Updates on Inter-agency work on
Medical Devices
IPC Meeting, WHO Geneva
6th June 2014
Medical devices
 Interagency list for reproductive , maternal, new born and child care
 Technical specifications
– Nomenclature
 UNCLSC
– 3 types of commodities involving 13 medical devices
 Pricing survey
 Future / on going Publications
 Compendium of innovative health technologies
 Pneumonia diagnostics.
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IPC Meeting, WHO, Geneva, Switzerland
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2008
Background
2011
2010
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IPC Meeting, WHO, Geneva, Switzerland
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Interagency list of medical devices for reproductive,
maternal, newborn and child health
 Objective. Provide a publication containing a
list with the essential interventions and medical
devices related to them.
 UNFPA, UNICEF and WHO in
collaboration with specific WHO areas:
•
•
•
•
•
•
•
•
•
•
•
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Injection Safety
Blood transfusion
Safe Surgery
Diagnostic and Laboratory
Reproductive Health
Maternal Health
Neonatal Health
Waste management
STI’s
Infertility
Cancer
IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
 Meetings held
–
–
–
–
–
June 2012- Copenhagen
August 2012-Geneva
November 2012- Geneva
February 2013- Copenhagen
January 2014- Copenhagen
FIRST MEETING
Copenhagen, Denmark. June 27th-29th 2012

United Nations Population Fund (UNFPA)
–
–
–
–
–
Dr. Yves Bergevin, Senior Maternal Health Advisor,
Coordinator, Maternal Health Thematic Fund, TD
Dr. Kabir Ahmed, Technical Adviser, Commodity Security
Branch
Ms Wilma Doedens, Technical Adviser, Humanitarian
Response Unit
Ms Agnes Chidanyika, Technical Specialist
Ms Isabel Lucas Manzano, Technical Consultant

United Nations Children’s Fund (UNICEF)
–
–
–
–
–
–

World Health Organization (WHO)
–
–
–
–
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Ms Adriana Velazquez Berumen, Coordinator of Medical
Devices Unit, Essential Medicines and Health Products
Department
Ms Åsa Cuzin-Kihl, Department of Reproductive Health and
Research; Research Capacity, Policy and Programme
Strengthening
Dr Metin Gulmezoglu, Department of Reproductive Health
and Research
Ms Lisa Hedman, Essential Medicines and Health Products
IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
–
–
–
–
–
Dr Hanne Bak Pedersen, Deputy Director, UNICEF Supply
Division
Dr Kim Eva Dickson, Senior Adviser (Maternal and Newborn
Health), Health Section UNICEF HQ
Dr Helene Moller, Chief, Health Technology Centre, UNICEF
Supply Division
Mr Francisco Blanco, Chief, Medicines & Nutrition, UNICEF
Supply Division
Mr Thomas Sorensen, Chief, Knowledge Management,
UNICEF Supply Division
Ms Etleva Kadilli, Contracts Manager, Medical Unit, Health
Technology Centre, UNICEF Supply Division
Dr David Muhia, Contracts Manager, Medicines & Nutrition,
UNICEF Supply Division
Ms Monique Supiot, Technical Officer, Health Technology
Centre, UNICEF Supply Division
Mr Ludo Scheerlinck, Technical Officer, Medical Unit, Health
Technology Centre, UNICEF Supply Division
Mr Henrik K. Nielsen, Technical Specialist, Medicines &
Nutrition, UNICEF Supply Division
Ms Clara Aranda-Jan, Consultant, Medical Unit, Health
Technology Centre, UNICEF Supply Division
SECOND MEETING
Geneva, Switzerland. August 6th-7th 2012.

