Implementation of a Comprehensive Testing Protocol for a Rapidly Manufactured Mechanical Ventilator

Area of Science:

• Medical Engineering
• Critical Care Medicine
• Biomedical Testing

Background:

• The COVID-19 pandemic exposed critical care capacity limitations, particularly a shortage of mechanical ventilators.
• Existing testing protocols for emergency ventilators lack international standardization and clinical validation.
• There is a need for a robust testing framework to ensure the safety and efficacy of rapidly developed ventilators.

Purpose of the Study:

• To compile and execute a comprehensive clinical testing protocol for a novel emergency mechanical ventilator.
• To evaluate the feasibility and effectiveness of a standardized pre-clinical and clinical testing approach.

Main Methods:

• A sequential testing protocol was designed, including preclinical, safety, clinician usability, and clinical stages.
• The protocol was applied to the Luca ventilator, a device developed for the COVID-19 pandemic.
• Clinical testing involved 15 critically ill patients with respiratory failure.

Main Results:

• The Luca ventilator met acceptable pressure and volume standards during preclinical and safety testing.
• Minor software adjustments resolved identified issues, and usability was rated excellent (System Usability Scale score = 90.5).
• Clinical testing demonstrated the protocol's power to detect significant differences with 15 patients.

Conclusions:

• The developed testing protocol is feasible and effective for evaluating emergency ventilators.
• The Luca ventilator proved accurate, reliable, safe, and user-friendly.
• Standardized testing protocols can facilitate the timely emergency authorization of crucial mechanical ventilators during health crises.