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GMDN or Global Medical Device Nomenclature is a system of internationally agreed generic descriptors used to identify all medical device products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
The main purpose of the GMDN is to provide health authorities / regulators, health care providers, medical device manufactures and suppliers, conformity assessment bodies and others with a single generic naming system that will support patient safety.
Medical device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the GMDN, based on the international standard ISO 15225.[1] The work was mandated by the European Commission in order to provide the necessary tool to carry out the implementation of the Medical Devices Directive,[2] including the European databank for medical devices (Eudamed).[3]
The GMDN meets the need to identify medical devices at the global level, as identified in the Global Harmonization Task Force (GHTF)[4] and its founder members, USA (Food and Drug Administration), Canada (Health Canada), EU (European Commission), Japan (Ministry of Health, Labour and Welfare), Australia (Therapeutic Goods Administration)[5] and now by many other countries and regions.
GMDN is managed by the GMDN Agency, a non-profit organization, which reports to its Board of Trustees, that represent medical device regulators and industry.
The GMDN Agency updates the GMDN utilizing member change requests, to add a new device term in the GMDN or to change an existing code. The decisions are made by an international expert team on how the new term is to be described, according to ISO 15225. The GMDN Agency releases updated GMDN terms on a daily basis, on their interactive website, the GMDN Database. The GMDN Database is priced according to organization size. The GMDN is available in English and other languages are being developed.
The codes for each device are known as a Preferred Terms (P). Uniquely, the GMDN uses Collective Terms (CT) to help users identify the correct P Term, by a defined medical condition or area of interest.
Information in the form of a 5 digit numeric GMDN Code is cross-referenced to a precisely defined Preferred Term, with which all specific devices having substantially similar generic features, can be identified by type. This is important for reasons of data exchange between healthcare authorities, manufacturers and others, exchange of post-market vigilance information, inventory control and purchasing.
The GMDN is used in the European Databank on Medical Devices - EUDAMED[6] which has been established by the European Commission to strengthen market surveillance and vigilance.
The GMDN has been identified[7] as part of the 'minimum data set' for the proposed US FDA Unique Device Identification for Medical Devices used in the United States.
The GMDN Agency has recently finalised the business principles that will form the basis of a long term cooperation with the IHTSDO[8]. The Cooperation Agreement shall result in the use of the GMDN as the medical device component of SNOMED CT. This Agreement is consistent with the aims of both organisations to minimise duplication and to support harmonisation. The following objectives were agreed:
The Agreement will benefit patients across the world and all users of SNOMED CT and the GMDN in promoting comprehensive terminology based medical records, covering the needs of regulators, the medical device industry and healthcare professionals. The arrangement will enhance the application of care to individual patients for medical device, patient risk and safety use cases.
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