美国FDA MAUDE数据库导尿管不良事件监测分析  

Monitoring and Analysis of Adverse Events of Catheter in US FDA MAUDE Database

作　　者：陈世伟 许玉龙 朱勇超 王丽[1] 刘伟[2] CHEN Shi-wei;XU Yu-long;ZHU Yong-chao;WANG Li;LIU Wei(Center for Food Reevaluation of Henan,Henan Zhengzhou 450000;School of Pharmaceutical Sciences,Zhengzhou University,Henan Zhengzhou 450000)

机构地区：[1]河南省食品药品评价中心,河南郑州450000 [2]郑州大学药学院,河南郑州450000

出　　处：《中国医疗器械信息》2020年第17期18-20,共3页China Medical Device Information

基　　金：河南省科技攻关项目(项目名称:一次性使用导尿管风险评价与控制研究,项目编号:182102310673)。

摘　　要：目的:对MAUDE数据库中导尿管不良事件报告数据进行研究,分析导尿管不良事件发生的风险因素,包括器械故障和患者伤害,旨在为我国导尿管风险监测提供参考。方法:通过对2015年~2018年美国FDA导尿管不良事件被动监测的数据库中5645份导尿管不良事件报告进行统计分析。结果:导尿管不良事件器械故障主要为球囊问题、漏尿、漏液和导尿管脱落;患者伤害主要为感染和损伤。结论:建议相关部门完善指导原则;增强企业责任意识;促进导尿管不良事件报告信息有效性和完整化;健全不良事件发生后,后续结果处理反馈机制,保障患者权益。Objective:By studying the data of adverse events report of catheter in MAUDE database and analyzing the risk factors of adverse events of catheter,including device failure and patient injury,in order to provide reference for risk monitoring of catheter in China.Methods:By analyzing the 5,645 urinary catheter adverse events which collected from FDA database in 2015 to 2018.Results:The equipment failure of urinary catheter was mainly balloon problem,urine leakage,fluid leakage and catheter shedding.The main injuries are infection and injury.Conclusion:Relevant departments should improve the guiding principles;Enhancing the sense of corporate responsibility;Promoting the effectiveness and completion of the information of urinary catheter adverse events;Improving the followup results processing feedback mechanism to protect the rights and interests of patients.

关 键 词：导尿管 风险因素 器械故障 患者伤害 

分 类 号：R197.39[医药卫生—卫生事业管理]