Sleep device market still affected by Philips CPAP recall

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The company produces repair kits and replacement devices, but these efforts have resulted in a shortage of devices.

A year after a major medical device manufacturer announced the recall of millions of ventilators and positive pressure devices, the issue continues to have major implications for the sleep device market and the patients who rely on it. of these devices.

Last June, Philips announced a voluntary recall ventilators, continuous positive airway pressure (CPAP) devices, and bi-level positive airway pressure (BiPAP) devices due to degradation of the sound-absorbing foam used in some of its models. The voluntary recall affects machines manufactured between 2009 and April 2021. The company said patients using the devices could be exposed to foam particles or chemical emissions.

Eric Mongeau, national sales manager at Aeroflow Healthcare, said 12 months later, the situation is still difficult.

“From an impact standpoint, not much has improved terribly,” he said.

Aeroflow is a North Carolina-based durable medical equipment supplier that sells devices made by Philips, among other manufacturers.

Phillips said it has produced 2.4 million repair kits and placement devices worldwide and shipped 1.1 million replacement devices to the United States, but Mongeau said shifting manufacturing resources to recall created a supply shortage.

“The big challenge is that half of the supply chain volume disappeared with part of the recall, and then all of those resources were then put into remediation – building new devices to then replace old devices – and no of these has been salable in this market.

Add to that the global pandemic-related supply chain issues, and you have what Mongeau said amounts to “a double whammy on the industry.”

Patients who use Philips devices have a difficult decision to make. The American Academy of Sleep Medicine has encouraged suppliers prescribe a different device, if possible. If that’s not possible, however, the academy said physicians and patients should carefully weigh the risks of continued use of the device against the risks of discontinuing treatment. When she announced the recall last June, Phillips said he had received limited reports of headaches, upper respiratory tract irritation, coughing, chest pressure, and sinus irritation, which he believed could be associated with the foam. However, they said it was also possible that the problem could lead to other more serious health consequences.

The recall and rush to replace devices has also created a shortage of the semiconductors needed to build cloud-connected machines, prompting a competing manufacturer to start shipping devices that use SD storage cards, which record data that must then be downloaded by the patient or a provider in order to obtain actionable information.

Mongeau said reverting to earlier technology is bad news, not just for medical equipment vendors like Aeroflow, but also for patients, providers and insurers.

“All of our business is based on early intervention, and you lose the ability to do that when you access an SD card,” he said.

Mongeau said Aeroflow has been working to reduce its backlog by sourcing other FDA-approved equipment. He said that right now there’s about a 4-week lead time between placing an order and fulfilling it, but he said his company hopes to cut that lead time in half by the end of this month.

In the meantime, he and others hope the FDA will grant emergency use authorizations (EUAs) to allow other devices to enter the US market in an emergency, similar to the way the ‘agency used his emergency powers to increase the supply of ventilators following the emergence of coronavirus disease 2019 (COVID-19).

“One of the things we’ve requested from the FDA is to actually have an EUA specific to the CPAP shortage, because that’s also a public health emergency,” he said.

Mongeau said such a move would likely lead to an influx of new entrants into the US market.

“There are really dozens of manufacturers in the world selling in Europe and Asia-Pacific [markets] that just haven’t entered the US market because of US entry barriers,” he said. “And if there was a CPAP and sleep apnea-specific EUA, that might be another option.”

Mongeau said he was optimistic such a move could be in sight. In the meantime, he said, demand for positive airway pressure devices continues to rise as more providers, including specialists like cardiologists and endocrinologists, screen patients. for sleep apnea.

“In the year it lasted, our demand nearly tripled,” he said. “And so it’s not slowing down.”

This article originally appeared on Managed Healthcare Executive.

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