The FDA is warning that parents should avoid using neck floats for infants with special needs or developmental delays.
According to the agency, companies have been advertising the products as having health benefits for children with physical and developmental problems, despite a lack of evidence for such claims. The companies, which the FDA did not name, claimed that water therapy with floats could help babies with special needs – like those with spina bifida – to increase muscle tone, boost flexibility and range of motion, and build lung capacity, among other benefits.
But used improperly, neck floats can lead to serious injury and death. At least one baby has died, and one was hospitalized, after using the floats, FDA officials said.
The inflatable plastic rings are worn around a baby’s neck, allowing them to float freely in water. Some of these products are being marketed for infants as young as 2 weeks old, as well as for premature babies. But the FDA said the safety and effectiveness of the products for these children have not been proved.
The 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,” the agency said in the June 28 statement.
While injuries and deaths from neck floats are rare, the FDA said families and caregivers should be aware that these incidents can and do occur.
People who have problems with the neck floats are encouraged to report them through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by the FDA are required to file new reports with the FDA.
Source
FDA: “Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication.”
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