First Global Forum on Medical Devices
World Health Organization
9-11 September
2010 Bangkok
Thailand
The Role of HTA for Innovative
and Emerging Technologies
Prof Brendon Kearney
Vice Chairman of EuroScan
Chair HPACT Australia
A bit of history (I)
Early warning systems part of the regular
approval processes in European countries
In January 1995, the Danish Hospital
Institute organised a meeting entitled.
"International Collaboration Concerning
Monitoring of Emerging Medical Technologies
(MEMT)".
Fourteen participants attended and discussed
national experiences concerning MEMT and the
possibility for a European collaboration.
A bit of history (II)
A survey in 1998 among INAHTA members
showed that 30% of agencies had continuing and
structured early warning activities
An international workshop "Scanning the Horizon
for Emerging Health Technology" in Copenhagen
in 1997
A small working group was established with
representatives from Denmark, the Netherlands,
Spain, Sweden and the United Kingdom plus
associated representatives from Canada and
Switzerland
EuroScan Framework
EuroScan – the international information network on
new and emerging health technologies - is a
collaborative network of member agencies for the
exchange of information on important new and
emerging health technologies.
Each member agency is unique in the way it
approaches its work but all have a common goal of
informing their customers about new and emerging
health technologies that may have a significant
impact on their health system.
Avoid duplication and share
“The drug itself has no side effects, but the number of HTA agencies
needed to prove its value may cause dizziness and nausea”
The international information network on new
and emerging health technologies
“A collaborative network of member agencies for the exchange
of information on important emerging new drugs, devices,
procedures, processes, and settings in health care”
Members
20 members
AETS - Agencia de Evaluación de Tecnologías Sanitarias. Instituto de Salud Carlos III, Spain
AETSA - Agencia de Evaluación de Tecnologías Sanitarias de Andalucía, Spain
AGE.NA.S – Agenzia nationale per I servizi Sanitari Regionali, Italy
AHTA - Adelaide Health Technology Assessment, Australia
ANZHSN - Australia and New Zealand Horizon Scanning Network, Australia and New Zealand
CADTH - Canadian Agency for Drugs and Technologies in Health, Canada
CEDIT - Committee for Evaluation & Diffusion of Innovative Technologies, France
DACEHTA - Danish Centre for Evaluation and Health Technology Assessment, Denmark
DIMDI - German Institute for Medical Documentation and Information, Germany
DMTP - Division of Medical Technology Policy, Ministry of Health, Israel
FINOHTA (MUMM) - Managed Uptake of Medical Methods programme, Finnish Office for Health
Technology Assessment, Finland
GR - Health Council of the Netherlands, Netherlands
HAS - Haute Autorité de Santé, France
HIQA - Health Information & Quality Authority, Ireland
IHSP - Italian Horizon Scanning Project, Servizio Farmaceutico Territoriale, Italy
LBI–HTA - Ludwig Boltzmann Institut für Health Technology Assessment, Austria
NHSC - National Horizon Scanning Centre, England
NOKC - The Norwegian Knowledge Centre for the Health Services, Norway
OSTEBA - Basque Office for Health Technology Assessment, Basque Country
SBU - The Swedish Council on Technology Assessment in Health Care, Sweden
SFOPH - Swiss Federal Office of Public Health, Switzerland
Organization
Executive committee
Made up of
representatives of
member agencies
Workgroups
By-laws
Strategy
Difussion
Present committee (2007-2009)
Chair
Iñaki Gutiérrez-Ibarluzea
(Osteba)
Vice Chair
Brendon Kearney
(ANZHSN)
Registrar
Kees Groeneveld (GR)
Treasurer
Christoph Kuenzli
(SFOPH)
Head of Secretariat
Claire Packer (NHSC)
Past committee members (2005-2007)
Chair
Jill Sanders (CCOHTA)
Vice Chair
Iñaki Gutiérrez (Osteba)
Registrar
Inger Norderhaug (SMM)
Treasurer
Anne-Florence Fay
(CEDIT)
Head of Secretariat
Claire Packer (NHSC)
Organization
Permanent
secretariat
Based at NHSC
(Birmingham)
Head of the
Secretariat
1 partly time
researcher
1 partly time
administrative
Joint research initiatives
The influence of early warning activities
on health care decision making and the
diffusion of new technologies (current)
Newsletter to inform on new and
emerging technologies for the EUnetHTA
project (commissioned research 2007)
Use of the Internet in identifying new
technologies (2004)
Comparative analysis of member agency
systems (2002-2005) and 2007-2010.
