NASA Seeks Manufacturers for New Ventilator; FDA Adds Device to Emergency Use Authorization

The U.S. Food and Drug Administration included, under the ventilator emergency use authorization (EUA) , a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19. The ventilator was added to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator EUA that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in healthcare settings to treat patients during the COVID-19 pandemic.

FDA included the NASA VITAL (Ventilator Intervention Technology Accessible Locally) under the ventilator EUA. VITAL is intended to last three to four months and is specifically tailored for patients with COVID-19, by providing respiratory support for patients that are experiencing respiratory failure or insufficiency. The device is designed to be built with components outside the current medical device supply chain and therefore does not impact the existing supply chain of currently made ventilators. Like all ventilators, VITAL requires patients to be sedated and an oxygen tube inserted into their airway to breathe. This medical device does not replace current hospital ventilators, which can last years and are built to address a broader range of medical issues.

This image shows the ventilator prototype for coronavirus disease patients designed and built by NASA's Jet Propulsion Laboratory in Southern California. (Credit:NASA/JPL-Caltech)

According to NASA, the device was developed by engineers at NASA's Jet Propulsion Laboratory in Southern California to free up the nation's limited supply of traditional ventilators so they may be used on patients with the most severe COVID-19 symptoms. The high-pressure ventilator was developed in just 37 days.

"We specialize in spacecraft, not medical-device manufacturing," says JPL Director Michael Watkins. "But excellent engineering, rigorous testing and rapid prototyping are some of our specialties. When people at JPL realized they might have what it takes to support the medical community and the broader community, they felt it was their duty to share their ingenuity, expertise and drive."

VITAL can be built faster and maintained more easily than a traditional ventilator, and is composed of far fewer parts, many of which are currently available to potential manufacturers through existing supply chains. Its flexible design means it also can be modified for use in field hospitals being set up in convention centers, hotels, and other high-capacity facilities across the country and around the globe.

Like all ventilators, VITAL requires patients to be sedated and an oxygen tube inserted into their airway to breathe. The new device wouldn't replace current hospital ventilators, which can last years and are built to address a broader range of medical issues. Instead, VITAL is intended to last three to four months and is specifically tailored for COVID-19 patients.

"Intensive care units are seeing COVID-19 patients who require highly dynamic ventilators," says Dr. J.D. Polk, NASA's chief health and medical officer. "The intention with VITAL is to decrease the likelihood patients will get to that advanced stage of the disease and require more advanced ventilator assistance."

“This FDA authorization is a key milestone in a process that exemplifies the best of what government can do in a time of crisis,” says NASA Administrator Jim Bridenstine. “This ventilator is one of countless examples of how taxpayer investments in space exploration — the skills, expertise and knowledge collected over decades of pushing boundaries and achieving firsts for humanity – translate into advancements that improve life on Earth.”

The Office of Technology Transfer and Corporate Partnerships at Caltech, which manages JPL for NASA, will offer a free license for VITAL and currently is reaching out to the commercial medical industry to find manufacturers for the device.