H4+ Interagency List of Essential Medical Devices for Maternal and Newborn Health, and other medical devices projects.

December 11, 2012

Adriana Velazquez Berumen

Coordinator of medical Devices

Essential Medicines and Health Products

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Agenda medical devices (interagency aspects)

Agenda medical devices (interagency aspects)

� Medical devices definition

� UN commission and update of Interagency list of essential medical

devices for reproductive health

� Technical specifications

� Innovative medical devices

� Assessment and management of medical equipment

� Nomenclature issues

� Regulations

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Medical deviceMedical device

� An article, instrument, apparatus or machine that is used in

the prevention, diagnosis or treatment of illness or

disease, or for detecting, measuring , restoring, correcting

or modifying the structure or function of the body for some

health purpose.

� Typically the purpose of a medical device is not achieved

by pharmacological, immunological or metabolic

means.Reference to GHTF, 2005.

� Examples: syringes, intraocular lenses, ophthalmoscopes,

pacemakers, hip replacements, defibrillators, anesthesia

machine, scalpel, stents, iv lines,…x ray equipment

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Medical devices are indispensable for health car

XXI C. still many have no access to essentialsWe all can help, what will you do?

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Interagency work on reproductive, maternaand new born health

Interagency work on reproductive, maternaand new born health

� Maternal new born and child

– Interagency Lists of medical

devices and medicines for

PMNCH

– UN life saving commodities

• UNICEF, UNFPA, WHO, BMGF, PATH,

• Regulations,

• Delivery chain - procurement and safe

use

• Market shaping

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RMNCH Continuum of Care

Commodity Usage

Reproductive health Female Condoms Family planning/Contraception

Implants Family planning/Contraception

Emergency Contraception Family planning/Contraception

Maternal Health Oxytocin Post-Partum Hemorrhage

Misoprostol Post-Partum Hemorrhage

Magnesium sulfate Eclampsia and Severe Pre-Eclamsia/Toxemia of

PregnancyNewborn Health Injectable antibiotics Newborn Sepsis

Antenatal Corticosteroid

(ANCS)

Respiratory Distress Syndrome for preterm babies

Chlorhexidine Newborn Cord Care

Resuscitation Equipment Newborn AsphyxiaChild Health Amoxicillin Pneumonia

Oral Rehydration Salts (ORS) Diarrhea

Zinc Diarrhea

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20112008

2010

Interagency list of essential medical devices, medicines for reproductive health

Interagency list of essential medical devices, medicines for reproductive health

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Methodology and scopeMethodology and scope

� Life cycle and continuum of care of mother and newborn :– Family Planning– Pregnancy– Childbirth– Post-natal mother– Newborn ( 40 days)

� Level of care:– Community level (Includes Health Post)– First level (Includes Health Center)– Referral level (Includes District Hospital– and Referral Hospital)

� Guidelines,

� Interventions,

� Medical devices and medicines

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Health Care Facilities consideredHealth Care Facilities considered

Health Post Health Center

District Hospital Referral Specialized Hospita

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H4+ Interagency List of Essential Medical Devices forReproductive, Maternal and Newborn Health

H4+ Interagency List of Essential Medical Devices forReproductive, Maternal and Newborn Health

� Objective. Provide a

publication containing a list with

the essential interventions and

medical devices/medicines

related to them.

� Meetings held

– June 2012- Copenhagen

– August 2012- Geneva

– November 2012- Geneva

� UNFPA, UNICEF and WHO.

� 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

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Table of contents of new publicationTable of contents of new publication

� Background

– Introduction: Briefing of the H4+ partnership.

– Objectives of the Interagency List of Essential Medical Devices and Medicines

(ILEMDM) for Reproductive, Maternal and Newborn Health (RMNH)

– Definitions for the purpose of this book:

• Levels of Care/Levels of delivery of interventions

– Community level (health post)

– First level (health center)

– Referral level (specialized, regional, university)

»District hospital

»Referral hospital

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• Continuum of Reproductive Healthcare (Definitions)

– Family planning (contraceptive)

– Maternal (pregnancy, childbirth, postnatal)

– Newborn (up to 28 days)

• Medicines

– Essential Medicines List

– Vaccines

• Health Counseling, education and promotion

– Job aids

– Educational programs

– Methodology

• Review of referral books + WHO guidelines + work with specialist

• Selection of interventions

• Selection of essential devices

�

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� General considerations by health care facilities• Standard Precautions

