Global trends in post-market surveillance of high-risk medical devices: An empirical analysis based on regulatory data.

Abstract

Background & objectives 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. Methods This study utilised 2024 data from EUDAMED (European Database on Medical Devices), BfArM (Bundesinstitut für 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. Results 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. Interpretation & conclusions 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.