Updates on Inter-agency work on Medical Devices IPC Meeting, WHO Geneva 6 th June 2014

Updates on Inter-agency work on Medical Devices

IPC Meeting, WHO Geneva6th June 2014

IPC Meeting, WHO, Geneva, Switzerland6th June 20142 |

Medical devicesMedical 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.


BackgroundBackground

2011

2008

2010



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 transfusion• Safe Surgery• Diagnostic and Laboratory• Reproductive Health• Maternal Health• Neonatal Health• Waste management• STI’s• Infertility• Cancer

Meetings held– June 2012- Copenhagen– August 2012-Geneva– November 2012- Geneva– February 2013- Copenhagen– January 2014- Copenhagen

Interagency list of medical devices for reproductive, maternal, newborn and child health

Interagency list of medical devices for reproductive, maternal, newborn and child health


Copenhagen, Denmark. June 27th-29th 2012Copenhagen, 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

World Health Organization (WHO)

– 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

United Nations Children’s Fund (UNICEF)

– 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

FIRST MEETING


Geneva, Switzerland. August 6th-7th 2012.Geneva, Switzerland. August 6th-7th 2012.


– Ms Isabel Lucas Manzano, Technical Consultant

– Ms Wilma Doedens, Technical Adviser, Humanitarian

Response Unit


– 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

– 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


– Ms Monique Supiot, Technical Officer, Health

Technology Centre, UNICEF Supply Division

SECOND MEETING



– Ms Isabel Lucas Manzano, Technical Consultant– Ms Wilma Doedens, Technical Adviser, Humanitarian Response Unit


– Ms Clara Aranda, Technical Consultant– Ms Monique Supiot, Technical Officer, Health Technology Centre, UNICEF

Supply Division


– Ms Adriana Velazquez Berumen, Coordinator, Diagnostic Imaging and Medical Devices, Essential Medicines and Health Products

– 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

Geneva, Switzerland. November 12-14th 2012.THIRD MEETING


MethodologyMethodology

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)


Interventions were reviewed according to evidence-based guidelines from WHO and with specialists.



Health Care Facilities consideredHealth Care Facilities considered

Health Post

Health Center

District Hospital Referral Specialized Hospital



InterventionsInterventions

Medical DevicesMedical Devices

FAMILY PLANNING TEMPLATEFAMILY PLANNING TEMPLATE


Interventions for NewbornInterventions for Newborn


Medical DevicesMedical Devices


Special notesSpecial 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• 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


Groups of medical devicesGroups 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


Interagency list of medical devices for reproductive, maternal, newborn and child health , June 2014

Interagency list of medical devices for reproductive, maternal, newborn and child health , June 2014

To come


UN Commission on life saving commodities

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


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 Commodities

List of medical devices for UN Commission on Life Saving Commodities


Dosage for NeonatesDosage for Neonates


Tools for country assessment v1

Tools for country assessment v1


Technical specifications by UN agencies, can harmonization be possible?

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 requested







https://unwebbut.org/




Other sources of technical specificationsOther sources of technical specifications

NGO’s, countries…


1. Medical Device Specification

2. Name and Coding

3. General

4. Technical1. Technical Characteristics

2. Physical Characteristics

3. Energy Source

4. Accessories, Spare Parts, Consumables

5. Bidding / Procurement Terms / Donation Requirements1. Environmental and Departmental Considerations

2. Standards and Safety

3. Training and Installation

4. Warranty and Maintenance

5. Documentation

Technical Specifications


Example of Female Condom(1)Example of Female Condom(1)

6 WHO Category

7 Generic name Female condom

8Specific type or variations

9 GMDN name Female condom, Hevea-latex and Female condom, non latex

10 GMDN code(s)4772147722.

11 GMDN category10 Single-use devices11 Assistive products for persons with disability

12 UMDNS name Condoms, Female

13 UMDNS code 18079

14 UNSPS code 53131622

15 Alternative name(s)

ContraceptiveFemidomCondomsCondoms, femalePouch, intravaginalProphylactic

16 Alternative code(s)

MS 35772, 206402008MS 43386MS 10985, 10985MS 18079, 18079MS 34045, MBUMS 44542, 289906000

NAME, CATEGORY AND CODING

17 KeywordsContraceptive 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

NomenclatureGMDN, UMDNS, UNSPS

Which nomenclature to use?


Example of Female Condom(2) Example of Female Condom(2)

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

22Overview of functional requirements

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.

23 Risk Classification

Class C (GHTF Rule 17)Class Ⅱ b (EU)Class Ⅱ (Japan)Class Ⅲ (USA)

PURPOSE OF USE

24 Detailed requirementsFemale 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.

26 User adjustable settings Not applicable

TECHNICAL CHARACTERISTICS

Risk classificationIMDRF/GHTF (International Medical Device

Regulators Forum/ Global Harmonization Task Force) http://www.imdrf.org/


30Sterility status on delivery (if relevant)

N/A

31 Shelf life (if relevant)The claimed shelf life shall be not less than three years and not more than seven years subject to confirmation by appropriate stability data

32Transportation and storage (if relevant)

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.

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 two-digit 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.

33 Labelling (if relevant) N/A

34Context-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.

