Application and Discussion of FMEA in Risk Analysis of Adverse Events of Catheter Medical Device
YIN Jianbing1, WANG Wen1, ZHANG Shuxia2
1. Zhejiang Medical Device Adverse Event Monitoring and Safety Research Center, Hangzhou Zhejiang 310009, China;
2. Huzhou Center for ADR Monitoring, Huzhou Zhejiang 313000, China
Abstract:In recent years, with the country’s intensive monitoring of the high risk medical devices, the need for the risk analysis
method is more and more urgent. In this paper, the failure mode and effects analysis (FMEA) model was established in the monitoring
of adverse events after the first exploration of the introduction of medical device catheter products. By monitoring the clinical data of
14 key monitoring points in the near two periods, the feasibility of applying FMEA model in the monitoring of adverse events in the
catheter products was obtained. It provides reference for the application of FMEA in the monitoring of non-source medical devices
and even the whole medical device.
尹建兵1,王雯1,张淑霞2. FMEA在导尿管类医疗器械不良事件风险分析中的应用探讨[J]. 中国医疗设备, 2018, 33(11): 162-165.
YIN Jianbing1, WANG Wen1, ZHANG Shuxia2. Application and Discussion of FMEA in Risk Analysis of Adverse Events of Catheter Medical Device. China Medical Devices, 2018, 33(11): 162-165.