Analysis of 2379 Adverse Event Reports on Active Medical Devices
Objective:This study aims to strengthen the detection and utilization of risk signals from adverse event reports on medical devices,identify the primary clinical use risks and causes of adverse events for high-risk devices,propose risk prevention and control measures,and provide a reference for improved monitoring and regulatory efforts to ensure patient safety in device use.Methods:A total of 2379 adverse event reports on active medical devices submitted by medical institutions between 2021 and 2023 in Xiamen were summarized and analyzed.The involved products were categorized,and the manifestations and causes of adverse events were examined.Results:Active medical devices with a high proportion of adverse event reports includes infusion pumps,patient monitors,injection pumps,defibrillation monitors,and hemodialysis filtration devices,accounting for 31.4％of total reports.The primary causes of adverse events in these five categories are equipment misalignment,non-electrical component failures,and electrical component failures,collectively representing 67％of all adverse events.The risk characteristics of different types of active medical devices show clear patterns.Conclusion:Based on the risk characteristics of these active medical devices,manufacturers should strengthen verification processes during the design and development stages.Medical institutions should improve operational training and maintenance of products during use.Municipal monitoring agencies should strengthen the analysis and handling of risk signals.Collaborative efforts among all parties are essential to ensure the safe use of medical devices for the public.
万方数据
维普
