Decreasing Oxygenator Failure Using Lean Six Sigma Methodology in Low-Volume Pediatric ECMO Centers

Introduction: Oxygenator failure, a source of increased morbidity and mortality for patients treated with Extracorporeal Membrane Oxygenation (ECMO), has a higher frequency in low-volume centers. Limited exposure and operational inefficiencies may contribute to higher failure rates, increased patient risk, time on ECMO, and programmatic costs. Our study aimed to evaluate and decrease the incidence of oxygenator failure using a data-driven quality improvement approach to optimize processes, improve quality outcomes, and reduce costs.


Methods: Applying the Lean Six Sigma Define, Measure, Analyze, Improve, Control framework, we initiated our project identifying the issue of recurrent oxygenator failure as defined by the Extracorporeal Life Support Organization (ELSO) Registry. Data review from Fiscal Years (FY)2018-2022 (172 ECMO days) revealed a failure rate of 35% per patient, with a high of 50% in FY2022, significantly exceeding ELSO’s benchmark of 10%. A “5-whys” analysis uncovered several root causes and key failure modes, including suboptimal circuit layout, inconsistent staff training, and variable adherence to recommended pump efficiency. In the “Improve” phase, we implemented targeted interventions following a Plan-Do-Study-Act approach specifically developing standardized protocols for circuit design, enhancing staff education, and improving quality control measures to evaluate oxygenator integrity. We also instituted a monitoring system to ensure adherence to these protocols and identify early stage potential failures.


Results: Intervention implementation resulted in 1 oxygenator failure in FY2023, a complication rate of 13% over 8 ECMO “runs”. We then made iterative adjustments and conducted diligent monitoring, resulting in successful sustainment of 0% failure over 330 ECMO days in FY 2024-present. Also, this achievement resulted in a 67% reduction in oxygenator-related costs overall and 44% improvement in usage per “run” compared to FY2018-2022.


Conclusions: Our findings demonstrate that Lean Six Sigma methodologies can be successfully integrated into low-volume ECMO center operations to systematically identify, analyze, and substantially reduce oxygenator failure. These results not only enhance patient safety and outcomes but optimize resource utilization, allowing for significant cost savings.