Sept. 29, 2010 -- The FDA and the Consumer Product Safety Commission (CPSC) have issued a joint warning against the use of sleep-positioning devices designed for babies.
The devices have caused 12 infant deaths over the past 13 years.
“Our goal is to make sure parents and caregivers are aware of the risks and to warn them to immediately stop using these devices,” said FDA principal deputy commissioner Joshua Sharfstein in a statement to reporters.
The devices, which have been on the market since the 1980s, have risers on their sides to hold a baby in place during sleep. Some also include wedges to raise the baby’s head. Several of the devices were cleared by the FDA as a means of alleviating symptoms caused by gastroesophageal reflux disease (GERD) and for preventing flat-head syndrome, a deformity caused by pressure on one side of a baby’s head.
However, the FDA, which has jurisdiction over the products because of the medical claims made by the manufacturers, has now determined that the risk of death far outweighs any potential benefits provided by the sleep positioners.
Sleep Positioners and SIDS
Perhaps most disturbing to parents is that while these devices are often marketed as aids in the prevention of sudden infant death syndrome (SIDS) -- a claim never approved by the FDA -- there is no evidence to support the claim. Instead, there is now significant evidence that these devices actually cause death.
“I can understand why parents choose to use them,” says Rachel Moon, MD, who chairs the American Academy of Pediatrics Sudden Infant Death Syndrome Task Force. “They believe these devices keep babies safe. But these devices do not keep babies safe.”
The majority of the deaths occurred after the baby rolled from side to stomach and became wedged against the side of the device or between the device and the side of the crib, causing the baby to suffocate.
Moon says many of the positioners come with a warning to stop using them when a baby begins to roll during sleep. This, she says, usually happens at age 4 months. However, it can happen as early as age 2 months, and it is dangerous for parents to try and predict when their baby will begin to roll.
“A baby can roll at any time,” she says.
The warning “is not a surprise,” says Deborah Lonzer, MD, chair of community pediatrics at Cleveland Clinic Children’s Hospital. “We’ve been recommending for years that parents don’t use them.”
Lonzer says she will now consider including adding a warning about the devices to the hospital’s literature for new and expectant parents.
“It’s a great idea to educate parents [about the risks of sleep positioners] in writing earlier than we do,” she says.
Recall Still a Possibility
Both the FDA and the CPSC advise parents that their baby should sleep on his or her back. They warn against putting anything soft -- such as pillows, blankets, quilts, or comforters -- beneath a baby in the crib.
The FDA and the CPSC are in touch with several manufacturers of sleep positioners, five of whom have given spoken agreements to stop manufacturing and marketing the devices. They expect to hear from the remaining manufacturers soon. No product recall has been announced, though the possibility has not been ruled out, Sharfstein says.
“You might see some recalls, you might see some court cases,” he says. “But the important thing now is the public health message. ... We don’t think [parents] should buy them, we don’t think they should use them, we don’t think stores should sell them, we don’t think manufacturers should make them.”