FDA Safety Warning: Stop Using Sleep Positioners

The Scoop

Think you're keeping your newborn safe through the night by using a sleep positioner? You're not, according to a stern report issued September 29, 2010, by the US Consumer Product Safety Commission (CPSC) and the Food and Drug Administration (FDA) that warns parents and caregivers to immediately stop using infant sleep positioners due to suffocation risk. Over the past 13 years, CPSC and the FDA have received 12 reports of infants between the ages of 1 month and 4 four months who died when they suffocated in sleep positioners or became trapped and suffocated between a sleep positioner and the side of a crib or bassinet.

"The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC," says CPSC Chairman Inez Tenenbaum in an advisory issued by the agency. "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 report notes that most of the infants suffocated after rolling from a side to stomach position. In addition to the reported deaths, CPSC 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 sleep positioners.

For Baby

According to the CPSC, the two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters. Both types of sleep positioners typically claim to help keep infants on their backs and reduce the risk of Sudden Infant Death Syndrome (SIDS). The FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS. In addition, CPSC and the FDA are unaware of any scientific studies demonstrating that infant positioners prevent SIDS or are proven to prevent suffocation or other life-threatening harm.

"To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS," says Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner and a pediatrician. "We want to make sure parents, healthcare professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners."

CPSC and the FDA are warning parents and childcare 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 naptime. To reduce the risk of SIDS, the American Academy of Pediatrics (AAP) recommends placing infants to sleep on their backs and not their sides.

Sleep positioners also typically claim to do one or all of the following: aid in food digestion to ease colic or the symptoms of gastroesophageal reflux disease (GERD); and prevent flat head syndrome (plagiocephaly). In light of the new safety data, FDA believes any benefit from using these devices to ease GERD or prevent plagiocephaly is outweighed by the risk of suffocation. The report also notes that the AAP does not support the use of any sleep positioner to prevent SIDS.