中国药物评价2025，Vol.42Issue(6)：416-420,5.
医院不良事件风险监测技术规范构建与实证研究
Study on the Construction of Technical Specifications for Risk Monitoring of Adverse Events in Hospitals
摘要
Abstract
This study is based on the regulatory needs of the whole life cycle of medical devices,and systematically elaborates the core value of constructing the risk signal monitoring system of medical device adverse events from the perspective of standardisation.It addresses the problems of low awareness and consciousness,lagging behind in the construction of risk monitoring system,insufficient regulatory basis and lack of operability in the investigation,analysis and reporting of risk signals of adverse events in hospitals.Follow-ing the design principles of science,comprehensiveness,practicality and dynamics,the technical specification framework is constructed with 7 dimensions and 13 items.The results of the pilot implementation of the technical specification show that the effectiveness of risk management in hospitals has been significantly improved,and it is suggested to deepen the research on the universality of the technical specification,form a scalable solution,and provide a new tool for the technical governance of the post-market safety supervision of med-ical devices.关键词
医疗器械警戒/不良事件/风险信号/技术规范Key words
Medical device vigilance/Adverse event/Risk signalling/Technical specification分类
医药卫生引用本文复制引用
玄怡,郑冬雁,王哲,牛惠芳,杨建卫,赵玉娟..医院不良事件风险监测技术规范构建与实证研究[J].中国药物评价,2025,42(6):416-420,5.基金项目
中国药品监督管理研究会立项课题(2024-Y-Q-010) （2024-Y-Q-010）
