医疗卫生装备2024，Vol.45Issue(7)：72-76,5.DOI:10.19745/j.1003-8868.2024135
241例体外诊断类和临床检验类医疗器械不良事件分析
Analysis of adverse events of in vitro diagnostic and clinical laboratory medical devices:241 case reports
唐剑 1袁文杰1
作者信息
- 1. 厦门市产品技术审评与审核查验中心,福建厦门 361005
- 折叠
摘要
Abstract
Totally 241 suspicious adverse event reports of in vitro diagnostic and clinical laboratory medical devices reported by medical institutions in Xiamen to the National Medical Device Adverse Event Monitoring Information System from October 2020 to October 2023 were collected.The medical devices involved in were analyzed in terms of the variety,classification and cause for adverse events,and the characteristics of the adverse events were summarized.Some suggestions were put forward including strengthening risk control of post-marketing adverse events of relevant products,enhancing quality management of the use of relevant products,actively exploring the risk signals and supervising the implementation of corrective actions.References were provided for the marketing license holders,medical institutions and supervisory authorities to improve the monitoring capacity,reduce the incidence of adverse events and ensure the safety of devices.[Chinese Medical Equipment Journal,2024,45(7):72-76]关键词
医疗器械/体外诊断类医疗器械/临床检验类医疗器械/不良事件/医疗器械监测Key words
medical device/in vitro diagnostic medical device/clinical laboratory medical device/adverse events/monitoring of medical device分类
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唐剑,袁文杰..241例体外诊断类和临床检验类医疗器械不良事件分析[J].医疗卫生装备,2024,45(7):72-76,5.
