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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.
As the FDA writes in a safety communication to parents and pediatricians, no devices are approved to prevent or reduce the chances of sudden infant death syndrome (SIDS) or sudden unexplained death in childhood (SUID). If a device says it will do this, the FDA advises avoiding that product entirely.
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.
Baby monitors that promise to track your baby’s vital signs include sock-style wearables, sensors that clip to the baby’s diaper or clothes, sensors that go under a mattress, and ones that are built into camera systems.
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 fail to measure the vital signs accurately
If they miss serious problems, making caregivers think everything is fine when it’s not
If they indicate a problem when there is none, leading to unnecessary medical care
Burns or rashes from the device itself
How to find approved devices
If your baby needs an accurate medical device, the best place to start is asking their pediatrician to point you to something appropriate. But if you want to use an over-the-counter device for peace of mind, there are two databases you can check to see if the device is FDA-cleared.
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 other is the 510(k) premarket notification lookup, which you can find here. This is for devices that are “substantially equivalent” to an already-approved device. Put in the company’s name under Applicant name.
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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