On June 28, 20222, the U.S. Food and Drug Administration (FDA) issued a warning to parents, guardians, health care providers, and caregivers not to use neck floats with babies for water therapy interventions. The warning announcement also states that the neck floats should also never be used with babies with special needs, developmental delays, spina bifida, Down syndrome, spinal muscular atrophy (SMA) type 1, or cerebral palsy. The FDA warns that these neck floats can lead to death or severe injury.
The FDA Provides the Following Recommendations for Parents and Caregivers:
- Never use baby neck floats for water therapy interventions, especially with babies who have special needs or developmental delays, because the floats can lead to death or serious injury.
- The use of neck floats with special needs babies can lead to an increased risk of neck injury, muscle strain, and other injuries.
- The U.S. FDA has not thoroughly evaluated neck floats, and the FDA states that they are not aware of demonstrated benefits concerning the use of neck floats during water therapy interventions.
- Should your baby or an individual under your care be harmed by a neck float, the FDA urges you to report the incident. Reporting these incidents helps the FDA better understand the risks associated with neck floats.
FDA Recommendations for Medical Professionals:
- Review this neck float safety communication with your care teams, parents, colleagues, and baby caregivers who utilize neck floats for water therapy intervention, and make sure that they understand the potential risk of severe injury and death linked to neck floats.
- Prevent the use of neck floats with babies, especially babies who have the aforementioned medical conditions.
- Should patients experience harm using neck floats, report the incident to the FDA to help the FDA identify and understand the risks associated with the neck floats.
Neck Float Device Description
According to the FDA, neck floats are inflatable plastic rings worn around a baby’s neck that help babies float freely in the water. Some neck floats products are retailed and marketed for premature babies and infants as young as two weeks old. They are intended to cradle a baby’s head as their body dangles in the water. People have used neck floats while bathing babies, while babies are swimming, and as a physical therapy tool for babies with disabilities and developmental delays.
The FDA acknowledges that some manufacturers claim these neck float products support water therapy interventions in babies who have special needs or developmental delays, and their benefits include greater flexibility, increased muscle tone, better range of motion, better sleep quality, increased lung capacity, and increased nervous system and brain stimulation. The effectiveness and safety of neck floats to promote motor development, for use as a physical therapy tool, or for strength building have not been established by the FDA.
Increased Risk of Injury or Death with the Use of Neck Floats in Babies
According to the FDA warning letter, the risks of using baby neck floats include strain, injury to a baby’s neck, and fatalities due to drowning and suffocation. Babies who have special needs, including SMA Type 1 or spina bifida, have a significantly increased risk for serious injury.
The FDA knows of at least one baby’s death and another baby who was hospitalized in connection with the use of baby neck floats. In these incidents, the babies were harmed because their caregivers were not monitoring them.
Although the FDA believes that severe injury or death caused by neck floats are rare, parents, medical professionals, and caretakers should be knowledgeable about these incidents can and these incidents can happen. It is possible that incidents have not been reported to the FDA.
The FDA is currently informing the public about the danger to babies who use neck floats, particularly babies with special needs or developmental delays, as the FDA works with external stakeholders to raise awareness of the problem.
The FDA recently became knowledgeable of companies marketing their neck float products as a water therapy tool without prior FDA approval or clearance. The FDA has expressed its concerns about promotional materials used by these companies, and the FDA will continue to monitor any promotional claims and materials for these neck float devices. The FDA will continue to inform the public about new, significant information as it becomes available.
Do You Have a Case?
If your child experiences injury or death associated with neck floats, we encourage you to contact our firm for your free case review and file a claim against the manufacturer.
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