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FDA warns about consumer electronics and implanted devices

May 14, 2021 By Sean Whooley

FDAThe FDA is advising the public that certain consumer devices have high-field strength-magnets that can send medical devices into “magnet mode.”

Magnets of this nature can affect the normal operations of implanted medical devices until the magnetic field is moved, according to the FDA news release.

These medical devices are designed with a “magnet mode” that allows for safe operation during certain medical procedures, such as an MRI scan. Such “magnet mode” safety features normally kick in when a high field strength magnet is near the implanted device.

According to the FDA, patients with these implanted medical devices should consider keeping consumer electronics, such as certain cell phones and smartwatches, 6 in. away from the implanted devices. Additionally, patients should consider avoiding carrying the electronics in a pocket over the medical device, while those concerned should contact a healthcare provider to learn more.

Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the release that 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,” Shuren said. “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.”

Shuren added that the risk to patients is low. FDA has not aware of adverse events associated with the potential problem.

“However, the number of consumer electronics with strong magnets is expected to increase over time,” Shuren said. “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.”

About The Author

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Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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