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. 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 – 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

1234567890 1234567890

2234567890

3234567890

Device Type = UDI Generic Device Group = GMDN

Hudson

Brooks

Woods

Hudson

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?