Testing of pandemic ventilators under early and agile development

Area of Science:

• Biomedical Engineering
• Respiratory Medicine
• Medical Device Development

Background:

• The COVID-19 pandemic highlighted the urgent need for specialized pandemic ventilators (PDVs).
• Rigorous in vitro testing is crucial for evaluating the performance of newly developed PDVs.
• Existing testing methods may not be agile enough for rapid, iterative device development.

Purpose of the Study:

• To present a novel, agile test protocol for the iterative assessment of pandemic ventilators (PDVs).
• To facilitate the rapid identification of specific performance characteristics and areas for improvement in PDVs.
• To support the continuous development and optimization of PDVs for clinical use.

Main Methods:

• Development of a test protocol emphasizing iterative and agile assessment.
• Utilizing a mechanical lung to simulate diverse patient lung mechanics and breathing cycles.
• Evaluating PDV control system accuracy, oxygen dynamics, and trigger response.
• Iterative in vitro testing of three developing PDVs against a Hamilton T1 reference ventilator.

Main Results:

• The protocol enabled fast identification of specific performance characteristics for each tested PDV.
• Continuous testing allowed for the quick pinpointing of critical application aspects requiring further improvement.
• The tested PDVs demonstrated promising performance metrics under the developed protocol.
• The iterative nature of the protocol facilitated agile development cycles.

Conclusions:

• The presented test protocol is effective for the agile and iterative assessment of PDVs.
• The protocol supports rapid identification of critical performance parameters for ventilator development.
• The tested PDVs show potential for clinical application, warranting further development based on this protocol.