FDA Issues Suffocation Warning On Infant Sleep Positioners

Federal health regulators are urging parents and caregivers not to use infant sleep positioners, indicating that the devices may increase the risk of infant death. 

In a safety alert issued on October 3, the FDA classified infant sleep positioners as dangerous, “never-use” devices.

The agency also cautioned parents and caregivers against buying products that claim to prevent or reduce the risk of Sudden Infant Syndrome (SIDS), such as baby monitors, special mattresses, crib tents, pillows, bumpers and other crib bedding, indicating that they can pose a serious injury and suffocation risk to babies.

“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,” the FDA warned in a consumer update issued the same day. “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.”

To avoid these risks, the FDA says infant sleep positioners should never be used, indicating that the safest crib is a bare crib with babies put on their backs to sleep.

Infant sleep positioners, sometimes called “nests” or “anti-roll” products, typically feature raised pillows known as bolsters attached to either side of a mat. They sometimes involve a wedge to raise the baby’s head. They are advertised as being able to keep a baby six months old or younger in a specific position while they sleep.

Some claim that they can prevent SIDS, gastroesophageal reflux disease (GERD) or flat head syndrome. However, the FDA notes that it has never approved an infant sleep positioner that claimed to prevent or reduce the risk of SIDS.

At one point, the FDA had approved some positioners for the reduction of GERD or flat head syndrome risks, but notes that it asked the manufacturers to stop marketing those products in 2010, after an investigation into reports of infant deaths revealed that the risks far outweighed the benefits.

There are about 4,000 infant sleeping deaths reported each year, according to the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Those deaths occur from accidental suffocation, SIDS, or unknown causes.