Stockholm meeting
To report the
achievements and
progress of the
EuroScan collaboration
To share information
on the methods and
results
To consider challenges
to the collaboration
To discuss its possible
future direction.
Actions
1. Improve the collaboration with other
organizations
2. Diffuse the activities of the network
3. Create discussion groups and workgroups
within the organization
4. Promote a newsletter on new and
emerging health technologies (newsletter)
5. Make publicly available the methods and
joint actions (methods toolkit)
1. Improve the collaboration with other
organizations
Collaborating partners of EUnetHTA
Building bridges with HTAi
EUSANH, IPTS, PHGEN
MoU with INAHTA
Final approval of INAHTA and EuroScan
partners
MoU with WHO
Preliminary draft sent to approval to
WHO
Shared actions
2. Diffuse the activities of the network
Webpage
Workshops
Panel sessions
Journal Articles
Newsletter (6
monthly)
Web 2.0, blogs
Webpage. http://www.euroscan.org.uk
Statistics
Usage Statistics for October 2009
Public Sessions
Member Sessions
Total Sessions
13426
151
13577
Event Totals
Public Follow Technology Report link
8085
Technology Search (Member Section)
4477
Public Technology Search
3859
View Report (Member Section)
1998
Land on home page
1084
Log In (Member Section)
177
Technology Update (Member Section)
72
Technology Created (Member Section)
14
3. Create discussion groups and workgroups
within the organization
Internal work
By-laws
External work
Strategy
Special interest work groups
Research
Disinvestment
Disinvestment
Approval of an interest subgroup in
the HTAi on disinvestment
promoted by members of EuroScan
and other allies
4. Promote a newsletter on new and
emerging health technologies (public)
Six monthly
News from members
News on new and
emerging technologies
Space for other
initiatives
Statistics of our
webpage
5. Make publicly available the methods and
joint actions (methods toolkit)
Aim:
to outline the various methods that
members of EuroScan employ to:
Find
Select
Evaluate important new and emerging health
technologies
to provide valuable information to those
interested in establishing, or improving an
existing, early awareness and alert system
Methods
ANZHSN prepare a draft
The draft was circulated by the Secretariat to all the
members in groups of three
Improved drafts were subsequently circulated to
next group
Final draft open to discussion in a meeting in
Helsinki
Editing and improving was done by Secretariat and
Osteba
Results
Final document with 9 sections
Identify your customers
Determine your time horizon
Horizon scanning and early identification
Filtration
Prioritisation
Assessment or prediction of impact
Peer review
Dissemination
Updating information
Final document
Includes a final checklist
Help those promoting EAAS
It will be self-printable in the webpage
The scheme contains hyperlinks to sections
Electronically available in EuroScan’s
webpage and printed version available in
INAHTA’s booth
Final document
3. Topic identification, filtration and
investigation
The NHSC’s identification process uses three principal approaches:
(i)
Focussed routine scanning – an ongoing ‘horizontal scan’
designed to identify significant and urgent advances regardless
of clinical specialty,
(ii)
Specialty-based scanning – a ‘vertical scan’ to ensure that each
clinical specialty is allocated time for an investigation of new
developments in the field, and
(iii)
In-depth vertical scanning – work in specific clinical or
technologies areas of interest to individual customers
Team members routinely scan sources for new and emerging health
technologies and for information on technologies that we are
monitoring. Sources include:
Commercial sources e.g. Script, Clinic, pharmaceutical company
