WASHINGTON — Those soft fabric sleep positioners that parents put in a crib to keep babies safely sleeping on their backs could be dangerous, even deadly, for little ones, the federal government warned Wednesday.
Citing 12 deaths, the Food and Drug Administration and the Consumer Product Safety Commission said the positioners are not safe and that parents, caregivers and others should not use them at all because of a suffocation risk.
The babies, ranging in age from one to four months, died when they suffocated in the positioner or after becoming trapped between the positioner and the side of a crib. The deaths spanned the last 13 years.
Most of the babies suffocated after rolling from a side to stomach position, the agencies said in their joint announcement.
“In most instances, these products provide no real benefit, and the risk of harm when they are used is significantly greater,” FDA deputy commissioner Joshua Sharfstein cautioned during a teleconference with reporters.
The positioners usually are made of a soft cloth mat with a cushion on each side to hug or cradle infants on their backs. The American Academy of Pediatrics has long urged parents not to use positioners, saying there’s no evidence they help keep a baby in place or that they reduce the risk of sudden infant death syndrome.
