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Infant Sleep Positioners Dangerous, U.S. Health Officials Warn
Date:9/29/2010

By Alan Mozes
HealthDay Reporter

WEDNESDAY, Sept. 29 (HealthDay News) -- Driven by reports of infant deaths, U.S. health officials warned Wednesday that infant sleep positioners are dangerous and should not be used.

The public health advisory, issued jointly by the U.S. Food and Drug Administration (FDA) and the U.S. Consumer Product Safety Commission (CPSC), follows government reports that at least 12 babies under 4 months old suffocated in the last 13 years after being placed in a crib outfitted with a sleep positioner.

All 12 died after rolling from a side to a stomach position or becoming trapped between a sleep positioner and the frame of a crib or bassinet. The government also has many more reports of babies found in potentially dangerous positions after being placed in one of these products.

"Based on the information that CPSC shared with FDA, both agencies agree and are working together to stop the use of these products and get them off the market," the FDA's principal deputy commissioner, Dr. Joshua Sharfstein, said during an afternoon teleconference with reporters.

Infant sleep positioners are typically flat mats with side bolsters or wedge mats with side bolsters and have been commonly used to help keep babies on their backs to reduce the risk of sudden infant death syndrome (SIDS), even though the FDA has never approved that use.

At the moment, manufacturers of the 18 sleep positioner products that have been cleared for sale by the FDA are not legally obligated to stop marketing their devices, Sharfstein said. And the warning provides no replacement or refund options for consumers who have purchased the products, he added.

That said, Sharfstein noted that the FDA began contacting makers of all known sleep positioners a month ago in an effort to get them to take the products off the market, and said the agency may take steps to force the issue down the road.

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