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(CNN) – The prototype of a high-pressure respirator, developed by NASA engineers to help patients with coronavirus, received approval on Thursday from the Food and Drug Administration (FDA), according to the agency. space.
The authorization is for use of the respirator only in patients with coronavirus, under the FDA approval of emergency use of ventilators, which was established by the agency on March 24.
Engineers at NASA’s Jet Propulsion Laboratory in Pasadena created the prototype of an artificial respirator designed to assist coronavirus patients.
“This FDA clearance is a key milestone in a process that exemplifies the best of what the government can do in times of crisis,” Jim Bridenstine, NASA administrator, said in a statement. “This respirator is one of countless examples of how taxpayer investments in space exploration – the skills, experience, and knowledge gathered over decades of pushing boundaries and achieving early accomplishments for humanity – translate into breakthroughs. that improve life on Earth, “he added.
The device is called VITAL, which stands for Locally Accessible Ventilation Technology for Intervention. Approval comes just after the prototype passed a key test at 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 actions. It also requires a ‘everyone, get to work’ approach, as demonstrated by NASA engineers who used their experience in spacecraft to design a respirator created for very sick patients with coronavirus. This example shows what we can do when everyone works together to fight covid-19, ”said FDA Commissioner Stephen Hahn in a statement.
“We believe that today’s action will increase the 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 the inventory of respirators,” he added.
Engineers at the NASA Jet Propulsion Laboratory (JPL), located in Pasadena, developed the artificial respirator that can be assembled quickly with few parts, many of which are available in today’s supply chains, he reported. the agency. And it will not compete with the existing supply chain for other respirators.
Currently, the California Institute of Technology, which manages JPL, is conducting outreach activities through its Office of Technology Transfer and Corporate Associations to offer a free license and find manufacturers for VITAL.
“Now that we have a design, we are working to move development to the medical community and ultimately to patients as quickly as possible,” said Fred Farina, director of innovation and corporate partnerships at Caltech, in a statement. “To that end, we are offering royalty-free license designs during the time of the pandemic,” he added.
What is VITAL?
The prototype works like traditional artificial respirators, in sedated patients they depend on an oxygen tube to help them breathe. But VITAL is designed to last three to four months, unlike hospital respirators that were created to last years and help patients with other medical problems. Engineers hope that more traditional devices can be released for those patients with the most severe cases of coronavirus if VITAL is implemented.
The prototype was created to free up traditional hospital respirators.
“We are very pleased with the results of the tests we perform in our high-quality human simulation laboratory,” said Dr. Matthew Levin, director of innovation at the Human Simulation Laboratory and associate professor of anesthesiology, perioperative medicine and analgesic, and genetics and genomic sciences at the Icahn School of Medicine.
“The NASA prototype performed as expected in a wide variety of simulated patient conditions. The team is confident that the VITAL respirator will be able to safely ventilate covid-19 patients here in the United States and around the world, ”he added.
The innovative ventilator was also designed to deliver more oxygen at higher pressures than usual models, because, according to Dr. Levin, some of the patients he is treating needed that capacity.
“Intensive care units are treating covid-19 patients who require highly dynamic respirators,” said Dr. J.D. Polk, NASA’s medical and health director, in a statement. “The intention with VITAL is to decrease the likelihood that patients will reach the advanced stage of the disease and require more advanced ventilation assistance.”
It was also created to be flexible with easy maintenance, which means it can be used in the many settings that house field hospitals, including hotels and convention centers.
“We specialize in spacecraft, not medical devices,” said Michael Watkins, director of JPL, in a statement. “But excellent engineering, rigorous testing, and rapid prototyping are some of our specialties. When the people at JPL realized that they might have what it takes to support the medical community and the community at large, they felt it was their duty to share their ingenuity, experience and create, ”he added.
NASA engineers sent the prototype artificial respirator for patients with coronavirus disease to the Icahn School of Medicine at Mount Sinai in New York.
