The FDA is on the potential risk of strangulation among children using enteral feeding systems.
In a safety alert issued on Tuesday, the agency said two toddlers died last year after becoming entangled in the systems' feeding tubes. Both children were younger than 2 years old and were found with tubing around their necks by their caregivers -- after about a 10-minute period of not being monitored, in one report.
"While the FDA believes that 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," the agency stated. "It is also possible that some cases have not been reported to the FDA."
Enteral feeding delivery sets are used to provide nutrition to people who have difficulty eating or swallowing, via a feeding tube that passes through the nose, mouth, or an artificial opening directly to the stomach or small intestine.
Healthcare providers who work with pediatric patients should ensure that care teams and caregivers are aware of the risk of strangulation when using enteral feeding tubes. Steps should be taken to prevent feeding tubes from getting wrapped around a patient's neck and enteral feeding tubes should be kept away from children as much as possible, the FDA said.
Clinicians should also take note of their patients' medical lines when providing care or conducting risk assessments to prevent potential entanglements, the FDA added.
The FDA said it was working with manufacturers and other stakeholders to evaluate risk and risk factors associated with using enteral feeding systems in pediatric patients and to raise awareness of the issue.
Clinicians should report any adverse events related to enteral feeding delivery systems to its program, the agency said.