医疗器械不良事件案例分析与优化管理措施研究  

Case Analysis of Medical Device Adverse Events and Study on Optimized Management Measures

作　　者：吕鹏[1] 白冰[1] 白雪[1] LU Peng;BAI Bing;BAI Xue(China-Japan Friendship Hospital of Jilin University,Jilin Changchun 130033)

机构地区：[1]吉林大学中日联谊医院,吉林长春130033

出　　处：《中国医疗器械信息》2020年第10期186-187,共2页China Medical Device Information

摘　　要：目的:探讨医疗器械不良事件的处理方法和优化管理措施在医疗器械管理方面的应用。方法:分析2例医疗器械不良事件,说明处理的经过、提出优化的管理措施与跟踪反馈的结果。结果:总结2例医疗器械不良事件的优化管理措施。医疗器械使用单位不断加强对医疗机械不良事件的管理,在医疗器械不良事件发生后及时评价和处理,才能不断提高医疗器械管理水平,保障使用安全。结论:医疗器械不良事件的收集、分析及上报,是提高医疗质量的重要方法,医院领导应该重视医疗不良事件的发生率,定期开展专题研讨会对医疗器械不良事件进行知识宣传,提高医务人员的认知,建立相关的奖励机制,鼓励不良事件上报,认真落实各项文件要求,不断完善监测体系。加强行政管理力度,建立监测小组,加大对医疗器械的管理,健全不良事件的上报流程,降低不良事件的发生率。Objective:To explore the application of medical device management methods and optimized management measures in medical device management.Methods:Two cases of medical device adverse events were analyzed,and the processing progress,the results of proposed optimal management measures and tracking feedback were analyzed.Results:The optimal management measures of 2 medical device adverse events were summarized.Medical device users continue to strengthen the management of adverse events of medical machinery,and timely evaluate and deal with adverse events of medical devices in order to continuously improve the management level of medical devices and ensure the safety of use.Conclusion:The collection,analysis and reporting of medical device adverse events is an important method to improve the quality of medical treatment.Hospital leaders should pay attention to the incidence of medical adverse events,and regularly conduct special seminars to publicize the knowledge of medical device adverse events and improve the recognition of medical staff We will establish relevant reward mechanisms,encourage the reporting of adverse events,conscientiously implement the requirements of various documents,and continuously improve the monitoring system.Strengthen administrative management,establish monitoring teams,increase management of medical devices,improve reporting procedures for adverse events,and reduce the incidence of adverse events.

关 键 词：医疗器械 不良事件 优化管理 分析 研究 

分 类 号：R197.32[医药卫生—卫生事业管理]