Experts Raise Concerns Over Accuracy, Safety Of Wearable Baby Monitors

PITTSBURGH (CBS) – “Smart clothes,” which track an infant’s vital signs and send real-time updates to a parent’s smartphone, are increasingly popular.

First-time mom, Kimberly Scarth says she was drawn to one such product because she wanted peace of mind.

“Especially having had a rough delivery, we wanted to make sure everything was okay with him,” she says.

Just two weeks after bringing little Elliott home, Scarth woke up in a panic.

Her Owlet smart monitor was flashing a red alert, warning Elliott’s oxygen level was falling dangerously low. Scarth says the gadget warned her to get to an Emergency Room immediately.

She considered it, but says her son seemed fine.

“[He was] smiling, kicking around, cooing,” she said.

Thinking it was a false alarm, Scarth says she followed instructions to reboot the product, but the red alerts continued into the night.

“We were already not getting enough sleep as it is, being first-time parents,” said Scarth.

Just in case, they scheduled a checkup with their pediatrician. Turns out, Elliott was fine.

High-tech baby monitors like the Owlet Smart Sock, were the subject of a recent editorial in the influential Journal of the American Medical Association.

The authors expressed concerns over a lack of “publicly available evidence” to support the products’ accuracy, safety and effectiveness. They warned that instead of reassuring parents, inevitable false alarms could lead to anxiety, and result in unnecessary emergency room visits and tests for babies.

On its YouTube channel, Owlet Baby Care shares a number of testimonials from parents who swear by the product.

“I don’t know what would have happened if I didn’t have the Owlet,” one mother says in a video.

The company says 80,000 families use its product and that it is confident in the positive results those families are experiencing.

Right now, the “smart clothes” are not regulated by the Food and Drug Administration. They don’t make any specific medical claims. Though Scarth says the threat of SIDS weighed into her decision to invest in the $250 product.

“It hasn’t been shown to prevent SIDS. Parents who use it in that way are being falsely reassured. That may lead them to do things that puts [babies] in an unsafe sleep environment,” said Dr. Justin Smith, a pediatrician.

On its website, Owlet warns that the device is not intended to treat, prevent or cure any disease or condition, including SIDS. It also warns the “Smart Sock” is not a medical device, though now the company is seeking FDA approval for a medical device.

When asked what the medical device would aim to treat, the company explained it was too soon to say definitively.

“We don’t want to speculate at this time. Our application is under review.”

Dr. Smith shared his concerns with relying on direct-to-consumer baby respiratory monitors.

“My advice, think about what it means for you. If you think it might cause more anxiety, if there’s any chance for that, you should really consider whether it’s a good idea,” Dr. Smith said.

The Scarths broke up with their monitor and got a full refund.

“It didn’t give us an ease or peace of mind,” Scarth says.

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