Children’s Wearables Selling “peace of Mind” Are Just Bad Medical Devices

Earlier this month, we saw a bunch of new smart gadgets for kids debut at the Consumer Electronics Show . While some may prove useful – I’d kill for a breast pump like Willow – others are more likely to drain parents’ wallets without providing anything of value.

For more dubious gadgets include the monitor cuts Bloomlife , bracelet for tracking fertility Ava and a whole class of products (already on the market), which promise to notify you if your child is sleeping stops breathing. These are all areas in which parents would like information, in which they can act, so that I can fully understand them. But if gadgets are really useful, why do you hear about them from TV shows and not from your doctor? It turns out there is a reason for this.

Some devices are sold to consumers because they have been rejected by healthcare professionals

If new sportswear hits the market as the first in its category, no one can accuse you of thinking that it will be the first to do what it promises. But some of these new wearable health devices are actually known as medical devices, and that’s not always promising.

Get the $ 149 Uterine Activity Monitor from Bloomlife . This is a new product, but the idea of ​​measuring and tracking contractions of a pregnant woman is not new. A 1998 study of home labor monitors found that they did not help detect early labor or predict labor. The American Congress of Obstetricians and Gynecologists (ACOG) states that it is unethical to recommend these monitors to prevent premature birth because there is no evidence that they help, and further states that they expose a pregnant woman to “unnecessary financial and personal costs.”

With a reduction monitor on the free market, anyone can decide that they need one, whether or not they are recommended. I could think of one for my third pregnancy, since I barely made it to the maternity hospital in time for my second. Then I tried to time the contractions using the free phone app, but in the fog of pain, I kept forgetting to press the start or stop button. This meant that I was not entirely sure if my contractions were on the textbook with a difference of five minutes. But instead of ordering the device, I could ask my husband to help me calculate their time – or I just realized that if I’m too distraught not to forget to press the button, I’m probably giving birth .

Without a clear scenario for using the product, it seems that we are getting a rejection from the medical industry. Selling “peace of mind” really means cash in on insecurity. This implies: without this device, you should be worried. But researchers who actually studied the topic came to the opposite conclusion.

Just because you can control something does not mean that you can do something about it.

You know a wearable device is useful if you can act on the information it collects. If your Fitbit says you haven’t taken many steps today, you can take a walk after lunch. But if a device collects information that you can’t really use, and isn’t even useful to view or verify once it’s collected, what’s the point?

Baby breathing monitors such as the Owlet smart sock ($ 250) and the button-sized Monbaby baby monitor ($ 150) fall into this category. They reach out to new and future parents who fear Sudden Infant Death Syndrome (SIDS) and who, even without gadgets, are likely to crawl into their child’s bedroom to make sure the child is still breathing . This is a great scenario from a marketer’s point of view. They provide people with the data they need, and people will pay a lot if they think their child’s safety is at stake .

The manufacturers of these devices do not claim to be life-saving. Instead, they sell the idea of ​​”peace of mind”. But there is no guarantee that silence means your child is okay, and checking the app can raise your anxiety level any more. A 1988 survey published in the Annals of the New York Academy of Sciences found just that. Although the technology has changed since then – for example, there are no more awkward wires – the benefits of the device have remained the same.

To this day, the American Academy of Pediatrics (AAP) does not recommend breathing monitors for healthy babies . Respiratory arrest detection will not help you detect or predict SIDS, the organization notes in the report that contains these recommendations. Monitoring may make sense for some high-risk children, but consumer gadgets are not suitable for the job . Instead, your doctor will help you get a validated medical device.

Meanwhile, the manufacturers of these consumer devices seem to be completely unprepared for their alarms to go off other than false positives. None of their websites has anything to say about what parents should do if their alarm goes off, not even an indirect statement about calling emergency services. The council invites you to check the size of the sock , nothing more.

All of this means that these devices are collecting data and engaging in emotional real estate without any evidence that they can actually allay the fear that drove you to shell out for them.

Even FDA Approved Devices Are Not Always Trustworthy

When I first read about the Ava Fertility Tracking Bracelet ($ 199), I thought I wasn’t going to discuss it in this article. Despite the fact that his statements looked sketchy, the manufacturer claims that Ava is FDA approved.

However, it turns out that FDA approval does not mean that the device has been tested and found to be effective. The FDA divides medical devices into three classes and only requires pre-market approval for class 3 devices. These are things like pacemakers, where people could be in danger if the device breaks down or doesn’t actually do what it should.

In contrast, the Ava bracelet is in the lowest risk category, Class 1, along with dental floss and examination gloves. The FDA hasn’t ruled that Ava can actually tell you which days you’re likely to get pregnant, it just isn’t likely to hurt anyone.

If you want confidence that a device does what it says, good luck finding it. The manufacturers say they have conducted a clinical trial but have not yet published it. Researchers presented it as a poster at the 2016 American Society for Reproductive Medicine (ASRM) meeting. This summary says the researchers followed 41 women for an average of four cycles each, monitoring their heart rate and temperature. They concluded that the bracelet can define certain dimensions that change with the state of a woman’s cycle. But the work is not yet complete: other factors besides the cycle (such as alcohol) can affect the temperature, so the bracelet is not yet trustworthy.

So it’s promising, but hasn’t proven to be as effective as the company’s marketing suggests. A fertility meter won’t endanger your life or health if it’s wrong, but it can disappoint you if it makes you miss your baby’s best birthdays.

If you decide to use a device that has not been tested or that doctors do not recommend, that is your right. Just don’t buy into the hype that encourages you to spend money and emotional effort in pursuit of “peace of mind.”

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