我院医用耗材不良事件监测报告及管理策略分析  

Analysis of Adverse Events Monitoring Report and Management Strategy of Medical Consumables in Our Hospital

作　　者：董桂青[1] 范医鲁[1] DONG Guiqing;FAN Yilu(Department of Medical Engineering,The First Affiliated Hospital of Shandong First Medical University(Shandong Provincial Qianfoshan Hospital),Jinan Shandong 250014,China)

机构地区：[1]山东第一医科大学第一附属医院(山东省千佛山医院)医学工程部,山东济南250014

出　　处：《中国医疗设备》2023年第10期113-118,共6页China Medical Devices

基　　金：山东省软科学研究计划自筹经费项目(2017RKB14005);山东省社科规划平安山东法治山东建设研究专项课题(22CFZJ37)。

摘　　要：目的 分析我院医用耗材不良事件监测报告及管理现状,为医用耗材不良事件的监测和防范提供参考和思路。方法 采取完善医疗器械不良事件管理架构与管理制度、优化上报流程、升级上报平台、采用SPD器械管理系统、加强监测员及监测队伍管理等措施对不良事件加强监管,对我院2020—2021年强化监管前后医疗器械管理类别分布、不良事件严重度分布、上报者职业分布及不良事件报告表必填项缺失情况进行对比分析。结果 2020—2021年全院医用耗材类不良事件共上报503份,其中2020年273份、2021年230份。不良事件发生概率最高的是“14注输、护理和防护器械”,占总报告数的47.91%;发生数量最多的是一次性使用输液器-带针,共计113份。强化管理后,2021年Ⅲ类医用耗材不良事件占比为63.04%,较2020年显著下降(P<0.05);轻、中度和重度及以上不良事件占比为53.91%,较2020年显著下降(P<0.05);上报者职业中,医师及技师占比较2020年明显提升(P<0.05);不良事件报告表中,产品批号、生产日期、有效期至、注册证号、原因分析、器械故障表现填写缺失率较2020年显著下降(P<0.05)。结论 通过制定和完善医用耗材不良事件的管理办法,鼓励人员上报不良事件,建立常态化的监督监管机制,可降低医疗风险,减少不良事件的发生。Objective To analyze the monitoring report and management status of adverse events of medical consumables in our hospital,and to provide reference and ideas for the monitoring and prevention of adverse events of medical consumables.Methods The measures were taken to strengthen supervision of adverse events including improving the management structure and system of medical device adverse events,optimizing the reporting process,upgrading the reporting platform,adopting SPD device management system and strengthening the management of monitors and monitoring teams.The distribution of medical device management categories,the severity distribution of adverse events,the occupation distribution of the reporter and the absence of required items in the adverse event report form before and after the strengthening of supervision in our hospital from 2020 to 2021 were compared and analyzed.Results A total of 503 adverse events of medical consumables were reported from 2020 to 2021,including 273 in 2020 and 230 in 2021.The highest probability of adverse events was“14 infusion,nursing and protective devices”,accounting for 47.91%of the total number of reports.The number of one-time infusion set with needle was the largest,113 cases in total.After strengthening management,the proportion of adverse events of ClassⅢmedical consumables in 2021 was 63.04%,significantly lower than 2020(P<0.05).The proportion of adverse events of mild,moderate and severe and above was 53.91%,significantly lower than 2020(P<0.05).Among the occupations of the reporter,the proportion of doctors and technicians increased significantly compared with 2020(P<0.05).In the adverse event report form,the missing rate of product batch number,production date,valid until,registration certificate number,cause analysis,and device failure performance decreased significantly compared with 2020(P<0.05).Conclusion By developing and improving the management methods of adverse events of medical consumables,encouraging personnel to report adverse events and establishi

关 键 词：医用耗材 不良事件上报 监测报告 医疗器械 

分 类 号：R197.39[医药卫生—卫生事业管理]