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FDA & CPSC: Infant Sleep Positioners Pose Suffocation Risk

US Dept of Health & Human Services

Following two recent deaths (and a total of 12 infant suffocation deaths tied to the products in the last 13 years), the Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC) are instructing parents and caregivers not to put babies in sleep positioning devices because of the risk of suffocation associated with their use. Most of the infants who died had suffocated after rolling from the side (how parents often placed them in the positioner) to the stomach. The CPSC also received dozens of reports of babies who had been placed in the positioners on their back or side, only to be found later in hazardous positions within or next to the product. The positioners should no longer be used, and the agencies now state that they are dangerous and unnecessary. This announcement follows an earlier recall of the Nap Nanny, a similar sleep positioning product that had gained attention when featured in a People magazine photo spread featuring new mom Sandra Bullock and her son, Louis.

The most common types of sleep positioners feature either a wedge (with or without side bolsters) to elevate the baby’s head or a thin, flat mat with bolsters attached to either side. They are meant to keep a baby (typically under 6 months old) in a desired position while sleeping. Some manufacturers have marketed the products as helpful in preventing gastroesophageal reflux disease (GERD), flat head syndrome, and, ironically, Sudden Infant Death Syndrome (SIDS). However, in order to reduce the risk of SIDS, the American Academy of Pediatrics suggests that babies be placed to sleep on their backs in a crib empty of pillows, quilts, blankets, and toys.

The FDA is requesting that all manufacturers of infant sleep positioners stop marketing them until submission and review of clinical safety and effectiveness data proving that their benefits outweigh the risk of suffocation.

If you have had a problem with an infant sleep positioner, you can file a voluntary report through the FDA’s MedWatch, through the CPSC, or through the CPSC’s hotline at (800) 638-2772.