Some phones and smartwatches may interfere with pacemakers, FDA warns

The U.S. Food and Drug Administration issued a warning this past week about the effect that magnets in some cell phones and smartwatches can have on pacemakers and other implanted medical devices.  

Although the FDA did not explicitly refer to a specific type or brand of phone, its new notice linked to several articles about magnets in the iPhone 12 interfering with cardiac devices – as well as to other pieces noting that the recommendation against placing a mobile phone over an implantable cardiac device long predates that model.  

“Recent studies have shown that consumer electronic devices with high field strength magnets may cause certain implanted medical devices to switch to ‘magnet mode’ and suspend normal operations until the magnet is moved away from the medical device,” read the release.  

WHY IT MATTERS  

As the FDA notes, many implanted medical devices are designed with a “magnet mode” allowing physicians to control the device without having to perform surgery.  

This means that electronics with high-field-strength magnets could potentially interfere with the medical device’s effectiveness.  

“For example, a cardiac defibrillator may be unable to detect tachycardia events,” read the notice. “Or it may change the operational mode of the devices such as turning on asynchronous … mode in a pacemaker.”  

The FDA noted that it was aware of articles describing the effect.  

“The FDA also conducted its own testing on some products that use the high field strength magnet feature and have confirmed the magnetic field is both consistent with the publications and strong enough to turn on the magnetic safety mode of the medical devices in question,” it said.  

The agency recommended – as did Apple, regarding several of its products – that patients keep potentially interfering electronics at least six inches away from implanted devices, especially cardiac defibrillators.  

“Cardiac implanted electronic devices are intended to support heart rhythm disorders, such as slow or fast heart rates. When the device stops working, a patient may experience dizziness, loss of consciousness or even death if therapy is not delivered when lifesaving shocks are required,” read the release.  

The FDA also pointed out that it is not aware of any adverse events associated with this issue at this time.  

THE LARGER TREND  

The FDA warning follows reports from Henry Ford cardiologists earlier this year about the possibility that the magnetic array in new iPhones could affect implantable cardiac devices.  

“We believe our findings have profound implications on a large scale for the people who live daily with these devices, who, without thinking, will place their phone in their shirt pocket or upper pocket or their coat – not knowing that it can cause their defibrillator or pacemaker to function in a way that could potentially be lethal,” said Henry Ford cardiologist Dr. Gurjit Singh.  

The story harked back to earlier fears about electromagnetic interference from cell phones in medical procedures – leading to their (temporary) ousting from patient care areas.  

ON THE RECORD  

“The 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,” said the agency.

Kat Jercich is senior editor of Healthcare IT News.
Twitter: @kjercich
Email: [email protected]
Healthcare IT News is a HIMSS Media publication.

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