摘要
目的:概述主动监测模式在医疗器械上市后监测中的应用进展,提出基于“深度监测”范式构建医疗器械主动监测体系的方法学建议。方法:检索全球医疗器械主动监测相关文件及文献,梳理医疗器械上市后监测的发展,总结主动监测的现状、特点及技术手段,提出“深度监测”的新范式。结果:在自发报告模式的基础上,各国和地区逐步探索建立主动监测模式,主动监测模式在一定程度上可弥补自发报告模式存在漏报和迟报的局限性。基于“深度监测”范式,构建一个涵盖多层次、多维度、全覆盖的多源数据主动监测体系,有望更有效、及时地识别并确认医疗器械不良事件。结论:建议基于“深度监测”范式构建医疗器械上市后主动监测体系,探索多源数据联动的医疗器械上市后主动监测和安全性评价。
Objective:This study aims to summarize recent progress in the application of active surveillance for post-market surveillance of medical devices and to propose methodological recommendations for constructing an active surveillance system based on the"deep surveillance"paradigm.Methods:Global policy documents and literature related to active surveillance of medical devices were reviewed.The evolution of post-market surveillance was outlined,and the current status,characteristics,and technical approaches of active surveillance were summarized,leading to the proposal of the"deep surveillance"concept.Results:Building on spontaneous reporting,many countries have gradually explored and established active surveillance model.The active surveillance model can,to some extent,compensate for the limitations of under-reporting and delayed reporting inherent in spontaneous reporting.Based on the"deep surveillance"paradigm,constructing a multi-level,multi-dimensional,and comprehensively covered active surveillance system that integrates multi-source data could enable more effective and timely identification and verification of adverse events related to medical devices.Conclusion:It is recommended to establish an active post-market surveillance system for medical devices based on the"deep surveillance"paradigm,leveraging multi-source data linkage to strengthen post-market surveillance and safety evaluation.
作者
郭宇
李栋
刘秋萍
陆梦溪
刘巍
赵燕
唐迅
邓刚
高培
GUO Yu;LI Dong;LIU Qiu-ping;LU Meng-xi;LIU Wei;ZHAO Yan;TANG Xun;DENG Gang;GAO Pei(Department of Epidemiology and Biostatistics,Peking University School of Public Health;Center for Drug Reevaluation,NMPA;NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance;Key Laboratory of Epidemiology of Major Diseases(Peking University),Ministry of Education;Clinical Research Institute/Institute of Advanced Clinical Medicine(Peking University))
出处
《中国食品药品监管》
2025年第12期4-15,共12页
China Food & Drug Administration Magazine
基金
国家科技创新2030四大慢病重大专项(2024ZD0527406)
国家自然科学基金(82373662)
北京市自然科学基金(IS24047)。
关键词
医疗器械
上市后监测
主动监测
深度监测
大数据
medical devices
post-market surveillance
active surveillance
deep surveillance
big data
