Management of Medical Equipment Clinical Trials Based on JCI
Standards
C H E N G Y i a , L U R U I - p i n gb ,Bugela MIJITIa, ZHANG YI-weia,SHEN Jieb, YUAN MING-kuia,YANG JIAN-huaa
a. Institutions of Drug Clinical Trial;
b. Xinjiang Medical Ethics Research
Institute, the First Affiliated Hospital of
Xinjiang Medical University, Urumqi
Xinjiang 830011, China
Abstract：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.
程毅a，鲁瑞萍b，布格拉·米吉提a，张翌韦a，申洁b，袁明奎a，杨建华a. 基于JCI标准规范的医疗器械临床试验管理[J]. 中国医疗设备, 2016, 31(6): 147-149.
C H E N G Y i a , L U R U I - p i n gb ,Bugela MIJITIa, ZHANG YI-weia,SHEN Jieb, YUAN MING-kuia,YANG JIAN-huaa. Management of Medical Equipment Clinical Trials Based on JCI
Standards. China Medical Devices, 2016, 31(6): 147-149.
