Monday, September 27

No, the FDA does not recommend avoiding the mobile phone if you have a defibrillator or pacemaker

It will be the summer, it will be the fear, as unfounded as it is widespread, of electromagnetism; the fact is that news appeared this august following a publication in the medical journal Heard Rhythm (Heart Rate) from a work by the Department of Electromagnetic Interferences of the Food And Drugs Administration (FDA), have a certain component of alarmist hype.

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Titled “In Vitro Tests Reveal Sample RFID Readers That Induce clinically significant electromagnetic interference to implantable pacemakers and implantable cardioverter-defibrillators, “the publication reveals a series of tests from this department, the Center for Devices and Radiological Health (CDRH), dependent on the FDA.

It explains that, in laboratory tests with different RFID radio frequency readers, interference has been detected in pacemakers and defibrillators depending on the frequency at which the reader emits electromagnetic waves and the distance between the health devices and the readers. .

Specifically, during exposure to low frequency RFID A reaction was observed in 67% of all pacemaker tests (maximum distance 60 cm) and 47% of all ICD tests (maximum distance 40 cm).

During exposure to HF RFID, a reaction was observed in 6% of all pacemaker tests (maximum distance 22.5 cm) and 1% of all ICD tests (maximum distance 7.5 cm) .

For both pacemakers and ICDs, no reactions were observed during exposure to ultra-high frequency RFID or continuous wave RFID. Therefore, in the tests, pacemakers and defibrillators were more susceptible to low-frequency RFID readers.

In conclusion, the researchers write: “While there is evidence in in vitro tests of interference in implantable pacemakers and defibrillators with low and high frequency RFID readers, the FDA has not received any incident reports caused by no RFID system. “And they add:” We do not believe that the current situation reveals an urgent risk to public health. ”

What is this all about?

Implanted pacemakers and defibrillators have a mode called “Magnet”, which temporarily stops them. This mode is only activated in the event that the person is to undergo magnetic resonance tests or other medical treatments that may interfere or be interfered with by the aforementioned devices.

To activate this “Magnet” mode, it is necessary to create a powerful 10G magnetic field (10 gauss or magnetic units). Well, in their tests the researchers claim that they measured the magnetic fields created by some of the RFID readers installed in mobiles and smartwatches, specifically in their payment systems, which use high and low frequency readers.

They were fields greater than 10G created in proximity to be able to transmit the payment signal to the dataphone, but that could eventually activate the magnet mode of defibrillators and pacemakers at distances less than 15 cm, but whose risk disappears at greater distances.

It is also worth knowing that the lower the frequency of wave emission by the RFID reader, the greater the possibility of interference. And finally, that these tests were performed on non-implanted pacemakers and defibrillatorsTherefore, the experiment is not very exportable as it does not know the protective effect produced by the skin.

Concern for the future

Seth J Seidman, Research Director, explains in an interview: “Due to these results, we are taking steps to provide information to patients and healthcare providers to ensure that they are aware of the potential risks and that they can take simple proactive and preventive measures such as maintaining electronic devices. consumer electronics, such as certain mobile phones and smart watches, within 6 inches of implanted medical devices and not carrying consumer electronics in a pocket over the medical device. ”

It gives preventive advice, but at no time does it issue a recommendation, much less an official FDA recommendation. In fact, he acknowledges that “the risk to patients is low and the agency is not aware of any adverse events related to this issue at this time. ”

Although it does show its concern for the future about the increasing magnetic power of RFID readers that manufacturers place in mobile phones and smart watches. Finally, he warned that “the FDA will continue to monitor the effects of consumer electronics on the safe operation of medical devices.”

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