Can low-cost, open-source ventilator designs help save lives?

MIT researchers hope to publish open-source designs for a low-cost respirator that could potentially help Covid-19 patients struggling with critical respiratory problems.

The motorized device automatically compresses widely available bag valve masks, the sort of manual resuscitator used by ambulance crews to assist patients with breathing problems. The designs could arrive as a growing number of engineers, medical students, and hobbyists attempt to build or share specifications for makeshift respirators—of unknown quality and safety—amid rising fears of widespread shortages as the coronavirus epidemic escalates.

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The team recently launched a website unveiling the MIT Emergency Ventilator Project, or E-Vent, which now states the device "is being submitted" to the Food and Drug Administration for rapid review under an “Emergency Use Authorization.” Last week, MIT Technology Review was informed the team intended to test the devices on pigs in recent days, though it’s still unclear what the results were.

“At present, we are awaiting FDA feedback," one member of the team told MIT News. “Ultimately, our intent is to seek FDA approval. That process takes time, however.”

It’s also not clear if the team has yet fully answered the fundamental question of the project: Is it possible to safely ventilate a Covid-19 patient by automatically actuating a manual resuscitator?

If that answer is yes, the hope is that openly publishing the designs, test results, and related medical information could enable those with the necessary manufacturing capacity and expertise to produce reliable, safe, and affordable respirators. Even so, the site stresses the device should be operated only under the supervision of trained medical professionals and is not a replacement for an FDA-approved intensive care unit ventilator “in terms of functionality, flexibility, and clinical efficacy.”

“The MIT E-Vent is anticipated to have utility in helping free up existing supply or in life-or-death situations when there is no other option,” the site adds.

Researchers at the University of Minnesota are developing a similar device, which also relies on automating the pumping of "ambu" bags. They also hope to soon publish open-source designs, according to reporting in the Star Tribune.

The MIT project dates back to about a decade ago, when a group of MIT students in the Precision Machine Design course developed a proof-of-principle version of the machine, working with Jussi Saukkonen of Boston University Medical Center. They published a paper on the device, but never moved forward with production.

They designed it mainly as a tool for rural areas in developing nations, which have high levels of chronic respiratory issues but limited access to mechanical ventilators. Even then, though, they noted it could also serve an important role in the US in the event of a wide-scale pandemic like the one now unfolding.

At the time, the group estimated it would cost about $100, compared with tens of thousands of dollars for standard hospital versions.

The current team referenced those original designs but made additional efforts to ensure it would be easier for others to reliably make and use the device. The site notes that the new version is solid and metal framed.

The emerging efforts to produce more ventilators comes after outbreaks in Italy, China, and Iran overwhelmed hospital systems, reportedly forcing life and death triage choices on medical professions. Officials in New York and Washington state have said they could soon run critically low on the machines.

As of February, the US had nearly 170,000 ventilators that could be made available to patients, according to an estimate by the Center for Health Security. But an outbreak as severe as the 1918 influenza pandemic could require more than 740,000.

Existing manufacturers are looking for ways to rapidly ramp up production. Ventec Life Systems, a ventilator company based in Bothell, Washington, is collaborating with auto giant GM to boost manufacturing as part of a “coordinated private sector response” called StopTheSpread.org. Similarly, GE Healthcare is working with Ford to accelerate ventilator output. 

Correction: The story was updated to clarify that the team hasn't yet submitted its designs for fast-track approval.