Updates on Inter-agency work on
Medical Devices
IPC Meeting, WHO Geneva
10 December 2015
Medical devices
 Interagency list for reproductive , maternal, new born and child care
 Medical Devices for NCD
– Cancer
– Other NCD for emergencies,
 Compendium of innovative health technologies
 Technical specifications
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Interagency book on medical devices
for essential interventions for
reproductive, maternal, new born and
child health
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2008
Background
2011
2010
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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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IPC Meeting, WHO, Geneva, Switzerland
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Health Center
Referral Specialized Hospital
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
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Interagency list of medical devices for reproductive,
maternal, newborn and child health , June 2015
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
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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•
•
•
•
•
•
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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
WHO medical devices information system ( WHO-MEDEVIS IN PROCESS)
Medical Devices regulations
Medical Devices innovation
•
•
Research and development
Innovative technologies for low
resource settings
•
•
•
•
Risk level
Nomenclature
Quality standards
Product standards
MEDEVIS
Web based,
updatable. Public
Health Technology Assessment
•
•
•
Cost effectiveness
Clinical Effectiveness
Country assessments
Clinical Procedures
•
•
Medical Devices information
•
•
•
•
•
•
Name
Nomenclature GMDN
Nomenclature UMNDS
Other names
Definition
Purpose of use
HTM, Health Technology
management
•
•
•
•
•
•
Technical Information
Image
Costs
Maintenance routines
Operation
Vendors
Clinical interventions
Sub- interventions
Medical device used in Health
facility
•
Type of health facility:
• Health post, health center
• District hospital
• Specialized hospital
Beirut workshop improved access
quality and use of medical devices
Medical Devices for Non
communicable diseases
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IPC Meeting, WHO, Geneva, Switzerland
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U.N. Strategy: 9 global NCD targets to be
attained by 2025 (against a 2010 baseline)
A 25% relative reduction in risk of
premature mortality from
cardiovascular disease, cancer,
diabetes or chronic respiratory
diseases
A 30% relative
reduction in
prevalence of
current tobacco
use
Halt the rise in
diabetes and
obesity
At least a 10%
relative reduction
in the harmful use
of alcohol
A 30% relative
reduction in
mean population
intake of
salt/sodium
A 10% relative
reduction in
prevalence of
insufficient physical
activity
An 80%
availability of the
affordable basic
technologies and
essential
medicines, incl.
generics, required
to treat NCDs
A 25% relative
reduction in
prevalence of
raised blood
pressure or contain
the prevalence of
raised blood
pressure
At least 50% of
eligible people
receive drug
therapy and
counselling to
prevent heart
attacks and
strokes
Beirut workshop improved access
quality and use of medical devices
Medical Devices for cancer
Beirut workshop improved access
quality and use of medical devices
Medical devices used for cancer management
Prevention
Screening
diagnosis
PR
treatment
• HPV vaccines
• Contraceptive devices.
CL
• Clinical laboratory,
• Pathology
DI
•Diagnostic radiology
•Ultrasound
•Endoscopy
Monitoring
SE
RT
Palliative
care
• Surgery
• Chemotherapy
• Radiotherapy
• Palliative Care
PC
Beirut workshop improved access
quality and use of medical devices
Methodology
Health
conditions
• Neoplasms (breast, colorectal,
leukemia, lung, prostate)
Guidelines
• Systematic review, most updated
Interventions • Recommended procedures
Technologies
• Medical
devices
Level of Care • Allocation
Beirut workshop improved access
quality and use of medical devices
Timeline for
cancer model list of medical devices
Date
Activity
Outcome
October
Develop Terms of Reference,
Working Tools,
Review and Nomination of
Experts
Terms of Reference and List
of preliminary experts from
nominations
27 October-9
November
Establish contact with
participants
Experts groups
9 November11 December
WebEx conferences and
discussions with Experts Groups
List reviewed with outlined
comments,
constraints and draft of
document with Key and
contextual considerations
(Pyramid health systems)
January-March
2016
Review and complete,
Experts groups will review
Final document
Beirut workshop improved access
quality and use of medical devices
Expert Working Groups
•
•
•
•
•
Surgery
Imaging and Nuclear Medicine
Pathology and Laboratory
