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The FDA and Consumer Products Safety Commission (CPSC) issued a joint release today calling for consumers to stop using infant sleep positioners, warning that 12 infants have suffocated over the last 13 years after being placed in them.

Sleep positioners are used to keep sleeping infants on their backs, with the hope of preventing Sudden Infant Death Syndrome (SIDS). However, no definitive cause of SIDS has been identified, and the release points out that both regulators “are unaware of any scientific studies demonstrating that infant positioners prevent SIDS or are proven to prevent suffocation or other life-threatening harm.” Indeed, many of the infant victims either suffocated inside the positioners or while trapped between the positioner and the side of the crib.

In addition to warning parents to stop using the positioners, the FDA and CPSC has also warned against using pillows and comforters to try to keep a sleeping infant on its back. Both organizations also requested that manufacturers submit clinical data demonstrating that the benefits of the devices outweigh the risks.

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