pipelines
Health-related media and journal e.g. NeLM daily news alert
Specialist trade publications, societies and journals e.g. IVT
Technology, MEDICA
General medical journals e.g. BMJ, The Lancet, NEJM, JAMA
Licensing sites e.g. EMEA for orphan drug opinions
Reports from specialist groups e.g. Gene Therapy Advisory Group
Other horizon scanning units e.g. EuroScan database, ECRI,
newsletter, CADTH (Canada), ANZHSN (Australia & New Zealand)
Identification of Sources by Technology Type
Devices and
Diagnostics – sources
Examples of Sources
Early Assessment & Alert Systems
Australia and New Zealand Horizon Scanning Network
National Horizon Scanning Centre
EuroScan
Health Organisations
HTA Organisations
Journals & Trade Publications
NHS
NHS National Library for Health
Canadian Agency for Drugs and Technologies in Health
National Institute for Health & Clinical Excellence (NICE)
The Cochrane Collaboration (only devices)
International Network of Agencies for HTA (INAHTA)
Centre for Reviews & Dissemination (CRD)
British Medical Journal
JAMA
Lancet
Archives of Surgery (only devices)
New Scientist
Clinica
Identification of Sources by Technology Type
Devices and
Diagnostics – sources
Examples of sources
Marketing Authorisation Agencies
U.S. Food and Drug Administration (FDA)
News sites
Medscape
Science Daily
Clinica
Clinica Diagnostics
Medgadget
Related organisations
ECRI Institute
HAYES
Societies
American Cancer Society
Drugs – sources
Examples of sources
Early Assessment & Alert Systems
National Horizon Scanning Centre
Euroscan
Health Organisation
NHS
HTA Organisations
Canadian Agency for Drugs and Technologies in
Health
National Institute for Health & Clinical Excellence
(NICE)
The Cochrane Collaboration
Journals & Trade Publications
British Medical Journal
JAMA
Lancet
Scrip
Marketing Authorisation Agencies
U.S. Food and Drug Administration (FDA)
European Medicines Agency (EMEA)
Drugs – sources
Examples of sources
News sites
National Electronic Library of Medicines (NeLM)
Pharmalive
Doctors Guide
Societies
American Cancer Society
Procedures – sources
Examples of sources
Early Assessment & Alert Systems
Australian and New Zealand Horizon Scanning Network
National Horizon Scanning Centre
EuroScan
Health Organisations
NHS
NHS National Library for Health
HTA Organisations
Canadian Agency for Drugs and Technologies in Health
National Institute for Health & Clinical Excellence (NICE)
Interventional Procedures Programme (IPP)
The Cochrane Collaboration
INAHTA
Centre for Reviews & Dissemination (CRD)
ASERNIP-S
Journals
British Medical Journal
JAMA
Lancet
Archives of Surgery
Procedures – sources
Examples of sources
News sites
Medscape
Doctor’s guide
Related organisations
ECRI Institute
HAYES
Societies
American Cancer Society
Programs – sources
Examples of sources
Early Assessment & Alert Systems
Australia and New Zealand Horizon Scanning Network
Euroscan
Health Organisations
NHS
HTA Organisations
Canadian Agency for Drugs and Technologies in Health
National Institute for Health & Clinical Excellence (NICE)
The Cochrane Collaboration
Centre for Reviews & Dissemination (CRD)
Journals
British Medical Journal
JAMA
Lancet
News sites
Medscape
Doctor’s guide
Related organisations
ECRI Institute
HAYES
Societies
American Cancer Society
Settings – sources
Examples of sources
Early Assessment & Alert Systems
Australia and New Zealand Horizon Scanning Network
Euroscan
Health Organisations
NHS
HTA Organisations
National Institute for Health & Clinical Excellence (NICE)
Canadian Agency for Drugs & Technologies in Health
The Cochrane Collaboration
Journals
British Medical Journal
JAMA
Lancet
New Scientist
News sites
Medcape
http://medgadget.com
Related organisations
ECRI Institute
HAYES
Societies
American Cancer Society
