摘要
随着生物医学工程学科的迅速发展,社会对医疗设备的临床应用可靠性提出了更高的要求。本文从寿命预测和故障诊断2个角度探讨了目前在医疗设备临床应用阶段可靠性分析的主流方法,包括威布尔(Weibull)分布、Markov模型、灰色模型、机器学习、故障树分析法、故障模式和影响分析等,并总结了每种方法的优缺点、适用范围及现有的应用情况,为医疗机构选择适当的风险分析技术提供参考;最后总结了医疗设备临床应用阶段采用的可靠性分析方法、目前存在的不足及今后研究的方向。
With the rapid development in the field of biomedical engineering,the society has put forward higher requirements for the reliability of medical devices for clinical applications.This paper discussed the mainstream methods of reliability analysis in the clinical application stage of medical devices from the perspectives of life prediction and fault diagnosis,including Weibull distribution,Markov model,gray model,machine learning,failure tree analysis,failure mode and effects analysis,and summarized the advantages and disadvantages,the scope of application,and existing applications of each method,so as to provide a reference for healthcare organizations to select appropriate risk analysis techniques.Finally,the current shortcomings of reliability analysis methods used in the clinical application of medical devices and the direction of future research were analyzed.
作者
樊立天
凌庆庆
王浩文
陈宏文
FAN Litian;LING Qingqing;WANG Haowen;CHEN Hongwen(School of Biomedical Engineering,Southern Medical University,Guangzhou Guangdong 510515,China;Department of Clinical Engineering,Nanfang Hospital,Southern Medical University,Guangzhou Guangdong 510515,China)
出处
《中国医疗设备》
2022年第7期148-151,165,共5页
China Medical Devices
基金
国家重点研发计划项目(2019YFC0121908)
国家卫生健康委医院管理研究所项目(20210206)。
关键词
医疗设备运维管理
可靠性分析
寿命预测
故障诊断
operation and maintenance management of medical devices
reliability analysis
life prediction
fault diagnosis