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某三甲医院医疗器械不良事件的管理 被引量:1

Study on the Management of Medical Device Adverse Events in a 3A Hospital
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摘要 [目的]回顾性分析医疗器械不良事件报告过程中存在的问题,对医用耗材管理进行流程再塑。[方法]利用NVivo12分析软件对2020年某三甲医院的医疗器械不良事件上报数据进行文本分析。[结果]医疗器械不良事件上报存在“轻低值重高值”、不规范不完整填报,以及医疗机构上报流程管理漏洞等问题。[结论]通过优化内部流程、信息化管理与循环质量管理等措施,进行医疗机构医疗器械管理的内部流程再塑,强化医疗器械及耗材的全生命周期管理和规范使用。 [Objective] Aim to analyse the problems of the process of the medical devices adverse event reports, which is about to remodel the medical device management. [Methods] Used NVivo software to analyze the data of the hospital’s suspicious medical device adverse event reporting in 2020. [Results] The report of adverse events of medical devices and consumables reveals that there are nonstandard and incomplete reporting, the phenomenon of “ignore the low-cost consumables’ adverse events”and the manage bugs of medical institutions’ reporting process. [Conclusion] Through the optimization of the internal management process, the information management and PDCA management, it is recommended to solve the problems from the aspects of remodeling the hospital’s internal management process, strengthening the safety life-cycle management and standard use.
作者 陈俊衣 姚瑶 伍子英 CHEN Junyi;YAO Yao;WU Ziying(Purchasing Department,The Third Affiliated Hospital of Guangzhou Medical University,Guangzhou 510150,China;Medical Quality Control Office,Fifth Hospital in Wuhan,Wuhan 430050,China)
出处 《清远职业技术学院学报》 2023年第1期59-63,共5页 Journal of Qingyuan Polytechnic
关键词 医疗器械不良事件报告 医疗器械管理 信息化管理 UDI Suspicious medical device adverse event report Medical device management Information management UDI
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