These products claim to help infants to sleep on their backs, reducing the risk of Sudden Infant Death Syndrome (SIDS).
But over the past 13 years, the FDA and the CPSC received 12 reports of the deaths of infants between the ages of one month and four months when they suffocated after becoming trapped within the bolsters of the sleep positioner or between the sleep positioner and the side of a crib or bassinette.
In addition to the reported deaths, the 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.
There is no evidence that the devices prevent SIDS, says the FDA. The American Academy of Pediatrics does not support the use of any sleep positioner to prevent SIDS. Read AAP recommendations on SIDS prevention.
Other claims made by makers of the devices include that they aid in food digestion, ease colic or the symptoms of gastroesophageal reflux disease (GERD); or prevent flat head syndrome (plagiocephaly).
But the risk of suffocation outweighs any reason to use a sleep positioner, says the FDA.
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.