Original Post
Date Issued: June 28, 2022
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.
Device Description
Neck floats are inflatable plastic rings that can be worn around a baby’s neck and allow babies to float freely in water. 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.
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.
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.
FDA Actions
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.
Reporting Problems to the FDA
If you experience adverse events associated with using neck floats, we encourage you 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)
If you believe a medical device is being marketed outside the scope of its FDA approval or clearance, you can report that allegation through FDA’s Allegations of Regulatory Misconduct process. You can also contact your local FDA Consumer Complaint Coordinator for assistance with this process.
Questions?
If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.
- Content current as of: 06/28/2022
- Regulated Product(s)
- Medical Devices
