Frequently Asked Questions

In an effort to prevent wrong route delivery of fluids and gases (tubing misconnections), there is an ongoing effort led by the International Organization for Standardization (ISO) to address small‐bore connectors for healthcare applications. The overall objective of the ISO 80369 series of standards is to specify designs of small‐bore connectors for various clinical applications to reduce the likelihood of tubing misconnections. The Final Draft International Standard 80369‐3 has been approved and published. The published standard addresses dose accuracy, neonatal applications, improved connector usability, engineering assessments, and other technical content supporting the common goal of improved patient safety. The ISO 80369‐3 connector design in the reverse orientation as defined below is commonly known by its federally registered trademarked name ENFIT.

References:

• GEDSA Position Statement
• GEDSA General FAQ v3
• GEDSA Enteral FAQ Clinician
• GEDSA Enteral FAQ v7
• SC15 brochure (US/CAN version)
• Patient Stories - Tubing Misconnections Video
• Stay Connected Video

The ISO 80369‐3 standard defines new connectors for enteral applications. Multiple global organizations have recognized the potential for misconnections with the existing products in use in the market, and these organizations have encouraged adoption to the new ISO standard.

References:

• ASPEN Nutr Clin Pract 2014 – Guenter 612‐4
• Sentinel Alert Issue 53
• ISMP Tubing Misconnection Assessment
• Nursing Times: Enhancing Patient Safety in Enteral Feeding
• NCBI: Making Health Care Safer II: Chapter 42 – Tubing Misconnections
• ECRI Annual Top 10 Health Hazards 2015
• AAMI: Tubing Challenges Focus of FDA Guidance
• GEDSA CA Guidance – July 1

Baxter can provide you with training materials and checklists to help ensure that you and your facility are ready. The product line offered by Baxter will include a full line of ENFIT enteral syringes, pharmacy bottle adapters, and tip caps to ensure you have what you need to fill and administer enteral medication to your patients. Refer to the Baxter ENFIT brochure for a complete list of products available.

References:

• Pharmacy Checklist, Supply Chain Checklist, Nursing Checklist, Patient Caregiver Checklist, Home Care Checklist, Facilities/Institution Checklist
• GEDSA General FAQ v3
• GEDSA Enteral FAQ Clinician
• GEDSA Enteral FAQ v7
• GEDSA FAQ – Home Enteral Nutrition
• Premier ENFIT Webinar JUL 2016

There is one ENFIT design that mates with the other ENFIT connectors. To meet clinicians’ needs for all medication delivery, there is an ENFIT design that includes a low dose-tip (LDT) concept. Baxter will offer a full line of enteral syringes from 0.5 mL–60 mL. Contact your sales associate for availability and configurations in your region.

References:

• ENFIT Low Dose-Tip Syringe Review
• GEDSA ENFIT® Position Statement
• ENFIT LDT FAQ v7.8
• Syringe Accuracy (TOGC) Estimates for ISO 7886‐1
• GEDSA Low Dose-Tip Poster

We are currently working with Smith’s Medical to get Baxter ENFIT syringes added to their drug library. In the meantime, please contact our Medical Information team at 800-422-2751, and they can work with you further on this process.

We are continually looking for opportunities to add to our ENFIT product line. As soon as we have more definitive details regarding specific products, we will communicate more broadly.

Baxter has a line of enteral syringes with ENFIT connectors ranging from 0.5 mL– 60 mL (including tip caps). In addition, Baxter has Pharmacy Bottle Caps to facilitate filling of the enteral syringes quickly and easily. ENFIT tip caps will be sold separately. Refer to your sales associate for the specific product listing in your region.

References:

• ENFIT Brochure
• ENFIT Transition Connector Sell Sheet

Baxter launched their transition connector in December 2016. The remainder of the portfolio was made available in early January 2017. Refer to your sales associate for further information.

References:

• ENFIT Brochure
• ENFIT Transition Connector Sell Sheet

For more information on the accuracy of Low Dose-Tip syringes, refer to the GEDSA Low Dose Tip presentation at http://stayconnected.org‐medical‐guidelines/.

References:

• ENFIT Low Dose-Tip Syringe Review
• ENFIT LDT FAQ v7.8
• Syringe Accuracy (TOGC) Estimates for ISO 7886‐1
• GEDSA Low Dose-Tip Poster
• GEDSA Low Dose-Tip PPT

For more information on the accuracy of Low Dose-Tip syringes, refer to the GEDSA Low Dose Tip presentation at http://stayconnected.org‐medical‐guidelines/.

All filling methods were tested to achieve the results, as any fill method can be used. If you have specific concerns and wish to maintain cleanliness of the exterior surfaces, then a fill straw may be desired. Note: it is best practice to use a fill straw, bottle cap, or other device to facilitate filling to reduce the amount of drug needed to fill the syringe.

References:

• ENFIT Low Dose-Tip Syringe Review
• ENFIT LDT FAQ v7.8
• Syringe Accuracy (TOGC) Estimates for ISO 7886‐1
• GEDSA Low Dose-Tip Poster
• GEDSA Low Dose-Tip PPT

No, the syringe hub does not need to be scrubbed.

References:

• Pharmacy Checklist, Supply Chain Checklist, Nursing Checklist, Patient/ Caregiver Checklist, Home Care Checklist, Facilities/Institution Checklist
• GEDSA General FAQ v3
• GEDSA Enteral FAQ Clinician
• GEDSA Enteral FAQ v7
• GEDSA FAQ – Home Enteral Nutrition

There are several tools available to facilitate conversion and training of your staff. Baxter, as an active participant of GEDSA, can suggest several items for reference, including:

Overview:

Being prepared and adopting new enteral connectors: what you need to know

• Raising Awareness: New Enteral Connectors
• Premier ENFIT Webinar JUL 2016
• GEDSA General FAQ v3
• GEDSA Enteral FAQ Clinician
• GEDSA Enteral FAQ v7
• GEDSA FAQ – Home Enteral Nutrition

Preparing:
Pharmacy Checklist, Supply Chain Checklist, Nursing Checklist, Patient/Caregiver Checklist, Home Care Checklist, Facilities/Institution Checklist

How to Use:

• How to use Videos (in partnership with GEDSA, ASPEN, ISMP, FDA)
• How to use Posters (in partnership with GEDSA, ASPEN, ISMP, FDA)
• Enteral Delivery Protocol

Yes - There is a great video on the GEDSA website readily available for viewing. This video goes through the conversion process for Valley Health Children’s Hospital. This is a great tool to leverage to better understand what a facility will have to consider when transitioning to this product line.

References:

• Valley Health Children’s Hospital conversion video on GEDSA website