FDA Issues Letter Strongly Encouraging Use of New Enteral Connectors

The U.S. Food and Drug Administration (FDA) is concerned by continued reports of misconnections with
enteral devices. To reduce the risk of misconnections and patient injury, the FDA recommends hospitals
and clinicians use enteral devices with connectors that meet the International Organization for
Standardization (ISO) 80369-1 or ISO 80369-3 standard, or that are otherwise designed to reduce the
risk of misconnections. There are currently marketed enteral connectors that meet the 80369-3
standards, many of which are identified by the tradename ENFit.

Misconnections between enteral devices and other medical devices, such as tracheostomy tubes, have
been associated with patient death and serious injuries. Since 2011, the FDA has received reports of 2
deaths, 24 serious injuries, and 32 device malfunctions related to enteral misconnections. The FDA is
also concerned that many misconnections, including enteral misconnections, are not reported, or are
reported as medication errors.

Medical device misconnections may occur when one type of medical device is mistakenly attached to
another type of medical device that performs a different function. Because the connectors on these
devices are easy to use and may be compatible with different medical devices, users can mistakenly
connect unrelated systems to one another.

In 2015, the FDA published a guidance document, Safety Considerations to Mitigate the Risks of
Misconnections with Small-bore Connectors Intended for Enteral Applications, which recommends
manufacturer’s design and test enteral connectors based on the ISO 80369 series standards to reduce
the risk of misconnections. The FDA also issued a letter to manufacturers of enteral products, health
care providers, and hospital purchasing departments about the danger of misconnections in 2010.

09/07/2018 The FDA Encourages Use of Enteral Device Connectors that Reduce Risk of Misconnection and Patient Injury - Letter to Health Care Providers, click the link to read the letter in its entirety.