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GMDN Global Medical Device Nomenclature

Mark WasmuthSecretary GeneralGMDN Agency

Contents

Background to GMDN Development of GMDN Scope of GMDN Who uses GMDN GMDN Data Structure Using GMDN on-line Database

Role of Global Nomenclature

Single nomenclature for the GHTF Regulatory Model

Provide Generic Terms with Definitions For efficient exchange of information

between Manufacturers, Regulators and Healthcare Providers

Analysis of data to support patient safety Support UDI

Nomenclature – Pre 1993

No Consistency in Regulation (pre 1990) Europe, USA, Canada, Japan, Australia and many

other parts of the world have little or no established regulations

Result = Initiative to investigate global procedures Conference In Brussels (Autumn 1991)

To explore existing MD nomenclatures Result = No conclusion!

First Formal Meeting of GHTF in Tokyo (1993) To establish a consistent approach to GMP, by using

international standards for Quality Systems Identified the need for a new Global Nomenclature

GMDN Source Nomenclature

Baseline data was adopted in agreement from existing nomenclatures:

ECRI - UMDNS FDA - CDRH ISO 9999 EDMA MHLW - JFMDA NKKN

GMDN Development 1993 – 2011

International Standard structure Resulted in ISO 15225:2000 Updated as ISO 15225:2010

Development to date: Establishment of GMDN Agency (2005) 18,933 Preferred Terms 1,980 Collective Terms (Device Attributes) 16 Categories (Scope) Web-based access to GMDN Members Translation (ongoing)

Translation of GMDN for world access

English (Reference) Japanese Russian Chinese (Mandarin) 20 EU Languages, including:

French German Italian Portuguese Spanish

Just started - Turkish, Serbo-Croat

GMDN Agency – Governance

Board of Trustees GHTF AHWP Industry and Regulators

Policy Advisory Group GHTF AHWP WHO Regional representatives as required

GMDN Categories (Scope)

1. Active implantable devices2. Anaesthetic and respiratory devices3. Dental devices4. Electro mechanical medical devices5. Hospital hardware6. In vitro diagnostic devices7. Non-active implantable devices8. Ophthalmic and optical devices9. Reusable devices10. Single-use devices11. Assistive products for persons with disability12. Diagnostic and therapeutic radiation devices13. Complementary therapy devices14. Biologically-derived devices15. Healthcare facility products and adaptations16. Laboratory equipment

GMDN – Members by Country 2009

Manufacturer by Country / Value EUR

35%

12%10%

USA

UK

Germany

Switzerland

France

Italy

Japan

Denmark

Belgium

Netherlands

Australia

Norway

Ireland

Sweden

Korea South

Canada

China

Other

Who regulates use of GMDN today?

Australia Japan Italy Greece Poland Turkey

Czech Republic Croatia Peru Mozambique Spain

Other countries will mandate use of GMDN during their own time plan

GHTF support for GMDN

Position Statement: Single Global Nomenclature System for Medical Devices (19th November 2010)

“…The GHTF therefore endorses the GMDN coding system as the preferred nomenclature system for regulatory purposes for medical devices and will continue to work to ensure its effective governance and availability.”

FDA support for GMDN

UDI Conference, Baltimore, 1 December 2010

FDA proposes to use GMDN as part of the ‘minimum data set’ for their UDI Database.

European Commission support for GMDN

European databank for medical devices (EUDAMED)

“An important tool for Eudamed is the Global Medical Device Nomenclature (GMDN)…GMDN presents the best practice for Eudamed purposes”

GMDN is referenced in COMMISSION DECISION of 19 April 2010 on EUDAMED

EUCOMED Support for GMDN

European Medical Technology Industry Association (EUCOMED)

“To ensure consistency of data, Eucomed recommends using the GMDN nomenclature as the ‘internationally recognised nomenclature”

GMDN Data Structure

GMDN is a poly-hierarchical system Preferred Terms are flat and linked to

Collective Terms (device attributes and high-level terms) which are used to create poly-hierarchies

Collective Terms allow searches by subject group

CTs allow analysis of the GMDN by product attribute or feature

GMDN – Collective Term Structure

Using GMDN (website access)

Using GMDN (searching for terms)

Using GMDN (selecting the term)

Using GMDN (multi-lingual display)

Summary

Endorsed by regulators and supported by manufacturers

Being used by more Regulators, Manufacturers and Hospitals each month

Has the necessary detail and tools to meet all Stakeholder needs

Database is updated daily following Manufacturer requests for new terms and users are automatically informed of any changes

Thank you for listening

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