HEALTH PACT
-
Horizon Scan Technology Classification
Experimental
Investigational
Nearly established
Established
Established but changed indication or modification of
technique
Should be taken out of use
HEALTH PACT
Once identified technologies prioritised
according to pre-defined criteria
-
Clinical need
Rate and pattern of diffusion
Estimated clinical impact
Estimated cost impact
Efficacy and safety issues
Ethical issues
Cultural or religious issues
Other
HEALTH PACT
A technology prioritised for Health PACT review if it
reaches one or more of the following threshold
criteria:
-
associated with obvious safety or ethical issues or controversies
it has not been assessed and is rapidly diffusing throughout the Australian
health system
it is applicable to a large proportion of the Australian population and may
have considerable clinical or cost impact
it is applicable to a small proportion of the population but has obvious and
far-reaching benefits
Those that do not reach the priority threshold
marked for monitoring/periodic review or archived
HEALTH PACT
Prioritising Summary
Impact Summary:
<Name of Industry> provides <Name of Technology>
with the aim of <Purpose>. The technology is available
through <Health Providers> for <Target group>
-
Clinical Need and Burden of Disease
Estimated speed and geographic and practitioner use
Existing comparators
Estimated clinical impact of the introduction of the technology
Estimated cost impact
Efficacy and safety issues
Ethical issues
Cultural or religious considerations
Others issues
HEALTH PACT
Outcomes of Prioritising Summary
-
Horizon Scanning Brief
Full Health Technology Assessment
Monitor: 6-12 monthly
Do not progress
HEALTH PACT
Horizon Scanning Brief
-
Introduction
Background
Description of the Technology: the procedure, intended purpose, clinical
need and burden of disease, stage of development
Treatment Alternatives: existing comparators
Clinical Outcomes: safety, effectiveness
Potential Cost Impact
Ethical Considerations: informed consent, access issues
Training and Accreditation: training, clinical guidelines
Limitations of the Assessment: search strategy, availability and level of
evidence, sources of further information
Impact Summary
Conclusions
References
Conclusions
Build on the basis that one doesn’t fit all
It has been based on the heterogeneity of
the members
It gives suggestions and solutions
It has been conceived as a live tool that
should be enriched with new information
The document is opened to suggestions
Other products and actions
Status reports
Database
External collaborations and
partnership
Joint actions
Status report 2005
Diffusion
Members
INAHTA members
Related
organization
Decision makers
Copies available in
HTAi
Newsletter
Database
External collaboration and
partnership
INAHTA (almost all members)
HTAi (active)
ECHTA-ECAHI (steering committee)
OECD (advisors)
EUNetHTA
Associate and collaborating partners
WP 7, 8 and 9
Joint actions (comparison of systems)
Packer C, Simpson S, Stevens,
A. International diffusion of new
health technologies: a tencountry analysis of six health
technologies. International
Journal of Technology
Assessment in Health Care 2006;
22(4): 419-428
Ibargoyen-Roteta N, GutierrezIbarluzea I, Benguria-Arrate G,
Galnares-Cordero L, Asua J.
Differences in the identification
process for new and emerging
health technologies. Analysis of
the EuroScan database. Int J
Technol Assess Health Care
2009;25(3): 367-373.
Joint actions (comparison of systems)
Experimental phase II
Investigational phase III
Nearly established
Established
Other
Information not available
Missing
70,0
60,0
50,0
40,0
30,0
20,0
10,0
0,0
Device
Diagnostics
Drug
Procedure
Programme
Differences among agencies
depending on the stage of diffusion?
