建设国家医疗器械不良事件监测哨点医院的思考

doi:10.19803/j.1672-8629.20250281

中国药物警戒 ›› 2025, Vol. 22 ›› Issue (7): 780-785.
DOI: 10.19803/j.1672-8629.20250281

建设国家医疗器械不良事件监测哨点医院的思考

李栋¹, 宋雅娜¹, 王立刚², 卞蓉蓉³, 赵燕^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辽宁省药品审评查验中心,辽宁沈阳 110033;
³江苏省药品不良反应监测中心,江苏南京 210002

收稿日期:2025-05-06 出版日期:2025-07-15 发布日期:2025-07-17
通讯作者: ^*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。E-mail：zhaoyan@cdr-adr.org.cn
作者简介:李栋,男,硕士,工程师,医疗器械上市后安全性监测与评价。
基金资助:
国家重点研发计划（2024ZD0527402）; 海南省科技专项资助项目（ZDYF2024LCLH007）; 中国药品监管科学行动计划第三批重点项目（RS2024X006）

Considerations for Establishing National Sentinel Hospitals for Medical Device Adverse Event Monitoring

LI Dong¹, SONG Yana¹, WANG Ligang², BIAN Rongrong³, ZHAO Yan^1,*

¹Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100076, China;
²Liaoning Center for Drug Evaluation & Inspection, Shenyang, Liaoning 110033, China;
³Center for ADR Monitoring of Jiangsu, Nanjing 210002, China

Received:2025-05-06 Online:2025-07-15 Published:2025-07-17

摘要/Abstract

摘要： 目的探讨医疗器械不良事件监测哨点（简称“哨点医院”）的职能定位与建设路径,探索构建科学、高效、可持续的哨点医院运行模式,为我国进一步完善医疗器械警戒体系提供参考。方法通过查阅国内外文献,分析我国医疗器械不良事件自发报告工作现状及美国食品药品监督管理局开展的医疗器械产品监督网络（MedSun）项目实践经验,阐述哨点医院的作用价值。结果与结论 我国通过建立哨点医院,进一步提升报告质量、增强风险识别能力、强化主动监测,为实现医疗器械警戒提供数据支撑。

关键词: 医疗器械, 不良事件, 自发报告, 哨点医院, 医疗器械产品监督网络, 警戒

Abstract: Objective To explore the functions and ways of establishing sentinel hospitals for medical device adverse event surveillance, and to establish a scientific, efficient, and sustainable operational model for sentinel hospitals in order to provide data for enhancing China's surveillance system for medical devices. Methods By reviewing domestic and foreign literature, this article analyzed the status quo of spontaneous adverse event reporting in China and elucidated the role and value of sentinel hospitals by drawing on the experience of the FDA's MedSun program. Results and Conclusion National sentinel hospitals should be established to improve the quality of reporting, upgrade risk identification, and enhance active surveillance so as to provide data for medical device vigilance in China.

Key words: Medical Devices, Adverse Events, Spontaneous Reporting, Sentinel Hospitals, MedSun, Vigilance

中图分类号:

R951
R994.11

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.

LI Dong, SONG Yana, WANG Ligang, BIAN Rongrong, ZHAO Yan. Considerations for Establishing National Sentinel Hospitals for Medical Device Adverse Event Monitoring[J]. Chinese Journal of Pharmacovigilance, 2025, 22(7): 780-785.

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建设国家医疗器械不良事件监测哨点医院的思考

Considerations for Establishing National Sentinel Hospitals for Medical Device Adverse Event Monitoring

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