TGA reviews CPAP masks after US recall

Concerns about magnetic interference have prompted the return of more than 17 million masks in the US.

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The TGA is in talks with Philips Electronics following a US recall for a range of CPAP masks used by millions, over fears that components may interfere with implants such as stents, pacemakers, insulin pumps and even shrapnel.

The recall affects five types of masks, used by patients with obstructive sleep apnoea, respiratory insufficiency or respiratory failure.

A TGA spokeswoman told The Medical Republic that no adverse event reports had been received in Australia relating to this new identified issue, however it was under review.

“The TGA can confirm that we are aware of this new issue associated with Philips’ positive airway pressure machines,” she said.

“We have requested information from the Australian sponsor Philips Electronics about the types of affected devices in Australia, the numbers supplied and the potential risks to patients.

“At this stage, no recall action has commenced, however after receiving information from Philips, we will publish information as quickly as we can to assist patients and healthcare professionals [to] understand the situation.”

TMR has approached Philips, who confirmed they were in discussion with the TGA and could not comment.

The masks, which are connected to bilevel positive airway pressure and continuous positive airway pressure machines, feature magnetic headgear clips to keep the device in place.

According to an FDA announcement, these magnets could interfere with a wide range of implanted metallic medical devices, potentially resulting in injury or death.

A recent update in JAMA Open Network warned the magnets could put individuals with metallic medical devices or metallic objects in their body at risk.

“Medical devices in patients – as well as in bed partners, caretakers, and others in close proximity to patients – that could be affected by the mask magnets include brain stents, embolic coils, aneurysm clips, pacemakers, implantable cardioverter-defibrillators, ventriculoperitoneal shunts, ocular implants, magnetic denture attachments, insulin pumps, certain neurostimulators used in and around the neck, cochlear implants, ocular implants, and any devices labelled as magnetic resonance unsafe,” the authors wrote.

“The masks could also affect people who have metallic objects in their body, such as shrapnel.”

The recall follows two unrelated events since 2021, both of which impacted Australian Philips customers.

In July this year, Philips recalled its CPAP, bi-level PAP devices and mechanical ventilators due to incorrect settings. In June 2021, the same products were recalled because of a safety concern involving polyester-based polyurethane foam degradation and emission.  

The two instances were addressed by the TGA and Philips, which initiated a repair/replacement program to correct the affected devices.

According to the JAMA report, 14 serious mask-related injuries had been reported by the FDA as of early September, including arrhythmia, seizures and irregular blood pressure.

It also identified a further 16 cases in which mask magnets may have affected medical devices, including defibrillators periodically shutting off, pacemaker interference, shunts requiring replacement and cognitive issues.

In the article, a spokesperson for Philips noted that “if neither patients nor the people in close proximity to them have metallic medical devices or metallic objects in their body, use can continue”.