ResMed is trying to solve the CPAP mask magnet problem

Magnets in continuous positive airway pressure (CPAP) masks led to Class I recalls in recent years for Philips Respironics and ResMed.

Those recalls — classified as the most serious kind by the FDA because the problems could lead to serious injury and death — were due to potential magnetic interference near certain implants and metallic objects in a person’s body.

The magnets, for example, could interfere with pacemakers. That risk is not only to the person wearing the mask, but extends to others in close proximity to the mask magnets, such as a CPAP patient’s spouse sleeping in the same bed.

ResMed and Philips reported a combined 20 injuries and zero deaths at the time of their respective recalls.

Can CPAP mask makers move forward without magnets, eliminating this potentially dangerous clash of medical devices?

ResMed’s latest CPAP mask still contains magnets, but magnetless alternatives already exist and more could be on the horizon, said ResMed Chief Product Officer Justin Leong.

“We’re working on new ideas to try and improve that situation,” he said in an interview with Medical Design & Outsourcing. “But at the moment, we still think magnets have a place in terms of making masks more simple and easy to use for people.”

In March, ResMed launched its newest CPAP mask for sleep apnea, the ultra-compact, full-face AirFit F40, with a design that includes magnets. Leong said the company’s main design goal for the AirFit F40 was comfort, with a flexible frame and soft silicone cushion. The design team kept magnets in the design for convenience, Leong said.

CPAP users often have to take their masks off in the middle of the night. In the darkness, the magnets help guide the mask back onto the face before clipping in, Leong said.

“CPAP therapy is something you have to use every night,” Leong said. “It’s something very personal to you and you want to make it as comfortable and convenient as possible. That’s what the magnets do.”

Only a small percentage of people have implants that are susceptible to magnetic interference, so ResMed is sticking with magnets for the convenience of the millions of CPAP users who don’t.

While Leong said masks that don’t use magnets aren’t as convenient, ResMed recently came out with products that don’t use them. ResMed’s non-magnet technology uses a small clip instead of a magnet, Leong said.

“That’s the best thing we’ve come up with so far,” he said. “We’ll continue to try and think of better solutions, but a little clip is basically what we’re going for now.”

Read more from our interview: How ResMed designed its new AirFit F40 CPAP mask