FDA Reemphasizes Importance of Using Enteral Device Connectors to Reduce Risk of Misconnection

September 21, 2018 | Aging Services Risk Management


​The U.S. Food and Drug Administration (FDA) released an open letter to manufacturers of enteral feeding tubes, healthcare professionals, and healthcare facility purchasing departments and distributors encouraging the use of enteral device connectors following continued reports of death and injury due to misconnections. FDA says it has received reports of two deaths, 24 serious injuries, and 32 device malfunctions related to enteral misconnections since 2011, and the agency fears more misconnections have not been reported or were mistakenly reported as medication errors. Misconnection injuries may result when one medical device is attached to another that performs a different function; because many connectors are compatible with multiple devices, users may mistakenly connect unrelated systems to one another. Misconnection can result in medication or other substances being delivered through the wrong tubing into the incorrect area of the body. The FDA has released multiple guidance and recommendation documents over the years in efforts to reduce the risk of patient injury, such as Safety Considerations to Mitigate the Risks of Misconnections with Small-Bore Connectors Intended for Enteral Applications in 2015 and an open letter similar to the current one in 2010.

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