AirFit

Nov 23, 2023

ResMed issues urgent field safety notice for AirFit masks Magnets in the masks could interfere with functionality of implanted devices or change position of metallic implants. Share this article The masks use magnets to provide easier attachment and detachment to headgear. Image credit: Shutterstock/sbw18. ResMed has issued an urgent field safety notice for certain models of its AirFit masks that contain magnets, citing issues around interference with medical implants. In a letter sent to patients on 20 November, the US-headquartered company updated the contraindications and warnings in the user guides for the masks. Go deeper with GlobalData The masks affected include multiple AirFit models from its full-face mask, nasal mask, and non-vented mask ranges and are used to deliver air from a positive airway pressure (PAP) device. The masks use magnets to provide easier attachment and detachment to headgear. The company says their use is especially important to patients with dexterity vision impairment, or those with disabilities. The safety notice is due to reports of magnetic interference of the magnets with implanted devices in the patient. ResMed has submitted five reports of serious harm, potentially caused by this issue, to regulatory authorities. No deaths have been reported. ResMed said that medical device function could be affected, whilst ferromagnetic implants could change position because of mask magnet proximity. How well do you really know your competitors? Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge. Not ready to buy yet? Download a free sample We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form By GlobalData Submit Tick here to opt out of curated industry news, reports, and event updates from Medical Device Network. I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the privacy policy Submit and download Active medical implants that could be affected include cardiovascular devices such as pacemakers, and implantable cardioverter defibrillators (ICD). Neurostimulators and cerebrospinal fluid (CSF) shunts can also suffer from interference, along with diabetes devices such as insulin/infusion pumps. ResMed also stated that patients with metallic implants containing ferromagnetic materials are contraindicated for using the masks. This includes, among others, patients with stents, valves, and flow disruption devices. ResMed warned users to keep the mask magnets at least six inches away from medical devices or implants that may be affected. According to the letter, ResMed has sold tens of millions of masks across the last nine years. The US Food and Drug Administration (FDA) tagged Philips’ recall as Class I, the most serious classification. The recall involved over 18 million devices sold in the US. Sign up for our daily news round-up! Give your business an edge with our leading industry insights.