The company is producing repair kits and replacement devices, but those efforts have led to a shortage of devices.
One year after a leading medical device maker announced a recall of millions of ventilators and positive airway pressure machines, the issue continues to have major implications on the sleep device market, and on the patients who depend on the devices.
Last June, Philips announced a voluntary recall of ventilators, continuous positive airway pressure machines (CPAP), and bi-level positive airway pressure machines (BiPAP) due to the degradation of sound abatement foam used in some of its models. The voluntary recall pertains to machines manufactured between 2009 and April 2021. The company said patients using the devices may be exposed to foam particles or chemical emissions.
Eric Mongeau, national sales director at Aeroflow Healthcare, said 12 months on, the situation is still difficult.
“From an impact perspective, not much has gotten terribly better,” he said.
Aeroflow is a North Carolina-based durable medical equipment provider that sells devices made by Philips, among other manufacturers.
Philips says it has produced 2.4 million repair kits and placement devices globally, and shipped 1.1 million replacement devices in the United States, but Mongeau said the shift of manufacturing resources toward the recall has created a supply squeeze.
“The big challenge is that half of the volume in the supply chain was gone with part of the recall, and then all of those resources were then put into the remediation—building new devices to then replace the old devices—and none of those were able to be sold into that market.”
Add to that the pandemic-related supply chain issues globally, and you have what Mongeau said amounts to “a double whammy against the industry.”
Patients who use Philips devices have a difficult decision to make. The American Academy of Sleep Medicine has encouraged providers to prescribe a different device, if feasible. If it is not possible, however, the academy said physicians and patients should carefully consider the risks of continued device usage against the risks of suspending therapy. When it announced the recall last June, Philips said it had received limited reports of headache, upper airway irritation, cough, chest pressure, and sinus irritation, which it said may be associated with the foam. However, they said it is also possible that the issue could cause other, more serious health consequences.
The recall and the rush to replace the devices has also created a shortage of the semiconductors necessary to build cloud-connected machines, prompting one rival manufacturer to begin re-marketing devices that use SD storage cards, which record data that then must be downloaded by the patient or a provider in order to get actionable insights.
Mongeau said that reversion to earlier technology is bad news, not just for medical equipment suppliers like Aeroflow, but also for patients, providers, and insurers.
“Our entire business is based on early intervention, and you lose the ability to do that when you go to an SD card,” he said.
Mongeau said Aeroflow has worked to cut its backlog of orders by sourcing other FDA-approved equipment. He said right now, there is about a 4-week lead time between an order being placed and being fulfilled, but he said his company hopes to cut that in half by the end of this month.
In the meantime, he and others are hoping the FDA will grant emergency use authorizations (EUAs) to allow other devices into the US market on an emergency basis, similar to how the agency used its emergency powers to boost the supply of ventilators following the emergence of coronavirus disease 2019 (COVID-19).
“One of the things that we've asked the FDA for is to actually have an EUA specific to the CPAP shortage, as this is also a public health emergency,” he said.
Mongeau said such a move would likely result in an influx of new entrants into the US market.
“There are truly dozens of manufacturers globally that are selling into Europe and the Asia Pacific [markets] that just haven't entered the US market because of the barriers to entry in the US,” he said. “And if there was an EUA specific to CPAP and sleep apnea, that could be another option.”
Mongeau said he is optimistic that such a move could be in the offing. In the meantime, he said, demand for positive airway pressure machines continues to rise as more and more providers—including specialists like cardiologists and endocrinologists—screen patients for sleep apnea.
“In the year that this has been going on, our demand has almost gone up threefold,” he said. “And so it's not slowing down.”