FDA Warns Against Infant Sleep Positioners Due to Suffocation Risk

Parents and caregivers of infants take note: the FDA has issued a safety warning against the use of infant sleep positioners due to the risk of infant suffocation and death.

Adorably decorated infant sleep positioners, also known as ‘nests’ or ‘anti-roll’ devices, are intended for infants up to 6 months old and are used to slightly elevate an infant’s head, or keep an infant in a fixed position between two cones, while sleeping. They are marketed to help reduce acid reflux symptoms, prevent SIDS (sudden infant death syndrome), or help with flat-head syndrome, but there is no medical evidence to support these product claims. In reality, infant sleep positioners sometimes become death traps if an infant rolls on his or her side or stomach, becomes trapped, and cannot breathe.

The ABC’s of Safe Infant Sleep

The American Academy of Pediatrics strongly recommends against the use of infant sleep positioners, instead reminding parents to follow the ABC’s of safe sleep: ‘Alone on the ‘Back’ in a bare ‘Crib.’

  • Always put baby to sleep on his or her back.
  • Always place baby in an empty crib on a firm mattress.
  • Never use infant sleep positioners.
  • Never put toys, pillows, loose bedding, comforters, quilts, or other items in a crib with a sleeping baby. Bedding is unnecessary as proper clothing can keep babies warm while sleeping.

For more information on safe infant sleeping, please follow the link to FDA Recommendations of Use of Baby Products.

Report Infant Sleep Positioner Problems to the FDA

And if you have experienced an incident or injury with an infant sleep positioner, it’s important that you report your experience to the FDA through its online MedWatch Safety Information and Adverse Event Reporting System at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home or call 1-800-FDA-1088. By reporting these incidents and injuries you can help the FDA keep dangerous drugs, medical devices and other items away from public consumption and use.