Tesla and SpaceX CEO Elon Musk said he’d be sending desperately needed “FDA-approved ventilators” to hard-hit hospitals across the nation dealing with the coronavirus crisis—but they haven’t been the high-grade kind needed to keep intensive care patients alive. Instead, those sent off so far appear to be Bilevel Positive Airway Pressure (BiPAP) machines of the kind used to treat sleep apnea, according to a Thursday report by the Financial Times’ Alphaville.
BiPAP machines are similar to CPAP machines but have two pressure settings instead of just one. They cost around $US800 ($1,322), according to Alphaville, while ICU-grade ventilators useful for severe cases generally retail for up to $US50,000 ($82,656) on the open market. Musk has said he secured around “1,255 FDA-approved ResMed, Philips & Medtronic ventilators” from suppliers in China for distribution, but Tesla-branded boxes in a photo tweeted by NYC Hospitals appear to show at least 40 of them are ResMed S9 Elite BiPAP machines, which appear to be discontinued. (It’s not clear how many of the 1,255 respirators touted by Musk are these BiPAP machines.)
It’s tempting to view this as déjà vu of that time Musk promised to save a Thai soccer team trapped in a cave with a useless “submarine,” and it’s not exactly a great look for a billionaire to promise “FDA-approved ventilators” and then delivering cheap devices that aren’t really ventilators, aren’t in short supply, and are far from desirable alternatives to ICU-grade gear. But that does not mean BiPAP machines are totally useless given the crisis situation the U.S. is now in.
The FDA has indeed released guidance indicating that non-invasive respiratory devices can be used to treat covid-19 patients—though they are unlikely to provide sufficient oxygen to patients doing poorly enough to end up in the ICU. Their use has also been questioned by the American Society of Anesthesiologists, which has noted that the BiPAP and CPAP machines “may increase the risk of infectious transmission.” The issue is that high-grade ventilators are closed systems that use breathing tubes to deliver oxygen to the lungs and filter the air supply, whereas the sleep apnea machines generally use face masks that can leak air and help aerosolize the virus.
According to Kaiser Health News, CPAP machines are suspected of contributing to the major outbreak at Life Care Centre of Kirkland in Washington state, one of the early U.S. epicenters of coronavirus infection. There, 129 residents, staff, and visitors were infected with the virus, with at least 40 associated deaths.
However, UCHealth critical care specialist Dr. Jeff Sippel told Kaiser that BiPAPs could be jury-rigged to work with breathing tubes, as “the hardware actually fits.” They wouldn’t necessarily make a lifesaving difference in truly at-risk patients, but could be used to aid breathing in less intense cases or for patients low on the list for ventilators (such as in anticipated triage situations as covid-19 patients flood hospitals). North Shore University Hospital medical director for respiratory therapy services Dr. Hugh Cassiere told Gothamist that medical personnel at his hospital have been doing just that: attaching breathing tubes and a filter to BiPAP machines. They’ve also been 3D printing connectors to make the conversions, which are reportedly running low.
“We’ve started using them in emergency cases,” Cassiere said. “We’re not recommending ventilating the world with it. We’re saying you have two choices, no ventilator and the patient dies, or use this method, and that’s the approach we’re taking.”
It’s not clear whether all the ResMed S9 machines in question are ones that could be effectively modified to support patients. According to a working protocol published by Dr. David Reich and other Mt. Sinai Health Systems doctors, they were able to convert ResMed S9 VPAP ST devices delivered by Musk to critical care capable systems. But the protocol notes that “the repurposed non-invasive ventilators should be discontinued as soon as a sufficient supply of ventilators becomes available.”
I note that the model in the picture appears to be the ResMed S9, which depending on the software package/model may not be able to support a paralyzed/sedated patient, and is not listed in Appendix B of the EUA, but some models (e.g., VPAP ST, VPAP ST-A) could do the job.
— Anand C. Patel (@anandcpatel) April 1, 2020
Very grateful to Tesla for providing Resmed ventilators that our team was able to convert to critical care-capable. Innovation by The Mount Sinai Hospital's team in a crisis! https://t.co/ZH6zCuiL1l
— David L. Reich, MD (@DrDavidReich) April 2, 2020
Similarly, some medical personnel have weighed modifications to ICU-grade ventilators so that they can be used to support multiple patients—although some experts are concerned that doing so could further endanger patients already at low odds of survival. Studies have shown that few covid-19 patients on ventilators survive, and those that do often have to remain on the machines for weeks, raising the risks of fatal complications.
“We think it’s great that Tesla purchased bilevel non-invasive ventilators from a platform of ours that we developed five years ago in Asia and sent them to New York,” the CEO of ResMed, Mick Farrell, told Alphaville. “… The bilevels featured in Tesla’s tweet are built on the same platform as our S9 CPAP machines for sleep apnea but deliver non-invasive ventilation that can be beneficial to many COVID-19 patients struggling to breathe while trying to fight off this virus.”
Farrell told CNBC that similar devices have seen extensive use in Europe and China, but conceded that Musk’s efforts might be better directed towards building batteries for use with invasive respirators.
Kaiser noted that some doctors are sceptical, especially about the use of the CPAP and BiPAP machines in the field.
“In general, we’re just telling them not to use it,” University of Colorado School of Medicine associate professor of clinical medicine Comilla Sasson told the site. “Because we are concerned about community spread, and we have to assume that anybody with respiratory distress is a COVID patient.”
Invasive ventilators are for worst case patients. Survival rate at that point is low, as Gov Cuomo has pointed out. Nonetheless, we start delivery of intratracheal Medtronic units in NYC tonight.
— Elon Musk (@elonmusk) April 2, 2020
In tweets on Thursday, Musk defended the donations and said that hospitals selected to receive the devices were given “exact specifications,” with all confirming they would be of “critical” help. Musk also said that Tesla was in possession of Medtronic intratracheal ventilators, which can be used in critical cases, and would begin delivering them to healthcare providers in New York City on Thursday night.