FDA Authorizes NASA Developed Ventilator for COVID-19
The FDA has added a ventilator developed by NASA to the list of authorized ventilators.
The US Food and Drug Administration (FDA) has added a ventilator developed by the National Aeronautics and Space Administration (NASA) to the list of authorized ventilators under the FDA’s ventilator emergency use authorization.
The original emergency use authorization was issued out of concern related to an insufficient supply of FDA-approved ventilators for use in health care settings during the coronavirus disease 2019 (COVID-19) pandemic.
The NASA Ventilator Intervention Technology Accessible Locally (VITAL) lasts for 3-4 months and is designed specifically to provide respiratory support for patients with COVID-19 who are experiencing respiratory issues. The device was developed by a team of engineers at NASA's Jet Propulsion Laboratory (JPL) in Southern California.
NASA administrator Jim Bridenstine called the authorization a key milestone in a process which "exemplifies the best of what government can do in a time of crisis."
“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," he said in a statement.
“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,” the FDA stated in its decision.
FDA commissioner Stephen Hahn, MD, praised the collaboration between federal science agencies, noting such collaborative innovation is necessary in the face of the pandemic.
"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," Hahn said. "This example shows what we can do when everyone works together to fight COVID-19."
The lack of ventilators has led to debates on how to ration care in the context of insufficient supply.
The FDA has also issued a variety of other emergency use authorizations during the COVID-19 pandemic. Just last month, FDA released an update on the 20 diagnostics authorized for emergency use up to that point. More have since been authorized. On April 14, an authorization was issued which concerned a method of N95-respirator decontamination.
