July 2016 - ISSUE 21  

 Join in on the Premier Safety Institute Webinar 

Transitioning to ENFit Connectors - A Safer Feeding Sytem

On July 14th, the Premier Safety Institute will be hosting a live public webinar to learn the reasons for implementation setbacks, solutions and updated information on the timeline for ENFit. This is a chance for everyone to understand the reason for the enteral feeding system redesign, timeline of implementation and where to find educational resources. Anyone impacted by the ENFit transition is encouraged to join this important update. Register today with the link provided below.   

Register for the Premier Safety Webinar here

UPDATE: Independence Day & The California Deadline

As many of us look forward to a long weekend to celebrate our countries independence, July 1, 2016,  represents the first day California legislation (AB444) will prohibit the use of enteral feeding devices with connectors that unintentionally connect into ports other than the type for which it was intended.   GEDSA members met last week to confirm their commitment and indicate their readiness to supply enteral feeding devices with ISO 80369-3 compliant ENFit connectors that address this law.  It is not clear how or when this law will be enforced by the state so GEDSA’s recommendation is to adopt enteral devices with ENFit connectors as soon as possible with adequate supply to meet the law’s requirements.  Facilities are encouraged to check with their supplier representatives to understand their precise product availability.  The time to transition to enteral devices with ENFit connectors is ultimately up to the facility.

Learn more about the law

  Did you know?  
The ENFit Low Dose Tip (LDT) syringe has been reviewed and gained FDA 510(k) clearance for two manufacturers.  This thorough review by the FDA further validates the industry’s ability to address dose accuracy concerns with the new ENFit syringes. In addition, this milestone clears the way for broader introduction of all ENFit components including syringes and various enteral feeding tubes. GEDSA strongly encourages adoption of enteral feeding devices with ENFit connectors as soon as possible with adequate supply.  Check with your syringe suppliers for availability of ENFit Low Dose Tip Syringes and usage information.
  Do you have?  
Facilities are recommended to have an action plan in place with cross functional teams to ease the transition. It is recommended to contact your supplier for product use and availability. You can find checklists and other educational material on our website.
  Have you met?  
Angie Mitchell
Director of Nursing Services at Health Trust Purchasing Group
“A primary function of the group purchasing organization, HealthTrust , is procuring medical products and devices for their members. This cannot be accomplished without a keen awareness and commitment to overall patient safety and specific global safety initiatives such as the ISO 80369 series for Small Bore Tubing Misconnections.

As Director, Nursing Services within the Clinical Operations Team at HealthTrust, a critical task is securing “real time” knowledge of these crucial clinical initiatives impacting healthcare today and understanding the position of every key player involved in an effort to provide the comprehensive clinical insight required for product selection, sourcing and deployment.

Through their collaborative efforts and Stay Connected patient safety initiative, GEDSA has brought key players from manufacturing, clinical practice, government, group purchasing and others together to ensure all perspectives are considered in developing standards for healthcare tubing connectors to optimize delivery and reduce complications. GEDSA has also provided education and resources to support the planning and development of required practice and product transition endeavors at the patient caregiver level effectively.  Together, GEDSA and HealthTrust are working to eliminate potentially recurring sentinel events that have been associated with tubing misconnections for decades.”

  Have you told?  
Share this email and other StayConnected content with your staff or anyone who may be impacted by changes to enteral feeding devices. Let’s keep every healthcare professional up to date on the ENFit connector transition.

Where to find us

July 5-9th OLEY Foundation Annual Conference
July 14th Premier Safety Institute Webinar
Sept 17-20th ESPEN Congress 2016
Oct 22-26th ASA Anesthesiology Annual Meeting 
Oct 23-26th FELANPE  Congress
Dec 4-8th ASHP Clinical Meeting & Exhibitor

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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