生物骨科材料与临床研究2018，Vol.15Issue(3)：77-80,4.DOI:10.3969/j.issn.1672-5972.2018.03.020
基于Reason模型的医疗器械不良事件的影响因素研究
Study on the factors contributing to adverse events of medical devices based on Reason model
朱未 1胡少科1
作者信息
- 1. 华中科技大学同济医学院附属协和医院医学工程科,湖北 武汉,430022
- 折叠
摘要
Abstract
Objective To investigate the influencing factors of medical devices adverse events. Methods Based on the literature analysis method, 273 related documents were retrieved from CNKI, Wanfang and other databases, and 74 of them were used as evidence documents. The Reason model is applied to analyze adverse events from organizational impact, unsafe supervision, unsafe behavior premises and unsafe behavior. Results Case analysis of literature combined with evidence, scholars analyzed the cause of medical device adverse events were summarized, and build a Reasonmodel formedical devices adverse events. Conclusion The influence factors of medical devices adverse events mapped to product clinical trials in the organization and management, supervision, product design, logistics management and clinical use link "hole" in the contact failure, and we should strengthen medical equipment listed before reliability requirement and the clinical use of risk control.关键词
医疗器械/不良事件/影响因素/Reason模型Key words
Medical device/Adverse event/Factors/Reason model分类
医药卫生引用本文复制引用
朱未,胡少科..基于Reason模型的医疗器械不良事件的影响因素研究[J].生物骨科材料与临床研究,2018,15(3):77-80,4.
