Infant Sleep Positioner Deaths
Written by Faith Anderson on November 24, 2012
Infant Deaths Linked to ISP Devices
In the agency’s report, CDC researchers reviewed information compiled by the U.S. Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC) regarding the nature of deaths associated with ISPs between 1997 and 2011. Study authors found that all 13 reported deaths linked to the devices occurred in children younger than four months, nine of whom were placed on their sides to sleep. Many of the affected infants were found lying on their stomachs, unresponsive; four victims had been born prematurely; four had recent histories of respiratory illnesses, and three victims were one of a pair of twins.
Sleep Positioners May Increase Risk of Suffocation
One victim, a 7-week-old male, had a well-baby doctor’s visit five days before his death and no health problems were found. He was fed the morning of his death and was placed to sleep on his side using an infant sleep positioner in a crib separate from his twin brother. Three hours later, he was discovered unresponsive with his face close to one of the ISPs foam pads. The autopsy listed the infant’s cause of death as suffocation by obstruction of the mouth and nose by a “foam positioning device.” In many of the cases of deaths involving infant sleep positioners, the devices were purchased by parents and caregivers hoping to prevent sudden infant death syndrome.
ISP Devices Not Approved for SIDS Prevention
“Although [infant sleep positioners] have been available since the 1980s, only a few ISP manufacturers have been cleared by the FDA to provide products, by prescription, to manage particular medical conditions,” CDC researchers reported. “Despite other manufacturers’ claims, regarding SIDS prevention or other health benefits, FDA has never cleared or approved an ISP for preventing or reducing the risk for SIDS.” Researchers also voiced concerns about some hand-me-down devices that have already been recalled, which may still be in use.
Reducing Risk of SIDS in Infants
In December 2010, the CPSC and FDA warned consumers against the use of ISP devices, which at the time had been linked to 12 infant deaths. The American Academy of Pediatrics also supported these recommendations, saying “The AAP believes sleep positioners represent a risk to sleeping babies.” In 2011, the Academy issued a policy statement on reducing SIDS in babies, advising parents to put babies to sleep on their backs and avoid the use of heavy blankets, pillows or stuffed animals in cribs. According to the CDC, unintentional suffocation is the leading cause of injury death for children younger than one in the United States. If you used an infant sleep positioner and your child was injured or killed as a result, contact an experienced product liability lawyer to discuss your legal options.