The Best Safety Product for Baby Heart Rate
'More Anxiety Than Relief': Baby Monitors That Track Vital Signs Are Raising Questions
After a popular app stopped receiving medical data, some families wondered how reliable monitoring is.
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This story was originally published on Sept. 12, 2019 on NYT Parenting.
It's a question almost all new parents have asked themselves while peering into their child's crib or bassinet: Is my baby breathing?
Worried by the rare but frightening possibility of sudden, unexpected infant death, some families are using electronic devices that allow them to not only watch their babies' movements and listen for signs of distress, but to track health data like their pulse and the oxygen levels in their blood.
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On the surface, such devices may seem like a godsend for bleary-eyed parents: It's impossible to watch a baby continuously for 24 hours, so why not use technology like cameras and motion sensors to ease worried minds? But experts say that these devices — particularly ones that collect medical data — aren't always reliable and can end up making new parents even more anxious.
Case in point: the widespread spiral of frustration that ensued last weekend after the Owlet Smart Sock — a popular product that wraps around a baby's foot to record sleep patterns, oxygen levels and heart rate — stopped communicating with the Owlet phone app.
The Smart Sock uses light to measure a baby's pulse rate and blood oxygen levels. It sends data via Bluetooth to the product's base station, a small device that must be within 100 feet of the sock. If the baby's vitals are normal and the device is working properly, the base glows green. If something goes wrong — if the sock is poorly positioned, for example, or if a baby's blood oxygen dips to an abnormal level — the base station will emit sounds and colored lights that signify what the problem is. At the same time, these live vital sign readings and alerts are sent via Wi-Fi to parents' phones through the Owlet smartphone app.
Owlet said that the disruption, which began last Thursday, stemmed from a bug in a new release of its app that caused its servers to crash. When the servers went down, parents were no longer able to see their child's heart rate or oxygen levels on the company's app, Kurt Workman, Owlet's chief executive officer, said in a video statement that was uploaded to Facebook on Saturday.
"I just want to take a moment to apologize to each and every one of you for this tremendous inconvenience that we've caused," said Mr. Workman, a father of three who said he uses the Smart Sock to monitor his 9-month-old.
On Sunday, Owlet said it had fixed the problem, but by then hundreds of parents had shared their frustrations on social media. Nearly 900 comments flooded the company's Facebook page. (On Wednesday, the comments appeared to have been removed and were no longer visible.)
"Hi, we have loved your product for about 5 months. However the last month has been extremely tough," one father wrote, adding that the product has triggered alarms multiple times "for no reason" and has caused "more anxiety than relief."
Others voiced their complaints on Twitter.
Courtney Bartlett, 25, of Harrisville, W. Va., asked for better communication from the company. "Maybe email users in the future if you can't have a notice in the app?" she wrote.
"We put our child to bed at 8 o'clock and trusted the app to monitor him all night," Jordan Young, 33, the father of a 7-month-old who lives in Nashville, said in an interview on Monday. "And at some point in the middle of the night, the app lost connection to the base station. I was never any wiser until well into the next day."
The Smart Sock seemed like a good investment to ensure his son's safety while he slept. But Mr. Young began questioning why his family was using a device with an app that could create what he called "a false sense of trust." If the app on your phone isn't working, the base station will still light up and make sounds if something goes wrong, he said, but that's only useful if you're sleeping near it.
Doctors have also become skeptical of the accuracy and reliability of health-tracking monitors like the Owlet Smart Sock, which debuted in 2015 and retails for $299. When purchased with the Owlet camera, the bundle costs $399.
A 2018 study published in the Journal of the American Medical Association, for instance, found that the Owlet Smart Sock 2 (the device currently on the market) and a similar device made by Baby Vida, which is currently unavailable, displayed certain inaccuracies when tested on 30 infants who were hospitalized at the Children's Hospital of Philadelphia. The researchers compared results from the two products with a Food and Drug Administration-cleared device that measures oxygen levels in the blood.
While the Owlet device correctly detected abnormally low oxygen levels in the blood, it didn't perform consistently, according to the study, and in several instances it falsely displayed problematic pulse rates when the reference monitor showed normal pulse rates. The Baby Vida, on the other hand, falsely displayed low pulse rates and never detected instances where oxygen levels became abnormally low.
