FDA approves new NASA ventilator for emergency response in COVID-19 treatment

FDA approves NASA ventilators for emergency use
FDA approves NASA ventilators for emergency use

HOUSTON – COVID-19 has created an urgent need for ventilators across the country.

Instead of building spacecraft, the NASA engineers at the Jet Propulsion Laboratory have worked tirelessly to create a ventilator prototype to answer the call. NASA’s JPL sought out the Emergency Use Authorization from the FDA to be able to go with the design.

The FDA approved the emergence-use authorization request Thursday. NASA has offered up the license to companies for free.

“This crisis is unprecedented in our lives, and it requires unprecedented action,” said Robert Manning, a NASA JPL Engineering Fellow.

“I see it in our team and that is a call to duty. I have this talent. I’m an engineer or scientist--I can do something,” said Leon Alkalai, a NASA engineering fellow.

Amidst the pandemic, the NASA JPL team in southern California has dedicated itself to creating life-saving solutions.

“We are designing an easy and rapidly mass manufacturable ventilator device, and it is a crazy project,” said Michelle Easter, a NASA Mechatronics Engineer.

Using their engineering and scientific instincts as their guide, the team found a very clever way to design a ventilator prototype, which they have worked on tirelessly.

The device, called VITAL, standing for Ventilator Intervention Technology Accessible Locally, is designed to be faster to build and easier to maintain than traditional ventilators with fewer parts.

"This is our first prototype circuit. What we did is dismantle a leaf blower," Easter said.

The high-pressure ventilator prototype is tailored to the needs of patients with COVID-19. In March, the prototype was sent out to the Icahn School of Medicine at Mount Sinai in New York for testing. Like all ventilators, VITAL requires patients to be sedated and have an oxygen tube inserted into their airway to breathe.

“I’m so amped up. I mean really the adrenaline rush, it’s exciting but it’s exhausting,” said Stacey Boland, a NASA Systems Engineer.

“I don’t have time to sleep,” said Michael R. Johnson, a NASA Mechatronics Engineer.

This sacrifice is well worth it, Johnson said. This team knows, they are doing work that could save many people.

“We have the potential to save human lives...people we might know: our neighbors, our family,” Easter said. “It’s amazing and as stressful as it’s been in the last couple of weeks, not one of us can stop.”

“This FDA authorization is a key milestone in a process that exemplifies the best of what government can do in a time of crisis,” said NASA Administrator Jim Bridenstine. “This ventilator is one of the 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 Emergency Use Authorization allows the use of the device specifically for COVID-19 patients, in efforts to address a lack of ventilators.

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

"Now that we have a design, we're working to pass the baton to the medical community, and ultimately patients, as quickly as possible," said Fred Farina, chief innovation and corporate partnerships officer at Caltech. "To that end, we are offering the designs for licensing on a royalty-free basis during the time of the pandemic."

This was a huge moment for NASA.

“We have a certain talent. We have a can-do attitude,” Alkalai said.

“Fighting the virus and treating patients during this unprecedented global pandemic requires innovative approaches and action. It also takes an all hands-on deck approach, as demonstrated by the NASA engineers who used their expertise in spacecraft to design a ventilator tailored for very ill coronavirus patients. This example shows what we can do when everyone works together to fight COVID-19,” said FDA Commissioner Stephen Hahn.

“We believe today’s action will increase the availability of these life-saving medical devices. The FDA will continue to add products to this emergency use authorization, as appropriate, during this pandemic to facilitate an increase in ventilator inventory.”