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Devices Claimed to Prevent SIDS Tied to Deaths

A  large proportion of infant deaths associated with infant sleep positioners (ISPs) occurred in children who were incorrectly placed on their sides to sleep, government researchers found.

Among 13 deaths related to ISP use between January 1997 and March 2011, the children had been placed on their sides in nine cases, wrote Joy Samuels-Reid, MD, of the FDA, and colleagues in the Nov. 23 issue of Morbidity & Mortality Weekly Report.

That finding "raises the concern that the 'back-to-sleep' message to position infants on their backs is either not being heard or not being followed," the researchers wrote.

Unintentional suffocation is the leading cause of injury death among children under a year old, accounting for about 1,000 infant deaths annually, the researchers reported, and the positioners may be tied to rising rates of accidental suffocation, they added.

Some of these ISPs are FDA-approved for gastroesophageal reflux or plagiocephaly, but many unapproved ISPs have been marketed with claims of preventing sudden infant death syndrome (SIDS), they wrote.

To characterize infant deaths associated with ISPs, teams from the FDA, the CDC, and the U.S. Consumer Product Safety Commission examined information on 13 infant deaths over the past 13 years associated with use of the devices.

In this case series, all of the infants, with the exception of one, were 3-months-old or less, and most had been placed on their sides to sleep. One infant had been placed in the prone position.

Many were ultimately found in the prone position, and accompanying medical issues included prematurity (four cases) and intercurrent respiratory illness: four had recent respiratory symptoms or diagnoses of respiratory illness, including respiratory syncytial virus infection and colds.

In addition, three of the deceased infants were one of a pair of twins.

Samuels-Reid and colleagues warned that the FDA has never cleared an ISP for preventing the risk of SIDS. "Cleared ISPs should only be used by prescription for treatment of specific medical conditions," they wrote.

They also reviewed ISP instructions for five of the cases in their report, and found that three instruction sheets indicated that side positioning an infant in the device was an acceptable use of the product.

When providing guidance for parents of newborns, they added, "healthcare providers need to emphasize the importance of placing infants to sleep on their backs in a safe sleep environment."

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