Infant sleep positioners (ISPs) promise to reduce risk for sudden infant death, prevent “flat heads” in babies who would otherwise sleep on their backs, and “keep baby safer and cooler.” But a new Centers for Disease Control and Prevention report says these devices contribute to the top cause of injury-related deaths in babies: Suffocation.
“Some specific ISPs have been cleared by the Food and Drug Administration (FDA) for the management of gastroesophageal reflux or plagiocephaly (asymmetry of the skull),” the report says. Those are available by prescription. “However, many unapproved ISPs have been marketed to the general public with claims of preventing Sudden Infant Death Syndrome (SIDS), improving health, and enhancing sleep comfort.”
Thirteen babies died due to suffocation with the use of sleep positioners between 1997 and 2011. They ranged in age from 21 days to four months old. Eight were boys; 14 had been born prematurely. Three were one of a pair of twins. Most had been placed on their sides to sleep -- rather than on their backs, as recommended by pediatricians’ groups. But the babies couldn’t breathe when their mouth and nose was trapped against one of the positioner’s foam-and-cloth bolsters.
The CDC’s advice to parents? Only use a positioner prescribed by your child’s doctor. “Despite other manufacturers’ claims regarding SIDS prevention or other health benefits, the FDA has never cleared or approved an ISP for preventing or reducing the risk for SIDS. Cleared ISPs should only be used by prescription for treatment of specific medical conditions.”
After a similar warning was issued by the FDA and the Consumer Product Safety Commission in 2010, the FDA contacted all manufacturers requesting that all sales be halted until companies submit safety and effectiveness data that not only support the medical claims of their devices but also demonstrate that benefits from use of the product outweigh the risks for suffocation. But the CDC warns that hand-me-down positioners are still out there -- and should be avoided.