摘要
阐述了国内医疗器械警戒体系的现状,介绍了以风险管理作为指导思想对构建该体系的指引作用,分析了明确医疗器械警戒体系的责任主体、构建医疗器械警戒体系的主要内容和关联医疗器械警戒体系风险信息的方法是构建该体系的路径,指出了该体系应在法规、管理和技术层面进一步完善。
The current situation of the medical device vigilance system was described in China,and the guiding role of risk management as the guiding ideology for constructing the system was introduced.The path of constructing the system involved in clarifying the responsible body,developing the main contents and correlating the risk information.It's pointed out that the system had to be improved in terms of regulation,management and technology.
作者
王丽
张培茗
夏兵
王新茹
WANG Li;ZHANG Pei-ming;XIA Bing;WANG Xin-ru(Center for Drug Reevaluation of Henan,Zhengzhou 450008,China;School of Health Science and Engineering,University of Shanghai for Science and Technology,Shanghai 200093,China)
出处
《医疗卫生装备》
CAS
2024年第6期83-86,共4页
Chinese Medical Equipment Journal
基金
河南省软科学研究计划项目(232400410219)。
关键词
医疗器械警戒体系
医疗器械不良事件
风险管理
medical device vigilance system
medical device adverse events
risk management
