FDA – According to a February 8, 2022 safety communication from the U.S. Food and Drug Administration (FDA), the FDA published a warning to parents, health care providers, and caregivers of pediatric patients who require enteral feeding. The safety communication letter states that there is a strangulation risk connected to enteral feeding delivery sets. According to the FDA, enteral feeding delivery set tubing can accidentally wrap around a child’s neck leading to strangulation or death.
The FDA’s safety communication states that the agency has received two reports of toddlers tragically dying after the enteral feeding delivery set tubing strangled them. Both incident reports involve children two years of age found with the tubing wrapped around their necks in approximately ten minutes when their caregivers were not watching them.
Enteral feeding delivery sets are used to supply nutrition to individuals who cannot swallow, eat, or be fed by mouth to satisfy their nutritional needs. These enteral feeding delivery sets include tubing that feeds the patient using a pump or gravity. Feeding tubes typically pass straight to the small intestine or stomach through the mouth, artificial opening in the abdomen, or nose.
The FDA recommends that parents, health care providers, and caregivers of pediatric patients avoid keeping the enteral feeding delivery set tubing in and leaving the children unsupervised.
The FDA also recommends that parents contact their child’s health care provider:
- If their child has a history of becoming entangled in their tubing.
- About measures that can be taken to make sure the feeding tubing doesn’t get wrapped around their child’s neck.
- If they have any concerns about the risk of feeding set tubing strangulation.
The FDA is also asking parents to report any incidents of their child being harmed by feeding set tubing to help improve patient safety.
Health care providers are asked to review this issue with their colleagues, caregivers, and care teams of pediatric patients who are using enteral feeding delivery sets. Moreover, the FDA is asking health care professionals to review the risks and careful use of enteral feeding tubes during the patient’s individual risk assessment. The FDA is asking health care providers to report any incidents of patients who suffered an adverse event associated with enteral feeding set tubing.
The FDA is contacting parents, health care providers, and caregivers of this danger to patients who receive enteral feeding as the FDA works with outside stakeholders to raise awareness of the issue. The FDA will also inform the public of all new information as it becomes available. The FDA is working with the medical device manufacturers about the risk in pediatric patients, and creating strategies to minimize patient risk.
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