Upload
vanhanh
View
214
Download
0
Embed Size (px)
Citation preview
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. Active implantable devices2. Anaesthetic and respiratory devices3. Dental devices4. Electro mechanical medical devices5. Hospital hardware6. In vitro diagnostic devices7. Non-active implantable devices8. Ophthalmic and optical devices9. Reusable devices10. Single-use devices11. Assistive products for persons with disability12. Diagnostic and therapeutic radiation devices13. Complementary therapy devices14. Biologically-derived devices15. Healthcare facility products and adaptations16. 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
119400, 35%
41945, 12%
34850, 10%
USA
UK
Germany
Switzerland
France
Italy
Japan
Denmark
Belgium
Netherlands
Australia
Norway
Ireland
Sweden
Korea South
Canada
China
Other
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 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 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
1234567890 1234567890
2234567890
3234567890
Device Type = UDI Generic Device Group = GMDN
Hudson
Brooks
Woods
Hudson