Utilizing child neck floats can result in dying or damage, the FDA says in a brand new warning. (Andrey Zhuravlev/iStock)
Regulators are warning {that a} system utilized in water remedy for infants with developmental disabilities may result in dying or severe damage.
The Meals and Drug Administration says that oldsters, caregivers and well being care suppliers shouldn’t use what are often called child neck floats for water remedy intervention, significantly with infants who’ve developmental delays or different disabilities together with spina bifida, spinal muscular atrophy kind 1, Down syndrome and cerebral palsy.
The floats, that are marketed for kids as younger as two weeks, are inflatable plastic rings that go round a child’s neck, permitting them to drift in water. They’ve been utilized by dad and mom within the bathtub, for swimming and as a bodily remedy instrument, the FDA mentioned.
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In a discover launched late final month, the FDA indicated that “some producers are claiming these merchandise assist water remedy interventions in infants with developmental delays or particular wants and that the advantages of those merchandise embody elevated muscle tone, higher flexibility and vary of movement, elevated lung capability, higher sleep high quality and elevated mind and nervous system stimulation.” Nonetheless, the company mentioned that “the security and effectiveness of neck floats to construct energy, to advertise motor growth or as a bodily remedy instrument, haven’t been established.”
Federal regulators mentioned that they know of 1 child who has died and one other who was hospitalized on account of using child neck floats. Each youngsters had been injured once they weren’t being instantly monitored, the FDA mentioned.
“Whereas the FDA believes that dying or severe damage from neck floats is uncommon, well being care suppliers, dad and mom and caregivers needs to be conscious that these occasions can and do happen. It is usually doable that some circumstances haven’t been reported to the FDA,” the discover states.
Child neck floats can result in dying from drowning and suffocation in addition to neck pressure or damage. The dangers could also be particularly acute for kids with disabilities, the FDA mentioned.
“Bear in mind that these neck floats haven’t been evaluated by the FDA and we’re not conscious of any demonstrated profit with using neck floats for water remedy interventions,” the discover signifies.
Along with warning dad and mom, caregivers and well being care suppliers in regards to the floats, the FDA mentioned it has communicated considerations to corporations which might be advertising and marketing the neck floats as a water remedy instrument with out federal clearance or approval and the company is constant to watch advertising and marketing supplies and claims.
Shoppers and well being professionals can report hostile occasions associated to using child neck floats to the FDA.
