FMEA在导尿管类医疗器械不良事件风险分析中的应用探讨  

Application and Discussion of FMEA in Risk Analysis of Adverse Events of Catheter Medical Device

作　　者：尹建兵 王雯 张淑霞 YIN Jianbing;WANG Wen;ZHANG Shuxia(Zhejiang Medical Device Adverse Event Monitoring and Safety Research Center,Hangzhou Zhejiang 310009,China;Huzhou Center for ADR Monitoring,Huzhou Zhejiang 313000,China)

机构地区：[1]浙江省医疗器械不良事件监测和安全研究中心,浙江杭州310009 [2]浙江省湖州市药品不良反应监测中心,浙江湖州313000

出　　处：《中国医疗设备》2018年第11期162-165,共4页China Medical Devices

基　　金：浙江省食品药品监督管理局财政专项项目(1823741)

摘　　要：近年来,随着国家对高风险医疗器械不良事件重点监测工作的深入开展,不良事件监测风险分析方法的多样化需求日益迫切。本文首次探索医疗器械导尿管类产品上市后,在不良事件监测中建立失效模式和效应分析(Failure Modes and Effects Analysis,FMEA)模型,并通过监测近两期14家重点监测点的临床数据,获取FMEA模式在导尿管产品不良事件监测中应用的可行性,为FMEA在无源类医疗器械,甚至整个医疗器械类产品上市后不良事件监测中的推广应用提供了参考。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.

关 键 词：医疗器械不良事件 风险分析 失效模式和效应分析 临床数据监测 

分 类 号：R193.7[医药卫生—卫生事业管理] R472[医药卫生—公共卫生与预防医学]