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.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://zgywjj.magtechjournal.com/CN/10.19803/j.1672-8629.2022.01.17

https://zgywjj.magtechjournal.com/CN/Y2022/V19/I1/79

参考文献

[1] National Medical Products Administration. Annual report of national medical device adverse event monitoring (2020)[EB/OL].(2021-03-29)[2021-03-29]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjylqx/20210329170305102.html.
[2] The State Council. Regulations on the supervision and administration of medical devices(2021)[EB/OL]. (2021-03-18) [2021-03-29]. http://www.gov.cn/zhengce/content/2021-03/18/content_5593739.htm.
[3] European Union Law. EU. regulation (EU) 2017/745 of the European Parliament and of the Council[EB/OL]. (2017-05-05)[2021-03-29]. https://ec.europa.eu/health/md_sector/new_regulations_en.
[4] The Global Harmonization Task Force. Global guidance for adverse event reporting[EB/OL]. (2005-09-15)[2021-03-29]. http://www.imdrf.org/ghtf/ghtf-archives-sg2.asp.
[5] State Administration for Market Regulation, Standardization Administration. Control Charts Part 2: Shewhart control charts(GB/T 17989.2-2020)(控制图第2部分:常规控制图(GB/T 17989.2-2020))[S]. Beijing: State Administration for Market Regulation, Standardization Administration, 2020.
[6] LI JW, LU YQ, LI JX.Application of SPC control chart in the development of small batch aerospace products[J]. Technology Innovation and Appli-cation(科技创新与应用), 2019 (2): 179-181.
[7] LIU ZS, WANG NK, LUO JP.Application of dynamic control chart in multi variety and small batch production[J]. Machinery Design & Manufacture(机械设计与制造), 2017 (5): 96-98.
[8] XU HL.Application of P control chart in quality control of medical devices[J]. Chinese Journal of Medical Instrumentation(中国医疗器械杂志), 2005, 29(4): 283-284.
[9] LIU HT. Application of EWMA control chart system in the management of medical device manufacturing[J]. China Medical Device Information(中国医疗器械信息), 2010, 16 (12): 25, 36.
[10] XIAO Q, LI GJ, ZHANG XB, et al.Application of statistical process control in evaluation of performance for beam-matched medical electron linacs[J]. Chinese Journal of Medical Instrumentation(中国医疗器械杂志), 2021, 45(1): 109-113.
[11] ZHOU HL, FENG WZ, LI HY, et al.Application of quality control chart in continuous improvement of medical quality[J]. Chinese Health Quality Management(中国卫生质量管理), 2015, 127(22): 30-32.
[12] GAO LH, MA DH, ZHANG L.Application of quality control chart in management of nursing adverse events[J]. Journal of Nursing Administration(护理管理杂志), 2020(12): 895-898.
[13] China Food and Drug Administration. YY/T 0287-2017 Medical device-quality management systems-requirements for regulatory purpose(YY/T 0287-2017 医疗器械质量管理体系用于法规的要求)[S]. Beijing: China Food and Drug Administration, 2017.
[14] State Administration for Market Regulation. Supervision order for adverse events monitoring and re-evaluation of medical devices[EB/OL].(2018-08-31)[2021-03-29]. http://gkml.samr.gov.cn/nsjg/bgt/202106/t20210624_331375.html.
[15] State Administration for Market Regulation, Standardization Administration. Control charts - Part 6: EWMA control charts(ISO 7870-6:2016)(控制图-第6部分:指数加权移动平均值控制图(ISO 7870-6:2016))[S]. Beijing: State Administration for Market Regulation, Standardization Administration, 2016.
[16] China Food and Drug Administration. YY/T 0316-2016 Medical devices-application of risk management to medical devices(YY/T 0316-2016 医疗器械风险管理对医疗器械的应用)[S]. Beijing: China Food and Drug Administration, 2016.
[17] LI LH, CHEN YF.Application of risk matrix in post-marketing drug risk assessment: a case study of Terfenadine[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2013, 10(6): 358-361.
[18] CHENG YZ, LUO WX, HUANG FF.Risk analysis of pacemaker system based on failure mode and effect analysis[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2014, 11(2): 104-108.
[19] National Medical Products Administration.Standard for writing periodic risk assessment report of medical devices(No.46, 2020)[EB/OL].(2020-07-24)[2021-03-29]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200702155401886.html.

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

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

[1]	李栋, 宋雅娜, 王立刚, 卞蓉蓉, 赵燕. 建设国家医疗器械不良事件监测哨点医院的思考[J]. 中国药物警戒, 2025, 22(7): 780-785.
[2]	李栋, 赵燕. 国家人工关节置换登记系统在医疗器械上市后监测中的作用与思考[J]. 中国药物警戒, 2025, 22(6): 640-644.
[3]	郭愿生, 左甜甜, 刘丽娜, 魏锋, 董喆, 李静, 金红宇, 马双成. 电感耦合等离子体质谱法测定麸炒薏苡仁中28种元素其风险评估[J]. 中国药物警戒, 2024, 21(9): 1008-1013.
[4]	赵培培, 温宝书. 国内外细胞和基因治疗药品监管研究[J]. 中国药物警戒, 2024, 21(9): 1019-1024.
[5]	仉琪, 陈敏, 张世庆. 美国医疗器械附条件批准介绍及启示[J]. 中国药物警戒, 2023, 20(9): 1007-1010.
[6]	昝珂, 赵磊, 姜大成, 王莹, 金红宇, 马彧, 马双成. 超高效液相色谱串联质谱法筛查款冬花中135种农药残留及其风险评估[J]. 中国药物警戒, 2023, 20(8): 885-890.
[7]	王然, 冯欣, 杜博冉. 围孕期妊娠用药暴露风险评价与药学实践进展[J]. 中国药物警戒, 2023, 20(7): 836-840.
[8]	聂黎行, 王馨平, 李静, 戴忠, 康帅, 马双成. 中药材（饮片）中马兜铃酸的含量分析及初步风险评估[J]. 中国药物警戒, 2023, 20(5): 553-559.
[9]	姚克宇, 张舒琪, 金锐, 刘丽红, 朱彦. 药物致肝损伤数据集的比较研究[J]. 中国药物警戒, 2023, 20(5): 568-573.
[10]	聂黎行, 陈佳, 张烨, 赵慧, 戴忠, 马双成. 板蓝根中外源性有害残留的全面检查及风险评估[J]. 中国药物警戒, 2023, 20(4): 379-382.
[11]	赵燕, 刘文博, 赵一飞, 李栋, 郑立佳, 宋雅娜, 赵玉娟, 董放. 患者登记研究应用于医疗器械监管科学的实践研究与思考[J]. 中国药物警戒, 2023, 20(4): 423-427.
[12]	赵燕, 李栋, 程音婕, 江滨, 赵一飞, 董放, 袁静. 医疗器械上市后安全性数据来源和信号识别方法研究进展[J]. 中国药物警戒, 2023, 20(2): 236-240.
[13]	田春华, 吴桂芝. 定期获益-风险评估报告在我国的实施思考[J]. 中国药物警戒, 2023, 20(12): 1382-1384.
[14]	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.
[15]	李海亮, 刘芫汐, 王赵, 昝珂, 王莹, 金红宇, 马双成. 菊花加工过程中农药残留转移行为及风险评估研究[J]. 中国药物警戒, 2023, 20(11): 1228-1233.