UPDATE: New ENFit connectors available in Q1 2015.
GEDSA Position Statement Supports ISO 80369 Vote
Second DIS 80369-3 awaiting approval
Across the globe, healthcare providers are preparing for the upcoming transition to safer connectors. In a recent set of position statements supporting the vote to approve the second Draft International Standard (DIS) 80369-3, publication, and, ultimately, FDA recognition, GEDSA cautions that any further delay of the standardization process or adoption of the new connector will prolong the heightened potential for misconnections among the patient population and exacerbate concerns regarding portability of devices.
Also in the Group 1 statement for the U.S., Canada, and Puerto Rico launch is news that the ENFit Transition Connector recently received FDA 510(k) premarket clearance and is suitable for use in all administration sets to transition to the new standard connectors.
Read the entire Position Statement for your market(s) in support of 80369-3
GROUP 1 U.S., Canada, Puerto Rico
GROUP 2 Europe, Middle East, Africa, Australia, New Zealand
GROUP 3 United Kingdom, Ireland (position statement forthcoming)
TIMING UPDATE: Transition to begin Q1 2015
Introduction of transition sets in the US, Canada, Puerto Rico has been rescheduled.
Revised timeline for US, Canada, Puerto Rico transition:
Q1 2015   Administration sets with new ENFit connector and ENFit Transition Connector
Q2 2015   Enteral-specific syringes with ENFit connector
Q3 2015   Enteral feeding tubes with ENFit connector
Timing is subject to change pending each manufacturer’s FDA 510(k) clearance. Check with your supplier representative for precise timing for the introduction of tube-feeding devices with new ENFit connectors.
Tell your colleagues
Did you know? Raising Awareness
The transition to safer connectors has wide-reaching and diverse effects across the industry. Make sure your team understands the key steps they need to take to get ready.
Download a transition checklist for:
Facilities & Institutions
Nurses & Clinicians
Supply Chain
Home Care Providers
Patients & Caregivers
Do you have? Raising Awareness
Stay Connected Video
Get a quick refresher on the Stay Connected initiative for safer connectors and share it with your colleagues. This short video explains misconnections, demonstrates how the new connectors work, and provides timing information.
Watch the Stay Connected video
Have you met?
Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.)
Institute for Safe Medication Practices
As president of the Institute for Safe Medication Practices (ISMP), a non-profit healthcare organization that focuses on preventing medication errors and adverse events, Mike has long advocated for changes to catheters and tubing to prevent serious errors, and in conjunction with Baxter created a self assessment tool to help healthcare facilities evaluate their current delivery systems.
“Tubing misconnections pose a significant threat to patient safety, and we applaud GEDSA and the Stay Connected effort for helping the healthcare community transition to new ISO standards. With the coming implementation of new standard connectors for feeding tubes, it is important that healthcare organizations perform a multidisciplinary risk assessment to identify the various types of catheters and fittings now in use, identify the possibility and potential severity of misconnections, and address process changes that need to be made to prevent patient harm.” —Mike Cohen, ISMP
Have you told?
Make sure your Pharmacy Directors are ready
Share this email and other Stay Connected tools and information with the pharmacy director, satellite pharmacy managers, clinical pharmacists, and pharmacy technicians to help smooth the transition to the new ENFit connectors.
Forward this email to your colleagues
Where to Find Us
Nov 11 Novation “New Small Bore Standards to Prevent Tubing
Misconnections: Preparing for Change” General Audience Webinar.

Session Number: 296 633 121
Dec 3 Novation “New Small Bore Standards to Prevent Tubing
Misconnections: Preparing for Change” General Audience Webinar.

Session Number: 291 027 831
Dec 7-11 ASHP Midyear Clinical Meeting and Exhibition, Anaheim, CA
Jan 17-21 Society for Critical Care Medicine’s 44th Critical Care Congress,
Phoenix, AZ
Feb 14-17       Clinical Nutrition Week, Long Beach, CA
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.
©2014 GEDSA, all rights reserved
692 N. High St. Suite 207
Columbus, OH 43215 USA
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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