医疗器械不良事件监测的实践与探讨  

Practice and Discussion on the Monitoring of Medical Device Adverse Events

作　　者：曾莉莉 ZENG Li-li(Medical Engineering Department,Huizhou First People's Hospital,Guangdong Huizhou 516003)

机构地区：[1]惠州市第一人民医院医学工程部,广东惠州516003

出　　处：《中国医疗器械信息》2023年第23期54-57,共4页China Medical Device Information

摘　　要：医疗器械不良事件监测是医疗器械全生命周期管理的重要组成部分,也是降低医疗器械使用风险,保障医疗器械使用安全,保证诊疗安全的重要措施。对2018年~2022年本院上报的医疗器械不良事件进行统计分析,总结监测和管理工作现状和存在问题,提出针对性的改进措施。通过完善监测体系、上报流程、培训宣教等管理措施,提高本院医疗器械不良事件监测和管理水平,有效控制医疗器械使用风险。同时,为上级部门提供监管依据,为促进国家医疗器械产业健康发展贡献一份力量。The monitoring of medical device adverse events is an important part of the medical devices life cycle management,and is also an important measure to reduce the usage risks of medical devices,to ensure the safety in use of medical devices,to ensure the safety of diagnosis and treatment.The adverse events of medical devices reported in our hospital from 2018 to 2022 were statistically analyzed,summarizing the current situation and existing problems of monitoring and management,and proposing specific improvement measures.Through the improving of monitoring system,reporting process,training and education and other management measures,to improve the level of adverse events monitoring and management of medical devices in our hospital,to reduce the usage risk of medical devices.At the same time,it provides a regulatory basis for superior departments and contributes to the healthy development of the national medical device industry.

关 键 词：医疗器械 不良事件监测 统计分析 质量控制 风险管理 

分 类 号：R197.39[医药卫生—卫生事业管理]