医疗器械不良事件报告计算机自动审核规则的初步探索  

Preliminary Exploration on Computer-Based Auto-Verification Rules of Medical Device Adverse Event Reports

作　　者：方雅宁 刘小瑜 汪曙 FANG Ya-ning;LIU Xiao-yu;WANG Shu(Shenzhen Institute of Pharmacovigilance and Risk Management,Guangdong Shenzhen 518000)

机构地区：[1]深圳市药物警戒和风险管理研究院,广东深圳518000

出　　处：《中国医疗器械信息》2025年第5期1-4,共4页China Medical Device Information

摘　　要：医疗器械不良事件(MDAE)报告是医疗器械上市后风险管理的关键信息来源。高质量的MDAE报告对于识别和预警可疑医疗器械风险信号至关重要,也是开展医疗器械安全性监测和评价的基础。在我国的监测评价体系中,报告单位提交的MDAE报告需要经过地市级监测机构的审核。随着报告数量的逐年增长,审核的压力也在逐年增加。因此,如何提高MDAE报告的审核效率和准确率,成为了一个值得思考和探索的问题。文章通过梳理个例MDAE报告的审核要点,对计算机自动审核报告的规则进行了初步探索,并提出了相关建议。Medical device adverse event(MDAE)reports are important information source for post-marketing risk management of medical devices.High-quality MDAE reports are of great significance for the identification and early warning of suspicious medical device risk signals,and are the basis for carrying out medical device safety monitoring and evaluation.In China,the MDAE reports need to be verified by the municipal adverse reaction monitoring institutions.The pressure is increasing as the number of reports increases year by year.It is worthwhile to explore a way to improve the verification efficiency and accuracy of MDAE reports.This paper sorted out the key points of verifying MDAE reports,and explored the computer-based verification rules as well as put forward suggestions.

关 键 词：医疗器械 不良事件报告 计算机自动审核 

分 类 号：R194[医药卫生—卫生事业管理]