FDA Warns Parents Not To Use Infant Sleep Positioners
September 29 2010 - 3:34PM
Dow Jones News
Parents and caregivers should stop using infant sleep
positioners because babies can suffocate, two federal government
agencies warned Wednesday.
The Consumer Product Safety Commission and the U.S. Food and
Drug Administration said they've received 12 reports of deaths
involving babies who've suffocated in a sleep positioner or became
trapped and suffocated between a sleep positioner and the side of a
crib or bassinet. The babies were between one month and four months
old and most suffocated after rolling from a side to stomach
position.
The two main types of infant sleep positioners are flat mats
with side bolsters or inclined mats with side bolsters.
Some of the positioners were cleared by the FDA in the 1980s to
reduce symptoms of gastrointestinal reflux disease or so-called
"flat-head" syndrome, but many products currently on the market
were never approved by the FDA.
Many of the sleep positioners claim to help keep babies on their
backs and reduce the risk of Sudden Infant Death Syndrome, but the
FDA has never cleared any of the products to reduce the risk of
SIDS.
Joshua Sharfstein, FDA's principal deputy commissioner, said the
FDA recently sent letters to 18 manufacturers of sleep positioners
asking to stop making their devices or to submit additional
information to the agency in support of the products.
Sharfstein said, however, he expects the manufacturers to stop
making their devices. The FDA does have a process to force the
products off the market if necessary.
The Consumer Product Safety Commission will ask major retailers
major to stop selling the products.
The government has also received dozens of reports of babies put
to sleep on their backs or side who were later found in a
potentially dangerous position within or near the sleep
positions.
Rachel Moon, the chair of the American Academy of Pediatrics'
Sudden Infant Death Syndrome task Force, said her group backs the
government's position calling on consumers not to use infant sleep
positioners.
The AAP also recommends always placing babies on their backs in
a bed or bassinet with a firm mattress covered with a fitted sheet.
Soft bedding, bumper pads, pillows and stuffed animals should also
be kept out babies' beds.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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