血液透析设备相关的309例可疑医疗器械不良事件报告分析与警示  

Analysis and Warning of 309 Suspected Medical Device Adverse Event Reports Related to Hemodialysis Equipment

作　　者：潘芳芳 PAN Fang-fang(Wuxi Drug Adverse Reaction Monitoring Center,Wuxi,Jiangsu Province,214029China)

机构地区：[1]无锡市药品不良反应监测中心,江苏无锡214029

出　　处：《中国卫生产业》2019年第22期173-175,共3页China Health Industry

摘　　要：为了有效利用不良事件监测数据,更好地防范和控制血液透析设备不良事件的发生,该文利用2011年12月—2018年12月收集的全无锡市的血液透析设备相关的医疗器械不良事件报告进行统计分析。研究讨论血液透析设备各组成部分的器械故障以及主要伤害的关联性,并给出相关警示信息,为企业改进产品质量,为医疗单位安全使用提供参考。In order to effectively use the adverse event monitoring data to better prevent and control the occurrence of adverse events in hemodialysis equipment,this paper uses the medical equipment related to hemodialysis equipment in Wuxi City collected from December 2011 to December 2018.The incident report is statistically analyzed.Study and discuss the equipment failure of each component of hemodialysis equipment and the correlation of major injuries,and give relevant warning information to improve the quality of products for enterprises and provide reference for the safe use of medical units.

关 键 词：血液透析设备 血液透析机 血液透析器 血液透析管路 不良事件 

分 类 号：R197.39[医药卫生—卫生事业管理]