March 2017  

Creating a Safety Culture

Sentinel Event Alert 57: The essential role of leadership in developing a safety culture

The Joint Commission (TJC) recently published Sentinel Event 57 that focuses on the importance of leadership taking the initiative to create a safer culture within their hospital. 

In the Sentinel Event Alert, TJC states, “Competent and thoughtful leaders contribute to improvements in safety and organizational culture. They understand that systemic flaws exist and each step in a care process has the potential for failure simply because humans make mistakes.”

GEDSA commends the TJC on this Sentinel Event as leadership within hospitals is vital in improving the safety culture, embracing changes to improve safety, and reducing risk for their institution. This Sentinel Event ties closely to the efforts of the Stay Connected initiative to reduce the risk of medical device tubing misconnections. Introducing ENFit connectors poses an immediate patient safety benefit and reduces the likelihood of a human error. Click the link below to view Sentinel Event 57.

Preview the Sentinel Event 


It’s Patient Safety Awareness Week! – Raising awareness and planning for the transition to ENFit  

There is no better time for GEDSA to highlight our recommendations on transitioning to ENFit than during Patient Safety Awareness Week. These recommendations will help you begin the transition to ENFit and celebrate the focus on patient safety.


1. Begin forming a transition team to plan for the implementation and schedule regular meetings.

2.  Work with your supplier representative and distributor network to understand their specific timing and product availability for transition.

3. Confirm syringe suppliers have adequate supplies of standard and LDT ENFit syringes.

  Did you know?  

GEDSA captured the first ENFit success story at Valley Children’s Hospital.

On the Stay Connected website, a new video has been posted that highlights the planning and coordination it took to successfully implement ENFit at Valley Children’s Hospital in Madera, California. The cross-functional team highlights their reason for transitioning, recommendations on planning for the transition, and reviews some areas they would have focused more attention to.

View the success story here

  Do you have?  

ISO Guideline for the implementation of medical products using small bore connectors specified in the ISO 80369 series

Recently, ISO granted free access to a white paper that provides a guideline for facilities to begin transitioning to the new connectors within the ISO 80369 standard series, which includes ENFit and NRFit. This document is a useful tool for any facility to utilize to begin the transition to ENFit and is supported by the Association for the Advancement of Medical Instrumentation (AAMI) and the Food and Drug Administration (FDA).

  Have you met?  

Robyn Jackins

MBA | Value Analysis | Materials Management | Children's Hospital Colorado


“Product implementations are what I do for a living.  But ENFit is a huge, huge, huge undertaking because it touches so many people.  Once you get through this, the rest will fall into place relatively easily”

            - Robyn Jackins, Children’s Hospital Colorado

  Have you told?  

It is important to communicate to the home health companies and retail pharmacies in your area that your facility has transitioned to ENFit. Find the representatives from those outside organizations you rely on most and invite them to be a part of your transition team. This will allow everyone to take the necessary steps to ensure there is adequate supply of ENFit products to continue care for the patient as they return home.


Where to find us

4/6-4/8 American Society of Regional Anesthesia (ASRA)
5/9-5/12 Society for Obstetric Anesthesia and Perinatology (SOAP)
5/22-5/25 National Home Infusion Association (NHIA)

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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