The U.S. 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. The use of these products can lead to death or serious injury.
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 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. Your report, along with information from other sources, can help the FDA identify and better understand the risks associated with medical devices.
Recommendations for Health Care Providers
- 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.
- Discourage use of neck floats in babies with these conditions.
- If a patient experiences a problem with a neck float, report this to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
Risk of Death or Injury with Use of Neck Floats in Babies
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 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.
Recently, the FDA became aware of companies marketing neck floats for use as a water therapy tool without FDA clearance or approval. The FDA has communicated our concerns about these promotional materials to these companies and will continue to monitor promotional materials and claims for these devices.
The FDA will keep the public informed if significant new information becomes available.