IPC Meeting WHO Geneva 6 th 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 ID: 463121
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Slide1
Updates on Inter-agency work on Medical Devices
IPC
Meeting, WHO Geneva
6
th
June 2014Slide2
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.
Slide3
Background
2011
2008
2010Slide4Slide5
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:Injection Safety
Blood transfusionSafe SurgeryDiagnostic and LaboratoryReproductive Health
Maternal HealthNeonatal
HealthWaste management
STI’sInfertilityCancer
Meetings
held
June 2012-
CopenhagenAugust 2012-GenevaNovember 2012- GenevaFebruary 2013- CopenhagenJanuary 2014- Copenhagen
Interagency list of medical devices for reproductive, maternal, newborn and child healthSlide6
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 BranchMs Wilma Doedens, Technical Adviser, Humanitarian Response Unit Ms Agnes Chidanyika, Technical Specialist
Ms Isabel Lucas Manzano, Technical Consultant World Health Organization (WHO)Ms Adriana Velazquez Berumen, Coordinator of Medical Devices Unit, Essential Medicines and Health Products DepartmentMs Åsa Cuzin-Kihl, Department of Reproductive Health and Research; Research Capacity, Policy and Programme Strengthening
Dr Metin Gulmezoglu, Department of Reproductive Health and
ResearchMs Lisa Hedman, Essential Medicines and Health
Products
United
Nations Children’s Fund (UNICEF)
Dr Hanne
Bak Pedersen, Deputy Director, UNICEF Supply DivisionDr Kim Eva Dickson, Senior Adviser (Maternal and Newborn Health), Health Section UNICEF HQDr Helene Moller, Chief, Health Technology Centre, UNICEF Supply Division
Mr Francisco Blanco, Chief, Medicines & Nutrition, UNICEF Supply DivisionMr Thomas Sorensen, Chief, Knowledge Management, UNICEF Supply DivisionMs Etleva Kadilli, Contracts Manager, Medical Unit, Health Technology Centre, UNICEF Supply
DivisionDr David Muhia, Contracts Manager, Medicines & Nutrition, UNICEF Supply DivisionMs Monique Supiot, Technical Officer, Health Technology Centre, UNICEF Supply Division
Mr Ludo Scheerlinck, Technical Officer, Medical Unit, Health Technology Centre, UNICEF Supply DivisionMr Henrik K. Nielsen, Technical Specialist, Medicines & Nutrition, UNICEF Supply DivisionMs Clara Aranda-Jan, Consultant, Medical Unit, Health Technology Centre, UNICEF Supply
DivisionFIRST MEETINGSlide7
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)Ms Adriana Velazquez Berumen, Coordinator of Medical Devices Unit, Essential Medicines and Health Products DepartmentMs Lisa
Hedman, Essential Medicines and Health ProductsMs Clara Aranda-Jan, Consultant, Medical Devices Unit, Essential Medicines and Health Products DepartmentMs Alicia de Hoyos Reyes, Intern, Medical Devices Unit,, Essential
Medicines and Health Products Department
Dr Viviana MANGIATERRA,
Scientist
Dr
Meena NATHAN
CHERIAN
,
Medical Officer, Clinical Procedures UnitMs Anita SANDS, Technical Officer, Diagnostic and Laboratory TechnologiesDr Selma KHAMASSI, Medical Officer, Clinical Procedures UnitDr
Neelam DHINGRA-KUMAR, Coordinator Health Policy, Development and ServicesMs María Mercedes PEREZ GONZALEZ, Technical
Officer, Diagnostic and Laboratory TechnologiesUnited Nations Children’s Fund (UNICEF) Ms Monique Supiot,
Technical Officer, Health Technology Centre, UNICEF Supply DivisionSECOND MEETINGSlide8
United Nations Population Fund (UNFPA)
Ms Isabel Lucas
Manzano
,
Technical Consultant
Ms Wilma Doedens, Technical Adviser, Humanitarian Response Unit
United Nations Children’s Fund (UNICEF)Ms Clara Aranda, Technical ConsultantMs Monique Supiot, Technical Officer, Health Technology Centre, UNICEF Supply DivisionWorld Health Organization (WHO
)Ms Adriana Velazquez Berumen, Coordinator, Diagnostic Imaging and Medical Devices, Essential Medicines and Health ProductsMs 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 ProgrammesDr 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 ServicesDr
Viviana Mangiaterra, Scientist, Research Capacity, Policy and Programme StrengtheningDr Meena Nathan Cherian, Medical Officer, Clinical Procedures Unit, Health Policy, Development and Services
Dr Severin Ritter Von Xylander, Medical Officer, Policy, Planning and ProgrammesMs Susan Wilburn
,
Technical Officer
,
Interventions for Healthy
Environments
Geneva,
Switzerland
.