United Nations Population Fund (UNFPA)
–
–
–
–
Ms Isabel Lucas Manzano, Technical Consultant
Ms Wilma Doedens, Technical Adviser,
Humanitarian Response Unit
–
–
–

World Health Organization (WHO)
–
–
–
–
–
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Ms Adriana Velazquez Berumen, Coordinator of
Medical Devices Unit, Essential Medicines and

Health Products Department
Ms Lisa Hedman, Essential Medicines and Health
Products
Ms Clara Aranda-Jan, Consultant, Medical Devices
Unit, Essential Medicines and Health Products
Department
Ms Alicia de Hoyos Reyes, Intern, Medical Devices
Unit,, Essential Medicines and Health Products
Department
Dr Viviana MANGIATERRA, Scientist
IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Dr Meena NATHAN CHERIAN, Medical Officer,
Clinical Procedures Unit
Ms Anita SANDS, Technical Officer, Diagnostic and
Laboratory Technologies
Dr Selma KHAMASSI, Medical Officer, Clinical
Procedures Unit
Dr Neelam DHINGRA-KUMAR, Coordinator Health
Policy, Development and Services
Ms María Mercedes PEREZ GONZALEZ, Technical
Officer, Diagnostic and Laboratory Technologies
United Nations Children’s Fund (UNICEF)
–
Ms Monique Supiot, Technical Officer, Health
Technology Centre, UNICEF Supply Division
THIRD MEETING
Geneva, Switzerland. November 12-14th 2012.

United Nations Population Fund
(UNFPA)
–
–

United Nations Children’s Fund
(UNICEF)
–
–

Ms Clara Aranda, Technical
Consultant
Ms Monique Supiot, Technical
Officer, Health Technology
Centre, UNICEF Supply Division
–
–
–
–
–
World Health Organization (WHO)
–
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Ms Isabel Lucas Manzano,
Technical Consultant
Ms Wilma Doedens, Technical
Adviser, Humanitarian Response
Unit
Ms Adriana Velazquez
Berumen, Coordinator,
Diagnostic Imaging and Medical
Devices, Essential Medicines and
Health Products
IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
–
Ms Alejandra Velez Ruiz Gaitan,
Technical Officer, Diagnostic
Imaging and Medical Devices,
Essential Medicines and Health
Products
Ms Alicia De Hoyos Reyes,
Intern, Diagnostic Imaging and
Medical Devices, Essential
Medicines and Health Products
Ms Anita Sands, Technical
Officer, Diagnostic and Laboratory
Technologies, Essential
Medicines and Health Products
Dr Maurice Bucagu, Medical
Officer, Policy, Planning and
Programmes
Dr James Farukai Tsimba
Chitsva, Technical Officer, Blood
Transfusion Safety, Health Policy,
Development and Services
Dr Mario Festin, Lead Specialist,
Promoting Family Planning
–
–
–
–
–
Dr Selma Khamassi, Medical
Officer, Clinical Procedures Unit,
Health Policy, Development and
Services
Dr Viviana Mangiaterra,
Scientist, Research Capacity,
Policy and Programme
Strengthening
Dr Meena Nathan Cherian,
Medical Officer, Clinical
Procedures Unit, Health Policy,
Development and Services
Dr Severin Ritter Von Xylander,
Medical Officer, Policy, Planning
and Programmes
Ms Susan Wilburn, Technical
Officer, Interventions for Healthy
Environments
Methodology
 From the Copenhagen meeting and the workshops held at WHO the following
was agreed:
– Life cycle and continuum of care of mother and newborn to be considered:
•
Family Planning
•
Pregnancy
•
Childbirth
•
Post-natal and mother
•
Newborn
– Level of delivery of intervention:
•
Community level (Includes Health Post)
•
First level (Includes Health Center)
•
Referral level (Includes District Hospital and Referral Hospital)
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Interventions were reviewed according to evidence-based
guidelines from WHO and with specialists.
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Health Care Facilities considered
Health Post
District Hospital
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Health Center
Referral Specialized Hospital
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FAMILY PLANNING TEMPLATE
Medical Devices
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Interventions
Interventions for Newborn
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Medical Devices
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IPC Meeting, WHO, Geneva, Switzerland
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Special notes
 Part A. Special notes related to program
•
•
•
•
•
•
Safe blood and Clinical transfusion
Diagnostic tests & Laboratory
Injection safety
Surgery and Anesthesia
Decontamination and sterilization at healthcare facilities
Health care waste management
 Part B. Special notes related to medical devices
•
•
•
•
•
•
•
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Regulations for medical devices
Health Technology Management
Label and instructions for use for medical devices
Units and biomaterials used for medical devices
Surgical instruments stainless steel
Surgical sutures
Textiles used for linen and clothing in healthcare facility
IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Groups of medical devices
Groups of medical devices
1.
