FDA warns against sleep positioners
Published 2:02 pm, Tuesday, October 3, 2017
Getting babies to sleep is a seemingly endless struggle that nearly all parents face. So it’s not surprising that parents might turn to devices for help. But the U.S. Food and Drug Administration cautions strongly against sleep positioners — also sometimes called “nests” or “anti-roll” products — as they can suffocate small children.
The two most common types of sleep positioners feature raised supports or pillows (called “bolsters”) that are attached to each side of a mat, or a wedge to raise a baby’s head. The positioners are intended to keep a baby in a specific position while sleeping and are intended for infants under 6 months old.
To reduce the risk of sleep-related infant deaths, including accidental suffocation and Sudden Infant Death Syndrome, the American Academy of Pediatrics recommends that infants sleep on their backs, positioned on a firm, empty surface. This surface should not contain soft objects, toys, pillows, or loose bedding.
Each year, about 4,000 infants die unexpectedly during sleep time from accidental suffocation, SIDS, or unknown causes, according to the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
The federal government has received reports about babies who have died from suffocation associated with their sleep positioners. In most of these cases, the babies suffocated after rolling from their sides to their stomachs.
In addition to reports about deaths, the federal government also has received reports about babies who were placed on their backs or sides in positioners — but were later found in other, dangerous positions within or next to these products.
The FDA regulates baby products as medical devices if the manufacturer claims that the product will cure, treat, prevent, or reduce a disease or condition in its labeling, packaging, or advertising.
Sleep positioners that do not meet the definition of a medical device may be regulated by the Consumer Product Safety Commission.
Some manufacturers have advertised that their sleep positioners prevent SIDS; gastroesophageal reflux disease, in which stomach acids back up into the esophagus; or flat head syndrome (plagiocephaly), a deformation caused by pressure on one part of the skull.
However, the FDA has never cleared an infant sleep positioner that claims to prevent or reduce the risk of SIDS. The FDA had previously approved some of these products for GERD or flat head syndrome. But because the agency learned in 2010 that these products have a risk of suffocation, the FDA then required manufacturers of FDA-cleared sleep positioners to submit data showing that the products’ benefits outweigh the risks. In 2010, the FDA asked manufacturers to stop marketing these products.