医疗器械的风险管理与质量控制  

Risk and Quality Control of Medical Instruments

作　　者：程述森[1] 石应康[2] 金蓓[1] 代勇[1] 吴晓东[1] 

机构地区：[1]四川大学华西医院采供维保部,成都610041 [2]四川大学华西医院胸外科,成都610041

出　　处：《中国循证医学杂志》2010年第6期754-755,共2页Chinese Journal of Evidence-based Medicine

摘　　要：本文全面介绍了四川大学华西医院在医疗器械质量管理中引入企业化风险控制理论,成功建立从器械引进前论证评估与招投标策略管理直至使用过程中的操作培训、设备维护维修、报废处置管理以及医疗器械质量控制的宝贵经验,可为国内各大型综合性医院的医疗器械质量管理和风险控制提供借鉴。Theory of risk control was introduced to medical instruments quality control management in West China Hospital.A quality control system for the whole life cycle management of instruments has been established,which includes evaluation before instrument purchase,policy and management of bidding,operation training,safe maintenance,maintenance management and waste disposal.Medical instrument quality system was introduced to provide information for medical instrument risk control and quality management in a large,general Chinese hospital.

关 键 词：医疗器械 质量管理 风险控制 

分 类 号：R197.3[医药卫生—卫生事业管理]