Warning: Stop Using Infant Sleep Positioners Immediately or Risk Suffocation Deaths

The U.S. Consumer Product Safety Commission (CPSC) and U.S. Food and Drug Administration issued a consumer alert today to warn parents to stop using infant sleep positioners, citing reports of 12 infants -- ages 1 month to 4 months -- who suffocated to death after being placed in the devices.

Most of the infants suffocated after rolling from a side to a stomach position; some of the infants suffocated on the device itself, while others succumbed after being trapped between a sleep positioner and the side of a crib or bassinet, according to CPSC Chairman Inez Tenenbaum.

In addition to the reported deaths, the CPSC has also received dozens of reports of infants who were placed on their back or sides in sleep positioners, only to be found later in potentially hazardous positions within or next to the devices.

"The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC," Tenenbaum said. "We urge parents and caregivers to take our warning seriously and stop using these sleep positioners, so that children can have a safer sleep."

The two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters (see above).

Both types of sleep positioners typically claim to help keep infants on their backs, thereby reducing the risk of Sudden Infant Death Syndrome (SIDS). There is, however, no evidence to support this claim, according to Dr. Rachel Moon, Chair of the American Academy of Pediatrics' Sudden Infant Death Syndrome Task Force.

"The American Academy of Pediatrics doesn't recommend any of the products that claim to protect against SIDS," Moon says, "Because, to our knowledge, none of these do actually protect against SIDS; there is no scientific evidence supporting these claims."

In addition, the FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS. Over the years, the FDA has approved 18 sleep positioner devices -- all of which had made claims of helping to reduce gastroesophageal reflux disease symptoms and/or preventing plagiocephaly -- also known as "flat head syndrome."

At this point, however, it has become clear that the risks of using infant sleep positioners outweigh the benefits, says Moon, so consumers are warned to immediately stop using the devices.

The FDA, which has jurisdiction over consumer products making medical claims, has contacted the manufacturers of the 18 approved infant sleep positioners and asked them to stop making these devices; the agency will also be contacting retailers to ask them to stop selling the devices, according to Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner.

Sharfstein advised that today's public health message is seen as the quickest way to get the warning out the consumers, so that they immediately stop buying the fatality-causing products. However, in the future, the FDA may issue for products that have not voluntarily been removed from the market; the agency will also be investigating reports of other, unapproved sleep positioning devices, as well as any other devices out there that claim to prevent or reduce the risk of SIDS.

The CPSC, FDA and AAP warn parents to:

• Stop using sleep positioners. 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. To reduce the risk of SIDS, the AAP recommends placing infants to sleep on their backs and not their sides.

Visit the CPSC's website for information about the agency's Safe Sleep initiative, which advises parents on how to help their kids sleep safely.