Respiratory device manufacturers Dräger and Resmed have informed the Medicines Safety Agency (ANSM) of risks of interference between their masks with magnets for their respiratory devices and metallic implanted medical devices, it said on Monday. In November 2022, the Dutch company Philips had already reported such risks.
This interference “may occur when patients or any member of their household wear metallic implanted devices” (e.g. pacemakers) “and are likely to be in close proximity to these masks containing magnets (at a distance less than at 15 cm),” explains the ANSM in a press release. They risk causing the implanted devices to malfunction.
Patients using these masks will be informed soon
Last year, fourteen cases were reported worldwide, mostly in the United States. Last September, a case was reported in France by Philips, without consequences for the patient.
Since then, respiratory device manufacturers Dräger (German) and Resmed (American) “have informed us of this same risk of interference with their masks with magnets,” writes the ANSM.
Patients using these masks with magnets have been or will soon be informed by home health providers (PSAD) about the implanted medical devices concerned and the course of action to follow, she adds.
Numerous lawsuits against Philips
Since June 2021, the Dutch group Philips has been forced to launch a massive global campaign to recall several defective models of respirators used in particular by patients suffering from sleep apnea.
Users risked inhaling or swallowing pieces of toxic sound-absorbing foam that could cause irritation and headaches. Philips is the subject of numerous lawsuits linked to this affair in several countries.