user’s attention might be diverted
to the patient, to another patient, to another product, or
to another activity that is occurring but that does not include them. They might misinterpret user instructions and
might believe they are using the product in accordance with
manufacturer instructions. In fact, the device might contribute to such “user errors,” and this contribution is important to identify and note. They might misinterpret device
194 SECTION | 3 Healthcare technology management
p­ resentations (e.g., visual warning or alarms), or correctly
interpret them, but not be able to act accordingly without
resetting the product.
An impartial, trained observer/recorder can watch how
the products are being used and misused. Difficulties in use,
product-related efforts that are particularly time consuming, and frequent need for replacement of accessories or options can be noted. Depending on the specific issue and any
safety ramifications, the observer/recorder can advise the
clinical user of the situation or can withhold this information until it can be analyzed and evaluated. An argument can
be made that the clinical engineer is well positioned to be an
observer/recorder as they already will have received training on the device and will have operated it in the course of
the testing laboratory and engineering evaluation. A strong
argument can be made for the observer/recorder to be a
member of the clinical staff that ultimately will make use of
the product, because that professional eventually will need
to be trained and also has direct, hands-on, clinical experience. Regardless of who is chosen to observe/record, it is
important to recognize that constant observation is neither
recommended nor possible. Clinical use during the evaluation should be as natural as possible and should not compromise patient or staff safety. Observers who have tried
to maintain constant vigilance for hours on end have been
found to miss many important events.
Features of a clinical evaluation should encompass objective and subjective observations. Performance results
(e.g., correct capture and identification of an arrhythmia
that has occurred) can prove out objectively. Setup might be
judged difficult by one evaluator, but easy by another. Such
subjective assessments deserve further analysis if possible.
It is important that the objective and subjective assessments
of clinical staff be captured during the clinical evaluation.
Objective assessments should be compared against, for
example, actual performance specifications provided by
the manufacturer and results of laboratory and engineering tests. Inconsistencies should be examined. Subjective
assessments that might impact positively or negatively on
final selection should be examined carefully to determine
whether any objective tests can be performed to prove out or
supplement the subjective results. One benefit of collecting
subjective assessments is that staff misunderstanding can be
addressed at that time and need not wait until the product
has been purchased and placed into actual use.
The results of clinical evaluation should be compiled,
and a recommendation provided, regarding whether and
how to proceed. The results might eliminate a product from
further consideration. They might identify two or more
products that clinical staff would find acceptable for acquisition. They might identify training or staff issues or costs
previously not identified. They might identify issues that remain to be clarified and, for example, require reexamination
in the laboratory.
Vendor evaluation
Certain aspects of vendor performance are part of other
evaluations (e.g., parts availability in testing laboratory and
engineering evaluation and past experience with a vendor’s
product by clinicians in the clinical evaluation). There are
additional aspects to consider and to include in the complete
process of technology evaluation. For example:
●
●
●
●
●
●
●
●
●
How long has the vendor been in business?
How financially stable is the vendor?
Does the vendor have the manufacturing capacity and
expertise to provide the product?
Will the vendor be providing training and support?
Is delivery reliable?
Are there supplier disaster plans in effect?
Does the vendor have an acceptable reputation within
the industry, and has it behaved responsibly?
Is the vendor willing to work within the purchasing organizations systems/processes?
Is the final price acceptable?
Final evaluation and selection
The process of final evaluation and selection should include
all affected parties. A small group of experienced evaluators
can cull through all of the information and results on the
various evaluations in order to identify specific information
that is important to the final decision, but inclusion of all
parties and their interests in the final determination is desirable. The small group might seek additional information
from others (e.g., manufacturers), who will clarify remaining outstanding issues to the extent possible. They might
seek to determine whether vendors are willing to provide
additional financial or other incentives, or to provide additional training that testing has determined would be necessary for staff based on the results of the laboratory and
engineering evaluation or the clinical evaluation. Where
more than one product has successfully passed all of the internal evaluations with no clear preferences identified, vendors should be advised that the organization is seeking ways
in which to differentiate one opportunity from another, to
facilitate a final decision. Vendors can offer concessions at
this point. In the absence of concessions, the organization
simply will make the best possible business decision.
Once all of the results and supplemental information
have been compiled, the small group can develop a cost
evaluation of the alternatives. The cost evaluation should
capture a myriad of factors, including, but not limited to,
the initial cost of the product purchase, the cost of accessories and options, freight cost, and installation cost. The cost
of such things as spare parts and consumables should be
identified. Costs related to staffing and training should be
provided. Costs for operating expenses, such as electric or
Technology evaluation/US and global perspectives Chapter | 31
water cooling, should be provided if they are significant. If
a life-cycle cost analysis can be developed and depended on
for the purposes of comparison of one product to another,
it should be provided as well. Armed with the results of the
various evaluations, a final decision can be made. The decision and the rationale for the decision should be provided to
all affected parties.
Conclusion
Technology evaluation is an important part of healthcare
operations. Throughout the process, it requires the cooperation of many professionals, including the clinical engineer.
It offers opportunities for the development of alliances and
sharing of information for the benefit of patients and staff
alike. If performed properly, it can provide a means for
195
r­ ational decision making that is acceptable to all stakeholders. It can help make the best use of human and financial
resources in an industry where both are limited.
References
Centers for Disease Control and Prevention, 1996. Evaluation of ­safety
devices for preventing percutaneous injuries among health care
workers during phlebotomy procedures. Morb. Mortal. Wkly Rep.
46 (2), 17.
Mendelsohn, M.H., 1998. Efficacy of a “Safety” Winged Steel Needle
in Preventing Percutaneous Injuries (PIs) in Health Care Workers.
Presented at the Eighth Annual Meeting of the Society of Health care
Epidemiology of America.
Younger, B., Hunt, E.A., Robinson, C., et al., 1992. Impact of a shielded
safety syringe on needlestick injuries among health care workers.
Infect. Control Hosp. Epidemiol. 13 (6), 349.
Chapter 32
Technology procurement
Gary H. Hardinga, Alice L. Epsteinb
a
Health Care, Greener Pastures, Durango, CO, United States, bCNA Insurance, Durango, CO, United States
Technology procurement is an important element of
the overall hospital technology management program.
Procuring technology is a complex, detail focused process,
although some members of the healthcare team and vendors believe that it is merely an act of writing the check.
Unless close attention to the procedure and detail is paid
throughout the procurement process, significant and even
catastrophic events may occur. For example, costly unbudgeted and unexpected “required options” might need to be
acquired after equipment has been ordered, or unexpected
installation changes could be required. In a worst-case scenario, the technology might not be usable by the facility at
all. It might be severely underutilized, thus having a dramatic financial impact, or use could result in injury to patient or staff.
It is imperative that an organized framework be developed to ensure that the actual procurement of technology
results in the organization receiving the proper technology
under the terms it believes appropriate. A flexible approach
to the process based on the variety of technologies to be acquired is suggested. However, it is important to note the use
of some basic, standardized tools; for example, a Request
for Quotation (RFQ), which can be modified when need indicates, can result in better performance of the procurement
process, thereby saving time and money. Procurement comprises the following three essential processes:
●
●
●
Organizing the presentation of initial crucial requirements, once a decision has been made to consider a
technology for acquisition.
Determining final specifications, options, terms, and
conditions under which technology will be acquired.
Ensuring that technology and services expected are provided and/or guaranteed for delivery before payment.
The clinical engineer (CE) can utilize many of the skills
learned in didactic training and through experience to assist the organization in methodically and safely procuring
technology. It is imperative that CEs remember at all times
that they are team members, and not solely responsible for
either the technology procurement itself or the process.
196
Technology procurement and the overall hospital technology management program require cooperation among and
participation of professionals from a variety of disciplines.
The CE should be a strong team member who can help
to ensure that the actual clinical needs of the user are identified, addressed, and, to the extent possible, met. The CE can
serve as a bridge for communication among professionals
of various disciplines, both inside and outside the organization. Attributes that contribute to the effectiveness of the
procurement process are as follows:
●
●
●
●
●
●
attention to detail and process
quick study of technical and healthcare issues, both
­clinical and administrative
ability to create and manage relationships, inter- and
­intradepartmentally as well as externally
willingness to ask questions and request clarifications
excellent communication skills, both written and oral
ability to compile and manage information with an emphasis on determining comparability
Breakdowns in communication (e.g., between clinicians
and vendor personnel) or lapses in process (e.g., specification of a term without a written commitment or agreement by the vendor in its response) can create significant
and even insurmountable problems later in the technology
acquisition process. The CE can facilitate the procurement
and the process by listening, interpreting, evaluating, and
teaching. By asking the right questions, communicating the
defined need, and monitoring whether expectations can be
or are being met, the CE can contribute to the quality and
scope of patient care as well as to the financial well-being
of the organization.
The remaining portions of this chapter discuss several
areas of specific importance to technology procurement and
provide additional resources for the CE to access.
Technology evaluation process
Procurement follows evaluation. However, benefits accrue
from the overlap of the two processes. The purpose of the
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00032-8
Copyright © 2020 Elsevier Inc. All rights reserved.
Technology procurement Chapter | 32
technology evaluation process is to determine the value and
need for the existing, new, and alternative technologies that
the organization must consider in order to provide clinical
care to the patient population it serves.
As the technology evaluation team and those responsible
for technology management assessment proceed through
the process, the need to integrate information and actions
with the technology procurement team becomes apparent.
●
●
●
Request for information
The acquisition of initial information about requested or alternative technology precedes procurement. While the technology evaluation team could seek this information independently
of the technology procurement team, there are several advantages to the procurement team’s collaboration in such steps as
the development of the initial request for information (RFI).
The procurement and evaluation teams can begin the cooperative process of understanding the scope of the technology to
be considered, the way the evaluation is to proceed, and the
terms and conditions under which the technology will make
its way into use. Specific advantages of close collaboration for
evaluation and procurement are as follows:
●
●
●
●
●
Identification of basic specifications, options, terms, and
conditions to be discussed in the early stages of the technology evaluation process.
The opportunity to advise vendors early in the process
and in a consistent manner as to what the “ground rules”
will be.
Vendors who are experienced in responding to standardized organizational requests and needs and who will appreciate the opportunity to respond in a thorough and
cost-effective manner.
Reduction in duplication of efforts (tasks generally will
be performed only once during the process).
Errors and omissions that might arise from lack of
(or miscommunication over) differences between the
technology evaluation process and the technology procurement process can be minimized, controlled, and addressed expediently.
The initial RFI is not intended to present all questions or
even to acquire all crucial information. It is intended to seek
adequate information from potential vendors of requested
and alternative technologies, and to allow the technology
evaluation team to compare information and prioritize some
initial decisions about the technology(ies), clinical procedures, and vendors that should be considered further. A
specific RFI can be prepared in cooperation with the technology evaluation team and distributed to potential vendors.
The two teams should work together to detail the current
specific clinical need identified within the organization and
should request related information from potential vendors.
Elements of the RFI should include the following:
●
●
●
●
●
197
A comparison, by each vendor, of the vendor’s and the
competition’s products, including past, current, and
alternative products that are intended to (or otherwise
might) meet the clinical need.
A discussion of other clinical specialties that might
make use of the products.
A discussion and description, with references, of the
clinical utility of the products, including all of the clinical procedures within the intended use of the product,
those that are not currently included within the intended
use but may be included at a later date, and those that are
not included.
The current status of device listing with the US Food and
Drug Administration (FDA) and the manner in which
the vendor received clearance to market the product.
The data that the vendor relied upon in its medical vendor submission to the FDA to assert that the product was
safe and effective.
A description of the actual equipment, options, and
accessories that will be necessary for the organization
to acquire in order to perform the clinical procedures
identified.
A description of the special considerations (e.g., for installation, utilities, service, or training) that the organization should consider during the technology evaluation
process.
All user, service, and installation documentation (e.g.,
manuals).
Many other questions can be asked or requests for additional information can be made; the extent of these questions and requests will vary based on the complexity of the
technology, the characteristics and timing structure of the
technology evaluation process, and the status of the technology (e.g., experimental vs widely accepted).
Information that is critical to the procurement process
might have already been gathered by the technology procurement team. Relevant information should be requested
from this team as well. It is often worthwhile to consider
proactively the need for information from all teams so that
the process for acquiring information can be standardized.
Technical specifications and other
requirements
The technology procurement team should identify questions
to be asked regarding specifications, as well as evaluate responses to the questions asked. Incomplete, unacceptably
limited, or incomparable specifications often can be identified in the initial analysis inspection.
Mistakes that might be made by comparing “apples
to oranges” can be reduced. Important comparable differences can be identified and can result in either discontinuation of consideration of that vendor or a request for further
198 SECTION | 3 Healthcare technology management
c­ larification. Initial efforts can assist in the development of a
detailed RFQ and can identify specific attributes that deserve
closer inspection during laboratory and clinical evaluations.
Standardization
There is intrinsic value in standardizing technology to the
extent practicable. Vendors, models, and characteristics of
similar (but not the same) equipment types, and service responsibilities can be standardized. The standardization can
be within the products and services offered by a specific
vendor, or include characteristics (e.g., communication
buss) and services (e.g., guaranteed availability of loaner
units across different vendors, service providers, and clinical areas of use). Members of the technology procurement
team can do the following:
●
●
●
●
●
Identify in which place and in what way standardization
is currently in place.
Evaluate whether existing or new standardization can
applied to the technologies under consideration.
Identify the specific standardization of vendors, features, or services that should be addressed.
Compare offerings to what is available or currently in
place within or throughout the organization.
Standardization of specific elements should be placed in
perspective with respect to other issues for the specific
technology and decision under consideration; for example, the opportunity to rate the value of standardization
against clinical utility.
Long-term relationship
The value of a long-term relationship with a vendor can be
vital to some decisions. If the vendor and the organization
have experienced the procurement process together over
prior acquisitions, and with great success, there is good reason to believe that additional successful mutual processes
are achievable by the organization and the vendor. However,
it is also important to be able to place a balanced perspective on long-term relationships with respect to all other aspects of the evaluation. For example, while an organization
may have a successful long-term relationship with a vendor
of patient monitoring equipment, other factors, such as the
need to work with a different division, or the offering of
first-generation equipment in another device type, could
call into question the value of the long-term relationship for
the specific technology under consideration. The CE can
help the organization to assess the value of long-term relationships for the specific technology under consideration.
Service and training
Service capabilities of the vendor and the clinical engineering department must be evaluated. The vendor’s present and
past ability to provide service and to train the hospital’s clinical engineering department in servicing the equipment are
essential procurement considerations. Training needs of the
user may encompass educational services as well as clinical user training. Aspects of safety training, such as those
required with laser equipment, should also be considered.
The vendor’s response to the RFI can provide a basic
understanding of the service and training needs from the
perspective of the vendor. The vendor is not the end user;
the vendor might understate those needs or might not understand the expected environment of use within the organization. The vendor might describe the needs and its ability to
provide support as it would like things to be, or as it perceives things to be, rather than as things actually are, from
the user’s perspective. CEs who are experienced in procurement can examine information submitted from all parties
and can compare it to their experience with these and other
vendors. An “apples to apples” comparison is more likely
to result, and differences in service and training can be kept
in the proper perspective among vendors and with other aspects of the evaluation.
Subjective bias
Subjective bias is decision-making or evaluation based on
personal, poorly measurable, and unverifiable data or feelings that are improperly weighted against objective, unbiased data. Subjective bias can cloud the issues, impede the
ability of a participant or group to make valid decisions,
and result in costly mistakes. Participants in the technology
evaluation and procurement processes might or might not
recognize subjective bias on their part or on the part of other
participants. As the relative power of the participant rises,
subjective bias on their part and its potential negative effect
on the process also rise. In an extreme case example, subjective bias on the part of the technology’s hospital advocate
who is already determined to select one vendor’s product
over all others can make it almost impossible to perform
a valid assessment to acquire the best technology for the
organization. If the technology from the “preferred because
of an invalid bias” vendor happens to be the best technology
for the organization, the outcome might be fruitful; if not,
the organization risks acquiring the inappropriate technology, or the organization could lose the services of a talented
clinician if decisions go against the clinician’s bias.
The CE can help to identify and eliminate subjective
bias simply by asking questions and requesting references
in support of a position. An inability or unwillingness to answer questions or to provide references could be the result
of subjective bias, although there might be other reasons as
well, for example, lack of competency in a new technology.
If resources within the organization or the vendor are unable
to answer questions or provide references, the CE can seek
an answer elsewhere, for example, in the literature, from
Technology procurement Chapter | 32
noted authorities, or from experienced users. Remembering
that the technology evaluation and procurement processes
are cooperative efforts, the CE can point out where there
is bias or subjectivity and the importance of objectivity in
decision-making whenever possible. In some cases, it can
be beneficial to utilize an unbiased, independent, expert
consultant to facilitate consideration.
Procurement financial alternatives
It is often highly desirable to consider the financial impact
and financial alternatives early in the technology evaluation
and procurement processes. One reason to do so is to find financial solutions that will permit the technology acquisition
in cases where capital is not available. Another reason is
to avoid eliminating equipment that the organization could
not afford under lump sum cash outlays, but might be able
to afford under long-term, periodic payment structures that
might be available.
There are three typical financial methods for acquiring
the use of technology: Cash/credit purchase, rental/lease, or
lease-purchase. Cash purchase typically requires the large,
upfront expenditure of capital with periodic and ongoing
maintenance, as well as service and upgrade costs. The purchaser typically owns the product as soon as it is accepted.
A portion of the value of the product can be written off each
year until the product is fully depreciated. Credit purchase
requires an existing line of credit. Rental based on an agreed
to monthly amount usually requires a lesser initial capital
expenditure, if any, and the organization does not own the
product. Leasing the equipment is similar to a rental agreement although typically for a longer period of time. There
is no depreciation of the product because it is not owned,
but there are periodic (e.g., annual or monthly) credit/rental/
lease payments. The lease-purchase alternative is somewhat
of a cross between purchase and rental; the terms of the
lease and transfer of ownership at some point during or at
the completion of the lease are negotiable and usually vary
dramatically.
Reasons for choosing one alternative over another include
cash flow considerations, source of funding, attractiveness
of offers, expected product life cycle, expected frequency
of upgrades required, and effects of each alternative on the
overall financial position of the organization. Another alternative, which is useful for especially costly technology
(e.g., a proton beam therapy system), is the development of
a joint venture among, for example, a h­ ealthcare provider, a
technical vendor, and a commercial partner. Upfront investments and responsibilities for various aspects of product use,
upgrade, and support are split among participants, with the
financial risk spread among them.
While scrutiny of the financial alternatives often rests with
financial and compliance specialists within the ­organization,
199
the CE can contribute to the validity of the data upon which
these professionals will rely; for example, examining and
evaluating the projected costs for maintenance, upgrades,
and service within each alternative. That is, if the projected
cost data and expected life expectancy of the product are incorrect, the financial assessment might be performed correctly, but the conclusion reached will be incorrect.
All of the above may be considered in the initial stages
of technology evaluation through a conceptual needs analysis. The CE responsible for procurement can contribute to
the decision of whether to move forward and with which
vendors and technologies to do so. Each recipient of the RFI
should be advised of all decisions affecting that vendor. If a
vendor has been eliminated from further consideration, the
rationale for doing so can be conveyed to its representatives
so that there is closure; the vendor can improve its sales
efforts in the future if it has the ability and desire to do so.
The vendors eliminated from the process might request the
opportunity to resubmit or to supplement the submission of
information. Permitting a vendor to resubmit should be a
joint decision made by all team members.
