WASHINGTON, D.C. — The following quote is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health:
“Ensuring the safety of our nation’s medical devices is a cornerstone of our consumer protection mission, especially as technology continues to advance. As part of this work, the agency reviewed recently published articles describing the possibility that certain newer cell phones, smartwatches and other consumer electronics with high field strength magnets may temporarily affect the normal operation of implanted electronic medical devices, such as pacemakers and implantable defibrillators. Based on our review, we decided to conduct our own testing to confirm and help inform appropriate recommendations for patients and consumers.
“As a result of these actions, today we’re taking steps to provide information for patients and health care providers to ensure they are aware of potential risks and can take simple proactive and preventative measures. 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. However, the number of consumer electronics with strong magnets is expected to increase over time. 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.
The FDA will continue to monitor the effects of consumer electronics on the safe operation of implanted medical devices.”
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