Providers should take extra precautions when using feeding tubes, according to new guidance from the Food and Drug Administration.
Concerns stem from the use of enteral feeding devices, which are prone to misconnections — when the tube is accidentally attached to another medical device that performs a different function. To minimize those risks, the FDA is urging skilled care and other providers to use connectors that meet guidelines spelled out by the International Organization for Standardization, found here, or that are otherwise built to reduce risk of improper connection.
The FDA notes that misconnections, with devices such as tracheostomy tubes, have been tied to resident death and injury. Since 2011, the administration has received reports of two deaths, 24 serious injuries and 32 device malfunctions related to enteral misconnections. The FDA also said it’s concerned with underreporting of these events.
In its letter, the FDA said it continues to work with providers, patients and other stakeholders to “reduce the chance of medical device misconnections, ensure patient safety and facilitate the availability of products that work for the multitude of patient populations, uses and care environments.”
The letter from William Maisel, M.D., the FDA’s director of the Office of Device Evaluation, is found here.
