New BSI guide will help boost safety of medical devices


November 20 2001

If your television doesn't work, it's a bore. If your car breaks down, it's a nuisance. But if the X-ray machine being used on you is faulty, the results could be fatal.

To help protect against defective and dangerous medical devices, BSI has launched a new guide which improves the way medical devices are named, registered and controlled. The guide, called GMDN (Global Medical Device Nomenclature), is a collection of internationally recognised terms for describing and cataloguing medical devices.

The GMDN will be useful to all parties involved with medical devices - manufacturers, regulators, conformity assessment bodies, traders, owners and users. Manufacturers must satisfy stringent quality and safety checks before they market anything from a sticking plaster to scanning equipment. The most important requirement is an unambiguous way to identify the medical device concerned. Once identified and coded, any device can then be traced to its ultimate source.

David Lazenby, director of British Standards, said: "By helping to improve medical safety, the GMDN will be of great benefit to society. It will also support world trade by simplifying electronic communication between member states in the European Union and other national or regulatory organisations. Other uses for the GMDN are also beginning to emerge, from stock control in hospitals to e-commerce."

Giving definitions for each device, the GMDN represents the best working tool so far for companies concerned to provide the best possible safety assurances for their customers.

"This nomenclature is an significant milestone in the continuing struggle to assure protection for consumers in this vitally important market," said Robert Allen, of the UK Medical Devices Agency.

Compiled by 70 medical device experts from 18 countries, the GMDN has taken almost four years of international consultation and discussion. It contains nearly 7,000 terms plus more than 10,000 synonyms to make the GMDN more user-friendly.

The GMDN is available in an electronic version on CD-ROM in the widely used Adobe® PDF format, which has search facilities, thumbnails to help navigation, and efficient printing functions.

The GMDN costs £300 and is available from: BSI, 389 Chiswick High Road, London W4 4AL, England. Phone +44 (0)20 8996 9001. Fax +44 (0)20 8996 7001. Email: