探究医疗器械不良事件对医疗器械使用质量控制影响  

Exploring the Impact of Adverse Medical Device Events on Quality Control of Medical Device Use

作　　者：韩蔚 HAN Wei(Medical Equipment Department of Huai’an First Hospital Affiliated to Nanjing Medical University(Huai’an First People’s Hospital),Jiangsu Huai’an 223300)

机构地区：[1]南京医科大学附属淮安第一医院(淮安市第一人民医院)医疗设备处,江苏淮安223300

出　　处：《中国医疗器械信息》2024年第14期151-153,共3页China Medical Device Information

摘　　要：目的:研究医疗器械不良事件对医疗器械使用质量控制影响。方法:分析2020年1月~2022年12月本院某病区医疗器械不良事件发生情况,随机抽取600例患者平均分为参照组和实验组进行管理,观察其医疗器械不良事件发生率及使用管理质量。结果:本院某病区共发生35件医疗器械不良事件。对比参照组,实验组管理后的医疗器械不良事件总发生率明显更低(P<0.05),医疗器械使用管理质量明显更高(P<0.05)。结论:医疗器械不良事件会影响医疗器械使用质量控制,需要落实医疗器械采取质量控制管理措施,以此有效提高患者诊疗期间的医疗器械安全管理质量,进一步减少患者诊疗期间医疗器械不良事件发生率。Objective:To study the impact of adverse events of medical devices on the quality control of medical device use.Methods:Analyze the incidence of medical device adverse events in a certain ward of our hospital from January 2020 to December 2022.Randomly select 600 patients and divide them evenly into a reference group and an experimental group for management.Observe the incidence of medical device adverse events and the quality of use management.Results:A total of 35 adverse medical device incidents occurred in a certain ward of our hospital.Compared with the control group,the total incidence of adverse events in medical devices managed by the experimental group was significantly lower(P<0.05),and the quality of medical device usage management was significantly higher(P<0.05).Conclusion:Medical device adverse events can affect the quality control of medical device use,and it is necessary to implement quality control management measures for medical device use,in order to effectively improve the quality of medical device safety management during patient diagnosis and treatment,and further reduce the incidence of medical device adverse events during patient diagnosis and treatment.

关 键 词：医疗器械 不良事件 医疗器械使用 质量控制 医疗器械使用管理质量 

分 类 号：R197.32[医药卫生—卫生事业管理]