STAGE OF DIFFUSSION
Experimental-phase I-II
Investigational- phase III
Nearly established
Established
Other
Total
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
Agency 1
11 (3.0%)
255 (69.7%)
51 (13.9%)
16 (4.4%)
33 (9%)
366 (100%)
Agency 2
1 (0.4%)
16 (6,6%)
78 (32.2%)
142 (58.7%)
5 (2.1%)
242 (100%)
Agency 3
25 (15.3%)
26 (15.9%)
28 (17.9%)
22 (13.5%)
62 (38%)
163 (100%)
Agency 4
18 (17.1%)
33 (31.4%)
31 (29.5%)
17 (16.2%)
6 (5.7%)
105 (100%)
Agency 5
6 (11.1%)
9 (16.7%)
4 (7.4%)
30 (55.6%)
5 (9.3%)
54 (100%)
Agency 6
-
2 (11.8%)
7 (41.2%)
8 (47.1%)
-
17 (100%)
Agency 7
2 (5.9%)
7 (20.6%)
7 (20.6%)
18 (52.9%)
-
34 (100%(
Agency 8
2 (10%)
2 (10%)
2 (10%)
14 (70%)
-
20 (100%)
Agency 9
4 (21.0%)
8 (42.1%)
6 (31.6%)
1 (5.3%)
-
19 (100%)
Agency 10
2 (13.3%)
-
10 (66.7%)
2 (13.3%)
1 (6.7%)
15 (100%)
Agency 11
1 (8.3%)
3 (25%)
3 (25%)
2 (16.7%)
3 (25%)
12 (100%)
Agency 12
-
2 (20%)
2 (20%)
5 (50%)
1 (10%)
10 (100%)
Agency 13
2 (25%)
6 (75%)
-
-
-
8 (100%)
Agency 14
-
-
2 (100%)
-
-
2 (100%)
Differences among agencies depending on
the type of technology?
TYPE OF TECHNOLOGY
Device
Diagnostics
Drug
Procedure
Programme
Setting
Other
Total
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
Agency 1
34 (9.3%)
28 (7.6%)
284 (77.4%)
11 (3%)
1 (0.3%)
-
9 (2.45%)
367 (100%)
Agency 2
58 (22.5%)
18 (7%)
137 (53.1%)
24 (9.3%)
-
-
21 (8.14%)
258 (100%)
Agency 3
73 (44.8%)
34 (20.9%)
1 (0.6%)
23 (14.1%)
10 (5.5%)
1 (0.61%)
22 (13.50%)
163 (100%)
Agency 4
15 (14.3%)
7 (6.7%)
24 (22.9%)
34 (32.4%)
14 (13.3%)
-
11 (10.48%)
105 (100%)
Agency 5
5 (9.3%)
3 (5.6%)
38 (70.4%)
3 (5.6%)
-
-
5 (9.26%)
54 (100%)
Agency 6
12 (60%)
3 (15%)
1 (5%)
4 (20%)
-
-
-
20 (100%)
Agency 7
17 (50%)
2 (5.9%)
-
7 (20.6%)
-
-
8 (23.53%)
34 (100%)
Agency 8
2 (10%)
5 (25%)
5 (25%)
6 (30%)
-
-
2 (10%)
20 (100%)
Agency 9
3 (15.8%)
1 (5.3%)
6 (31.6%)
7 (36.8%)
1 (5.3%)
-
1 (5.26%)
19 (100%)
Agency 10
7 (46.7%)
1 (5.3%)
-
7 (46.7%)
-
-
-
15 (100%)
Agency 11
2 (15.4%)
1 (6.7%)
6 (46.2%)
1 (7.7%)
-
-
3 (23.08%)
13 (100%)
Agency 12
1 (9.1%)
-
2 (18.2%)
5 (45.5%)
2 (18.2%)
-
1 (0.91%)
11 (100%)
Agency 13
2 (25%)
2 (25%)
-
-
1 (12.5%)
-
3 (37.5%)
8 (100%)
Agency 14
-
-
-
2 (100%)
-
-
-
2 (100%)
What can we offer?
Network experience working together
Experience in the identification of new
and emerging technologies
Different approaches and agreed
methodology in HTA of new and emerging
technologies
Experience in network productive
research
What can we offer?
