Agency Warns Parents to Stop Using Infant Sleep Positioners
Putting a baby on his or her back to sleep is recommended for protects them from sudden infant death syndrome or SIDS. However, a sleep positioning device used to keep babies from rolling onto their stomachs is more hazardous to infants and the US FDA and Consumer Product Safety Commission are warning parents against using them.
Infant sleep positioners have caused child suffocation
According to the Food and Drug Administration, 12 children have suffocated in the past 13 years in incidents related to infant sleep positioners which are flat or inclined mats fitted with side bolsters. In addition to the reported deaths, the agency has received dozens of reports of infants being found in potentially hazardous positions wither within or next to the devices.
In most cases, the babies were between one and four months old.
FDA principal deputy commissioner Dr. Joshua Sharfstein is unaware of any scientific studies demonstrating that the infant sleep positioners were proven to prevent SIDS, despite claims by some manufacturers. 18 brands of positioners were approved because of some evidence that the devices may ease the symptoms of gastroesophageal reflux disease (GERD) and prevent plagiocephaly (flattened head syndrome), but that “the modest evidence of benefit does not outweigh the risk.”
The American Academy of Pediatrics supports the warning against parents purchasing the sleep positioning devices.
Letters to the manufacturers of sleep positioners have been sent by the FDA asking them to stop making the devices or to submit additional information to the agency in support of the products. Dr. Sharfstein says that the FDA may follow up with enforcement actions or recalls in the future. The CPSC is additionally asking major retailers to pull the products off the shelves.