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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:
The communication made the following recommendations for clinicians:
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.
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