Health officials are warning parents not to use a special device designed to help keep babies in certain positions as they sleep. The device, called a sleep positioner, has been linked to at least 13 deaths in the last 15 years, officials with two federal agencies said on Wednesday.
"We urge parents and caregivers to take our warning seriously and stop using these sleep positioners," Inez Tenenbaum, the chairman of the Consumer Product Safety Commission, said in a statement.
The sleep positioner devices come primarily in two forms. One is a flat mat with soft bolsters on each side. The other, known as a wedge-style positioner, looks very similar but has an incline, keeping a child in a very slight upright position.
Makers of the devices claim that by keeping infants in a specific position as they sleep, they can prevent several conditions, including acid reflux and flat head syndrome, a deformation caused by pressure on one part of the skull. Many are also marketed to parents as a way to help reduce a child's risk of sudden infant death syndrome, or SIDS, which kills thousands of babies every year, most between the ages of 2 months and 4 months.
But the devices have never been shown in studies to prevent SIDS, and they may actually raise the likelihood of sudden infant death, officials say. One of the leading risk factors for sudden infant death is placing a baby on his or her stomach at bedtime, and health officials have routinely warned parents to lay babies on their backs. They even initiated a "Back to Sleep" campaign in the 1990s, which led to a sharp reduction in sudden infant deaths.
With the positioner devices, if an infant rolls onto the stomach, the child's mouth and nose can press up against a bolster or some other part of the device, leading to suffocation. Even if placed on the back, a child can move up or down in the positioner, "entrapping its face against a bolster or becoming trapped between the positioner and the crib side," Gail Gantt, a nurse consultant with the Food and Drug Administration, said in an e-mail. Or the child might scoot down the wedge in a way that causes the child's mouth and nose to press into the device.
"The baby's movement may also cause the positioner to flip on top of the baby, trapping the baby underneath the positioner or between the positioner and the side of the crib," she said.
Of the 13 babies known to have suffocated in a sleep positioner since 1997, most died after they rolled from their sides onto their stomachs. The Consumer Product Safety Commission has also received dozens of reports of babies who were placed on their sides or backs, "only to be found later in hazardous positions within or next to the product," the F.D.A. said in a statement.
Many baby books for new parents specifically urge against using sleep positioners, and the American Academy of Pediatrics does not support their use for SIDS prevention. Though the F.D.A. has never approved the positioners for the prevention of SIDS, it has in the past approved a number of the devices for the prevention of gastroesophageal reflux disease and flat head syndrome. But the agency said that in light of the new safety data, it believed any benefits from using the devices were outweighed by the risk of suffocation.
As of Wednesday, the agency is explicitly advising parents to stop using sleep positioners, and it has asked manufacturers of the devices to submit clinical data showing that the benefits of their products outweigh the risk of serious harm. In addition to avoiding the devices, experts say, parents should keep things like pillows, comforters, quilts and bumpers away from their infants and their cribs. Soft bedding can increase the likelihood of a baby suffocating.
"The safest crib is a bare crib," Dr. Susan Cummins, a pediatric expect with the F.D.A., said in a statement. "Always put your baby on his or her back to sleep. An easy way to remember this is to follow the ABC's of safe sleep – Alone on the Back in a bare Crib."
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