The trouble seemingly never ends for Philips’ beleaguered Respironics division. Since beginning a recall of around 5.5 million ventilators and other breathing support machines more than a year ago, in June 2021, the company has uncovered a handful of other safety issues within its respiratory device portfolio.
The latest of these came to light this week when both Philips and the FDA alerted users of its CPAP and BiPAP machines—and their caregivers and healthcare providers—to a potential health risk linked to the magnets embedded in some masks used with the machines.
According to Philips, the recall spans more than 17 million of its masks that contain magnetic headgear clips or straps to hold them in place. The affected products include the Amara View, DreamWisp, DreamWear, Wisp, Wisp Youth and Therapy Mask 3100 models.
The magnets in those masks could potentially interfere with implanted medical devices, including pacemakers, neurostimulators, metallic stents, ocular implants, aneurysm clips and more—with possibly fatal results, per the FDA. Because of the strength of their magnetic fields, they can interfere with devices from at least six inches away.
Philips said that as of Aug. 30, it has received 14 reports linking implant malfunctions to the mask magnets. The incidents include issues with the devices, like pacemaker interference and failure and unplanned defibrillator resets and shutoffs, which have in turn led to health problems such as arrhythmia, seizures, irregular blood pressure and cognitive issues.
The safety concerns have led Philips to issue updated instructions and labeling for all of its CPAP and BiPAP machine masks containing the magnetic clips and straps. The newly issued warning makes note of the possible magnetic interference and lists the presence of any metallic implants—either in the mask user themselves or the household members, caregivers and bed partners in their close vicinity—as a specific contraindication for the masks.
Instead, affected users should consult with their healthcare providers and, if possible, switch to a non-magnetic mask. Providers, meanwhile, should no longer prescribe use of the magnetic masks to patients who may come into close contact with metallic implants.
Though the magnet-based recall isn’t directly associated with Philips’ June 2021 safety event—which stems from the possible breakdown of polyester foam embedded in millions of the company’s respiratory support devices—there is some overlap in the products affected by each recall.
As Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, noted in the agency’s release, “This latest recall raises further safety concerns both for Philips devices already subject to a recall, as well as additional devices.”