警戒视域下开展医疗器械上市后主动监测的实践研究与思考

doi:10.19803/j.1672-8629.20230529

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (12): 1385-1390.
DOI: 10.19803/j.1672-8629.20230529

警戒视域下开展医疗器械上市后主动监测的实践研究与思考

赵燕¹, 李尧^2△, 宋雅娜¹, 郑立佳¹, 李栋¹, 赵一飞¹, 卞蓉蓉^2#, 董放^1*

¹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 100076;
²江苏省药品不良反应监测中心，江苏南京 210002

收稿日期:2023-08-30 出版日期:2023-12-15 发布日期:2023-12-15
通讯作者: ^*董放,男,硕士,高级工程师,医疗器械上市后安全性监测与评价。E-mail：dongfang@cdr-adr.org.cn; ^#为共同通信作者。
作者简介:赵燕,女,硕士,高级工程师,医疗器械上市后安全性监测与评价。^△为并列第一作者。
基金资助:
国家重点研发计划（2021YFC2009100、2021YFC- 2009104）; 中国药品监管科学行动计划第二批重点项目([2021]37-10)

Post-marketing active monitoring of medical devices under vigilance

ZHAO Yan¹, LI Yao^2△, SONG Ya’na¹, ZHENG Lijia¹, LI Dong¹, ZHAO Yifei¹, BIAN Rongrong^2#, DONG Fang^1,*

¹Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
²Center for ADR Monitoring of Jiangsu, Nanjing Jiangsu 210002, China

Received:2023-08-30 Online:2023-12-15 Published:2023-12-15

摘要/Abstract

摘要： 目的结合我国医疗器械警戒试点工作,研究我国开展医疗器械上市后主动监测的可行性和必要性,提出利用主动监测新方法开展医疗器械警戒实践的建议。方法通过文献分析,结合我国现行医疗器械不良事件监测工作实践,分析中国和美国开展的主动监测研究实例,阐述主动监测在医疗器械警戒活动中的应用。结果主动监测作为一种医疗器械警戒新方法,将在医疗器械上市后安全监管领域发挥重要作用。结论在我国医疗器械风险管理新要求下,借鉴美国医疗器械监管经验,建议在我国医疗器械警戒试点过程中研究探索主动监测新方法,持续提升医疗器械风险监测效能,有效保障公众用械安全。

关键词: 医疗器械, 警戒, 主动监测, 上市后, 风险管理, 安全性

Abstract: Objective To study the feasibility and importance of post-marketing active monitoring of medical devices in China based on the pilot vigilance of medical devices and to offer recommendations for active monitoring using new methods for medical device vigilance. Methods Based on the current methods for adverse event monitoring of medical devices, cases of research on active monitoring conducted at home and in the United States were analyzed while the applications of active monitoring in medical device vigilance were elaborated. Results As a new mean of medical device vigilance, active monitoring will play an important role in the field of post-marketing safety supervision of medical devices. Conclusion In order to adapt to new requirements for risk control over medical devices and draw on the experience of the United States in terms of regulation of medical devices, it is recommended that new methods for active monitoring of medical device vigilance be explored in China in order to continue to improve the effectiveness of risk monitoring of medical devices and ensure the safety of medical devices.

Key words: medical device, vigilance, active monitoring, post-marketing, risk monitoring, safety

中图分类号:

R951

赵燕, 李尧, 宋雅娜, 郑立佳, 李栋, 赵一飞, 卞蓉蓉, 董放. 警戒视域下开展医疗器械上市后主动监测的实践研究与思考[J]. 中国药物警戒, 2023, 20(12): 1385-1390.

ZHAO Yan, LI Yao, SONG Ya’na, ZHENG Lijia, LI Dong, ZHAO Yifei, BIAN Rongrong, DONG Fang. Post-marketing active monitoring of medical devices under vigilance[J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1385-1390.

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警戒视域下开展医疗器械上市后主动监测的实践研究与思考

Post-marketing active monitoring of medical devices under vigilance

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