gmdn global medical device nomenclature mark wasmuth secretary general gmdn agency
TRANSCRIPT
GMDN Global Medical Device Nomenclature
Mark Wasmuth
Secretary General
GMDN 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
