Wang Longchen, Li Bin, Hu Bing, Shen Guofeng, Zheng Yunxin, Zheng Yuanyi
Department of Ultrasound in Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China.
Department of Biomedical Engineering, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, China.
BMC Health Serv Res. 2022 Apr 1;22(1):429. doi: 10.1186/s12913-022-07843-4.
Medical ultrasound device has been more and more widely used in the hospital and Its safety risk is significantly increased when failures occur. However, there is a lack of quantitative risk assessments of different types of failure modes for medical ultrasound device. This study utilizes a failure mode, effect and criticality analysis (FMECA) approach for quantitative risk evaluation of different failure modes for ultrasound devices.
The 4216 medical ultrasound device failure records at various hospitals were investigated. A failure mode and effect analysis method was developed for the quantitative evaluation of the risks of different failure modes. Visual correlation analysis was conducted for all categories to identify the causes of various failure modes. Based on the severity, occurrence and detectability of the failure causes determined, the risk priority number (RPN) for each failure mode was back-calculated through the obtained tracking diagram.
The failure modes of unclear images, unable to power on and dark shadows on an image had the highest RPNs. One failure mode could be caused by various factors, and the failure location was not necessarily related to the cause of the failure.
This quantitative approach more accurately evaluated the risks of different failure modes, and the results of the corresponding analysis of failure modes and causes could support the rapid determination of the causes of failures in clinical practice.
医用超声设备在医院中的应用越来越广泛，故障发生时其安全风险显著增加。然而，目前缺乏针对医用超声设备不同类型故障模式的定量风险评估。本研究采用故障模式、影响及危害性分析（FMECA）方法对超声设备不同故障模式进行定量风险评估。
对各医院4216条医用超声设备故障记录进行调查。开发了一种故障模式及影响分析方法用于对不同故障模式的风险进行定量评估。对所有类别进行视觉相关性分析以确定各种故障模式的原因。根据确定的故障原因的严重性、发生概率和可检测性，通过获得的跟踪图反算出每种故障模式的风险优先数（RPN）。
图像不清晰、无法开机和图像上有暗影等故障模式的RPN最高。一种故障模式可能由多种因素引起，且故障位置不一定与故障原因相关。
这种定量方法更准确地评估了不同故障模式的风险，相应的故障模式及原因分析结果可为临床实践中快速确定故障原因提供支持。
