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

doi:10.19803/j.1672-8629.2022.01.03

Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (1): 13-17.
DOI: 10.19803/j.1672-8629.2022.01.03

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

Abstract

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

CLC Number:

R994.11

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

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