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FDA warning on cellphone effects on implanted medical devices

The US Food & Drug Administration (FDA) has warned in a statement that certain cellphones and smartwatches, as well as some other electronic devices, might include high field strength magnets which could cause malfunction in various implanted medical devices, reports MedicalBrief.

The FDA said recent studies have shown that some electronic devices with high field-strength magnets may cause certain implanted medical devices to switch to “magnet mode” and suspend normal operations until the magnet is moved away. Many implanted medical devices are designed with a “magnet mode” allowing safe operation during certain medical procedures such as undergoing an MRI scan. Typically, physicians will place a high field-strength magnet on “magnet mode” near the implanted device. Removing the magnetic field causes the device to return to normal operation.

The FDA recommends patients keep any consumer electronic devices that may create magnetic interference, including cellphones and smartwatches, at least 15cm away from implanted medical devices, particularly cardiac defibrillators.

Many implanted medical devices have FDA-approved information patient-labelling, cautioning patients to keep their phones and smartwatches a safe distance from the pacemaker or implanted medical device. The FDA suggests patients with these implanted devices do not carry consumer electronics in a pocket over the medical device and to check the device using a home-monitoring system, if they have one.

The agency also recommends patients talk to their health care providers if they experience any symptoms or have questions regarding magnets in consumer electronics and implanted medical devices.

When near high-strength magnets, devices with a magnetic safe mode could stop working or change how the device works. For example, a cardiac defibrillator may be unable to detect tachycardia events. Or it may change the operational mode of the devices such as turning on a synchronous (ie two or more events not happening at the same time) mode in a pacemaker.

Cardiac-implanted electronic devices are intended to support heart rhythm disorders, like slow or fast heart rates. When the device stops working, a patient may experience dizziness, loss of consciousness or even death if therapy is not delivered when lifesaving shocks are required.

The FDA has conducted its own testing on some products that use the high field-strength magnet feature and has confirmed the magnetic field is strong enough to turn on the magnetic safety mode of the medical devices in question. However, it believes the risk to patients is low, and is not aware of any adverse events associated with this issue at this time.

 

Full FDA statement (Open access)

 

See also from the MedicalBrief archives:

 

Newest cellphones may pose 'significant risk' to pacemakers and ICDs

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