14660例可疑医疗器械不良事件报告分析  

Statistic Analysis of 14660 Medical Device Administration Events Reports

作　　者：曾茜 叶月华 杨翠连 何基琛 汤祖青 欧秋琦 庞婷 ZENG Qian;YE Yuehua;YANG Cuilian;HE Jichen;TANG Zuqing;OU Qiuqi;PANG Ting(School of Public Health,Guangxi Medical University,Nanning Guangxi 530021,China;Department of Business,Guangxi Medical Device Testing Center,Nanning Guangxi 530021,China;Department of Quality Control,Liuzhou General Hospital,Liuzhou Guangxi 545006,China;Department of Orthopedic,The People's Hospital of Guangxi Zhuang Autonomous Region,Nanning Guangxi 530021,China)

机构地区：[1]广西医科大学公共卫生学院,广西南宁530021 [2]广西壮族自治区医疗器械检测中心业务科,广西南宁530021 [3]柳州市人民医院质控科,广西柳州545006 [4]广西壮族自治区人民医院骨科,广西南宁530021

出　　处：《中国医疗设备》2019年第9期143-145,149,共4页China Medical Devices

摘　　要：目的对2016年广西可疑医疗器械不良事件报告进行分析,了解我区医疗器械不良事件监测的整体情况,为合理监测评价和进一步加强监测工作提供参考建议。方法采用回顾性分析方法,对广西壮族自治区药品不良反应监测中心2016年收集到的14660例可疑医疗器械不良事件报告进行统计分析。结果医疗器械不良事件报告来源的86.40%为使用单位;报告人职业和使用场所主要在医疗机构;报告质量有待提高;宫内节育器、一次性使用输液器、静脉留置针等Ⅲ类医疗器械产品引起的不良事件所占比例较高。结论需要提升对医疗器械不良事件风险监测的认知,开展针对性的宣传培训,健全医疗器械不良事件监测网络及报告制度,进一步推动监测工作开展,保证人民用械安全。Objective To understand the overall situation of medical device administration events monitoring in Guangxi by analyzing the reports of medical device administration events collected in Guangxi in 2016,and provide reference for reasonable monitoring and evaluation and further strengthening monitoring work.Methods A retrospective analysis method was used to analyze the statistical results of 14660 cases of medical device administration events collected by the Guangxi Zhuang Autonomous Region Adverse Drug Reaction Monitoring Center in 2016.Results In the survey,86.40%of the sources of medical device administration events reports were units of use.The occupation and use of reporters was mainly in medical institutions.Report quality needed to be improved.High proportion of administration events caused by Class III medical device products such as intrauterine devices,disposable infusion sets,and intravenous indwelling needles.Conclusion We need to improve awareness of risk monitoring of medical device adverse events,carry out targeted publicity and training,improve the monitoring network and reporting system for medical device administration events,further promote monitoring and ensure the safety of people's machinery.

关 键 词：医疗器械 不良事件 不良事件监测 不良事件报告 不良事件分析 

分 类 号：R197.39[医药卫生—卫生事业管理]