241例体外诊断类和临床检验类医疗器械不良事件分析OACSTPCD
Analysis of adverse events of in vitro diagnostic and clinical laboratory medical devices:241 case reports
收集了 2020年10月至2023年10月厦门市医疗机构上报在国家医疗器械不良事件监测信息系统上的241例体外诊断类和临床检验类医疗器械可疑不良事件报告,分析了医疗器械的品种、分类及不良事件产生的原因,总结了医疗器械不良事件的特点,提出了加强相关产品上市后不良事件的风险控制、加强相关产品的使用质量管理以及主动挖掘风险信号并督促整改落实等建议,为上市许可持有人、医疗机构和监测监管部门提升监测能力、降低不良事件发生率以及保障用械安全提供了参考.
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]
唐剑;袁文杰
厦门市产品技术审评与审核查验中心,福建厦门 361005
基础医学
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
medical devicein vitro diagnostic medical deviceclinical laboratory medical deviceadverse eventsmonitoring of medical device
《医疗卫生装备》 2024 (007)
72-76 / 5
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