Database with more than 1.000
identified technologies
Clearing-house experience
A newsletter or digest for nonmembers
A formalised, centralised early warning
activity
An open-mind to new initiatives and
collaboration networks
WHO call on innovative technologies
WHO call on innovative
technologies
Invitation to participate
Agreed joint action by members if
more than 7 members agreed to
participate
14 members out of 20 agreed and
volunteered
No experience assessing devices
Lack of time or dedicated staff
EuroScan involvement
Agency
Evaluators
Agencia de Evaluación de Technologías Sanitarias de Andalucía (DETECTA), Seville, Spain
Dr Aurora Llanos
Agenzia Nazionale per I Servizi sanitari Regionali (Age.na.s), Rome , Italy
Dr Maria Rosaria Perrini
Assistance Publique-Hôpitaux de Paris, Committee for Evaluation and Diffusion of Innovative
Technologies, France (CEDIT)
Ms Anne-Florence Fay
Australia and New Zealand Horizon Scanning Network (ANZHSN)/HPACT
Prof Brendon Kearney
Australian Health Technology Assessment (AHTA)
Prof Janet Hiller
Linda Mundy
Australian Safety and Efficacy Register of New Interventional Procedures – Surgical
(ASERNIPS)
Irving Lee
Alun Cameron
Basque Office for Health Technology Assessment (Osteba), Spain
Dr. Iñaki Gutiérrez Ibarluzea
Canadian Agency for Drugs and Technologies in Health (CADTH)
Andra Morrison
Deutsches Institut furMedizinisches Dokumentation und Information (DIMDI)
Dr Hans-Peter Dauben
Health Council of the Netherlands (GR)
Dr Kees Groeneveld
Cees Postema
Health Information and Quality Authority (HIQA), Ireland
Martin Flattery
HTA Reviews and Dissemination Department, Norwegian Centre for Health Services
Research (NOKC)
Dr Inger Norderhaug
Helene Arentz-Hansen
Integrated Care & Aged. Department of Health, Victoria, Australia
Dr Paul Fennessy
National Horizon Scanning Centre (NHSC), England and Wales
Dr Claire Packer
Distribution of tasks
14 members
Each technology
evaluated by 2
members
10 technologies
per member
Timeframe 3
weeks
Secretariat
pooled the
results
Results
The deadline was met in all cases,
the majority, some days before
The degree of agreement was high
The assessment process was
coherent
The process was accountable
Members who participated were
happy to have taken part in this call
Selected innovative technologies
Call for innovative technologies that address global
health concerns
Applications have been evaluated by a team of international experts appointed by WHO. The
lists of selected innovative technologies include the technologies that the team of experts has
found to meet the selection criteria defined in the call for innovative technologies that meet
global health concerns.
CATEGORY 1
Category 1 is for commercialised products or products which are commercialisable. This includes
new products; products which have been commercialised for less than five years in high-income
countries and which are not (yet) widely used in low- and middle-income countries; recent
adaptation of existing non-health products for a health purpose; and/or recent adaptation of an
existing medical device for low- and middle-income settings.
CATEGORY 2
Category 2 is for products in a non-commercialised or a non-commercialised stage. This includes
products which are under development or otherwise in a conceptual stage.
1.1
The Global Initiative on Health
Technologies (GIHT)
The goal of the GIHT is to help make available the benefits of
core technologies at an affordable price, particularly to
communities in resource-limited settings, in order to
effectively control important health problems. The GIHT
includes the formulation of Health technology policies,
guidance and management tools, as well as the ‘Call for
innovative technologies that address global health concerns’
STEP 1
Screening
WHO internal experts will screen all applications. The
ones which are incomplete or non medical devices will,
in principle, not be processed further. An identifier
code will be assigned to the application and all
information about the application will be removed to
maintain confidentiality
Step 2
Evaluation
After screening, eligible submissions are passed on to external
independent experts as well as to WHO designated staff for
evaluation. Evaluation will occur concurrently and independently.
Applications will have been made anonymous before the evaluation
procedure starts.
The WHO internal evaluators will, based on provided selection
methodology (Table 1), analyse and grade the submitted
applications. A total score for each submission will be used for the
selection of technologies to be presented to the meeting participants
in the Advisory Group on Innovative Technologies meeting. The five
submissions that have obtained the highest scores in each category
will be shortlisted and presented to the AGIT meeting on 27-29 April
2010.
