FDA: The iPhone 12 and MagSafe pose a low risk to patients with implanted pacemakers

An investigation by the US Food and Drug Administration into devices such as MagSafe and the iPhone12 concluded they posed a low risk to patients with implanted pacemakers but recommended caution.

The FDA says the iPhone12 and MagSafe pose a low risk to patients with implanted pacemakers

The FDA issued its own guidance after Apple changed the wording of its supporting documents for the iPhone12 and MagSafe to recommend careful use of the devices near pacemakers. The agency has conducted its own tests and says that while caution is needed, the risk of problems is small.

"We believe the risk to patients is low, and we are not aware of any adverse events related to this issue." JeffShuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a statement.

"However, the number of consumer electronics with strong magnets is expected to increase over time," he continued. "Therefore, we recommend that people who use implantable medical devices talk to their healthcare provider to make sure they are aware of this potential risk and the right technology to use safely."

The potential problem with magnets in devices like Apple's was first raised in January 2021 in the journal of the Heart Rhythm Society. Apple had advised users to consult a doctor if they were unsure whether magnets would interfere, but it has since updated that advice to give more detailed guidance.

Specifically, it advises iPhone12 users with implanted pacemakers or similar medical devices to keep their phones 6 to 12 inches away from such devices. Separate tests by the FDA have produced similar recommendations.

"It is important to emphasize the following: To avoid interference between phones and smartwatches and your heart device, keep them at least 6 inches (15 centimeters) away from the implanted medical device," the FDA said in an accompanying advisory. "Also, avoid placing phones, smartwatches and other consumer electronics near your implantable medical devices."

While the FDA is focused on phones and smartwatches, its views about increasing the use of magnets are not limited to those products. In addition to using magnets in various iPad models, Apple is also looking at expanding the use of magnets in cases and wearable AppleWatch straps.