{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T05:26:39Z","timestamp":1790227599132,"version":"4.1.0"},"reference-count":15,"publisher":"Scientific Scholar","content-domain":{"domain":["ijmr.org.in"],"crossmark-restriction":true},"short-container-title":["Indian J Med Res"],"abstract":"\n Background & objectives<\/jats:title>\n To analyse post-market surveillance (PMS) trends for high-risk medical devices (Class IIb and III) in different geographic regions and evaluate the effectiveness of field safety corrective actions (FSCAs) in mitigating device-related risks.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This study utilised 2024 data from EUDAMED (European Database on Medical Devices), BfArM (Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte), and MAUDE (Manufacturer and User Facility Device Experience (FDA database)) to identify recurring incidents, associated device types, and the outcomes of FSCAs. A quantitative analysis was conducted to evaluate the frequency and severity of reported incidents, focusing on hardware failures, software malfunctions, and calibration issues. The impact of recalls, software updates, and field modifications on incident recurrence was also assessed.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Orthopaedic implants, infusion pumps, and cardiac monitoring devices reported the highest number of incidents, primarily due to hardware failures and software issues. FSCAs involving hardware modifications significantly reduced recurrence rates, particularly for high-risk devices like pacemakers and ventilators. In contrast, software-driven devices exhibited persistent issues despite corrective actions, highlighting challenges in maintaining long-term reliability.<\/jats:p>\n <\/jats:sec>\n \n Interpretation & conclusions<\/jats:title>\n The findings underscore the importance of robust PMS systems and tailored corrective actions in mitigating risks associated with high-risk medical devices. While FSCAs have demonstrated effectiveness in addressing hardware-related failures, enhancements in regulatory frameworks are necessary to improve the management of software-driven devices.<\/jats:p>\n <\/jats:sec>","DOI":"10.25259\/ijmr_86_2025","type":"journal-article","created":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T07:45:55Z","timestamp":1760168755000},"page":"163-168","update-policy":"https:\/\/doi.org\/10.25259\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Global trends in post-market surveillance of high-risk medical devices: An empirical analysis based on regulatory data"],"prefix":"10.25259","volume":"162","author":[{"given":"Oviyaasri","family":"Manimuthukumar","sequence":"first","affiliation":[{"name":"Department of Neuroscience, National University of Ireland Galway, Roscam, Galway, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manjuladevi","family":"M.","sequence":"additional","affiliation":[{"name":"Department of Science & Humanities, SNS College of Technology, Coimbatore, Tamil Nadu, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arunkumar","family":"T.","sequence":"additional","affiliation":[{"name":"Department of Science & Humanities, SNS College of Technology, Coimbatore, Tamil Nadu, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10894","published-online":{"date-parts":[[2025,10,10]]},"reference":[{"key":"10.25259\/IJMR_86_2025\/ref-1","doi-asserted-by":"publisher","first-page":"1155","DOI":"10.1002\/pds.4859","article-title":"EU postmarket surveillance plans for medical devices","volume":"28","author":"Pane","year":"2019","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"10.25259\/IJMR_86_2025\/ref-3","volume-title":"Registries for evaluating patient outcomes: a user\u2019s guide","year":"2014","edition":"4th ed"},{"key":"10.25259\/IJMR_86_2025\/ref-8","volume-title":"IEC TR 60601-4-5:2021. 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