Faculty of Pharmacy.
Verlab, Research Institute for Biomedical Engineering, Medical Devices and Artificial Intelligence, Sarajevo, Bosnia and Herzegovina.
Technol Health Care. 2022;30(6):1315-1329. doi: 10.3233/THC-220284.
Medical devices (MDs) represent the backbone of the modern healthcare system. Considering their importance in daily medical practice, the process of manufacturing, marketing and usage has to be regulated at all levels. Harmonized evidence-based conformity assessment of MDs during PMS relying on traceability of medical device measurements can contribute to higher reliability of MD performance and consequently to higher reliability of diagnosis and treatments.
This paper discusses issues within MD post-market surveillance (PMS) mechanisms in order to set a path to harmonization of MD PMS.
Medline (1980-2021), EBSCO (1991-2021), and PubMed (1980-2021) as well as national and international legislation and standard databases along with reference lists of eligible articles and guidelines of relevant regulatory authorities such as the European Commission and the Food and Drug Administration were searched for relevant information. Journal articles that contain information regarding PMS methodologies concerning stand-alone medical devices and relevant national and international legislation, standards and guidelines concerning the topic were included in the review.
The search strategy resulted in 2282 papers. Out of those only 24 articles satisfied the eligibility criteria and were finally included in the review. Papers were grouped per categories: medical device registry, medical device adverse event reporting, and medical device performance evaluation. In addition to journal articles, national and international legislation, standards, and guidelines were reviewed to assess the state of PMS in different regions of the world.
Although the regulatory framework prescribes PMS of medical devices, the process itself is not harmonized with international standards. Particularly, conformity assessment of MDs, as an important part of PMS, is not measured and managed in a traceable, evidence-based manner. The lack of harmonization within PMS results in an environment of increased adverse events involving MDs and overall mistrust in medical device diagnosis and treatment results.
医疗器械（MDs）是现代医疗体系的支柱。鉴于它们在日常医疗实践中的重要性，制造、营销和使用过程必须在各个层面进行监管。在 PMS 期间，依靠医疗器械测量的可追溯性，对 MD 进行协调一致的基于证据的符合性评估，可以提高 MD 性能的可靠性，从而提高诊断和治疗的可靠性。
本文讨论了 MD 上市后监测（PMS）机制中的问题，以期为 MD PMS 的协调统一铺平道路。
检索了 Medline（1980-2021）、EBSCO（1991-2021）和 PubMed（1980-2021）以及国家和国际立法和标准数据库，以及相关法规机构（如欧洲委员会和美国食品和药物管理局）的参考列表和指南，以获取相关信息。包含有关独立医疗器械 PMS 方法学信息的期刊文章以及有关该主题的国家和国际立法、标准和指南的文章被纳入审查。
搜索策略共产生了 2282 篇论文。其中只有 24 篇文章符合入选标准，最终被纳入审查。论文按类别分组：医疗器械登记册、医疗器械不良事件报告和医疗器械性能评估。除了期刊文章外，还审查了国家和国际立法、标准和指南，以评估世界不同地区的 PMS 状况。
尽管监管框架规定了医疗器械的 PMS，但该过程本身并未与国际标准协调一致。特别是，作为 PMS 重要组成部分的 MD 符合性评估，没有以可追溯和基于证据的方式进行衡量和管理。PMS 内缺乏协调导致涉及 MD 的不良事件增加，以及对医疗器械诊断和治疗结果的整体不信任。
