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Regulatory Focus™ > News Articles > 2021 > 5 > FDA cautions cell phones, smart watches may trigger magnet mode in implanted devices

FDA cautions cell phones, smart watches may trigger magnet mode in implanted devices

Posted 14 May 2021 | By Michael Mezher 

FDA cautions cell phones, smart watches may trigger magnet mode in implanted devices

High field strength magnets in some consumer electronic devices may trigger “magnet mode” in certain implanted medical devices such as pacemakers and cardiac defibrillators, the US Food and Drug Administration said on Thursday.
Many implanted electronic medical devices feature a magnet mode to allow the safe operation of the device during medical procedures such as an MRI scan. While in magnet mode normal device operations are suspended and the mode is typically engaged by placing a high field strength magnet near the implanted device.
FDA said it has reviewed recent scientific literature that describes the possibility of newer cell phones and smart watches, including Apple’s iPhone 12, affecting the normal operation of implanted medical devices. The agency said its own testing confirmed the magnetic field from certain consumer electronic devices “is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question.”
“As a result of these actions, today we’re taking steps to provide information for patients and health care providers to ensure they are aware of potential risks and can take simple proactive and preventative measures. We believe the risk to patients is low and the agency is not aware of any adverse events associated with this issue at this time. However, the number of consumer electronics with strong magnets is expected to increase over time. Therefore, we recommend people with implanted medical devices talk to their health care provider to ensure they understand this potential risk and the proper techniques for safe use,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health.
Patients with implanted medical devices, particularly cardiac defibrillators, are advised to keep electronic devices at least six inches from their implanted medical devices and against carrying electronics in pockets over implanted devices. Patients are also instructed to check on their devices using their home monitoring systems (if available) and to speak with their health care provider if they experience any symptoms or have questions related to magnets in consumer electronics and their implantable medical devices.
FDA also points out that many implanted medical devices include labeling advising patients to keep cell phones and smart watches at least six inches away from their implanted devices.
“FDA continues to monitor all relevant scientific information about this ongoing issue and will continue to take appropriate action, including informing the public and providing additional information, if the need arises based on its risk analysis,” the agency said.


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