Baby Sleep Positioners Linked to 12 Deaths

November 27, 2012 — Health officials are warning that parents should not use sleep positioners to help their infant stay in a certain position while sleeping because the products are “dangerous and unnecessary.” Infant sleep positioners have been linked to 12 deaths in the last 13 years, according to a statement from the Consumer Products Safety Commission (CPSC).

Sleep positioners are foam mats or wedges with bolsters on either side. The manufacturers advertise them as a way to prevent Sudden Infant Death Syndrome (SIDS), acid reflux, colic, and a flat head syndrome called plagiocephaly caused by pressure on one part of an infant’s skull.

Unfortunately, according to Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner, “To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS.”

The FDA has also never cleared any positioners to reduce the risk of SIDS. Instead, the devices may actually increase an infant’s risk of death. The agency is asking manufacturers to stop making these claims until the devices receive proper clearance from the FDA.

The problem is that infants can or suffocate in the sleep positioner or between the positioner and their crib. Infants who roll onto the stomach may press their mouth and/or nose against the sides of the device, which could cause suffocation. Infants could also scoot in a way that flips the positioner on top of the baby, trapping them underneath. Even infants who are placed on their back could potentially move into a dangerous position and suffocate.

All of the incidents occurred in infants who were between 1 month and 4 months old, usually when the infant rolled from a side position to a stomach position.

According to 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 CPSC and the FDA are recommending that parents and child caregivers:

• Stop using sleep positioners because using a device to hold an infant on his or her back for sleep is both dangerous and unnecessary.
• Never put pillows, sleep positioners, comforters, or quilts under a baby or in a crib.
• Always put a baby on his or her back to sleep to reduce the risk of SIDS.

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