摘要
目的:通过对北京市医疗器械上市许可持有人贯彻落实新版《医疗器械不良事件监测和再评价管理办法》工作情况的调研和分析,提出推进医疗器械持有人主动开展医疗器械不良事件工作的建议,促进持有人由被动参与到主动监测,为更全面地、科学地、主动地开展医疗器械不良事件监测工作提供参考。方法:采用数据检索与持有人问卷调查、培训、座谈相结合的方法。结果:在国家医疗器械不良事件监测信息系统中完成1313家北京市持有人100%注册,2020年收到涉及北京市医疗器械持有人报告24240份,收到持有人主动报告894份;北京市药品不良反应监测中心收到651份持有人问卷调查,对持有人进行3000人次培训,对70家进行座谈走访。结论:了解持有人医疗器械不良事件监测情况,提出主动监测工作的建议,更加全面地、科学地、主动地进行医疗器械风险控制。
Objective:To investigate and analyze the implementation of the new version of“Administrative Measures for Monitoring and Re-evaluation of Medical Device Adverse Events”by holders of Beijing medical device marketing licenses.Put forward suggestions to promote medical device holders to actively carry out medical device adverse events,promote the holders to go from passive participation to active monitoring,and provide reference for more comprehensive,scientific and active monitoring of medical device adverse events.Method:The method of data retrieval combined with the holder’s questionnaire survey,training,and seminars was adopted.Results:100%registration of 1,313 Beijing holders was completed in the National Medical Device Adverse Event Monitoring Information System.In 2020,24,240 reports involving Beijing medical device holders were received,and 894 reports were received from holders on their own initiative;The Beijing Adverse Drug Reaction Monitoring Center received 651 questionnaires from holders,trained 3,000 holders,and conducted seminars and visits to 70 holders.Conclusion:Understand the monitoring situation of the holder's medical device adverse events,put forward suggestions for active monitoring work,and conduct medical device risk control more comprehensively,scientifically and actively.
作者
杨飞
翟伟
梁伟
孟永成
刘文斐
孙文竹
李学函
钟蕾
刘东红
YANG Fei;ZHAI Wei;LIANG Wei;MENG Yong-cheng;LIU Wen-fei;SUN Wen-zhu;LI Xue-han;ZHONG Lei;LIU Dong-hong(Beijing Center for ADR Monitoring,Beijing 100035)
出处
《中国医疗器械信息》
2021年第17期3-6,共4页
China Medical Device Information
关键词
上市许可持有人
主动监测
医疗器械不良事件
风险控制
medical device listing approval holder
active monitoring
medical device adverse event
risk control