Grouping of common
medical equipment by
clinical area in health-care
facility
2.
Grouping of common
surgical instruments by
surgical procedure
3.
Grouping of medical device
consumables by size and
capacity
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Interagency list of medical devices for reproductive,
maternal, newborn and child health , June 2014
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
UN Commission
on life saving commodities
Defining a list of overlooked
life-saving commodities for
women and children
Identifying key barriers
preventing access to and
use of these commodities
Recommending innovative
action to rapidly increase
both access and use
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
List of medical devices for
UN Commission on Life Saving Commodities
Reproductive health commodities
• Female condom
Injectable antibiotics for newborn sepsis
Resuscitation devices for newborn
asphyxia
• Self-inflating neonatal resuscitation bag
with masks for pre-term(size 0) and
term(size 1) babies
• Electric or foot operated suction
machine/pump, negative pressure less
than 100mm Hg, with 1 bottle
• Syringe 2 mL with needle 23 G 25 mm
• (with re-use prevention feature)
• Suction catheter , length 50 cm, single
use, conical tip, Fr # 8
• Syringe 2 mL with needle 23 G 25 mm
(without re-use prevention feature)
• Single use suction bulb
• Sharps container, for used
syringes/needles
• Infant scale less than 20 kg
• Clinical thermometer, non-mercury
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
• Multi-use suction bulb that can be
opened, cleaned and sterilized
• Training mannequin/simulator for
neonatal resuscitation
• Infant stethoscope
Dosage for
Neonates
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IPC Meeting, WHO, Geneva, Switzerland
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Tools for country
assessment v1
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IPC Meeting, WHO, Geneva, Switzerland
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Technical specifications by UN agencies, can
harmonization be possible?
UNICEF Supply catalogue
UNOPS UN Webbuy
https://supply.unicef.org/
WB has
requested
UNFPA AccessRH
https://myaccessrh.org/
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
https://unwebbuy.org/
Other sources of technical specifications
NGO’s, countries…
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Technical Specifications
1.
Medical Device Specification
2.
Name and Coding
3.
General
4.
Technical
1.
2.
3.
4.
5.
Bidding / Procurement Terms / Donation Requirements
1.
2.
3.
4.
5.
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Technical Characteristics
Physical Characteristics
Energy Source
Accessories, Spare Parts, Consumables
Environmental and Departmental Considerations
Standards and Safety
Training and Installation
Warranty and Maintenance
Documentation
IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Example of Female Condom(1)
NAME, CATEGORY AND CODING
6
7
WHO Category
Generic name
8
Specific type or
variations
9
GMDN name
Female condom
Female condom, Hevea-latex and Female condom, non latex
10 GMDN code(s)
47721
47722.
11 GMDN category
10 Single-use devices
11 Assistive products for persons with disability
12 UMDNS name
13 UMDNS code
14 UNSPS code
Condoms, Female
18079
53131622
15 Alternative name(s)
Contraceptive
Femidom
Condoms
Condoms, female
Pouch, intravaginal
Prophylactic
16 Alternative code(s)
MS 35772, 206402008
MS 43386
MS 10985, 10985
MS 18079, 18079
MS 34045, MBU
MS 44542, 289906000
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Nomenclature
GMDN, UMDNS, UNSPS
Which nomenclature to use?
17 Keywords
Contraceptive device, Pregnancy prevention, prevention of sexually transmitted infections(STI)
including HIV, AIDS, syphilis, gonorrhoea, chlamydia, trichomoniasis
18 GMDN definition
47721; A Hevea-latex sheath with rings on either end that is inserted into the vagina before coitus
to prevent sperm from gaining access to the female reproductive tract and/or to prevent the
transmission of sexually transmitted infections (STI) between sexual partners. This is a single-use
device.
