基于JCI标准规范的医疗器械临床试验管理  

Management of Medical Equipment Clinical Trials Based on JCI Standards

作　　者：程毅[1] 鲁瑞萍[2] 布格拉.米吉提 张翌韦 申洁[2] 袁明奎[1] 杨建华[1] 

机构地区：[1]新疆医科大学第一附属医院药物临床试验机构,新疆乌鲁木齐830011 [2]新疆医科大学第一附属医院新疆维吾尔自治区医学伦理学研究所,新疆乌鲁木齐830011

出　　处：《中国医疗设备》2016年第6期147-149,共3页China Medical Devices

摘　　要：本文对我院在JCI评审中对医疗器械临床试验管理的具体做法进行探讨和总结。按照JCI标准,通过完善医疗器械质量管理机制和建立医疗器械管理小组,从医疗器械临床立项、质量控制、不良事件的管理等环节规范医疗器械的管理,促进持续的质量改进,最大限度保障受试者的安全和权益。This paper discussed and summarized the practices of the First Affiliated Hospital of Xinjiang Medical University in medical equipment clinical trial management during JCI（Joint Commission International） assessment. Through the improved quality management mechanism for medical equipment and establishment of a medical equipment management group in line with JCI standards, the management of medical equipment was standardized in various aspects ranging from clinical project establishment, quality control to adverse event management, which promoted continuous quality improvement and ensured the security and interests of the subjects at the maximum.

关 键 词：JCI标准 医疗器械临床试验 医疗器械管理 质量控制 

分 类 号：R197.3[医药卫生—卫生事业管理] R969[医药卫生—公共卫生与预防医学]