Infant Sleep Positioners Pose Suffocation Risk, F.D.A. Says, nytimes
Infant sleep positioners that are used to keep babies on their backs and protect them from sudden infant death syndrome have led 12 children to suffocate in the past 13 years and should no longer be used, federal officials said Wednesday.
Most of the infants suffocated after rolling from a side position to a stomach position. In addition to the reported deaths, the government has received dozens of reports of infants who were placed on their backs or sides in sleep positioners, only to be found later in potentially hazardous positions within or next to the sleep positioners.
The two main types of infant sleep positioners are flat mats with side bolsters or inclined mats with side bolsters.
Both types of sleep positioners typically claim to help keep infants on their backs and reduce the risk of sudden infant death syndrome, or SIDS, but the Food and Drug Administration has never approved these products as safe. And the government said it was unaware of any scientific studies demonstrating that infant positioners prevented death or were proven to prevent suffocation or other life-threatening harm.
“To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS,” said Dr. Joshua Sharfstein, the F.D.A.’s principal deputy commissioner.
Most of the infants suffocated after rolling from a side position to a stomach position. In addition to the reported deaths, the government has received dozens of reports of infants who were placed on their backs or sides in sleep positioners, only to be found later in potentially hazardous positions within or next to the sleep positioners.
The two main types of infant sleep positioners are flat mats with side bolsters or inclined mats with side bolsters.
Both types of sleep positioners typically claim to help keep infants on their backs and reduce the risk of sudden infant death syndrome, or SIDS, but the Food and Drug Administration has never approved these products as safe. And the government said it was unaware of any scientific studies demonstrating that infant positioners prevented death or were proven to prevent suffocation or other life-threatening harm.
“To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS,” said Dr. Joshua Sharfstein, the F.D.A.’s principal deputy commissioner.
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