The U.S. FDA is warning healthcare providers, parents, and caregivers of pediatric patients who receive enteral feeding that there is a risk of strangulation from the use of enteral feeding delivery sets.
Enteral feeding delivery sets are medical devices used to provide nutrition to people who are unable to eat, swallow, or be fed by mouth to fully meet their nutritional needs. The FDA says the feeding set tubing can become wrapped around a child’s neck and cause strangulation or death. The FDA received reports of two toddlers who died after being strangled by the tubing.
While the FDA believes death or serious injury from strangulation with enteral feeding set tubing in children is rare, healthcare providers 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 says it is working with external stakeholders to increase awareness of the issue and is also working with manufacturers to evaluate information about the risk in pediatric patients, including follow-up with health care providers, parents and caregivers.
The FDA will keep the public informed if significant new information becomes available. The FDA encourages users who believe they have a problem with their device to report the problem through the MedWatch Voluntary Reporting Form.
Featured image: Picture of feeding set tubing. Other feeding set tubing may look different. (Photo: FDA)