基于灰色关联的呼吸机人因不良事件数据挖掘分析

Data mining analysis of ventilator human-factor-related adverse event based on grey correlation

目的:探讨呼吸机人因不良事件发生的诱因及结果,以针对性地采取相应措施减少人为使用失误的发生。方法:检索美国食品药品监督管理局(Food and Drug Administration,FDA)的制造商和用户器械使用体验(Manufacturer and User Facility Device Experience,MAUDE)数据库,获取2009年7月31日至2019年7月31日上报的101例呼吸机人因不良事件。先对101例呼吸机人因不良事件的人为使用失误的类型、形成原因以及后果进行统计学描述分析,然后采用灰色关联分析方法对101例呼吸机人因不良事件的形成原因及事件后果展开关联分析。结果:研究结果表明,呼吸机人因不良事件常见的人为使用失误类型为违反操作规程、通气参数设置错误和使用错误的通气模式;导致人为使用失误发生的主要原因为使用人员培训和经验不足/操作不熟练、操作人员疏忽和违规使用;人为使用失误导致的最常见后果是呼吸机发生故障。灰色关联分析结果表明,人机交互界面设计缺陷、工作负荷过高、培训和经验不足/操作不熟练是诱发呼吸机人为使用失误形成的重要诱因。结论:灰色关联分析可应用于呼吸机人因不良事件的形成结果及后果的追溯分析,为呼吸机人为使用失误的管控提供了新的解决思路及方法。

Objective To explore the causes and results of ventilator human-factor-related adverse events so as to take corresponding measures to reduce the occurrence of human use errors.Methods Totally 101 cases of ventilator humancaused adverse events from 31 July 2009 to 31 July 2019 were found in the U.S.Food and Drug Administration(FDA)Manufacturer and User Facility Device Experience(MAUDE)database.Statistical description and analysis of the types,causes of formation and consequences of human use errors in the 101 cases of ventilator adverse events were first performed,and then the gray correlation analysis method was used to develop a correlation analysis of the causes of formation and consequences of the events.Results The results showed that the common types of human use errors included violation of operating rules,wrong ventilation parameter settings and wrong ventilation modes;the main causes of the human use errors were insufficient training and experience/unskilled operation,operator negligence and illegal use;the most common consequence of human use errors was ventilator malfunction.The results of the grey correlation analysis proved that the causes for ventilator human use errors involved in the problems in human-machine interface design,workload,insufficient training and unskilled operation.Conclusion Grey correlation method can be used to analyze the ventilator human adverse events,and it provides a new solution and method to control the risk of ventilator human errors.