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Updates on Inter-agency work on Medical Devices Updates on Inter-agency work on Medical Devices

Updates on Inter-agency work on Medical Devices - PowerPoint Presentation

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Updates on Inter-agency work on Medical Devices - PPT Presentation

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

health medical technical devices medical health devices technical unicef officer supply medicines diagnostic essential unit pneumonia care specifications suction

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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

2010Slide4
Slide5

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.Slide11
Slide12

Health Care Facilities

considered

Health Post

Health

Center

District

Hospital

Referral

Specialized

HospitalSlide13
Slide14

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 CompendiumSlide43
Slide44

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