一种调查医疗器械不良事件原因的结构性方法的研究

A Structural Approach to Investigate the Causes of Adverse Events in Medical Devices

目的:提出一种结构化的方法,支持在临床背景下深入调查医疗设备不良事件的原因。方法:既往医疗器械相关的不良事件往往仅归因于“器械”或“操作者”的问题,但医疗设备的使用涉及设备、临床团队、患者、基础设施等环节。因此,开发一个基于医疗设备和临床团队在基础设施上的医疗保健应用的概念框架,来探索医疗设备不良事件的原因,利用该方法对文献和匿名事件数据库中的事件进行分析。结果:该方法识别并分类了事故的潜在原因,探索了“设备”“操作员”或“基础设施”故障的细节。由于不同设备类型产生的故障原因不同,进而通过建立事故数据库来确定设备导致无法使用的原因。结论:结构化的方法能够深入挖掘不良事件更深层的原因,利用该方法可以全方位地探索原因,从而帮助开发一致的术语来描述和共享有关医疗器械不良事件的原因信息。

Objective:We propose a structured approach that supports in-depth investigation of the causes of adverse events in medical devices in a clinical context.Methods:Previous medical device related adverse events are often attributed to “device” or “operator” problems.But,the use of medical equipment involves equipment,clinical team,patients,infrastructure and other links.From this,we developed a conceptual framework to explore the causes of adverse events in medical devices,based mainly on the healthcare applications of medical devices and clinical teams in the infrastructure.In this paper we use this method to analyze events in the literature and anonymous event databases.Results:The method identifies and classifies the potential causes of accidents,and explores the details of “equipment” “operator”,or “infrastructure” failures.Due to different failure causes of different equipment types,an accident database is established to determine the cause of the equipment failure.Conclusion:The structured approach can dig deeper into the causes of adverse events,which can comprehensively explore the causes,thus helping to develop consistent terminology to describe and share information about the causes of medical device adverse events.