This week the FDA and the Consumer Product Safety Commission jointly urged to parents to stop using infant sleep positioners until further notice. The positioners are pads with bolsters and are designed to prop babies in position in a crib. According to the report, the positioners may pose a suffocation risk to babies if they rollover onto their stomachs.
Over the last 13 years, 12 infant deaths are said to have occurred after use of the product, which prompted the agencies to make the announcement. In most of these cases, the babies had rolled from their backs or sides onto their stomachs.
The FDA plans to review the safety of the products and determine whether the benefits outweigh the risks. Sleep positioners are often advertised to prevent sudden infant death syndrome (SIDS), gastroesophagael reflux disease (GERD), and flat head syndrome, by keeping the baby in the desired position. The American Academy of Pediatrics urges parents to place babies on their backs to sleep (not stomachs or sides, as was the case years ago), to reduce the risk of SIDS.
Though the FDA has approved some products to prevent GERD or flat head syndrome, they are now requiring that the manufacturers of these products prove that the benefits outweigh the risks. The agency has asked the manufactures of both FDA-approved and non-approved items to stop marketing them while the review is being done.
According to the FDA announcement, parents should:
What’s the safest way for baby to sleep without a sleep positioner? According to FDA pediatric expert Susan Cummins, "The safest crib is a bare crib. Always put your baby on his or her back to sleep. An easy way to remember this is to follow the ABC’s of safe sleep-Alone on the Back in a bare Crib."
