The U.S. Food and Drug Administration (FDA) has issued finalized guidance for manufacturers, FDA reviewers, and others involved in manufacturing devices that use small-bore connectors for enteral feeding. Originally released as a draft on July 27, 2012, Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications recommends that devices with connectors that are part of, or form connections to, enteral feeding tubes conform to Association for the Advancement of Medical Instrumentation's (AAMI) AAMI/CN3:2014 (PS) Part 3; however, conformance to the standard is not a requirement. It also recommends that manufacturers design and test enteral connectors based upon AAMI/CN3:2014 (PS) and AAMI/CN20:2014 (PS) to ensure that each proposed enteral connector is physically incompatible with nonenteral devices and that manufacturers of enteral connectors that do not meet AAMI/CN3:2014 (PS), also known as proprietary connectors or transition connectors, continue to design and test the devices based upon the AAMI/American National Standards Institute (ANSI)/International Organization for Standardization (ISO) 80369-1 standard. Other recommendations in the guidance include using rigid or semirigid materials in connector construction to prevent "forced fit" misconnections that more flexible materials allow, using mechanical testing to assess incompatibility, conducting a risk assessment for each device manufactured, avoiding color-coding in the absence of demonstrated non-interconnectability, and using a simplified and easy-to-understand labeling system. More information on the risks of tubing misconnections is available on FDA's web page Tubing and Luer Misconnections: Preventing Dangerous Medical Errors.

HRC Recommends: Organizations should review the FDA guidance and take steps to ensure that their purchase specifications for enteral tubing require that the tubing manufacturer conform to recommended standards. Using connectors that are physically incompatible with nonenteral devices increases patient safety by effectively ensuring that the tube cannot be inadvertently misconnected.