Request for quotation
RFQ is also known as the request for bid, request for
proposal, and request for tender. Assuming that the technology evaluation processes have been performed and a
decision to move forward has been made, a much more
complete and detailed effort is necessary in order to identify specific equipment, services, and support that can be
provided by each qualifying vendor. Extraneous applications and options can be eliminated from further consideration. Each vendor who is still under consideration can
be provided with a much more complete idea of the nature
and scope of the clinical need and technology interest. The
RFQ is the organization’s document; it is an opportunity
for the organization to ask for whatever it wants. CEs who
have been involved in prior procurements may have an
advantage based on their experience to lead the effort to
convey the interests and expectations of the organization
to the vendor because they were involved in the initial RFI
and some parts of the decision-making process. As it is
likely that much of the information eventually will be restated in the form of an acquisition contract, it is expedient
for there to be consistency in the RFI, RFQ, and purchase
contract processes. It should be understood that the RFQ,
while an essential component in the overall process, is not
a legal transaction. It is an evolving process, that is, it is
subject to change, for example, new information or opportunities are identified. Information that is gleaned from
other subsequent tasks (e.g., laboratory testing and clinical
evaluation) and discussions might require clarifications or
changes in the RFQ.
200 SECTION | 3 Healthcare technology management
Standard template
It is unwise to attempt to reinvent the wheel every time a
technology is evaluated. While the RFQ document should
be flexible to evaluate varying technology, starting with a
standard template and making necessary modifications to
fit the specific technology have distinct advantages. There
is a greater likelihood that the request will be complete and
not miss a crucial item and that it will be compiled more
rapidly and efficiently. Vendors can become experienced in
what the healthcare organization expects of them and can
“standardize” their responses if applicable, thereby reducing their costs. Those who are responsible for evaluating
vendor responses can become experienced in responses and
their implications. Often, a standardized comparison tool
(e.g., a tabular program) can be more easily utilized if the
RFQ is based on a standardized format. The process can expediently drive the comparison of “apples to apples.” Often,
the simplest way to begin developing a standardized request
is to review and modify samples of RFQs that the organization has utilized successfully in the past.
One purpose of the RFQ is to convey the organization’s
interests and expectations to the vendor. In order to do so,
the communication must be clear and understandable. The
structure of the RFQ might include sections devoted to specific topics, for example, introduction, equipment specifications, terms and conditions, installation, service, and
training. Similarly, questions and requirements should be
clear, concise, and easy for the vendor to understand.
There is a variety of templates available for consideration, but most include some or all of the following
elements:
●
●
●
A narrative description of the organization’s interest in
the technology(ies), the contacts within the organization, and the period in which responses, presentations,
and procurement is expected to take place. It is not
necessary to fully detail, for example, the clinical significance or efficacy of the device, as the vendor theoretically is expert in these areas or would not be providing
the technology.
Technical specifications that are particularly important
to the intended clinical use of the technology and to the
specific installation in the physical facility. Often, the
RFQ provides the vendor with sufficient information on
the basis of which to ask for and to gain more detail
(from, e.g., the clinical sponsor and the facilities engineer within the organization).
Options that are mandatory and those that would or
should be considered. The RFQ is an opportunity for the
organization to ask for and to receive sufficient information on the basis of which to acquire and to use technology without the immediate need for additional options
or costs subsequent to this acquisition, as well as to plan
●
●
●
●
●
●
●
for clinical service changes and technology upgrades in
the future.
Consumables that must or should be acquired in order to
use the technology. Cost is not the only issue related to
consumables; availability also might be a key consideration if consumables are subject to back order, recall, or
replacement.
Documentation that will be provided. Typically, user
and service manuals are mandatory. Descriptions of diagnostic software and specialty tools (e.g., test boards)
are helpful.
Installation requirements, including space, power, cooling, and weight. Typically there are two approaches to
examine installation requirements. The organization
can detail what it expects will be necessary, and it can
require the vendor to advise the organization if this is
correct and complete, or it can require the vendor to advise it as to what is necessary for a complete and correct
installation. In either event, it is reasonable to require
the vendor to perform a site analysis as part of the RFQ
process so that unexpected and unnecessary problems
(e.g., the floor’s inability to carry the weight) do not occur at the time of actual installation.
Costs over the expected lifetime of the technology (lifecycle costs) for the various acquisition options (i.e.,
cash purchase, rent, lease, or joint venture) that are
available through the vendor or that have been utilized
by others acquiring the technology. Vendors are often
aware of methods and sources of financing, as well as
reimbursement.
Training courses and materials that are available from
the vendor, their agents, or others that are mandatory
or desirable for clinical staff and service/repair professionals. Disclosure of cost, if any, should be required.
In some cases (e.g., lasers), special physician training
might be strongly recommended. In most cases, training
of clinical staff may need to be performed in multiple locations throughout the 24-hour period, or the vendor will
need to train the trainers. The need for service training
should not be overlooked, even if vendor or third-party
service is expected. At least one professional within the
organization should have a working knowledge of the
technology. Turnover in clinical and service staff occurs,
and some mechanism to address training in the event of
turnover is desirable.
Identities of 10 most similar clients, including contact
names and information. It should be clear to the vendor that the organization intends to contact these clients
to discuss their experience with the technology and the
vendor, including use, service, and costs.
Service options and resources available. The RFQ is an
opportunity for the organization to learn everything that
it can about what to expect in the way of service after
Technology procurement Chapter | 32
●
procurement and installation are complete. Service topics that can be examined are as follows:
⚪
service contracts and cost, as well as reduction in cost
if first screening is performed by the organization
⚪
guaranteed up time
⚪
employer or independent dealer service
⚪
location and availability of service personnel including number of personnel at the service location
trained on the specific equipment, and location of
backup service and contact options (e.g., hotline)
⚪
details specific to the vendor’s provision of clinical/
user staff to operate the equipment (if applicable)
⚪
availability and attributes of guaranteed response time
⚪
parts availability, location, shipping schedule, and
price list
⚪
emergency/disaster support
⚪
labor rate(s), standard hours, and travel time
⚪
frequency and content of preventive maintenance
provided
⚪
availability of loaner equipment
⚪
indemnification and liability insurance coverage
Terms and conditions under which the technology will
be acquired. This is the opportunity to do the following:
⚪
require the vendor to install and acceptance test the
technology
⚪
identify how and when the vendor will receive
payment
⚪
specify penalties if the technology does not perform
reliably or is not installed according to schedule
⚪
detail how future versions of product hardware and
software will be made available, performed, and
charged
⚪
require evidence of compliance with local, state, and
federal codes and regulations
If the organization has unreasonable or unrealistic expectations or asks for information that is impossible to obtain, responses may be minimal without any need for them
to be so. Hence, it is paramount for the organization to think
about the aspects of the technology and vendor support or
other offerings that are important to and desirable for the
specific procurement. The organization might even direct
(in the RFQ) vendors to contact the organization to discuss
any aspects of the RFQ that the vendors find confusing or
objectionable. Although obtaining the best technology at
the best price is always foremost on the minds of the organization, the organization and the vendor must work together
effectively throughout the lifetime of the technology. If the
RFP (Request for Proposal) and subsequent interactions are
fair, a solid working relationship can result.
Aspects of the RFQ and the successful vendor responses
eventually will be reduced to a procurement contract. If the
RFQ or responses are incomplete, the procurement contract
might be expected to be incomplete. If, for example, a v­ endor
201
does not respond and agree to provide service manuals, this
issue probably will arise later, perhaps unexpectedly.
Vendor presentation
Some organizations find that a formal presentation by the
vendor is beneficial. Vendor presentations are opportunities
for learning, both for the professionals within the organization and for the vendor. Clinical professionals can learn
new information about the attributes of the technology and
gain an understanding of the extent of costs that will be assumed and the support that will be required. Vendors can
learn more about the relative importance the organization
places on cost vs performance, or on some other attribute of
the procurement.
In some instances, it might be possible to eliminate a
vendor from further consideration based on preliminary
analysis or on the vendor’s response and presentation; to
do so it should be clearly indicated and supported objectively. It would be unwise to eliminate a vendor where a
more complete analysis of the vendor’s response or subsequent questioning might result in that vendor as the best,
not the worst, alternative. Rebidding should be discouraged
as it costs both the organization and the vendor time and
money, although when significant changes result from the
preliminary analysis rebidding may be necessary.
Response analysis
Following the vendors response to the RFQ, the responses
should be compiled and compared. If the RFQ is standardized, the responses are complete, and a standardized
analysis tool can be utilized, then the process may be fairly
straightforward. Many organizations find a tabular format
easy to use. One major responsibility of those who are responsible for the analysis is to be sure to compare “apples
to apples.” If a like comparison is not possible, contact with
the vendors should be made in order to acquire information
that is more comparable.
The analysis should focus on information that are key
considerations when comparing procurement options. First
ensure that all of the vendors’ technology meets the basic
required technical specifications. Once this determination
has been made, this level of information can be eliminated
from the comparison table with a notation that specific or all
vendors meet the specifications. It is important to identify
differences among vendor responses (e.g., price); however,
it is just as important to remember that a vendor’s response
could be subject to change or negotiation if it becomes a
potential justification for eliminating that vendor. Providing
vendors with the opportunity to provide the rationale for
questionable items may identify a miscommunication and
subsequent clarification.
202 SECTION | 3 Healthcare technology management
Comparison and tabular presentation of differences in responses with regard to price, payments, and terms (including
warranties) are typical. Ensure that the comparison captures
crucial information such as omissions and errors in the responses, a vendor’s special attributes, and special technology
attributes. Omissions and errors should be discussed with the
vendor to determine whether additional information can be
acquired from the vendor. Special attributes of the vendor
often relate to the vendor’s history in the industry and their
reputation with customers. For example, if the vendor has a
history of unsatisfied customers, and the dissatisfaction is
based on objective information, this is important information
to include in the analysis. Remember that some causes of dissatisfaction (e.g., service response time) can be addressed,
to some extent, by terms and conditions within the purchase
contract. Special attributes of the technology often relate to
such issues as a small installed base, a brand new product
line, or an older system, compatibility, or special design.
Ultimately, the analysis may include a formal tabular
comparison, additional objective findings, subjective findings, and points raised in the analysis to develop recommendations for proceeding. The results of the analysis can range
from discontinuation of the procurement and technology
evaluation process to elimination of some of the responding
vendors, to consideration of all responding vendors in subsequent steps. Many organizations find it helpful to stress
within the analysis that the results, findings, terms, and conditions are subject to change prior to procurement, either
because of changes in need or as the result of negotiations.
Laboratory testing and clinical evaluation
Once the analysis is completed, decisions related to laboratory testing and clinical evaluation can be finalized. Which
vendors to consider, what technology and options to request
for evaluation, and the timetable to be utilized to perform the
evaluations will have to be decided. It is advisable to keep
the CE who is responsible for procurement in the information loop during the evaluation period. Decisions made and
information learned may directly affect the procurement
process subsequent to the evaluation. Comparison of vendor
specifications alone or undue emphasis on vendor specifications is unwise. Laboratory testing and clinical evaluation by internal and external professionals can identify what
may be key differences between specified performance and
actual performance. Once these evaluation aspects of the
process are completed, tasks that are related to the procurement process can be expected to accelerate.
include identification of the preferred vendor(s), specific options, accessories, features, training, or service. Procurement
professionals should work closely with the evaluation team to
identify any desirable changes or additions that have become
apparent during the evaluation process. It is common for questions to remain and to require addressing by the vendor(s).
Unless there is overwhelming reason to do so, it is not
typically wise to reduce the field of vendors for final procurement to one vendor. Doing so can minimize the organization’s ability to negotiate such items as cost and terms.
In addition, it is reasonable and ethical to explain to each
vendor the identified differences and shortcomings of the response and equipment, along with an offer to each vendor to
explain any rationale for the difference or the ability to compete. Questions about cost, performance, and options are
ethically appropriate for the vendor and organization alike.
Capture and communicate to team members and decision makers requirements for installation, training, and service for each of the vendors who remain in competition. In
some instances, a recompilation and reanalysis of information might be necessary. Occasionally, a rebid of the entire
procurement may be necessary. Procurement professionals
should be tasked with the responsibility to collaboratively
analyze the information received from the initial RFQ process, the information received from the results of the evaluation processes, and any clarifying information received by
the vendors to determine whether sufficient information
exists on which to finalize the award. If additional information is needed, or if insufficient information exists, the
procurement professional should take the time to rectify the
situation or to ensure that the proper professionals within
the organization are aware of the issues. Assuming that adequate information on which to base the award has been
collected, and that the original RFQ was complete, the process of revision can be expedited. If the revision document
is complete, the process of moving to award with a procurement contract can be expedited.
Selection and payment
RFQs, evaluations, and revisions have been completed.
Thus, the procurement team moves to “award” and the job
of the CE in the procurement process is done, right? Wrong!
The CE should participate in the process that ensures that
the technology, options, services, and other “promised
items” are delivered. The first step in assuring that promised
items are delivered is to provide an award document that
clearly spells out what these promised items are.
Revision of technical specifications and
other requirements
Contract
Revision of specifications is often necessary based in part on
what is learned during the evaluation process. Revision may
A procurement or purchase or lease contract, by whatever name, is desirable. The language and essential legal
Technology procurement Chapter | 32
e­ lements of the document should be tailored to the specific
aspects of the technology and should be approved by legal and compliance counsel. If the contract is standardized, transferring information into the award procurement
contract from the preceding procurement documents can
be expedited. Standard features of a procurement contract
include a detailed description of the technology, options, accessories, documentation, software, and updates to be provided by the vendor. The contract usually also includes the
specific conditions of sale, as follows:
●
●
●
●
●
installation requirements, responsibilities, and timetable
acceptance testing requirements, responsibility, and
timetable
warranty details, replacement and spare parts availability
service requirements
clinical and other training to be provided, assignment of
cost for same, and schedule for doing so
Of course, the contract will incur costs. Often, it is wise
to identify not only the costs for which the organization will
take responsibility, but also the costs for which the vendor
or others involved in the procurement will take responsibility. Doing so can avoid subsequent questions of payment responsibility and the unexpected need to assign more dollars
than expected. The contract also typically identifies payment schedules (e.g., 10% withheld until final acceptance
testing complete), ability to assign the contract, grounds for
and methods of cancellation, and price protection.
The CE who is responsible for the procurement can protect
the organization by taking the time to identify the technology
features, options, accessories, services, and other acquisition
issues that are vital to the organization, and for ensuring that
those items are included within the procurement contract.
Sufficient detail should be included in order to identify what is
required, to ensure that each is delivered, and to specify penalties can minimize misunderstandings and future problems.
Sometimes overlooked in the process is the need to advise vendors that are not receiving the award that an award
has been made. The vendors typically have devoted time
and resources to their response, and each vendor deserves to
be advised. The organization should document the reasons
for the selection. Depending on the situation, there may
be merit in advising the vendor(s) of the reasons. Vendors
might be able to improve their marketing and presentation
response in the future and might decide to improve their
technology and offerings. In some cases, the organization
might subsequently need to consider acquisition of technology from a vendor that it did not select for a particular
procurement.
Incoming inspection and acceptance
Once the award has been made, the process of monitoring
and verifying the installation and delivery of the technology
203
begins. While this is an important aspect of the procurement
process, it is discussed in detail elsewhere. In short, acceptance testing, monitoring installation, and verifying delivery
of specified items ensures the following:
●
●
●
●
the technology safely performs its intended function
initial (baseline) performance characteristics are measured and recorded
incoming inspection and acceptance testing is performed and met
the remaining terms and conditions of contract are met
Payment
Assuming that payment conditions have been detailed in the
procurement contract, the CE should advise the appropriate
personnel in the organization when milestones are achieved
and when there are problems which interfere with the delivery of health care. In the event that a problem arises, the CE
responsible for procurement may assume primary responsibility for determining the manner in which the problem is to
be resolved, and may negotiate costs in collaboration with
the organizations’ financial department based on the effect
of the problem. While CEs may not have the final authority
on these aspects of the process, they can and should contribute significantly, identifying the ramifications of problems
and the adequacy of proposed resolutions.
Monitoring
The procurement process is not complete upon agreement
of the contract by both parties. Often, monitoring of medical staff satisfaction, equipment performance (e.g., uptime),
provision of subsequent services (e.g., preventive maintenance and quality control), and calculation of life-cycle
costs must be performed. Along with addressing contractual obligations, meeting clinical and operational promises
and needs can contribute to the organization’s knowledge
base and expertise for future acquisitions. In some instances, it can help to contribute to meeting accreditation
(e.g., The Joint Commission, TJC) and to satisfying regulatory requirements (e.g., Clinical Laboratory Improvement
Amendments, CLIA).
Conclusion
The CE has a solid background on which to assume primary
responsibility for the procurement process. The CE needs
to recognize the clinical and financial experts within the
organization as critical participants in the process. Careful
attention to detail throughout the process with the intent to
capture important information and to advise the organization and vendor of this information helps to improve the
process. Developing a request for proposal and following
204 SECTION | 3 Healthcare technology management
through to the procurement contract, payment, installation,
and use of the technology is truly a lesson in communication. Expediting communication through the assurance that
adequate information is passed along to all parties and that
responsibilities are clear can make the process a win-win
one for all participants.
Further reading
Clark, T., 2016. Medical device integration: acquisition; focus on request
for information and replacement planning. In: AAMI 2016 Conference
and Expo, June 3-6, 2016, Tampa FL. http://accenet.org/publications/
Downloads/Symposiums/AAMI%202016_ACCE%20Symposium_
Presentation%20Deck_PART2_s.pdf.
ECRI Institute, 1976. Request for proposal template. In: Healthcare
Product Comparison System, Plymouth Meeting, PA.
HIMSS. RFP Sample Documents. www.himss.org/rfp-sample-documents-0.
The National Learning Consortium (NLC). Information Technology:
Template; Request for Proposal (RFP) Template for Health. www.
healthit.gov.
Chapter 33
Equipment control and asset
management
William M. Gentles
BT Medical Technology Consulting, Toronto, ON, Canada
Introduction
An essential first step in managing the assets of an organization is to obtain an accurate inventory of the assets owned
by the organization. In addition, most HTM (health technology management) activities cannot be performed effectively without an accurate inventory of all assets that are
included in the HTM program. This chapter discusses some
of the principles of asset management that are necessary in
an effective HTM program.
The inventory
An inventory is a detailed list of all assets that are held by
an organization. A Health Technology Management (HTM)
program may be responsible for managing a subset of the
organization’s inventory of assets, for example, the HTM
program will not be responsible for maintaining office furniture, even though this furniture might be included in the
inventory of capital assets. In addition, the HTM program
might include in its scope of responsibility items such as
blood pressure measuring devices that do not qualify as
capital assets. Thus the HTM program needs to clearly define in writing the process it uses to identify the assets that
it is responsible for, and that it will include in the HTM
inventory.
Because the requirement to perform scheduled maintenance of all assets in the HTM inventory is unachievable
with the staffing levels found in most clinical engineering
services, most of these services have adopted a risk-based
categorization of assets in the HTM inventory.
Although there are many published discussions of different methods of assigning risk to medical devices, Ridgway
(2001) has proposed an approach in which medical devices to
be included in a “monitored maintenance program” are those
that are “critical devices in the sense that they have a significant potential to cause injury if they do not function properly”
and that are “maintenance sensitive in the sense that they
have a significant potential to function improperly if they
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00033-X
Copyright © 2020 Elsevier Inc. All rights reserved.
are not provided with an adequate level of PM (Preventive
Maintenance).” Noncritical devices are excluded from scheduled maintenance, as are devices for which there is no evidence of benefit from “planned maintenance.” Nonetheless,
all patient care equipment should be included in the HTM
inventory, even if it does not have a scheduled maintenance
activity associated with it. Unscheduled maintenance events
(repairs) on this equipment need to be documented, to allow
the inclusion of the equipment in a scheduled maintenance
program should the data acquired indicate that scheduled
maintenance would improve equipment reliability.
Regulations that are country specific will often define
what items must be managed by the HTM program, and
what maintenance activities are required [e.g., JCAHO
(Joint Commission on the Accreditation of Healthcare
Organizations) and CMS (Centers for Medicare and
Medicaid Services) requirements in the United States]. It
is beyond the scope of this chapter to discuss such countryspecific requirements.
