A Systems Engineering Based Approach for Informing Extracorporeal Membrane Oxygenation (ECMO) Therapy Improvements

Abstract

Extracorporeal Membrane Oxygenation (ECMO) therapy provides stable heart and lung functions via mechanical means for patients with severe but reversible cardiac or respiratory failure [1]. As a result, the survival rate of these patients can improve from 25% to nearly 75% [2]. While there are over 235 medical centers world-wide that employ ECMO [3], no formal standards exist for the composition of an ECMO ‘circuit,’ best practices for operation and maintenance, or training and certification of ECMO specialists. Since 2011 the Professional Masters of Applied Systems Engineering (PMASE) program at the Georgia Institute of Technology (GIT) and medical staff from ECMO centers have collaborated to characterize and improve upon state- of-the-art ECMO therapies. This paper details the collaborators’ work in applying systems engineering principles and practices to ECMO therapies including the use of model based systems engineering (MBSE) to capture the ECMO domain, concept of operations, need statement, high level use cases, requirements, system and user behaviors, and both abstract and concrete structural designs. Finally, the paper explains how this work is applicable towards improvements in data collection, human factors, trade-off analysis for future technology insertions, and other ECMO improvement projects.