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EMF Studies

18 February 2017

The Emerging Market of Smartphone-Integrated Infant Physiologic Monitors

Example of a "smart" onesie.  Choice of image
by Editor, "Towards Better Health"
"Despite the lack of publicly available evidence supporting the safety, accuracy, effectiveness, or role of these monitors in the care of well infants, sales of these products are brisk and the market is expanding....  There are no medical indications for monitoring healthy infants at home ....The makers of consumer infant physiologic monitors have avoided US Food and Drug Administration (FDA) medical device regulation by not making claims that the devices prevent SIDS."

The Emerging Market of Smartphone-Integrated Infant Physiologic Monitors

Viewpoint
JAMA, January 24/31, 2017

Christopher P. Bonafide, David T. Jamison, Elizabeth E. Foglia. The Emerging Market of Smartphone-Integrated Infant Physiologic Monitors. JAMA. 2017;317(4):353-354. doi:10.1001/jama.2016.19137

No Abstract

Excerpts

In the past 2 years, a new class of infant physiologic monitors marketed to parents for use in the home has emerged. Smartphone applications (apps) integrated with sensors built into socks, onesies, buttons, leg bands, and diaper clips have the capability to display infants’ respirations, pulse rate, and blood oxygen saturation, and to generate alarms for apnea, tachycardia, bradycardia, and desaturation (Table). Despite the lack of publicly available evidence supporting the safety, accuracy, effectiveness, or role of these monitors in the care of well infants, sales of these products are brisk and the market is expanding....

There are no medical indications for monitoring healthy infants at home ....



The makers of consumer infant physiologic monitors have avoided US Food and Drug Administration (FDA) medical device regulation by not making claims that the devices prevent SIDS.

There are a few potential paths to establishing the safety, accuracy, and effectiveness of consumer infant monitors ...

Even if consumer monitors were highly accurate, the clinical appropriateness of monitoring healthy infants would remain in question ... these monitors could increase the risk of overdiagnosis and potential harm if these innocuous events generate alarms.

The current market of smartphone apps integrated with sensors that monitor infants’ vital signs are innovative and have potential to improve care. However, their performance characteristics are unknown to the public and there are no medical indications for their use. Until these monitors have been thoroughly evaluated and guidelines for use have been established, the recommendations physicians should give to parents who ask about these products is simple. There is no evidence that consumer infant physiologic monitors are life-saving, and there is potential for harm if parents choose to use them. Child and family advocates should make it clear to the FDA and policy makers that regulatory guidance and research evaluating the safety, accuracy, and effectiveness of these products are needed.

http://bit.ly/2jn4B04

Thank you to Dr. Moskowitz for this information:

Joel M. Moskowitz, Ph.D., Director
Center for Family and Community Health
School of Public Health
University of California, Berkeley

Electromagnetic Radiation Safety
Website: http://www.saferemr.com

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