FDA Warns of Child Strangulation Risks Linked To Enteral Feeding Delivery Sets

Following at least two deaths linked to pediatric feeding tubes, federal health officials are warning parents and medical professionals to be aware of the potential strangulation risks associated with enteral feeding delivery sets.

The U.S. Food and Drug Administration (FDA) issued an enteral feeding system warning on February 8, instructing those using the devices to be cautious about the placement of the delivery system’s plastic tubing, which could possibly become wrapped around a child’s neck and cause strangulation or death.

Enteral feeding sets are often used for premature infants, critically ill neonates, babies and young children. The systems may be recommended by healthcare professionals when a child or preterm baby has trouble eating, cannot eat safely, has food allergies or cannot consume enough calories to meet their nutritional needs.

The systems deliver liquid food or baby formula through a pediatric feeding tube, using either gravity or a pump. The feeding tubes are placed in the nose, mouth or artificial opening in the abdomen to pass food directly to the stomach or small intestine.

These types of feeding systems are commonly used in the NICU, PICU and other pediatric hospital settings, but FDA officials warn that they may place children at risk of suffocation if they become tangled in the flexible plastic tubing.

The warning indicates that two enteral feeding tube strangulations have been identified, which resulted in the deaths of young children found with tubing wrapped around their necks after a brief period of time when their caregivers were not directly monitoring them. Both of the incidents involved two-year old children, who were only left unmonitored around the enteral feeding delivery sets for approximately 10 minutes, according to the reports.

While the FDA states these types of feeding tube strangulations are rare, the agency recommends pediatric care settings review the topic and importance of enteral feeding system monitoring, and be aware of the risk of strangulation.

The FDA indicates that it will also begin working with manufacturers of the devices to evaluate warning information provided to healthcare providers, parents and caregivers to mitigate patient risk.

Although there is no eternal feeding set recall being issued, the FDA is encouraging customers or patients to report any problems or adverse events associated with the devices to the agency’s MedWatch Voluntary Reporting System.

Infant Enteral Feeding Timing May Decrease Necrotizing Enterocolitis (NEC) Risks

One of the most vulnerable populations to require the use of enteral feeding systems are premature babies in the NICU, specifically, infants who are forced to be fed baby formulas such as Enfamil or Similac, either due to either a mother’s inability to produce milk or other infant feeding difficulties. However, premature infants face a serious risk of necrotizing enterocolitis (NEC) from baby formula containing cow’s milk, which may occur when harmful bacteria breaches the walls of the intestines, causing portions of the intestines to become inflamed or die.

Following years of research that established a link between NEC and baby formula, a growing number of families are now pursuing a Similac lawsuit or Enfamil lawsuit, each raising similar factual allegations and claims that infants may have avoided the devastating diagnosis if accurate warnings and information had been provided by the manufacturers about the risks associated with their products.

In a recent study published in the Journal of Pediatric Gastroenterology and Nutrition, researchers found that among 12,387 very low birth weight infants born between 2000 and 2014, those who received slower feeding advancements through enteral feeding methods had lower necrotizing enterocolitis (NEC) risks and fatal outcomes.