中国国际医疗器械设计与制造技术展览会(Medtec China)2021

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August 31-September 2 2022 | SWEECC H1&H2

FDA Warns of Pediatric Feeding Tube Strangulation

2022-02-17

FDA said it has received reports of two toddlers who died after being strangled by the their enteral feeding tube. In addition to raiding awareness of this issue, the agency said it is also working with manufacturers to evaluate information about the risk in pediatric patients. The feeding tube can become wrapped around a child's neck and cause strangulation or death, the agency warns.

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. These sets include tubing that delivers feeding to the patient’s enteral tube (or feeding tube) using gravity or a pump. A feeding tube passes directly to the stomach or small intestine through the nose, mouth, or artificial opening in the abdomen.

Recommendations for parents and caregivers of children who use a feeding tube

Be aware that the feeding set tubing can get wrapped around a child’s neck, which can lead to strangulation or death.
To the extent possible, avoid leaving the feeding set tubing where infants or children can become entangled.
Discuss with your child's healthcare provider if your child has been tangled in their tubing before, steps you can take to prevent the tubing from getting wrapped around your child's neck, and any other concerns you may have about the risk of strangulation from the feeding tube.
If your child is injured by feeding set tubing, please report the event to FDA. Your report, along with information from other sources, can provide information that helps improve patient safety.

Recommendations for healthcare providers

Review this topic and the information noted above with your colleagues, care teams, and caregivers of pediatric patients who use enteral feeding tubes, to ensure they are aware of the potential risk of strangulation with the associated tubing and are taking appropriate measures to keep the tubing away from the child as much as possible.
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.
If a patient experiences an adverse event related to enteral feeding set tubing, you are encouraged to report the event to FDA. Prompt reporting of adverse events can help the agency identify and better understand the risks associated with medical devices.

Article source: Qmed and MD+DI