Radiotherapy
Palliative Care and Systemic therapy
Beirut workshop improved access
quality and use of medical devices
Expert Meetings
Experts Groups
Meetings
No Experts
Accept
Actively
Participating
Surgery
4
14
10
Nuclear Medicine
and Imaging
4
16
13
Radiotherapy
3
16
13
Systemic therapy
and Palliative
Care group
4
13
12
Pathology and
Laboratory
3
13
12
TOTAL
18
72
60
Beirut workshop improved access
quality and use of medical devices
Using Working Tools
Beirut workshop improved access
quality and use of medical devices
Defining basic interventions
Beirut workshop improved access
quality and use of medical devices
Function/InterventionSpecific Medical
Devices
Effectiveness*
Safety*
Patient
reported
outcomes
(PROs)
Therapeutic
benefit*
Multi-disease
Multi-cancer
Ease of use
Ease of
training
Remote
communities
(Telemedicine
)
Affordability
Affordability –
maintenance /
replacement
Positive
consequences
on healthcare
resource
utilization
Quality of
evidence
Working Tool 3 to select the
technologies
External beam radiation therapy
XXX
XX
XXX
XXX
X
XXX
XX
XX
NA
XX
X
XX
XXX
High-dose-rate (HDR) brachytherapy
XXX
XX
XXX
XXX
NA
XX
XX
XX
NA
XXX
XX
XXX
XXX
Low-dose-rate (LDR) brachytherapy
Intersticial
XXX
XX
XXX
XXX
X
X
XX
XX
NA
X
XXX
XX
XXX
Low-dose-rate (LDR) brachytherapy
Intracavitary
XXX
XX
XXX
XXX
X
XX
XX
XXX
NA
XXX
XXX
XX
XXX
Value Criteria (see definitions and guidance for scoring in table above) Complete as applicable
Beirut workshop improved access
quality and use of medical devices
Other NCD
“ Kit for EMRO countries”
Beirut workshop improved access
quality and use of medical devices
NCDs
Devices
Blood pressure measurement device
Peak flow meter
Spacers for inhalers
Glucometer
Pulse oximeter
Oxygen concentrator
Glucometer
Urine protein and ketones strips
Troponin tests
Electrocardiograph
Beirut workshop improved access
quality and use of medical devices
Future activities to be done , requires
more funding and commitment
• Implementation mechanisms mentioned
as a guidance, prioritization
• Further develop technical specifications.
• Quantification and Indicators on Medical
Devices
• Link this project with Human resources
• Funding and activities to continue this
project until implemented in countries
Beirut workshop improved access
quality and use of medical devices
Neonatal Resuscitation Devices
UNCLSC
Beirut workshop improved access
quality and use of medical devices
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
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• Multi-use suction bulb that can be
opened, cleaned and sterilized
• Training mannequin/simulator for
neonatal resuscitation
• Infant stethoscope
Tools for country
assessment v1
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Neonatal Resuscitation Devices.
Technical Specifications Dec 2015.
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Compendium of innovative
Technologies
Assistive Devices, E-health
Medical Devices, Technologies for outbreaks.
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2011-2013 Compendium
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IPC Meeting, WHO, Geneva, Switzerland
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Technical Specifications
Beirut workshop improved access
quality and use of medical devices
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
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https://unwebbuy.org/
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
2638User
| 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
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
Medical Devices Technical Series
 For 2014-2015:
– Regulations
( pre-market, postmarket)
– Human resources
– Global Atlas of MD
For 2016
- Decommissioning
- Safe use of Medical
Devices
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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
48 |
IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
+
Country survey , 2013 data:
Next steps…
– Use / disseminate the tools available
– INNOVATE: DEVELOP IT SOLUTIONS EASY TO USE TO
have available information to USE.
• To have on line catalogues, reference information
• To have IT / mhealth systems to measure access, availability, counterfeit
– Harmonize the format of the technical specifications?
– Nomenclature work?
– Participate in the pricing survey?
– To select better innovative technologies?
– Participate in the next books:
• Decommissioning of medical devices
• Safe use of medical devices.
50 |
IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
WHO Medical Devices
Publications (2008-2014)
Country
Publications
WHO Regions
51 |
IPC Meeting, WHO, Geneva, Switzerland
6th June 2014
Thank you !
www.who.int/medical devices
velazquezberumena@who.int
Medical_devices@who.int
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IPC Meeting, WHO, Geneva, Switzerland
6th June 2014