医疗机构医疗器械警戒能力建设初探  

Preliminary Exploration of Medical Device Vigilance Capacity Building in Medical Institutions

作　　者：朱未 ZHU Wei(Union Hospital,Tongji Medical College,Huazhong University of Science and Technology)

机构地区：[1]华中科技大学同济医学院附属协和医院

出　　处：《中国食品药品监管》2024年第3期34-41,共8页China Food & Drug Administration Magazine

摘　　要：我国自2002年启动医疗器械不良事件监测试点及运行,2020年提出探索研究医疗器械警戒制度。医疗器械不良事件监测、医疗器械警戒两项技术手段有所不同,医疗机构始终是这两项技术手段的重要承载主体。本文基于华中科技大学同济医学院附属协和医院多年开展医疗器械不良事件监测和医疗器械警戒的工作经验,初步探索医疗机构医疗器械警戒能力建设,围绕医疗器械警戒体系构建和效能提升提出一系列举措和方略,部分医疗器械警戒新观念、新架构、新路径正付诸实践。China began the pilot and operation of medical device adverse event monitoring in 2002,and proposed to explore and study the alert system of medical devices in 2020.The two technical means of medical device adverse event monitoring and medical device vigilance differ,with medical institutions always serving as the important carrier of these two technical means.Based on years of work experience in medical device adverse event monitoring and medical device vigilance at Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,this paper conducts a preliminary exploration of medical device vigilance capacity building,and proposes a series of relevant measures and strategies for the construction and efficiency improvement of medical device vigilance system.Some new concepts,structures,and paths of medical device vigilance are being put into practice.

关 键 词：医疗机构 医疗器械不良事件监测 医疗器械警戒 体系构建 效能提升 

分 类 号：R95[医药卫生—药学]