mardi 24 janvier 2017

Pricey Wearable Baby Monitors May Be Better At Giving Parents Anxiety Than Monitoring Babies

Raising a baby can be pretty nerve-wracking, especially for first-time parents. Babies make weird sounds, do bizarre things, and can’t describe when something’s actually wrong. Meanwhile, it’s 2017 and our solution to basically every old problem is: “Have you tried throwing new technology at it?”

And so we have a whole industry of “smart,” connected, smartphone-app-using baby monitors that can tell you junior’s every heartbeat and breath… but expert scientists say these devices are effectively useless, and may cause parents to panic more than they should.

That’s the upshot of a review published in the Journal of American Medical Association today. At the very least, the authors found, there’s no scientific evidence that the devices do anything useful, and they may even do some tangible harm by making parents freak out without cause.

The devices the authors specifically call out are smartphone-linked wearables, like smart socks, onesies, diaper clips, and more. They measure babies’ biometrics — respiration, pulse rate, blood oxygen, and the like — and send those measurements to parents’ apps.

Specifically, the authors cite the Baby Vida, MonBaby, Owlet, Snuza Pico, and Sprouting wearables, which cost anywhere from $150 to $300 each.

The idea is that if you’re in the next room over while your baby is napping, you can simply look at your phone for reassurance that your baby is still breathing without you staring at them.

The devices are not regulated by the FDA, researchers point out, and in order to stay that way (and presumably, also avoid problems with the Federal Trade Commission) they don’t make specific claims about their ability to prevent sudden infant death or distress.

Owlet, for example, says, “We can’t promise to prevent SIDS right now, it’s an unknown issue but… we believe notifying parents when something’s wrong maybe can help.”

That’s similar to Baby Vida, which states in its marketing, “What sound does your baby make if he or she stops breathing?”

New parents, often sleep-deprived and navigating a haze of contradictory advice from well-intentioned sources, are particularly susceptible to doing everything they can “just in case.”

“These devices are marketed aggressively to parents of healthy babies, promising peace of mind about their child’s cardiorespiratory health,” pediatrician Dr. Christopher P. Bonafide, with the Children’s Hospital of Philadelphia, said. “But there is no evidence that these consumer infant physiological monitors are life-saving or even accurate, and these products may cause unnecessary fear, uncertainty and self-doubt in parents.”

For starters, the authors note that nobody actually knows if the apps even work properly. Wearable sensor tech may not be entirely accurate for adults, let alone kids.

One blood pressure app, the authors write, inaccurately told nearly 80% of participants with hypertension that their blood pressure was in the normal range.

So what can be done? Well first, the FDA could step in and categorize these wearable, app-using sensors as medical devices, the authors suggest. That would mean they have to hit certain thresholds for accuracy and function or else face regulators’ wrath.

Barring that, the authors suggest, scientists should get to work and start testing the heck out of these devices. Results should be published “either independently or in partnership with patient safety organizations or the device companies,” the authors suggest.

Either way, the safety, effectiveness, and accuracy of wearables needs to be measured and shared so parents can make informed decisions.

Okay, you may be thinking, so it doesn’t help — but does it actually hurt anyone to clip a sensor on your kid that measures pulse and respiration?

The authors suggest that it does: “By continuously monitoring healthy infants, parents will inevitably experience some alarms for conditions that are not life-threatening.”

Parents, being deeply concerned about their offspring and usually not trained medical professionals, may overreact to both false-positive readings and “true-positive alarms for events that are not clinically important,” the authors note.

Real babies are variable and their stats might occasionally, and totally normally, drop below “ideal” stats. You don’t know that your sleeping child’s oxygen desaturation is under 80% for a few minutes if you’re just watching them, for example, but if there’s a monitor on their ankle, your phone will go off like gangbusters, and you’re likely to worry.

That can lead to over-diagnosis, the authors note, which is one color in the rainbow of potential problems.

For example, say a phone monitor goes off, signaling low pulse oximetry. While that’s resolved on its own a few minutes later, worried parents have whisked their kid to an ER, where the confused baby undergoes a whole battery of tests… just to end up with results showing that the tests are coming back fine or that results are inconclusive. In the end, everyone’s spent a bunch of money just to come home without answers, and still worried that their kid’s life is at risk.

The authors conclude that for now, nobody should be recommending infant wearable devices to parents of healthy kids.

“Their performance characteristics are unknown to the public and there are no medical indications for their use,” the authors conclude. “There is no evidence that consumer infant physiologic monitors are life-saving, and there is potential for harm if parents choose to use them.”

For now, “child and family advocates should make it clear to the FDA and policy makers that regulatory guidance and research” on high-tech baby monitors is needed, to make sure that they actually do what they say — and that what they claim to do is actually beneficial.



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