GMDN
Global Medical Device Nomenclature
Mark Wasmuth
Secretary General
GMDN Agency
Contents
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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
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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:
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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
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English (Reference)
Japanese
Russian
Chinese (Mandarin)
20 EU Languages, including:
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French
German
Italian
Portuguese
Spanish
 Just started - Turkish, Serbo-Croat
GMDN Agency – Governance
 Board of Trustees
 GHTF
 AHWP
 Industry and Regulators
 Policy Advisory Group
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GHTF
AHWP
WHO
Regional representatives as required
GMDN Categories (Scope)
1.
2.
3.
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5.
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8.
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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
GMDN – Members by Country 2009
Manufacturer by Country / Value EUR
USA
UK
Germany
Switzerland
France
Italy
35%
Japan
Denmark
Belgium
Netherlands
Australia
Norway
Ireland
12%
10%
Sweden
Korea South
Canada
China
Other
Who regulates use of GMDN today?
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Australia
Japan
Italy
Greece
Poland
Turkey
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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 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
[email protected]
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Global Regulation & Nomenclature of Medical Devices