In mid-March, Prakash had just returned from a work trip in France when he found himself coughing, short of breath and burning with fever. He ended up at Stanford University Medical Center, where he tested negative for the coronavirus but still went home to quarantine and recover.
Prakash, 40, locked himself in with everything he brought home from that trip — including his snorkel mask. He thought of his time at the hospital, when doctors and nurses threw away their personal protective equipment or PPE after each check-in. Could he make a reusable PPE from his snorkel mask that could be used by doctors and nurses if, or when, hospitals start to run out?
That question soon turned into a potential solution called Pneumask, which costs about $40 to make. It combines an off-the-shelf, full-face scuba mask with a medical-grade filter. It works by attaching a filter commonly found in a hospital to the mask.
In two weeks, Prakash and a team of about 10 Stanford students conducted research on the effectiveness of the Pneumask design and submitted their findings to the Food and Drug Administration.
“Nothing about this is normal,” Prakash said, adding that they’ve never before submitted research to the FDA in such a short period. “There’s nothing normal about what’s happening around the world right now. I wish we had more time. I wish we were not here.”
The FDA gave them a green light to label their product as a face shield or surgical mask — not a respirator — so they could ship the masks to health-care workers as soon as possible. Respirators are designed to seal to the face and protect from airborne particles, including viruses, while surgical masks offer less protection and are a barrier to larger substances such as saliva.
The FDA said it needed more information to decide whether the device can be a reusable substitute to N95 respirators, and Prakash said that any approval would take some time.
This week, the group is shipping 1,500 masks free to clinicians in Alabama, California, Florida, Illinois and New York. They’re planning to send an additional 7,000 Pneumasks in the coming weeks.
Prakash’s team is publishing its work in a public Google doc so health-care professionals can be informed about how best to use the Pneumask, as well as sterilize it between uses.
The goal is that Pneumask can be used if hospitals run out of masks or other PPE, with no other options for protection. The FDA has said it does not object to health-care professionals improvising PPE when all other alternatives are unavailable.
There are reports of doctors in Spain, Belgium and elsewhere around the world using full-face scuba masks to protect against the novel coronavirus. Prakash is hoping his lab can support these efforts to develop reusable PPE.
“My desire would be that nobody would have to use anything like this, but, on the other hand, there are no good solutions out there,” Prakash said.
Prakash has formed an international coalition of medical experts and clinicians, with backing and technical support from companies such as Boston Scientific and Medtronic. With coordination through the coalition, doctors in Chile and France are working to use full-faced scuba masks as acceptable alternatives for respirators in hospitals.
The parts in a Pneumask require one custom piece connecting the mask to the filter. Prakash created the piece using medical-grade equipment. He said that anecdotally he knows of people who have made the piece from a 3-D printer, but said that method might not ensure an airtight seal.
Roberto Miki, an orthopedic surgeon who runs a private practice in Miami, is one of the doctors helping Prakash in his coalition. Before he knew about the coalition, Miki fashioned his own scuba mask solution and posted the device on YouTube. Now, Miki said, he’s using his own funds to buy and distribute masks using the Pneumask design for medical staff and first-responders in the Miami area.
There is a need for reusable alternatives to N95 masks and other disposable equipment, Miki believes, because the supply chains won’t be able to support the demand for masks as the pandemic continues and more people are hospitalized.
“A lot of light needs to be shed on this project,” he added. “There’s a [coronavirus] peak that’s coming and if this project doesn’t get off the launchpad quick enough, we’re going to miss part of that peak. We’re going to miss saving some people.”
No matter how many masks they make, the Pneumasks will remain a limited resource, Prakash said. There are only so many full-faced scuba masks in the world. The goal is to create 50,000 to deliver, and the group has made about 1,700. Prakash said his plan will rely on hospitals sending back masks when they no longer need the extra support. If it works, the masks will be able to follow the spread of the virus, aiding medical professionals who need help the most.
After the crisis, when the pandemic is under control, Prakash said there will be a “remarkable amount of innovation” born out of the solutions people are piecing together now under pressure.
“What this pandemic has done is truly expose the underbelly of weaknesses that we have in our protection for health-care workers,” he added.
The Pneumask is just one of many projects underway in Prakash’s lab to help health-care workers combat covid-19. In a separate effort, Stanford students are working on a way to create filters that compare to N95 respirators by using cotton-candy machines, or a similar rotary device, and Styrofoam.
“You have to look at an object with a different eye, and you’ll see a solution in it,” Prakash said.
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