The approval is for the use of special ventilators for coronavirus patients under the authorization of the Emergency Use of the FDA ventilator, which was established by the agency on March 24.
“This FDA authorization is an important milestone in the process that exemplifies the best of what governments can do in times of crisis,” NASA Administrator Jim Bridenstine said in a statement. “This ventilator is one of the countless examples of how taxpayers’ investments in space exploration – the skills, expertise and knowledge gathered over decades of pushing boundaries and reaching the first for humanity – translate into progress that enhances life on earth.”
This is called VITAL, or Ventilator Intervention Technology, which can be accessed locally. The approval came on the heels of the prototype passing critical tests at the Icahn Faculty of Medicine on Mount Sinai in New York last week.
“Fighting viruses and treating patients during this unprecedented global pandemic requires innovative approaches and actions. It also requires an all-hands approach, as demonstrated by NASA engineers who use their expertise in spacecraft to design ventilators designed specifically for patients. “sick coronavirus. 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 actions will increase the availability of these life-saving medical devices,” he added. “The FDA will continue to add products to this authorization for emergency use, as appropriate, during this pandemic to facilitate increased ventilator inventory.”
Engineers at NASA’s Jet Propulsion Laboratory in Pasadena are developing ventilators, which can be built quickly using fewer parts, which are mostly available in the current supply chain, the agency said. But it will not compete with existing supply chains for ventilators.
At present, the California Institute of Technology, which manages JPL, is conducting outreach through its Technology Transfer and Corporate Partnership Office to offer free licenses and find manufacturers for VITAL.
“Now that we have a design, we are working to give a stick to the medical community, and ultimately the patient, as quickly as possible,” Fred Farina, head of innovation and corporate partnership officer at Caltech, said in a statement. “For this reason, we offer designs for royalty-free licenses during the pandemic.”
What is VITAL?
The prototype functions like a traditional ventilator, in which patients who are given sedatives rely on oxygen cylinders to help them breathe. But it was built to last three or four months, unlike ventilators in hospitals that are designed to last for years and help patients with other medical problems. The engineers hope that more traditional ventilators can be released for patients with the most severe cases of coronavirus if VITAL is implemented.
“We are very pleased with the results of the tests we carried out in high-fidelity human simulation laboratories,” Dr. Matthew Levin, innovation director for the Human Simulation Laboratory and associate professor of anesthesiology, perioperative and pain relievers, and genetics and genomics at the Icahn School of Medicine, said in a statement.
“The NASA prototype was carried out as expected under a variety of simulated patient conditions. The team felt confident that the VITAL ventilator would be able to safely ventilate patients suffering from Covid-19 both here in the United States and throughout the world.”
This innovative ventilator is also designed to offer more oyxgen at higher pressures than a typical model because Dr. Levin said some of the patients treated needed this ability.
“The intensive care unit is meeting Covid-19 patients who need very dynamic ventilators,” Dr. J.D Polk, NASA’s chief health and medical officer, in a statement. “The intention with VITAL is to reduce the likelihood that patients will reach an advanced stage of the disease and need the help of more advanced ventilators.”
It was also designed to be flexible with easy maintenance, meaning that it can be used in a variety of field hospital hosting arrangements, including hotels and convention centers.
“We specialize in spacecraft, not manufacturing medical devices,” Michael Watkins, director of JPL, said in a statement. “But excellent techniques, rigorous testing and rapid prototyping are some of our specialties. When people at JPL realize that they might have what it takes to support the medical community and the wider community, they feel it is their duty to share ingenuity, expertise and encouraging. “
Rise up to a challenge
Engineers like Stacey Boland stepped forward, compelled to do whatever they could to help. The last 40 days have taken everything they had to make VITAL. The team works long hours every day, which turns into non-existent weekends.
At MAIA, Boland has worked with epidemiologists to determine the data they need from the mission.
At VITAL, Boland acts as the operations leader to create a communication channel between engineers, designers, and visualization specialists with doctors, nurses, respiratory therapists, and intensivists (board-certified doctors provide specialized care for critically ill patients). Translating among various professions to put everyone on the same page is a challenge, but one he enjoys.
Operating during a pandemic means they rely on calls, sending pictures and video conferencing to make products in real time. Medical professionals call their lunch breaks, still in scrubs, describing what they see in patients and what they will need for VITAL.
One staff member is limited to working alone on the hardware, while the other video team is negotiating. Boland literally wrote a manual for how to operate VITAL while it was being built.
For Boland, this is a personal matter. His sister is a hospital nurse practitioner at Memorial Hospital in Gulfport in Mississippi. He will call his sister, send her photos and ask questions when they are working on the device, and her sister will send feedback in real time.
Boland calls it a lifetime of experience, working on teams that are able to find friendship through their single desire to create something useful during challenging times.
When they find obstacles while working on VITAL, there is no sleep on the decisions that need to be made, said Boland. Normal coping mechanisms are thrown out the window, and they work through problems in real time to overcome the next challenge.
Already adrenaline, working on a ventilator in a short time, and the team hopes it’s in better shape. But the VITAL team was driven to help.
“I’m not a medical device engineer, but when I hear someone on the front lines needs something, I want them to have it,” Boland said. “We want to be there for them. It is a blessing and a privilege to have something so challenging but very relevant to do.”
Leon Alkalai, a technical partner at JPL, manages the strategic partnership office. In recent years, he has led small efforts 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 that the FDA was very supportive. And the doctors at Mount Sinai were interested in partnering together at VITAL after he reached out and shared ideas.
The collaboration between NASA and the FDA and medical professionals is an example of how various institutions with different fields of expertise come together to create solutions for this pandemic.
“We are rocket scientists and engineers, we know how to land on the moon and Mars,” Alkalai said. “But building medical devices is new. We are humbled by the challenge of doing something we have never done before for a good cause. It is against our culture to do things quickly in a domain where we are not experts. But that matches JPL’s mantra: ‘Dare Mighty Things.’ “
Help for help
In addition, NASA is trying to help fill the gap due to lack of other medical equipment in the local community, such as Antelope Valley, California. One new device is the Aerospace Valley Positive Pressure Helmet, which can be used to help treat coronavirus patients with mild symptoms so they don’t have to use a ventilator. It functions more like continuous positive airway pressure, or a CPAP machine, which is commonly used to treat sleep apnea, the agency said.
This has been successfully tested and submitted to the FDA for authorization for emergency use. Meanwhile, 500 are in production.
The device is a collaboration between NASA’s Armstrong Aviation Research Center in California in partnership with Antelope Valley Hospital, Lancaster City, Virgin Galactic and The Spaceship Company, Antelope Valley College, and members of the Antelope Valley Task Force.
The prototype for VITAL and helmets is the result of NASA’s call to action issued on April 1 called the NASA @ Work challenge. In two weeks, NASA employees have sent 250 ideas.
NASA Glenn Research Center in Ohio previously partnered with Emergency Products and Research, an Ohio company, to work on portable small devices that decontaminate ambulances quickly and much cheaper than the current system called AMBUStat. They are looking for the best way to implement this during the pandemic too.
Indeed, “NASA’s strength has always been our ability and passion – collective and individual – to solve problems,” Bridenstine said in a statement. “All work carried out shows how NASA is uniquely equipped to assist in the federal response to the corona virus by utilizing the ingenuity of our workforce, mobilizing investments made in the US space agency to combat this disease and working with public and private partnerships to maximize results. “