FDA Addresses Philips CPAP Recall Concerns and Provides Answers to Frequently Asked Questions

In the aftermath of a massive Philips Respironics CPAP, BiPAP and ventilator recall, federal regulators have released new information intended to help users of the breathing machines understand the risks associated with continuing to use the devices, and address concerns about how to manage sleep apnea and other conditions the machines were intended to treat.

On June 14, Philips Respironics, also known as Koninklijke Philips, issued a recall for 3.5 million breathing machines which were distributed with unsafe and defective sound abatement foam that may degrade and release black particles or toxic chemicals directly into the lungs of users who rely on the devices for treatment of sleep apnea and other conditions.

Exposure to the toxic particles and gases released by a polyester-based polyurethane (PE-PUR) foam inside has been linked to reports of cancer, severe respiratory problems and other health complications.

The recall impacted millions of devices, the vast majority of which were DreamStation CPAP machines used to provide sleep apnea therapy. Those users have been urged to immediately stop using the machines due to the serious health risks, but Philips has not replaced the machines or provided compensation required to help buy a new one. This has resulted in an onslaught of class action lawsuits over the Philips CPAP recall in recent weeks.

On July 29, the FDA released a list of Frequently Asked Questions to help consumers understand the recall, the CPAP machine health risks, and provides a series of recommendations on what consumers relying on the machines for sleep apnea treatments should do.

For those who would be left without CPAP therapy for their sleep apnea, the FDA recommends they continue to use the recalled device if their doctor determines the benefits outweigh the risks. The agency also has a website listing other potential sleep apnea treatments, and noted it is engaging patient advocacy groups and professional societies to convince them to help spread information about alternative sleep apnea treatments.

The FDA notes that, as the manufacturer, Philips is responsible for establishing an appropriate mitigation strategy for the recalled devices and the affected consumers. The agency indicates it is currently reviewing information Philips has provided regarding replacement devices and corrective actions. The FDA indicates Philips’ responsibilities in the recall include:

• Conducting a health hazard evaluation.
• Making it easy for consumers to identify the recalled products
• Determining the degree to which the problem is obvious to the consumer or user
• Determining which products should be recalled
• Ensuring the continued availability of essential products.

“The FDA understands the concerns from people using these affected devices,” the agency’s FAQ states. “The FDA is continuing to work with Philips Respironics to assure that the company provides sufficient evidence to show the safety and effectiveness of its proposed actions to correct the product defect.”

What consumers should not do, according to the FDA, is try to remove the foam from the devices themselves, as that could affect the machine’s performance and could release more foam debris into the device.

The agency urges consumers to register the device on Philip’s website or by calling Philips Respironics at 877-907-7508.