Meeting the challenge
Engineers like Stacey Boland stepped forward, motivated to do their best to help. During the last 40 days they have taken everything necessary to create VITAL. The team worked long hours each day, which lasted until nonexistent weekends.
Boland is a project systems engineer developing the MAIA instrument, which stands for Multi-Angle Imaging Camera for Aerosols that will capture particulate matter in air pollution. This device could provide data that helps medical professionals determine what types of contamination correlate with negative health outcomes.
At MAIA, Boland has worked with epidemiologists to determine the information they would need for the mission.
In the case of VITAL, Bolando served as the operations leader to create a communication pathway from engineers, designers, and visualization specialists to doctors, nurses, respiratory therapists, and intensivists (the certified doctors who provide special care to patients in critical condition). Managing to translate between different professions to put them all on the same page was a challenge, but she liked it.
Working during a pandemic also meant that the team relied on calls, image sending, and video conferencing to make a product in real time. Medical professionals called during their lunch breaks, still in their uniforms, to describe what they were seeing in patients and what they would need VITAL to do.
A small staff physically worked on the hardware, while the rest of the team participated in video conferences. Boland literally wrote the instruction manual on how to operate VITAL while it was being built.
For Boland, it is personal. Her sister is a nurse practitioner at Memorial Hospital in Gulfport, Mississippi. She would call her sister, send her photos and ask questions while working on the device, and her sister would send her comments in real time.
Boland calls it the experience of a lifetime: He worked in a team that was able to achieve camaraderie through his unique desire to create something useful during such a challenging time.
When they ran into obstacles while working at VITAL, the decisions that had to be made couldn’t wait, Boland explained. Normal mechanisms for dealing with problems were not an option, and they worked through problems in real time to overcome the next challenge.
It has been an adrenaline rush to work on a fan in such a short time, and the team wish it had been under better circumstances. But the people behind VITAL were driven to help.
“I am not a medical device engineer, but when I hear that someone on the front line needs something, I want them to have it,” Boland said. “We want to be there for them. It has been a blessing and a privilege to have something so challenging and so relevant to work with, ”he said.
Leon Alkalai, technical member of JPL, manages the office of strategic associations. In recent years, he has led 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 the JPL. Mount Sinai Hospital, the FDA, and the United States Department of Homeland Security.
Alkalai noted that the FDA has been extremely supportive. And the Mount Sinai doctors were interested in partnering at VITAL after he reached out and shared the idea.
The collaboration between NASA, the FDA and medical professionals is an example of how institutions with different areas of expertise can come together to create solutions to the pandemic.
“We are scientists and aerospace engineers, we know how to land on the Moon and Mars,” said Alkalai. “But building a medical device is something new. We are honored by the challenge of doing something we have never created before for a good cause. It is against our culture to do something quickly in a domain in which we are not experts. But it fits in with the JPL mantra: ‘Dare to do powerful things,’ ”he added.
A friendly hand
Additionally, NASA is trying to help fill the gaps due to a shortage of other medical equipment in local communities, such as in Antelope Valley, California. A 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 wear a respirator. It works more like a continuous positive airway pressure machine, or CPAP, 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, there are currently 500 in production.
NASA engineer Mike Buttigieg works on the Aerospace Valley positive pressure helmet
The device is the result of a collaboration between NASA’s Armstrong Flight Research Center in California, Antelope Valley Hospital, the city of Lancaster, Virgin Galactic and The Spaceship Company, Antelope Valley College, and members of the Antelope Valley.
The VITAL prototype and helmet are the result of NASA’s call to action, issued on April 1, called the NASA @Work challenge. In two weeks, NASA employees had submitted 250 ideas.
NASA’s 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 at less cost than current systems called AMBUStat. They are also looking for the best way to implement this during the pandemic.
In fact, “NASA’s strength has always been our ability and passion – collective and individual – to solve problems,” Bridenstine said in a statement. “All the work being done shows how NASA is uniquely equipped to assist in the federal response to the coronavirus, leveraging the ingenuity of our workforce, mobilizing investments made in the US space agency. to combat this disease and working with public and private associations to maximize results, “he concluded.
