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
Key words
medical institution/medical device adverse event monitoring/medical device vigilance/system construction/efficiency improvement
维普
万方数据