浅谈医院医疗器械不良事件监测与管理体制建立  

Discussion on the establishment of supervision and management system of hospital medical equipment incident(HMEI)

作　　者：汤黎明[1] 吴敏[1] 沈苏静[1] 于京杰[1] 

机构地区：[1]南京军区南京总医院,江苏南京210002

出　　处：《医疗设备信息》2006年第2期41-42,27,共3页Information of Medical Equipment

摘　　要：本文提出了对医院医疗器械不良事件发生后如何进行监测与管理的看法。就医院医疗器械不良事件报告、评价模式、分类和时间性,以及监测管理机构、技术人员队伍、制度法规建立进行了探索性叙述。医院医疗器械不良事件监测将为我国医疗市场的健康发展,保证医疗器械的更安全、有效、可靠奠定基础。This article presents a view on how to supervise and manage hospital medical equipment incidents, and gives an exploring description on the report, judging models, the classification and timeliness of HMEI and on the establishment of supervision and management system, technician teams and concerning laws and regulations as well. The supervision of HMEI will lay a foundation for the healthy development of our medical market and the safer, more effective and more reliable use of medical equipments.

关 键 词：医疗器械 不良事件 监测 管理 报告制度 

分 类 号：R197.32[医药卫生—卫生事业管理]