FDA warns magnets in cellphones and smartwatches can affect pacemakers and other EP devices

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May 14, 2021 – The United States Food and Drug Administration (FDA) advises patients and caregivers to keep all consumer electronics, such as cell phones and smart watches, at least 6 inches from medical devices. implanted electrophysiology (EP), such as pacemakers and automatic implantable defibrillators (ICDs).

The FDA is aware that some newer consumer electronics, including cell phones and smartwatches, have magnets that can put certain implanted medical devices into magnetic safety mode and temporarily suspend normal operation. Magnetic safety mode allows safe operation during certain medical procedures such as MRI imaging exam.

The FDA considers the risk to patients to be low and the agency is not aware of any adverse events associated with this issue at this time. The FDA continues to monitor all relevant scientific information (including adverse event reports) on this ongoing issue and will continue to educate the public and healthcare providers as the need arises. basis of a risk analysis.

Some consumer electronics, such as some cell phones and smartwatches, use high field strength magnets. Recent studies have shown that consumer electronics devices with high field strength magnets can cause some implanted medical devices to go into “magnet mode” and suspend normal operations until the magnet is removed from the device. medical.

These safety devices are typically activated by physicians using a high field magnet placed near the implanted device, placing it in “magnet mode” for MRI scans. Removal of the magnetic field causes the device to return to normal operation.

Precautions for patients with pacemakers, ICDs and cathode ray machines to avoid interference from cell phones and smart watches

The FDA recommends that patients keep all consumer electronic devices that may cause magnetic interference, including cell phones and smartwatches, at least 6 inches from implanted medical devices, especially cardiac defibrillators. Many implanted medical devices contain written FDA-approved patient information (patient labeling), which warns patients to keep all cell phones and smartwatches at least six inches from the implanted medical device.

People with implanted medical devices may want to take a few simple precautions, including:
• Keep consumer electronics, such as some cell phones and smartwatches, six inches away from implanted medical devices.
• Do not carry consumer electronics in a pocket above the medical device, such as a breast pocket in a coat or shirt.
• Check your device using your home monitoring system, if you have one.
• Talk to your health care provider if you experience any symptoms or have questions about magnets in consumer electronics and implanted medical devices.

In the vicinity of high resistance magnets, devices with a magnetic safety mode may cease to function or alter the operation of the device. For example, an implantable cardiac defibrillator (ICD) may be unable to detect tachycardia events. Or it can change how devices work, for example by activating asynchronous mode in a pacemaker.

Implanted electronic cardiac devices are intended to manage cardiac arrhythmias, such as slow or fast heart rates. When the device stops working, a patient may experience dizziness, unconsciousness or even death if treatment is not given when life-saving shocks are needed.

The FDA has stressed the importance of avoiding interference between cell phones and smartwatches and a patient’s heart device by keeping them at least 15 centimeters (6 inches) from implanted medical devices. In addition, do not place cell phones, smartwatches, and other consumer electronics near your implanted medical device.

The FDA is aware of published papers that describe the effect that sufficiently strong magnetic fields can activate Magnetic Safety Mode upon close contact. The FDA has also performed its own tests on certain products using the high field magnet function and has confirmed that the magnetic field is both consistent with the publications and strong enough to activate the magnetic safety mode of the medical devices in question. The FDA considers the risk to patients to be low and the agency is not aware of any adverse events associated with this issue at this time.

The FDA continues to monitor all relevant scientific information on this ongoing issue and will continue to take appropriate action, including notifying the public and providing additional information, if the need arises based on its analysis of risks.

Read the FDA’s full warning.

Related article from January 2021: iPhone 12 may cause implantable cardioverter defibrillators to malfunction.

Find more news about EP technology

The FDA includes a list of recent peer-reviewed journal articles that raise concerns about the problem with cellphone magnets:


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