The U.S. Consumer Product Safety Commission and the U.S. Food and Drug Administration (FDA) said the deaths occurred when the babies got trapped between the positioner and the side of a crib or bassinet and suffocated. The dozen deaths were recorded over 13 years, in addition to dozens of other reports of close calls.
Most of the suffocation deaths occurred when the infants rolled from their sides onto their stomachs.
"The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC," CPSC Chairman Inez Tenenbaum said in a written statement. "We urge parents and caregivers to take our warning seriously and stop using these sleep positioners, so that children can have a safer sleep."
Sleep positioners typically are either mats with bolsters or wedges with bolsters and are marketed as a means to help reduce the risk of Sudden Infant Death Syndrome.
The FDA said it hasn't approved one of these devices, sold since the 1980s, as a means to do that. And both agencies said there is no science to back up the claims.
"To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS," Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner and a pediatrician, said in a statement. "We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners."
The FDA also said any companies selling the positioners that makes a medical claim must demonstrate proof or stop making the claim. He said at a press briefing to expect recalls and possible legal action against some of the companies making the marketing claims.
It was most important, Sharfstein said, to warn parents about what he called a public health issue before taking action against companies.
A child safety advocacy group praised the announcement.
"We hope that the warning and the requirement by FDA that they prove their medical claim that sleep positioners can prevent SIDS is enough to convince manufacturers to stop making this useless and dangerous product," Kids in Danger executive director Nancy Cowles said in a statement sent to Consumer Ally. "We urge retailers to stop selling them immediately, parents to stop using them and expectant parents to cross them off their registry. "
The American Academy of Pediatrics also expressed its support for the warning.
"We see no scientific evidence these positioners protect infants from death," said Dr. Rachel Moon, who chairs the group's Sudden Infant Death Syndrome Task Force. In fact, she said, the situation is clearly the opposite.
The agencies also offer these cautions:
- Using a positioner to hold an infant on his or her back or side for sleep is dangerous and unnecessary.
- Never put pillows, infant sleep positioners, comforters or quilts under a baby or in a crib.
- Always place an infant on his or her back at night and during nap time.