November 12-14th 2012.
THIRD MEETINGSlide9
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
NewbornLevel of delivery of
intervention:Community level (
Includes Health Post)First
level (Includes Health Center)Referral level
(Includes District Hospital and
Referral
Hospital)Slide10
I
nterventions
were
reviewed according to evidence-based guidelines from WHO and with
specialists.Slide11Slide12
Health Care Facilities
considered
Health Post
Health
Center
District
Hospital
Referral
Specialized
HospitalSlide13Slide14
Interventions
Medical
Devices
FAMILY PLANNING TEMPLATESlide15
Interventions for
NewbornSlide16
Medical DevicesSlide17
Special notes
Part A. Special notes related to program
Safe blood and Clinical transfusion
Diagnostic tests & Laboratory
Injection safety
Surgery
and AnesthesiaDecontamination and sterilization at healthcare facilitiesHealth care waste managementPart B. Special notes related to medical devicesRegulations for medical devices
Health Technology ManagementLabel and instructions for use for medical devicesUnits and biomaterials used for medical devicesSurgical instruments stainless steel
Surgical suturesTextiles used for linen and clothing in healthcare facility
Slide18
Groups of medical devices
Groups of medical devices
Grouping of common medical equipment by
clinical area in health-care facility
Grouping of common surgical instruments by
surgical procedure
Grouping of medical device consumables by
size and capacitySlide19
Interagency list of medical devices for reproductive, maternal, newborn and child health , June 2014
To comeSlide20
UN Commission on life
saving
commoditiesSlide21
Reproductive health commodities
Resuscitation devices for newborn asphyxia
Female condom
Self-inflating neonatal resuscitation bag with masks
for pre-term(size 0) and term(size 1) babies
Injectable antibiotics for newborn sepsis
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
Multi-use suction bulb
that can be opened, cleaned and sterilized
Infant scale
less than 20 kg
Training mannequin/simulator
for neonatal resuscitation
Clinical thermometer,
non-mercury
Infant stethoscope
List of medical devices for
UN Commission on Life Saving CommoditiesSlide22
Dosage for NeonatesSlide23
Tools for country assessment v1Slide24
Technical specifications by UN agencies, can harmonization be possible?
UNICEF Supply catalogue
https://
supply.unicef.org
/
UNFPA
AccessRH
https://
myaccessrh.org
/
UNOPS
UN
Webbuy
https://
unwebbuy.org
/
WB has requestedSlide25
Other sources of technical specifications
NGO’s, countries…
Slide26
Medical Device Specification
Name and
Coding
General
Technical
Technical CharacteristicsPhysical Characteristics
Energy SourceAccessories, Spare Parts, ConsumablesBidding / Procurement Terms / Donation Requirements
Environmental and Departmental Considerations
Standards and SafetyTraining and Installation
Warranty and Maintenance
Documentation
Technical SpecificationsSlide27
Example of Female
Condom(1)
Nomenclature
GMDN, UMDNS, UNSPS
Which nomenclature to use? Slide28
Example of Female Condom(2)
Risk classification
IMDRF
/
GHTF
(International Medical Device Regulators Forum/ Global Harmonization Task Force) http://www.imdrf.org/Slide29
Packaging
Shelf life, transportation, Labelling
Example of Female Condom(3) Slide30
Example of Female
Condom(4)
Standards:
e.g. Quality management systems(ISO13485), Standards for electric devices(IEC),Female condoms-- requirements and test methods(ISO25841)
Which standards to include?Slide31
WHO technical specifications of
70 medical devices including UNCLSC devices
1
Abortion suction system
2
Anaesthesia Ventilator
3
Bilirubinometer4
Capillary patient thermometer
5
Cardiovascular ultrasound
6
CPAP unit
7
Cryosurgical Unit
8
Darkroom Automatic X-ray Film processor
9Daylight Automatic Xray Film Processor
10Diagnostic spirometer11
Electrocardiographic monitor12
Examination Treatment Light
13
Floor Scale electronic
14
Floor Scale mechanical
15
Foetal
cardiac monitor
16
Foetal vacuum extraction
17
General purpose Electrosurgical Diathermy
18
General purpose Tabletop Centrifuge
19
General purpose Ultrasound
20
Incubator Infant Stationary
