For months, physicians around the world worried that the rise in COVID-19 cases would cause an international ventilator shortage as patients relied on machines to help them breathe.
Health care administrators looked to stopgap measures from reserving the ventilators for the sickest to taking patients who are near death off the ventilators to hand-pumping air into a person’s lungs.
Now, a group of Rice University researchers and a Houston manufacturing company are introducing an automated version of one type of ventilator known as a bag valve mask that could be an inexpensive solution to global shortages. Bag valve mask ventilators are traditionally hand pumped by doctors, nurses and emergency medical technicians to help patients breathe.
The manufactured version of the Rice ventilator, called the ApolloABVM, replaces human power with machine power by using electric motors and tiny, portable computers programmed to squeeze the bag at regular intervals. It offers a solution to medical professionals who would otherwise squeeze the bag for minutes, even hours, to help patients breathe while waiting for an advanced ventilator.
“What this can do is provide a kind of ‘bridge’ ventilation,” said Maria Oden, director of Rice’s Oshman Engineering Design Kitchen, an engineering projects lab.
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Student engineers at the Oshman Engineering Design Kitchen on Rice’s campus developed the ApolloABVM, which was in the works long before the pandemic.
In 2018, Dr. Rohith Malya, an assistant professor of bioengineering at Rice, brought the idea to student engineers at the lab after watching doctors and the families of dying patients spend hours pumping air into lungs by hand.
Two years later, engineers have developed a machine that squeezes the bag automatically and provides a small screen that shows the respiratory rate. The manufacturer, Stewart & Stevenson Healthcare Technologies, a subsidiary of Houston barge tank operator Kirby Corp., recently won emergency use authorization from the Food and Drug Administration, which regulates medical devices.
Each device costs less than $300 in materials to produce, a far cry from ventilators that can cost thousands of dollars. Bag valve masks are usually used in emergency situations when a ventilator may not be readily available.
Medical professionals prefer the more expensive and sophisticated machines when a patient needs long-term ventilation. While a version of the mask in the lab has run for roughly three weeks, ApolloABVM is best used in settings where ventilation is needed for just a few hours.
“We can now commence manufacturing and distribution of this low-cost device to the front lines, providing healthcare professionals with a sturdy and portable ventilation device for patients during the COVID-19 pandemic,” said Joe Reniers in a statement. Reniers is president of Kirby Distribution and Services, a Kirby Corp. subsidiary that sells industrial equipment.
Companies around the globe have rushed to fill shortages of equipment used to fight COVID-19, from developing personal protective equipment such as masks and face shields to ventilators. The demand for medical equipment skyrocketed at the beginning of the pandemic and remains high in burdened health care systems.
Full-fledged ventilators require many components, some of which are custom made, and highly skilled workers to assemble them. This caused demand to quickly outstrip supply, said Margaret Kidd, a professor who studies supply chain and logistics at the University of Houston. That led to fights to buy what equipment was available.
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“Everyone was trying to game the system and buy ventilators wherever they were, and they were bidding against each other,” Kidd said.
More than 6,500 ventilators were available and not in use in the state as of Wednesday, and most hospitals in the United States have an adequate number of ventilators for their COVID-19 patients. But some rural areas and hospitals overseas, particularly in countries where there aren’t many ventilators, could benefit from the automated pumping devices. They could also be used in ambulances when transporting patients to other medical facilities.
“If they’re not needed here in the United States, I have every belief that they will fill a niche worldwide that is very, very needed,” Oden said.
Filling the niche is also made possible by federal officials who have granted emergency use authorizations (EUAs) for the duration of the pandemic to make up for shortages of medical supplies.
Under an EUA, manufacturers usually don’t have to provide years of data to prove the efficacy of a device, said Christina Talley, an adjunct professor at the University of St. Thomas’s clinical translation management program, which studies the business of biosciences and regulatory affairs. But, she said, they are still required to prove that the product is safe and would relieve medical professionals in an overburdened system.
“The main purpose of the EUA function is to address a public health crisis,” Talley said, “allowing a route for a product that isn't approved through a normal channel to have an express route.”
Part of the draw of the ventilator product is that Stewart & Stevenson’s manufacturers, located in Texas and Oklahoma, won’t be the only ones making the devices. The Rice engineers posted plans for the device online, and it requires less than $300 in materials to produce. The plans have been downloaded by nearly 3,000 people worldwide.
The decision by Rice researchers to make it open-source, rather than patenting it, is a good sign for health care costs, experts said. It means that product prices will remain low if people have access to the plans to produce the devices.
“Normally high tech is patented and protected,” Kidd said. “You’re seeing the best in humanity come out.”
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