WASHINGTON — The U.S. Food and Drug Administration warned caregivers of small children on Tuesday against using neck floats with babies as a physical therapy tool after fielding reports of at least one child death and one hospitalization linked to the flotation devices.
The warning applies especially for infants who have developmental delays or special needs including spina bifida, spinal muscular atrophy type 1, Down syndrome or cerebral palsy, WEYI-TV reported.
Traditionally, the inflatable plastic rings are marketed for babies as young as 2 weeks old, and even premature babies, because they are designed to cradle the infant’s head while their body moves freely in the water, the FDA stated in a news release.
Common uses for the neck floats include during a baby’s bath or while swimming, but use as a physical therapy tool – often called water therapy intervention – has not been approved the FDA.
The products’ misuse, the FDA stated, can lead to death via drowning or suffocation, among other serious injuries.
“Recently, the FDA became aware of companies marketing neck floats for use as a water therapy tool without FDA clearance or approval,” the agency stated.
“The FDA has communicated our concerns about these promotional materials to these companies and will continue to monitor promotional materials and claims for these devices,” the statement continued.
Meanwhile, the agency cautioned the caregivers of infants to bear in mind the following:
- The use of neck floats in babies with special needs or developmental delays can lead to an increased risk of neck strain and injury.
- 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.”
- Report any injury caused by a neck float to the FDA in order to help the agency “better understand the risks associated with medical devices.”
To date, the FDA has learned of one baby who died and one baby who required hospitalization related to the use of the products, but in both cases the infants were injured when their caregivers were not monitoring them directly, WEYI reported.
“The FDA is aware that some manufacturers are claiming these products support water therapy interventions in babies with developmental delays or special needs and that the benefits of these products include increased muscle tone, greater flexibility and range of motion, increased lung capacity, better sleep quality, and increased brain and nervous system stimulation,” according to the news release.
“The safety and effectiveness of neck floats to build strength, to promote motor development or as a physical therapy tool have not been established,” the agency concluded.
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