Presentation on theme: "GMDN Global Medical Device Nomenclature"— Presentation transcript:
1 GMDN Global Medical Device Nomenclature Mark WasmuthSecretary GeneralGMDN Agency
2 Contents Background to GMDN Development of GMDN Scope of GMDN Who uses GMDNGMDN Data StructureUsing GMDN on-line Database
3 Role of Global Nomenclature Single nomenclature for the GHTF Regulatory ModelProvide Generic Terms with DefinitionsFor efficient exchange of information between Manufacturers, Regulators and Healthcare ProvidersAnalysis of data to support patient safetySupport 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 regulationsResult = Initiative to investigate global proceduresConference In Brussels (Autumn 1991)To explore existing MD nomenclaturesResult = No conclusion!First Formal Meeting of GHTF in Tokyo (1993)To establish a consistent approach to GMP, by using international standards for Quality SystemsIdentified the need for a new Global Nomenclature
5 GMDN Source Nomenclature Baseline data was adopted in agreement from existing nomenclatures:ECRI - UMDNSFDA - CDRHISO 9999EDMAMHLW - JFMDANKKN
6 GMDN Development 1993 – 2011 International Standard structure Resulted in ISO 15225:2000Updated as ISO 15225:2010Development to date:Establishment of GMDN Agency (2005)18,933 Preferred Terms1,980 Collective Terms (Device Attributes)16 Categories (Scope)Web-based access to GMDN MembersTranslation (ongoing)
7 Translation of GMDN for world access English (Reference)JapaneseRussianChinese (Mandarin)20 EU Languages, including:FrenchGermanItalianPortugueseSpanishJust started - Turkish, Serbo-Croat
8 GMDN Agency – Governance Board of TrusteesGHTFAHWPIndustry and RegulatorsPolicy Advisory GroupWHORegional representatives as required
9 GMDN Categories (Scope) Active implantable devicesAnaesthetic and respiratory devicesDental devicesElectro mechanical medical devicesHospital hardwareIn vitro diagnostic devicesNon-active implantable devicesOphthalmic and optical devicesReusable devicesSingle-use devicesAssistive products for persons with disabilityDiagnostic and therapeutic radiation devicesComplementary therapy devicesBiologically-derived devicesHealthcare facility products and adaptationsLaboratory equipment
11 Who regulates use of GMDN today? AustraliaJapanItalyGreecePolandTurkeyCzech RepublicCroatiaPeruMozambiqueSpainOther countries will mandate use of GMDN during their own time plan
12 GHTF support for GMDNPosition 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 – Preferred Term Structure Term NameCodeDefinitionNon-evacuated blood collection tube IVD, EDTA57900A 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.
17 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-hierarchiesCollective Terms allow searches by subject groupCTs allow analysis of the GMDN by product attribute or feature
23 Summary Endorsed by regulators and supported by manufacturers Being used by more Regulators, Manufacturers and Hospitals each monthHas the necessary detail and tools to meet all Stakeholder needsDatabase is updated daily following Manufacturer requests for new terms and users are automatically informed of any changes
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