Step 3
AGIT final selection
The AGIT will make a recommendation for a final selection of
a set of technologies for the two categories “commercialised”
and “non-commercialised” products. The AGIT will also
analyse the challenges that may face selected medical
devices when trying to successfully reach the intended
markets in low and middle-income countries with the aim to
present a way forward on how to overcome those challenges.
Selection Criteria
1.
What is the level of safety for user, patient and the
environment
2.
How effectively does the technology address the health
concern(s) in question.
3.
How well is the technology adapted to local infrastructures in
resource-limited setting.
4.
What is the ease of use level. What is the ease of
maintenance.
5.
How high are cost-effectiveness and affordability.
6.
How high are cultural and social acceptability of the technology
7.
Is the product innovative.
Innovation e.g.
a product from a significant new drug class
a product with potentially greater efficacy
or reduced adverse effects than current
options
a new formulation of a licensed product
that may have additional patient or service
benefits
1.1
Stool sample collection and preparation kit
The intended purpose* of the stool sample collection and preparation
kit is to simplify faecal examination by reducing the number of
consumables and steps required for the procedure. The kit could therefore
facilitate the diagnosis of parasitological diseases. Additionally, the kit does
not appear to require water or electricity and is claimed to prevent
recontamination of the environment.
1.2
LED phototherapy unit
The intended purpose* of the LED phototherapy unit is to treat
hyperbilirubinaemia in newborn infants by phototherapy. The unit could
increase the safety of the procedure by using a radiation source that produces
blue light and minimizes the exposure to harmful ultraviolet radiation.
Further potential advantages are that the unit measures the actual output of
light at useful wavelengths and is claimed to have lower energy consumption
than previous designs.
1.3
System for on-site production of wound irrigation solution
The intended purpose* of the system for on-site production of wound irrigation
solution is to produce aqueous solutions for the topical treatment of wounds
and infections using a power source, demineralised water and salt. Solutions
produced by the system could be used to treat a host of conditions including
traumatic injuries, post-natal infections and neglected tropical diseases that
cause ulcerations and infections.
1.4
SMS smoking cessation system
The intended purpose* of the SMS (short message service) smoking cessation
system is to provide tailored SMS-based smoking cessation support to its
users. According to preliminary research submitted, the system facilitates selfmanagement of smoking cessation and increases the likelihood of user
adherence to smoking cessation programs. The interactive system claims to be
capable of answering messages about cravings to support the user.
1.5
Reusable neonatal suction system
The intended purpose* of the reusable neonatal suction system is to remove
obstructive mucus from the air passages in newborn infants to reduce the risk
of asphyxia and to support neonatal resuscitation. The device is claimed to be
reusable and capable of being cleaned and boiled between uses. The device is
claimed to be made of durable silicone and not to require electric power.
1.6
Fluorescence visualisation system for cancer screening
The intended purpose* of the fluorescence visualisation system for cancer
screening is to use the natural fluorescence of mucosal tissues when excited by
a voilet/blue light to inform clinicians about the presence of abnormalities in
the mucosa in the oral cavity. This system could aid in the early detection of
oral/oropharyngeal cancers and thereby reduce morbidity and mortality
associated with these diseases.
1.7
Transcutaneous bilirubin measurement system
The intended purpose* of the transcutaneous bilirubin measurement system is
to provide an alternative to blood sample analysis for the diagnosis of
hyperbilirubinaemia in newborn infants. The system uses spectral analysis of
light reflected from the patient’s vascular bed to determine levels of bilirubin in
the blood. The device is claimed to be non-invasive and to rapidly give a readout.
1.8
Isotherma nucleic acid amplification system for tuberculosis
diagnosis
The intended purpose* of the isothermal nucleic acid amplification system for
tuberculosis diagnosis is to offer a point-of-care alternative to sputum smear
microscopy. The technology is claimed not to require any additional
equipment and to yield a rapid visual read-out of the diagnostic result.
