As hospitals in the United States faced ventilator shortages amid the COVID-19 pandemic, in addition to companies from Dyson to Ford and General Motors utilizing their resources to manufacture ventilators, groups of engineers, physicians and other experts at universities around the country also banded together to figure out how to make or re-work ventilators — at a super low cost.
So what happens now that there's evidence that the coronavirus curve is flattening and the shortage of ventilators is no longer critical in cities like New York City, Chicago and New Orleans? The innovation does not have to go to waste.
There could be sustained utility beyond the pandemic for the cohorts' new devices, according to a consortium at New Lab in New York City working on a ventilator called the Spiro Wave.
"I by no means think that it's over," Mitchell Katz, president and CEO of NYC Health + Hospitals, said of the need for emergency vents on a press call Monday. "We may well be using these Spiro Wave devices in our emergency rooms in the future."
Ventilators are machines that help people breathe when they can't do so on their own, according to MedlinePlus. Typically, a tube is placed in a patient's mouth or windpipe, which attaches to a machine that's controlled by a doctor, nurse or respiratory therapist.
When shortages started, groups at universities including the University of Illinois and Massachusetts Institute of Technology (MIT) got to work to help, and each now have prototypes that were created in line with strict guidelines from the Food and Drug Administration.
Engineers at the U of I developed a prototype for a simple emergency ventilator, called Rapid Vent, that would only cost $100 to $200 to make.
Rapid Vent is a pressure-controlled ventilator that connects into the oxygen supply available in any regular hospital room. Air flows from the hospital oxygen supply into the ventilator and then into the patient's lungs through a tube or a mask.
"We were intentional in picking something simple, so that it could possibly be scaled up in time to meet a crisis," Bill King, project lead and professor of mechanical engineering at the University of Illinois Urbana-Champaign, tells CNBC Make It.
They've made the ventilator technology available to download for free on their website, so anybody can access it. However, "it takes a lot of expertise to get this right, and people should not do this at home," King says.
At MIT, the MIT Emergency Ventilator Project, is dedicated to creating an open-source, low-cost ventilator, based on a project that was completed in a MIT engineering class back in 2010. Students made a ventilator prototype using less than $200 of materials, which is much cheaper than the typical ventilator that can cost as much as $30,000. Today, these materials would cost close to $400 or $500.
A photo of MIT's early prototype ventilator design.
"We very quickly realized that we actually had a duty to reprise this project and see if it could be done safely, Nevan Hanumara, a research scientist in mechanical engineering at MIT, tells CNBC Make It.
The MIT design utilizes an "Ambu bag," or a bag-valve resuscitator, which is a hand-operated resuscitator that's commonly found in hospitals. Healthcare providers use these tools to manually pump artificial breaths into a person's lungs when they cannot breathe adequately or at all, Timothy Myers, a registered respiratory therapist and the chief business officer for the American Association for Respiratory Care tells CNBC Make It.
The new ventilator device uses an Ambu bag (blue), that's squeezed by mechanical paddles (center) driven by a small motor.
The goal of MIT's E-Vent Project has been to find a way to automate these resuscitator bags using mechanical paddles that continuously, precisely and gently squeeze the sides of the bag. Instead of relying on someone's hands to manipulate the bag and deliver oxygen, the idea is that this device could do it automatically, and act as a long-term ventilator.
In addition to innovating, the group is documenting their findings and publishing their "reference design" on the E-Vent Project website in an open-source format, in order to foster a dialogue and exchange information with other universities and groups. (They stress that it's meant for experienced manufacturers working closely with clinicians who have taken medical devices to market.)
In fact, New York City's New Lab based its $3,330 Spiro Wave ventilator on MIT's design, and it received FDA authorization for emergency use on April 17, meaning the device can be deployed to use in a health care setting during the Covid-19 pandemic. (Each manufacturer that utilizes the open-source information would have to seek FDA clearance individually. The group from U of I has not had its research approved by the FDA.)
But Spiro Wave intends to "steer the technology through the entire FDA 510K approval process in order to give clinicians the opportunity to use this product outside of the emergency use authorization [and] pandemic application," Marcel Botha, founder and CEO of 10XBeta, the product development firm behind the Spiro Wave, said on the press call.
The Spiro Wave group intends to pursue the clearance so the vents could be used in the ER in the future in situations where a full-service ventilator wasn't available. For example, there could be additional waves of Covid-19 that happen amid regular flu seasons going forward and create the need for more ventilators, according to the press call.
Still, some experts question how safe these devices would be in a clinical setting. "While it is entirely possible to adapt current medical equipment for alternative uses, I would hesitate to say that any of these adaptions are safe," Myers says.
The MIT E-Vent is "a completely off-label use," the experts wrote on the E-Vent Project's website. "But we recognize the global interest when a hospital has used up all ventilators and the only option is manual bagging a patient." (Misuse of a bag-valve resuscitator can lead to serious injuries or death.)
"There's a lot of risk involved in ventilating person," Hanumara says.
"Studies have documented the inconsistency in controlling pressure [and] volumes, respiratory rate and inspiratory times with manual resuscitation devices," Myers says. These devices may not provide the sophisticated alarms or monitoring that current critical care ventilators provide, he adds.
The FDA-approved Spiro Wave does have safety software, alarms and sensors that allow the clinicians operating the device to monitor crucial factors that influence patient's respiratory and ventilation (such as tidal volume and respiratory rate). The team reiterates that the device should only be used in a healthcare setting under supervision from trained clinicians.
And in a situation where there is a desperate need, whether during the pandemic or in the future, such "bridge devices" could be a an answer when there are no other options.
"We're all humans trying to fight this together," Kim Jung, a graduate student and PhD candidate at MIT, tells CNBC Make It of the E-Vent project.
"This has been quite a special opportunity to be able to do something as a team, where we could hopefully be part of the solution," King says.
All photos courtesy of the MIT E-Vent researchers.
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