• Infrastructure: Energy, Water, Medical Gases, Waste disposal

• Sterilization

• Basic equipment dotation by level of care

• Laboratory

• Clinical transfusion

• Surgical Sets

• Health Counseling by Continuum of Reproductive Healthcare

� FAMILY PLANNING:

– Medical devices

– Medicines

� PREGNANCY CARE

– Medical devices

– Medicines

� CHILD BIRTH

– Medical devices

– Medicines

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� POSTNATAL CARE

– Medical devices

– Medicines

� NEWBORN CARE

– Medical devices

– Medicines

� Special notes

– First part: (Special notes related to program)

• Safe blood and Clinical transfusion

• Diagnostic tests & Laboratory

• Core infection prevention and control interventions for health-care facilities

• Injection safety

• Surgery and Anesthesia

• Disinfection and sterilization at healthcare facilities

• Health care waste management

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– Second part: (Special notes related to medical devices)

• Medical devices regulations

• 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

� Guidance for supply quantification for procurement

– For supply

– In case of emergency

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Interventions were reviewed according to evidence-based

guidelines from WHO and with specialists.

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InterventionsInterventions

Medical DevicesMedical Devices

FAMILY PLANNING TEMPLATEFAMILY PLANNING TEMPLATE

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Interventions during PregnancyInterventions during Pregnancy

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Interventions for ChildbirthInterventions for Childbirth

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The commodities were selected according to the Master List

of UNICEF and some additions and modifications have been

done.

For example, the addition of the colposcope and the

inclusion of the specifications for the items.

Also for the nomenclature of the commodities, the GMDN

categorization and coding was used.

For medicines the EML definitions are used.

The commodities were selected according to the Master List

of UNICEF and some additions and modifications have been

done.

For example, the addition of the colposcope and the

inclusion of the specifications for the items.

Also for the nomenclature of the commodities, the GMDN

categorization and coding was used.

For medicines the EML definitions are used.

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Medical DevicesMedical Devices

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A crossmatch was needed for each of the interventions and the devices which are needed to perform them, according to the levelof care of the health facility.

Pregnancy

Inte

rve

ntio

n 1

Inte

rve

ntio

n 2

C F D R C F D R

Equip 1 Code 1 X X X X

Equip 2 Code 2 X X X

Equip 3 Code 3 X X X X

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Family PlanningFamily Planning

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Post-natalPost-natal

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Special notesSpecial notes

– First part: (Special notes related to program)

• Safe blood and Clinical transfusion

• Diagnostic tests & Laboratory

• Core infection prevention and control interventions for health-care facilities

• Injection safety

• Surgery (or surgical environment?) and Anaesthesia

• Disinfection and sterilization at healthcare facilities

• Health care waste management

– Second part: (Special notes related to medical devices)

• Medical devices regulations

• 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

Some special sections were identified as key complementary services and added in each of the life cycle periods.

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Special note on label and instructions for use of medical devices

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timelinetimeline

� December 2012

– Conclude medical devices revision by intervention

– Send template to “medicines” specialists to fill template

– Include the “special notes” for medicines

– Ensemble the “book” and give data to data base developers

– Include information on technical specifications based in UNICEF,

UNFPA and WHO catalogue, Add pictures as required database

� January… March 2013

– Have a first draft book through GRC, and publication clearance

– Review the database and applications

• Website, excel, access, ipad, mobile,,, etc

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Work discussed with WB then UNICEF and UNFPAWork discussed with WB then UNICEF and UNFPAWork discussed with WB then UNICEF and UNFPAWork discussed with WB then UNICEF and UNFPA

Technical Technical Technical Technical Specifications Specifications Specifications Specifications

for medical devices: part for medical devices: part for medical devices: part for medical devices: part

1111, medical equipment, medical equipment, medical equipment, medical equipment

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Approved medical devices for national procurement or reimbursement

Approved medical devices for national procurement or reimbursement

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1. Medical Device Specification

2. Name and Coding

3. General

4. Technical1. Technical Characteristics2. Physical Characteristics3. Energy Source4. Accessories, Spare Parts, Consumables

5. Bidding / Procurement Terms / Donation Requirements1. Environmental and Departmental Considerations2. Standards and Safety3. Training and Installation4. Warranty and Maintenance5. Documentation

Technical SpecificationsTechnical SpecificationsTechnical SpecificationsTechnical Specifications

