Two government agencies are warning parents and other caregivers not to put babies in sleep positioning products as two recent deaths underscore concerns about suffocation.

The Food and Drug Administration (FDA) and the Consumer Product Safety Commission issued the warning after reviewing reports of 12 known infant deaths were associated with the products.

The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. The sleep positioners are intended to keep a baby in a desired position while sleeping. They often are used with infants younger than 6 months old.

To reduce the risk of Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends infants be placed on their backs and on a firm surface free of soft objects, toys, and loose bedding to sleep.

Advice for Consumers
  • STOP using infant positioning products. Using this type of product to hold an infant on his or her side or back is dangerous and unnecessary.
  • NEVER put pillows, sleep positioners, comforters, or quilts under the baby or in the crib.
  • ALWAYS place a baby on his or her back at night and during nap time.
  • REPORT an incident or injury from an infant sleep positioner to the Consumer Product Safety Commission.
Suffocation and Other Dangers

During the past 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach.

In addition to the deaths, the 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.

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 and 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.

Medical Claims

Some manufacturers have advertised that their products prevent SIDS, gastroesophageal reflux disease (GERD), and/or flat head syndrome, a deformation caused by pressure on one part of the skull.

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, the FDA is requiring makers of FDA-cleared sleep positioners to submit data showing the products’ benefits outweigh the risks. FDA also is requesting that these manufacturers stop marketing their devices while the FDA reviews the data.

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