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.
"We will use our authority in this case and in other cases to protect children," he said. Five manufacturers have already indicated they will stop selling their sleep positioners, he added, and "we anticipate that the device manufacturers will stop marketing these devices."
Until then, CPSC chair Inez Tenebaum told reporters, the warning
"is a way for us to communicate directly and quickly with
Tenebaum noted that Wednesday's action is the latest step taken
as part of CPSC's "Safe Sleep" initiative, a national campaign
designed to educate parents about federal safety standards for
cribs and potential bedding hazards.
Sharfstein explained that infant sleep positioners first came to
the U.S. market in the 1980s, as a sleep aid that promised to help
reduce infant gastroesophageal reflux disease (GERD), as well as
the risk for "plagiocephaly."
Also known as "flat head syndrome," plagiocephaly occurs when a
baby develops a flat spot or an asymmetrical head shape in response
to external pressure. The immobility promised by a sleep positioner
was advertised as a way to prevent the type of infant movement that
could cause such a complication.
But many parents have turned to the device because of
suggestions that by keeping infants on their backs sleep
positioners actually reduced the risk of SIDS.
Sharfstein stressed that "the FDA has never approved an infant
sleeper to prevent SIDS."
Dr. Rachel Moon, chair of the Sudden Infant Death Syndrome Task
Force with the American Academy of Pediatrics, told reporters that,
as a pediatrician and a parent, she understands the impetus to
place an infant in a positioner if there is some inkling that it
might prevent SIDS.
But she was adamant that there was "no scientific evidence" to
support such a claim, while mounting indications strongly suggest
that positioner devices actually threaten babies with "at least a
risk of injury and even a risk of death."
"To me," she said, "they do not pass the test of 'first do no harm.'"
Dr. Judith S. Palfrey, president of the American Academy of
Pediatrics, issued this statement after the FDA action: "The AAP
believes sleep positioners represent a risk to sleeping babies. The
AAP also recommends that parents never use pillows, stuffed
animals, heavy blankets or other soft or puffy items in babies'
cribs. Soft bedding can end up over their face and block their
breathing. Babies should have their own crib, with a firm mattress
and a fitted sheet."
For more on the infant sleep positioner warning, visit the
U.S. Food and Drug Administration.
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