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UPDATE: 80369-3 US Provisional to be Recognized
JANUARY 2015 - ISSUE 10

Provisional American National Standard Published

AAMI/CN3 (PS): 2014 Published

The Association for the Advancement of Medical Instrumentation (AAMI) published AAMI/CN3 (PS): 2014 on Friday, December 12, 2014. This US provisional standard is a result of the work completed on the second Draft International Standard (DIS) 80369-3 through the International Organization of Standardization (ISO) process. With the adoption of ISO 80369-3 published standard the US provisional standard will be replaced by a parallel adoption of ISO 80369-3 and the text will be aligned to the ISO standard.

The next step in the process is for the US Food and Drug Administration (FDA) to recognize this US Provisional Standard. Along with this recognition, the FDA also intends to provide additional guidance and assist in a clear regulatory pathway for all manufacturers impacted by the ISO 80369 small bore connectors. This marks a significant step forward in the introduction of new, safer connectors starting with the new ENFit connector enteral administration sets in Q1 2015. Click here for the US, Canada, and Puerto Rico timeline and additional details on the introduction.
Did you know?
GEDSA was recently awarded the George Didomizio Industry Award by the Institute for Safe Medication Practices (ISMP) for contributions toward important and lasting patient safety. GEDSA received this award for the development and global leadership of the Stay Connected initiative.
 
Comprised of more than 30 manufacturers, distributors, and component suppliers, GEDSA’s mission is to facilitate a successful transition from medical device applications that allow connection between unrelated delivery systems to new, safer connectors. The new ENFit connector will ensure compatibility and consistency while reducing the risk of tubing misconnections.
 
ISMP is an independent, nonprofit, charitable organization that works closely with healthcare practitioners and institutions, regulatory agencies, consumers, and professional organizations throughout the globe to provide education about medication errors and their prevention. For more information about ISMP please visit www.ismp.org
 
Do you have?
Inservice Slide Deck—Group 1
 
Get a quick refresher on the Stay Connected initiative for safer connectors and share it with your colleagues. This slide deck helps to prepare your team for the change and includes a video from Dr. Peggi Guenter explaining misconnections, demonstrating how the new connectors will work, and providing timing information.

Download the inservice slide deck
 
Have you met?
Joan Bishop
Executive Director
The Oley Foundation

Joan Bishop has been with The Oley Foundation since 1985, serving in numerous capacities. As Executive Director, Joan is dedicated to fulfilling the Foundation’s mission of enriching the lives of those requiring home intravenous and tube feeding through education, outreach, and networking by serving its more than 14,500 members with critical information on important healthcare topics.
“Minimizing misconnections is an important goal. The Oley Foundation staff is aware of the anxiety that is building as the tube feeding community awaits the new connectors.  We encourage strong patient/clinician partnerships and open dialogue to achieve a smooth and successful transition. As always we encourage questions and are eager to listen and help facilitate support.”
 
—Joan Bishop, The Oley Foundation
 
Have you told?
Make sure your cross-functional team is ready
 
If you do not have a cross-functional team in place to help implement the impending connector changes, it’s time to assemble this multi-disciplinary group. Include nursing, pharmacy, supply chain, risk management, and others to discuss how your facility can best work with suppliers to carefully transition to new safer connectors.
 
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

Pharmacies

Home Care Providers

Patients & Caregivers

 
 

Where to find us

January 14

Webinar, MedAssets: Reducing the Risk of Medical Tubing Misconnections-ENFit Transition

January 17-21 Society for Critical Care Medicine’s 44th Critical Care Congress, Phoenix, AZ
February 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.

Visit StayConnected2015.org

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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