Dr. Christopher P. Bonafide, a pediatrician at Children's Hospital of Philadelphia who co-authored the study, said on Tuesday that the various problems consumers encounter with these products speak to "the fragile state of unregulated consumer health tech."
Because these are consumer devices, neither went through the rigorous F.D.A. approval process that is required of hospital-grade medical devices, Dr. Bonafide said, and as a result, their "accuracy and reliability have not been scrutinized to the same degree."
The Owlet might seem like a medical device, but — as the manufacturer clearly states on its website — it is "not as stringent as a medical monitor" and "only intended to assist you in tracking your baby's well-being."
Medical devices used in hospitals are quite different, in part because they're routinely checked to make sure that they're working properly, said Dr. Elizabeth Murray, a pediatric emergency medicine physician at the University of Rochester Medical Center, who said she often sees children whose parents have received a false-positive alarm from a monitoring device.
"I do frequently see parents coming into the emergency department with a wonderful, healthy, beautiful baby — but the alarm has triggered, and so they're terrified that something awful might have happened to their child," Dr. Murray said, adding that she worries about the "additional angst and stress" these devices can sometimes cause.
A sound monitor or even a video monitor is "totally appropriate and fine," she said, but "the chances of error are very, very great" when monitoring heart rate and oxygen saturation. "I think that your money is better spent elsewhere."
Continuously monitoring healthy infants can lead to overdiagnosis, according to an editorial co-authored by Dr. Bonafide that appeared in JAMA in 2017. Studies have shown that healthy infants can experience oxygen levels that occasionally dip below 80 percent and are not a cause for alarm, the authors said.
To ensure that your baby is safe, the American Academy of Pediatrics recommends that parents sleep in the same room as their infants for at least the first six months or, ideally, the first year of the baby's life. In addition, babies should be placed to sleep on their backs in a crib with a firm sleeping surface with nothing other than a tightfitting, thin sheet, to help prevent sleep-related death.
While the rate of sudden, unexpected infant deaths has declined since the emergence of public health campaigns encouraging safe sleep habits, there are still approximately 3,500 babies in the United States who die suddenly and unexpectedly each year from accidental suffocation, Sudden Infant Death Syndrome or unknown causes, according to the Centers for Disease Control and Prevention.
The academy's policy statement on safe sleep says there is no data indicating that SIDS can be prevented by using at-home monitors that track heart rate and blood oxygen levels.
Even so, companies that promise to ease parents' minds are profiting.
The global baby monitors market size is projected to reach $1.63 billion by 2025, according to a 2017 report from Hexa Research, a market research and consulting firm. The North American region accounted for almost half of global sales in 2016, the report said.
In 2017, Owlet earned $25 million in revenue, according to the business magazine Inc. When asked about the company's 2018 earnings and the number of socks sold, Mr. Workman declined to comment.
A class-action lawsuit filed in April accused Owlet of using false and deceptive marketing practices, claiming that its Smart Sock regularly gives false alarms and fails to detect abnormal heart rates or oxygen levels.
Mr. Workman said in a statement that the company disputes the allegations.
"Owlet is transparent in how its products work and looks forward to being vindicated in court," the statement said.
Despite any technical difficulties, a working Owlet still provides reassurance to Ms. Bartlett.
She plans to keep using the Smart Sock on her 2-month-old son, even though she said that the monitor has trouble connecting to her phone and once sounded a false alarm in the middle of the night, indicating the sock was positioned incorrectly.
"For me, I just like the peace of mind of being able to check on my phone and see, yeah, he's O.K.," she said. "I just know that it's not going to work as much as it should for the price."
Mr. Young, the father of the 7-month-old, agreed.
"I would buy it again, I think," he said. "But I don't know that I would put as much trust into it as I have."
In the end, he added, "nothing can replace good parenting, you've just got to find some things to help you."
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The Best Safety Product for Baby Heart Rate
Source: https://www.nytimes.com/2020/04/17/parenting/owlet-baby-monitor.html
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