A recall of respiratory devices had left millions of patients facing lengthy delays for replacements and providers concerned about short supplies—particularly as Covid-19 hospitalizations increase around the country, Joshua Brockman reports for the New York Times.

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Millions of devices affected by recall

In June, Philips Respironics issued a recall for more than a dozen of its BiPAP (bi-level positive air pressure), CPAP (continuous positive air pressure), and ventilator machines manufactured before April 26, due to potential health risks from faulty components, Brockman reports.

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Last month, FDA warned the potential health risks from the recalled machines could be "life-threatening, cause permanent impairment, and require medical intervention." Specifically, the agency said the polyester-based polyurethane foam used to dampen sound and vibration in the machines could, over time, degrade and cause users to breathe in chemicals or inhale black debris.

According to FDA, potential risks from particulate and chemical exposure from the recall devices include asthma, irritation to the skin and respiratory tract, and "toxic and carcinogenic effects" to organs, such as the kidneys and liver.

The recall affects up to an estimated 2 million devices in the United States, according to Mario Fante, a spokesperson for Royal Philips, the parent company of Philips Respironics. So far, the company has recommended that customers with affected devices register their products and consult their doctors about what to do next.

In addition, FDA has required Philips to submit a repair-and-replacement program for the faulty components in the devices. However, replacements for the millions of affected patients may be delayed due to supply shortages and backlogged orders of similar devices being used in ERs and ICUs during the coronavirus pandemic, Brockman reports.

According to Fante, while the company is "not able to provide an immediate solution," it is working "expeditiously." And Philips is "already producing repair kits and replacement devices in large quantities." Around 55,000 units a week are being produced, although they have not yet been cleared for shipping, Brockman reports.

Widening gap in supply has providers concerned

According to Brockman, the Philips recall has further increased a gap in supply for ventilators and other respiratory care machines—leaving many providers concerned as the delta variant of Covid-19 continues to fuel surges across the country.

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An April 2020 survey of home medical-equipment suppliers found that more than half reported supply-chain delays for CPAP machines, and 62% reported delays of up to 60 days. And the Philips recall "certainly exacerbated" these issues, said Thomas Ryan, CEO of the American Association for Homecare.

"Given the shortages of materials to make these devices, such as resins and computer chip modules, and transportation bottlenecks, I expect that supply will continue to lag behind demand into 2022," Ryan said. "It is becoming a crisis."

Already, the American Hospital Association has had to reactivate a program to distribute ventilators and other supplies to areas that have been hit the hardest by the delta variant, according to Thomas Jordan, a spokesperson for the organization.

"Because the number of people coming into the hospital with severe respiratory symptoms has increased as a result of Covid-19, the demand for these devices has also increased, which is problematic since available supply has decreased as a result of the Philips recall," David Schulman, a pulmonary and critical care medicine specialist at Emory Healthcare, said.

Separately, Timothy Morgenthaler, a sleep medicine specialist at the Mayo Clinic, said new patients and those affected by the recall have been placed on waiting lists by medical suppliers and still don't know when their devices will arrive even several weeks later. (Since the recall was issued, according to Brockman, Mayo Clinic has contacted more than 4,500 patients and removed affected devices from its hospitals and sleep clinics.)

In addition, providers are unsure what to recommend patients do in light of the recall, Brockman reports.

According to Schulman, the Philips recall has left both physicians and their patients "extremely uncertain," with a lack of clear information. He added, "How do we advise our patients when we know that the potential risks are serious, but haven't any idea whether they are extremely rare or just uncommon?"

Morgenthaler said that it would be helpful to know how much time was needed for replacements and how to quantify the health risks for patients, but Philips has so far not made that information available.

"The risk of good or bad decisions is passed to the patient and provider," Morgenthaler said. "I hope we are doing it right." (Brockman, New York Times, 8/17)