Construction of key performance indicator system of clinical quality control for ECMO equipment based on Delphi method
10.3969/j.issn.1672-8270.2025.06.020
- VernacularTitle:基于德尔菲法的体外膜肺氧合设备临床质量控制关键性能指标体系构建研究
- Author:
Xuebin CHEN
1
;
Jing ZHAO
;
Zhangxi ZHU
;
Zhanguo LI
;
Yong CUI
Author Information
1. 中日友好医院医学工程处 北京 100029
- Publication Type:Journal Article
- Keywords:
Extracorporeal membrane oxygenation(ECMO);
Delphi method;
Clinical application;
Quality control template for performance
- From:
China Medical Equipment
2025;22(6):103-107
- CountryChina
- Language:Chinese
-
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.
