The TGA is aware that some face and nasal masks used to deliver CPAP and BiPAP therapy may contain high strength magnetic clips to hold these masks in place on the face. This sort of magnet may be similar to those used in newer consumer electronics (e.g. mobile phones, smart watches). Magnets could potentially interact with certain implanted medical devices (e.g. pacemakers, defibrillators, cochlear implants, certain shunts). The risk is that the magnetic field may cause active implantable devices to malfunction or result in movement of other implanted devices.
The TGA recommends patients with active implantable medical devices (such as pacemakers or implantable defibrillators) and other implanted devices (such as aneurysm clips) to keep any masks with magnets 16cm away from these implants; and follow any warnings or contraindications that come with the device. If patients are unsure as to whether their mask containing magnets (or other magnets) may affect their specific implanted medical device, they are encouraged to discuss the matter with their treating doctor.
The TGA is monitoring the occurrence of adverse events from interactions between implantable medical devices and masks which have magnetic components, and is in communication with other international regulators.
Philips Electronics Australia Ltd has worked with the TGA to undertake a Product Defect Correction to update the contraindications and warnings to strengthen the current labelling and warnings related to magnets. More information can be found on Philips’ face and nasal masks with magnetic clips.
On 6 September 2022, both Philips Respironics and the US Food and Drug Administration (FDA) released a statement/safety communication relating to this issue.
The TGA strongly encourages you to report all problems associated with face and nasal masks that contain magnets. Your reports help us monitor the performance and safety of medical devices.
Visit Report a problem or side effect to complete the online form and share any problems you may be experiencing. Please include as much information as you can, including detail about the mask which contains magnets, and the implanted device which was affected.