医院医疗器械不良事件管理实践的分析与探讨

Analysis and Discussion on the Management Practice of Medical Devices Adverse Events in Hospital

目的探讨医院可疑医疗器械不良事件管理实践中存在的问题及对策,以期提高医院可疑医疗器械不良事件监测管理能力。方法收集某医院上报的114例医疗器械不良事件报告数据,利用Excel软件功能,进行分类筛选、统计和对比分析。结果各种医疗器械均有发生不良事件的可能,且不良事件的表现形式和伤害程度多样;医院可疑医疗器械不良事件报告存在报告数量偏少、质量偏低、报告人类别占比不均等问题。结论应重视医院可疑医疗器械不良事件的监测管理,加强相关的制度建设、宣教培训和信息系统的开发利用,科学有效管理,保证用械安全。

Objective To explore the problems and countermeasures in the management practice of suspicious medical device adverse events in hospitals,in order to improve the ability of the hospital for monitoring and managing the suspicious medical device adverse events.Methods The data of 114 cases of medical device adverse events reported by a hospital were collected,and the classification screening,statistics and comparative analysis were carried out by using the function of Excel software.Results All kinds of medical devices had the possibility of adverse events,the manifestations and extent of injury of adverse events were various.The reports of suspicious medical device adverse events in hospitals had problems such as low quantity,low quality,and unequal proportion of reporter categories.Conclusion It is necessary to pay attention to the monitoring and management of adverse events of suspicious medical devices,strengthen the construction of relevant system,education and training,and the development and utilization of information systems,conduct scientific and effective management to ensure the safety of medical devices.