April 2017  

Fatal Medical Device Tubing Misconnections

Stories told by those impacted by misconnections

Every day we are faced with busy work schedules and personal life commitments that we can lose focus on important initiatives. GEDSA is taking a moment to remind everyone of the reason why facilities around the world are taking time to plan for and transition to the ISO 80369 standard series connectors.  

Below is a link to a video of family members impacted by tubing misconnections, this video is a reminder of the importance in adopting a new safer system. 

Video of those impacted- In their own words


UPDATE: ECRI Publishes Guidelines in Support of the ENFit Introduction

GEDSA is happy to announce that ECRI has been recently added to our list of supporting organizations. ECRI is an independent nonprofit organization that researches the best approaches to improving patient care, designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality.

On April 26th, ECRI released a guidance document that is available to the public in efforts to encourage the adoption of the new ENFit connectors.

Click here to read their guidance document on the ENFit connectors. It is recommended to adopt their guidance as best practices for implementing ENFit.

  Did you know?  

In response to dose accuracy concerns, GEDSA and its supporting organizations resolved the problem by creating a small volume syringe known as the ENFit Low Dose Tip (LDT) syringe.  The ENFit Low Dose Tip syringe is within the dimensional tolerances specified to the ISO 80369-3 standard.  After polling clinical experts, it was determined that the expected range for dosing accuracy among small volume doses was ±10% accuracy for a 0.2ml dose delivered with a 1mL syringe. After testing was completed by an accredited third party lab, it was confirmed the LDT syringe meets clinical recommendations for dose accuracy. For results and more information about this testing, please click here.

  Do you have?  

In a recent video captured at Valley Children’s Healthcare, the designated ENFit task force shared best practices and recommendations for implementing ENFit. In addition to this video, GEDSA is working on a master tool kit for facilities to utilize while planning for the transition to ENFit. Stay tuned for an update on the master tool kit but in the meantime watch the video by clicking here.

  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

May 6th-9th Digestive Disease Week Annual Conference
May 9th-12th Society for Obstetric Anesthesia and Perinatology Annual Conference
May 22nd-25th National Home Infusion Association Conference
May 23rd-24th Quarterly GEDSA Member Meeting

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


If this email was forwarded to you and you would like to sign up to Stay Connected, click here.

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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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