Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Thursday, 18 November 2010

SIDS: FDA warns against sleep positioners


Nancy Zielinski

September 29th, 2010

The Food and Drug Administration, FDA, and the Consumer Product Safety Commission, CPSC, have issued warnings not to use infant sleep positioners due to the reported deaths of 12 babies due to suffocation. Most of the babies suffocated after rolling from the side to the stomach.
The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby's head. The sleep positioners are intended to keep a baby in a desired position while sleeping, and often used with infants under six months old.
The government agencies are warning consumers to stop using infant positioning products, and to never put pillows, sleep positioners, comforters, or quilts under the baby or in the crib. To reduce the risk of Sudden Infant Death Syndrome, SIDS, the American Academy of Pediatrics recommends infants be placed to sleep in their backs on a firm surface free of soft objects, toys, and loose bedding.
The Consumer Product Safety Commission is advising consumers to report any incident or injury from an infant sleep positioner by visiting their website at www.cpsc.gov/cgibin/incident.aspx or calling 800-638-2772.
Over a twelve year period, the state of Michigan has reduced the number of SIDS deaths by 80 percent. This reduction in infant mortality is credited, in part, to the Back-to-Sleep campaign and an increased recognition of unsafe sleep conditions. The Back-to-Sleep campaign was initiated in 1994 nationally with the collaboration of the National Institute of Child Health and Human Development, American Academy of Pediatrics, Association of SIDS and Infant Mortality Programs and SIDS Alliance. Michigan saw its first significant decline in SIDS death between 1992 and 1995, reflecting the positive impact of the message to change infant position.

Saturday, 16 October 2010

SIDS: Dangerous products

GARDINER HARRIS and ANDREW MARTIN
The New York Times
WASHINGTON — Twelve infants have been suffocated and dozens have been endangered by sleep positioners marketed as protecting against sudden infant death syndrome (SIDS), federal officials said Wednesday.
The officials, from two federal agencies, said the devices — flat or inclined mats with side bolsters — should be taken off the market.
"We are very concerned about the risk that this product poses to babies," said Inez Moore Tenenbaum, chairwoman of the Consumer Product Safety Commission.
The positioners, sold in baby-supply stores, are supposed to keep infants lying on their back. But the government said most of the infants suffocated after rolling from a side to a stomach position.
The officials said that none of the many products being promoted for SIDS prevention had ever been proved effective and that nearly all should be avoided.
"Many products are out there making these claims, and these must stop," said Dr. Joshua Sharfstein, principal deputy commissioner of the Food and Drug Administration. "They are illegal devices."
Dr. Rachel Moon, chairwoman of the American Academy of Pediatrics' task force on the syndrome, said that other worrisome anti-SIDS products on the market included crib bumpers, "co-sleepers," breathable mattresses, wedges and foam pads.
"There are hundreds of these products out there that could potentially cause harm," said Moon.
Products that have extensive foam, memory foam, significant cushioning or anything else on which a baby might suffocate should never be used in a crib, Moon said.
http://seattletimes.nwsource.com/html/nationworld/2013031860_infant30.html