47722; A sheath made of synthetic polymers (e.g., polyurethane or nitrile) with rings on either end
that is inserted into the vagina before coitus to prevent sperm from gaining access to the female
reproductive tract and/or to prevent the transmission of sexually transmitted infections (STI)
between sexual partners. It typically includes a lubricant to minimize friction during coitus. This is a
single-use device
IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Example of Female Condom(2)
PURPOSE OF USE
19 Clinical purpose
Barrier to prevent unwanted pregnancy and transmission of STIs and HIV
20 Level of institution
Individual level, as given in the user leaflet/labelling
21 Clinical department/ward Not applicable
22
Overview of functional
requirements
23 Risk Classification
Lines vaginal canal and is designated to be retained in vagina during sexual intercourse to prevent
unwanted pregnancy and transmission of STIs. The external component of the devices can
provide coverage to the external female genitalia.
Class C (GHTF Rule 17)
Class Ⅱb (EU)
Class Ⅱ (Japan)
Class Ⅲ (USA)
Risk classification
IMDRF/GHTF (International Medical Device
Regulators Forum/ Global Harmonization Task
Force) http://www.imdrf.org/
TECHNICAL CHARACTERISTICS
24 Detailed requirements
Female condoms come in different designs and materials therefore Dependent on manufacturer's
specifications and WHO/UNFPA specifications and ISO standard.
25 Displayed parameters
Female condoms come in different designs and materials therefore Dependent on manufacturer's
specifications and WHO/UNFPA specifications and ISO standard.
IPC Meeting,
WHO,
Switzerland
settings
NotGeneva,
applicable
2628User
| adjustable
6th June 2014
Example of Female
Condom(3)
PACKAGING
Sterility status on delivery
30 (if relevant)
31 Shelf life (if relevant)
N/A
The claimed shelf life shall be not less than three years and not more than seven years subject to
confirmation by appropriate stability data
The inner boxes shall be packed into plastic or other waterproof lining bags, which will be placed in
three-wall cartons made from weather-resistant corrugated fibreboard with a bursting test strength
of not less than 1900 kPa.The inner boxes will be marked in a legible manner to facilitate
identification in case of subsequent query.
The carton flaps shall be secured with water-resistant adhesive applied to not less than 75% of the
area of contact between the flaps, or with water-resistant tape, 75 mm wide, applied to the full length
of the centre seams and extending over the ends by not less than 75 mm. The cartons may be
secured by plastic strapping at not less than two positions. Alternatively, wire-bound, cleated
plywood or nailed wood boxes are acceptable when lined with a waterproof barrier material.
The barrier material must be sealed at the edges with waterproof tape or adhesive, and there must
be no sharp protrusions inside the boxes.
Packaging
Shelf life, transportation,
Labelling
Transportation and
32 storage (if relevant)
33 Labelling (if relevant)
The exterior shipping carton, like the inner box, shall be marked with information about the contents
in a clearly
legible manner. Information should be printed on two adjacent sides. The following information
should be included in the inner box marking and exterior shipping carton. The information shall
include:
• a description of the contents;
• Lot identification number;
• month and year of manufacture (including the words Date of Manufacture, Month, Year) in
language(s) to be
specified by the purchaser. The year shall be written as a four-digit number and the month as a twodigit
number;
• month and year of expiry (including the words Expiry Date, Month, Year) in language(s) to be
specified by the
purchaser. The year shall be written as a four-digit number and the month as a two-digit number;
• name and address of the manufacturer and/or supplier;
• number of female condoms contained in the carton;
• the consignee details;
• instructions for storage and handling.
N/A
ENVIRONMENTAL REQUIREMENTS
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IPC Meeting, WHO, Geneva, Switzerland 34
6th June 2014
Context-dependent
requirements
Female condoms should be stored away from extreme heat (not more than 35 degrees C), be
protected from moisture and direct sunlight in a well ventilated environment.
Example of Female Condom(4)
STANDARDS AND SAFETY
46 Risk Classification
Regulatory Approval /
47 Certification
Standards:
e.g. Quality management
systems(ISO13485),
Standards for electric
48 International standards
devices(IEC),Female
condoms-- requirements and
test methods(ISO25841)
Which standards to include?
