Table of Contents
The U.S. Food and Drug Administration (FDA) reports that parents and caregivers should be careful while providing enteral feeding to children as there is a high risk of strangulation caused by the feeding delivery tubes. The enteral feeding tubes may become wrapped around a child’s neck and result in strangulation or death. FDA has received reports of two children that got strangled due to wrapping of tubes.
Guidelines for parents and caregivers who use enteral feeding tubes for children
Be conscious of feeding sets so that it does not get wrapped around child’s neck. It may result in strangulation or death.
Discuss with the healthcare provider:
- If child has been tangled in the tubes before.
- Ensure that the child does not get engaged in the device sets, thus keep the tubes away from the child.
- Any concerns regarding the risk of strangulation should be effectively communicated.
Report any mishappening to FDA, if the child is injured by feeding tubes. This will help the companies to design the devices after thoroughly investigating patient’s safety.
Guidelines for Health Care Providers while caring paediatric patients
- Understand the problems related to enteral feeding tubes for paediatric patients. Convey the complications and risks to the care teams and caregivers to prevent any risk to the child. This would ensure that parents and caregivers take appropriate measures to prevent risk of strangulation through feeding tubes.
- When caring for children who require enteral feeding tubes be aware of the risks of strangulation and understand protocols associated with device safety.
- In case of any adverse events associated to tubing, ensure to report this to the FDA. Adequate reporting of adverse events will help the FDA to understand the risks and accordingly modify the medical device.
Description of Device
Enteral feeding tubing sets are medical equipment that provide nutrition to individuals who cannot swallow, eat, or have food intake through mouth to meet their nutritional requirements.
Enteral feeding tubes are sets that provide feeding to the patient through feeding tube via a pump or gravity. A feeding tube enters the stomach or small intestine through the mouth, nose, or via an artificial opening in the abdomen.
FDA regulations
In 2021, FDA received reports of strangulation from two parents when children were entrapped with feeding tubes. Both the children were less than 2 years old and tubes caused strangulation within a short span. In one case, children’s neck was wrapped in just 10 minutes when the children were left unattended.
The FDA is striving to promote awareness about patient safety among parents, caregivers and healthcare providers, especially who receive enteral feeding. This will create a better understanding regarding risks associated with medical devices.
FDA encourages to report the problems of the device sets through the MedWatch Voluntary Reporting Form
Conclusion
Risks of strangulation are minimal with feeding tubes, but recent reports have shown that additional care is required while designing enteral feeding device sets. Patient safety is the main priority of FDA and it will be possible if the healthcare providers, caregivers, and parents are aware and well-informed about the risks of enteral feeding tubes.
