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GMDN Global Medical Device Nomenclature

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.

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GMDN Global Medical Device Nomenclature

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  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 • GHTF • AHWP • 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. Australia Japan Italy Greece Poland Turkey Czech Republic Croatia Peru Mozambique Spain Who regulates use of GMDN today? • 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 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

  17. GMDN – Collective Term Structure

  18. Using GMDN (website access)

  19. Using GMDN (searching for terms)

  20. Using GMDN (selecting the term)

  21. Using GMDN (multi-lingual display)

  22. 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

  23. Thank you for listening mark.wasmuth@gmdnagency.org

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