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ENFit® Low Dose Tip Syringe Update
 

ENFit tip syringe for administering lower doses of medication

Through close collaboration with the clinical community and best practice organizations, it was determined that there was an expectation of ±10% dose accuracy when delivering a target volume of 0.2mL from a 1 mL syringe. 
There have been concerns raised about using ENFit syringes for delivering medications enterally, for cases which require highly accurate doses at very low volumes.  Previously there were no standards or references for dose delivery accuracy for any syringes or syringe systems, including enteral syringes and/or administration systems. In absence of a standardized test, no baseline data existed for comparison.

GEDSA and its members assessed the ability of the standard ENFit syringes to meet this ±10% delivery accuracy expectation and determined that ENFit syringes of size 5 mL and smaller may require a new ENFit connector design to meet this target.

Initially, several manufacturers brought forth potential designs that were intended to address the low dose accuracy concerns.  These designs went through preliminary testing and the design offered by NeoMed® Inc. was selected for detailed evaluation. This design came to be known as the “Low Dose Tip.”  An accredited third party laboratory then conducted performance testing on the low dose tip design.  This lab also tested several legacy syringe designs, which are in use today, in order to establish a baseline.  Of the baseline syringes that were tested, the low dose tip ENFit syringe design was found to perform substantially equivalent to standard orientation (male) syringes that are commonly used today, and the design was found to outperform reverse system (female) syringes that are in use today.  The low dose design also mitigates the risk of inadvertent tubing misconnections, a feature of the regular ENFit connector.

Usability tests were also carried out on this new design.  Almost 150 respondents from multiple disciplines and countries took part in the usability testing which involved several use scenarios.  Overall, users found the low design feature acceptable for filling and administering enteral doses.

The low dose syringe is compliant with the ISO 80369-3 standard and will be introduced in the market after required regulatory approvals/clearances.  The low dose syringe design is available for all manufacturers to use through a fee free license agreement offered by its designer.
 
 
 

View GEDSA’s Presentation on the ENFit® Low Dose Tip
 

 
 

The Stay Connected initiative is organized by the Global Enteral Device Supplier Association (GEDSA) in partnership with leading regulators, associations and other supporting organizations.

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GEDSA is a 501(c)(6) federal tax exempt Non-Profit Trade Association incorporated in the State of Ohio, USA. GEDSA’s mission is to promote initiatives surrounding safe and optimal delivery of enteral feeding and connectivity. It is GEDSA’s policy and the responsibility of every GEDSA member to comply in all respects with federal, state and international antitrust laws. Any discussion is strictly prohibited for the purpose of raising, lowering, or stabilizing prices; regulating production; allocating markets; encouraging boycotts; fostering unfair trade practices; or assisting monopolization at any GEDSA function. Any questions regarding the meaning or applicability of this policy, as well as any concerns regarding activities or discussions at GEDSA functions, should be promptly brought to the attention of GEDSA’s executive director, officers, and/or legal counsel.

All material provided in this email is intended for informational purposes only and should not be used to replace regulatory or company-specific documents, nor should it replace the advice of a qualified professional. This information is based on the draft ISO 80369 standard; does not imply or suggest any regulatory clearance of any specific product and may not be predictive of clinical outcomes. Images provided do not imply endorsement of any specific product. All products and product designs are the responsibility of each specific legal manufacturer, distributor or supplier. Products with these design features may be pending regulatory clearance or may not be available in a specific geography. Consult your supplier representative for product-specific availability, indications, contraindications, precautions, and warnings.

 

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