Washington, DCThe FDA and Consumer Product Safety Commission (CPSC) have issued a warning that baby sleep positioners can carry the risk of suffocation and death. Health officials say the mats with barriers designed to prevent a baby from rolling over should not be used under any circumstances.
The warning was prompted by reports of 12 deaths among infants from 1 to 4 months of age received by the CPSC over the past 13 years, including dozens of nonfatal cases in which babies awoke in unsafe positions after being placed in a sleep positioner. The sleep positioners prevent a baby from rolling over; once they turn they are face down without any escape.
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Since the 1980s, about 18 sleep positioners have been FDA-approved because some evidence suggested that the devices ease the symptoms of gastroesophageal reflux disease (GERD) and prevent flattening of one side of the skull. As well, some manufacturers claim their products can also reduce the risk of sudden infant death syndrome (SIDS), which has not been approved by the FDA. "Many products are out there making these claims and these must stop. They are illegal devices," said Dr. Joshua Sharfstein, principal deputy commissioner of the FDA, adding that the devices should not be used and that the modest benefit does not outweigh the risk.
The FDA recently contacted the manufacturers of the agency-approved devices asking them to stop marketing their products unless they can submit data showing that the benefits outweigh the suffocation risks.