Recommended data that should be
included in inventory records (from
WHO, 2011)
Equipment identification number or asset tag number
Type of equipment using standard nomenclature
and including UMDNS (Universal Medical Device
Nomenclature System) code or GMDNS(Global
Medical Device Nomenclature System) code or the
newly developed WHO medical Device Nomenclature
code for the item
Brief description of equipment/item, what it is used for
Safety or risk classification
Name of manufacturer
Model number and model name
Serial number
Current software and firmware version numbers, network addresses as applicable
205
206 SECTION | 3 Healthcare technology management
Physical location within healthcare facility, including
building name and room number
Condition/operating status, e.g., functioning, good
condition/functioning, worn condition/not functioning,
awaiting repair/not functioning, unrepairable
Power requirements, e.g., 240 V AC, 50 Hz, 5 Amps
Special requirements needed for operation or service of
the equipment
Date placed in service
Acceptance testing information and results
Date inventory last updated
Maintenance service provider, including full contact
details
Purchase supplier including full contact details
Purchase cost
Purchase date
Warranty expiration date
Preventive maintenance schedule and procedures
Calibration dates performed and results, dates due and
procedures
Associated or connected devices/systems/accessories
Expected equipment lifetime
Operating and service history
Other custom fields as necessitated by the local healthcare
environment
Maintaining inventory accuracy
An inventory will quickly become out of date or develop
inaccuracies if there is no active program to maintain the
data. This program typically consists of three stages:
1. Initial data collection: The first step in setting up an
HTM program is the collection of inventory data. This
data will not be accurate unless the people performing
the inventory understand the function of the equipment
they are documenting in the inventory.
2. Information update: The equipment inventory must
be updated whenever there is any change in information for any inventory item, such as a move to
another location, or removal from service.
3. Annual audit: Every year, the clinical engineering staff
must perform a review of the medical equipment inventory. The purpose of this review is to check that all of the
information is accurate and to make any updates.
Computerized systems for inventory
management
A computerized maintenance management system (CMMS)
generally combines inventory, repair and maintenance history, and work-order control into one system. Other information as needed may also be included in a CMMS. For
more information, see the separate chapter on CMMS.
In low-resource countries, there may not be funds available to acquire a commercial CMMS. In these situations,
the inventory data should still be collected in a form that
allows analysis and sharing of data. A simple Excel spreadsheet is adequate for collecting inventory data.
Effective uses of the inventory
A complete and accurate inventory has many uses in a
healthcare organization, and a clinical engineering department. The following is a partial list:
1. running an effective HTM program
2. performing needs assessment
3. developing replacement and disposal policies and
goals
4. making a case for equipment standardization
5. forecasting and developing budgets for the purchase of
new equipment
6. planning and equipping a workshop to provide on-site
repairs and calibration
7. determining required staffing levels and expertise requirements of clinical engineering staff
8. identifying training needs of the clinical staff
9. managing service contracts for equipment that is serviced by an outside service provider
10. planning for spare parts and consumables orders
11. performing risk analysis, management, and mitigation
12. planning for disasters and emergencies
The challenge of managing mobile
equipment
An increasing number of medical devices used in health
care are portable (e.g., point of care devices) or mobile devices on wheels (e.g., infusion pumps). In the case of infusion pumps, a large hospital may have a fleet of hundreds
or even thousands of these devices, whose location at any
given time could be extremely difficult to determine. The
management of such mobile devices requires special strategies that recognize their lack of a fixed location. The problem is particularly acute in emergency departments, where
admitted patients are often sent to a care unit attached to an
infusion pump. This means that the emergency department
will constantly require that their inventory of pumps be replenished. Nurses in the emergency department frequently
find themselves spending a great deal of their time chasing
after the pumps that have left the department, and persuading the care units to return them. This is a very poor use of
nursing time.
One of the strategies to deal with mobile equipment
is to assign ownership of these devices to a central equipment pool, rather than to individual care units. The devices
are loaned (or rented) from the pool by the care units, and
Equipment control and asset management Chapter | 33
r­ eturned to the pool when no longer required. A small float
of extra devices is kept in intensive care units to address
urgent needs. This float is monitored and replenished daily
by the staff of the equipment pool. When the float is depleted and additional pumps are required, nurses simply
call the pool and request additional inventory. There are
several advantages to actively managing mobile equipment
in this manner: (a) Fewer devices are required to provide
the same level of service, which reduces capital equipment
costs. (b) Hoarding of devices is reduced or eliminated. (c)
Much nursing time is saved as they no longer spend time
hunting for a pump. (d) Delivery staff who delivers the
pumps is trained on basic front line troubleshooting. In one
case, this resulted in a reduction in “no fault found” service
calls of 50% (Gentles, 2000). (e) The clinical engineering
staff spends less time searching for pumps that are due for
scheduled maintenance or software updates. More detail on
the benefits of an equipment pool was provided by Gentles
(2000).
Another strategy that may be used whether or not an
equipment pool is implemented is the use of RFID (radio
frequency identification) tags along with RTLS (real-time
locating system) software. As of 2017, the use of RTLS in
health care is still quite low, because of the ongoing debates
about the cost benefits, and the complexity of implementation. RTLS is analogous to an indoor GPS (global positioning system). The argument for implementing an RTLS
system for assets is most persuasive in large organizations
with thousands of mobile assets. In these organizations,
staff may be spending large amounts of time hunting for
mobile equipment, and unknown numbers of portable devices leave the building, never to return. It is challenging to
calculate the ROI (return on investment) from reducing the
207
amount of staff time that is spent hunting for equipment, as
it is a very difficult quantity to measure with any accuracy.
Vendors will argue that the ROI will result in cost savings
over time. If considering an investment in RTLS, hospitals
should examine carefully the claims of vendors, and check
references thoroughly.
Concluding remarks
The challenge of effectively managing assets in an HTM
program is not to be underestimated. The diversity of types
of equipment, the critical nature of some equipment, and
the increasing number of portable devices present ongoing challenges which can only be effectively managed by
knowledgeable staff with experience in HTM.
References
Gentles, W., 2000. The central equipment pool, an opportunity for improved technology management. Biomed. Instrum. Technol. 34 (3),
213–216.
Ridgway, M., 2001. Classifying medical devices according to their maintenance sensitivity: a practical, risk-based approach to PM program
management. Biomed. Instrum. Technol. 35 (3), 167–176.
WHO, 2011. Introduction to Medical Equipment Inventory Management.
Available at: http://www.who.int/medical_devices/publications/med_
dev_inventory/en/. (Accessed December 1, 2017).
Further reading
Kamel Boulos, M., Berry, G., 2012. Real-time locating systems (RTLS) in
healthcare: a condensed primer. Int. J. Health Geogr. 11, 25. Available
at http://www.ij-healthgeographics.com/content/11/1/25. Accessed
December 2017.
Chapter 34
Computerized maintenance
management systems
Theodore Cohena, Matthew F. Baretichb, William M. Gentlesc
a
Clinical Engineering, UC Davis Health, Fair Oaks, CA, United States, bBaretich Engineering, Inc., Fort
Collins, CO, United States, cUniversity of Toronto, Toronto, ON, Canada
How do clinical engineers (CEs) ensure that the medical
systems installed in their customers’ healthcare organizations are functioning optimally? What do they do when
those medical systems malfunction? What is the quickest route to restoring performance of the medical system
to the customer’s satisfaction, and at what cost? How do
they help determine when to replace a major system? How
do they interact with the healthcare providers and all their
other customers (e.g., vendors, manufacturers, and hospital
administrators) in a modern, complex, healthcare organization? Most use some type of computerized record-keeping
system to help manage their clinical engineering business.
Computerized maintenance management systems
(CMMSs) have evolved into a key tool in providing technology support. Whether supporting a three-technician
shop, a large multihospital healthcare delivery organization (HDO), or an international CE program almost all
medical equipment support organizations are using some
type of CMMS in their operations. These CMMSs can be
broadly classified as internally developed (typically using
commercial off-the-shelf computer hardware and database
software), locally hosted commercial CMMS applications,
or a web-based application service provider. Many commercial systems offer both local and web-based systems.
This chapter reports on the current status of CMMSs in use
in hospitals and healthcare systems today and some of the
more advanced applications that are starting to be used by
the future-leaning providers of medical technology support
services.
All CMMSs provide equipment inventory management
and work order management. A complete and accurate
medical equipment inventory is fundamental to any CE operation. The CMMS tracks basic equipment inventory information with data provided by the HDO (e.g., purchase
source and price information) and the device manufacturer
(e.g., model and serial number). All CE medical devicerelated work activities should be documented in the work
208
order module(s). All planned maintenance (PM) and unscheduled or corrective maintenance (CM) activities are
recorded to keep track of maintenance and repair events
performed on the equipment.
Based on the equipment inventory and work order data,
CMMSs can provide the technology management staff with
a wealth of information to help manage their technology
support-related functions. Examples include the following:
1. Quantitative equipment reliability assessments can be
made based on the failure rate, downtime, and repair and
maintenance costs. These assessments can be used to
determine equipment that should be replaced, and assist
in the subsequent vendor selection for the new product
being purchased.
2. User/operator training needs can be identified based
on the trends in use error problems (e.g., use-related
“knobology” problems, liquid spills, and physical
damage).
3. Scheduled maintenance can be prioritized based on the
maintenance needs of the device, regulatory requirement constraints, the risk to the patient of an equipment
failure, and the likelihood that routine maintenance can
reduce that risk. CMMSs can be used to optimize this
often very large workload.
4. Scheduled maintenance program effectiveness can be
measured by the rate of problems identified (yield),
parts replaced, and equipment not found/not available as
compared to the total number of inspections performed.
The CMMS core
The core of an equipment management system is equipment
inventory, work order control and repair, and maintenance
history. The equipment inventory is an automated file of all
the equipment that has been included in the CMMS. The
consolidated repair and maintenance history is a record of
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00034-1
Copyright © 2020 Elsevier Inc. All rights reserved.
Computerized maintenance management systems Chapter | 34
209
FIG. 1 Simplified CMMS module structure. (From Cohen, T., Baretich, M., 2017a. Computerized Maintenance Management Systems for Healthcare
Technology Management, third ed. Association for the Advancement of Medical Instrumentation, Arlington, VA.)
each repair and maintenance event, independent of who initiated the event and who provided the service. Work order
control is used to dispatch and prioritize requested work,
schedule periodic inspections and preventive maintenance,
and track the status of pending scheduled and unscheduled
work orders (see Fig. 1).
Equipment inventory
In the typical CE program, when new equipment is received,
a biomedical equipment technician (BMET) is dispatched
via a work order to complete an incoming inspection. The
BMET makes sure the purchase order is complete and inspects and tests the device in accordance with the service
manual provided as part of the order. Based on the type of
device, local regulatory requirements, the organization’s inventory inclusion criteria, and the policies of the clinical engineering organization, he/she then determines if the device
needs to be included in the medical equipment management
program. Note that in the United States, based on the regulatory requirements, most hospitals are required to include
all medical equipment in the inventory. The BMET then enters (or completes a form so a data entry clerk can enter) the
new item onto the CMMS database as well as completing
the incoming inspection work order.
Device-type descriptions, manufacturer names, department names, building names, and other foundational data
should be made as consistent as possible and referenced
from a single location (e.g., foundation tables). For example, device-type descriptions should use standards-based
nomenclature such as ECRI Institute’s Global Medical
Device Nomenclature System (ECRI, 2017), Global Device
Identification (Global Medical Device Nomenclature, 2017),
or in the near future, UDI (FDA, 2017). Other equipment inventory fields can then be defaulted from the foundational
data (e.g., model-based scheduled maintenance information
such as inspection frequency and maintenance procedures).
A similar construct can be used for the owning department
(cost center), with defaults for minimum scheduled maintenance frequency and location information. This building
block approach, with references to foundational data, and
built-in default values, allows equipment records to be built
quickly with maximum data integrity and flexibility.
Sample definitions for the fields that are typically stored
as part of the equipment inventory are listed in Cohen and
Baretich (2017a).
Work order subsystem
The work order subsystem of the typical CMMS consists
of the following: an unscheduled (requested) work order
manager and technician dispatcher, a routine maintenance
scheduler, and a PM procedure reference library.
The unscheduled work order manager documents incoming requests for repair and other CE services and keeps
track of the work order until completion. Typical information tracked includes requestor name and contact information, equipment identification, equipment problem and/or
service requested, equipment location, type of work order
(e.g., repair, new inspection, and product recall/alert), and
the priority of the work order (e.g., how soon the customer
needs to have the work completed). See Cohen and Baretich
(2017a) for a list of work order fields and their definitions.
The PM scheduler is used to initiate and manage scheduled inspections, scheduled parts replacement, and scheduled preventive maintenance work orders. In the typical
210 SECTION | 3 Healthcare technology management
CMMS, each item of equipment requiring PM has associated with it scheduled inspection data that includes the following: assigned technician default, or service provider if a
vendor provides the PM, service interval (e.g., 12 months),
fixed/floating flag, a synchronization date for fixed scheduling, the most recent completion date, and the next due date.
The next due date is calculated based on either a fixed
or floating basis. A fixed schedule results in the work being
scheduled at the same time(s) of year each year based on the
interval and a synchronization date regardless of when the last
inspection was completed. A floating schedule results in a new
due date determined by the inspection interval and the date the
last inspection was completed. Upon request, or at fixed times
(e.g., once a week or once a month), the inspection scheduler
generates scheduled work orders for the designated time period (e.g., next month’s scheduled work) and preassigns them
to the default assigned technician or service provider.
The inspection/preventive maintenance procedure library consists of a set of equipment type- and/or modelspecific procedures itemizing the tasks and parts required to
complete periodic inspections, preventive maintenance, and
periodic parts replacement. The procedure library may be
part of the CMMS, online external from the CMMS, and/or
a paper-based service manual library [see the alternative
equipment maintenance (AEM) section].
CMMS issues in low resource countries
Low resource countries are those countries classified by the
World Bank categories of “low income” or “lower middle income.” The challenges faced by CEs in these countries can be
unimaginable, and completely foreign to CEs in the developed
world. At the Second Global Forum on Medical Devices, held
in Geneva in May 2017, a workshop on CMMS for low resource countries was held. In preparation for that workshop,
a survey to understand the level of implementation of CMMS
software in those countries was circulated on the online discussion group INFRATECH. There were 42 responses to the
survey, of which 32 were from low or lower middle income
countries. The table below summarizes the results for the
question: “What type of CMMS software do you use?”
Type of
CMMS
used in
developing
countries
Number
of
responses
A commercial
product
6
Locally
written
software
1
Type of
CMMS
used in
developed
countries
Number of
responses
A
commercial
product
12
Locally
written
software
1
Open source
or free
software
4
Spreadsheet
13
Total
responses
24
Total
responses
13
These results suggest that the majority of CEs in the developing countries are still managing their assets with a
spreadsheet. Lack of funds may be a primary cause for this
situation, as the cost of commercial CMMS products, and
their support contracts are simply beyond the reach of these
countries. There have been several attempts to address the
cost issue by individuals or groups releasing CMMS software that is “open source” or available for free download.
Despite the availability of these systems, there has been
limited adoption to date. The reason for this is partly due
to the magnitude of the effort required to change processes
to align them with the more rigorous processes required by
any CMMS. The time required to implement such a large
change is often not available to understaffed and underresourced clinical engineering units. In addition, a significant
cultural change will be necessary to change work habits,
and document every service intervention in a database.
Such documentation adds a significant workload to an already underresourced department, and is another obstacle to
wider implementation of CMMS software in low resource
countries.
Spreadsheets can successfully be used for small equipment
inventories, but it is difficult to manage large inventories,
and any service histories, without a database. For example,
in Mongolia, before 2017 the only medical equipment inventories were on spreadsheets in each hospital. There was
no national inventory of medical devices. In 2017, they began the rollout a country-wide CMMS that had been written
locally in the Mongolian language. This CMMS is web based
and for the first time will provide a nation-wide picture of
the state of the medical equipment in that country. The cultural change required to get all clinical engineering staff to
document all their work in the CMMS is ongoing, and is
expected to take at least a year.
Bill Gentles, December 2017
Parts and service provider management
One of the underlying philosophies of a quality CMMS
is that all services are tracked, and costs recorded regardless of the service provider. This section describes various
ways to track and manage purchased repair parts and vendor services.
Computerized maintenance management systems Chapter | 34
211
Parts
Service provider management
When repair parts are needed, they are typically obtained
from “stock” parts, parts purchased directly from a vendor
and shipped to the hospital for specific use on a specific
repair, or parts supplied by the vendor as part of vendor
service that includes installation labor, either on a fee-forservice basis or as part of a prepaid service contract.
Stock parts are parts that are stored locally, and typically, for future use. These parts may be stored in a stock
room, at a technician’s workbench or in other locations.
All clinical engineering departments maintain some stock
of basic electrical and electronic components, batteries,
wire, nuts, bolts, and other common hardware. Many departments also stock commonly used components such as
certain circuit boards and other more expensive devicespecific parts. The decision as to which parts to stock and
which parts can be ordered on an as-needed (just-in-time)
basis is based on how critical the device is and the ability of CE to obtain specific parts from the parts source
quickly. Since it is impossible to predetermine all failures
and it is cost prohibitive to stock all parts for all devices,
then, ideally, major high-cost, low failure rate parts would
not need to be stocked.
Clinical engineering departments need to have the ability to place parts orders quickly via their own purchasing
authority (e.g., CE purchase orders, credit cards) or a responsive HDO procurement group. The ability to place
parts orders quickly, combined with a parts receiving function in clinical engineering and the availability of same-day
and overnight freight carriers, can allow the ordering and
receipt of parts to routinely occur within 24 h, therefore,
minimizing the need to stock high-cost, low failure rate
parts. However, depending on the locations of device manufacturers’ parts depots, in some areas of the world shipping
times may be lengthy and customs regulations may further
slow parts delivery mandating increased parts stock.
CMMS-based parts management software typically requires that all parts entered reference a unique part number.
This part number can be either clinical engineering issued
or use a unique manufacturer part number as the index to
the parts management module. Other fields that typically
are collected include a part description, price(s), reorder
level, manufacturer id, manufacturer part number, vendor
id, and vendor part number.
For just-in-time parts purchases, practices vary with
some HDOs placing all parts into the stock parts system,
whereas others issue purchase orders, or use credit cards,
and manage just-in-time parts in a similar manner to managing service provider repairs as discussed below. Regardless,
it is important that certain details of the parts transaction
(e.g., parts id, description, and pricing) get placed in the
CMMS’s consolidated service history with a reference to
the specific work order and its associated medical device.
No clinical engineering department can provide 100%
of the equipment service required 100% of the time on
100% of the equipment inventory. In order to control the
cost and quality of vendor medical equipment repair and
­maintenance services, it is appropriate for CE to coordinate
vendor equipment services. Vendor services can consist of
non-billable warranty work, service performed on a feefor-service basis, service performed under a prepaid service contract, billable services performed under a prepaid
service contract but outside the prepaid terms and conditions of the contract, and other billable and non-billable
services (e.g., product recalls, installation work). All costs
(e.g., prepaid, billable, freight, tax, parts, and labor) should
be tracked in the CMMS. All vendor service work needs
to be coordinated and tracked in a similar manner to the
data collected for in-house work. Typically, vendors complete service reports when they have completed a task and
these service reports are one of the key documents used for
data collection. Service reports should be required and provided to CE for all vendor work, billable, and non-billable.
Service report technical detail and cost data, often from
subsequent invoice(s), need to be entered into the CMMS
and become part of the consolidated service history.
Service contracts
Sometimes the only practical service strategy for a complex
system is a prepaid service contract. For prepaid contracts,
the CMMS needs to contain the following: pricing, type of
coverage (e.g., full service, PM only, and parts only), term,
special terms (e.g., major part inclusions and exclusions),
and coverage hours. Each device under contract is identified
in the CMMS and contract information displayed on each
work order for that device. Contract pricing is allocated to
the individual devices on the contract for the time periods
of the contract. When the service provider completes any
service under the contract terms, a service report is provided
and the service report information is added to the CMMS,
including a summary of work completed, any additional
costs, parts used, and any other work completed or work
still needed to be completed.
Recalls and alerts
Medical device product recalls, alert and field modification
notices are published periodically by governmental agencies (e.g., FDA), subscriber services (e.g., ECRI Institute),
and original equipment manufacturers (OEMs). Equipment
identified on these notices need to be reviewed and matched
to the CMMS inventory, either manually or semiautomatically, to determine if any of them are applicable to the HDO.
