Infant sleep positioning aids, intended to keep babies in a desired position while they sleep, have been available to the public for years and have been marketed as a solution to a number of infancy-related ailments.
Following the deaths of two babies, the Federal Food and Drug Administration (FDA) and the U.S. Consumer Product Safety Commission (CPSC) issued a joint warning for parents and caregivers to immediately stop using infant sleep positioning aids because of a grave product liability issue.
Over the past 13 years, the deaths of at least 12 infants between the ages of one and four months have been reported. The babies died when they suffocated within the cushions of their sleep positioner or became trapped between their sleep positioning aid and the side of a crib or bassinet and then suffocated.
Sleep positioning aids are generally flat, thin mats with side bolsters intended to keep the infant in a desired sleep position. Some models offer a built-in wedge intended to elevate an infant’s head.
Manufacturers of sleep positioners often claim that their products may lessen colic and ease gastroesophageal reflux disease, in which stomach acid backs up into the esophagus. Some advertise that their devices prevent plagiocephaly or “flat head” syndrome, a deformation that occurs when a baby’s skull develops a flat spot or becomes asymmetrical due to positional pressure.
Some manufacturers even claim that their products may reduce the risk of Sudden Infant Death Syndrome (SIDS), the leading cause of death in infants under one year of age.
The FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS. The FDA and CPSC said they were unaware of any scientific studies showing that infant sleep positioning aids prevent SIDS.
Because of the hazards now known to be associated with infant sleep aids, the FDA is requiring all manufacturers of even previously FDA-cleared products to submit clinical data showing that their products’ benefits outweigh the risks. The FDA is also asking these manufacturers to stop producing, marketing or distributing their products until after all data has been reviewed and approved.
The federal agencies are warning parents and caregivers that the use of sleep positioning aids is dangerous and unnecessary. They recommend infants be placed flat on their backs, on a firm surface, without pillows, quilts, blankets or toys. Consumers are being advised to follow the ABC’s of safe infant sleep: “alone” on the “back” in a bare “crib.”
The American Academy of Pediatrics also recommends that infants be placed on their backs for sleep. The Academy supports the federal government’s position, calling on the public not to use sleep positioners to prevent SIDS or to promote sleep.
Many of the injured infants suffocated after rolling from their side onto their stomach. In addition to the reported deaths, CPSC has received dozens of reports of close calls: babies who were put to sleep on their sides or backs, only to be found later in dangerous positions within or beside their sleep aids.