Stop Using Infant Sleep Positioners According to the FDA

A joint announcement by the Food and Drug Administration (FDA) and Consumer Product Safety Commission (CPSC) concerning baby sleep positioners advises parents and caregivers to immediately stop using the products.

Despite claims that the baby sleep positioners protect infants from Sudden Infant Death Syndrome (SIDS), the use of the positioners themselves have led to the death of a dozen children between the ages of 1 to 4 months from suffocation since 1997. Most of the infants suffocated when they rolled from their backs or sides to sleeping on their stomachs. Most manufacturers recommend discontinuing use once the child begins to move in their sleep, but the timing of the first movement of a child during sleep is impossible to predict.

“The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC,” said CPSC Chairman Inez Tenenbaum. “We urge parents and caregivers to take our warning seriously and stop using these sleep positioners, so that children can have a safer sleep.”

The FDA has never approved the products as safe for use with infants in the United States and has never endorsed the claims that the use of the positioners prevents SIDS. The FDA has contacted every manufacturer of the sleep positioners and asked them to stop selling their products. The American Academy of Pediatrics does not support the use of any sleep positioner to prevent SIDS.

As part of the announcement, the CPSC and the FDA are warning parents and child care providers to:

• STOP using sleep positioners. Using a positioner to hold an infant on his or her back or side for sleep is dangerous and unnecessary.
• 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 nap time. To reduce the risk of SIDS, the American Academy of Pediatrics recommends placing infants to sleep on their backs and not their sides.