Parents should immediately stop using products that help keep infants in place while sleeping, the U.S. Consumer Product Safety Commission and the Food and Drug Administration said.
The two agencies received 12 reports of babies who died when they suffocated after the devices were placed in cribs or bassinets, according to a statement today. The CPSC also received dozens of reports of infants rolling off their backs into potentially hazardous positions, it said.
“The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern,” CPSC Chairman Inez Tenenbaum said in the statement. “We urge parents and caregivers to take our warning seriously.”
Most sleep positioners are flat mats with side bolsters or a wedge-shaped mat with bolsters, the agencies said. Both types are marketed to help keep infants on their backs while sleeping to reduce the risk of Sudden Infant Death Syndrome.
The fatalities were reported for babies from 1 to 5 months old who either suffocated in the position or died after becoming trapped between the device and the side of their crib or bassinet, the agencies said.
The FDA has approved 18 sleep-positioning devices for use in reducing risks from reflux or flat-head syndrome, said Joshua Sharfstein, the FDA’s principal deputy commissioner, a pediatrician. The regulator hasn’t cleared any device for preventing or reducing the risk of sudden death. Both agencies said they’re not aware of any scientific studies that demonstrate sleep positioners prevent SIDS or suffocation.
Sleep Positioner Retailers
Among the companies making sleep positioners are Life Innovations LLC, Kamber Corp., the Ludlow Company LP, Pedicraft Inc. and Olympic Medical Corp., according to the FDA. The products are sold by retailers led by Wal-Mart Stores Inc. and Target Corp.
Both agencies are working to remove products from stores, Sharfstein said. In the past month, the FDA asked all companies making the sleep positioners to pull their products, he said. Five companies have agreed, he said.
The agencies aren’t issuing a recall and consumers won’t receive a refund or a repaired product, Tenenbaum said. Recalls have to be negotiated with a company after a defect is found, she said. Recalls may still occur, Sharfstein said.
“We will use all of our authority to protect children,” Sharfstein said. “We do not want these types of sleep positioners used. We have asked the companies to stop selling them.”
Sufficient evidence shows a potential risk from using positioners, said Rachel Moon, a doctor and chairman of the SIDS Task Force at the American Academy of Pediatrics. Instructions for positioners usually tell parents to stop using the product when babies start to move, she said.
“You cannot predict when a child will begin to do something,” Moon said. “You have to assume your baby will move at any time.”
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