21
Infant Resuscitation Table
22
Infrared thermometer, ear
23
Infrared thermometer, skin
24
Intensive-care ventilator
25
Laboratory urine
analyser
IVD
26
Laboratory water bath
27
Laryngoscope
28
Manual Emergency Suction System
29
Microscope Light
30
Mobile basic diagnostic x-ray system, analogue
31
Mobile basic diagnostic x-ray system, digital
32
Mobile flouroscopic x-ray system, analogue
33
Mobile flouroscopic x-ray system, digital
34
Neonatal physiologic monitoring systems
35
Non-rechargeable professional semi-automated external defibrillator
36
Obstetrical table, line-powered
37
Obstetrical table, manual
38
Operating light (fixed)
39
Ophthalmoscope, direct
40
Otoscope
, direct
41
Overhead infant phototherapy unit
42
Peak Flow Meter
43
Physiologic Monitoring System
44
Portable Ventilator Electric
45
PulseOximeter Line Powered
46
PulsoOximeter Battery Powered
47
Scale Patient Infant
48
Single Channel Electrocariograph
49
Sphygmomanometer
50
Stationary Basic Diagnostic Xray System Analogue
51
Stationary Basic Diagnostic Xray System Digital
52
Stethoscope mechanical
53
Suction system
54
Syring
Pump
55
Thermometer laboratory
56
Transport infant incubator
57
Universal operating table electrohydraulic
58
Universal operating table
electromechanic
59
Universal operating table hydraulic60Unwrapped steam sterilizer61Viewbox X-ray
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
resuscitationSlide32
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.
ConsiderationSlide33
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, 2010Slide34
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 surveySlide35
Safety and quality . Regulatory institutions
Innovation Universities
Medical devices industry
HOSPITAL SERVICES BIOMEDICAL ENGINEERING: SELECTION, USE , MAINTENANCE OF EQUIPMENT
HTA,
SELECTION OF PRIORITY MEDICAL DEVICES MEDICAL DEVICES FOR REIMBURSEMENT, FOR COVERAGE
, Slide36
Medical devices technical seriesSlide37
Books on medical devices for 2014-2015:
Regulations
( pre-market, post-market)
Safe use of medical devices
Human resources
Decommissioning Slide38
Image of the linkage with data sourcesSlide39
WHO medical devices information system (MEDEVIS)
the development in 2014
Medical
device
information
Procedural use
of medical devices
Areas
of
use
within
a
given
health
care
system
Clinical
information
linkage
Disease related to procedure
Clinical indication
Region/healthcare system
Type of facility
Group of healthcare section
Procedural information
Regulatory information
Procurement information
Assessment information
Device name
Description/Definition
Technical information
Picture
Economic
information
Global Atlas,
MDs by health care facilities…
Pricing survey,
Compendium,
Nomenclature….
Interagency list,
Other sources…
Technical specifications,
Other sources..Slide40
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 sourcesSlide41
2010 call for innovative technologies that address global health concerns: outcomesSlide42
2011-2013 CompendiumSlide43Slide44
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.Slide45
Novel Diagnostic Tools for Childhood Pneumonia
Prevention
Diagnosis
Treatment
Pneumococcal vaccination
Other vaccines
Access to antibiotics
Vitamin A
Malaria
Pneumonia
Other infections
Bacterial Pneumonia
Viral Pneumonia
Respiratory Rate
Oxygen Saturation
Fever
BIOMARKERS: PCT, CRP, Lpc-2, Heptoglobin…
Crackles
Chest
X-ray
Treatment
Access to antibiotics
Vitamin A
Treatment
Access to antibiotics
Vitamin A
Treatment
Antibiotic Resistance
Tachycardia
WheezingSlide46
Country survey , 2013 data:Slide47
Country survey on Medical devices. Update 2013. Slide48
Approved medical devices for national procurement or reimbursementSlide49
Lists of devices per facility or clinical procedure
Examples:
Per hospital
Per health center
Per area of care:
ICUSurgeryPer diseaseH1N1HIV
VaccinesSlide50
WHO Regions
Country
Publications
WHO Medical Devices
Publications
(
2008-2014)Slide51
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 devicesSafe use of medical devices.Slide52
Thank you !
www.who.int/medical
devices
velazquezberumena@who.int
Medical_devices@who.int