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SafetyShare® newsletter brought to you by the Premier Safety Institute®
June 18, 2015
 


 SafetyShare®

New enteral feeding products with ENFit connectors: Implementation timeline delayed

The U.S. has moved forward with an AAMI1 / ANSI2 provisional standard for small bore connectors for enteral applications without
waiting for final approval of the international standard from ISO3. This enteral standard is the first in a series that will eliminate the use
of a common connector design, such as Luer connectors and reduce the risk of unintended connections between devices that have different intended uses. The
new enteral connector standard describes a unique connector, ENFit, intended for only enteral applications, thus reducing the risk of unintended
connections between enteral and non-enteral devices.

Timeline for enteral feeding products pushed back due to delay with enteral syringes

The transition to new enteral feeding products with ENFit connectors, includes transition feeding
administration sets, enteral-specific syringes, and new enteral feeding tubes and was projected to occur in phases throughout 2015. Because of delays in
production and capacity, the timeline has been pushed back to provide additional time for syringe manufacturers to ensure an adequate supply of
enteral-specific syringes with ENFit tips to access feeding tubes with ENFit connectors. Enteral-specific syringes with ENFit are the only syringes that
will connect with enteral feeding tubes with ENFit connectors and are required to check placement, administer medications and deliver feedings. See Figure
for updated timeline.

This timeline is only a guide and introduction of new products by specific manufacturers may differ subject to FDA4 510(k) pre-market clearance
or other factors. Details regarding this
timeline in U.S. and internationally, as well as
other resources to assist with implementation are available at www.stayconnected.org.

ENFit syringes – safety considerations for low dose medications

Some safety concerns have emerged related to potential low dose medication accuracy risks with the new ENFit enteral-specific syringe use with feeding
tubes in neonates, infants and some pediatric patients. Potential risks can be reduced with proper education and supplies. The ISMP5 in its April 9, 2015 newsletter, outlines specific processes and supplies (bottle
adaptors, draw up straws, tip caps) that should be used when preparing liquid medications in ENFit syringes for administration via ENFit feeding tubes,
especially for low dose (less than 2 ml) medications. GEDSA6 has also released a statement, which includes step-by-step guidance on
the appropriate methods for preparing and administering liquid medications using ENFit syringes and ENFit feeding tubes. Note: ENFit enteral-specific
syringes were designed for use with ENFit feeding tubes and are not recommended for administering oral medications, particularly low dose volumes (less
than 2 ml).

Resources

1. Association for the Advancement of Medical Instrumentation (AAMI)

2. American National Standards Institute (ANSI)

3. International Standards Organization (ISO)

4. U.S. Food and Drug Administration (FDA)

5. Institute for Safe Medication Practices (ISMP)

6. Global Enteral Device Supplier Association (GEDSA)

 

 


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