Whenever a match occurs a notification to the end user, and
212 SECTION | 3 Healthcare technology management
where applicable, an HTM work order, needs to be issued
so that follow-up can be accomplished and the alert and/or
recall recommendations can be completed and documented
in the CMMS. Note that more and more recalls and alerts are
software related so keeping track of the software rev levels
has become increasingly important (see IT section further).
Incidents
Health delivery organizations have incident reporting systems for reporting internally significant issues that have
caused patient injuries or deaths, or “near misses,” due to
process problems or errors. Clinical engineering typically
has responsibility for following up on medical devicerelated incidents. CMMS work orders should be issued
for any medical device involved in an incident so that the
equipment problem and follow-up repair or other incidentrelated device information is included in the CMMS’s consolidated history.
The consolidated history record
An important part of the core of the CMMS is the consolidated history record. The consolidated, or integrated, history
record concept provides a service-provider-­
independent,
date and time-tagged repair and maintenance history associated with each service event. Example fields for an integrated
history record are listed in Cohen and Baretich (2017a).
The typical history record contains the following information: the original problem request, work order type (e.g.,
scheduled, corrective, and incoming), origination date and
time, and one or more tasks. Each task contains the following information: start and end dates and times for each task;
status of the work order at the end of the task (e.g., complete, awaiting parts, referred to a vendor); who performed
the task (vendor or clinical engineering and which technician/­
engineer); labor hours for the task including travel and overtime; and parts and materials used and their cost. For major
systems, it is also important to track system downtime.
Associated with each task is a list of specific actions
taken as part of the task. Certain special fields that cause
other action(s) to occur are encoded (e.g., codes that indicate the status of the work order, codes used to update the
PM scheduler due dates). Other action fields can be either
free text or encoded or both. Free text generally provides
more comprehensive information, while encoded data are
generally easier to analyze.
Basic reports
All commercially available CMMSs provide basic reporting
capability. Basic reports include: equipment inventory lists,
work order lists (open, closed, scheduled, and unscheduled),
equipment history repair records with aggregated costs and
downtime, foundation table lists (e.g., equipment-type lists,
customers, manufacturers, and technicians), and a variety
of additional performance and management reports (see advanced reporting and dashboards below).
Comprehensive CMMS
Modern CMMS offers many features in addition to the “core”
features discussed above. The advances in medical technology, the complexities of some products (e.g., imaging systems), the integration of medical devices with IT networks
and applications [e.g., picture archiving and communication
system (PACS), electronic medical record (EMR)], have
created a need to manage systems, and systems of systems,
in addition to the management of individual devices. More
and more of the “higher end” commercial CMMSs are adding features to assist CE departments in comprehensive
­healthcare technology management of these systems. A few
of these newer features are discussed below.
Network-connected medical devices
With the growing number of medical devices connected
to IT systems, it has become essential for CMMSs to keep
track of IT-relevant fields for network-connected medical
devices. For example, Internet Protocol (IP) address, media access control (MAC) address, operating system version, application software version, encryption capabilities,
and whether confidential patient identifiable healthcare
information [e.g., electronic protected health information
(ePHI)] is stored and/or transmitted.
The increased interconnectivity of medical devices creates an increased vulnerability to hacking, malware, and
other cybersecurity and privacy problems (see Chapter 40).
CMMSs need to keep track of software and firmware version numbers and security patches so they can be tracked,
monitored, and documented when installed, so it is known
which devices are awaiting patching and which device
patches are complete. Virus protection software is one
method to contain malware. CMMSs should track whether
the connected devices allow antivirus software, which antivirus software is installed (product name and version), how
the antivirus is updated (e.g., automatic or manual), and any
restrictions on antivirus use (e.g., only run antivirus when
the system is off-line).
Advanced reporting and dashboards
Effective communication both inside the CE department
and throughout the HDO for equipment-relevant information is of paramount importance. CMMS-relevant communication techniques include written reports (on paper and
Computerized maintenance management systems Chapter | 34
e-mailed) and dashboards as described below. Reports and
dashboards should be focused on needs of their audiences
(e.g., HTM staff, HTM management, HDO management,
and HTM customers).
Basic reports were mentioned in the core CMMS section above. Most CMMSs offer a variety of built-in reports
as well as a custom report generator (e.g., Microsoft SQL
Server Reporting Services, Crystal Reports) and data export
utilities (e.g., Microsoft Excel compatible exports) for more
advanced reporting capabilities. Using these tools, every
field in the CMMS can be reported as needed. Examples of
advanced reporting include: cost of service ratio (COSR)
reports that display the ratio of total repair and maintenance
costs for the active inventory, or a defined subset (e.g., all
imaging equipment), divided by the aggregated acquisition
price for that same equipment; failure rate for a defined set
of devices (e.g., number of infusion pump failures per year
per pump); and downtime reports for HDO-critical systems.
Dashboards are used by HTM staff and management
to display near-real-time status of pending work as well as
relevant metrics such as open work orders, completed PMs
for the month, active projects, and much more. Dashboards
can also display key performance indicators (KPIs) such as
PM compliance, COSR, and downtime of critical systems.
Some dashboards are user configurable to offer real-time
updates to many of the available CMMS reports.
Interfaces
A variety of interfaces has been developed between CMMSs
and other IT systems. These include real-time location systems (RTLS), whereby a wireless tag is attached to a medical device and the device’s location is automatically tracked
via wireless signals, either Wi-Fi or proprietary wireless
technology. The interface to the CMMS allows these systems to automatically populate the device’s current location
in the CMMS’s location field. Other interfaces to CMMSs
have included LDAP/Advanced Directory for institutionwide user name and password authentication and authorization, interfaces to material management systems for parts
and vendor services, purchasing, receipt and invoicing, and
interfaces to preferred parts providers.
interface to ServiceNow-based CMMSs. These applications
allow work orders to move relatively seamlessly between
the clinical engineering CMMS for technician dispatch and
the IT help desk for IT service response. Some of these
systems also offer configuration management databases
(CMDB) that interface the IT-related network-connected
medical device data so that the IT parameters are all stored
on the IT system are available, but not redundantly stored
and maintained, in the CMMS. This prevents this information from getting out of sync between CE and IT.
A feature on the horizon is interfacing surveillance monitoring to the CMMS. An example of surveillance monitoring is the network connection of devices (e.g., defibrillators,
Zoll, 2017) that, in addition to sending clinical data to the
EMR, also are capable of sending self-test data, battery capacity and other technical information to a database, and in
the near future, to the CMMS. For example, a defibrillator
could do a self-test daily and send the data to the CMMS
and if there is a problem automatically notify clinical users
and the CE department for technician dispatch. Standardsbased protocols, via IHE profiles, are under development
for this type of automated technical interface to the CMMS
(IHE PCD MEM, 2017).
Data accuracy and integrity
Without accurate and complete data, a CMMS is not going
to be of much use to the CE department. All CE staffs are
responsible for assuring that the data they enter and update
are complete and accurate. Incomplete and inaccurate data
make it difficult to report useful information, which can
lead to poor decision making (Cohen and Baretich, 2017b).
Good data quality depends on several factors, including
the following:
●
●
Emerging CMMS features
CMMS vendors are always working on new features that
will help improve CE operations. Some of these features
that have been recently released (2017), or are likely to soon
be released, are applications that better integrate IT systems
and the CMMS. With more and more network-connected
medical devices, it has become more difficult for the clinical end user to determine if a problem requires IT or CE
support. There are IT service desk software products based
on the ServiceNow platform (e.g., Connectiv, Nuvolo) that
213
●
Availability of CE-relevant data sources: Source data
need to be available to the HTM staff. For example,
medical device acquisition cost data, which should be
included on every equipment asset record, requires purchase order or invoice information in order to accurately
capture the device’s price.
CE employee accountability: Documentation quality
begins at the source, the employees. CMMS training
and documentation expectations and guidelines should
be provided to every CE employee. Assessment of documentation quality should be included in employee performance appraisals.
Referential integrity: For the foundational data, the underlying database structure and the CMMS application
error-checking capability are important to ensure high
data quality. The database should include appropriate
referential integrity in order to make sure that related
fields do not have any “orphan” data. For example, every
equipment record should have a manufacturer r­ eference,
214 SECTION | 3 Healthcare technology management
●
●
●
and every manufacturer reference should have a manufacturer name, address, and so on.
CMMS data standards: Operation of a high data quality CMMS depends on multiple levels of data field
definitions. These include fields defined by the CMMS
vendor, fields defined within the HDO, and fields that
use nationally or internationally published “standardized” definitions. Internal CE department guidelines
should indicate which data definitions HTM staff should
use. For example, fields that indicate which department
“owns” a medical device can use the HDO’s chart of
accounts. Device-type fields can use the Global Medical
Device Nomenclature (2017) or ECRI Institute’s
Universal Medical Device Nomenclature System
(UMDNS, 2017). HTM supervisory personnel or the
CMMS database administrator should be responsible
for managing (adding, deleting, and updating) these and
other foundation data tables (e.g., department, building,
equipment-type, manufacturer, and vendor lists).
Field definitions: Each CMMS field should have a
written definition so every HTM staff member uses the
field the same way. Without field definitions, individual
staff may interpret a single field in different ways. For
example, is the model number the information on the
name plate on the back of the device (recommended),
the model’s part number in the company catalog, or the
model name of the device on its front panel.
Maintenance activity coding: Where sharing or comparison of maintenance data is desirable or required,
maintenance activities must be consistently and accurately coded. Dropdown lists and other coding techniques help standardize data, although sometimes at the
expense of detail. Definitions are paramount to make
sure “apples to apples” comparisons can be made. For
example, it is very difficult to compare “use error”
across different HDOs unless they are both using a common definition of use error.
Data integrity starts with staff at data entry time.
When data entry errors or omissions do occur, the sooner
the CMMS can present an error or warning message, the
more likely the error will be corrected. Certain fields in
the CMMS are always required (e.g., equipment control number). Other fields may be required by HDO/CE
policy, and the CMMS should allow these to be configured (e.g., downtime). If a required field is left blank, the
CMMS should enforce a “hard stop.” The CMMS should
provide a robust set of configurable error checks. For
example:
●
●
Data types: The CMMS should automatically ensure
that each field has the appropriate data type entered
(e.g., string, number, dollar amount, date).
Range constraints: Range constraints should be configured to make sure that data entry is stopped, or a
●
●
●
­ arning issued, if a value is out of the expected range
w
(e.g., a pulse oximeter that cost $1,000,000 USD).
Dates: Dates (and times) need to have a consistent format throughout the CMMS. Also, some dates (e.g., next
PM due date) must be in the future when initially entered. Most other dates should be current or in the past
when entered (e.g., work order completion date).
Multifiled error checking: Multiple-field error checking is more complex often requiring special CMMS
configuration or customization. For example, suppose that downtime is a required field when an asset
is a “critical system,” but optional if it is not. Multiplefield error checking would be configured to require that
downtime is always recorded on critical system repair
work orders.
CE and HDO business rules: An HDO may have internal requirements that mandate certain rules in the
CMMS. For example, business rules may authorize different levels of purchasing authority for parts and services for different levels of CE personnel, based on the
cost of the order (e.g., a staff BMET is allowed to place
a parts order up to $1000 USD without additional approval, whereas a BMET supervisor is allowed to place
an order up to $5000 USD).
In addition to CMMS error checking, periodic audits
are necessary to maintain data quality. Some data problems that require data aggregation cannot be immediately
caught at data entry. For example, recognition that an insufficient number of labor hours have been documented on
work orders compared to payroll system-related data (e.g.,
time card entries). Sampling audits by supervisors can also
check for problems that are difficult to automate, such as
verification that work orders are accurate and documented
in sufficient detail.
Equipment planning
Acquisition of medical equipment is a major financial
issue for HDOs. Because a substantial portion of the
organization’s capital expenditures goes toward medical technology, good decision making can have a major impact on the bottom line. This is true for both new
equipment—medical technology to support new and
expanded services—and equipment to replace existing
technology that is no longer able to cost-effectively support patient care.
Best practice for medical equipment planning is to include all stakeholders and all parties with relevant knowledge. On both counts, CE needs to be at the table. With
its responsibilities for medical equipment maintenance and
repair, CE is a financial stakeholder; with extensive data regarding medical equipment-related costs, CE is a source of
essential knowledge. Much of the relevant information can
be found in the CMMS database.
Computerized maintenance management systems Chapter | 34
Here are some examples of key data:
●
●
●
●
Remaining useful lifetime. The CMMS includes the
acquisition dates for medical devices in the inventory.
This information can be compared to reference data,
such as the American Hospital Association’s Estimated
Useful Lives of Depreciable Hospital Assets (American
Hospital Association, 2013). Reports can be generated
to identify equipment that should be considered for
­replacement in the near future. Many CMMS databases
also include fields for the end date of manufacturer support, availability of alternative (non-manufacturer) parts
and service resources, and so on.
Maintenance costs. One of the core functions of the
CMMS is to record maintenance costs for equipment
in the inventory. To be useful, cost information must
include all costs—both internal (the true cost of time
and materials provided by the CE department itself)
and external (the cost of time and materials provided
by outside vendors and other service providers and, importantly, service contract costs). The cost data must be
comprehensive, complete, and accurate. The cost of internal labor must be based on the realistic, fully loaded
calculations of the effective hourly rate (Cohen et al.,
2015). Excessive maintenance costs are clearly a major
factor in equipment replacement planning.
Reliability. Decreasing reliability is another critical
factor, independent of increasing maintenance costs.
Unreliable equipment has a negative impact on the cost
and quality of patient care. A simple measure of reliability is the number of CM (repair) work orders per year
for a particular medical device (excluding repairs related
to abuse and other “use error” causes). The CMMS can
comb through repair data to identify particular devices
that are significantly less reliable than other devices of
the same type and age. These are candidates for replacement. Similar reports can be generated on the basis of
downtime and on the occurrence of adverse incidents.
Device standardization. The CMMS can also produce
reports regarding the degree of standardization of equipment types. For example, many HDOs have multiple
manufacturer-model combinations for infusion pumps
that perform similar clinical functions. This can increase
the HDO’s cost for disposables (e.g., infusion sets) as
well as for maintenance. Perhaps more importantly, it
can complicate user training and increase the likelihood
of use error. Moving the HDO toward standardization
can reduce costs while increasing patient safety.
Regulatory compliance
HDOs are highly regulated organizations and their CE programs are subject to a variety of regulatory requirements. An
essential function of the CE program is to maintain c­ ompliance
with these requirements. This involves both continuous
215
­ onitoring of compliance status and the ability to readily genm
erate compliance reports for the regulatory agencies.
As examples, here are two regulatory requirements that
are currently challenging CE programs in the US hospitals:
●
Scheduled maintenance completion rate. Hospitals
that rely on funding from the US Centers for Medicare
and Medical Services (CMS) are required to achieve
100% on-schedule completion of scheduled maintenance for medical equipment. The CMMS is the basic
repository for scheduled maintenance data. However, to
meet the 100% criterion, there are two critical factors
that must be addressed in the CMMS configuration.
First, the CMMS must incorporate the CE program’s
exact definition of “on-schedule completion.” Typically,
CE program policies allow a “window” for completion of
scheduled maintenance. For example, a policy might allow
±30 days for completion of work that is scheduled for a
particular month. That window must be programmed into
the CMMS for purposes of calculating the “on-schedule
completion of scheduled maintenance” metric. However,
the CMMS must also be able to report meaningful “realtime” metrics that support CE program management. For
example, to avoid having scheduled maintenance work
routinely delayed until the end of the completion window,
the CMMS should be configured to project the completion
rate and provide early warning of shortfalls.
Second, the CMMS must track cases in which
scheduled maintenance is legitimately not possible—
equipment that is in use, cannot be located, is out for
repair, and so on. Such cases can be subtracted from
the denominator of the metric, moving the value of the
metric toward 100%. However, the CMMS must also be
configured so that equipment does not go without scheduled maintenance for too many maintenance cycles. One
way to accomplish this is to create a CMMS report that
is generated regularly to “audit” the scheduled maintenance process and flag such anomalies.
Scheduled maintenance completion
Completed
=
Scheduled − Unavailable
●
AEM Programs. Another regulatory challenge for the
US hospitals is compliance with AEM requirements
from CMS. By default, scheduled maintenance for medical equipment must follow manufacturer recommendations in terms of activities (specific maintenance tasks to
be performed) and frequencies (when these tasks should
be performed). However, within limitations, it is acceptable for CE programs to adopt alternative activities and
frequencies for scheduled maintenance.
Implementing an AEM program has the potential to
significantly reduce medical equipment maintenance
216 SECTION | 3 Healthcare technology management
costs. A full discussion of AEM programs is beyond the
scope of this chapter; for additional detail,see Baretich
(2017). Here are two examples of how CMMS data can
contribute to the success of an AEM program:
First, when deciding which equipment to include in
an AEM program, one of the key data resources is the
maintenance history of the equipment—particularly the
history of equipment failure. If the history shows that,
for example, infusion pump batteries last much longer
than the manufacturer’s recommended battery inspection
frequency, it may be appropriate to adopt an AEM procedure with less frequent battery inspections. Similarly,
if the history shows that the risk of failure of a particular
component is very low, it may be appropriate to adopt an
AEM procedure that does not include inspection of that
component. Obviously, complete and accurate maintenance history data are essential for reducing maintenance
costs without adversely affective equipment safety.
Second, when monitoring the AEM program to ensure that the adoption of AEM procedures has not reduced safety, the CMMS should be configured to support
periodic reporting on equipment safety. One way to do
this is to add a field to work orders (for both scheduled
maintenance and CM) that is used to flag “scheduled
maintenance-preventable” device failures. These are
failures that might be eliminated or reduced by “better”
scheduled maintenance; that is, maintenance procedures
using strategies, activities, or frequencies that are more
effective at addressing the identified risk.
Performance monitoring
and improvement
Effective CE management requires continuous performance
improvement. In every aspect of performance—financial
management, service quality, and all other areas of CE
­responsibility—improvement is not only possible but also
expected by HDO leadership.
Performance improvement depends on performance
monitoring. We need to know where we are at before we
can create a roadmap for moving ahead. AAMI’s HTM
Levels Guide (Baretich et al., 2016) includes checklists for
creating a roadmap addressing all aspects of CE performance improvement.
The COSR, a basic metric for CE financial management, illustrates how the CMMS can support performance
monitoring and improvement:
COSR =
Annual maintenance cost
Acquisition cost
There are two major categories of medical equipment
maintenance costs: the cost of acquiring the technology
and the cost of maintaining it. The ratio of these costs takes
into account the fact that maintenance costs are higher for
e­ xpensive medical devices. It costs more to maintain a magnetic resonance imaging system than an infusion pump. The
COSR metric lets the CE program monitor maintenance
costs relative to the value of the equipment maintained.
The COSR numerator requires complete and accurate aggregation of all maintenance-related costs. This can be accomplished by an appropriately configured CMMS, as long
as all costs are aggregated in a standard way (Cohen et al.,
2015). The COSR denominator requires complete and accurate data on the value of the equipment being maintained. A
number of definitions for “value of equipment” have been
proposed (e.g., list price, replacement cost, and depreciated
value), but the growing consensus is to use acquisition cost as
the simplest and most readily available measure. Even acquisition cost data can be difficult to acquire in some HDOs, but
it’s worth the effort to get it into the CMMS database.
Staff management
CE personnel are a critical resource for cost-effective CE
program management. Here are two examples of how
CMMS data can contribute to successful staff management:
●
Productivity. It is essential to monitor staff productivity—not only to encourage CE personnel toward high
levels of productivity but also, perhaps more importantly, to identify organizational barriers to high productivity. Many definitions of productivity have been
proposed but, again, a definition that relies on simple
and available data is preferable. For example:
Productivity =
Productive Hours
Paid Hours − PTO
In this equation, PTO represents “paid time off,” hours
for which an employee is paid but not available for productive work (e.g., during sick leave, vacation, and holiday).
The key factor is productive hours, which represents time
as recorded in the CMMS for scheduled maintenance, CM,
authorized work on projects, and so on.
