FDA: Infant Sleep 'positioners' Unsafe

WASHINGTON, Sept. 29 (UPI) — Devices used to keep babies on their backs and intended to protect them from sudden death syndrome are a suffocation hazard, U.S. health officials say.

The so-called infant sleep positioners have led to the deaths of 12 children in the past 13 years and should no longer be used, the U.S. Food and Drug Administration said.


Most of the infants suffocated after rolling from a side position onto their stomachs, and the government has received dozens of reports of infants who were placed on their backs or sides in sleep positioners only to be found later in potentially hazardous positions within or next to the devices, The New York Times reported.

The sleep positioners are flat or inclined mats with side bolsters.

Both types claim to help keep infants on their backs and reduce the risk of sudden infant death syndrome, or SIDS, but the FDA has never approved these products as safe, the Times reported.

There have been no scientific studies demonstrating that infant positioners prevented death or were proven to prevent suffocation or other life-threatening harm, the FDA said.

“To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS,” Dr. Joshua Sharfstein, the FDA’s principal deputy commissioner, said.

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