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 health care settings to treat patients during the COVID-19 pandemic.
“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 M. Hahn, M.D.
“We believe today’s action will increase 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.”
The 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 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 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.”