Practical Implementation of Failure Mode and Effects Analysis for Extracorporeal Membrane Oxygenation Activation

Area of Science:

• Cardiovascular and Respiratory Systems
• Medical Devices and Technology
• Critical Care Medicine

Background:

• Extracorporeal membrane oxygenation (ECMO) is a vital treatment for severe hypoxemic respiratory failure and cardiopulmonary arrest.
• Timely initiation of ECMO is crucial for patient outcomes, yet clinical and operational delays can occur.
• Failure Modes and Effects Analysis (FMEA) is a systematic method for identifying potential process failures.

Purpose of the Study:

• To identify and analyze clinical and operational failure modes contributing to delays in ECMO initiation.
• To develop targeted interventions to mitigate identified risks and improve ECMO accessibility.

Main Methods:

• A Failure Modes and Effects Analysis (FMEA) was performed on the ECMO initiation process.
• Key failure modes leading to delays were identified and prioritized based on risk.
• Interventions were developed to address the highest-risk failure modes.

Main Results:

• The highest-risk failure modes included delayed candidacy determination, incomplete pre-consult evaluation, unavailability of the ECMO team, and delayed cannulation.
• Four collective interventions were implemented: ECMO response pager system, standardized inclusion/exclusion criteria, clinician education, and a mobile ECMO insertion cart.
• These interventions collectively addressed over 95% of identified system failures.

Conclusions:

• Systematic analysis using FMEA effectively identified critical delays in ECMO initiation.
• Targeted interventions, including improved communication, standardized criteria, education, and equipment, significantly enhance ECMO process efficiency.
• These improvements are essential for optimizing patient access to this life-saving therapy.