Health Information System - Medical Devices Nomenclature System

The subject of the article is to evaluate the current systems of internationally agreed generic descriptors for the identification of medical devices. The aim of this article is to assess the strengths and weaknesses of the Global Medical Device Nomenclature (GMDN), officially recognized within the European Economic Area (EEA), as compared to Unique Device Identity (UDI) valid in the United States. The methods used include a literature review of available professional sources, PEST analysis and guided structured interviews with experts from the Czech Association of Manufacturers of Medical Devices (CzechMed). Comparison of both systems was also performed. The introductory part of the article defines the basic concepts and obligations that international regulations set for MD manufacturers. It also describes the current situation in information systems associated with MDs. The comparison focuses on two transnational systems - Global Medical Devices Nomenclature (GMND) and Unique Device Identity (UDI). The synthesis of knowledge highlights the strengths and weaknesses of both systems. The conclusion of the article deals with the overall evaluation and recommendations on the given issue.