FDA issues public warning over interference from consumer electricals on implanted devices

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The US Food and Drug Administration (FDA) has issued advice to patients with implanted devices such as pacemakers or implantable defibrillators to take precautions against the risk of magnetic interference from smartphones and smart watches.

According to the FDA, some newer consumer electronic devices have high field strength magnets capable of placing medical devices in their “magnet mode.” These magnets can affect normal operations of the medical device until the magnetic field is moved.

The FDA advises patients with implanted medical devices to consider taking precautions, including keeping consumer electronics, such as certain cell phones and smart watches, six inches away from implanted medical devices, and refraining from carrying consumer electronics in a pocket over the medical device.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said: “Ensuring the safety of our nation’s medical devices is a cornerstone of our consumer protection mission, especially as technology continues to advance. As part of this work, the agency reviewed recently published articles describing the possibility that certain newer cell phones, smart watches and other consumer electronics with high field strength magnets may temporarily affect the normal operation of implanted electronic medical devices, such as pacemakers and implantable defibrillators. Based on our review, we decided to conduct our own testing to confirm and help inform appropriate recommendations for patients and consumers.

“As a result of these actions, today we are taking steps to provide information for patients and healthcare 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 with their health care provider to ensure they understand this potential risk and the proper techniques for safe use.

“The FDA will continue to monitor the effects of consumer electronics on the safe operation of implanted medical devices.”

A letter published in the journal Heart Rhythm in January first warned of possible interference to implantable cardioverter defibrillator (ICD) therapy caused by magnets in the iPhone 12.

The letter, authored by Joshua Greenberg and colleagues from the Henry Ford Heart and Vascular Institute, Detroit, USA, noted that when an external magnet is applied to a defibrillator, high voltage shock therapy for ventricular tachycardia and ventricular fibrillation is suspended.


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