2.1
Simplified anaesthesia unit
The intended purpose* of the simplified anaesthesia unit is to function as an
anaesthesia machine for surgical use in low-resource settings. The device
features an innovative valve system with reduced technical complexity
compared to traditional devices. The device is claimed to function with oxygen
from different sources including ambient air and therefore would not require
compressed oxygen.
2.2
Single use assistive vaginal delivery system
The intended purpose* of the single use assistive vaginal delivery system is to
assist foetus extraction in cases of prolonged second stages of labour without
having to use forceps, to use a vacuum extractor or to resort to caesarean
sectioning. The lack of rigid instruments in the system is claimed to reduce
the risk of injury to both mother and child.
2.3
Portable on site cell sorter and coutner for HIV and malaria
diagnosis
The intended purpose* of the portable on site cell sorter and counter for HIV
and malaria diagnosis, a lab-on-a-chip, is to monitor AIDS in HIV-infected
people as well as blood cell alterations indicating malaria. The system appears
to be a small and portable device that would allow for rapid automated
screening of a blood sample for indicator of AIDS and/or malaria.
2.4
Decision support system for paediatrics HIV
The intended purpose* of the decision support system for paediatrics HIV is to
move away from paper-based medical records while ensuring easy and reliable
access to patient-centred information. This electronic health records system is
targeted at paediatric HIV cases and is intended to aid clinical decision-making
processes such as weight-based dosing support for antiretroviral drugs.
2.5
Transcutaneous anaemia monitoring system
The intended purpose* of the transcutaneous anaemia monitoring system is to screen populations
for insufficient levels of haemoglobin in the blood and to carry out diagnosis of severe anaemia. The
system is claimed to be based on spectrophotometric analysis. The device appears to be portable,
non-invasive and is claimed to give a read-out in less than a minute.
2.6
Solar-powered autoclave
The intended purpose* of the solar-powered autoclave is to sterilise medical instruments. It is
claimed to run solely on solar power. This technology could allow sterilisation of medical instruments
in remote rural areas with no access to electricity and hence reduce the risk of infections associated
with carrying out medical interventions with dirty equipment.
2.7
Portable infant warmer
The intended purpose* of the portable infant warmer is to improve the care of premature and lowbirth-weight babies by providing heat at a constant temperature in order to prevent hypothermia.
This portable device is claimed not to require electricity and would allow for close mother-to-baby
contact. The product is targeted fro use in urban and rural healthcare settings, and in home
settings.
Positive issues (SMART process)
Specific
Measurable
Accountable
RealisticReliable
Time-bound
Previous experiences
EUnetHTA
newsletter on
new and
emerging
technologies
Issues to think about
Technical issues
Difficulties to fulfill the evaluation
sheets
Submission and evaluation
processes
Definition of innovative technology
Low quality of submissions
Lack of information
Same weight of criteria
Not only is technology
Ways of improvement
Technical issues
Centralised web platforms for submission
and evaluation
Submission and evaluation processes
Definition of innovation
Workshop on how to submit proposals
Scoring system. Previous work on
weighting criteria, defining cut-off points
for each criterion or groups of criteria
Acknowledgements
All members of EuroScan
Participating organizations
Dr Aurora Llanos; Dr Maria Rosaria Perrini; Ms AnneFlorence Fay; Prof Brendon Kearney; Prof Janet
Hiller; Linda Mundy; Irving Lee; Alun Cameron; Dr.
Iñaki Gutiérrez Ibarluzea; Andra Morrison; Dr HansPeter Dauben; Dr Kees Groeneveld; Cees Postema;
Martin Flattery; Dr Inger Norderhaug; Helene
Arentz-Hansen; Dr Paul Fennessy; Dr Claire Packer
Suggestions
EuroScan Secretariat, Department of Public Health,
Epidemiology & Biostatistics, University of
Birmingham, Edgbaston, Birmingham, B15 2TT, UK
Tel: +44 (0)121 414 7496
http://www.euroscan.org.uk
Questions?