Why the FDA Is Warning Against the Use of Some Wearable Child Monitoring Devices
Unfortunately, it’s quite common for new parents to feel paranoid about their baby’s breathing when putting them to bed. Gadgets promise peace of mind—for example, heart rate or movement monitors that attach to your baby or crib. However, the U.S. Food and Drug Administration (FDA) warns against using most of them.
As stated in the FDA’s informational notice for parents and pediatricians, no device is approved to prevent or reduce the risk of sudden infant death syndrome (SIDS) or sudden unexplained infant death syndrome (SUDD). If a device claims to have such an effect, the FDA recommends discontinuing its use entirely.
As for devices that claim to simply measure heart rate or blood oxygen levels, there are several approved products on the market, including Owlet’s Dream Sock, but many of them aren’t FDA-approved at all. The FDA doesn’t disclose names, but when I searched for “wearable baby monitor” on Amazon and Google Shopping, most of the brands that appeared in the search results weren’t in the FDA database. The unapproved devices I saw often cost between $100 and $150, while the most popular FDA-approved device, the Owlet Dream Sock , was significantly more expensive at $239.99.
What are these monitors and why can they be dangerous?
Baby monitors that promise to track your baby’s vital signs include wearable devices that come in the form of socks, sensors that attach to your baby’s diaper or clothing, sensors that fit under the mattress, and sensors that are built into camera systems.
These monitors may claim to track heart rate, blood oxygen levels, respiratory rate, and other metrics, and alert caregivers to any problems. However, the FDA claims they can cause harm in the following ways:
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If they cannot accurately measure vital signs
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If they miss serious problems, leading caregivers to think everything is fine when it is not
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If they indicate a problem when there is none, leading to unnecessary medical care
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Burns or rashes from the device itself
How to find approved devices
If your child requires a precision medical device, it’s best to start by contacting your pediatrician for a recommendation. However, if you prefer an over-the-counter device for your own peace of mind, there are two databases you can use to check whether it’s approved by the U.S. Food and Drug Administration (FDA).
The first is a de novo device search. It’s designed for devices whose manufacturer has applied for designation as a new type of medical device. These devices are called 513(f)(2) devices. Follow this link and enter the company name in the “Applicant Name” field. If the product is in the database and its classification code is QYU , it has been evaluated and authorized by the FDA. For example, here’s an entry for the Owlet Dream Sock with the code QYU.
Another option is to search for Form 510(k) for prior notification, which can be found here . This search is for devices that are “substantially equivalent” to an already approved device. Enter the company name in the “Applicant Name” field.
The FDA adds that if you experience any problems with the device, including inaccurate measurements or anything that results in injury, you can report it to MedWatch here .