Reginal / Local
49 Standards
50 Regulations
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Class C (GHTF Rule 17), Class Ⅱb (EU, Australia), Class Ⅱ (Japan, Canada), Class Ⅲ (USA)
FDA approval(USA); CE mark(EU)
ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory
purposes (European Union, Canada and Australia)
ISO 14971:2007 Medical devices -- Application of risk management to medical devices
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration
laboratories
ISO 2859-1:1999 Sampling procedures for inspection by attributes -- Part 1: Sampling schemes
indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 10993–1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within
a risk management process
ISO 10993–5: 2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO 10993–10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin
sensitization
ISO 11346:2004 Rubber, vulcanized or thermoplastic -- Estimation of life-time and maximum
temperature of use
ISO 4074:2002 Natural latex rubber condoms -- Requirements and test methods
Cor 1:2003
Cor 2:2008
ISO 25841:2011 Female condoms -- Requirements and test methods
ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with
Natural Rubber Latex Condoms (USA)
US regulations
21 CFR part 820; 21CFR Section 884.5330 (USA);
EU regulations
Council Directive 93/42/EEC
Directive 93/68/EEC (CE Marking)
WHO technical specifications of
70 medical devices including UNCLSC devices
1 Abortion suction system
41 Overhead infant phototherapy unit
21 Infant Resuscitation Table
2 Anaesthesia Ventilator
42 Peak Flow Meter
22 Infrared thermometer, ear
3 Bilirubinometer
43 Physiologic Monitoring System
23 Infrared thermometer, skin
4 Capillary patient thermometer
44 Portable Ventilator Electric
24 Intensive-care ventilator
5 Cardiovascular ultrasound
45 PulseOximeter Line Powered
25 Laboratory urine analyser IVD
6 CPAP unit
46 PulsoOximeter Battery Powered
26 Laboratory water bath
7 Cryosurgical Unit
47 Scale Patient Infant
27 Laryngoscope
8 Darkroom Automatic X-ray Film processor
48 Single Channel Electrocariograph
28 Manual Emergency Suction System
9 Daylight Automatic Xray Film Processor
49 Sphygmomanometer
29 Microscope Light
10 Diagnostic spirometer
Stationary Basic Diagnostic Xray
30 Mobile basic diagnostic x-ray system, analogue
11 Electrocardiographic monitor
50 System Analogue
31 Mobile basic diagnostic x-ray system, digital
Stationary Basic Diagnostic Xray
12 Examination Treatment Light
32 Mobile flouroscopic x-ray system, analogue
51 System Digital
13 Floor Scale electronic
33 Mobile flouroscopic x-ray system, digital 52 Stethoscope mechanical
14 Floor Scale mechanical
34 Neonatal physiologic monitoring systems53 Suction system
15 Foetal cardiac monitor
35 Non-rechargeable professional semi-automated
54 Syringexternal
Pump defibrillator
16 Foetal vacuum extraction
36 Obstetrical table, line-powered
55 Thermometer laboratory
17 General purpose Electrosurgical Diathermy
37 Obstetrical table, manual
56 Transport infant incubator
18 General purpose Tabletop Centrifuge
38 Operating light (fixed)
Universal operating table
19 General purpose Ultrasound
39 Ophthalmoscope, direct
57 electrohydraulic
20 Incubator Infant Stationary
40 Otoscope, direct
Universal operating table
58 electromechanic
59 Universal operating table hydraulic
60 Unwrapped steam sterilizer
61 Viewbox X-ray
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
62 Female condom
63 Syringe 2 mL with needle 23 G 25mm
(with re-use prevention feature)
64 Syringe 2 mL with needle 23 G 25mm
(without re-use prevention feature)
65 Sharps container, for used
syringes/needles
66 Self-inflating neonatal resuscitation bag
with masks for pre-term and term babies
67 Suction catheter , length 50 cm, single
use, conical tip, Fr# 8
68 Single use suction bulb
69 Multi-use suction bulb that can be
opened, cleaned and sterilized
70 Training manikin/simulator for neonatal
resuscitation
Consideration
1) WHO technical specifications should be tailored appropriately by users according to
the specific situation, e.g. local standards and legislation; local regulations and conditions;
languages; electrical range, capacities, utility environment and other local specific
conditions.
2) Technical characteristics of WHO technical specifications are indicate basically
appropriate standard equipment for low- and middle- income countries.
3) The number of accessories, consumables, spare parts and other components indicates
usual and/or ideal number, not mandatory.
4) For tender purposes, should consider not only medical equipment itself, also related
services to be able to use the equipment, e.g. installation, supplier testing, training,
warranty.
