ALERT: Final Draft of ISO 80369-3 passed  
  May 2015 - ISSUE 20  

Final Draft International Standard Passes

ISO 80369-3 passes international ballot

As part of an effort to prevent wrong route delivery of fluids and gases (tubing misconnections) over the past several years there has been an ongoing joint effort by the International Organization for Standardization (ISO) to address small-bore connectors for healthcare applications.  GEDSA has received notification from The Association for the Advancement of Medical Instrumentation (AAMI) that the Final Draft International Standard (ISO/FDIS 80369-3) has received a positive passing vote and will move forward to publication.  Publication and US FDA recognition is anticipated sometime this summer. 

UPDATE: ENFit Low Dose Tip performance testing

Recently dose accuracy concerns have been raised with the use of an ENFit Tip syringe with small volumes (less than 2.0mL).  Clinicians and pharmacists indicated they would expect to see dose accuracy to fall within ± 10% with a target volume of 0.2 mL (when delivered using a 1 mL syringe). As a result of these concerns GEDSA member companies collaborated to identify a safe solution that both delivers an accurate dose for small volumes of medication while reducing the risk of tubing misconnections and maintaining dimensional and performance requirements with the ISO 80369-3 standard.  Through this collaboration the ENFit Low Dose Tip Syringe was evaluated and validated to meet these demands.   In fact, The ENFit Low Dose Tip syringe design was found to perform better than current reverse gender syringes and substantially equivalent to standard orientation (male) oral/enteral syringes commonly used today. The misconnection assessment concluded that The  ENFit LDT provides a solution for accurate enteral dosing while maintaining a high level of mitigation to the risk of inadvertent tubing misconnections.
  Did you know?  
In response to dose accuracy concerns, GEDSA and supporting organizations resolved the problem by creating a small volume syringe called the ENFit Low Dose Tip.  The ENFit Low Dose Tip design is within the dimensional tolerances specified within the ISO 80369-3 standard for female connectors.  The LDT is strongly advised for use with 1mL and 3mL syringes and should be considered for syringes up to 5mL.  Your supplier representative will be able to provide further guidance on the appropriate use of an ENFit LDT syringe.
  Do you have?  
The ENFit Low Dose Tip presentation provides details on the approach and findings of the dose accuracy performance test, usability and human factors testing as well as misconnections risk analysis. 

View the Presentation
  Have you met?  

Beth Lyman, the Co-Director of the Nutrition Support Team at Children's Mercy Hospital.  She holds an MSN in nursing from the University of Missouri-Kansas City and an active member of ASPEN.

"I have been a nurse for 40 years and during those years, case reports have come to my attention involving a nurse accidentally administering an enteral formula, breast milk, or an enteral medication intravenously because it was physically possible to do so, albeit with some creativity on the nurse’s part.  The efforts by GEDSA to address this issue from an incompatibility by design manufacturing concept will prevent this often fatal error from ever happening again.  Not only will patients be safer but nursing practice will be safer.  I am coordinating the ENFit transition at Children’s Mercy Kansas City, along with many professionals from other departments such as value analysis, pharmacy and homecare.  While theENFit transition period is going to be a challenge, we need to support the change 100% because our patients deserve it."
  Have you told?  
Share this email and other StayConnected context with your staff or anyone who may benefit. Let’s keep every health care professional up to date on the small bore connector transition.

Where to find us

July 5th-9th Oley Foundation Annual Conference
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Dec. 4th-8th ASHP Midyear Clinical Meeting & Exhibitor

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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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