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摩洛哥可报销植入物编码的度量标识和映射到全球医疗器械命名法 (GMDN) 和欧洲 (EUDAMED)。

Metric identification and mapping of reimbursable implant codes in Morocco to the global nomenclature (GMDN) and European (EUDAMED) of medical devices.

机构信息

Laboratoire biologie et santé, faculté des sciences, université Ibn Tofail, Kénitra, Morocco; Groupe de recherche d'ingénierie biomédicale et pharmaceutique, département d'ingénierie des technologies de la santé-(ENSAM Rabat), Mohammed V University Rabat, Rabat, Morocco; Higher Institute of Nursing and Technical Health Professions Rabat - Ministry of Health and Social Welfare, Rabat, Morocco.

Groupe de recherche d'ingénierie biomédicale et pharmaceutique, département d'ingénierie des technologies de la santé-(ENSAM Rabat), Mohammed V University Rabat, Rabat, Morocco.

出版信息

Ann Pharm Fr. 2024 Nov;82(6):1025-1033. doi: 10.1016/j.pharma.2024.05.005. Epub 2024 May 29.

Abstract

BACKGROUND

The list of medical devices (MD) eligible for reimbursement under the Compulsory Health Insurance in Morocco is set by Ministerial Order comprising 869 items between life-support equipment, external prostheses, and implants. The objective of the present study is to analyze the nomenclature of implantable medical devices (IMD) appearing on this list and compare them with the global nomenclature of MD (GMDN) and the European nomenclature of MD (EMDN).

METHODS

The study deals with (i) the mapping of the codes of the IMD list with 170 DM per cardinality and (ii) a metric identification by Sørensen-Dice coefficient of terminological similarity of the IMD with respect to the two databases.

RESULTS

The 170 IMD codes are mapped onto 493 terms in the GMDN and 344 terms in the EMDN. The 37.7% of implants are mapped to more than or equal to 2 terms of GMDN while 36.5% are mapped to more than or equal to 2 terms to the EMDN. The comparison of cardinality distributions has revealed no significant difference (P=0.430) between the two databases. The implants examined are divided into 11 categories whose strong similarity is given to active cardiovascular implants in the EMDN database with sim=0.534.

CONCLUSION

Healthcare authorities need to align with nomenclature standards to improve interoperability and rely on a more efficient and rational regulatory process.

摘要

背景

摩洛哥强制性医疗保险涵盖的医疗器械清单由部长令规定,其中包括 869 项生命支持设备、外部假体和植入物。本研究的目的是分析该清单中列出的可植入医疗器械 (IMD) 的命名法,并将其与全球医疗器械命名法 (GMDN) 和欧洲医疗器械命名法 (EMDN) 进行比较。

方法

该研究涉及 (i) 将 IMD 清单的代码与 170 个 DM 进行映射,每个 DM 具有 170 个 DM,(ii) 通过 Sørensen-Dice 系数对 IMD 与两个数据库的术语相似性进行度量识别。

结果

170 个 IMD 代码映射到 GMDN 中的 493 个术语和 EMDN 中的 344 个术语。37.7%的植入物映射到 GMDN 中的至少 2 个术语,而 36.5%的植入物映射到 EMDN 中的至少 2 个术语。卡方分布的比较显示两个数据库之间没有显著差异 (P=0.430)。检查的植入物分为 11 类,其中 EMDN 数据库中的主动心血管植入物具有最强的相似性,sim=0.534。

结论

医疗保健当局需要与命名法标准保持一致,以提高互操作性,并依赖更高效和合理的监管流程。

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