摘要
目的:探讨FMEA(失效模式与效应分析)管理工具在医疗器械不良事件监测管理中的应用,以优化医疗器械不良事件上报流程,提高上报数量及质量,保障临床使用安全。方法:组建FMEA团队,对医疗器械不良事件监测管理过程中的风险进行识别、分析和评估,找出潜在失效模式并进行危急值评价及危害分析,根据分析结果制定针对性的干预改进措施。结果:干预措施实施后医疗器械不良事件的检测管理相较实施前有了较为明显的改善,上报数量提升110.47%,上报审核通过率提高16.87%。结论:将FMEA工具应用于医疗器械不良事件的监测管理,确定流程中潜在失效模式,制定针对性的改进措施,能够有效提高不良事件的监管力度和管理质量。
Objective:The application of FMEA(Failure Mode and Effect Analysis)management tools in the monitoring and management of medical device adverse events is discussed to optimize the reporting process of medical device adverse events,improve the number and quality of reports,and ensure the safety of clinical use.Methods:Set up the FMEA team to identify,analyze and evaluate risks in the process of monitoring and management of medical device adverse events.Identify potential failure modes,conduct critical value evaluation and hazard analysis,and formulate intervention improvement measures based on the analysis results.Results:After the implementation of the intervention measures,the detection and management of medical device adverse events have been significantly improved compared with those before the implementation.The number of reports has increased by 110.47%,and the approval rate of reports has increased by 16.87%.Conclusion:Applying FMEA tools to the monitoring and management of medical device adverse events,identifying potential failure modes in the process,and formulating targeted improvement measures can effectively improve the supervision and management quality of adverse events.
作者
邱春冬
王金毅
曾闻如
徐海青
杨玉志
马思雨
QIU Chundong;WANG Jingyi;ZENG Wenru;XU Haiqing;YANG Yuzhi;MA Siyu(Department of Clinical Medical Engineering,Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing,Jiangsu 210008)
出处
《江苏卫生事业管理》
2022年第7期876-880,共5页
Jiangsu Health System Management
关键词
失效模式与效应分析
医疗器械
不良事件
监测管理
Failure Mode and Effect Analysis
Medical Devices
Adverse Events
Monitoring and Management