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Name and coding

General use

1

1.1 Clinical purpose To treat precancerous cervical lesions

1.2Used by clinical

department/ward

Gynaecology clinics, outpatient clinics

1.3 Level of institution District hospital, provincial hospital, specialized hospital, specialized clinics

1.4Overview of functional

requirements

Hand held unit with probe capable of achieving a probe tip temperature of at least -20°C that can be applied to the

lesion on the cervix to freeze the lesion

USE

GENERAL

GMDN name Cryosurgical units, general purpose

GMDN code(s) 11067

GMDN category 04 Electro mechanical medical devices

UMDNS name Cryosurgical units, general purpose, Cryotherapy units

UMDNS code 11-067, 18-051

UNSPS code (note: code 42151615 applies to dental cryosurgical units

Alternative name(s) Cryosurgery unit/equipment, Cryotherapy unit/equipment

Alternative code(s) N/A

Keywords Cryosurgery, cryotherapy

GMDN definition An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g.,

liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction

and removal. The system typically includes a mechanical regulator to control the flow of cryogen,

contained in an attached cylinder, and the probe(s) to apply the cold. The system is typically used

NAME AND CODING

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9.1 Warranty Typical product lifetime (years): 10

9.2 Maintenance tasks technicians, engineers, medical staff, manufacturer/service staff. Any maintenance of the gas supply

9.3Service contract clauses,

including prices

WARRANTY AND MAINTENANCE

Documentation10

10.1Operating manuals, service

manuals, other manuals

Manufacturer's documentation on installation, operation, trouble-shooting, maintenance, advanced maintenance

tasks

User, technical and maintenance manuals to be supplied in English or specified language. List to be provided of

equipment and procedures required for local and routine maintenance

10.2Other accompanying

documents

N/A

10.3Recommendations for

maintenance

DOCUMENTATION

Warranty and maintenance

11

11.1 Other information Contact details of manufacturer, supplier and local service agent to be provided.

11.2Recommendations or

warnings

NOTES

Notes

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Intensive-care ventilatorIntensive-care ventilator

� NAME AND CODING

GMDN name Intensive-care ventilator, adult/infant

GMDN code(s) 42411

GMDN category 02 Anaesthetic and respiratory devices , 11 Assistive products for persons with disability

UMDNS name Ventilators, Intensive Care

UMDNS code 17-429

UNSPS code

Alternative name(s)

Alternative code(s)

Keywords

GMDN definition A mains electricity (AC-powered) automatic cycling device used to provide long-term alveolar ventilation support for

infant (neonatal/paediatric) to adult patients in critical care settings; most use positive pressure to deliver gas to the

lungs at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy. It typically

consists of a breathing circuit, a control system, monitors, and alarms. The gas is typically delivered via an

inhalation limb with sites where it may be heated/humidified; an exhalation limb includes an exhaust valve to

release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient

triggered).

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Electrocardiographic monitorElectrocardiographic monitor

� General

1

1.1 Clinical purpose Continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors

attached to the patient

1.2Used by clinical

department/ward

1.3 Level of institution Health centre, district hospital, provincial hospital, specialized hospital

1.4Overview of functional

requirements

Continuous display of patient ECG and heart rate on screen

Allows display of single, 3 lead ECG or simultaneous display of at least 3 waves selected from up to 12 points

Operator can set audiovisual alarm levels for low or high heart rate

Operates from mains voltage or from internal rechargeable battery

Patient connectors that are sterilisable and reusable are preferred, though reusable cables that attach to

disposable connection patches are also acceptable

Hard copy printout of traces will not be required

USE

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Suction systemSuction system

� BIDDING / PROCUREMENT TERMS / DONATION

REQUIREMENTS10

10.1Operating manuals, service

manuals, other manuals

User, technical and maintenance manuals to be supplied in ************** language.

List to be provided of equipment and procedures required for local calibration and routine maintenance

10.2Other accompanying

documents

List to be provided of important spares and accessories, with their part numbers and cost. Certificate of calibration

and inspection to be provided.

10.3Recommendations for

maintenance

10.4 Others

11

11.1 Other information Contact details of manufacturer, supplier and local service agent to be provided

11.2Recommendations or

warnings

DOCUMENTATION

NOTES

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Future steps in technical specificationsFuture steps in technical specifications

� Provide them to industry to verify no specific to one vendor

� Upload in WHO website and other UN organizations

� The ones from UNICEF integrate in same template and

add to the database of the interagency list

� On going work ,continuous collaboration with NGO,

proffessional organizations, CC, MoH units of technology

and the industry.

