UDI and the GMDN (Global Medical Device Nomenclature) Mark Wasmuth Secretary General GMDN Agency 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 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 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) GHTF Purpose Encourage Regulatory Convergence Promote innovation Facilitate Trade Information exchange forum Study Groups established More at www.ghtf.org 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 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 GMDN Source Nomenclature Baseline data was adopted from established Nomenclature: ECRI - UMDNS FDA - Procodes ISO 9999 EDMA JFMDA NKKN 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 GMDN Categories (Scope) 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 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 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 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 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! GMDN – Members by Country 2009 Manufacturer by Country / Value EUR USA UK Germany Switzerland France Italy 119400, 35% Japan Denmark Belgium Netherlands Australia Norway Ireland 41945, 12% 34850, 10% Sweden Korea South Canada China Other GMDN – Preferred Term Structure Term Name Non-evacuated blood collection tube IVD, EDTA Code 57900 Definition 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 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 GMDN – Collective Term Structure Using GMDN (website access) Using GMDN (searching for terms) Using GMDN (selecting the term) Using GMDN (multi-lingual display) 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) GMDN and UDI Relationship Device Type = UDI Generic Device Group = GMDN Hudson Hudson 1234567890 1234567890 Brooks 2234567890 Woods 3234567890 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?