某院医疗器械不良事件原因分析与对策研究  

Analysis of the Causes of Adverse Events of Medical Devices in a Hospital and Countermeasures

作　　者：胡文静[1] 邱杰[1] HU Wenjing;QIU Jie(Medical Engineering Department,Peking Union Medical College Hospital,Beijing,100730 China)

机构地区：[1]北京协和医院医学工程处,北京100730

出　　处：《中国卫生产业》2021年第29期172-176,共5页China Health Industry

摘　　要：目的通过分析该院医疗器械不良事件数据,为医疗器械不良事件的监测与防范提供参考。方法全面梳理统计2019年1月—2020年12月该院60例医疗器械不良事件,对上报科室、器械类型、发生原因进行整理汇总,分析医疗器械不良事件产生的原因。结果通过数据统计分析,发现医疗器械不良事件发生的原因包括医疗器械在设计、制作中存在缺陷,人为操作不规范、存放不当、责任难以界定、缺乏事后追踪反馈机制等。结论通过完善工作制度及流程、引入第三方鉴定机构、充分发挥医学工程处管理职责、大力推进医工转化、建立PDCA闭环管理等措施,避免不良事件发生,保障医疗器械使用安全。Objective To provide reference for the monitoring and prevention of medical device adverse events by analyzing the data of medical device adverse events in the hospital.Methods A comprehensive analysis of 60 cases of medical device adverse events in the hospital from January 2019 to December 2020.Organize and summarize the reported departments,device types,and causes.Analyze the causes of adverse events of medical devices.Results Through statistical analysis of data,it was found that the causes of medical device adverse events included defects in the design and manufacture of medical devices,irregular operation,improper storage,difficulty in defining responsibilities,lack of follow-up and feedback mechanism afterwards,etc.Conclusion By improving the work system and procedures,introducing third-party appraisal agencies,giving full play to the management responsibilities of the Medical Engineering Office,vigorously promoting the transformation of medical workers and establishing PDCA closed-loop management measures,avoid adverse events and ensure the safe use of medical devices.

关 键 词：医疗器械 不良事件 医学工程 质量控制 

分 类 号：R19[医药卫生—卫生事业管理]