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。
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.
作者
李栋
宋雅娜
王立刚
卞蓉蓉
赵燕
LI Dong;SONG Yana;WANG Ligang;BIAN Rongrong;ZHAO Yan(Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China;Liaoning Center for Drug Evaluation&Inspection,Shenyang,Liaoning 110033,China;Center for ADR Monitoring of Jiangsu,Nanjing 210002,China)
出处
《中国药物警戒》
2025年第7期780-785,共6页
Chinese Journal of Pharmacovigilance
基金
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)。
