The FDA and the Consumer Product Safety Commission (CPSC) have issued a joint warning against the use of sleep-positioning devices designed for babies.
The devices have caused 12 infant deaths over the past 13 years.
“Our goal is to make sure parents and caregivers are aware of the risks and to warn them to immediately stop using these devices,” said FDA principal deputy commissioner Joshua Sharfstein in a statement to reporters.
The positioners, have risers on their sides to hold a baby in place during sleep. Some also include wedges to raise the baby’s head. Several of the devices were cleared by the FDA as a means of alleviating symptoms caused by gastroesophageal reflux disease (GERD) and for preventing flat-head syndrome, a deformity caused by pressure on one side of a baby’s head.
However, the FDA, which has jurisdiction over the products because of the medical claims made by the manufacturers, has now determined that the risk of death far outweighs any potential benefits provided by the sleep positioners.