- The FDA announced a voluntary recall by Philips of multiple CPAP and BiPAP machines.
- The FDA has now classified the recall the most serious or a Class 1 recall.
- The masks have magnetic clips that can affect implanted devices such as pacemakers.
The U.S. Food and Drug Administration has identified a recall of BiPAP and CPAPA machines by Philips Respironics as a Class 1
This is the most serious type of recall and the FDA warns that using the products can result in serious injuries or death.
Philips Respironics (Philips) has announced the recall of over 17 million masks used for people living with sleep apnea and other respiratory issues due to risks posed by magnets that may affect some implanted medical device
The recalled masks are worn by people using a bilevel positive airway pressure (BiPAP) or continuous positive airway pressure (CPAP) machine and have magnetic clips that hold them in place.
According to a post from the Food and Drug Administration (FDA), the
“These potential adverse events can occur in people who use the masks, or in people near a person using the mask,” reads the
Five mask types are included in this recall: the DreamWisp, DreamWear, Amara View, Wisp, and Wisp Youth masks.
“The most common indication for CPAP and BiPAP use is obstructive sleep apnea,” Dr. Margarita Oks, a critical care pulmonologist at Lenox Hill Hospital in New York, told Healthline.
According to Oks, BiPAP can also be used to treat other sleep-related disorders such as
The company advises anyone with an implanted metallic device or object in the body to stop using the recalled mask and switch to a non-magnetic mask if available.
“Ensure the recalled mask is kept at least 6 inches away from metallic medical implants, metallic objects in the body, or medical devices that can be impacted by the magnetic fields,” the company warned.
According to the recall notice, these masks may continue to be used according to “updated instructions and labeling” if patients or people in close proximity to them don’t have implanted metallic medical devices or metallic objects in the body.
Philips recommends that affected patients consult their physician immediately to determine if another mask can be used for their therapy.
“All patients need to speak to the physician managing the disease for which the CPAP or BiPAP was prescribed about whether or not to continue use, and if it is safe to stop use altogether until a replacement device is available,” said Oks.
She cautioned that wait times for replacement devices are long so a patient should not decide to stop machine use until consulting with their physician.
“In cases of moderate to severe sleep apnea, lack of therapy is more dangerous and can result in the return of excessive daytime sleepiness, resulting in accidents, heart rhythm disturbances, elevation in blood pressure and mood issues,” said Dr. Bruce R Tammelin, FCCP FAASM, Director Mission Sleep Disorders Institute At Providence Mission Hospital in Orange County, California.
He explained what patients using the recalled devices can do to ensure they have the overnight breathing assistance they need.
“The patients are asked to contact their sleep physician who reviews the original sleep study to assess the severity, determine if there is a sleep position which is safer, repeat a home study with a positioning cushion and in some cases use supplemental oxygen,” Tammelin said.
“In the cases of severe sleep apnea, we can convince the CPAP supplier to expedite the process,” he added.
The FDA issued a
The agency said that black debris from the foam or certain chemicals released into the device’s air pathway might be “inhaled or swallowed” by people using the device.
“The patients who used the
Oks said that ideally, a recalled device should be replaced as quickly as possible.
“Impacted users should register their faulty equipment with Phillips to get on queue for a replacement,” she advised.
Oks also noted that there may be other treatment options available for certain diseases for which CPAP is prescribed and these should be considered.
“All of these scenarios need to be discussed with a physician,” she added.
Oks emphasized that the recall has put a “remarkable amount of strain” on the field of sleep medicine as replacement equipment has significant delays.
“Insurance carriers are not authorizing new replacement machines for those with the recalled equipment, and there is limited guidance from Phillips to physicians and DMEs (durable medical equipment companies; suppliers of the equipment),” she said.
“This is confounded by shipping delays and backorders on equipment from other CPAP/BiPAP manufacturers,” Oks added.
Philips Respironics is recalling over 17 million masks used by people with sleep apnea and other respiratory issues due to magnets that may affect metallic implanted medical devices.
Experts say that affected patients should speak with their doctor regarding the best course of action until the situation can be resolved.