医疗器械故障类不良事件自动报告模式研究  

Research on Auto-Reporting Mode of Adverse Events of Medical Device Failure

作　　者：董放[1] 吴世福 黄琳 王刚[1] 田月洁 鞠毅[3] 李洪利[4] 刘松峰[5] 赵玉娟 玄怡 牛惠芳 DONG Fang;WU Shifu;HUANG Lin;WANG Gang;TIAN Yuejie;JU Yi;LI Hongli;LIU Songfeng;ZHAO Yujuan;XUAN Yi;NIU Huifang(National Center for ADR Monitoring,Beijing 100045,China;Shandong Center for ADR Monitoring,Jinan Shandong 250012,China;Weihai Municipal Hospital,Weihai Shandong 264200,China;Binzhou Medical University Hospital,Binzhou Shandong 256603,China;Yuhuangding Hospital,Yantai Shandong 264000,China)

机构地区：[1]国家药品不良反应监测中心,北京100045 [2]山东省药品不良反应中心,山东济南250012 [3]威海市立医院,山东威海264200 [4]滨州医学院附属医院,山东滨州256603 [5]烟台毓璜顶医院,山东烟台264000

出　　处：《中国医疗设备》2018年第7期142-146,共5页China Medical Devices

基　　金：国家食品药品监督管理总局药品评价中心课题:医疗器械故障类不良事件自动报告模式研究

摘　　要：目的基于医疗器械信息化管理系统,研究自动生成不良事件报告、一键上报的模式。方法采用文献检索的方式,分析国内外医疗机构利用信息化技术监测和上报不良事件的模式。以问卷调查和实地调研了解研究的可行性和需求。将该模式在试点医院试运行,并进行验证和改进。结果医疗器械故障类不良事件自动报告模式包括字典库的建立、医疗器械故障的报修、医疗器械的维修和记录、"一键生成"不良事件报告和"一键上报"五个过程。试点医院增加该功能后,故障类不良事件上报数量明显增加,发现风险信号的能力有所提高。结论研究设计的故障类医疗器械不良事件报告模式和"一键生成"参数标准适应我国医疗机构医疗器械不良事件监测和报告工作,是可以推广实施的。Objective Based on the information management system of medical device,we studied a mode that adverse event reports could automatically generate and report.Methods The mode of using information technology to monitor and report adverse events in medical institutions at home and abroad was analyzed with the method of literature retrieval.Then the feasibility and demand of the research were understood through questionnaire and field investigation.The model was tested in the pilot hospital and verified and improved.Results The automatic reporting mode included five processes:the establishment of dictionary database,the report of medical equipment failure,the maintenance and record of medical equipment,“one click generates”bad event report and“one key report”adverse event report.The number of failure adverse events reported increased significantly,and the ability to detect risk signals was improved after implementing automatic reporting mode.Conclusion The adverse event auto-reporting model and parameter standards are adapted to the monitoring and reporting of medical device adverse events in Chinese medical institutions,which can be popularized and implemented in the whole nation.

关 键 词：医疗器械不良事件 自动报告模式 参数标准 字典库 

分 类 号：R197.3[医药卫生—卫生事业管理]