Abstract：This paper discussed and summarized the specific practices of medical devices adverse event
management under joint commission on accreditation of healthcare organizations (JCI) assessment
standards. In line with JCI standards, our hospital established unified anomalous event management
system as well as reporting encourage mechanism. Abnormal events were defined, classified and graded.
Then the procedures for submission and disposal were determined according to the assessment on the
abnormal event severity. Based on the unified anomalous event management system, the equipment
department structured an effective system on medical devices adverse event management, and established
a specific recall procedure, ensuring safe use of medicine. Thus the reporting quantity and quality of
medical devices adverse events in our hospital were significantly improved by above specification
procedure.
陈朝繁，彭天舟，王上东，黄海丹. JCI评审标准下医疗器械不良事件管理体系的构建[J]. 中国医疗设备, 2017, 32(3): 150-152.
CHEN Chao-fan,
PENG Tian-zhou,
WANG Shang-dong,
HUANG Hai-dan. Construction of Medical Devices Adverse Event Management System Under
JCI Assessment Standards. China Medical Devices, 2017, 32(3): 150-152.
