Baby sleep positioners pose fatal risks

If you do a ‘google search’ with “baby sleep positioners” as key words, products costing from a few tens to a few hundred US $, emerge. Many wax eloquent on their unique features;”real life savers” one ad claimed. Now, these claims are set to change.

On September 29,2010 the US Food and Drug Administration (FDA) and the Consumer Product Safety Commission warned parents and other caregivers not to put babies in sleep positioning products; two recent deaths underscore concerns about suffocation.

They received 12 known infant deaths associated with the products. Most of them died due to suffocation after rolling from the side to the stomach.

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

To reduce the risk of Sudden Infant Death Syndrome (SIDS), the American Academy of Paediatrics recommends infants be placed to sleep on their backs on a firm surface free of soft objects, toys, and loose bedding.
FDA advised thus: 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
FDA cautioned that in addition to the deaths, the Consumer 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.

Inez Tenenbaum, chairman of the Commission urged parents and caregivers to take their warning seriously and stop using these sleep positioners so children can be assured of a safe sleep.

According to FDA paediatric expert Susan Cummins, M.D., M.P.H, 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 cautioned the parents. “Always put your baby on his or her back to sleep” she suggested. She insisted that it is better to follow the ABC’s of safe sleep—Alone on the Back in a bare Crib.

“Some manufacturers have advertised that their products prevent SIDS, gastroesophageal 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”(FDA release September 29, 2010).

FDA conceded that it has approved many products for GERD or flat head syndrome; but new information suggests the positioners pose a risk of suffocation.

Now FDA directed makers of FDA-cleared sleep positioners to submit data showing the products’ benefits outweigh the risks. FDA also requested that these manufacturers stop marketing their devices while it reviews the data.

The agency experts asserted that presently there is no scientifically sound evidence to support the medical claims being made by the manufacturers of these infant sleep positioners.

FDA asked manufacturers making medical claims without its clearance to stop marketing those products immediately, adding that there’s no evidence that the devices have benefits that outweigh the risk of suffocation.

Think twice before you add this comfort product to your nursery.

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About ksparthasarathy

I am a former Secretary of the Atomic Energy Regulatory Board. I am a former Raja Ramanna Fellow in the Department of Atomic Energy. Free lance journalism is my hobby
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