- For Immediate Release:
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, smart watches 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.”
- Today, the U.S. Food and Drug Administration is advising the public that some newer consumer electronic devices such as certain cell phones and smart watches, have high field strength magnets capable of placing medical devices in their “magnet mode.” These magnets can affect normal operations of the medical device until the magnetic field is moved.
- Many medical devices are designed with a “magnet mode” to allow for safe operation during certain medical procedures, such as undergoing an MRI scan. These safety features are typically initiated with the use of a high field strength magnet that is placed near the implanted device placing it into a “magnet mode.”
- The FDA advises patients with implanted medical devices to consider taking precautions, including:
- Keeping consumer electronics, such as certain cell phones and smart watches, six inches away from implanted medical devices.
- Refraining from carrying consumer electronics in a pocket over the medical device.
- Talking to your health care provider if you have questions regarding magnets in consumer electronics and implanted medical devices.
- The FDA encourages health care professionals and patients to report adverse events or safety problems to FDA’s MedWatch Adverse Event Reporting program:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Jeremy Kahn