我院医疗器械不良事件的监测与管理  

Monitoring and Management of Medical Device Adverse Events in Our Hospital

作　　者：鄂恒 刘禹[1] 李丹[1] 胡海泉[1] 沈岚[1] E Heng;LIU Yu;LI Dan;HU Haiquan;SHEN Lan(Department of Medical Equipment,Renmin Hospital of Wuhan University,Wuhan Hubei 430060,China)

机构地区：[1]武汉大学人民医院医疗设备处

出　　处：《中国医疗设备》2019年第10期152-154,167,共4页China Medical Devices

摘　　要：目的加强我院医疗器械不良事件的监测与管理,及早发现产品风险、减少同类不良事件的重复发生、消除安全隐患、保护公众健康安全。方法分析我院医疗器械不良事件监测中存在的问题,针对性地提出一系列改进措施与办法,进一步提升我院医疗器械不良事件的监测与管理。结果医务人员与临床工程师用械安全意识不断提高,医疗器械不良事件上报例数逐年增多,医院医疗器械管理与质量体系得到进一步完善。结论通过成立不良事件监测领导小组、建立三级监测体系、优化完善上报流程、组织开展宣传与培训等管理措施,提升了我院医疗器械不良事件的监测与管理水平,降低了医疗器械使用风险,为公众用械的安全有效提供了保障。Objective To strengthen the monitoring and management of adverse events of medical devices in our hospital, to detect product risks as early as possible, reduce the recurrence of similar adverse events, eliminate safety risks, and protect public health and safety. Methods The study analyzed the problems existing in the monitoring of adverse events of medical devices in our hospital, and put forward a series of targeted improvement measures and methods to further improve the monitoring and management of adverse events of medical devices in our hospital. Results Medical staff and clinical engineers’ awareness of the safety of medical devices was continuously improved, and the number of adverse events reported on medical devices was increasing year by year. The management and quality system of medical devices in hospitals was further improved. Conclusion Through the establishment of a leading group for adverse event monitoring, the establishment of a three-level monitoring system, the optimization and improvement of the reporting process, the organization of publicity and training and other management measures, the level of adverse event monitoring and management of medical devices in our hospital has been improved, the use risk of medical devices has been reduced, and the safety and effectiveness of public devices has been guaranteed.

关 键 词：医疗器械 不良事件 监测体系 医疗器械管理 

分 类 号：R197.39[医药卫生—卫生事业管理]