英国2008年度医疗器械不良事件报告对我国的启示  

The Enlightenment for Our Country from the UK 2008 Annual Report of Medical Device Adverse Event

作　　者：曹波[1] 张素敏[1] 

机构地区：[1]国家食品药品监督管理局药品评价中心,北京100045

出　　处：《中国药物警戒》2009年第10期584-588,共5页Chinese Journal of Pharmacovigilance

摘　　要：通过对英国药品和保健产品管理局(MHRA)2008年度医疗器械不良事件报告情况进行分析,了解了MHRA的工作情况及,总结了英国医疗器械不良事件监测工作的特点,以期我国医疗器械不良事件监测机构能及时借鉴其管理经验,加强医疗器械不良事件监测的信息化建设,强化生产企业的主体责任,注重与报告人之间的反馈。Using the UK 2008 annual Report of Medical Device Adverse Event as the starting point, this paper briefly introduces the progress of the work of the MHRA, concludes the characteristics of the monitoring of medical device adverse events, and expects monitoring bodies in our country can learn from their management experience timely, strengthening the information construction of the adverse events monitoring, strengthening the main responsibility of enterprises, putting emphasis on feedback between report.

关 键 词：医疗器械不良事件 不良事件调查 反馈 

分 类 号：R955[医药卫生—药学]