FDA says iPhone 12 MagSafe risk to pacemakers is low

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An investigation by the US Food and Drug Administration into devices such as MagSafe and the iPhone 12, has concluded that the risk to patients with pacemakers is low, but advises caution.

Following Apple's rewording of its iPhone 12 and MagSafe support documents to recommend careful use of the devices near pacemakers, the FDA has issued its own guidance. The FDA has conducted its own testing and says that although care is needed, the risk of problems is slight.

"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," says Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, in a statement.

"However, the number of consumer electronics with strong magnets is expected to increase over time," he continued. "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."

Potential issues with magnets in devices such as Apple's, were first raised in the Heart Rhythm Society's journal in January 2021. Apple had advised users to consult medical practitioners if they were unsure about the magnets interfering, but it then updated that to give more detailed guidance.

Specifically, it advises iPhone 12 users who have pacemakers, or use similar medical equipment, to keep the phone between 6 and 12 inches away from such devices. The FDA's separate testing has resulted in similar advice.

"It is important to emphasize the following: to avoid interference between cell phones and smart watches and your heart device, keep them at least six inches (15 centimeters) away from implanted medical devices," says the FDA in an accompanying advisory. "Also, do not place cell phones, smart watches, and other consumer electronics close to your implanted medical device."

Although the FDA concentrated on cell phones and smart watches, its point about increasing use of magnets is not confined to that category of products. Besides magnets in assorted models of iPad, Apple has separately been researching an expanded use of magnets in case covers, and wearable Apple Watch bands.

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