![]() ![]() Recently, the FDA became aware of companies marketing neck floats for use as a water therapy tool without FDA clearance or approval. The FDA is informing parents, caregivers, and health care providers of the risk to babies who use neck floats, especially babies with developmental delays or special needs, while we work with external stakeholders to increase awareness of the issue. It is also possible that some cases have not been reported to the FDA. While the FDA believes that death or serious injury from neck floats is rare, health care providers, parents, and caregivers should be aware that these events can and do occur. In both cases the babies were injured when their caregivers were not directly monitoring them. The FDA is aware of one baby who died and one baby who was hospitalized related to the use of baby neck floats. Babies with special needs such as spina bifida or SMA Type 1 may be at an increased risk for serious injury. The risks of using baby neck floats include death due to drowning and suffocation, strain, and injury to a baby’s neck. Risk of Death or Injury with Use of Neck Floats in Babies 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 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. Parents and caregivers have used these products during a baby’s bath, while their baby is swimming, and as a physical therapy tool (water therapy intervention) for babies with developmental delays or disabilities. ![]() Some neck floats are marketed for babies as young as two weeks old or premature babies and are designed to cradle a baby's head while their body moves freely in the water. Neck floats are inflatable plastic rings that can be worn around a baby’s neck and allow babies to float freely in water. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If a patient experiences a problem with a neck float, report this to the FDA.Discourage use of neck floats in babies with these conditions.Review this safety communication with your colleagues, care teams, parents and caregivers of babies who use neck floats for water therapy intervention, to ensure they are aware of the potential risk of death or injury associated with neck floats.Recommendations for Health Care Providers Your report, along with information from other sources, can help the FDA identify and better understand the risks associated with medical devices. If a baby or individual in your care is injured by a neck float, we encourage you to report this to the FDA.Be aware that these 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.Be aware that the use of neck floats in babies with special needs can lead to increased risk of neck strain and injury.The use of these products, especially with babies with developmental delays or special needs, can lead to death or serious injury. Do not use baby neck floats for water therapy intervention.Recommendations for Parents and Caregivers The use of these products can lead to death or serious injury. ![]() Food and Drug Administration (FDA) is warning parents, caregivers, and health care providers not to use neck floats with babies for water therapy interventions, especially with babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy (SMA) type 1, Down syndrome, or cerebral palsy. ![]()
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