UDI and the GMDN (Global Medical Device Nomenclature)

1. UDI and the GMDN (Global Medical Device Nomenclature) Mark Wasmuth Secretary General GMDN Agency

2. Contents • Background to GMDN & GHTF • Development of GMDN Codes • Scope of GMDN • Who uses GMDN and why • GMDN Data Structure • Using GMDN Database • GMDN and UDI

3. Need for Harmonisation • Provide consistent application of regulatory principles and approaches • Improves regulatory system efficiency and effectiveness • Reduces duplication • Rationalise time and cost • Allow new product / technology to enter market place • Create transparency • Regulatory programmes are expected to: • Use available international standards • Proactively influence their development • Consult with stakeholders

4. Global Harmonisation Task Force • Voluntary group established in 1992 • Founding Members: USA, EU, Canada, Australia, Japan • Partnership between regulators and industry • Liaison with: • Asia Harmonisation Working Party (AHWP) • World Health Organisation (WHO) • Pan American Health Organisation (PAHO) • International Standards Organisation (ISO)

5. GHTF Purpose • Encourage Regulatory Convergence • Promote innovation • Facilitate Trade • Information exchange forum • Study Groups established • More at www.ghtf.org

6. Role of Global Nomenclature • Global Medical Device Nomenclature • Single nomenclature for GHTF regulatory Model • Provides Generic terms with definitions • For efficient exchange of information between regulators and others • Analysis of data supports patient safety

7. 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 as a basis ISO 9001 as the reference for regulations, introducing the use of Quality Systems • Need for Global Nomenclature identified

8. GMDN Source Nomenclature Baseline data was adopted from established Nomenclature: • ECRI - UMDNS • FDA - Procodes • ISO 9999 • EDMA • JFMDA • NKKN

9. GMDN Development 1993 – 2011 • International Standard structure • Resulted in ISO 15225:2000 • Updated as ISO 15225:2010 • Development to date: • 18,933 Preferred Terms • 1,980 Collective Terms (Device Attributes) • 16 Categories (Scope) • Translation to 23 languages (ongoing) • Web-based access

10. 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

11. Use of GMDN • The GMDN is requested by the Medical Device Regulator when products are registered in a country • The introduction of UDI has required us to standardise on GMDN • The GMDN is also being used by hospitals to reference their inventory • Governments use GMDN to analyse the expenditure on Medical Devices • The EU is implementing a data exchange system (EUDAMED) that collects information on Medical Device failures

12. EUDAMED • European commission commenced development of European Database for Medical devices (EUDAMED) to establish reporting link between all European Union regulatory bodies + EFTA countries. • EUDAMED is an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission and the Competent Authorities in the European Union Member States. • More information on EC website

13. Adoption of Nomenclature • The following countries require the use of GMDN for product registration (known about): • Australia • Japan (local variant) • Italy • Greece • Poland • Czech Republic • Turkey • Croatia • Peru • Mozambique • Other countries are planning or in the process of adopting, so we are in a transition period!

14. GMDN – Members by Country 2009

15. 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 ethylenediaminetetraacetic 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 – Preferred Term Structure

16. GMDN Structure • GMDN is a polyhierarchical system • Preferred Terms are flat and linked to Collective Terms (device attributes and high-level terms) which are used to create polyhierarchies • 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. GMDN and UDI • GHTF (following the lead by FDA) are preparing guidance on UDI and UDI Databases (Master Data) • The GMDN is the chosen nomenclature • Part of the Master Data (not on the label) • The challenge for manufacturers: • Get your Master Data in order • Manage your UDI and GMDN Codes (ongoing) • Publish the data (where needed)

23. GMDN and UDI Relationship Device Type = UDI Generic Device Group = GMDN Hudson Hudson 1234567890 1234567890 Brooks 2234567890 Woods 3234567890

24. Summary • Being used by more Manufacturers, Regulators and Hospitals • Has the necessary detail and tools to meet Stakeholder needs • Database is updated daily following Manufacturer requests for new terms and users are informed of changes • Questions?