Objective To explore the risk factors during the final stage of clinical trials of medical devices and propose management strategies for high-risk factors.Methods With the completion of 5 clinical trial project data from a certain tertiary hospital as the research object,the Failure Mode and Effects Analysis(FMEA)method was used to statistically analyze the material verification,document organization,sub-center summary,and financial status related information of the project,identify failure modes,and conduct specific analysis of high-risk factors.Finally,targeted management strategies were proposed.Results A total of 10 failure modes were identified during the final stage of clinical trials of medical devices,by using FMEA.With the analysis of three failure modes with a Risk Priority Number(RPN)≥24[incomplete experimental process file content,incomplete follow-up information in the original record table,and no serious adverse event(SAE)record in the original record]as high-risk factors,strengthening the management of original records and experimental process documents,establishing and improving the research team management system,standardizing SAE judgment standards and disposal processes,and other related risk response measures have been proposed.Conclusion As an active risk management tool,applying FMEA to risk management during the final stage of medical device clinical trials can effectively ensure the quality of clinical trial completion and improve institutional management level.
关键词
失效模式与效应分析/医疗器械/临床试验/结题/风险因素/策略
Key words
Failure mode and effect analysis/Medical devices/Clinical trials/Conclusion/Risk factors/Strategy
维普
万方数据