From innovation to regulations,

assessment and management

Medical devices

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Research and development based on needs

Health

Technology

Assessment

Regulations :

Medical devices

Registration and

premarket approval

Needs

Assessments/

Selection

User

training

and clinical

effectivene

ss

Decommissioning

, Replacement

Installation,

Inventories;

CMMS,

Maintenance

Post market surveillance and Adverse event

reporting

Policies/ plans and human resources ( Biomedical Engineers)

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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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To achieve universal coverage, in the medical devices arena:

To achieve universal coverage, in the medical devices arena:

Regulations

Management

Assessment

Research and innovat

ion

IMDRF, GHTF,

Clinical Engineering:Selection, incorporation, AccessSafe useIFMBE

HTAi Evaluations, CE, priority setting

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Medical devicestechnical seriesMedical devicestechnical series

to ensure improved access,

quality and use of medical

devices:

Policies

Innovations R&D

Regulations

– HTR

Assessment

– HTA

Management:

– Clinical engineering

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Innovation: Scoping study on local production of medical devices

Innovation: Scoping study on local production of medical devices

� Overview of the medical device production in low-resource settings.

– Global medical devices market, Innovation of medical devices, Research and development for medical devices, Technology transfer and intellectual property, Governance and regulation, etc.

� Country case studies phase I:

– Brazil¦ Americas Region

– China¦ Western Pacific Region

– Ethiopia¦ Africa Region

– India¦ South-East Asia Region

– Jordan¦Eastern Mediterranean Region

� Country cases phase II: – Ethiopia, Nigeria, South Africa, Tanzania

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Innovation: Medical devices and ehealth solutionscompendium (60)

Innovation: Medical devices and ehealth solutionscompendium (60)

Future: Innovative tech with UNICEF: Pneumonia

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Status of Nomenclature Systems in 144 MSStatus of Nomenclature Systems in 144 MS

68

11 15

16

14

1

4

1

4

10

65

none

other

only UMDNS

only GMDN

only nationally developed

UMDNS + GMDN + nationallydeveloped

UMDNS + GMDN

UMDNS + nationally developed

GMDN + nationally developed

no info

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Clinical Engineering, health technology managementClinical Engineering, health technology management

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Medical device technical seriesMedical device technical series

� The first eight books were published in May 2011:– Development of medical device policies,

– Health technology assessment of medical devices,

– Needs assessment for medical devices,

– Procurement process resource guide,

– Medical device donations

– Introduction to medical equipment inventory management,

– Medical equipment maintenance programme overview,

– Computerized maintenance management system

� Currently working on : and would like to have interagency documents!!

• Human resources for MDs

• Decommissioning of MDs

• Regulation of MDs

• Safe use of MDs

• Measuring clinical effectiveness of MDs

• Innovation for MDs

• Nomenclature for MDs

• Regulation of MDs

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Lack of awareness of The hidden costs of medical devices… (

iceberg).

Lack of awareness of The hidden costs of medical devices… (

iceberg).

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Knowledge management: Documents available in

medical devices website and EMP library

WHO Regions

Country PublicationsWHO Medical Devices Reports (2008-2011)

Regulations of medical devices

Needs!!!

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Barriers faced in commercializing/selling medical devices

Barriers faced in commercializing/selling medical devices

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Regulations for medical devicesRegulations for medical devices

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From GHTF to IMDRF to global harmonization

From GHTF to IMDRF to global harmonization

� GHTF: (1992- 2012) last session Japan November .

� Other harmonization groups, like AHWP. ( Asian H. Work P)

� IMDRF: 2012: Singapore February, September Australia. Members

– Australia

– Brazil

– Canada

– China

– Japan

– Europe

– United States

– Observers: WHO, AHWP, APEC,

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International Medical Devices Regulators Forum, 2012 tasks:

International Medical Devices Regulators Forum, 2012 tasks:

� Regulated Product Submission

� Review of NCAR ( Adverse reporting) system.

� Implementation of UDI ( unique device identifier) system,

� Medical Devices Single Audit Program

� International standards recognized by IMDRF

Management Committee Members

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Most important Challenges on medical devices

Most important Challenges on medical devices

To have a global nomenclature that we can use for medical devices

across all stakeholders: UN family, and Member states, regulators, and

industry.

To support regulatory process SPECIFIC for medical devices being

implemented in member states.

To support health technology management: from needs assessment,

selection, procurement, inventories, maintenance and safe use, as well as

logistics as core business.

To support biomedical engineers as the responsible human resource for

development, regulation and management of medical devices globally.

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Thank you!Looking forward to working with all of

you !

www.who.int/medical devices