Monday, October 18, 2010

Young children sleep Positioners pose suffocation risk

The FDA and the Consumer Product Safety Commission (CPSC) are warning against the use of infant positioning products after two recent deaths because of suffocation.
Some manufacturers have advertised that their products prevent SIDS, gastroesophageal reflux disease (GERD), or flat head syndrome, a deformation caused by pressure on one part of the skull.
The federal government is aware of 12 reports of infant deaths in the last 13 years attributed to the sleep positioners. The Consumer Product Safety Commission has received "dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product," the according to a statement from the FDA.
"We urge parents and caregivers to take our warning seriously and stop using these sleep positioners so children can be assured of a safe sleep," says Inez Tenenbaum, chairman of the Consumer Product Safety Commission.
FDA pediatric expert Susan Cummins, M.D., M.P.H, says, "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."
Although in the past FDA has approved a number of these products for GERD or flat head syndrome, new information suggests the positioners pose a risk of suffocation. As a result, FDA is requiring makers of FDA-cleared sleep positioners to submit data showing the products' benefits outweigh the risks. FDA is also requesting that these manufacturers stop marketing their devices while FDA reviews the data.
Infant sleep positioner manufacturers who are making medical claims without FDA clearance must stop marketing those products immediately, agency experts say, adding there's no evidence the devices have benefits that outweigh the risk of suffocation.

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