Consolidated Health Informatics Initiative
Final Recommendation Information Sheet1
Domain Title & Team Lead:
Medical Devices and Supplies: Brock Hefflin, FDA
This domain is defined as a terminology used to inventory or exchange information on medical devices and medical supplies within and between agencies, and between agencies and the public. The workgroup excluded “staff” resources from the domain’s scope, as its members were unfamiliar with terminologies that covered the subject and believed it was relatively unrelated to medical devices and supplies.
The group believes that the terminology should be highly comprehensive and sufficiently specific, to the generic device/supply group level, to accommodate regulatory and inventory activities. The terminology should provide definitions for device/supply terms. The terminology should be organized in a simple hierarchy to enhance structure and facilitate navigation.
- UNSPC (United Nations System for Product Classification)
- HCPCS (Healthcare Common Procedure Coding System)
- GMDN (Global Medical Device Nomenclature)
- UMDNS (Universal Medical Device Nomenclature System)
- FDA Medical Device Classification
No one terminology is recommended, rather the recommendation is to wait for the Global Medical Device Nomenclature (GMDN) and the Universal Medical Device Nomenclature System (UMDNS) to merge and to adopt the resulting terminology.
The GMDN and the UMDNS are very similar in scope, i.e., each provides names, definitions, and unique codes for essentially all medical devices and supplies at the generic device group level (device attributes, however, are being considered for the GMDN which will increase its level of specificity significantly). Both terminologies are being used internationally, the GMDN primarily by regulatory agencies and the UMDNS primarily by healthcare institutions.
The GMDN is owned by the European Standards Body (CEN) and is a CEN/ISO standard. It was recently developed largely through the harmonization of six established medical device terminologies including a previous version of the UMDNS and the terminology used by the Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA). The GMDN is managed and its content maintained by an International Maintenance Agency with significant FDA representation.
The UMDNS is owned by ECRI, a U.S.-based non-profit health services research agency. The terminology has been used internationally for a few decades, especially by healthcare institutions. The UMDNS is managed and its content maintained by ECRI.
The UMDNS is supported by an established business plan and is incorporated into the U.S. Library of Medicine’s Unified Medical Language System (UMLS). The business plan for the GMDN is still in formation, however the terminology is an international standard and is strongly supported by the FDA for global medical device data communication and to eventually replace the FDA medical device terminology. Efforts are being made to merge the GMDN and UMDNS into one terminology, hopefully within the next three years. The GMDN Maintenance Agency has recently invited ECRI to participate in the GMDN effort. In addition, the FDA and ECRI are collaborating on a CRADA (Cooperative Research and Development Agreement) to map/link the UMDNS to the GMDN in the first step towards merging the terminologies. The terminology resulting from a merge of the GMDN and UMDNS will enable the U.S. federal system components to utilize one set of medical device/supply names, definitions, and codes, and to use these same product identifiers to communicate with foreign establishments.
This recommendation is contingent upon the success of the GMDN business plan and/or other resources (e.g., from medical device regulators or industry) to adequately support the terminology.
1 Information Sheet designed specifically to facilitate communication between CHI and NCVHS Subcommittee on Standards and Security resulting from May 20, 2003 testimony. CHI may seek assistance to help further define scope, alternatives to be considered and/or issues to be included in evaluation process.