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 WHO Regional representatives as required

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

GMDN – Members by Country 2009

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 – 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.

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 mark.wasmuth@gmdnagency.org