PACKAGING

ENVIRONMENTAL REQUIREMENTS

PackagingShelf life, transportation,

Labelling

Example of Female Condom(3)

Example of Female Condom(3)


Example of Female Condom(4)Example of Female Condom(4)

46 Risk Classification Class C (GHTF Rule 17), Class Ⅱ b (EU, Australia), Class Ⅱ (Japan, Canada), Class Ⅲ (USA)

47Regulatory Approval / Certification

FDA approval(USA); CE mark(EU)

48 International standards

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 devicesISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratoriesISO 2859-1:1999 Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspectionISO 10993–1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management processISO 10993–5: 2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicityISO 10993–10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitizationISO 11346:2004 Rubber, vulcanized or thermoplastic -- Estimation of life-time and maximum temperature of useISO 4074:2002 Natural latex rubber condoms -- Requirements and test methods Cor 1:2003 Cor 2:2008ISO 25841:2011 Female condoms -- Requirements and test methods

49Reginal / Local Standards

ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms (USA)

50 Regulations

US regulations21 CFR part 820; 21CFR Section 884.5330 (USA); EU regulationsCouncil Directive 93/42/EEC Directive 93/68/EEC (CE Marking)

STANDARDS AND SAFETY

Standards: e.g. Quality management systems(ISO13485), Standards for electric devices(IEC),Female condoms-- requirements and test methods(ISO25841)

Which standards to include?


WHO technical specifications of 70 medical devices including UNCLSC devices

WHO technical specifications of 70 medical devices including UNCLSC devices

1Abortion suction system

2Anaesthesia Ventilator

3Bilirubinometer

4Capillary patient thermometer

5Cardiovascular ultrasound

6CPAP unit

7Cryosurgical Unit

8Darkroom Automatic X-ray Film processor

9Daylight Automatic Xray Film Processor

10Diagnostic spirometer

11Electrocardiographic monitor

12Examination Treatment Light

13Floor Scale electronic

14Floor Scale mechanical

15Foetal cardiac monitor

16Foetal vacuum extraction

17General purpose Electrosurgical Diathermy

18General purpose Tabletop Centrifuge

19General purpose Ultrasound

20 Incubator Infant Stationary

21 Infant Resuscitation Table22 Infrared thermometer, ear23 Infrared thermometer, skin24 Intensive-care ventilator25Laboratory urine analyser IVD26Laboratory water bath27Laryngoscope28Manual Emergency Suction System29Microscope Light30Mobile basic diagnostic x-ray system, analogue31Mobile basic diagnostic x-ray system, digital32Mobile flouroscopic x-ray system, analogue33Mobile flouroscopic x-ray system, digital34Neonatal physiologic monitoring systems35Non-rechargeable professional semi-automated external defibrillator 36Obstetrical table, line-powered 37Obstetrical table, manual38Operating light (fixed) 39Ophthalmoscope, direct 40Otoscope, direct

41Overhead infant phototherapy unit 42Peak Flow Meter43Physiologic Monitoring System44Portable Ventilator Electric45PulseOximeter Line Powered46PulsoOximeter Battery Powered47Scale Patient Infant48Single Channel Electrocariograph49Sphygmomanometer

50Stationary Basic Diagnostic Xray System Analogue

51Stationary Basic Diagnostic Xray System Digital

52Stethoscope mechanical53Suction system54Syring Pump55Thermometer laboratory56Transport infant incubator

57Universal operating table electrohydraulic

58Universal operating table electromechanic

59Universal operating table hydraulic60Unwrapped steam sterilizer61Viewbox X-ray

62 Female condom63 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/needles66 Self-inflating neonatal resuscitation bag with masks for pre-term and term babies67 Suction catheter , length 50 cm, single use, conical tip, Fr# 868 Single use suction bulb69 Multi-use suction bulb that can be opened, cleaned and sterilized70 Training manikin/simulator for neonatal resuscitation


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.

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.

ConsiderationConsideration


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


WHO Global medical devices pricing survey 2014WHO 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


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 ,


Medical devices technical seriesMedical devices technical series


Books on medical devices for 2014-2015:

– Regulations

( pre-market, post-market)– Safe use of

medical devices– Human resources – Decommissioning


Image of the linkage with data sourcesImage of the linkage with data sources


WHO medical devices information system (MEDEVIS)the development in 2014WHO medical devices information system (MEDEVIS)the development in 2014

Medical device information

Procedural use of medical devicesAreas 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..


Structure of MEDEVIS web tool as per WHA60.29

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


2010 call for innovative technologies that address global health concerns: outcomes2010 call for innovative technologies that

address global health concerns: outcomes


2011-2013 Compendium2011-2013 Compendium



Pneumonia: UNICEF and WHO

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.

+Novel Diagnostic Tools for Childhood Pneumonia

Prevention Diagnosis Treatment

Pneumococcal vaccination

Other vaccines

Access to antibioticsVitamin A

MalariaPneumonia

Other infections

Bacterial PneumoniaViral Pneumonia

Respiratory Rate

Oxygen Saturation Fever

BIOMARKERS: PCT, CRP, Lpc-2, Heptoglobin…

Cra

ckles

Ch

est

X-r

ay

Treatment


Treatment


TreatmentAntibiotic Resistance

Tachycardia

Wh

eezin

g

+Country survey , 2013 data:


Country survey on Medical devices. Update 2013.

Country survey on Medical devices. Update 2013.


Approved medical devices for national procurement or reimbursement

Approved medical devices for national procurement or reimbursement


Lists of devices per facility or clinical procedureLists of devices per facility or clinical procedure

Examples:

Per hospital

Per health center

Per area of care:– ICU– Surgery

Per disease– H1N1– HIV– Vaccines


WHO Regions

Country Publications

WHO Medical Devices Publications (2008-2014)


Next steps…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.


Thank you !Thank you !

www.who.int/medical devices

[email protected]

[email protected]

http://www.who.int/medical

mailto:[email protected]

mailto:[email protected]

Documents

Updates on Inter-agency work on Medical Devices IPC Meeting, WHO Geneva 6 th June 2014