FDA Issues Guidance on the Manufacturing of Connectors for Enteral Tubing

February 27, 2015 | Aging Services Risk, Quality, & Safety Guidance

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​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.

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