Infant Sleep Positioners Linked to12 Deaths

Both the US Food and Drug Administration (FDA) and the US Consumer Product Safety Commission (CPSC) have issued a warning not to use <"">Infant Sleep Positioners.

In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their Infant Sleep Positioners. Most of the babies suffocated after rolling from their sides to their stomachs.

The CPSC has also received dozens of reports of babies who were placed on their backs or sides in the positioners only to be found later in hazardous positions within or next to the product.

“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,” said Inez Tenenbaum, CPSC chairman.

FDA pediatric expert Susan Cummins, M.D., M.P.H, said parents and caregivers can create a safe sleep environment for babies if they leave the crib free of pillows, comforters, quilts, toys, and other items. “The safest crib is a bare crib,” she says. “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.”

The most common types of Infant Sleep Positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. Infant Sleep Positioners are intended to keep a baby in a desired position while sleeping and are often used with infants under six months of age.

Consumers are warned to stop using infant positioning products and are also being advised to never put pillows, sleep positioners, comforters, or quilts under the baby or in the crib.

To reduce the risk of Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends infants be placed to sleep on their backs on a firm surface free of soft objects, toys, and loose bedding. Always place a baby on his or her back at night and during naptime.

Some manufacturers have advertised that their products prevent SIDS, gastro esophageal reflux disease (GERD)—in which stomach acids back up into the esophagus—or flat head syndrome, a deformation caused by pressure on one part of the skull.

And, 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. “At this time, there is no scientifically sound evidence to support the medical claims being made by the manufacturers of these infant sleep positioners,” says Cummins.

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