外来医疗器械质量管理要求的国内外现状

Current situation of quality management requirements for loaner medical devices at home and abroad

本文系统回顾了国内外外来医疗器械质量管理和清洁灭菌处理的现状,并比较两者的差异。我国各级医疗机构对外来医疗器械的管理较重视,但管理环节及细节有待完善,医疗机构应将外来医疗器械纳入医院的程序化管理,规范供应商行为,重视器械在各流程、环节的质量管理,借鉴国外先进的管理理念和处置方式,提高我国外来医疗器械的管理质量,有效控制医院感染,确保患者安全。

This article systematically reviews the current situation of quality management,cleaning and sterilization of loaner medical devices at home and abroad, and compares the differences between them. All levels of medical institutions in China attach importance to the management of loaner medical devices,but management links and details need to be improved,medical institutions should incorporate loaner medical devices into procedural management of hospital,standardize the behavior of suppliers,attach importance to the quality management of devices in various processes and links,learn from foreign advanced management concepts and disposal methods,and improve management quality of loaner medical devices in China,effectively control healthcare -associated infection to ensure safety of patients.