Quality assurance of extracorporeal membrane oxygenation (ECMO) - optimization through evidence-based quality indicators

Background The high mortality rates associated with extracorporeal membrane oxygenation (ECMO) treatment in Germany compared to international benchmarks indicate potential issues with treatment quality and require an analysis of the quality assurance of ECMO treatment. Objective Firstly, this article aims to analyze whether the legal requirements for quality standards of complex medical and technical measures as well as the demands of professional societies for guideline adherence in treatment can currently be verified. Secondly, the goal is to develop cross-procedural, evidence-based quality indicators (QI) for a specific comprehensive quality management system (QMS) for ECMO treatment in Germany, to enable a comparison of centers and a continuous improvement process. Material and methods A review of the literature concerning quality management for ECMO treatment was conducted. Data from relevant quality reporting platforms were analyzed. Strong recommendations from guidelines on ECMO treatment were used to derive specific cross-procedural QIs. These were categorized by structural, process and outcome quality and compared with existing registry data. Results Three data registers for ECMO treatment in Germany were identified, revealing a lack of specific QIs and effective monitoring of guideline adherence. Consequently, a comprehensive analysis of treatment quality is currently not possible. From the guideline recommendations 22 QIs were defined to be integrated into a standardized quality management system for ECMO treatment. Conclusion Implementing evidence-based QIs can enhance quality assurance, improve transparency regarding legal requirements and guideline adherence, while also facilitating continuous improvement and enabling benchmarking. Recommendations on the indications and minimum implementation numbers can be made based on evaluation of the data obtained.