●
Staffing levels. Determining the appropriate level of
staffing—by number and skill set—is a major challenge.
The most granular and data-driven approach is to base
staffing levels on expected hours of maintenance work
for different types of equipment (Cohen, 2011). This approach depends on good historical data for maintenance
activities. It also depends on accurate productivity metrics to translate expected maintenance hours into fulltime equivalent (FTE) staffing data.
Benchmarking and data sharing
As described above, performance improvement depends
on performance monitoring—knowing your current level
of performance. Performance improvement also depends
on knowing what’s possible—what level of performance
Computerized maintenance management systems Chapter | 34
is realistically achievable. That’s where benchmarking
comes in.
Every CE program should be doing internal benchmarking, monitoring its own performance overtime. Moving to
the next level requires external benchmarking, monitoring
the program’s performance relative to other programs with
similar characteristics. For internal benchmarking, all you
need are performance metrics that are internally consistent
overtime; in other words, use the same metrics from year
to year. For external benchmarking, you need to use performance metrics that are standardized across CE programs
(Cohen et al., 2015). To accomplish that, you need to configure your CMMS to generate standard metrics.
For example, if you find that your performance on one
metric is near the level of your peer CE programs, then your
room for improvement is limited. In this case, consider focusing on a different aspect of performance. On the other
hand, suppose you find your performance on a different
metric is significantly below your peers. This tells you that
there’s room for improvement, a genuine opportunity for
achievable improvement. Consider focusing your efforts in
this area.
Considerations in selecting
a new or replacement CMMS
Hosting options
Most modern CMMSs will be deployed in a data center,
either locally (HDO-managed) or “in the cloud” (CMMS
vendor-managed as software-as-a-service). Access to the
CMMS server will be on desktop computers, typically via
a browser application, and via mobile devices such as laptops, tablets, and/or smart phones. Mobile devices may be
connected to the CMMS server via cellular networks and/or
Wi-Fi. Simpler work order activities can be completed on a
smart phone device, whereas the other devices provide the
complete CMMS application.
CMMS software evaluation and selection process
CMMSs vary widely in cost based on the features discussed in this chapter. Some CMMS only provide basic
inventory, scheduled and unscheduled work orders, and
basic reporting features. Others provide HTM automation tools including interfaces to other applications (e.g.,
RTLS, material management) and increasingly sophisticated IT management features (e.g., CMDB, help desk,
and dispatching).
To start a CMMS evaluation project, select your team
that will be assisting in this evaluation. Include BMETs,
CE office staff, IT staff, and anyone else who represents
CMMS users and support. Develop a list of the features
liked, and deficiencies, of the current CMMS. Next develop
217
a ­high-level list of key required and desirable features for
a new system. With that information, do some research of
available CMMS products (e.g., online, at conferences) and
discuss the planned project with HDO administration in order to determine a realistic preliminary budget estimate.
Next, invite a few CMMS vendors to provide an online demonstration of their software. Tell the vendor your
requirements and have them focus their demonstration on
those requirements. From these demonstrations, and the
other information you gather, you can develop a more formal requirements document and pursue your selection process through request for information (RFI) and/or tender/
request for proposal/quotation (RFP/RFQ) processes depending on your HDO’s procurement process requirements.
Send the formalized requirements to vendors likely to meet
your CMMS needs with a response due date. Each vendor
should provide a written response to each of your requirements along with a pricing proposal.
The next step is to review the vendor’s written responses
and see which products meet your specifications. Be wary
of any need for customizations. They can be very expensive,
take a long time to develop and are often difficult to maintain. Contact references and, if needed, schedule additional
demonstrations. Limit additional demonstrations to top candidates based on pricing and features. Pricing comparisons
should be based on life-cycle costs [i.e., initial pricing and
support and software licensing pricing for a period of time
(e.g., 5 years and 10 years)]. Then determine which product comes closest to meeting both feature requirements and
budget. Once the evaluation team has decided on a single
product, the next step is to negotiate a final price, schedule,
and terms and conditions with the vendor. Get all the vendor
promises in writing. Be clear about deliverables, responsibilities, expectations, and schedules, particularly customization and data imports.
Implementation
The implementation phase includes system customization,
if applicable; configuration; system testing; data conversion; training for the CMMS application administrator,
super-users, and other users; and final implementation/
cutover. Most modern software application vendors offer a
test system or test “instance” that allows initial configuration and conversion, and ongoing updates, to be tested on
a separate system, prior to going “live” on the production
system and for testing ongoing updates.
Some CMMSs are highly configurable, whereas others
are “what you see is what you get.” Areas that may need
to be configured include user roles (e.g., BMET, manager,
office staff, customer), required fields and the various other
error-checking rules described earlier in this chapter.
Converting data from the existing CMMS is another
key component of CMMS replacement. Data conversion is
218 SECTION | 3 Healthcare technology management
usually at least a two-step process whereby a preliminary
data conversion process is developed and tested on the test
system, often multiple times, and then a final conversion
immediately before “go-live.” Typically, the equipment inventory data are fairly easy to convert. Unfortunately, work
orders and work histories are usually more difficult to convert since there is no standardized structure for these data.
Prior to final go-live a comprehensive test should be
completed on the test system This should be completed by
both the vendor and the CE staff. All CE staffs will need to
be trained on the new CMMS. After final testing and training
are completed, it’s (finally) time for final cutover. Another
quick system test is required as new users are brought up on
the new “live” production system. Usually, there will be a
period of high intensity support required as issues are found
and, hopefully, resolved quickly.
Once implemented and fully operational, the CMMS
will require less attention but still needs a designated
CMMS system administrator. Depending on the size of the
CE department, this may be a part-time task for someone
in CE, or possibly IT. Their responsibility is to manage issues, coordinate updates and changes, write special reports,
and help coordinate other CMMS support activities (e.g.,
backups).
Conclusion
Information and communication technologies are rapidly changing and CMMSs are taking advantage of
some of these changes (e.g., smart mobile devices and
cloud-based CMMSs). The integration of IT and medical devices is driving HTM CMMSs to become more and
more like their big brothers in IT service management
(ITSM) via features and interfaces. (How long will it be
before CE calls work orders “tickets”?) New automation
(e.g., surveillance monitoring) is on the horizon and may
significantly change and improve support models for
­network-connected devices. Also, new decision s­upport
tools will help convert the large amount of collected repair and maintenance data to HTM useful information
which should help optimize healthcare technology management practices. All of these new features can help CE,
but will also drive the initial and annual CMMS support
costs much higher.
References
American Hospital Association, 2013. Estimated Useful Lives of
Depreciable Hospital Assets. Revised 2013 edition, American Hospital
Association, Chicago.
Baretich, M.F., 2017. AEM Program Guide: Alternative PM for Patient
Safety. Association for the Advancement of Medical Instrumentation,
Arlington, VA.
Baretich, M.F., Painter, F., Cohen, T., 2016. HTM Levels Guide: A
Program-Planning Tool for Healthcare Technology Management
Departments, second ed. Association for the Advancement of Medical
Instrumentation, Arlington, VA.
Cohen, T., 2011. Staffing metrics: a case study. Biomed. Instrum. Technol.
45 (4), 321–323.
Cohen, T., Painter, F.R., Baretich, M.F., 2015. HTM Benchmarking Guide:
Why Benchmarking Matters, and How You Can Do It. Association for
the Advancement of Medical Instrumentation, Arlington, VA.
Cohen, T., Baretich, M., 2017a. Computerized Maintenance Management
Systems for Healthcare Technology Management, third ed. Association
for the Advancement of Medical Instrumentation, Arlington, VA.
Cohen, T., Baretich, M., 2017b. CMMS Data Integrity, 24 X 7. http://
www.24x7mag.com/2017/06/cmms-data-integrity/. (Accessed December
28, 2017).
ECRI Institute, 2017. https://www.ecri.org/Components/UMDNS/Pages/
default.aspx. (Accessed November 26, 2017).
FDA, 2017. UDI Basics. https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/UniqueDeviceIdentification/
UDIBasics/default.htm. (Accessed December 16, 2017).
Global Medical Device Nomenclature, 2017. https://www.gmdnagency.
org/About/Database. (Accessed November 26, 2017).
IHE PCD MEMDMC. 2017, https://ihe.net/uploadedFiles/Documents/PCD/
Inside%20IHE%20PCD%202017%20slides.pdf Accessed 11-10-17.
Zoll Medical, 2017. https://www.zoll.com/medical-products/data-management/defibrillator-dashboard/. (Accessed November 17, 2017).
Chapter 35
Maintenance and repair of
medical devices
Rabeh Robert Hijazia, Arif Subhanb
a
Healthcare Technology Professional, Detroit, MI, United States, bDepartment of Veterans Affairs, Los Angeles,
CA, United States
This chapter discusses maintenance and repair methods and
activities used to manage healthcare technology. This chapter will provide an overview of maintenance protocols and
processes as well as standards and regulations that impact
healthcare technology management (HTM) and delivery
of services. Keep in mind that there is no such thing as a
“silver bullet” as standards and regulations are constantly
changing to accommodate the changing needs of the field as
we constantly work toward reducing risks to preserve safe
medical equipment practices and enhance patient safety.
Framework guiding maintenance and
repair regulation
Before maintenance and repair work is carried out, it is important to establish the regulatory framework under which
such work is to be undertaken, to ensure compliance with
local requirements. Requirements may vary according to the
equipment categories, risk, usage, location, medical equipment management plan, and manufacturer requirements.
In some countries, regulation may be established by the
department of health or ministry of health and are seldom
regulated based on the third-party organizations. Equipment
maintenance might be carried out by any capable person,
regardless of qualifications, experience, or training. Some
countries regulate the registration of technical personnel,
including supervising personnel, and might further regulate
repair and maintenance to the extent that these activities can
be audited to ensure that quality control is maintained. In
such instances, manufacturers will seldom take responsibility for maintenance and repairs performed by personnel,
outside their organization.
In addition, there are various standards and regulations that govern the field of HTM. Most countries adopt
at least one such standard, either as part of the overall quality process or more rigorously as a legislative requirement.
Typically, such standards define the nature and frequency
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00035-3
Copyright © 2020 Elsevier Inc. All rights reserved.
of safety and performance testing but do not define maintenance requirements other than in the most general terms.
These standards seldom if ever define repair quality issues.
Personnel who are responsible for medical equipment
management programs should be well informed as to the
regulatory requirements in their area. Further, they should
know whether there are requirements covering the qualifications of technical personnel and whether standards exist
to cover maintenance and repair procedures. If all requirements covering device management can be met, then the
recipient healthcare organization should meet reasonable
public expectation for quality healthcare delivery, given local circumstances, and should have its capability assured.
Risk management
The significance of risk management is to ensure that
healthcare technologies function in a safe and effective
­
manner to preserve a safe, effective, and operational work
environment toward the users and the patients. In a perfect
world, it is imperative that a risk assessment be performed
on every equipment category within a facility to be able to
further improve preventative maintenance strategies, educate users, or even to prevent future events that jeopardize
the users and/or patients. Risk assessments can be performed
in multiple settings. They can be performed in the form of a
failure mode effect analysis (FMEA), upon evaluating a new
technology or to enhance maintenance strategies with the
use of previous maintenance historical data or records. Risk
management typically involves developing a “matrix” with
the probability of failure along one axis and the consequence
of failure (from minor to major) along another. Devices can
be placed in the matrix according to where they sit on each
axis and ranked, allowing resources to be targeted at the
highest risk items (i.e., those where both the probability and
consequence of failure are highest). The rationale behind
any technique adopted should always be documented. When
219
220 SECTION | 3 Healthcare technology management
evaluating medical devices for risk assessments, there are
four main components that need to be accounted for: equipment function, physical risk of failure, maintenance requirements, and user experience utilizing the device. Equipment
functionality can range from life support to patient or staffrelated devices; whereas outcomes for physical risk of failure can range from death to no significant risk. Maintenance
requirements can vary from full disassembly to user maintenance only, such as cleaning. User experience and education using the device is also important to take into account
and can range from extensive education required to minimal.
This can be tracked by tracking use error or operator error
work orders.
Today, the risk management does not just include managing and being proactive to reduce physical risk or harm.
Instead it’s also inclusive of network security and cybersecurity. The significance of performing risk management
on medical networks is to ensure they are safe and secure.
Today’s technologies encompass various devices that are
interfaced and networked with each other. There are numerous interfaces that exist across numerous networks,
where facilities are able to transmit data, medical records,
and images amongst each other. Remote access to picture
archiving communication systems (PACS) is an example,
where clinicians are able to remote into medical servers and
read images from remote location. The significance of implementing risk management practices on medical networks
is critical to ensure that all communications and information are identified, secured, and encrypted. Strategies that
have been adopted to protect all networked medical devices
are to isolate them by placing them on their own isolated
network and applying an access control list (ACL) which
provides an extra layer of protection and ensures that data
transmission only occurs via open channels or ports.
In terms of physical security, performing risk assessments on hardware is also important. Risk management
strategies include securing server rooms, applying twofactor-authentication access, and ensuring passwords are
changed often.
Maintenance strategy
Regardless of the technique adopted to balance available
resources against “risk,” fundamental maintenance and
calibration strategies will help to improve device management efficiency overtime. Further innovative strategies such
as utilizing device maintenance history and best practices
should always be sought out and considered, particularly
if they bring increases in efficiency, as any increase in efficiency can reduce the overall risk.
One fundamental step is to move toward “standardization” of the devices being managed and to reduce the
different types of devices found across a healthcare organization. This may be done without compromising service
delivery, while still allowing a degree of clinical choice. If
implemented carefully, it will benefit an organization because there will be less variation in maintenance and repair
requirements, thus allowing limited resources to be more
effectively applied. Standardization also reduces costs from
not having to keep an inventory of miscellaneous parts and
kits for devices made by different manufacturers. Staff
training (both technical and clinical) can become more focused. Such a strategy seldom needs justification. For the
maintenance and repair service provider or medical device
manager to have the most valuable insight into this process,
they need clinical knowledge as well as technical familiarity with the devices being used. The best approach to standardization is to involve various stakeholders in the process.
This includes but not limited to fiscal, logistics, clinical users, and patient safety personnel. A decision made with the
stakeholders carries weight and allows for a smooth transition, especially with buy-in from numerous stakeholders.
Prepurchase estimation of projected maintenance costs
needs to be considered, particularly as these costs often can
exceed the capital cost of the equipment over its lifetime. An
example is the purchase of a computed tomography (CT)
scanner for $800,000 and over the course of 10 years; maintenance costs may exceed the purchase price. Although often overlooked by clinical staff and management, it should
be an essential consideration in any procurement process. If
the maintenance requirements can be paralleled with existing equipment (e.g., by using the same type of batteries or
other components), then such factors should be investigated
because it might be possible to reduce overall long-term
­labor and parts costs.
Other strategies to consider include balancing the level
of support against available technical capability, both internal and external. In some countries, healthcare organizations find it almost impossible to obtain any technical
support for their medical devices, while in other countries
the capability and availability of such services are high.
Scrutiny of all technical resources available to a given locality is essential in order to ensure that the highest quality and
most cost-­effective service are provided to the healthcare
organization.
There always will be new and different strategies to consider. Some of these will be brought about by changes to
technology and improvements in device management techniques. Others will be brought about by changes in financial or business requirements. No single strategy should be
considered sacrosanct, and new strategies always should be
considered or sought out.
Maintenance requirements
The maintenance requirements associated with healthcare
technology have to align with the manufacturer specifications, the organization’s medical equipment management
Maintenance and repair of medical devices Chapter | 35
plan, and regulatory bodies. The manufacture specifications
and maintenance requirements are critical and can be used
as a “starting point.” The service manual should provide
specific instructions and steps toward ensuring the device
is properly maintained and operating optimally. Keep in
mind that with time and experience, HTM professionals
can add additional steps to the manufacturer recommendations and even modify the recommended testing frequency,
with justified historical maintenance data and information
that show the change or modification in testing frequency
or procedure, for example, does not increase the risk of failure or harm. This has to be followed up with conducting a
risk assessment to document the reasoning of this change.
Different organizations have adopted various strategies to
help ensure that all equipment is tested when required, with
differing degrees of success. The best strategies often depend largely on local knowledge and contacts.
Safety and performance testing of devices varies by
equipment criticality, function, and risk. High-risk devices
such as life support equipment can be scheduled every
3–6 months, while non-high-risk devices such as a noninvasive blood pressure unit can be scheduled annually. Again,
this is based on the manufacturer recommendations and/or
alternate equipment maintenance (AEM) program, where a
risk assessment must be conducted for each equipment category within the facility. In terms of strategies, an electrical
safety test is a common test performed to ensure that the
ground resistance and leakage current parameters are within
limits. The National Fire Protection Agency (NFPA99), references acceptable electrical safety limits for ground resistance and leakage current.
In terms of standards, the Joint Commission is a great
example of an organization that provides standards that apply directly to the maintenance of medical devices. Their
standards detail the requirements that healthcare organizations have to comply with to obtain accreditation through
this organization.
Forward planning and forecasting of maintenance procedures is important. This process requires detailed knowledge of maintenance requirements and the resources that
are required in order to perform maintenance. The resources
221
required include labor, parts, materials, and tool costs. If
maintenance is contracted, then all of these costs are often
rolled into one by the contractor, although with some contracts, parts costs might be kept separate.
In terms of documentation, if the work completed is not
properly recorded, then this will put the organization at a
risk and jeopardize access to the equipment work history.
Its critical to select a system that would enable healthcare
technology professionals to have access at a minimum to
the following work order data: equipment manufacturer,
model, serial number, labor hours, cost of labor, cost of
parts, purchase order number, problem, work performed,
assigned technician, and date complete. Based on the established criteria, an automated maintenance scheduling
of various devices can be input into this program to help
automate the process and enable reports to automatically
generate at the frequency that is determined. These benefits
include running reports to achieve better budget forecasting, the opportunity to identify items that might no longer
be cost effective to maintain, and the potential to rationalize
maintenance expenditure across an organization. To establish maintenance requirements, the current condition and
maintenance history must be determined for the devices to
be managed. If no reliable maintenance history is available,
then stick to the manufacturer guidelines.
Maintenance planning should be realistic and achievable. Planning should take into account expected costs
based on the historical data. Initially, a best practice is to
start working on the high-risk devices and after completion,
move toward the lower criticality devices. With time and
confidence, maintenance and repair providers or managers
will move from prescriptive and reactive strategies to more
creative and proactive management techniques. In doing
so, capacity and capability will increase, and the ability to
adapt to changing conditions will improve.
Further reading
NFPA-99, 2018. Standard for Health Care Facilities.
The Joint Commission Manual for Hospitals. n.d. Environment of Care
Standards, current edition.
Chapter 36
Outsourcing clinical
engineering service
Peter Smithson, David Dickey
Medical Equipment Organization, Bristol, United Kingdom, Medical Technology Management, Inc., Clarkston,
MI, United States
Clinical equipment ownership results in a financial liability
that extends far beyond the cost of equipment purchasing, installation, testing, and user training. Yet when properly defined
and aggressively managed, a consolidated medical equipment
service management program can create substantial cost savings for any healthcare organization, especially given the
continued increase in new and replacement high-technology
equipment purchases. Considering the fact that many capital
acquisitions are of assets that have a useful life of seven or
more years (especially when considering the asset’s longevity through planned upgrades), it is not uncommon to expect
an annual ownership (service) expenditure of 5%–12% of the
equipment’s original purchase price, depending upon the mix
of equipment modality. Choices as to the best way to provide
for a consolidated medical equipment maintenance management program can typically be categorized into two types of
program models: (1) insourced (in-house) and (2) outsourced.
Outsourcing
What is outsourcing? Essentially, it is the transfer of any
defined business operation or responsibility to another organization. In terms of clinical engineering, it could involve
the transfer of responsibility for selected portions of equipment service, procurement, or program management to an
external business entity or organization, all for one agreed
upon or “not to exceed” price. It could involve transfer of
the financial risk, with or without service staffing, as well.
Typically the company providing the outsourced service
makes all service decisions and assumes responsibility for
all outcomes (i.e., good and bad).
