CHINESE JOURNAL OF DRUG EVALUATION >

2025 , Vol. 42 >Issue 6: 416 - 416-420

DOI: https://doi.org/magtech-2025-04-14-00004

Study on the Construction of Technical Specifications for Risk Monitoring of Adverse Events in Hospitals

  • 怡 玄
Expand
  • 1.Shandong Center for ADR Monitoring， Shandong Jinan 250014， China；
    2.Zibo Municipal Center for Pharmacovigilance， Shandong Zibo 255000， China；
    3.People′s Hospital of Linzi District of Zibo， Shandong Zibo 255400， China

Received date: 2025-04-14

  Accepted date: 2026-01-07

  Online published: 2026-01-07

Supported by

医疗机构医疗器械不良事件风险信号报告规范研究(2024-Y-Q-010)

Fold

Abstract

This study is based on the regulatory needs of the whole life cycle of medical devices， and systematically elaborates the core value of constructing the risk signal monitoring system of medical device adverse events from the perspective of standardisation. It addresses the problems of low awareness and consciousness， lagging behind in the construction of risk monitoring system， insufficient regulatory basis and lack of operability in the investigation， analysis and reporting of risk signals of adverse events in hospitals. Following the design principles of science， comprehensiveness， practicality and dynamics， the technical specification framework is constructed with 7 dimensions and 13 items. The results of the pilot implementation of the technical specification show that the effectiveness of risk management in hospitals has been significantly improved， and it is suggested to deepen the research on the universality of the technical specification， form a scalable solution， and provide a new tool for the technical governance of the post-market safety supervision of medical devices.

Key words： ; font-size:medium; ">Medical device vigilance；Adverse event；Risk signalling；Technical specification

Cite this article

怡 玄 . Study on the Construction of Technical Specifications for Risk Monitoring of Adverse Events in Hospitals[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2025 , 42(6) : 416 -416-420 . DOI: magtech-2025-04-14-00004

References

[1] 国家药品监督管理局. 国家药监局关于进一步加强药品不良反应监测评价体系和能力建设的意见(国药监药管〔2020〕20号)[EB/OL]. (2020-07-30) [2025-03-28]. https：//www. nmpa. gov. cn/xxgk/fgwj/gzwj/gzwjyp/20200731134330152.
     [2] 国家药品监督管理局. “十四五”国家药品安全及促进高质量发展规划[EB/OL]. (2021-12-30) [2025-03-28]. https：//www. nmpa. gov. cn/ zwgk/ghcw/ghjh/20211230192314164.
     [3] 赵燕，李尧，宋雅娜，等. 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.
     [4] 沈传勇，宋雅娜，赵燕，等. 新时代构建我国医疗器械警戒体系的思考[J]. 中国药物警戒， 2022，19(7)：697-701.
     [5] 国家卫生健康委员会. 国家卫生健康委办公厅关于印发2025年国家医疗质量安全改进目标的通知（国卫办医政函〔2025〕106号）[EB/OL]. (2025-03-21) [2025-03-28]. http：//www. nhc. gov. cn/cms-search/xxgk/getManuscriptXxgk. htm?id=faa451a3ee7e 4872b708c6196a5677e5.
     [6] 黄琳，李霞，杨建卫，等. 监护仪不良事件分析及比例失衡法在风险信号检测的应用[J]. 中国医药导刊，2024，26(10)：975-980.
     [7] 国家市场监督管理总局和国家卫生健康委员会. 医疗器械不良事件监测和再评价管理办法(国家市场监督管理总局令第1号) [EB/OL]. (2018-08-13) [2025-03-28]. https：//www. samr. gov. cn/zw/zfxxgk/fdzdgknr/bgt/art/2023/art_4b69cde387db4c4fa4465 aad987157e0.
     [8] 王丽，张培茗，夏兵，等. 构建医疗器械警戒体系的路径探究[J]. 医疗卫生装备，2024，45(6)：83-86.
     [9] 朱未. 医疗机构医疗器械警戒能力建设初探[J]. 中国食品药品监管，2024，(3)：34-41.
     [10] 潘康宁，袁明辉，赵玉娟，等. 基于深度学习的医疗器械不良事件风险类型的研究[J]. 中国医学工程，2024，32(8)：34-37.
Options
Outlines

/

〈 〉

[an error occurred while processing this directive]