在用医疗器械管理现状文献分析  

Literature Analysis on the Current Management Situation of In-Use Medical Device

作　　者：李穗 焦卫红 詹杨 余超 罗培 徐玉茗 LI Sui;JIAO Wei-hong;ZHAN Yang;YU Chao;LUO Pei;XU Yu-ming(Jiangxi Center of Adverse Drug Reaction Monitoring,Jiangxi Nanchang 330046)

机构地区：[1]江西省药品不良反应监测中心,江西南昌330046

出　　处：《中国医疗器械信息》2021年第17期159-162,共4页China Medical Device Information

基　　金：江西省药品监督管理局科研项目(项目名称:基于YY/T0316探索在用医疗器械风险管理模式,项目编号:2019JS29)。

摘　　要：目的:通过文献研究,探讨我国在用医疗器械管理普遍存在的问题,为医疗机构合理管理医疗器械提供信息支持。方法:检索CNKI学术期刊数据,收集2010年~2019年在用医疗器械管理现状的文献,对其统计分析。结果:共筛选出98篇文献,经统计发现,医疗器械运行质量控制不足、管理制度不健全、采购管理不规范、技术人员数量或能力不足等问题突出。结论:医疗机构对在用医疗器械的管理意识不足,管理现状混乱具有普遍性。医疗机构和相应监管部门应高度重视在用医疗器械的管理,采取合理控制措施,改善当前的管理现状,提高在用医疗器械的使用安全。Objective:Through literature study,explore the common problems in the management of in-use medical devices in China,to provide information support for medical institutions to manage medical devices reasonably.Methods:The data of CNKI academic journals were retrieved,and the current management situation of in-use medical device from 2010 to 2019 were collected for statistical analysis.Results:A total of 98 literatures were selected,and the results showed that the operation quality control of in-use medical devices was insufficient,the management system was not perfect,the procurement management was not standardized,and the number of technicians or the ability was insufficient.Conclusion:Medical institutions have insufficient awareness of the management of in-use medical devices,and the current management situation is general confusion.Medical institutions and relevant regulatory departments should attach great importance to the management of in-use medical devices,take reasonable control measures,improve the current management Situation,and improve the safety of in-use medical devices.

关 键 词：在用医疗器械 管理 管理制度 现状 文献分析 

分 类 号：R197.39[医药卫生—卫生事业管理]