失效模式与影响分析在血液透析类设备风险管理中的应用研究

Application of failure mode and effect analysis in risk management of hemodialysis equipment

目的:运用失效模式与影响分析(FMEA)风险管理方法,对血液透析类设备进行风险管控,评估保障患者透析安全的作用。方法:根据FMEA风险管理方法构建流程图,结合临床实际选定血液透析机型及参与人员,剖析血液透析机主要系统中关键要素结构和功能,通过失效分析建立失效链,评估其风险等级,针对高中风险值事件采取有效持续改进措施并引入再评价机制实现闭环管理,形成规范化的管理制度文件。结果:项目实施1年后血液透析机整体风险事件发生频度较实施前3年降低46%,可探测度提升65%,高风险事件100%下降至中风险;选定机型血液透析机整体故障率下降43%,维修周期降低35%,患者满意度上升5%。结论:FMEA风险管理方法能有效指引血液透析类设备关键要素的预防性维护保养,降低设备使用风险,保障设备使用安全,提升医疗服务满意度。

Objective:To introduce failure mode and effect analysis(FMEA)risk management method to carry out risk management and control of hemodialysis equipment and ensure the safety of patients hemodialysis.Methods:According to the FMEA risk management method,the flow chart was constructed,the models of hemodialysis machine and participants were selected based on clinical practice,the structure and function of the key elements in the main system of hemodialysis machine were analyzed,a failure chain was established through failure analysis,the risk level was evaluated,the effective continuous improvement measures were taken for the high-risk events,and a re-evaluation mechanism was introduced to achieve the closed-loop management and the system standardized management system documents were formed.Results:One year after the implementation of the project,the frequency of the overall risk events of the hemodialysis machines was reduced by 46%compared with the three years before the implementation,the detectable rate increased by 65%,and the high-risk events were 100%reduced to medium risk;the overall failure rate of the selected models of hemodialysis machine decreased by 43%,the maintenance cycle decreased by 35%,and the patient satisfaction increased by 5%.Conclusion:The FMEA risk management method can effectively guide the preventive maintenance of key elements of hemodialysis equipment,reduce equipment use risk,ensure the safety of equipment,and improve the medical service satisfaction.