A mechanical ventilator can cost a hospital tens of thousands of dollars up front, and even more money each day it’s used to keep oxygen flowing into a sick patient’s lungs. It’s unsurprising, then, that some small U.S. hospitals can count theirs on one hand. There are about 160,000 ventilators in use in hospitals nationwide—about half the number of confirmed COVID-19 cases in the U.S. as of April 6.
As the number of coronavirus diagnoses ticks upward, inventors are resorting to increasingly creative solutions to stave off an impending ventilator shortage. But the stakes are high for getting it right—and some doctors aren’t sure resorting to emergency-made ventilators is worth the risk.
Dr. Ken Lyn-Kew, a pulmonologist at National Jewish Health in Colorado, commends inventors for wanting to help, but says jerry-rigged ventilators that may not work as well as the real thing present doctors with yet another difficult decision in the midst of the outbreak. “Do I do something that’s likely to be harmful for the sake of doing something,” he asks, “or do I not do something?”
COVID-19 has not created so much as re-exposed the country’s ventilator supply problem. More than a decade ago, the U.S. government—recognizing the need for a larger fleet of ventilators in its Strategic National Stockpile—agreed to buy around 40,000 machines from a small California manufacturer, but the deal fell apart when the company was acquired by a competitor that allegedly wanted to prevent it from making lower-cost machines that would compete with its pricier versions, the New York Times reported. The government started over with a new company in 2014, but that contract has not yet yielded any new ventilators, leaving the National Stockpile inadequately supplied and riddled with broken machines.
Now, faced with a respiratory illness pandemic, doctors are scrambling to fill the void. Physicians at Columbia University and NewYork-Presbyterian Hospital have developed a protocol for ventilating two patients using the same machine, and institutions are working on devices that can split ventilators for this purpose. The U.S. Department of Health and Human Services has signed off on ventilator sharing, but only “as an absolute last resort.”
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The Food and Drug Administration (FDA), seeking to avoid that grim worst-case scenario, is urging inventors and institutions to apply for an Emergency Use Authorization—a “lower bar to get to market,” according to an agency spokesperson—for ventilator workarounds. “FDA will work interactively with these manufacturers,” to get their products on the market, the spokesperson said. The agency has also partnered with the National Institutes of Health, the Department of Veterans Affairs and manufacturing innovation nonprofit America Makes to encourage non-traditional production during COVID-19.
Hospital systems are taking advantage of that leeway. New York’s Northwell Health, for example, is 3D-printing converters that help BiPAP machines (which are used to ease breathing conditions such as sleep apnea and COPD) function more like full-on ventilators. Others have repurposed anesthesia machines.
Many hospitals, universities and individual inventors are getting even scrappier, using everything from windshield wiper parts to hardware-store supplies to make ventilating devices. But the things that make mechanical ventilators so expensive and difficult to manufacture—their wide range of functions, settings and feedback gauges—are also what makes them effective for critical care, Lyn-Kew says. If functionality is stripped away to rush out an emergency design, you may end up sacrificing efficacy for speed. And at that point, he says, the devices may do more harm than good, especially if hospitals don’t have enough staff to even run these machines.
“I find it terrifying and concerning because we know if we’re doing that, we’re going to be providing substandard care to people in an attempt to give care,” Lyn-Kew says. “Is it better to give one person good care or two people really bad care?”
Dr. Rohith Malya, an assistant professor at the Baylor College of Medicine, sees it differently. He’s been advising an engineering team at Texas’ Rice University, where he is also an adjunct assistant professor of bioengineering, to help them fine-tune a device that automates bag ventilation (squeezing an inflated bag to manually deliver oxygen to a patient’s lungs). The team’s $300 design, which they have made open-source to encourage others to duplicate it, is ready for testing on COVID-19 patients once it clears legal review, its designers say.
Desperate times, Malya says, call for desperate measures. “At the point when hospitals are asking people to bring in their home BiPAP machines,” and “the alternative is sure death,” people need to think outside the box, Malya says.
Glen Meyerowitz, a biodesign fellow at the University of California, Los Angeles, also disagrees that a streamlined design is inherently ineffective. He made a stripped-down ventilator prototype entirely out of parts purchased from Home Depot, eliminating some of a mechanical ventilator’s settings to focus a narrower range of functions likely to be needed during coronavirus care. Doing so, he says, makes it possible to build the machines efficiently and affordably.
Of course, a DIY design “is really far from a product you’d want in a medical environment,” Meyerowitz says, so he’s working with a manufacturing firm and UCLA medical experts to bring his design from “hobbyist-grade” to hospital-grade. With UCLA fast-tracking the clinical study process, he hopes to be testing it in a hospital within eight weeks.
But not all aspiring inventors have access to world-class hospital systems and medical advisors. It is concerning, Malya says, that some inventors may go forward without proper guidance, potentially creating a dangerously oversimplified device. “We don’t want to put something like a DIY, Home Depot version into a hospital and see how many patients it can kill,” he says.
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Contributor: Jamie Ducharme