Dive Brief:
- Resmed has contacted customers about the potential for magnets in its masks used in positive airway pressure therapy to interfere with other medical devices.
- The respiratory company published an urgent field safety notice last month, and followed up with a press release this week, to share updated instructions to mitigate the risk of interference.
- Like its rival Philips, Resmed has determined that patients should not wear magnetized masks if they or anyone in close physical contact has implants that interact with magnets.
Dive Insight:
Last year, Philips issued a notice about the potential for 17 million masks to affect patients with certain implanted medical devices. The notice addressed the risk that magnets used to connect components and hold masks in place during positive airway pressure therapy could affect medical devices such as brain stents and cardioverter defibrillators.
Now, Resmed has issued a notice about the risks posed by magnets in its rival masks. All the masks are safe when used in accordance with the updated instructions, Resmed said, but they are contraindicated in patients who have, or come in close physical contact with, certain medical implants. Active implants such as pacemakers and metallic objects including valves are among the contraindicated devices.
The Food and Drug Administration on Thursday classified the recall as Class I, the most serious type of recall. It includes millions of masks under the AirFit and AirTouch brand names, according to the FDA enforcement report.
Resmed sold the masks with magnets across the U.S. from 2014 until last month. Over that time, the company submitted five reports of serious harm, which it called “medical intervention/hospitalization,” that were potentially related to magnetic interference with an implanted device. No permanent injuries or deaths have been reported.
To mitigate the risk of further harm, patients using masks with magnets should keep at least 6 inches away from implants and devices that may be adversely affected by magnetic interference. People need to return the masks only if they are contraindicated because of proximity to an implant.
Resmed published the press release one month after sending the urgent field safety notice. The notice prompted a recall alert from Australia’s device regulator, which followed up earlier this month with a second notice discussing Resmed’s action in the context of Philips’ earlier recall.