Over-The-Air Updates Could Turn Millions Of Inexpensive Devices Into Much-Needed Ventilators To Treat Seriously-Ill COVID-19 Patients — If Manufacturer Helps
from the profits-before-people dept
Last week we wrote about attempts to repair much-needed ventilators for serious coronavirus cases being stymied by manufacturers’ refusal to allow hospital technicians to carry out the necessary work. Trammell Hudson, who describes himself as “a programmer, photographer, frequent hacker and occasional watchmaker“, has come up with another approach to supplying ventilators to hospitals. It involves taking the inexpensive and widely-used Constant Positive Air Pressure (CPAP) devices typically used for sleep apnea, and turning them into emergency ventilators suitable for COVID-19 patients. These are known as Bi-level Positive Airway Pressure (BiPAP) machines. BiPAP devices are more sophisticated than CPAP ones: they apply higher pressure when the patient tries to breathe in, and lower pressure when they start to breathe out. In investigating the popular Airsense 10 CPAP device manufactured by ResMed, Hudson made a remarkable discovery:
Our work indicates that the actual difference between a low-end CPAP device and a high-end iVAPS [intelligent volume-assured pressure support] device is just a software upgrade. The CPAP machines have many of the same sensors as the more expensive models, and the Airsense 10 CPAP devices include in their firmware all of the other modes, such as iVAPS and BiPAP-ST [spontaneous/timed mode]. When we unlock that mode in software, the CPAP device functions like a much more capable and expensive iVAPS device.
This idea, that the difference between CPAP and BiPAP machines is a software change rather than a hardware change, is at the root of our work. If the common, highly distributed CPAP devices could have a software upgrade that turns them into iVAPS or BiPAP-ST devices capable of ventilating COVID patients, that would be a huge boon to the hospitals and health care workers around the world who are struggling with a lack of ventilators or alternatives to treat the influx of COVID patients.
Following his discovery, Hudson wrote a firmware patch that can be applied to the Airsense 10 CPAP device in order to access its more advanced features. However, he stresses:
We want to be very clear here: this modified firmware should not be flashed on CPAP machines and used to treat COVID patients immediately. The firmware that we’ve developed is an effective demonstration of the capability, and while it has been reviewed and validated by expert researchers, biomedical engineers, and clinical pulmonologists, it has not yet been put through FDA approval.
Although FDA approval could be sought, Hudson points out that by far the best solution would be for ResMed itself to provide the software upgrade — something that doesn’t need FDA permission. There are two other big benefits of taking this route. First, the manufacturer could more easily provide the slightly different patches for the various models of its devices. Perhaps even more importantly, for the majority of machines, the manufacturer could use a built-in always-on cellular connection to upgrade them over the air, without even needing to open them up. Unfortunately, it seems unlikely that the manufacturer will embrace this idea. On its Web site, a FAQ specifically addresses the issue of using a CPAP machine as a ventilator:
CPAP devices are designed to provide only PAP (positive airway pressure) and would require significant rework in order to function as a ventilator.
Hudson’s work suggests that is not true: a simple software upgrade is pretty much all that is required. When asked by Ars Technica whether the company would be willing to work with researchers to convert low-cost models to more capable ventilators, a representative wrote: “We are already exploring that option, but our primary focus is to maximize production of our current ventilation devices, masks, and accessories”. In other words, rather than helping to save thousands of lives by carrying out over-the-air upgrades of existing machines — millions of them in the US alone, according to Hudson — the “primary focus” is on selling more expensive machines. As with the previous story about repairing ventilators, it seems that even during a pandemic, profits are more important than patients.