基于真实世界数据的高风险植入类无源医疗器械上市后风险监测技术专家共识  

Expert consensus on post-marketing risk monitoring technology for high-risk implantable passive medical devices based on real world data

作　　者：谭婧[1,2] 刘春容 黄诗尧 高培 王杨[5] 李晨[6] 贺勇[6] 袁洪[7] 王雯[1,2] 李玲[1,2] 熊益权 任燕[1,2] 姚明宏 赵燕 董放[8] 沈传勇 孙鑫 TAN Jing;LIU Chunrong;HUANG Shiyao;GAO Pei;WANG Yang;LI Chen;HE Yong;YUAN Hong;WANG Wen;LI Ling;XIONG Yiquan;REN Yan;YAO Minghong;ZHAO Yan;DONG Fang;SHEN Chuanyong;SUN Xin(Chinese Evidence-based Medicine Center,West China Hospital,Sichuan University,Chengdu Sichuan 610041,China;NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan,Chengdu Sichuan 610041,China;Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu Sichuan 610037,China;Department of Epidemiology and Health Statistics,School of Public Health,Peking University,Beijing 100191,China;National Center for Cardiovascular Diseases,Fuwai Hospital Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100037,China;Department of Cardiology,West China Hospital,Sichuan University,Chengdu Sichuan 610041,China;Xiangya Third Hospital,Central South University,Changsha Hunan 410013,China;Center for Drug Reevaluation,NMPA,NMPA,Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100021,China)

机构地区：[1]四川大学华西医院中国循证医学中心,四川成都610041 [2]国家药品监督管理局海南真实世界数据研究与评价重点实验室,四川成都610041 [3]成都中医药大学附属医院/四川省中医药循证医学中心,四川成都610037 [4]北京大学公共卫生学院流行病与卫生统计学系,北京100191 [5]中国医学科学院北京协和医学院阜外医院国家心血管病中心医学统计部,北京100037 [6]四川大学华西医院心脏内科,四川成都610041 [7]中南大学湘雅三医院,湖南长沙410013 [8]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100021

出　　处：《中国药物警戒》2022年第1期13-17,31,共6页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(72174132);国家药品监督管理局中国药品监管科学行动计划第二批重点项目;国家药品监督管理局药品评价中心课题(20186X001)。

摘　　要：高风险植入类无源医疗器械的上市后监测是医疗器械风险管理的重要环节,通过对高风险医疗器械上市后安全性信号的监测和评价,最大限度地控制医疗器械潜在的风险,保证医疗器械安全、有效地使用,避免发生群体性严重后果,是医疗器械生产、经营、使用机构和技术监测部门的共同职责。为了更好地促进和辅助高风险植入类无源医疗器械的上市后监测,本专家共识采用系统性文献回顾、专题小组讨论和专家咨询过程,系统梳理国内外医疗器械上市后风险监测现状,并提出适宜于我国国情的高风险植入类无源医疗器械上市后风险监测模式和高风险医疗器械风险监测关键技术。Post-market surveillance of high-risk implantable passive medical devices is one of key aspects in the risk management of medical device.It is the common responsibility of medical device industry,operations,user institutions and regulatory departments to control the potential risks of medical devices to the maximum extent,and ensure the safe and effective use of medical devices and avoid mass serious consequences,which can be achieved by post-market surveillance and evaluation management of safety signals of high-risk medical devices.In order to promote and assist the post-market surveillance of high-risk implantable passive medical devices,by systematic literature review,focus group discussion and expert consultation,this expert consensus systematically reviewed the status quo of post-market surveillance of risk among medical devices home and board,further constructed the mode of risk monitoring of high-risk implantable passive medical device and key technologies which could be suitable for China’s national conditions.

关 键 词：真实世界数据 无源植入类医疗器械 上市后监测 

分 类 号：R994.11[医药卫生—毒理学]