摘要
医疗器械全生命周期监督管理应包含研发﹑生产﹑准入﹑经营﹑使用﹑再评价等环环相扣,而"不良事件监测与再评价"由于各方在理解上的偏颇,一直作为"雷区"不被接受与重视。《医疗器械不良事件监测和再评价管理办法》的公布,是强化医疗器械全生命周期科学监管。该文梳理了医疗器械监督管理制度的发展历程,更全面地诠释"不良事件监测与再评价"这一理念,携手各方搭建医疗器械产品风险防控网,维护和保障公众用械安全及健康权益。
The whole life cycle of supervision and management on medical devices should include R&D, production, access, operation, use and re-evaluation, which interlock with each other.However,"adverse event monitoring and reappraisal" has always been regarded as a "minefield" because of the misunderstanding.Publish of 《Measures for monitoring and reevaluating medical device adverse events》 is to strengthen the scientific supervision on the whole life cycle of medical devices.The aim of this article is to interpret the concept of "adverse event monitoring and re-evaluation"more comprehensively by combing the development process of medical device supervision and management system.Join hands with all parties to build a risk prevention and control network for medical devices to safeguard and protect the safety and health rights of the public.
作者
张徐婧
ZHANG Xujing(Assets Management Department of Rui Jin Hospital,Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai,200025)
出处
《生物医学工程学进展》
CAS
2019年第1期43-46,共4页
Progress in Biomedical Engineering
关键词
医疗器械
不良事件监测
再评价
medical apparatus and instruments
adverse event monitoring
reevaluation
