Research supports FDA recommendation: Patients with implanted medical
devices should keep their smart phones and watches at least six inches away


Date:
August 26, 2021
Source:
Elsevier
Summary:
A new study supports the FDA recommendation that patients keep any
consumer electronic devices that may create magnetic interference,
including cell phones and smart watches, at least six inches
away from implanted medical devices, in particular pacemakers and
cardiac defibrillators.



FULL STORY ========================================================================== After reports of smart phone and watch interference with implanted
medical devices, investigators affiliated with the Center for Devices
and Radiological Health (CDRH) at the US Food and Drug Administration
conducted a study that supports the FDA recommendation that patients keep
any consumer electronic devices that may create magnetic interference, including cell phones and smart watches, at least six inches away
from implanted medical devices, in particular pacemakers and cardiac defibrillators. Their findings appear in Heart Rhythm, the official
journal of the Heart Rhythm Society, the Cardiac Electrophysiology
Society, and the Pediatric & Congenital Electrophysiology Society,
published by Elsevier.


========================================================================== "Ensuring the safety of our nation's medical devices is a cornerstone
of our consumer protection mission, especially as technology continues
to advance," explained lead investigator Seth J. Seidman, MS, Research Electrical Engineer and EMC Program Advisor with the CDRH. "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." Cardiac implanted electronic devices are intended to support heart rhythm disorders, such as slow or fast heart rates. Implantable pacemakers and cardioverter defibrillators (ICDs) include a "magnet mode" designed to
be used when a patient is undergoing a procedure where electromagnetic interference is possible, or when suspension of the device is necessary
for medical treatment.

However, this feature can also be triggered accidentally from strong
magnetic fields greater than 10G, which can change how the device works
and could result in serious harm to the patient.

Historically, magnets strong enough to trigger this magnet mode were
very large and identifiable, such as stereo speakers or electronic
motors in cordless tools. With the advent of small rare-earth magnets,
however, strong magnetic fields can be found in headphones, door locks,
or small phone speakers.

The investigators tested the magnetic field output of all iPhone 12 and
Apple Watch 6 models at varying distances from the devices. They found
that all the devices have static magnetic fields significantly greater
than 10G in close proximity, high enough to place implanted cardiac
devices into magnet mode.

However, when a separation distance of six inches or more is maintained,
the phones and watches will not trigger magnet mode.

"Because of these results, we are taking steps to provide information for patients and healthcare providers to ensure they are aware of potential
risks and can take simple proactive and preventive measures like keeping consumer electronics, such as certain cell phones and smart watches,
six inches away from implanted medical devices and not carrying consumer electronics in a pocket over the medical device," advised Mr. Seidman.

"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 healthcare providers 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
medical devices," noted Mr.

Seidman.

========================================================================== Story Source: Materials provided by Elsevier. Note: Content may be edited
for style and length.


========================================================================== Journal Reference:
1. Seth J. Seidman, Joshua Guag, Brian Beard, Zane Arp. Static magnetic
field measurements of smart phones and watches and applicability to
triggering magnet modes in implantable pacemakers and implantable
cardioverter-defibrillators. Heart Rhythm, 2021; DOI: 10.1016/
j.hrthm.2021.06.1203 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2021/08/210826090845.htm

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