摘要
目的探讨在用医疗器械不良事件的影响因素。方法基于文献分析法,在CNKI、万方等数据库检索相关文献273篇,并采用其中74篇作为证据文献;应用Reason模型,从组织影响、不安全监督、不安全的行为前提和不安全的行为方面分析不良事件成因。结果结合证据文献的案例分析,对学者分析的导致医疗器械不良事件的原因进行归纳,并构建了医疗器械不良事件影响因素的Reason致因模型。结论医疗器械不良事件的影响因素映射为产品在组织管理、临床试验监管、产品设计、物流管理和临床使用环节中出现的"漏洞"中的隐形失效,应该加强医疗器械上市前可靠性要求和临床使用风险管控。
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 Reason model for medical 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.
作者
朱未
胡少科
Zhu Wei;Hu Shaoke(Department of Biomedical Engineering,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan Hubei,430022,China)
出处
《生物骨科材料与临床研究》
CAS
2018年第3期77-80,共4页
Orthopaedic Biomechanics Materials and Clinical Study
