FDA Warns Against Use of Baby Neck Floats

Federal regulators are warning parents and caregivers to immediately stop using any sort of baby neck floats, due to the risk of serious injury and possibly death.

On June 28, the U.S. Food and Drug Administration issued a safety communication indicating that the baby floats, which have been marketed for use during bath time, while swimming or during certain water therapy treatments, are particularly dangerous for infants who have developmental delays or special needs such as spina bifida, spinal muscular atrophy type 1, Down syndrome, or cerebral palsy.

The agency warns the use of baby neck floats can result in neck injuries, including strain and even death from drowning and suffocation. While the FDA indicates that cases of injury and death are rare, the products still pose a serious risk and should be avoided during water therapy intervensions.

At present, the FDA is aware of at least two incidents involving baby neck float injuries. One involved a child who needed to be hospitalized and the other incident resulted in a child’s death. Both occurred when their caregivers were not directly monitoring children, and officials are concerned other incidents may have occurred which were not properly reported.

Baby neck floats are inflatable plastic rings placed around the child’s neck that are designed to cradle the head, while allowing the infant’s body to float freely in the water. Some manufacturers of infant floatation devices have claimed that they can be used to support physical therapy –also called water therapy intervention- for babies suffering from developmental delays. The advertised benefits of this would include greater flexibility and range of motion, increased lung capacity and muscle tone, better sleep quality, and increased brain and nervous system stimulation.

The FDA indicates it has not established the safety or effectiveness of baby neck floats as physical therapy tools. The agency says it has contacted these companies and is working to monitor the advertisements and claims they are making about the unproven therapeutic benefits of using these devices.

The agency has provided a list of recommendations for parents and caregivers to help avoid serious injury and infant death.

• Do not use baby neck floats for water therapy intervention. The use of these products, especially with babies with developmental delays or special needs, can lead to death or serious injury.
• Be aware that the use of neck floats in babies with special needs can lead to an increased risk of neck strain and injury.
• Be aware that these neck floats have not been evaluated by the FDA and we are not aware of any demonstrated benefit with the use of neck floats for water therapy interventions.
• If a baby or individual in your care is injured by a neck float, we encourage you to report this to the FDA. Your report, along with information from other sources, can help the FDA identify and better understand the risks associated with medical devices.

Any consumer who experiences adverse events associated with the use of a baby neck float is urged to file a report through MedWatch, the FDA Adverse Event Reporting program.