摘要
目的探讨医疗器械临床试验结题阶段的风险因素,并针对高风险因素提出管理策略。方法以某三甲医院已完成结题的5个临床试验项目资料作为研究对象,采用失效模式与效应分析(FMEA)方法统计结题项目的物资核对、文件整理、分中心小结及财务状况相关资料,识别失效模式并对高风险因素进行分析,提出针对性管理策略。结果采用FMEA方法共识别出医疗器械临床试验结题阶段的10种失效模式,将风险优先系数(RPN)≥24的3种失效模式[试验过程文件内容不完整、原始记录表中随访信息不完整、原始记录中未见严重不良事件(SAE)记录]作为高风险因素进行分析,提出加强原始记录与试验过程文件管理、建立并完善研究团队管理体系建设、规范SAE判定标准及处置流程等相关风险应对措施。结论FMEA作为一种主动风险管理工具,应用于医疗器械临床试验结题阶段风险管理中,能较好地确保临床试验结题质量,提升机构管理水平。
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.
作者
张晓燕
韩安珂
朱丹丹
李艳娜
李岳飞
Zhang Xiaoyan;Han Anke;Zhu Dandan;Li Yanna;Li Yuefei(Inner Mongolia Autonomous Region People's Hospital,Hohhot Inner Mongolia 010020,China;School of Computer Information,Inner Mongolia Medical University,Hohhot Inner Mongolia 010010,China)
出处
《医疗装备》
2024年第6期53-56,60,共5页
Medical Equipment
基金
内蒙古自治区科技计划项目(2021GG0135)
内蒙古自治区卫生健康委员会公立医院科研联合基金科技项目(2023GLLH0098)。
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
Failure mode and effect analysis
Medical devices
Clinical trials
Conclusion
Risk factors
Strategy
