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ALERT: FDA recognizes AAMI CN3 & CN20 US Provisional Standard 
February 2015 - ISSUE 11

FDA Takes Unprecedented Steps to Aid Adoption of New, Safer Connectors

The FDA Recognizes AAMI Standards and offers Guidance to Manufacturers of Small-Bore Connectors for Enteral Applications

Effective February 11, 2015 the US Food and Drug Administration (FDA) recognized the AAMI Provisional American National Standards AAMI/CN3(PS):2014 “Small-bore connectors for liquids and gases in health care applications” – Part 3: Connectors for enteral applications and AAMI/CN20:2014 - Part 20: Common test methods. These standards cover Parts 3 and 20 of the International Standards Organization (ISO) 80369 series, which are currently in final development. Once the final versions of ISO 80369-3 and ISO 80369-20 are approved by ISO, these provisional standards will be replaced by a parallel adoption of ISO 80369-3 and ISO 80369-20.

The FDA anticipates recognizing future standards for other small-bore connector applications as they are developed.
 
The FDA’s newly released final guidance: Safety Considerations to Mitigate the Risks of Misconnections with Small-Bore Connectors Intended for Enteral Applications provides recommendations to manufacturers, FDA reviewers, and others involved in manufacturing devices that use small-bore connectors for enteral feeding. This guidance also provides support for those submitting or reviewing premarket notification submissions [510(k)s] for these types of devices. 
 
For more information visit the FDA's resource page on Tubing and Luer Misconnections
 
Did you know?
The impact of tubing misconnections can be life-threatening. Listen as three women tell their stories of tubing misconnections and reinforce the need to change to new, safer connectors in order to enhance patient safety.

Click here to watch the video
 
 
Do you have?
Stay Connected Group 2 Timeline

The Stay Connected initiative will introduce new standard connectors globally. Group 2 markets—including most of Europe, Middle East, Africa, Australia, and New Zealand—will introduce new connectors starting in third quarter 2015 and into first quarter 2016. Find the latest timeline and other details in the print-friendly brochures in English and six other languages here.
 
Have you met?
Australian anaesthesiologist Phoebe Mainland joined national and international standards committees for medical equipment ten years ago, and in 2012 the ISO committee responsible for Small Bore Connectors. As liaison between several ISO committees and the World Federation of Societies of Anaesthesiologists, she values her role in standards development as a clinical representative, and as a conduit for information between clinicians and standards developers. As a clinician, Phoebe is well aware of the potential consequences of misconnections between devices for different clinical applications.
“Engineering for patient safety has a long history, including the famous action of Dr John Snow, when in 1854 he removed the Broad Street pump to control the cholera outbreak in London. Alongside other initiatives for enhancing patient safety, such as professional training, checklists and protocols, and ongoing clinical education, equipment development contributes to reducing errors in health care. Designing and implementing application-­specific connectors is a huge enterprise towards this end. Of course there will be challenges in the implementation of these connectors, but improvement in patient safety will be the reward.”  
Have you told?
Your leadership needs to know about these impending changes. Be sure to make your administration know what to expect with inventory and clinical practice. The following checklist can help guide that discussion.  

Transition Checklist for Facilities and Institutions
 

Where to find us

February 14 - 17 A.S.P.E.N.’s Clinical Nutrition Week
Long Beach, CA
April 7 - 9 MedAssets Healthcare Business Summit
Las Vegas, NV
May 19 - 21 NTI AACN
San Diego, CA
June 5 - 8 AAMI 2015 Conference & Expo
Denver, CO
June 29 - July 3 Oley Foundation Annual Conference
Saratoga Springs, NY

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 StayConnected.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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