RODALE NEWS, EMMAUS, PA—Just days after a major recall of toddler toys by Mattel, The Food and Drug Administration (FDA), American Academy of Pediatrics, and U.S. Consumer Product Safety Commission are voicing major concerns with infant sleep positioning devices, saying parents and caretakers should immediately stop using them because they pose a suffocation risk and are not necessary to use, anyway. "After clear evidence that some babies have died using these products, the FDA now says the risks of these products are greater than the potential benefits," explains Diana Zuckerman, PhD, president of the National Research Center for Women & Families. She also cites tricky laws that make an immediate ban on sale or mandatory recall difficult. "The agency wants to recall the devices, but that will take a lot of time because there are so many companies making them and so little research about the risks or the benefits," says Zuckerman. "Unfortunately, our laws make it easier for the FDA to allow a company to sell products like this than to recall it, or to forbid companies from continuing to sell them."
THE DETAILS: Infant sleeping devices don't all look alike, but companies marketing them advertise that they allow babies to sleep more comfortably and safety, reducing gastric reflux and sudden infant death syndrome, or SIDS. Some even make cosmetic claims, saying the sleepers will prevent one side of the baby's head from becoming flat during sleep. The most common type features bolsters attached to each side of a thin mat, and wedges to elevate the baby's head. The government and the largest pediatrician group in the country are telling parents to stop using them immediately after reviewing 12 infant deaths linked to the products. Companies claim that the sleep positioning devices help reduce reflux and SIDS, although these claims were never required to be tested, Zuckerman explains.
Some examples of infants sleep positioning devices.
WHAT IT MEANS: "Since the benefits are very modest—and actually, nobody is sure if these products are truly effective in preventing gastric reflux or flattened heads—parents are being warned not to take the risk of using these products," says Zuckerman. "There are other, safer (and free) ways to make sure that babies’ heads don’t get flat on one side. If there weren’t, we’d have millions of children and adults with heads that are flat on one side."
These infant sleep positioning devices are most commonly used in children under 6 months (when a baby is most prone to SIDS) in the crib and other places where babies sleep. "SIDS is frightening to all parents, but fortunately, it is much less common now that babies are sleeping on their backs," explains Zuckerman. "There are no products that reduce the risk of SIDS." And as mentioned above, these products actually increase the risk of tragedy.
Published on: October 1, 2010
Updated on: October 4, 2010