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ENFit® Update
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ENFit® Update

The Oley Foundation was founded over thirty years ago to serve home enteral and parenteral nutrition (HEN and HPN) consumers. The safety and well-being of nutrition support consumers is in the forefront of all that we do. Today, changes seen in the enteral market—specifically, the introduction of International Organization for Standardization (ISO) standard 80369-3 and new enteral tubing connectors known as ENFit®—have the potential to affect both HEN and HPN consumers. And while HEN consumers are having a mixed reaction to the change, both HEN and HPN consumers may benefit as the risk of tubing misconnections will be reduced and patient safety increased.

Oley is aware of several concerns surrounding ISO 80369-3 and ENFit, and remains committed to facilitating an open dialogue between consumers, members of industry, the Food and Drug Administration (FDA) and the clinical community, and working towards seeing these issues resolved. We also applaud the effort to reduce tubing misconnections, which is the stated goal behind this initiative.

 

Syringes

ENFit tip syringes are available by prescription, and as such should be covered by insurance. They must be obtained from either a licensed pharmacy that provides your medication or the company that provides your enteral nutrition. Retail pharmacies should provide ENFit tip syringes when they provide medication to be administered via a feeding tube with an ENFit connector. It might be worth a call to make sure your pharmacy knows you will be giving the medication through a feeding tube, and to be sure they stock the syringes you will need. At this time, ENFit tip syringes are not considered over-the-counter devices, and therefore they cannot be ordered online or purchased at local pharmacies.

Oley remains committed to the issues that impact you, including reimbursement and availability, and is part of a working group to discuss both of these issues in regard to ENFit tip syringes.

“Legacy” Tubes

We are also being told by manufacturers that the current “legacy” feeding tubes, without ENFit connectors, will remain available indefinitely. Mayo Clinic in Rochester, Minnesota, and the FDA have been researching the flow rates and force required to administer different commercial and homemade formulas through the legacy and ENFit tubes, and hope to publish the results of those studies some time this summer. We look forward to sharing the results with you.

From the FDA: “While the FDA encourages manufacturers to incorporate the new connector design standards for enteral devices and other future device types, the [FDA] is not requiring manufacturers to switch to the new standard design, or to remove products currently in use from the market. Devices with older designs (legacy devices) may still be available on the market for patients who rely on them for their care.”

To read more from the FDA go to:

 

https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TubingandLuerMisconnections/ucm313267.html

We know some of our members are concerned about the new connectors, fearing they may impact their ability to use a blenderized diet, to administer formula quickly, or lead to other problems. Others are excited about the new connectors, because they cannot interconnect with an IV line and are less likely to come apart (once the adapters are out of the picture). If you have experiences with the ENFit connectors—positive or negative—please share them with us at (518) 262-5079 or metzgel@mail.amc.edu.

For further information regarding ENFit, including frequently asked questions, visit www.stayconnected.org. There is also information on the Oley website at oley.org/page/enfitconnectors.


LifelineLetter, March/April 2017

This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

 

Updated in 2015 with a generous grant from Shire, Inc. 

 

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
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