270例医疗器械不良事件报告分析  

Report Analysis About 270 Cases of Adverse Events of Medical Devices

作　　者：蒋亚萍[1] 胡志强[1] Jiang Yaping;Hu Zhiqiang(Yixing Hospital Affiliated to Jiangsu University,Yixing Jiangsu 214200,China)

机构地区：[1]江苏大学附属宜兴医院,江苏宜兴214200

出　　处：《医疗装备》2021年第17期43-44,47,共3页Medical Equipment

摘　　要：目的探讨医院医疗器械不良事件发生的基本情况和特点。方法利用国家医疗器械不良事件监测中心数据库软件,采用回顾性研究方法,统计分析医院2019年上报的270例合格(审核通过)的医疗器械不良事件。结果270例报告中,严重伤害为31例(11.48%),其他为239例(88.52%)。在270例报告中,监护仪引起的不良事件为52例(19.26%),占比最高,其他依次为微量注射泵(4.81%)、一次性使用输液器带针(4.44%)、一次性使用医用棉签(4.44%)等。结论医院应加强对医疗器械不良事件的日常监测,保障患者用械安全。Objective The basic situation and char acteristics of adverse events of medical devices in the hospital were explored.Methods Through the database software of National Medical Device Adverse Reaction Monitoring Center,270 cases of qualified medical device adverse events reported by the hospital in 2019 were statistically analyzed retrospectively.Results Among the 270 cases,31 cases(11.48%)were identified as serious injury,while the other 239 cases(88.52%)were not.Among the 270 cases reported,52 cases(19.26%)were caused by monitor,which accounted for the largest proportion,followed by micro syringe pump(4.81%),disposable infusion set with needle(4.44%),disposable medical cotton swab(4.44%),etc.Conclusion The hospital should strengthen the daily monitoring of adverse events of medical devices to ensure the safety of patients for using medical devices.

关 键 词：医疗器械 不良事件 回顾性研究 日常监测 用械安全 

分 类 号：R197.39[医药卫生—卫生事业管理]