医用耗材不良事件院内上报管理模式优化与成效分析  

Optimization and effectiveness analysis of in-hospital reporting management mode of adverse events of medical consumables

作　　者：吴丽华[1] 罗金燕 缪家清 谭嘉文 余冬兰[1] WU Lihua;LUO Jinyan;MIAO Jiaqing;TAN Jiawen;YU Donglan(Medical Engineering Department,the First Affiliated Hospital of Sun Yat-sen University,Guangzhou,Guangdong 510080,China;Institute for Hospital Management of Tsinghua University,Shenzhen,Guangdong 518055,China)

机构地区：[1]中山大学附属第一医院医学工程部,广东广州510080 [2]清华大学医院管理研究院,广东深圳518055

出　　处：《中国医学工程》2025年第4期6-9,共4页China Medical Engineering

摘　　要：目的分析某三甲公立医院医用耗材不良事件上报管理模式优化成效,为医用耗材不良事件的监测和精细化管理提供参考。方法针对样本医院医用耗材不良事件上报数量低、内容填写不规范不完整等问题,组织医用耗材不良事件上报培训,改善医用耗材不良事件上报流程和升级填报信息系统,优化医用耗材不良事件上报管理模式。通过分析样本医院优化前、过渡期和优化后三个阶段不良事件报告数量和报告表内容完整性,进而分析医用耗材不良事件上报管理模式优化成效。结果随着医用耗材不良事件上报管理模式的优化,严重伤害不良事件上报比例、Ⅲ类管理类别不良事件上报比例和无源产品不良事件上报比例均上升(P<0.05)。与优化前阶段相比,过渡期和优化后阶段的不良事件报告表的总体缺失情况,产品编号、生产日期、有效期和伤害表现的缺失情况均得到改善(P<0.05);同时,与过渡期阶段相比,优化后阶段的产品编号、生产日期、有效期项的缺失情况亦得到改善(P<0.05)。结论医用耗材不良事件上报是医用耗材风险管理的重要环节之一,优化不良事件上报管理模式,有助于优化流程、控制潜在风险,进而保证用械安全,保护患者安全。【Objective】To analyse the effectiveness of optimising the management mode of reporting adverse events of medical consumables in a tertiary public hospital,and to provide reference for the monitoring and refined management of adverse events of medical consumables.【Methods】Aiming at the problems of low number of reported adverse events of medical consumables and irregular and incomplete filling of contents in the sample hospital,we organised training on reporting of adverse events of medical consumables,improved the reporting process of adverse events of medical consumables and upgraded the information system,so as to optimise the management mode of reporting of adverse events of medical consumables.We analyzed the number of adverse event reports and the completeness of the reporting form in the three phases of pre-optimization,transition and post-optimization in the sample hospitals,and then analyzed the effectiveness of the optimization of the medical consumable adverse event reporting management mode.【Results】With the optimisation of medical consumables adverse event reporting management mode,the number of adverse event reports showed a yearly increasing trend(P<0.05).Compared with the preoptimisation stage,the overall deficiency situation of the adverse event report form,and the lack of the product code item,the production date item,the expiry date and the injury performance in the transition and post-optimisation stages were all improved(P<0.05).At the same time,compared with the transition stage,the lack of the product code item,the production date item,and the expiry date item was improved(P<0.05).【Conclusion】The reporting of adverse events of medical consumables is one of the important links in the risk management of medical consumables,and the optimisation of the management mode of reporting adverse events helps to optimise the process and control the potential risks,which in turn ensures the safety of devices and protects the safety of patients.

关 键 词：公立医院 医用耗材 不良事件 精细化管理 

分 类 号：R197.32[医药卫生—卫生事业管理] R197.39[医药卫生—公共卫生与预防医学]