Sleep positioners, touted for helping infants sleep safely, are, in fact, dangerous and should not be used, U.S. regulators say.
The U.S. Consumer Product Safety Commission and the Food and Drug Administration jointly announced Wednesday that they've received 12 reports in the past 13 years about the devices.
The reports concerned infants between the ages of one month and four months who suffocated to death in sleep positioners or became trapped and suffocated between a sleep positioner and the side of a crib or bassinet.
Most of the infants suffocated after rolling from a side to a stomach position.
The CPSC has also 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 sleep positioners.
"In most instances, these products provide no real benefit, and the risk of harm when they are used is significantly greater," cautioned FDA principal deputy commissioner Joshua Sharfstein during a teleconference with reporters.
Sleep positioners are often made of a mat with a cushion on each side to cradle the baby.
The products are marketed for babies six months and younger and typically claim to help keep infants on their backs to reduce the risk of Sudden Infant Death Syndrome, or SIDS.
The FDA said it has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS.
The two groups jointly warned parents and caregivers to:
- Stop using sleep positioners.
- Never put pillows, infant sleep positioners, comforters, or quilts under a baby or in a crib.
- Always place an infant on his or her back at night and during naps.
Health Canada gives the same advice.