欧盟医疗器械上市后风险趋势分析方法研究

doi:10.19803/j.1672-8629.2022.01.17

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (1): 79-82.
DOI: 10.19803/j.1672-8629.2022.01.17

欧盟医疗器械上市后风险趋势分析方法研究

郑超¹, 吴艳¹, 张兰¹, 胡凯¹, 曾叶¹, 王雯^1,*, 王玲²

¹浙江省医疗器械审评中心,浙江省医疗器械不良事件监测中心,浙江杭州 311121;
²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 100022

收稿日期:2021-04-28 出版日期:2022-01-15 发布日期:2022-01-20
通讯作者: ^*王雯,女,教授级高级工程师,医疗器械不良事件监测与评价。E-mail：1254733662@qq.com
作者简介:郑超,男,博士,高级工程师,医疗器械不良事件监测与评价。
基金资助:
国家重点研发计划（2020YFC2007101）

Methods for risk trend analysis of EU post-marketing surveillance for medical devices

ZHENG Chao¹, WU Yan¹, ZHANG Lan¹, HU Kai¹, ZENG Ye¹, WANG Wen^1,*, WANG Ling²

¹Zhejiang Center For Medical Device Evaluation (Zhejiang Center For Medical Device Adverse Events Monitoring), Hangzhou Zhejiang 311121, China;
²Center For Drug Reevaluation, NMPA/NMPA, Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China

Received:2021-04-28 Online:2022-01-15 Published:2022-01-20

摘要/Abstract

摘要： 目的研究医疗器械上市后风险评估的统计学方法,提高风险管理的科学水平。方法参考欧盟医疗器械新法规中即将实施的趋势报告要求,探索趋势分析方法在医疗器械上市后风险评估中的实践运用,举例说明通过历史数据确定控制限和持续趋势监测的过程,讨论实践中面临的问题。结果趋势分析是科学评估医疗器械上市后风险的方法之一,适于在国内推行。结论企业可运用真实世界风险数据开展趋势分析,提升上市后风险预警能力。

关键词: 医疗器械, 趋势分析, 风险评估, 控制图, 欧盟

Abstract: Objective To improve the level of risk management based on a study of statistical methods for post-marketing risk assessment of medical devices. Methods The applications of trend analysis methods for post-marketing risk assessment of medical devices were explored by reference to the trend reporting requirements in the new EU medical device regulations. The process of determining the control limits and continuous trend monitoring via historical data was analyzed by examples, and related problems were discussed. Results Trend analysis was one of the methods for scientifically evaluating the risks of post-marketing medical devices, and it could be implemented in China. Conclusion Manufacturers can use real-world risk data to carry out trend analysis and improve the ability to warn against post-marketing risks.

Key words: medical devices, trend analysis, risk assessment, control chart, EU

中图分类号:

R951

郑超, 吴艳, 张兰, 胡凯, 曾叶, 王雯, 王玲. 欧盟医疗器械上市后风险趋势分析方法研究[J]. 中国药物警戒, 2022, 19(1): 79-82.

ZHENG Chao, WU Yan, ZHANG Lan, HU Kai, ZENG Ye, WANG Wen, WANG Ling. Methods for risk trend analysis of EU post-marketing surveillance for medical devices[J]. Chinese Journal of Pharmacovigilance, 2022, 19(1): 79-82.

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欧盟医疗器械上市后风险趋势分析方法研究

Methods for risk trend analysis of EU post-marketing surveillance for medical devices

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