• Aditya Vasan, Reiley Weekes, William Connacher, Jeremy Sieker, Mark Stambaugh, Preetham Suresh, Daniel E Lee, William Mazzei, Eric Schlaepfer, Theodore Vallejos, Johan Petersen, Sidney Merritt, Lonnie Petersen, and James Friend.
• Medically Advanced Devices Laboratory Center for Medical Devices Department of Mechanical and Aerospace Engineering Jacobs School of Engineering and Department of Surgery School of Medicine University of California San Diego La Jolla CA 92093 USA.
• Med Devices Sens. 2020 Jun 5: e10106.

AbstractThe 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.This article is protected by copyright. All rights reserved.

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