The project brought together a team of experts from industry and regulatory bodies to create a single global medical device nomenclature. This involved the implementing of the new European and International Standard EN ISO 15225 Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange, which defines the format and structure of terms for medical devices both for written communication and electronic databases.
An important feature of the project has been the maintenance of traceability between the new and old nomenclature terms. This will assist users changing to the new nomenclature to use and interpret data collected over time without having to establish a new set of records.
Six different existing nomenclatures with around 13 500 terms, some are common others are ifferent, have been used as the source for the new global nomenclature. These nomenclatures cover a wide range of terms defining medical devices.
The six chosen nomenclatures were:
The work of reviewing and amending the terms and preparing new ones has been done using the basic rules of the project. It was carried out by a carefully screened and selected group of approximately 60 medical device experts organized in 12 different Device Expert Task Groups (DETG) each containing teams of 2 - 10 specialists from Europe, USA and Japan. The Nordic countries have contributed with 9 of these experts.
The GMDN has been prepared in English, and the first version will have some 6 200 preferred GMDN terms, each with a unique code and definition. These are supported by some 700 templates and 8 900 synonyms to assist the user when searching for specific nomenclature terms.
The work has been overviewed by the Expert Advisory Team (EAT), a top expert advisory group consisting of 6 pre-selected nomenclature/language experts with special knowledge in medical device nomenclatures. These experts have worked according to the rules and guidelines laid down for the production of the GMDN and have provided the very foremost expertise on all nomenclature aspects. This group was involved in the project planning, build-up of the various systems involved, the training programmes, QA, and the approval processes of the nomenclature work.
The project began on 17 September 1997 with the first meeting in London of the Project Council. The initial phase of the work involved preparation and training of the groups of experts followed by the main task of selecting and amending terms for the global medical device nomenclature. Overall, the project has taken 43 months.
Following the project, an organization will need to be identified to maintain the nomenclature for the future. Since industry is continually developing new technology and clinical practices will improve, new terms will need to be produced to reflect the changes in the medical devices used world-wide.
Chairman: Mike Barwick, Scotland
Secretary: Ian Wilson, BSI, UK
The Nordic interests have been handled by Mr. Jacob W. Nordan (recently retired from the Norwegian Board of Health).
| Robert Allen | Manager | Medical Device Agency (MDA) | UK |
| Ian Wilson | Secretary | British Standards Institution | UK |
| Vivian Coates | Member | ECRI | USA |
| Rich Farb | Member | Baxter Healthcare Corp. | USA |
| Maurice Freeman | Member | MTC (Medical Technology Consultants Ltd.) | UK |
| Tom Gross | Member | FDA - Division of Surveillance Systems | USA |
| Leighton Hansel | Member | FDA Division of Surveillance Systems | USA |
| Bo Højdefors | Member | Commission of the European Communities (CEC) | Sweden |
| Naito Masaaki | Member | Nihon Kohden Corp. | Japan |
| R. Moore | Member | EUCOMED | Belgium |
| Jacob W. Nordan | Member | Recently retired from the Norwegian Board of Health | Norway |
| Werner Stoeber | Member | DIMDI | Germany |
| Alan Fields | NKKN | Norway |
| Brock Hefflin | FDA | USA |
| Jordi Gol | AETS | Spain |
| Pierre Guizier | CHdV | France |
| Beth Richardson | ECRI | USA |
| Manfred Wolf | EMTEC | Germany |
The 12 different DETG's
No.: Device category Convenor Country DETG 01 Active implantable devices Sven Erik Jensen Denmark DETG 02 Anaesthetic and respiratory devices Ann A. Graham USA DETG 03 Dental devices Corrado Paganelli Italy DETG 04 Electro-mechanical devices Elisabeth G. Boberg Norway DETG 05 Hospital hardware Margrethe Os Norway DETG 06 In vitro diagnostic devices Cecilia Brown UK DETG 07 Non-active implantable devices Bob Smith UK DETG 08 Ophthalmic and optical devices Mo Jalie UK DETG 09 Reusable instruments Joseph Mertis USA DETG 10 Single use devices Paul Evans USA DETG 11 Technical aids for disabled persons Birgitta Thaning Sweden DETG 12 Diagnostic and therapeutic radiation devices Sharon F. Dillard USA