医疗器械不良事件监测工作分析与管理探讨

Analysis and Management of Medical Device Adverse Event

医疗器械不良事件监测管理工作是医疗质量安全控制中的一个重要环节。通过对2016年~2018年全院上报处理的126例的可疑医疗器械不良事件及其管理进行分析和研究,总结出提高医疗器械不良事件上报率、上报质量和提升监测管理能力的方法及建议。

Monitoring and management of medical devices adverse event is an important part of medical quality and safety control.Based on the analysis of 126 cases of suspicious medical device adverse events reported and handled by the hospital from 2016 to 2018,summarizing the methods and suggestions to improve the reporting rate,quality and management ability of medical device adverse events.