FDA Issues Communication on CIEDs and Certain Consumer Devices
May 13, 2021 - The U.S. Food and Drug Administration (FDA) issued a communication on potential interactions between certain cell phones and smart watches.
Publication Date: May 21, 2022
On May 13, 2021, the U.S. Food and Drug Administration (FDA) issued a communication on potential interactions between certain cell phones and smart watches. HRS has been participating in meetings with FDA and others about this topic.
CIEDs are designed to respond to an externally applied magnetic field if it is strong enough (approximately 10 gauss). Many cell phones and other wearable devices contain magnets which may be strong enough to trigger magnet mode if placed close to a CIED. Normal device function resumes when the device is moved away from the CIED.
There have been recently published reports of cell phones with high field strength internal magnets affecting ICD and PM functionality. In January, a case was reported in which a cell phone, when placed over the left chest of a patient with an implanted transvenous ICD, triggered magnet mode, suspending tachy-therapies This is not unique or new. A magnetic e-cigarette device was reported to cause a patient's ICD to revert to magnet mode when stored in the left shirt pocket over his defibrillator. The magnetic wrist bands in smart watches have also been shown to elicit magnet mode when placed within 2.0-2.4 cm of a CIED.
Industry standard ISO 14117 states that CIED labeling should include a warning that advises a minimum separation of 15 cm (6 in) between the CIED and any portable device that transmits electromagnetic waves. CIED patient manuals from the device manufacturers do state that patients should avoid getting strong magnetic fields too close to their implanted CIED medical device.
The U.S. Food and Drug Administration (FDA) Office of Science and Engineering performed its own testing on some consumer electronic devices that use high field strength magnets and determined that the static magnetic fields from these devices are strong enough to cause a CIED to revert to magnet mode. However, they state that they believe the risk is low and emphasized that to avoid interference, cell phones and smart watches should be kept at least 6 inches away from the implanted device [FDA communication].
Apple has updated its support page and provided additional details on their guidance to customers about the magnets inside the iPhone 12 models.
HRS will continue to provide updates when new information becomes available.