中国医疗设备2017，Vol.32Issue(3)：150-152,3.DOI:10.3969/j.issn.1674-1633.2017.03.041
JCI评审标准下医疗器械不良事件管理体系的构建
Construction of Medical DevicesAdverse Event Management System Under JCIAssessment Standards
陈朝繁 1彭天舟 1王上东 1黄海丹1
作者信息
- 1. 瑞安市人民医院 设备物资科,浙江温州 325200
- 折叠
摘要
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.关键词
JCI标准/医疗器械不良事件/医疗器械异常事件/医疗器械召回Key words
joint commission on accreditation of healthcare organizations standards/medical device adverse event/medical device anomalous event/medical device recall分类
医药卫生引用本文复制引用
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):150-152,3.
