WASHINGTON — The U.S. Food and Drug Administration and the American Heart Association are cautioning Americans with pacemakers or implantable cardioverter-defibrillator that some cell phones or smartwatches can impact the devices.
The FDA on May 13 said it's updating its recommendations to keep all electronic devices with magnets at least six inches away from implanted medical devices.
"When near high strength magnets, devices with a magnetic safe mode could stop working or change how the device works," the FDA said.
The FDA said the risk to patients is low, but continues to monitor studies and information about the ongoing issue. The agency encourages anyone with a pacemaker or other device to not carry electronics in a pocket over the medical device.
An internal pacemaker is a small device that uses electric stimulation to help keep the heart beating regularly. An implantable cardioverter-defibrillator is a device also placed under the skin and attached to the heart so that if an abnormal heart rhythm is detected it can initiate a small electric shock to restore a normal heartbeat, according to the American Heart Association.
The American Heart Association on Wednesday released a small study that found 11 of 14 pacemakers and defibrillators were interfered with when an iPhone 12 Max Pro was held over the devices. The study tested three implanted devices and the rest were still in their original packaging.
"Clinically identifiable magnetic interference was detected in all three of the implanted devices, and in about three quarters (eight of the 11) of the new, in-the-package cardiac devices," the study said. "In total, 11 of the 14 devices (79%) experienced malfunctioning when within 1.5 cm of the iPhone 12 Pro Max."
However, researchers for the study did explain that the biggest limitation to the study is that there were such a small number of devices tested and that the results might not be the same for all devices.
Apple's support team in March released a warning about magnets inside its iPhone 12s and MagSafe accessories and patients with pacemakers.
"Though all iPhone 12 models contain more magnets than prior iPhone models, they're not expected to pose a greater risk of magnetic interference to medical devices than prior iPhone models," Apple said. "To avoid any potential interactions with these devices, keep your iPhone and MagSafe accessories a safe distance away from your device (more than 6 inches / 15 cm apart or more than 12 inches / 30 cm apart if wirelessly charging)."
“The American Heart Association and manufacturers of pacemakers and implantable cardioverter defibrillators have long recommended that cell phones be used in the ear opposite the side of the body of an implanted device, and that the cell phones be kept at least 10 cm away from the device, therefore not in a shirt or coat pocket on the same side as the cardiac device,” said N.A. Mark A. Estes, M.D., professor of medicine and director of the Clinical Cardiac Electrophysiology Fellowship Program at the Heart and Vascular Institute of the University of Pittsburgh School of Medicine, and an American Heart Association volunteer.
He added: “While the risk from temporary interference was only tested with specific devices and cell phones, the Association reminds people with cardiac implantable electronic devices to remain informed of the latest FDA guidance for their heart device, the manufacturers’ safety guidelines and to contact their health care professional with any questions or concerns."