A ventilator developed by NASA has been given an emergency use authorization by the Food and Drug Administration amid the spread of COVID-19. The FDA issued the authorization on Thursday.
The ventilator is said to be specially designed for use by COVID-19 patients.
The NASA VITAL provides 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, the FDA said.
“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.”
Along with the authorization, NASA is providing manufactures a free license to build the machine. This is a general practice NASA uses with its research, allowing private industry to benefit off of taxpayer-funded research.
“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 availability of these life-saving medical devices.
The device is said to 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.
An “emergency use authorization” allows doctors to use the device despite it not gaining full FDA approval.
An emergency use authorization stipulates that “the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.”
Doctors can use devices and treatments under an emergency use authorization by weighing the potential benefits against the potential side effects.
