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

doi:10.19803/j.1672-8629.2022.01.03

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (1): 13-17.
DOI: 10.19803/j.1672-8629.2022.01.03

• 真实世界数据支持药械监测与评价(一）专栏 • 上一篇下一篇

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

谭婧^1,2, 刘春容^1,2,△, 黄诗尧^1,3, 高培⁴, 王杨⁵, 李晨⁶, 贺勇⁶, 袁洪⁷, 王雯^1,2, 李玲^1,2, 熊益权^1,2, 任燕^1,2, 姚明宏^1,2, 赵燕⁸, 董放⁸, 沈传勇^8#, 孙鑫^1,2,*

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

收稿日期:2021-10-08 出版日期:2022-01-15 发布日期:2022-01-20
通讯作者: ^*孙鑫,男,博士,研究员,临床流行病学与循证医学。E-mail：sunx79@hotmail.com。^#为共同通信作者。
作者简介:谭婧,女,博士,副研究员,临床流行病学与循证医学。^△为并列第一作者。
基金资助:
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）

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

TAN Jing^1,2, LIU Chunrong^1,2,△, HUANG Shiyao^1,3, GAO Pei⁴, WANG Yang⁵, LI Chen⁶, HE Yong⁶, YUAN Hong⁷, WANG Wen^1,2, LI Ling^1,2, XIONG Yiquan^1,2, REN Yan^1,2, YAO Minghong^1,2, ZHAO Yan⁸, DONG Fang⁸, SHEN Chuanyong^8#, SUN Xin^1,2,*

¹Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu Sichuan 610041, China;
²NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu Sichuan 610041, China;
³Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu Sichuan 610037, China;
⁴Department of Epidemiology and Health Statistics, School of Public Health, Peking University, Beijing 100191, China;
⁵National Center for Cardiovascular Diseases, Fuwai Hospital Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China;
⁶Department of Cardiology, West China Hospital, Sichuan University, Chengdu Sichuan 610041, China;
⁷Xiangya Third Hospital, Central South University, Changsha Hunan 410013, China;
⁸Center for Drug Reevaluation, NMPA, NMPA, Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100021, China

Received:2021-10-08 Online:2022-01-15 Published:2022-01-20

摘要/Abstract

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。

关键词: 真实世界数据, 无源植入类医疗器械, 上市后监测

Abstract: 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.

Key words: real world data, passive implantable medical devices, post-marketing risk monitoring

中图分类号:

R994.11

谭婧, 刘春容, 黄诗尧, 高培, 王杨, 李晨, 贺勇, 袁洪, 王雯, 李玲, 熊益权, 任燕, 姚明宏, 赵燕, 董放, 沈传勇, 孙鑫. 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[J]. 中国药物警戒, 2022, 19(1): 13-17.

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. Expert consensus on post-marketing risk monitoring technology for high-risk implantable passive medical devices based on real world data[J]. Chinese Journal of Pharmacovigilance, 2022, 19(1): 13-17.

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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

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