The U.S. government has invoked a decades-old statute to increase production of the machines, while a number of companies, both in the medtech space and outside of it, have stepped forward in an effort to get as many ventilators into hospitals as possible to treat COVID-19 patients.
Amid the shortage, research teams took to developing alternatives to assist less-critical patients who don’t need the invasive, intensive care unit ventilators. The FDA relaxed guidance on ventilation, citing CPAP and BPAP machines, commonly used for sleep apnea treatment, as potential stopgap options.
However, while those intermediate alternatives can be useful, the main objective is to get every coronavirus patient who needs this kind of treatment on the invasive ventilators produced by companies like Hamilton Medical, Vyaire, Zoll Medical, Royal Philips (NYSE:PHG), Medtronic (NYSE:MDT), ResMed (NYSE:RMD) and more that usually cost between $25,000 and $50,000.
So, what exactly are these vital machines, and why is their function irreplaceable in medical care?
“Those things are very well-designed,” University of Minnesota Earl Bakken Medical Center lab supervisor Aaron Tucker told the DeviceTalks Weekly Podcast. “They work extremely well. They have all kinds of fantastic feedback that the clinician gets. They tell you different pressures, different ratios for inspiration versus expiration. They’re very, very reliable.”
As part of a collaboration at the University of Minnesota, Tucker helped develop the Coventor, an alternative Ambu-bag-based ventilator that received FDA emergency use authorization (EUA). He said machines like the Coventor are for helping out during a ventilator shortage and bridging the gap until ventilators are available.
Georgia Tech Woodruff School of Mechanical Engineering associate professor Shannon Yee, a collaborator on a device similar to the Coventor, echoed Tucker’s sentiment. The alternatives, including CPAP and BPAP machines, particularly don’t have the long-term usage that standard ICU ventilators have. In fact, Yee told Medical Design & Outsourcing that the FDA relaxed its guidelines because of the CPAP and BPAP capabilities, but that those don’t reach the level of the necessary machines.
“A lot of them already come with options to be used as ventilators,” Yee said. “They just don’t do it as well.”
What makes these ventilators so important? Electrical Engineering World executive editor Lee Teschler explained that there are more than 22 different technical standards a ventilator must meet. A ventilator’s design must undergo independent testing to prove it meets those standards before it can be put to use.
Device Events founder & CEO Madris Tomes, who previously worked in the FDA’s post-market surveillance division, pointed out to MDO that the stockpiled ventilators targeted for use during the shortage may be well beyond their expiration date.
The intricacies of such devices mean that even outdated software could prevent the ventilators from doing their job, Tomes said. The software systems are created by the manufacturers or subcontractors and are also subject to strict standards, much like the technical aspects. With increased reliance on the stockpiled devices in particular, it becomes a matter of life and death in many cases.
“Are these ventilators just expired or what is wrong with them when you say they’re broken?” Tomes said. “We’re asking the manufacturer ‘what is it that’s needed to make these work?’ It’s not just sending them out and hoping they work.”