1. GMDN Global Medical Device Nomenclature
Mark Wasmuth
Secretary General
GMDN Agency

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

3. 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

4. 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

5. GMDN Source Nomenclature
Baseline data was adopted in agreement from existing nomenclatures:
ECRI - UMDNS
FDA - CDRH
ISO 9999
EDMA
MHLW - JFMDA
NKKN

6. 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)

7. 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

8. GMDN Agency – Governance
Board of Trustees
GHTF
AHWP
Industry and Regulators
Policy Advisory Group
WHO
Regional representatives as required

9. GMDN Categories (Scope)
Active implantable devices
Anaesthetic and respiratory devices
Dental devices
Electro mechanical medical devices
Hospital hardware
In vitro diagnostic devices
Non-active implantable devices
Ophthalmic and optical devices
Reusable devices
Single-use devices
Assistive products for persons with disability
Diagnostic and therapeutic radiation devices
Complementary therapy devices
Biologically-derived devices
Healthcare facility products and adaptations
Laboratory equipment

10. GMDN – Members by Country 2009

11. 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

12. 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.”

13. 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.

14. 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

15. 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”

16. GMDN – Preferred Term Structure
Term Name
Code
Definition
Non-evacuated blood collection tube IVD, EDTA
57900
A non-evacuated sterile glass or plastic tube, sealed with a stopper, containing the anticoagulant ethylene diamine tetra acetic acid (EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.

17. 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

18. GMDN – Collective Term Structure

19. Using GMDN (website access)

20. Using GMDN (searching for terms)

21. Using GMDN (selecting the term)

22. Using GMDN (multi-lingual display)

23. 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

24. Thank you for listening