UNITED STATES (KSNT) – The U.S. Food and Drug Administration is warning parents and other caregivers about possible dangers associated with the use of neck floats for babies.

According to the FDA, baby neck floats pose a health risk to infants. The warning applies especially to babies with developmental delays or special needs such as spina bifida, spinal muscular atrophy type 1, Down syndrome or cerebral palsy. The FDA says the use baby neck floats has lead to at least one death and serious injuries.

Neck floats are inflatable plastic rings that are placed around a baby’s neck to cradle their heads while they float freely in the water. These neck floats are marketed for infants as young as two weeks old and premature babies. These products are often used during a bath, while the baby is swimming and as a physical therapy tool for babies with developmental delays or disabilities.

Some manufacturers claim these products help increase muscle tone, flexibility, range of motion and lung capacity, while providing better sleep quality and increased brain and nervous system stimulation. The safety and effectiveness of neck floats has not been established by the FDA.

The FDA says the use of neck floats can lead to drowning and suffocation deaths, strain and injury to a baby’s neck. Infants who have special needs, such as spina bifida or SMA Type 1, may be at an increased risk for serious injury.

One baby died and another baby was hospitalized, according to the FDA, as a result of using neck floats. In both cases, caregivers were not directly monitoring the babies when the incidents occurred. Though cases of death or serious injury from neck floats is rare, health care providers, parents and caregivers should be aware these events can and do occur. It is possible that not every case has been reported to the FDA.

The FDA says some companies are continuing to market neck floats for use as a water therapy tool without FDA approval or clearance. These companies have been notified of the FDA’s concerns.

The FDA gave the following recommendations for parents and caregivers:

  • 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 increased risk of neck strain and injury.
  • Be aware that these neck floats have not been evaluated by the FDA and they 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, you are encouraged to report it 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.

The following recommendations are for health care providers:

  • Review this safety communication with your colleagues, care teams, parents and caregivers of babies who use neck floats for water therapy intervention, to ensure they are aware of the potential risk of death or injury associated with neck floats.
  • Discourage use of neck floats in babies with these conditions.
  • If a patient experiences a problem with a neck float, report this to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

To report problems to the FDA regarding neck floats, you can file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Be sure to include information on the device name, manufacturers and details of the adverse event in your report.

If you have any questions, email the Division of Industry and Consumer Education at dice@fda.hhs.gov or call 800-638-2041 or 301-796-7100.