Two service models
One key differentiating factor between the two program
models of outsource and in-house relates to identification
of the financial risk. As is seen in Table 1, all programs can
222
be divided into two main categories, depending on who is
taking on the program overbudget risk.
It is important to realize, however, that most in-house
(insourced) clinical engineering programs typically continue to utilize the services of external vendors, as it would
be unusual for any single program to have sufficient internal
resources to be able to perform 100% of required services.
Given the high number of inventoried devices typically contained within a clinical equipment management program,
it would not be unusual for the in-house staff to service
only 70%–80% of the equipment base, relying on external
vendors, with their specialized expertise, to service the remaining items. Therefore, an in-house (insourced) program
still contains some elements of an outsourced program. For
the purposes of this discussion, an outsourced program is
defined as one that is fully provided by nonhospital staff
and whose management (the entire service function) is the
responsibility of an external provider. Under a fully outsourced program, all staff are on the outsourced vendor’s
payroll, and the vendor is fully responsible for all aspects
of program management, performance, and financial outcomes. The hospital pays one price to one vendor, who then
assumes all responsibility for paying for all subcontractors,
staff salaries, parts, supplies, and overhead.
While there are no requirements or regulations stipulating who can (or must) provide repair services on most medical equipment, certain countries and/or individual states may
have guidelines relating to service, testing, or calibration of
specific device types such as high-energy radiation treatment
or mammography systems. In the United Kingdom (UK),
the Medical Devices Agency (MDA) has issued guidelines
to hospitals and community-based health facilities that state
that any servicing organization must maintain a properly
trained staff, the correct manuals and tools, access to spare
parts approved by the manufacturer, and adequate quality
control procedures (MDA, 1988, 2000). These could apply
to in-house as well as outsourced program providers.
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00036-5
Copyright © 2020 Elsevier Inc. All rights reserved.
Outsourcing clinical engineering service Chapter | 36
TABLE 1 Two models for hospital medical technology
service.
Hospital transfers risk
(outsourced program)
Hospital carries risk
(insourced program)
OEM full-service contractsa
OEM T/Mb
ISO/OEM asset managementc
ISO T/M
Maintenance insurance
In-house self-insured
a
OEM—Original Equipment Manufacturer.
T/M—Time and materials.
c
ISO—Independent service Organization.
b
Why outsource?
The reasons why many organizations consider use of an
outsourced program typically include the following:
1. Desire to reduce the number of employees who are directly on the hospital payroll. Many organizations have
management goals to reduce the total number of employees [full-time equivalents (FTEs)] to meet required
staffing benchmark levels based on total number of employees per occupied bed.
2. Cost savings. Many outsourced programs are sold and justified on the total program cost, which is shown to be less
than the actual or estimated cost of the organization’s current in-house programs. This is especially true when the
majority of the equipment base, such as for a radiology
service program, comes from one vendor or manufacturer
who has access to parts and labor at their internal cost.
3. Access to resources that are not readily available to the
organization (e.g., trained staff and parts). Many outsourced programs are provided by equipment manufacturers who have direct access to parts, supplies, and
software products directly or indirectly related to the
equipment base of the program being outsourced. In addition, most outsourced programs have developed custom policies, procedures, and software systems that can
be rapidly installed at a low cost.
4. Short-term solution to a problematic in-house program.
Many in-house programs are short staffed or have employees with limited expertise and service capabilities.
The outsourced vendor may have underutilized staffing
resources in the local geographical area who can be assigned full- or part-time to assist in implementing or
providing routine support to the organization.
5. Reduced internal overhead related to invoice processing.
Given the high cost of processing individual purchase
orders for parts, supplies, and individual vendor repair
services, an outsourced program can have an indirect
impact on the hospital’s cost if the internal overhead
need to process these invoices and related paperwork
can be eliminated or reduced.
223
OEM full-service contracts
One form of outsourcing involves contracting with numerous vendors for defined capped cost services on individual
equipment. Contract costs from the OEM have come down
over the years and can range from 2% to 12% of the equipment acquisition cost, depending on equipment modality. Service staff provided are typically well trained, and
they have access to all of the tools, software diagnostics,
and spare parts designed by the OEM for supporting the
equipment.
During the sales process, the equipment vendor may offer discounts to its multiyear agreement and may hope that
the one-time offer of the discount will persuade the purchaser to sign up. Many multiyear agreements do not have
an out clause or have a high cancellation penalty should the
purchaser elect to cancel early. Signing a multiyear service
agreement with no “out clause” might not be advisable, as it
severely limits future cost savings opportunities, especially
if the equipment failure rate is determined to be lower than
expected. However, if you bought an item that has a high
failure rate, locking in a reduced-rate service agreement
would have been advisable. Doing an adequate amount of
homework on expected failure rates prior to signing the purchase agreement is obviously advisable.
Given the fact that most of today’s medical equipment
is software driven, OEM vendors have the ability to bundle new software upgrades into their contract pricing, thus
making the software upgrades appear to be “no charge.”
However, not all equipment will need routine software upgrades, and the astute purchaser should consider negotiating
a “not to exceed” price for future upgrades, independent of
any full-service contract options. While there is nothing inherently wrong with the full-service contract approach, the
main concern is that if you sign a multiyear, full-service
agreement, you exclude yourself from all options and future
cost saving opportunities should the equipment have a low
failure rate or should you wish to use an alternate service
vendor or to convert to an in-house program.
OEM asset management/multivendor
service programs
It is difficult to identify exactly when the first OEM advertised multivendor program was marketed, but it seems
to have coincided with the onset of “asset management”
programs. While most advertisements tried to market these
programs as something new, the concept of having a dedicated or shared technical staff who are trained to service
a multitude of products has been one of the key features
of hospital-based clinical/biomedical engineering programs
going back as far as the early 1970s.
What is new for the OEMs is the offering of their
ability to have their employees service equipment not
224 SECTION | 3 Healthcare technology management
­ anufactured by them, hence “multivendor services.” The
m
interesting twist here is the fact that for years, many OEMs
had continued to claim that only they could service their
equipment, as it was so complex, requiring parts that only
they could supply. Then, almost overnight, they suddenly
had the expertise to be able to service anyone’s equipment,
regardless of manufacturer or model.
The reality is that the majority of equipment problems do
not always require specialized training and can be resolved
by a generalist (biomedical or radiology service) engineer
who has basic knowledge and experience on modalitybased products. When specialized expertise is needed, it is
not uncommon for the multivendor service provider to call
in their competitor for assistance, paying for the work under
a negotiated time and material (T/M) basis.
Total program cost for a consolidated multivendor asset
(service) management program typically will be less than
the cost of individual service contracts. Customer satisfaction for these types of programs varies by facility, with most
problems relating to irregular staffing, increased equipment
down time, and lack of value-added services (to support
basic biomedical equipment management functions not
specifically outlined in the contract agreement). One primary concern relates to the concern over conflict of interest,
based on the questioning as to how the on-site multivendor
equipment service staff could possibly work as hard in making their competitors equipment work as well as their own?
such systems when needed. A well-trained ISO program
should be able to provide first-call maintenance services on
60%–75% of the equipment base, with the balance serviced
primarily by the OEM.
Over the years, the number of qualified ISO programs
has diminished, with many having been bought up by the
large OEMs as a means to expedite their entry into the multivendor service market. The main concern over the use of
ISO problems is business longevity.
Maintenance insurance
The concept of maintenance insurance works on the premise that, by bundling together the service contract budgets
of multiple items, one can lower the overall program cost
by averaging the T/M service cost needs of all items (Tran,
1994). Using actuarial service cost data on multiple types of
equipment, the maintenance insurance program establishes
an estimate of T/M costs for each item, including preventive maintenance (PM) costs, then adds in an overhead and
profit margin. Under the ideal program, the equipment user
then continues to call in their previously used OEM for service when needed, then either pays the bill itself and waits
for insurance reimbursement or submits the bills directly to
the insurance carrier for payment.
Over the years, variations on the insurance program
concepts have been implemented, such as:
●
ISO maintenance service programs
The Independent Service Organization (ISO) has been in
the multivendor service business since the early 1960s. It
offers a cost-effective alternative to the OEM or total inhouse service program. As outsourced maintenance service
providers, ISOs have been providing asset managementtype services well before the entry of OEMs into this market, and they typically function at a cost that is less than
that charged by the OEM provider. One key feature of an
ISO program is that it typically does not manufacture or
sell any vendor’s equipment, thereby leading to the potential claim that they can truly be unbiased on the issue of
equipment-­replacement selection. Many of the ISO programs are geographically based, with ability to offer costeffective services only to a client population within their
geographical proximity.
As with an in-house program, the ISO is generally able
to service and support a wide range of equipment, but it
may lack the specialized training that is necessary to perform extensive troubleshooting and maintenance of complex systems such as newer computerized tomography (CT)
and magnetic resonance imaging (MRI) scanners. ISO programs generally call in the OEM vendor for assistance, either on T/M service or under a limited contract to support
●
●
●
●
●
●
●
Inclusion of a rebate or shared savings component to
reward the hospital in working with the insurer to minimize the annual service costs
Reimbursement to the hospital when allowing their inhouse staff to perform a portion of the maintenance (at
in-house labor costs of $35–$70 per hour instead of paying the OEM rates of $120–$230 per hour)
Provision of a first-dollar vs stop-loss limit-based program
Provision of on-site clerical and/or technical staff to assist with management of the program, and its paperwork
An arrangement whereby the insurer pays the service
vendor directly
Multiyear agreements whereby the annual program premium cost increase is capped
Ability to add and delete individual items via a pro-­
ration schedule
Telephone support assistance in locating alternate parts
and labor sources
Some programs have restrictions and other program
requirements, however, that could limit the maintenance
insurance program applicability to many healthcare organizations, such as:
●
The mandate that all equipment items are included in the
program rather than allowing the hospital to select the
items that are included for coverage
Outsourcing clinical engineering service Chapter | 36
●
●
●
●
●
●
●
●
●
Selective coverage, or the situation where the insurance carrier drops coverage for a specific item should its
maintenance costs greatly exceed the itemized premium
Timing restrictions, whereby field service reports and
invoices must be submitted within a predefined number
of days after the work event, or else they will be excluded from coverage
The requirement that a work event that is predicted to result in a cost that exceeds a predefined limit (e.g., $5000
or $10,000) must be called in to the insurance program
for authorization prior to having the work initiated
The requirement that the insurance program can mandate the source of parts and labor for certain equipment
items. Repairs performed by nonauthorized sources
(usually at a higher cost) may not be covered by the program, even if the equipment owner has determined that
their source (in many cases, the OEM) is better able to
perform the repair.
Scheduled preventive-maintenance procedures that take
longer than what the insurance carrier has estimated
may be excluded from coverage
If the equipment is scheduled for PM, or if a noncritical repair is needed but the equipment is unavailable,
the service staff may have to wait for the equipment to
become available, which might be billable time from the
service vendor, but might not be covered by the insurance program
Certain glassware components such as X-ray tubes,
image intensifiers, gamma camera crystals, ultrasound
transducers, and CRT displays might not be covered if
they need to be replaced because of poor image quality (rather than catastrophic failure), as the failure might
be categorized as a planned-obsolescence replacement
rather than a covered maintenance event.
Because of cash flow limitations, the insurance carrier might elect not to pay the maintenance vendors
within previously stated time frames, thus resulting in
the service vendor putting the hospital on “credit hold,”
meaning that no additional maintenance services will be
provided until all owed payments are made.
Many marketed maintenance insurance programs are not
endorsed by regulated insurance carriers. If not held to
the same standards as the insurance industry, they could
cancel their contract (or drop selected equipment coverage) with the hospital at any time should their profitability targets not be met. Should they go out of business
or have cash shortfalls, the hospital could become liable
for having the overdue invoices paid, even though they
have already paid the maintenance insurance vendor.
Maintenance insurance, when properly selected and
used, can be a useful tool for a growing in-house service
program, especially if it results in the taking over of service
and support of items previously under warranty or OEM
225
full-service agreement where no maintenance cost data
were kept or monitored. This transfers the risk of going over
budget while the hospital collects maintenance cost data for
a year or two, thus allowing the hospital to be in a better
position to self-insure their budget. Ideally, maintenance
insurance should not be used for a period greater than one
year, or two at a maximum. If annual maintenance costs
exceed the program premium, the insurance carrier could
raise their rates in order to recover their losses.
Larger hospitals (i.e., those with 300 beds or more) may
be positioned to self-insure their maintenance budgets, assuming that they have the infrastructure to manage the paperwork and vendor-services aspects of the program. Cost
savings by going to a self-insured program typically cost
less than the cost of the maintenance insurance program.
However, if a maintenance insurance program is desired,
be sure that it is underwritten by a regulated insurance carrier that has a high rating. Programs that the provider “self-­
insures” should be considered with caution! In the UK,
official guidelines advise National Health Service users not
to use insurance-based schemes, as their experience has
shown that the promised savings are not as high as predicted.
Summary
When selecting an outsourced service provider, it is important that all program components be identified in writing and
made part of the contractual agreement. Issues related to onsite, dedicated staffing, parts sources, scheduled PM, backup
support, external OEM vendor assistance, data ownership,
reporting, equipment relocations, upgrades, software, test
equipment, user training, committee participation, and total
budgetary responsibilities also must be clearly defined.
The cost-effectiveness and quality impacts of outsourced
clinical engineering programs vs in-house programs have
been the subject of much debate, with many organizations
having tried both models. One given fact is that a service
program that is outsourced to a for-profit company has two
masters to serve: The hospital client, and the business entity shareholders. One master wants the lowest cost and the
other wants maximum profit margin. The hospital mandates
quality and the outsourcer is obligated to deliver it. The debate over cost-effectiveness and long-term impact on equipment quality continues to make the choice over outsourcing
vs insourcing a case-by-case determination.
Even with a fully outsourced program, the hospital still
holds the ultimate responsibility for the impact of its equipment on patient care outcomes. The outsourcing of the
management of the service program does not mean that the
hospital will not be held harmless for patient injuries because of malfunctioning equipment. An outsourced program
still needs to be audited, monitored, and held to the same
standards to which an in-house program would be held.
226 SECTION | 3 Healthcare technology management
References
MDA, 1988. Medical Device and Equipment Management for Hospital
and Community-Based Organizations. Medical Devices Agency
Device Bulletin 9801.
MDA, 2000. Medical Devices and Equipment Management: Repair and
Maintenance Provision. MDA DB2000 (02), Medical Devices Agency.
Tran, T.G., 1994. Use of maintenance insurance to minimize costs. J. Clin.
Eng. 19 (2), 143–147.
Further Information
The Management of Medical Equipment in NHS Acute Trusts in England,
report by the comptroller and auditor general for the NHS executive. National audit office H. C. 475 session 1988–99, The Stationery
Office, London, June 10, 1999.
Insurance in the NHS: Employers/Public Liability and Miscellaneous
Risk Pooling, Health Service Circular HSC 1999:021, Department of
Health, http://www.open.gov.uk/doh/coinh.htm, February 3, 1999.
Medical Devices Management, 1999. NHS Executive Controls Assurance
Standard, Rev. 01, November.
http://isostartup.neodyme.com.
Bendor-Samuel, P., Turning Lead into Gold. The Demystification of
Outsourcing. http://www.turning-lead-into-gold.com.
http://www.outsourcing-journal.com/.
http://www.outsourcing-exchange-center.com/.
An Insider’s Look at Increasing Role of Service Outsourcing in the Health
Care Market D. F. Blumberg Associates, Inc. http://www.dfba.com/
hc_service.htm, 2003.
http://www.echohealth.org.uk/.
Chapter 37
Medical equipment
replacement planning
J. Tobey Clark
WHO Collaborating Center for Health Technology Management, Technical Services Partnership, University of
Vermont, Burlington, VT, United States
Introduction
The best way to maximize the value of healthcare technology is the implementation of a system of comprehensive, “cradle-to-grave” healthcare technology life-cycle
planning and management. The healthcare technology
planning process includes assessment of technologies
new to the health entity, replacement of existing technologies, budgeting based on these inputs along with the
realities of funding, followed by acquisition of approved
devices and systems. This planning has to be done in
close alignment with the overall strategic planning process of the health entity which will be in part based on
mission and context.
The Technical Services Partnership (TSP) at the
University of Vermont (UVM) has created an illustration
to show the areas of clinical engineering (CE) involvement from the time a technology is approved for use in
the healthcare system until its disposal. The two distinct
parts of the life cycle—Planning and Management—are
shown in Fig. 1. The Planning process includes assessments of technologies new to the entity for benefits, impact, costs, and need. The second input into the budget
phase is the replacement of existing technologies. New
and replacement technologies deemed acceptable move
on to determine their priority in the overall capital budget. A budget approved item then goes through the acquisition process. The data collection “ring” around the
planning phase is the constant monitoring of technologies, the market place, safety issues, reimbursement, and
clinical outcomes. Planning input very importantly also
comes from the histories and outcomes of like devices
during their utilization in the healthcare system. The start
of the Management phase is when the device is deployed
into the healthcare system. Key activities are education,
compliance with regulations and standards, patient safety,
and maintenance. The data collection during this phase
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00037-7
Copyright © 2020 Elsevier Inc. All rights reserved.
is ­primarily from the computerized maintenance management system (CMMS) which should provide a complete
history for each device. At the end of life, the disposal
process is instituted.
In Fig. 1, Replacement is a key element in the Planning
process. Replacement planning utilizes Outcomes data related to the history of successes and failures for like technology (e.g., manufacturer, model, type) which have been
input into the CMMS. At the same time, there may be
advantages with new technologies which may offer lower
costs, fit the current healthcare delivery practices such as
integration of medical devices into the network, or enhance
overall health benefits.
All technologies reach the point in its life where the
cost–benefit value goes to the negative due to excessive
downtime, lack of safety features, poor support, increased
operating costs, devices not meeting the standard of care,
regulations prohibiting use, true obsolescence, or reduced
reliability as shown in the bathtub graph in Fig. 2.
At the extreme, some devices no longer offer a health
benefit and are just not used anymore.
●
●
●
●
●
●
Unfortunately, some hospitals respond to healthcare
technology replacement requests with “knee jerk” reactions causing immediate, unplanned, and unbudgeted replacement of expensive technology. Examples reactive
replacement requests include events when:
The device fails at a critical time.
A physician returns from a conference and states, “the
current technology is obsolete and must be replaced.”
A department manager complains “my equipment never
works right” at the capital budget meeting.
During repair, it is found that parts and support are no
longer available.
Integrating a medical device into the network to transfer
data to the electronic health record (EHR), it is found
that the device has to be replaced.
227
228 SECTION | 3 Healthcare technology management
FIG. 1 Healthcare technology life cycle shows replacement of technology as part of the planning phase but receiving evidence-based input from data
gathered during the management part of the cycle.
FIG. 2 The bathtub curve which describes device failure frequency over time (Bathtub Curve, n.d.).
Medical technology replacement should not be a political process, or an impulsive action related to isolated,
anecdotal events. Unless a quantified, defensible system
with clear reporting of replacement needs and priority is
developed, unplanned subjective replacement requests or
emergent replacement events will occur. Healthcare organizations have limited funding for capital purchases with
many under strict budgeting guidelines—the days of the
“wish lists” are gone. A plan for replacement can also be a
big help when a device needs a major repair or overhaul—
Should the device be fixed, replaced, or retired without
replacement?
Replacement should be accomplished through a systematic, evidence-based plan to replace equipment in a
prioritized fashion. The replacement plan needs to include
accurate, robust data not only acquired during the planning
cycle from the literature and expert sources, but also based
on the history of existing devices such as safety, reliability,
costs, and other factors.
The ideal healthcare technology replacement planning
system would be system wide covering all clinical technology, utilize accurate, objective data for analysis, have clear
prioritization to schedule replacement, be flexible enough
to incorporate nonequipment factors, and be futuristic by
including strategic planning related to clinical and marketplace trends and hospital strategic initiatives related to
technology. The plan should be based on equipment factors
and evidence related to cost-effectiveness, safety, support,
standardization, and clinical benefit to make it objective.
