The COVID-19 pandemic has produced critical shortages of ventilators worldwide. There is an unmet need for rapidly deployable, emergency-use ventilators with sufficient functionality to manage COVID-19 patients with severe acute respiratory distress syndrome. Here, we show the development and validation of a simple, portable and low-cost ventilator that may be rapidly manufactured with minimal susceptibility to supply chain disruptions. This single-mode continuous, mandatory, closed-loop, pressure-controlled, time-terminated emergency ventilator offers robust safety and functionality absent in existing solutions to the ventilator shortage. Validated using certified test lungs over a wide range of compliances, pressures, volumes and resistances to meet U.S. Food and Drug Administration standards of safety and efficacy, an Emergency Use Authorization is in review for this system. This emergency ventilator could eliminate controversial ventilator rationing or splitting to serve multiple patients. All design and validation information is provided to facilitate ventilator production even in resource-limited settings.
Keywords: COVID‐19 pandemic; acute respiratory distress syndrome; critical care; mass casualty incidents; mechanical ventilation; medical device design; respiratory insufficiency.
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