Philips Respironics CPAP Machine Respiratory Concerns Lead To FDA Safety Communication

Individuals with Philips Respironics CPAP machines are being urged to take heed of a recent recall which impacts millions of DreamStation products and other devices that may release “black debris” from sound abatement foam directly into the lungs.

The U.S. Food and Drug Administration (FDA) issued a safety communication on June 30, issuing a series of recommendations for users of CPAP machines and ventilators that may contain a defective and dangerous design that could pose serious health risks.

On June 14, a massive Philips Respironics CPAP machine recall was issued for millions of DreamStation devices used by individuals with sleep apnea, as well as Bi-PAP and ventilator devices, which may face issues with foam degradation, where particles from the polyester-based polyurethane (PE-PUR) sound abatement foam may cause respiratory and other health problems.

Philips has indicated that the CPAP foam degradation issues may be exacerbated by unapproved cleaning products, which use ozone and high heat.

At issue is polyester-based polyurethane (PE-PUR) foam used for sound abatement in the recalled devices. The FDA warns it can break down into particles which can be inhaled or swallowed.

“These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent damage,” the FDA safety communication warns.

In its safety communication, the FDA issued recommendations that users of affected BiPAP or CPAP machines, or caregivers, stop using the devices immediately, switch to another device which is not part of the recall, or use alternative treatments for sleep apnea; such as positional therapy or oral appliances, like sports mouth guards or orthodontic retainers.

The FDA also recommends they initiate long term therapies for sleep apnea, such as weight loss, abstaining from alcohol, quitting smoking or potentially consider surgical options. However, the FDA did indicate that some consumers should continue to use the recalled devices if their health care provider has determined the benefits outweigh the risks.

The agency called on consumers to follow manufacturer’s instructions for cleaning and replacement of CPAP machines and accessories. The FDA also warned that ozone cleaners may make the foam breakdown problem worse, and that there are other potential risks linked to the use of ozone and ultraviolet light to clean CPAP devices.

The FDA issued a similar warning earlier this year to CPAP users and healthcare professionals not to use illegally marketed ozone gas or ultraviolet (UV) light cleaning products to disinfect or sanitize CPAP machines. Some have speculated the warning and the Philips Respironics CPAP recall may be connected, since Philips also included a warning about the use of ozone cleaning techniques in its recall.

CPAP devices provide steady air pressure through a mask or nosepiece, granting continuous positive airway pressure to prevent the user’s airway from collapsing, thus preventing constant broken sleep.

The devices are often used by those diagnosed with obstructive sleep apnea, which is a condition which causes a person’s airway to collapse during sleep, resulting in short periods of time where the individual stops breathing. Individuals suffering from sleep apnea have a greater risk of experiencing adverse health and heart problems. Typically, these individuals have a higher risk of suffering hypertension, stroke, heart disease and daytime sleepiness.

The FDA indicates it has received at least 11 reports of CPAP cleaning problems involving use of ozone or UV light products from 2017 through 2019, involving individuals who experienced coughing, difficult breathing, nasal irritation, headaches, asthma attacks and other breathing problems after using the unapproved products.