《中国卫生质量管理》[ISSN:1006-7515/CN:CN 61-1283/R]
卷:
第24卷
期数:
2017年02期
页码:
90-93
栏目:
卫生技术评估专栏
出版日期:
2017-03-28
- 作者:
-
黄晓玲陈英耀*何露洋刘静王弓茹孙辉
-
复旦大学公共卫生学院/国家卫生计生委卫生技术评估重点实验室
- 关键词:
-
医疗器
- Keywords:
-
Medical Instrument; Adverse Event; Monitoring System
- DOI:
-
10.13912/j.cnki.chqm.2017.24.2.27
- 摘要:
-
医疗器械不良事件监测是医疗器械安全监管的重要组成部分，也是确保医疗器械安全的重要手段。各国医疗器械不良事件监测体系均不相同，就美国、欧盟与我国的医疗器械不良事件的报告来源、报告时间、 不良事件数据库以及不良事件的反馈及控制等方面进行梳理和比较，探索我国医疗器械不良事件监测体系的改进策略，包括信息系统、上报机构、召回监管等。
- Abstract:
-
Medical device adverse events monitoring is an important part of safety supervision of post-marketing medical devices. It is also one of the important means to ensure safety and effectiveness of medical devices. National medical device adverse event monitoring system is different. In the United States, the European Union and China, medical device adverse events reporting sources, reporting time, adverse events database and adverse events feedback and control and other aspects were combed and compared, which aimed to explore improvements on China's medical device adverse events monitoring system, including information system, reporting agencies, recall regulation, etc.
更新日期/Last Update:
2017-03-28