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Three Dimensions to Consider When Moving
Towards Universal Coverage
Health systems financing: the path to universal coverage. Executive Summary,
The World Health Report, WHO/IER//WHR/10.1, 2010
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
WHO Global medical devices pricing survey 2014
•
•
•
Collect data in different stakeholders and settings
Statistical analysis
Report findings of the pricing survey
Global medical devices pricing survey
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Innovation
Universities
Medical devices
industry
HOSPITAL SERVICES
BIOMEDICAL
ENGINEERING:
SELECTION, USE ,
MAINTENANCE OF
EQUIPMENT
Safety and
quality .
Regulatory
institutions
HTA,
SELECTION OF PRIORITY
MEDICAL DEVICES
MEDICAL DEVICES FOR
REIMBURSEMENT, FOR
COVERAGE
,
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Medical devices technical series
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
 Books on medical
devices for 20142015:
– Regulations
( pre-market, postmarket)
– Safe use of
medical devices
– Human resources
– Decommissioning
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Image of the linkage with data sources
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
WHO medical devices information system (MEDEVIS)
the development in 2014
Clinical information
Global Atlas,
MDs by health care facilities…
•
•
Disease related to procedure
Clinical indication
Procedural use
of medical devices
Areas of use within a given
health care system
•
•
•
linkage
Region/healthcare system
Type of facility
Group of healthcare section
Medical device information
Pricing survey,
Compendium,
Nomenclature….
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Interagency list,
Other sources…
•
•
•
•
•
Device name
Description/Definition
Technical information
Picture
Economic information
•
•
•
•
Procedural information
Regulatory information
Procurement information
Assessment information
Technical specifications,
Other sources..
Structure of MEDEVIS web tool as per
WHA60.29
-
Review data sources and linking points
Design appropriate data-structure for MEDEVIS to
be able to link various data sources
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
2010 call for innovative technologies that
address global health concerns: outcomes
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
2011-2013 Compendium
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Pneumonia:
UNICEF and WHO
 Pneumonia is the leading cause of death in children
worldwide.
 Pneumonia kills an estimated 1.4 million children under the
age of five years every year – more than AIDS, malaria and
tuberculosis combined.
 Pneumonia can be caused by viruses, bacteria or fungi.
 Pneumonia can be prevented by immunization, adequate
nutrition and by addressing environmental factors.
 No diagnostic method is available for low resource settings.
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IPC Meeting, WHO, Geneva, Switzerland
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+ Novel Diagnostic Tools for Childhood Pneumonia
Access to
antibiotics
Vitamin A
Pneumococcal
vaccination
Other vaccines
Prevention
Malaria
Pneumonia
Oxygen Saturation
Viral Pneumonia
Fever
Tachycardia
Bacterial Pneumonia
Treatment
BIOMARKERS: PCT, CRP, Lpc-2, Heptoglobin…
Crackles
Antibiotic Resistance
Other infections
Wheezing
Respiratory Rate
Chest X-ray
Treatment
Diagnosis
+
Country survey , 2013 data:
Country survey on Medical devices.
Update 2013.
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Approved medical devices for national
procurement or reimbursement
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Lists of devices per facility or clinical
procedure
 Examples:
 Per hospital
 Per health center
 Per area of care:
– ICU
– Surgery
 Per disease
– H1N1
– HIV
– Vaccines
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
WHO Medical Devices
Publications (2008-2014)
Country
Publications
WHO Regions
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Next steps…
– Circulate for revision: the interagency book on medical devices
for essential interventions on reproductive, maternal, new born
and child care. And publish.
– UNCLSC define final tech specs, PQ available, regulatory
pathway
– Harmonize the format of the technical specifications?
– Nomenclature work?
– Participate in the pricing survey?
– Participate in the evaluation of the innovative technologies? For
the compendium on innovative technologies?
– Participate in the next books:
• Decommissioning of medical devices
• Safe use of medical devices.
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IPC Meeting, WHO, Geneva, Switzerland
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Thank you !
www.who.int/medical devices
velazquezberumena@who.int
Medical_devices@who.int
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IPC Meeting, WHO, Geneva, Switzerland
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