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News & Trends - MedTech & Diagnostics

ResMed issues safety warning, one year after competitor alert

Health Industry Hub | November 30, 2023 |

MedTech & Diagnostics News: To address potential risks associated with positive airway pressure (PAP) masks, Australian medical device company ResMed has been directed to update product safety information and warnings. This move comes in the wake of concerns raised over the interference of magnets in PAP devices with various medical implants.

The masks in question, part of ResMed’s AirFit and AirTouch lines, incorporate magnets designed to secure the devices in place. This safety issue follows a prior product recall notice by ResMed’s key competitor, Philips, in September 2022. Philips raised alarms about the potential for magnets in its masks to interfere with the functioning or positioning of specific implanted metallic medical devices, affecting more than 17 million masks.

Responding to the regulatory notice issued by the Therapeutic Goods Administration (TGA) in Australia, ResMed has undertaken to update safety information and warnings for 12 products in its mask lines.

These changes primarily target individuals with active medical implants, encompassing a wide range from pacemakers, Implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps to various metallic objects like stents, valves, ocular implants, electrodes, aneurysm clips/flow disruption devices, and implants for hearing or balance restoration containing implanted magnets.

“The risk is that the magnetic field may cause active implantable devices to malfunction or result in movement of other implantable devices which has the potential to lead to serious injury or death,” the TGA wrote.

ResMed said in a statement “We understand how important the right mask is to ongoing therapy for people with sleep apnoea, COPD, and other chronic diseases. Over the past year, we have been engaged in discussions with Health Regulators to ensure that we are up to date with the latest recommendations around the use of magnets when in close proximity to certain implants and medical devices.”

The company is actively revising the contraindications and warnings sections in the AirFit and AirTouch product lines’ instructions for use (IFUs). The company has also pledged to provide non-magnetic replacement masks to affected patients.

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