Key factors to assess
A key to developing a robust equipment replacement plan is
accurate data for analysis. An accurate equipment i­ nventory
Medical equipment replacement planning Chapter | 37
is absolutely essential. The inventory should contain not
only basic equipment data such as manufacturer, model,
and serial number, but also include fields which support the
process of equipment replacement. Secondly, work orders
related to this inventory form the basis of the device history and help guide the equipment replacement plan. Thus,
229
a robust CMMS is the indispensable tool in the process.
External factors not normally included in the CMMS should
also be tracked. Some of these are quantitative while others
are qualitative requiring judgment by the clinical engineer.
Table 1 is a comprehensive list of factors to evaluate in determining equipment replacement.
TABLE 1 Replacement factors—Factors with an asterisk (*) are documented in robust, comprehensive computerized
maintenance management systems.
Factor
Reference
Weight
Comments
Age*
AHA estimated life guide American Hospital
Association (2018) or equivalent
Low to Medium
From purchase date or via
manufacturer
Risk analysis*
Functional assessment per Table 2 or
equivalent
High
Based on device function, e.g., life
support
Risk assessment per Table 2 or equivalent
High
Risk to patient and staff if device fails
Mission criticality assessment per Table 2 or
equivalent
High
What is the impact on the healthcare
facility if the device is not available
and there is no backup?
End of Support data from manufacturers
Medium to high
Alternative sources for support can
provide short-term sustainability
End of support from all sources
High
Additional research is necessary to
vet
Reliability*
Corrective maintenance work orders including
problems found during PM/inspection
Medium to high
Reliability should be trended with
the most recent data being the most
important
Condition assessment*
Assessment ranges from excellent to poor.
Medium to high
One method is to base the condition
on the estimated cost of restoring the
device to the manufacturer’s original
specifications versus replacement
cost Ridgway (2002)
Safety issues*
Recalls and alerts
Medium to high
Recalls affecting device safety and
not resolved would have a high
weight
Adverse events
Medium to high
Adverse events determined to be
caused by the device would have a
high weight
Safety issues
Medium to high
Unresolved safety issues would have
a high weight
Use error and no problem found work orders
Medium to high
Derived from work order failure
classification
Purchase cost*
Purchase cost derived from purchase order or
other source during incoming inspection
Medium
Higher priced technologies require
more advanced planning to develop
funding sources Capuano (2010)
Application*
Fixed or portable
Medium
Portable devices are subject to higher
wear than fixed devices
Maintenance costs*
Maintenance costs for parts and labor
Medium
Cost trend with projection is most
valuable data. Prior studies have used
cumulative costs
Support status*
Continued
230 SECTION | 3 Healthcare technology management
TABLE 1 Replacement factors—Factors with an asterisk (*) are documented in robust, comprehensive computerized
maintenance management systems—cont’d
Factor
Reference
Weight
Comments
Depreciation*
Book value or residual value, calculated based
on original purchase price and estimated
number of years of useful life. Typically a
straight-line annual deduction of value.
Low
Depreciation used for accounting
purposes. Although not related to
device functional replacement,
important to administration
Backup equipment*
Backup equipment available or not
Low to medium
Higher weight for mission critical
equipment or life support devices
Regulatory*
Meets current regulations or does not
High
Note, in the United States, some
devices such as imaging system
which don’t have certain safety or
digitization features result in less
reimbursement but are not prohibited
Upgrade level*
Rating: Current, not current but upgradable,
not upgradable
Medium to high
Refurbishment may be another
option for certain equipment types
Cybersecurity
assessment of
networked devices*
Assessed through NEMA/HIMSS MDS2 form
National Electrical Manufacturers Association
(n.d.), MDRAP MDISS (n.d.) or equivalent
Medium to high
Also for devices that are being
considered for network connections
Utilization
Heavy, normal, or limited utilization based on
device type and application.
Medium to high
For devices used for scheduled
procedures, e.g., radiology, data is
available. Some devices have use logs
to download. Data from networked
devices via CMMS or other network
connection is available Smith (2014)
Uptime
% of time the device is fully functional for
patient care
Medium to high
For devices used for scheduled
procedures, e.g., radiology, data is
available
Network integration
Ease of integrating the device to the network
Assessment ranges from directly connectable,
connected via external hardware/software, or
not connectable.
Medium
For devices that are being considered
for network connections
Standardization
Device conforms to health entity standard—
manufacturer, model, consumables, etc.
Medium to high
For equipment used throughout the
hospital such as general purpose
infusion pumps, standardization takes
on a high weight
Cost savings/revenue
increase if replaced
with new technology
Financial advantage of new technology
(Depends of the
level of savings or
revenue)
Research required
Product status
Manufacturer related: new product, current
sold but not new, no longer sold
Medium
Major product line changes should
be flagged. Related to end of support
and obsolescence
Technological status
Emerging, current, or obsolete
Medium
Research required to determine
Standard of Care
Meets current clinical standards or does not
meet standards
Medium to high
Standards of care are established
by specialty groups—cardiology,
pediatrics, anesthesia, etc. These
standards may call for equipment
to meet certain standards for
performance and/or operation
Clinical acceptance
Input from clinicians determines if the device
is completely acceptable, adequate for most
but not all needs, or unacceptable
Medium to high
It would be preferred to have
documentation supporting the
replacement of equipment based
on published outcomes on what is
now considered to be the currently
accepted technology
Medical equipment replacement planning Chapter | 37
TABLE 2 As an example of risk categories to assess in
classifying medical equipment.
Criteria
Scoring
Clinical function
No patient contact
1
Device may make contact with patient but function
is noncritical
2
Device is used for patient diagnosis, or direct
monitoring
3
Device is used to deliver direct treatment to the
patient
4
Device is used for a life support
5
Physical risk
Device poses no appreciable risk due to failure
1
Device failure will result in low risk
2
Device failure will result in inappropriate therapy,
misdiagnosis or loss of monitoring
3
Device failure could result in severe injury to, or
death of, patient or user
4
Mission criticality
Device is not important for patient care as care can
be done via alternative methods
1
Device is important for individual patient care
2
Device is very important for one department
3
Device is very important for multiple hospital
departments
4
Device is essential for overall hospital function
5
Factors not listed include physician recruitment and
retention, marketing, malpractice and other insurance advantages, GPO contracts, payer reimbursement, tax advantages, and other factors which are out of the scope for CE
departments but will likely be included in final decision
making.
Medical equipment replacement planning
Typically, planned equipment replacement will involve a
number of healthcare staff including administration, clinicians, supply chain, facilities, information technology,
key department managers, and Clinical Engineering (CE).
The CE role focuses on our technical expertise, available
resources, equipment database ownership, and networking
with other CE departments, interaction with governmental (e.g., FDA), and independent agencies such as ECRI
231
Institute. Also, the clinical engineer’s knowledge of devicepatient and device-network systems is critical making this
an opportunity for leadership in this process.
It is essential to validate the inventory prior to the work
on the replacement plan. An analysis program can then be
used to interrogate the equipment management database to
list a “first pass” listing of items for replacement and scoring. The analysis should cover all clinical equipment on the
healthcare systems inventory. The factors, sample scoring
and weights for CMMS data were shown with an asterisk
in Table 1. Some are absolute factors calling for urgent replacement such as serious safety issues, no support options,
or regulatory prohibition. Other factors may have formulas
associated with the data which are used to determine if a
threshold has been exceeded.
Once the first pass list is generated from the CMMS data,
qualitative factors (no *) shown in Table 1 would be added
to the analysis. Scoring these factors requires professional
CE staff making assessments and adjusting the scoring
based on their knowledge and communication with administration, clinicians, BMETs, and others. Also, knowledge
of the healthcare entity’s strategic plans, addition/renovation projects, or group purchases is required. Reduced costs
and/or improved revenues, strong user preference, and cited
clinical advantages are some other factors which would
put a device or system into a high priority category for replacement. Various algorithms have been developed for this
analysis some using a simple scoring system and formulas
to more complex systems that employ predictive cost, reliability, and parts availability data and/or analysis. If the
equipment replacement cost is not part of the database, this
data must be included in the final equipment replacement
report. It is important for the clinical engineer to have the
biomedical equipment technicians/specialists who perform
the inspections and repairs on the equipment inventory review the report for accuracy especially related to the inventory and assessments.
One class of equipment for which additional analysis
might be necessary is major medical equipment—imaging systems, laboratory analyzers, and other high-tech/
high-cost systems. For these equipment types, factors such
as utilization, clinical input, upgrades, projected maintenance costs and reliability, and technological status take
on a greater weight in decision-making and must be carefully analyzed. Also, fleet (e.g., infusion pumps) or system
(e.g., ICU monitors) replacement is a high cost endeavor
requiring additional due diligence into replacement justification. The clinical engineer needs to be cognizant to align
system replacements in light of individual device shortcomings such that systems can be replaced as a whole or
in planned phases. In general, higher cost items have to
be planned for further in advance due to funding source
development.
232 SECTION | 3 Healthcare technology management
A departmental report should be provided to managers prior to their budget submission with meetings or other
communication to support guidance in the process. Some
hospitals prefer an all-inclusive report go to administration.
The reports should be easy to read and show inventory item,
justification for replacement and, replacement cost. The department report listing recommended replacement should be
presented a minimum of a month ahead of budget submissions by department heads to allow review and discussion.
It should be clear that the equipment replacement report is a
recommendation, which provides guidelines and generates
discussion and should never be considered a mandate by
CE. Following finalization of the budget submission by the
departments or the hospital’s overall budget requests, it is
important that the clinical engineer participate in the budget
review process to justify the recommendations based on the
hard data, assessment of the more qualitative factors, and
discussions with department heads and other hospital staff.
Note, not all items recommended for replacement may be
approved due to financial limitations or new equipmentintensive service additions.
Once the replacement plan has been finalized by administration/leadership, the agreed upon replacement date
should be loaded into the equipment management database
to allow proactive actions should maintenance be required
or safety issues occur for the identified device. For example,
if an item were listed for replacement in the current or succeeding fiscal year, a message should appear in the CMMS
to alert BMET staff when a work order was opened that
major repairs should not be undertaken.
Sometimes a replacement item is purchased but equipment recommended for replacement is put into secondary
use or storage. This causes inventory creep. Healthcare entities should be aware that there are costs associated with each
inventory item as all have to be managed, inspected routinely, and, if the device does fail, repair may not be possible.
The following year reporting should take into consideration prior reports especially items listed as high priority for
replacement but still existing on the inventory.
●
●
●
●
●
●
Prior work on equipment replacement
planning
A number of methodologies have been put forth in the past
to determine what technologies should be replaced and
when. These schemes primary address the medical equipment component of healthcare technology.
●
Factors including safety, reliability, usability, standards
of care, product support, repair costs, standardization,
and obsolescence were first used to develop clinical
equipment replacement reports by a shared service CE
group in a multihospital system (Clark and Forsell,
1990, 2015; Clark, 2004).
●
A formula-based method using 10 attributes addressing four primary replacement issues: equipment service
and support; equipment function; cost benefits; and
clinical efficacy was developed. The output results in
urgent, next fiscal year, and advisory recommendations
(Fennigkoh, 1992).
The preliminary equipment replacement table looks at
seven factors: three facility related; two ­manufacturer
related; and two maintenance related. It compounds
the results of the analysis into a single figure of
merit—total replacement points. The prioritized short
list is created by ranking the inventory according to
each item’s total replacement points (Ridgway, 2002).
A method focusing on return on investment alternatives—(1) repair, (2) replace with new equipment, or (3)
replace with used equipment was developed using net
present value (NPV) concepts. This includes a revenue
calculation (income allocation) determined by the percentage of expenses that can be attributed to the equipment used in a procedure using the life-cycle cost model.
This percentage can be used to allocate income obtained
from all procedures provided with the equipment. The
expenses calculation calculates the “profit margin” of
the dept. or organization from its annual report, multiply
the income allocated by profit margin to get expenses
(Wang, 2002).
A simple method has been suggested to state the retirement date as the year of manufacture plus the life expectancy cited by standard sources. When combined with
the item’s replacement cost, total annual cumulative
replacement budgets can be derived over several years
(Dondelinger, 2003).
An order of merit number has been proposed incorporating age factor + repair workorder factor + repair
cost factor + advancement in technology factor + fit
into 5-year factor with differing weights and formulas
(Dondelinger, 2004).
A priority index was developed based on price factor + condition factor + support factor + age factor + labor factor + parts factor + risk factor + utilization factor.
All of these factors are scored, then a weighting factor is
applied to come up with the priority index for replacement. The data can be sorted in multiple ways as needed
with graphical output showing characteristics of the inventory (Capuano, 2010).
Regarding repair/replacement decisions, one hospital system policy states: If the cumulative costs of all
repairs, plus the loss of revenue from not having the
equipment in service during the repair process is greater
than 70% of the cost of new equipment or cumulative
costs of all repairs greater than 50% of the cost of new
equipment, the equipment should be replaced (Duke
University Health System, 2007).
Medical equipment replacement planning Chapter | 37
An important document related to replacement
planning is Decommissioning of Medical Devices.
Decommissioning is a removal of medical devices from
their originally intended use in the healthcare facility to an
alternative use or disposing of the device. This guide will be
part of the WHO Medical device technical series.
Although significant work has been done to develop
these planning methods, weaknesses and limitations have
been cited related to inaccurate quantitative results, valuation of data, difficulty in finding valid data sources and
assessment of qualitative factors, lack of or inaccurate financial figures, and the ever changing healthcare and technology environmental factors.
Example equipment replacement report
The TSP at the UVM has been providing equipment replacement reports to its 30+ member institutions since the mid1980s (Clark and Forsell, 1990, 2015). Since this time to
the present, the CMMS utilized has been HEMS, EQ2, Inc.
Charlotte, NC). HEMS was originally developed by TSP via
funding from the Kellogg Foundation and spun off to the private sector in 1993.
In determining the replacement year, a scoring system
is used. Automatically calculated are the scores related
to risk factors (the highest weighted factors), age, obsolescence, regulatory prohibition (absolute), manufacturer
end-of-support, and cost of support. A significant aid in
equipment replacement planning has been a manufacturermodel library which contains unique parameters such as
end-of-support date, equipment life, function and risk
scores, network assessments, regulatory status, recalls/
alerts, and average purchase cost to support the replacement process. This database automatically populates new
like manufacturer-model inventory additions. From the
calculated data, additional factors including safety issues,
trends for reliability and costs, upgrade status, and security are added via CE review. The equipment replacement
The University of Vermont
Technical Services Partnership
analysis is evaluated on an individual item basis although
in some cases, manufacturer and model are key elements
particularly where standardization has a high weight. The
draft report is then reviewed by the resident BMET(s) at
the healthcare site for accuracy, devices deemed in poor
condition, and general feedback regarding site planning.
The final report is then produced to be presented to department heads and hospital leaders.
The Medical Equipment Life-Cycle Management Report
is produced annually timed to adequately precede departmental budget submission. This report is provided to all 30+
TSP member hospitals with availability of ad hoc reports as
needed. The objective, evidence-based report is provided in
MS Excel format for flexibility in adaptation by each hospital. Although the report interrogates the entire medical
device inventory, it only shows items to be considered for replacement over a 3-year period. The report has tabs for each
department showing the calculated age of the device and the
useful life based on standard tables including AHA, VA, and
other sources with the final determination made via expert
review by the CE. The proposed action year is the fiscal year
when the device is recommended to be replaced along with
the primary factor shown in the column—justification. In the
action column, capital items are those costing greater than
$5000 while items shown as replace and contingency can be
replaced at a lower cost. Contingency items are low cost, low
risk which would typically be replaced through operational
funding (Fig. 3).
The preferred method of distributing the report is to
first present the departmental report to those responsible
for submitting the departmental budget. In some cases,
administration prefers to control the information, thus
the full inventory for replacement is presented to them.
Once the recommended list has been reviewed, questions
answered, and priorities changed related to hospital specific needs, the replacement costs are gathered for the
finalized items and added to the report prior to budget
submission.
MEDICAL EQUIPMENT LIFE CYCLE MANAGEMENT REPORT
Medical Equipment Managemnet Services
Non-profit Est 1973
Dept:
233
Anywhere Medical Center
12/26/2018 10:38:33 AM
AMBULATORY SERVICES UNIT
Control
Number
Device Type
Manufacturer
Model
Age
Action
SCALE,ADULT
DETECTO SCALE CO DIV CARD
338
20
Useful Life Proposed
Action Year
2018
10
Justification
34626
AGE
CONTINGENCY
34885
WARMER,CABINET
PEDIGO PRODUCTS INC
P2010-S
17
12
2018
AGE
CAPITAL BUDGET
34886
WARMER,CABINET
BLICKMAN INC (BLICKMAN HE
7922SSD
17
12
2018
AGE
CAPITAL BUDGET
58078
THERMOMETER,ELECTRONIC
WELCH ALLYN INC(TYCOS,MED
678
6
5
2019
AGE
REPLACE
52716
THERMOMETER,ELECTRONIC
WELCH ALLYN INC(TYCOS,MED
692
6
5
2019
AGE
REPLACE
82111
RF LESION GEN
NEUROTHERM
NT1100
9
9
2019
END SUPPORT
CAPITAL BUDGET
75231
VEIN FINDER
ACCUVEIN LLC
AV300
6
7
2020
MAINT COST
REPLACE
53179
WEIGHT, TEST, METRIC
SCALE-TRONIX INC
5125
5
10
2020
OBSOLETE
REPLACE
47419
MONITOR
OLYMPUS SURGICAL & INDUST
OEV-191H
6
8
2021
MAINT COST
REPLACE
FIG. 3 A departmental replacement report for a department in a small community hospital.
234 SECTION | 3 Healthcare technology management
Options for equipment selected for
replacement
Replacement of an item with a score above the threshold
may not be the only option. For some items, an upgrade
may solve safety or performance issues which would allow
the hospital to keep the equipment in service. A second option which retains the device in the system would be the
transfer of the device to a less critical application or use as
a backup device. If the device is put in storage, it should be
noted that the device will have to evaluated fully prior to
return to clinical service.
Also of note, not all items removed from service have
to be replaced. If the need is not there, the item should
not be replaced saving the hospital the cost of device purchase, testing, maintenance, space/utilities utilization, and
training.
The decommissioned, removed equipment item may be
disposed of, traded in for new equipment, sold to a used
equipment dealer, donated for humanitarian purposes, used
in a research lab, or “cannibalized” for parts.
An important point regarding any of these options where
the equipment is removed from the facility is to destroy any
patient health data or personal information, and confidential
or private information related to the entity from the device.
Data destruction should follow industry best practices for
policies and procedures including compliance with NIST
standards (NIST, n.d.) or equivalent standard. If the data
destruction process is outsourced, the vendors should be
certified to applicable standards. The hospital identifying
information, control number, and other labels should also be
removed. Typically, devices should be sold in an as-is condition, and your organization should have a sign-off form
to reduce liability. Cannibalized devices should have components to be discarded going into the proper waste stream.
Any hazardous or regulated items should be removed from
the device.
If the equipment is considered for donation, the donation guidelines of the World Health Organization must be
followed (World Health Organization, n.d.). A high percentage of donated equipment is never effectively used because
it lacks support resources, consumables, facilities limitations for power and other environmental issues exist, lack
of training of staff and clinicians, it just does not work upon
arrival, or it just is not needed by the recipient.
Future trends
Current and future trends in replacement planning are driven
by several factors. One is the convergence of technologies where devices are connected to the network via wired
and wireless telecommunication systems—the Internet of
things (IoT). Today, there are 3.7 million medical devices
in use that are connected to and monitor various parts of
the body to inform healthcare decisions (IoMT, 2018). The
initial push was to provide data for the EHR such as clinical information, images, alarms, and other data. Older technologies that are planned to connect to these networks may
require significant upgrades and middleware or cannot be
connected to the network, thus will rise to the top of the
equipment replacement list.
Concurrently with the push to connect devices to the
network, there is a major concern regarding cybersecurity.
