A New York volunteer tech consortium from Newlab will quickly produce thousands of MIT's innovative FDA-authorized automatic resuscitators, called Spiro Wave.
The growing spread of COVID-19 across the country made it immediately apparent that US hospitals did not have enough ventilators to treat victims of the coronavirus pandemic. But now, thanks to the minds at the Massachusetts Institute of Technology, MIT's E-vent design of an FDA-authorized emergency automatic resuscitator can be mass produced at scale quickly. MIT's E-vent (emergency ventilator) team was formed on March 12 as a response to the pandemic and the great need for ventilators.
About 30% of patients hospitalized for COVID-19 need ventilation. Manufacturers are ramping up to produce as many as 50,000 traditional (large-scale) ventilators, but distribution to hospitals is still months away, and this new emergency ventilator, now called Spiro Wave, is ready to be produced and manufactured this month.
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There was a surge in need for ventilators beyond a hospital's capacity for the many patients who needed basic ventilation, said MIT's Dr. Albert Kwon, anesthesiologist, Westchester Medical Center, one of the core members of the Emergency Ventilator Response Initiative (EVRI), during a conference on Zoom Monday, announcing the launch and distribution of the new ventilator.
Another collaborator, the New York City Economic Development Corporation (NYCED) provided a seed grant of $100,000 to adapt and prototype Spiro Wave's design and mobilized major hospitals to vet the new technology.
Medical, tech, and manufacturing teams act quickly
When Newlab's team of developers and engineers realized what was needed--quickly-- it began a "fever of activity," and hundreds of people "dropped what they were doing" to help speed the development and manufacturing, said Newlab co-founder Scott Cohen at the press conference on Zoom Monday. Cohen also is lead for the EVRI.
Multi-disciplinary tech-center Newlab, based and housed at the former Brooklyn Navy Yard, partnered with 10xBeta, Boyce Technologies, and the City of New York to create and distribute. The team also conducted intensive consultation with those at the frontline, New York clinicians and hospitals.
Faced with the great demand and need for ventilators, the collaborators were "fierce and steady," and unbelievable to work with, Cohen said. "We realized we were racing against the clock to forge this 'glimmer of light.'"
The Spiro Wave emergency ventilator replicates a hospital's manual ventilator, both freeing up clinicians to address other pressing needs while giving healthcare facilities the ability to treat more patients.
New York City has ordered 3,000 of the emergency ventilators, and thousands are set to be sent—at no cost—to areas worldwide that have been hit hard by the pandemic.
Spiro Wave will be swiftly manufactured, with the first 500 units produced by the Queens-based Boyce Technologies.
FDA says OK
The Spiro Wave project collaborators quickly obtained Emergency Use Authorization (EUA) from the FDA on Friday, April 12.
To further production, Newlab is in discussions with FDA-compliant factories in other jurisdictions to qualify the manufacturer to grow production.
How the Spiro Wave ventilators work
The Spiro Wave compresses a manual resuscitator in the same way a care provider would do so by hand and is compatible with standard Ambu and other BVM bags, which are flexible, plastic pouches used in hospitals throughout the country to pump air into a patient's lungs in emergency situations, and one that has been repeated thousands of times during the pandemic.
Clinicians can effectively monitor and adjust key respiratory and ventilation parameters like tidal volume, respiratory rate (BPMs), I/E ratio with the Spiro Wave's software, sensors, and safety systems.
The Spiro Wave can't replace a full-feature ventilator needed by the most sick patients, but does includes the basic core features of a conventional ventilator, and provides a bridge and surge support for patients who need more invasive mechanical ventilation therapy but don't yet need a full ICU ventilator. It frees ICU ventilators for the most severe cases.
Cost efficiency imperative
Hospitals needed a "low-cost" solution, stressed manufacturing lead and 10XBeta CEO Marcel Botha, who is also an EVRI lead, during the press conference.
New York hospitals will receive the first devices to help them get through the current surge in cases and then manufacturers around the world can use the Spiro Wave design to meet the global ventilator shortfall.
Spiro Wave works with readily available standard medical components found in most hospital settings. Pressure sensors and alarm systems allow clinicians to monitor and adjust key respiratory and ventilation parameters, including:
I/E ratio (inspiratory/expiratory)
Positive end-expiratory pressure (PEEP)
Airway limit pressure
Additional manufacturing plants are being vetted to ensure they can produce medical-grade devices because the Spiro Wave will be "a sustained utility and can combat costs throughout the world," Cohen said. Managed open-source, he said, will be offered to qualified manufacturers.
Social and cultural impact
Historically, there has been "insufficient coordination" during crises, said press conference participant Melissa Berman, president and CEO, Rockefeller Philanthropy Advisors. "The efforts [of this consortium] represent coordination on a global scale," she said.
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