Baby swim sessions where infants are able to float around a tub with their heads attached to a circular inflatable device have become very popular in recent years.
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. 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.
Now the U.S. Food and Drug Administration (FDA) is warning parents, caregivers, and health care providers not to use these devices 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. The use of these products can lead to death or serious injury.
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. 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 risks of using baby neck floats include death due to drowning and suffocation, strain, and injury to a baby’s neck. Babies with special needs such as spina bifida or SMA Type 1 may be at an increased risk for serious injury.
The FDA is aware of one baby who died and one baby who was hospitalized related to the use of baby neck floats. In both cases, the babies were injured when their caregivers were not directly monitoring them.
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. It is also possible that some cases have not been reported to the FDA.
The FDA is asking parents or caregivers who have experienced adverse events associated with using neck floats to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
Please include the following information in your reports:
Device Name (Brand Name)
Manufacturer’s, Importer’s, and/or Distributor’s Name
Details of Adverse Event and Medical and/or Surgical Interventions (if applicable)
Recommendations for Parents and Caregivers
- Do not use baby neck floats for water therapy intervention. The use of these products, especially with babies with developmental delays or special needs, can lead to death or serious injury.
- Be aware that the use of neck floats in babies with special needs can lead to an increased risk of neck strain and injury.
- 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.
- If a baby or individual in your care is injured by a neck float, we encourage you to report this to the FDA.
