【摘要】 目的:构建临床使用过程中体外膜肺氧合(ECMO)设备性能质量控制指标体系,提高ECMO产品临床应用可靠性的科学评价能力,为ECMO技术规范与临床应用可靠性提供保障。方法:检索ECMO行业标准规范、相关研究文献以及ECMO设备操作说明书等资料,汇总整理ECMO性能参数质量控制指标,通过个人访谈和小组讨论的方式对质量控制指标条目进行分析,采用德尔菲法开展3轮专家函询,建立ECMO性能参数指标库,通过分析各指标权重构建ECMO设备临床质量控制关键性能指标体系。结果:ECMO设备临床质量控制关键性能指标体系包含一级指标(离心泵、空氧混合器和变温水箱3项关键部件),二级指标(血泵流量、血泵转速、氧浓度、温度、泵前压力和泵后压力6项性能参数),以及三级指标(6项性能测试范围)的ECMO性能质量控制指标。结论:通过对ECMO设备关键性能指标的分析,梳理ECMO设备临床质量控制指标体系,构建ECMO临床使用过程中的质量控制模板,为ECMO设备临床使用质量控制管理进行了探索。更多还原

【Abstract】 Objective: To construct a quality control indicator system for the performance of extracorporeal membrane oxygenation(ECMO) equipment during clinical use, and to improve scientific evaluation ability for the reliability of clinical application of ECMO products, so as to provide guarantees for ECMO technical specifications and its reliability in clinical application. Methods:The ECMO industry standard specifications, relative research literature and ECMO equipment operation manuals were retrieved,and the quality control indicators of ECMO performance parameters were summarized and organized. The items of indicators were analyzed through individual interviews and group discussions. Three rounds of expert inquiries were conducted using the Delphi method to construct indicator library of ECMO performance parameters. And then, a key performance indicator system of clinical quality control for ECMO equipment was constructed through analyzed the weight of each indicator. Results: The key performance indicator system of clinical quality control for ECMO equipment included 3 key components(primary indicators)(centrifugal pump,air oxygen mixer, and water tank of variable temperature), 6 performance parameters(secondary indicators)(flow rate of blood pump, blood pump speed, oxygen concentration, temperature, pressure pre operating pump, and pressure post operating pump), and 6 performance testing ranges(tertiary indicators), all of which were indicators of quality control for ECMO performance. Conclusion:This research organized an indicator system of clinical quality control for ECMO equipment through analyzed the key performance indicators of ECMO equipment, and constructed quality control template for ECMO in clinical application, and conducted beneficial explorations for the management of quality control for ECMO equipment in clinical application.更多还原