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FDA issues warning for neck floats used for water therapy

The US Food and Drug Administration (FDA) has issued a safety communication warning about the risk of serious injury or death associated with neck floats when used for water therapy in babies with special needs.

Neck floats are marketed to parents and caregivers for a variety of uses, from swimming to being used as a physical therapy tool for water therapy in infants with developmental delays or disabilities. Some manufacturers even market them for use with infants as young as 2 weeks of age. Therapeutic claims include improved lung capacity, increased muscle tone, and greater range of motion. However, the US Food and Drug Administration (FDA) has issued a Safety Communication warning parents and caregivers that using them for water therapy can lead to serious injury or death in infants with spina bifida, spinal muscular atrophy, type 1, cerebral palsy, or other neurodevelopmental conditions. The communication offers recommendations for both parents and health care providers.

Recommendations for parents include:

  • Awareness that using a neck float with an infant who had special needs could potentially increase the risk of neck strain and injury.
  • Know that neck floats have not been evaluated by the FDA and no demonstrated benefit has been seen with their use.
  • Do not use neck floats for water therapy.
  • Report any injury caused by a neck float to the FDA.

The communication made the following recommendations for clinicians:

  • Go over the safety communication with staff, colleagues, and parents during well-child visits.
  • Offer clear discouragement for using neck floats in infants with special needs.
  • Encourage parents who experience injury or death because of neck float use to report it to the FDA.

The communication is the result of 2 known cases of injury or death due to use of the device. Both cases occurred when the infant was not directly monitored. Additionally, the therapeutic claims made by manufacturers has been made without clearance from the agency. Companies who made these claims have been informed of the FDA’s concerns and future marketing will be monitored.

Reference

Do not use baby neck floats due to the risk of death or injury: FDA safety communication. US Food and Drug Administration. Published June 28, 2022. Accessed June 29, 2022. https://www.fda.gov/medical-devices/safety-communications/do-not-use-baby-neck-floats-due-risk-death-or-injury-fda-safety-communication