Cybersecurity is the ECRI Institute’s 2018 and 2019 Top
Health Technology Hazard (ECRI, n.d.). 67% of medical
device manufacturers and 56% of healthcare delivery organizations think an attack is likely to occur on their medical
devices (Synopsys, n.d.). Medical equipment vulnerability
assessments are important to determine device status and
will play an increasingly important role in replacement
decision.
A second focus area as we move further into the 21st
century is patient safety factors. The volume of adverse
events reports to the US Food and Drug Administration is
over one-half a million in 2018 with over 5000 deaths and
175,000 plus injuries (Clark, 2018). Medical device failures
account for 13% of all type of adverse events in medicine
according to Frost & Sullivan. Poor human factors design
leading to usability issues is a related issue taking on increased importance in replacement decisions.
Medical equipment management systems vendors are
developing automated reporting systems for technology
replacement decision-making. Also, CMMS systems conforming to integrating the Healthcare Enterprise medical
device domains allow information from the medical devices
to be communicated to the CMMS (Smith, 2014). In particular, CE departments will be able to track equipment utilization. This ability will permit clinical engineers to make
significant impacts on health care related to replacement
recommendations and healthcare delivery.
Summary
The Medical Equipment Replacement Plan serves as an objective tool to support replacement decisions. It must include
expert input from multiple sources—Clinical staff, CE, materials management, and administration. When combined
with nontechnical factors and hospital budget limitations,
a rational plan for replacement of medical technology can
be made. Immediate benefits include reducing dramatically
emergency purchases of replacement equipment and improving the safety and effectiveness of clinical technology.
Medical equipment replacement planning Chapter | 37
Medical equipment replacement planning is an important part of the technology planning process. Clinical engineers should take a leadership role in this area to show the
value of the field. CEs have the tools, knowledge, and information to be an invaluable resource for health care through
these efforts.
Acknowledgments
Recognition to the TSP CE team for supporting development of the
medical equipment replacement activity—Wally Elliott CCE, Leah
Francoeur, CCE, Michael Lane CHTM, and especially Raymond
Forsell CCE who has been the lead clinical engineer in this area.
References
American Hospital Association, 2018. Estimated Useful Lives of
Depreciable Hospital Assets. American Hospital Association.
Bathtub Curve, Wikipedia, By Bathtub_curve.jpg: Wyattsderivative work:
McSush (talk)—Bathtub_curve.jpg, Public Domain, https://commons.
wikimedia.org/w/index.php?curid=7458336.
Capuano, M., 2010. Prioritizing equipment for replacement. Biomed.
Instrum. Technol. 44 (2), 101–109.
Clark, J.T., 2004. Healthcare technology replacement planning. In: Dyro, J.
(Ed.), Clinical Engineering Handbook. Elsevier, Oxford, pp. 153–154.
Clark, J.T., 2018. Adverse event notification, investigation and regulatory reporting in the United States. In: 4th Global Forum on Medical
Devices, World Health Organization, Visakhapatnam, India, presented
December 13.
Clark, J.T., Forsell, R., 1990. Clinical equipment replacement planning.
Biomed. Instrum. Technol. 24 (4), 271–276.
Clark, J.T., Forsell, R., 2015. Medical equipment replacement. In: Atles,
L. (Ed.), A Practicum for Healthcare Technology Management, second ed. Association for the Advancement of Medical Instrumentation
(AAMI), pp. 167–184.
Dondelinger, R., 2003. A simple method of equipment replacement planning. Biomed. Instrum. Technol. 37 (6), 433–436.
Dondelinger, R., 2004. A simple method of equipment replacement planning. Biomed. Instrum. Technol. 38 (1), 26–31.
235
Duke University Health System Clinical Engineering Policy CE-023: Repair
or Replace Determination. 2007. Policy and Procedure Manual.
ECRI, Top 10 health Technology Hazards. https://www.ecri.org/top-tentech-hazards/. (Accessed December 28, 2018).
Fennigkoh, L., 1992. A medical equipment replacement model. J. Clin.
Eng. Quest Publishing Co. 17 (1), 43–47.
IoMT, 2018. Why The Internet Of Medical Things (IoMT) Will Start to
Transform Healthcare in 2018. https://www.forbes.com/sites/bernardmarr/2018/01/25/why-the-internet-of-medical-things-iomt-willstart-to-transform-healthcare-in-2018/#38c882024a3c.
(Accessed
December 28, 2018).
MDISS Medical Device RiskAssessment Platform (MDRAP), Medical Device
Innovation, Safety and Security (MDISS) Consortium, https://www.
mdiss.org/mdrap-lp?__hstc=26490466.ff9b29dbff7ac3cdd173b640
d5dc5190.1546181603989.1546181603989.1546181603989.1&__
hssc=26490466.1.1546181603990&__hsfp=806667876.
National Electrical Manufacturers Association, Manufacturer Disclosure
Statement for Medical Device Security (MDS2), National Electrical
Manufacturers Association, https://www.nema.org/Standards/Pages/
Manufacturer-Disclosure-Statement-for-Medical-Device-Security.
aspx.
NIST Guidelines for Media Sanitization, National Institute of Standards
and Technology, (NIST), https://nvlpubs.nist.gov/nistpubs/specialpublications/nist.sp.800-88r1.pdf.
Ridgway, M., 2002. Preliminary equipment replacement planning
(PERT) report. In: Presentation at the Advanced Clinical Engineering
Workshop, San Jose, Costa Rica; February 28.
Smith, J., 2014. A Call to Action in Making the ‘Systems’ Work.
AAMIBlog, July 31, http://aamiblog.org/2014/07/31/jim-smith-acall-to-action-in-making-the-systems-work/. (Accessed November
20, 2014).
Synopsys, Medical Device Security: An Industry Under Attack and
Unprepared to Defend. https://www.synopsys.com/content/dam/synopsys/sig-assets/reports/medical-device-security-ponemon-synopsys.
pdf. (Accessed December 28, 2018).
Wang, B., 2002. Repair, replacement & retirement criteria for health
equipment. In: Presentation at the Advanced Clinical Engineering
Workshop, Guayaquil Ecuador, September 9-13.
World Health Organization, Donation of Medical Equipment, World Health
Organization, https://www.who.int/medical_devices/management_use/
manage_donations/en/.
Chapter 38
Integrated health technology
package
Thomas M. Judda, Peter Heimannb, Andrei Issakovc
a
Clinical Engineering Division, IFMBE, Marietta, GA, United States, bHealthcare, Luxembourg Development,
Vientiane, Laos, cProcess Management System, Sarl, Geneva, Switzerland
Background
The World Health Organization (WHO) health resource and
planning tool, formerly known as essential health technology package (EHTP), was described in-depth in the 2004
CE Handbook. Shortly after the earlier handbook was published, WHO renamed the tool as the integrated Health
Technology Package (iHTP) to better reflect its scope and
purpose, as well as implementation and use in countries by
way of their Ministries of Health (MOH), development assistance agencies, and international organizations.
References were gleaned from work done in the 1980s,
1990s, and in 2000, led by Peter Heimann (the inventor of
iHTP) and Andrei Issakov (the WHO sponsor of iHTP).
Thomas M. Judd was among the CE-HTM professionals
trained to implement iHTP in 2000 and began several years
of work with MOHs in Kyrgyzstan (Central Asia), Namibia
(southern Africa), and then Mexico, in partnership with the
other two authors. Overall, iHTP had been implemented in
some 20 different countries, and used by several WHO programs as a resource planning and management instrument
as well as many more countries and projects have shown
interest in using this methodology. The iHTP tool however
fell into disuse in 2010 after leadership changes at WHO.
Nevertheless, iHTP concept remains continuously valid,
and the need for a comprehensive and evidence-based resource planning and costing of health interventions only
increases over time, particularly within the context of the
universal health coverage and sustainable development
goals.
What is iHTP (WHO, n.d.; Peter, 2007)
iHTP is essentially a resource planning methodology
and software-based tool that provides guidance on an
adequate mix of resource inputs, comprising human resources, medical devices, pharmaceuticals, and facilities,
needed to deliver a defined set of health interventions.
236
It integrates healthcare needs, disease profiles, patient
demographics, clinical practice, medical device availability, technology requirements and constraints, associated capital and recurrent costs, and system’s technology
management capacity into one single tool, linking these
to the resources needed to deliver a defined set of health
interventions. The iHTP methodology was developed on
the premise that:
●
●
Effective and efficient healthcare delivery is dependent on the availability of the right mix of healthcare
technologies required for delivery of specific health
interventions.
These healthcare technologies are carefully chosen
with consideration of recurrent implications of a capital investment, and system’s capacity for their adequate
utilization.
Within iHTP, resources are linked with clinical interventions; replete with detailed technology unit costs and
time utilization so that informed decisions can be made
on their optimal acquisition, deployment, and utilization.
iHTP is intervention based; scenarios form processes
and pathways of linked clinical interventions. These
scenarios are representative of treating diseases and reflect evidence-based clinical practice guidelines (CPGs).
Resource requirements are then simulated for each clinical scenario using patient demographic and coverage data
entered into the simulation tool. It also allows for a comprehensive technology GAPS analysis between the current and intended practice, that is, for scaling up priority
interventions.
Why iHTP (Peter, 2007)
●
In mid-1990s, WHO’s Strengthening of Health Services
Division and South African Medical Council by developing EHTP (later iHTP) have responded to the identified urgent need for optimizing resource planning for
Clinical Engineering Handbook. https://doi.org/10.1016/B978-0-12-813467-2.00038-9
Copyright © 2020 Elsevier Inc. All rights reserved.
Integrated health technology package Chapter | 38
●
●
●
●
●
health interventions in a holistic and integrated way ensuring a right balance of different categories of resource
inputs replete with their costing, and system’s capacity
to manage purchased inputs throughout their life cycle
in terms of recurrent implications of capital investments
and required skills.
The iHTP concept and approach have been strongly
reinforced by the 2000 World Health Report “Health
Systems: Improving Performance” that explicitly included human and physical (facilities, equipment, and
pharmaceuticals) resource generation as one of four
key health system’s functions emphasizing that the
way investment decisions related to generation and
purchase of resource inputs are made, how those inputs
are planned and managed are critical for the performance of a health system and quality of health services
provided.
iHTP provided an important input toward addressing health Millennium Development Goals, that is,
#4, #5, and #6 (reduce child mortality, improve maternal health, and combat HIV/AIDS, malaria, and
other diseases) by assisting country decision-making
on defining evidence-based investment strategies and
service mix.
iHTP offers an integrated health resource planning
and management modeling of all combinations among
health systems resource inputs that are seamlessly related to clinical procedures and cost data has invaluable potential for contributing to the achievement of
the Universal Health Coverage and other targets of the
health Sustainable Development Goal #3.
Problem Scope
○ Serious imbalances exist in many countries in terms
of human and physical resources, equipment, and
pharmaceuticals, as well as imbalances between investment and recurrent expenditures, and the different categories of inputs frequently create barriers to
satisfactorily perform health systems.
○ In early 1990s, WHO estimated that in most developing countries half of the inventory, in some cases
as much as 75%–80%, lay idle at any given time.
○ Underutilized assets (at 15%) represented approximately 22% of total healthcare spending in the
WHO African Region.
Summary
○ Health needs and priorities are normally known, but
rarely linked to resource planning.
○ Program and implementation strategies have often
been developed without looking at long-term resource planning implications.
○ Resource are planned and implemented vertically.
○ Planning, implementation, training, monitoring, and
evaluation often done in isolation.
○ The strategic and operational divide is evident.
○
237
Healthcare technology (HT) is a major strategic factor in determining a community perception of the
health system.
How is iHTP used (WHO, n.d.)
Health services aim to protect or improve health. However,
they so effectively depend on whether which services
are provided and how they are delivered and organized.
Resources should be used for interventions that are known
to be effective, in accordance with national or local priorities. Because resources are limited, there will always be
some form of rationing but prices should not be the chief
way to determine who gets what care (World Health Report,
2000, WHO).
iHTP improves health service delivery because its simulation tool systematically demonstrates—with thorough input data anchored in national priorities—to decision-makers
which services are necessary and cost-effective given available resources. Furthermore, it does so without using price
as the sole aspect of planning—instead, the simulation tool
integrates information on patient demographics and disease
profiles to successfully embed local needs and priorities to
a resource and costing analysis.
Providing health care efficiently requires financial resources to be properly balanced among many inputs used
to deliver health services (World Health Report, 2000,
WHO). iHTP basically performs this balancing act once
all of the essential input data are in. For example, large
numbers of staff do not improve health service delivery
without adequately built, equipped, and supplied facilities. Available resources should thus be allocated both to
investments in new skills, facilities and equipment, and
to maintain the existing infrastructure (World Health
Report, 2000, WHO). iHTP synthesizes these needs and
renders decision-makers with output information that
allows discernment on which investment is effective at
what time, at what cost, and with which technologies. In
order to reduce the risk of future imbalances, new investment choices must be made carefully and the existing mix
of inputs needs to be monitored on a regular basis (World
Health Report, 2000, WHO). iHTP shows resource planners several possibilities on where to focus their new
investments in addition to possible outcomes; this gives
them the necessary information to make an appropriate
decision. The iHTP implementation program also envisions regular monitoring and evaluation sessions after
new investment decisions have been made; this allows for
revision of these choices if necessary, with new simulation models and new input data.
Health service delivery is greatly improved by iHTP’s
inevitable horizontal integration through coordination
of services. If, for example, iHTP is being used for the
238 SECTION | 3 Healthcare technology management
­ aternity ward and a neonatal care unit in the same rem
gion, services for measuring the baby’s weight need not be
taught twice. IHTP identifies similarities of different programs and provides a coordinating capacity, thus reducing
costs. The iHTP projects in the past have also demonstrated
a consolidation capacity by agreeing on standard practice
with each of the various groups involved—whether it is
between two hospital departments or between nongovernmental organization (NGOs) or United Nations (UN)
agencies.
The rapidly changing and increasingly complex health
services industry poses significant challenges for health
services management, responsible for planning, directing,
coordinating, and supervising the delivery of health care.
Improving service delivery and ensuring better access,
complicated by technological advance and changes in demography and epidemiology, must involve all the major
stakeholders in the health system—the policymakers in
MOH and public administration, health service managers
and workers, public and private providers, and clients and
communities themselves). IHTP amalgamates the issues of
technology, demography, and epidemiology into one system for simple comprehension by all various stakeholder to
enable them to make more informed decisions and ameliorate health services.
At what level is iHTP used
(WHO, n.d.)
From the administrative and clinical point of view, there are
several levels of healthcare delivery: a national or tertiary
level, a provincial level, a district level, and finally, a primary care level. The various levels have different functions
within a country’s healthcare system.
Primary care is seen as an “integral, permanent, and
pervasive part of the formal healthcare system in all countries” or as the “means by which the two goals of health
services system—optimization of health and equity in distributing resources—are balanced” (Basch, 1990). It addresses the most common problems in the community by
providing preventive, curative, and rehabilitative services
to maximize health and well-being. Tertiary care refers to
highly specialized care given to patients who are in danger
of disability or death often requiring sophisticated technologies (e.g., neurosurgeons or intensive care units). The
intermediary levels such as provincial or district usually
are within the sphere of influence of the local government.
They provide health care which links local priorities with
national health policies.
iHTP is developed for all different levels of health care.
It ensures that the scope and complexity of healthcare
technologies is realistic for any given level of healthcare
­delivery. The iHTP consists of a comprehensive map of all
HT needs per intervention per healthcare level (Heimann
and Kader, 2002). iHTP contributes to a clearer understanding of why the resources are needed at each level
of ­healthcare delivery, in what quantities the resources
are needed and how they fit together into an integrated
­healthcare system.
iHTP inherently bridges the gap between the planners
at the strategic levels (national or regional), who may not
have full knowledge of field realities, and practitioners at
the operational level, who may be too immersed in their
day-to-day clinical activities to be aware of the big picture.
iHTP allows technology needs appropriate for each level
of health care to be identified (Heimann, 2001); it thus facilitates the upward flow of information to be amassed into
national requirements.
User network (WHO, n.d.)
WHO has created several generic scenarios for their
iHTP project. These scenarios belong to the responsible
WHO department; they can be obtained through them
in the context of an iHTP implementation project under
their auspices. Other generic scenarios are the sole property of the institution that created them, such as MoHs.
Currently, generic scenarios on all major obstetric, neonatal, pediatric, and noncommunicable diseases have
been created by WHO. Chronic disease scenarios are
presently in review.
The WHO department ‘Making Pregnancy Safer’
has been actively involved in creating scenarios on maternal and child health in recent years. These scenarios
are anchored in WHO clinical guidelines also developed
by the department. National-level generic scenarios are
currently being developed in Democratic Republic of
Congo, Kyrgyzstan, Malawi, Mexico, South Africa, and
Ukraine.
Software tool description
(WHO, n.d.)
The iHTP Simulation tool is software program that allows the user to integrate linked interventions to CPGs,
health and patient profiles, and health packages by creating
scenarios.
The simulation tool has four main components. The first
incorporates the economic analysis of HT. Basic economic
information such as medical equipment fixed and recurrent
costs, human resource costs, drug costs, and facility costs
are stored in the generic iHTP template database and are
accessed by the Simulation Package. Here, the stored costs
are applied to the simulation tools and costing analysis becomes available.
Integrated health technology package Chapter | 38
239
iHTP simulation tool
Clinical guidelines
Sharing of resources
HCT constraints
Patient profiles
iHTP databases
Country
database
Simulations
Simulations and
planning
Reference database
Inputs (Peter, 2007)
Clinical guidelines
Medical equipment
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Comprehensive medical equipment database (UMDNS
based);
Technology, maintenance, and costing data;
Usability and technical criticality indicators;
Separated scenario and reference database for improved
country implementation.
Pharmaceuticals
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Comprehensive pharmaceutical database
Based on WHO pharmaceutical database
Scheduling and drug interaction capability
Country specific costs can be linked to any
pharmaceutical
Outputs (Peter, 2007)
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Epidemiological profiles
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Reports—static →
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Static HT reports
(for pharmaceuticals, medical equipment, Human
resources, and facilities);
iHTP reference database contains 4500 prelinked
procedurals
250 clinical guidelines (iHTP terminology: scenarios)
completed
Scenarios can be adapted to any country situation.
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Population indicators
Coverage rate and hospital admissions
Target indicators (e.g., C-section rates) can be modeled
over specific years
Allows scaling up
Can be used for static equipment lists, that is, pedicure equipment procurement; technology scope
evaluation
Does not indicate quantity
240 SECTION | 3 Healthcare technology management
Reports—dynamic ↓
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Dynamic HT reports include quantities—calculation
based on workload and schedule
Provides operational costs; dynamic quantities; recurrent;
and opportunity cost
Takes into consideration HT availability;
Reports provide ‘drill down technology’; ideal in evaluating cost drivers.
Examples ↑ →
Country implementation
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Mapping of Mother and Child health package
Approximately 30 guidelines based on observations and
recommended clinical practice
Primary and secondary levels of care
Resource requirements, including operational and
­recurrent costs.
Ukraine overview
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Identification of cost drivers
Minimum quantities of resources
Critical path identification
Optimization through evidence
Total
required
Unit
cost
(min)
Unit
cost
(max)
Oper
cost
Replace
cost
Furniture general
Group
Type
Simulated
qty
Bench
{Not Specified}
Furniture
General
Reusable
0.7
1.0
300.00
394.00
260.71
394.00
Desk
{Not Specified}
Furniture
General
Reusable
2.8
3.0
300.00
320.00
895.37
960.00
Racks, Test Tube
{Not Specified}
Furniture
General
Reusable
0.9
1.0
30.00
35.00
30.66
35.00
Cabinets, Laboratory
{Not Specified}
Furniture
Medical
Reusable
0.3
1.0
140.00
160.00
47.05
160.00
Chairs, Office
Furniture
Medical
Reusable
4.9
5.0
70.00
90.00
443.97
450.00
Footstools,
Two/Three-Step
{Not Specified}
Furniture
Medical
Reusable
0.1
1.0
80.00
120.00
10.79
120.00
Tables, Examination/
Treatment,
Adjustable,
Obstetrical
Furniture
Medical
Reusa