Thursday, August 26, 2021

New cell phone and smart watch models can interfere with pacemakers and defibrillators

Patients with implanted medical devices should keep their smart phones and watches at least six inches away; researchers confirm FDA recommendation in a new report in Heart Rhythm

Peer-Reviewed Publication

ELSEVIER

Magnets in cell phones and smart watches may affect pacemakers and other implantable devices 

IMAGE: NEW RESEARCH FINDINGS VERIFY FDA RECOMMENDATION FOR PATIENTS WITH IMPLANTED MEDICAL DEVICES TO KEEP THEIR SMART PHONES AND WATCHES AT LEAST SIX INCHES AWAY TO AVOID INTERFERENCE WITH IMPLANTED MEDICAL DEVICES. view more 

CREDIT: US FOOD AND DRUG ADMINISTRATION

Philadelphia, August 26, 2021 -- 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.

Waterloo developing a mobile alert app for missing people with dementia

Peer-Reviewed Publication

UNIVERSITY OF WATERLOO

Researchers are working with community leaders to develop a mobile alert app to help locate missing people with dementia.

Noelannah Neubauer, a postdoctoral fellow at the University of Waterloo’s School of Public Health Sciences, said “Community ASAP” is aimed at addressing a gap in available tools when it comes to alerts for missing older adults and people living with dementia in Canada.

"We have Amber Alerts for missing children, but nothing for this population other than police and civilians circulating information via social media such as Twitter and Facebook,” said Neubauer, who is the first author of a study that tested the efficacy and useability of Community ASAP.

The U.S. already uses a system called Silver Alert, and there have been efforts in some provinces, such as British Columbia, to create a citizen-led alert system. The issue with piggybacking onto the Amber Alert system is that too many people go missing every day, according to Neubauer. Almost 750,000 Canadians live with dementia, and 60 per cent of them wander at least once, and some repeatedly.

“The sheer number of missing people from this population would mean that alerts would go off multiple times a day in certain jurisdictions, running the risk of significant alert fatigue,” Neubauer said. “Community ASAP gets around this by having people sign up to receive the alert on Android and iOS operating systems and choosing the radius from where the missing person was last seen to their current location. Most missing cases take place one kilometre from the place they were last seen.”

"A key concern is that if someone gets lost and is not found within 24 hours, they have a 50 per cent chance of experiencing serious injury or death," said Lili Liu, principal investigator, and dean of the Faculty of Health at Waterloo. "We proposed recommendations for community alert systems specific to Canada, such as Community ASAP, at an online national forum on community alert systems for missing older adults last fall." 

For the study, researchers engaged people living with dementia, their care partners, police services, search and rescue organizations and health and social service providers in Ontario, Alberta and British Columbia to develop the alert system that engages community citizens, as volunteers, to look out for people with dementia reported missing. 

They went through three iterations of the app and consulted with these stakeholder groups along the way to test its accuracy and useability, walking through scenarios to simulate the events that transpire during a missing person event. In these scenarios, participants assumed the key roles in the Community ASAP system, including the missing person with dementia, care partner, coordinator, and volunteers. 

The idea for this app came from Ron Beleno, an entrepreneur with experience caring for his father, who lived with dementia. Beleno is turning Community ASAP into a start-up company, and Liu's research team continues to work with governments and organizations to coordinate a system that works across the country.

The study, "Mobile alert app to engage community volunteers to help locate missing persons with dementia," co-authored by Noelannah Neubauer, Christine Daum, Antonio Miguel-Cruz and Lili Liu, all affiliated with the University of Waterloo, was recently published in Plos One.

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