医疗卫生装备2023，Vol.44Issue(10)：76-80,5.DOI:10.19745/j.1003-8868.2023211
输液输血加温设备质量关注要点分析与评价
Analysis and evaluation of quality concerns of fluid infusion and blood transfusion warmer
摘要
Abstract
The main components and working principle of the fluid infusion and blood transfusion warmer were introduced,and the causes for the adverse events of the warmer were summarized based on National Medical Device Adverse Event Monitoring Information System and related literature in the world.The potential risks of the warmer were analyzed during operation,and the quality concerns and corresponding evaluation methods were proposed for the warmer from the aspects of device marking and documentation,structure,and temperature.References were provided for standard preparation,pre-market technical review and system verification of the fluid infusion and blood transfusion warmer.[Chinese Medical Equipment Journal,2023,44(10):76-80]关键词
输液输血加温设备/不良事件/质量评价/使用风险Key words
fluid infusion and blood transfusion warmer/adverse events/quality evaluation/utilization risk分类
医药卫生引用本文复制引用
牟鹏涛,张克,牛惠芳,付丽,卢建,张在爱,黄建忠..输液输血加温设备质量关注要点分析与评价[J].医疗卫生装备,2023,44(10):76-80,5.基金项目
国家药监局标准制修订项目(药监办[2018]26号) （药监办[2018]26号）
