可疑医疗器械不良事件监测的质控管理  

Quality Control Management of Adverse Event Monitoring of Suspicious Medical Devices

作　　者：杨婉玲 YANG Wan-ling(Equipment Department,Huadu District Peopleʼs Hospital,Guangzhou,Guangdong Guangzhou 510800)

机构地区：[1]广州市花都区人民医院设备科,广东广州510800

出　　处：《中国医疗器械信息》2020年第13期47-48,共2页China Medical Device Information

摘　　要：医疗器械是指直接或者间接用于人体的仪器、设备、器具、体外诊断试剂等耗材,在使用医疗器械问题(故障、功能退化),已经或者可能已经或可能会导致不良事件。为保障患者用械安全,通过对可疑医疗设备和器械不良事件相关质控管理工作,防止不良事件重复发生,降低使用医疗器械的相关风险。因此,医院可疑医疗器械不良事件监测的质控管理工作不容小觑。Medical devices refer to the consumables used directly or indirectly in human body,such as instruments,equipment,apparatus,in vitro diagnostic reagents,etc.,has caused or may have caused or may cause adverse events.In order to ensure the safety of patients using medical devices,the related quality control and management of suspicious medical devices and device adverse events are carried out to prevent the recurrence of adverse events and reduce the risks associated with the use of medical devices.Therefore,the hospital suspicious medical device adverse events monitoring quality control management can not be underestimated.

关 键 词：医疗器械 不良事件 质控管理 

分 类 号：R197.39[医药卫生—卫生事业管理]