【作者】 成定胜； 仲辉； 马宪礼； 马筠； 肖媛泽慧；

【Author】 Cheng Dingsheng;Zhong Hui;Ma Xianli;Ma Jun;Xiao Yuanzehui;Department of medical engineering, Subei people’s Hospital of Jiangsu Province;

【机构】 江苏省苏北人民医院医学工程部；

【摘要】 目的:提高医疗器械不良事件上报数量与质量,降低医疗器械临床使用风险。方法:梳理医疗器械故障维修案例,对照医疗器械不良事件定义进行积极上报,同时对上报案例进行分类分析,查找原因并有针对性的进行改进。结果:提高了医疗器械不良事件尤其是有源医疗器械不良事件上报数量,提升了医疗器械不良事件上报报告的质量,强化了医疗设备厂家与医院的沟通联系,提高了设备维护维修效率,降低了临床用械风险。结论:基于医疗器械故障的医疗器械不良事件上报,强化了工程技术人员的风险意识,增强了对设备故障的分析思考能力,促进了预防性维护的质量提升。更多还原

【Abstract】 Objective:Objective to improve the quantity and quality of medical device adverse events reporting, and reduce the risk of clinical use of medical devices. Methods:Sort out the maintenance cases of medical device failure, report the cases according to the definition of medical device adverse events, analyze the reported cases by classification, find out the causes and make targeted improvement. Results: Through the comparative analysis of adverse events in medical device maintenance failure in recent two years, the number of adverse event reports was improved, the quality of medical device adverse event reports was improved, and strengthen the communication between medical device manufacturers and hospitals.Conclusion:The reporting of medical device adverse events based on medical device failure strengthens the risk awareness of engineering and technical personnel, improves the analysis and thinking ability of equipment failure, and promotes the quality improvement of preventive maintenance.更多还原