Strangulation Deaths Spur FDA Alert on Pediatric Enteral Feeding Kits

Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the US Food and Drug Administration (FDA). The safety alert was prompted by two deaths linked to the medical devices.

The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.

Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a February 8 safety communication.

“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.

Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s healthcare provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.

Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.

The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.

“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”

Parents and healthcare providers can report injuries caused by these devices to the FDA.

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