The approval is for use of the ventilator specifically for coronavirus patients under the FDA’s ventilator Emergency Use Authorization, established by the agency on March 24.
“This FDA authorization is a key milestone in a process that exemplifies the best of what government can do in a time of crisis,” NASA Administrator Jim Bridenstine said in a statement. “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.”
It’s called VITAL, or Ventilator Intervention Technology Accessible Locally. The approval comes on the heels of the prototype passing a critical test at the Icahn School of Medicine at Mount Sinai in New York last week.
“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,” FDA Commissioner Stephen Hahn said in a statement.
“We believe today’s action will increase availability of these life-saving medical devices,” he added. “The FDA will continue to add products to this emergency use authorization, as appropriate, during this pandemic to facilitate an increase in ventilator inventory.”
Engineers at NASA’s Jet Propulsion Laboratory in Pasadena developed the ventilator, which can be built quickly using fewer parts, most of which are available in current supply chains, the agency said. But it won’t compete with the existing supply chain for ventilators.
Currently, the California Institute of Technology, which manages JPL, is conducting outreach through its Office of Technology Transfer and Corporate Partnerships to offer a free license and find manufacturers for VITAL.
“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, in a statement. “To that end, we are offering the designs for licensing on a royalty-free basis during the time of the pandemic.”
What is VITAL?
The prototype works like traditional ventilators, where sedated patients rely on an oxygen tube to help them breathe. But it’s built to last three or four months, unlike ventilators in hospitals that were designed to last for years and help patients with other medical issues. The engineers hope that more traditional ventilators can be freed up for patients with the most severe cases of coronavirus if VITAL is put into place.
“We were very pleased with the results of the testing we performed in our high-fidelity human simulation lab,” said Dr. Matthew Levin, director of innovation for the Human Simulation Lab and associate professor of anesthesiology, perioperative and pain medicine, and genetics and genomics sciences at the Icahn School of Medicine, in a statement.
“The NASA prototype performed as expected under a wide variety of simulated patient conditions. The team feels confident that the VITAL ventilator will be able to safely ventilate patients suffering from Covid-19 both here in the United States and throughout the world.”
The innovative ventilator was also designed to offer more oyxgen at higher pressures than typical models because Dr. Levin said some of the patients he’s treating needed that capability.
“Intensive care units are seeing Covid-19 patients who require highly dynamic ventilators,” said Dr. J.D. Polk, NASA’s chief health and medical officer, in a statement. “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.”
It was also designed to be flexible with easy maintenance, meaning it can be used in the diverse settings hosting field hospitals, including hotels and convention centers.
“We specialize in spacecraft, not medical device manufacturing,” Michael Watkins, JPL director, said in a statement. “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.”
Rising to the challenge
Engineers like Stacey Boland stepped up, driven to do anything they could to help. The last 40 days have taken everything they had to make VITAL. The team worked long hours each day, which bled over into nonexistent weekends.
On MAIA, Boland has worked with epidemiologists to determine the data they would need from the mission.
On VITAL, Boland acted as the operations lead to create a communication pathway between engineers, designers and visualization specialists with doctors, nurses, respiratory therapists and intensivists (board-certified physicians providing special care for critically ill patients). Translating between the different professions to put everyone on the same page was a challenge, but one she enjoyed.
Operating during a pandemic meant that they were relying on calls, sending images and video conferencing to make a product in real time. Medical professionals called in on their lunch breaks, still in scrubs, describing what they were seeing in patients and what they would need VITAL to do.
A limited staff worked in person on the hardware, while the rest of the team video conferenced in. Boland was literally writing the instruction manual for how to operate VITAL as it was being built.
For Boland, it’s personal. Her sister is a hospitalist nurse practitioner at Memorial Hospital at Gulfport in Mississippi. She would call her sister, send her pictures and ask questions as they worked on the device, and her sister would send feedback in real time.
Boland calls it the experience of a lifetime, working on a team that was able to find camaraderie through their singular desire to create something helpful during such a challenging time.
When they encountered obstacles while working on VITAL, there was no sleeping on decisions that needed to be made, Boland said. Normal coping mechanisms were tossed out the window, and they worked through issues in real time to overcome the next challenge.
It’s been an adrenaline rush, working on a ventilator in such a short time, and the team wished it were under better circumstances. But the VITAL team was driven to help.
“I am not a medical device engineer, but when I hear someone on the front line needs something, I want them to have it,” Boland said. “We want to be there for them. It’s been a blessing and a privilege to have something so challenging and yet so relevant to be working on.”
Leon Alkalai, a technical fellow at JPL, manages the office of strategic partnerships. In recent years, he’s been leading a small effort to build relationships with the medical engineering community. He joined the VITAL team in a leadership role and helped establish communication between JPL and Mount Sinai, the FDA and the US Department of Homeland Security.
Alkalai said the FDA has been extremely supportive. And the doctors at Mount Sinai were interested in partnering together on VITAL after he reached out and shared the idea.
The collaboration between NASA and the FDA and medical professionals is an example of how institutions with different areas of expertise are coming together to create solutions for the pandemic.
“We’re rocket scientists and engineers, we know how to land on the moon and Mars,” Alkalai said. “But building a medical device is new. We were humbled by that challenge to do something we’ve never done before for a good cause. It goes against our culture to do something quickly in a domain where we’re not experts. But it fits with the JPL mantra: ‘Dare Mighty Things.'”
A helping hand
Additionally, NASA is trying to help fill the gaps due to shortages of other medical equipment in local communities, like Antelope Valley, California. One new device is the Aerospace Valley Positive Pressure Helmet, which can be used to help treat coronavirus patients with minor symptoms so they don’t have to use a ventilator. It functions more like a continuous positive airway pressure, or CPAP, machine, commonly used to treat sleep apnea, the agency said.
It has already been successfully tested and submitted to the FDA for emergency-use authorization. Meanwhile, 500 are currently in production.
The device is the result of a collaboration between NASA’s Armstrong Flight Research Center in California partnered with Antelope Valley Hospital, the City of Lancaster, Virgin Galactic and The Spaceship Company, Antelope Valley College and members of the Antelope Valley Task Force.
The prototype for VITAL and the helmet are the result of NASA’s call to action issued on April 1 called the [email protected] challenge. Within two weeks, NASA employees had submitted 250 ideas.
The NASA Glenn Research Center in Ohio previously partnered with Emergency Products and Research, an Ohio company, to work on small, portable devices that decontaminate ambulances quickly and much cheaper than current systems called AMBUStat. They’re looking at the best way to apply this during the pandemic as well.
Indeed, “NASA’s strength has always been our ability and passion — collective and individual — for solving problems,” Bridenstine said in a statement. “All the work being done shows how NASA is uniquely equipped to aid in the federal response to coronavirus by leveraging the ingenuity of our workforce, mobilizing investments made in the U.S. space agency to combat this disease and working with public and private partnerships to maximize results.”