Date of issue: June 28, 2022
The United States Food and Drug Administration (FDA) warns parents, caregivers, and health care providers not to use cervical floats with babies for water therapy procedures, 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. Use of these products can result in death or serious injury.
Recommendations for Parents and Guardians
- Do not use baby neck floats for a water therapy procedure. Use of these products, particularly with babies with developmental delays or special needs, could result in death or serious injury.
- Be aware that the use of neck floats on babies with special needs may lead to an increased risk of neck strain and injury.
- Please 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 procedures.
- If a baby or someone in your care is injured by a neck floater, we encourage you to report it 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 co-workers, care teams, parents and caregivers of babies using neck floats for a water therapy procedure to ensure they are aware of the potential risk of death or injury associated with neck floats.
- Discourage the use of neck floats in babies with these conditions.
- If a patient experiences a problem with a neck float, report it to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
Description of the device
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 while bathing a baby, while their baby is swimming, and as a tool for physiotherapy (water therapy intervention) for babies with developmental delays or disabilities.
The FDA is aware that some manufacturers claim that 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 for building strength, promoting motor development, or as a physical therapy tool have not been established.
Risk of Death or Injury from Using Cervical Floaters on Babies
Risks of using baby neck floats include death from drowning and suffocation, fatigue, and injury to a baby’s neck. Babies with special needs like spina bifida or SMA type 1 may be at increased risk of serious injury.
The FDA is aware of one baby who died and one baby hospitalized due to the use of baby floats. In both cases, the babies were injured while their caregivers were not directly supervising them.
Although the FDA believes that deaths or serious injuries from cervical floaters are rare, healthcare 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 Notifies Parents, Caregivers, and Health Care Providers of Risk to Babies Using Neck Floats, Particularly Babies with Developmental Delays or Special Needs, as We Work with Stakeholders to raise awareness of the problem.
Recently, the FDA has become aware of companies marketing neck floaters for use as a water treatment tool without FDA clearance or approval. The FDA has raised our concerns about these promotional materials with 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 Issues to the FDA
If you experience any adverse reactions associated with the use of neck floats, we encourage you to voluntarily file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities subject to FDA user facility reporting requirements must follow the reporting procedures established by their facilities.
Please include the following information in your reports:
- Device name (brand name)
- Name of manufacturer, importer and/or distributor
- Details of adverse event and medical and/or surgical procedures (if applicable)
If you believe a medical device is being marketed outside the scope of its FDA approval or clearance, you may report that allegation through the FDA regulatory misconduct allegation process. You can also contact your local FDA Consumer Complaints Coordinator for assistance with this process.
If you have any questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796- 7100.