The Global Medical Device Nomenclature (GMDN) Agency has released a research paper that it says marks a milestone in medical device nomenclatures.
Led by Dr Vasileios Zampetoulas, this study delves into the feasibility of mapping GMDN to the European Medical Device Nomenclature (EMDN), uncovering intricate challenges that could impact prospects for global harmonisation.
The GMDN is the leading global standard for the naming, classification, and categorisation of medical devices, providing a universal language for healthcare professionals, regulators, manufacturers, and stakeholders to communicate and exchange information. The GMDN is used by regulators in over 70 countries worldwide and has members in 145 countries across the globe.
The paper presents the results of a feasibility study, which evaluated the direct term-to-term mapping of GMDN Terms to EMDN terms at the terminal level. This latest research explores the compatibility between the GMDN and EMDN terminologies, shedding light on the complexities inherent in unifying these nomenclatures. The study involved an exhaustive examination of over 10,000 general medical device GMDN Terms against approximately 8,000 EMDN terminal-level terms. Astonishingly, the results revealed that only 26% of GMDN Terms found close correspondences in specifically named EMDN terminal terms.
Three out of four (74%) of GMDN Terms corresponded to other or various EMDN terminal terms and 1 in 10 (10%) corresponded to "Various devices not included in other classes – other."
The findings showed that a direct mapping between the two nomenclatures faces significant challenges due to fundamental differences in categorisation parameters and attribute definitions, which resulted in a low level of correspondence and potential grouping of devices with differing features.
Dr Vasileios Zampetoulas, lead author of the study, commented on the findings: "Our research illuminates the inherent disparities in data design and structure between the GMDN and EMDN, posing substantial challenges to direct term-to-term mapping. Despite our aim to foster global harmonisation, the majority of GMDN Terms inevitably correspond to 'other' and 'various' named EMDN terminal terms, emphasising the intricate nature of aligning these nomenclatures. To the best of our knowledge, this research is the first published attempt at a large-scale direct term-to-term mapping exercise.”
The GMDN is designed to be flexible and adaptable to accommodate new and emerging technologies, and it is continually updated to reflect changes in the medical device landscape. It has become a critical component of the global regulatory infrastructure for medical devices.
Deniz Bruce, CEO of the GMDN Agency, reiterated the Agency's dedication to the medical device industry: "This research underscores the critical role of the GMDN in a rapidly evolving landscape. While the complexities are evident, we remain steadfast in our commitment to supporting global harmonisation and facilitating innovation through the GMDN."
The GMDN Agency invites healthcare professionals, regulators, manufacturers, and researchers worldwide to access the full research paper, providing invaluable insights into the nuances of medical device nomenclature and its implications for global healthcare.
The research paper can be downloaded at this link.
