Philips CPAP Recall Has Left Supply Shortage, Confusion for Physicians and Patients

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 Philips CPAP Overview

• Who: Philips recalled millions of CPAP and other breathing devices, worsening a supply shortage.
• Why: The continuing COVID-19 pandemic and Philips CPAP recall have left supplies stretched thin, say experts. 
• Where: The Philips CPAP recall and pandemic affect US consumers, as well as the world. 

A Class 1 recall of Philips CPAP machines has worsened a serious shortage of breathing devices that has been heightened by the COVID-19 pandemic, reportedly leaving patients and physicians at a loss.

In June, Philips first announced the recall of its CPAP, BiPAP, and ventilator devices, which the Food and Drug Administration found may cause serious injury or death due to potential risks of chemical exposure posed by noise-reducing foam in the devices made from polyester-based polyurethane.

According to the agency, risks from the chemical exposure include irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. Between three and four million of the Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices were recalled.

Philips CPAP Recall Escalates Shortage

Due to the recall, there is now an even steeper shortage in ventilators and other respiratory care machines that was brought on by the COVID-19 pandemic, leaving providers concerned as the pandemic continues to surge across the country, Advisory Board reports.

David Schulman, a pulmonary and critical care medicine specialist at Emory Healthcare, told The New York Times that the number of people coming into the hospital with severe respiratory symptoms had increased as a result of COVID-19, and “the demand for these devices has also increased, which is problematic since available supply has decreased as a result of the Philips recall.”

In April 2020, more than half of medical equipment suppliers were already reporting delays for CPAP machines, with the majority saying those delays were more than 60 days, a survey by American Association for Homecare showed.

CEO Thomas Ryan said: “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. It is becoming a crisis.”

The American Hospital Association has restarted a program that delivers ventilators and other supplies to areas that have been hit the hardest by the COVID-19 Delta variant, spokesperson Thomas Jordan said.

The FDA has required Philips to submit a repair-and-replacement program for the faulty components in the devices, but those replacement parts may face delays due to supply shortages and backlogged orders of similar devices being used in ERs and ICUs.

A company spokesperson said it was “already producing repair kits and replacement devices in large quantities.” Philips has recommended that customers with affected devices register their products and consult their doctors about what to do next.

But even doctors don’t have the answers. Schulman, of Emory Healthcare, told The New York Times that both physicians and their patients  were”extremely uncertain,” with a lack of clear information.

“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?”

Sleep medicine specialist at the Mayo Clinic Timothy Morgenthaler said it would be helpful for physicians to know how much time was needed for replacements and how to quantify the health risks for patients.

“The risk of good or bad decisions is passed to the patient and provider,” he said.

Has the Philips CPAP recall affected you in any way? Tell us your experience in the comments section!

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