In the wake of several deaths that have been reported over the past 13 years, the FDA, the Consumer Product Safety Commission (CSPC), and the American Academy of Pediatrics (AAP) are urging parents to stop using infant sleep positioners.
According to the CPSC, 12 infants between the ages of one and four months died when they suffocated in sleep positioners or became trapped and suffocated between a sleep positioner and the side of a crib or bassinet.
“Sleep positioners do not prevent SIDS and in fact can increase the risk of babies suffocating. These deaths are tragic and avoidable,” said AAP President Judith S. Palfrey, MD, in a statement
. Infants should be placed on their backs to sleep, which reduces the risk of Sudden Infant Death Syndrome (SIDS) by more than 50%. “Sleep positioners do not prevent SIDS and in fact can increase the risk of babies suffocating. These deaths are tragic and avoidable. “
According to the CPSC, most of the deaths resulted from 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.
“The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC,” said CPSC Chairman Inez Tenenbaum in a statement
. “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 two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters. Although both types typically claim to help keep infants on their backs and reduce the risk of 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,” said Joshua Sharfstein, MD, FDA Principal Deputy Commissioner and a pediatrician. “We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners.”
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 CPSC, FDA, and AAP also warn that parents should never put pillows, stuffed animals, comforters, or quilts under a baby or in a crib. “Soft bedding can end up over their face and block their breathing,” said Palfrey. “Babies should have their own crib, with a firm mattress and a fitted sheet.”