As a new parent, it’s unfortunately pretty normal to be paranoid about whether your baby is breathing when you put them down for a nap. Gadgets promise peace of mind—like heart rate or movement sensors that attach to your baby or their crib. But the FDA is warning against most of them.
When it comes to devices that just claim to give you metrics like heart rate or blood oxygen, there are a few approved products on the market, including the Dream Sock by Owlet, but many of the devices in this category aren’t FDA-cleared at all. The FDA doesn’t name names, but when I searched for “wearable baby monitor” on Amazon and on Google Shopping, most of the brands that popped up are ones that aren’t in the FDA’s database. The unapproved ones I saw were often in the $100-150 price range, while the most popular FDA-cleared device, the Owlet Dream Sock, was significantly more, at $239.99.
These monitors may say they can track heart rate, blood oxygen levels, and respiratory rate, among other metrics, and notify caregivers if something is wrong. However, the FDA says that they can cause harm in these ways:
If they miss serious problems, making caregivers think everything is fine when it’s not
Burns or rashes from the device itself
How to find approved devices
The first is the de novo device lookup. This is for devices where the manufacturer has applied for recognition as a new type of medical device. These are known as 513(f)(2) devices. Go to this link and type the company’s name in the blank marked Requester name. If the product is in the database and the classification product code is QYU, it’s been evaluated and authorized by the FDA. For example, here is the entry for the Owlet Dream Sock, with a QYU code.
The FDA adds that if you have a problem with a device, including inaccurate measurements or anything that resulted in an injury, to report it to MedWatch here.
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