医院可疑医疗器械不良事件监测与上报管理

Monitoring and Reporting Management of Suspicious Medical Device Adverse Events in Hospitals

医疗器械是直接或间接作用于人体的仪器、装置、仪表、体外诊断试剂等,对于医疗器械而言,经过长时间的运行和操作,其难免会出现各类问题(故障、功能退化),有些已经或可能出现不良情况,影响医疗结果的准确性,严重则会威胁患者的生命安全,产生严重的医疗事故。为了确保患者使用医疗器械的安全性,必须通过对疑似医疗器械不良事件进行相应的监测以及上报,以避免不良事件的多次出现,从而降低使用医疗器械而引发不良事件的发生率。所以,在对医院的管理中,针对疑似医疗器械的不良事件进行质控管理工作不可忽视,需引起管理层的重视,提高医院可疑医疗器械的管理力度。

Medical devices are instruments,devices,instruments,in vitro diagnostic reagents,etc.that directly or indirectly act on the human body.For medical devices,various problems(malfunctions,functional degradation)may inevitably occur,and some have already or may have adverse effects.In order to ensure the safety of patients using medical devices,it is necessary to monitor and report suspected adverse events of medical devices to avoid multiple occurrences of adverse events and reduce the probability of related problems caused by the use of medical devices.Therefore,the quality control management work of monitoring suspected adverse events of medical devices in hospitals cannot be ignored.It is necessary to raise the level of attention from the management and improve the management of suspicious medical devices in hospitals.