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  April 2015 - ISSUE 13  
 

ENFit Tip Syringes and Medication Dosing

ENFit Tip Syringes

   Along with the introduction of new design standards for small bore connectors comes change.  GEDSA members are working hard to ensure there is minimal disruption into clinical practice.  However, with the transition to the new ENFit connectors for enteral feeding there are some important safety considerations which may impact clinical practice.
     Syringes are used today in enteral feeding for flushing, hydration, bolus feeds and administering medications.  The new ENFit feeding tubes and extension sets will operate with ENFit tip syringes.  Most syringes for enteral applications will be used the very same way catheter, luer, and oral tip syringes are used today.  The main difference between current design and ENFit tip syringes is the ENFit tip syringes have a reverse orientation from male tip to female tip.  The female tip impacts what is commonly referred to as dead space. When administering medications it is important to understand what happens to the fluid captured in the dead space.  The Institute for Safe Medication Practices (ISMP) has released an article in their newsletter outlining safety considerations while transitioning to the new ENFit tip syringe.
 

Read more about ENFit tip syringes

 
   
  Did you know?  
 

The development of the ISO 80369 Small-Bore Connectors series of design standards will change not only enteral connector design but of other applications such as tubing for respiratory, limb cuff inflation, and neuraxial applications. The StayConnected initiative will help communicate all of these changes over time.  The next connector standards for neuraxial devices are anticipated in late 2016.


View the most recent AAMI timeline

   
  Do you have?  
 

New Item Numbers

Many GEDSA members have changed their item numbers for their enteral devices with ENFit connectors.  Ask your supplier representative for their latest cross reference with item numbers for products with the new ENFit connectors.
 

   
  Have you met?  
 

Terry Longman
International Standards Organization/British Standards Institution Development Consultant
 
Terry Longman is a consultant specializing in the development of standards for medical devices and has been involved in Standards work since 1985. He was trained in the UK as a mechanical engineer and has worked in the medical device industry since 1965 on both the technical and commercial sides of the industry.
 
In 1995 he became a consultant and now chairs several UK National (BSI) standards committees as well as the European standards committee CEN TC215 for anaesthetic and respiratory medical devices. He is also a member of several sub-committees of ISO TC 121, the International committee for anaesthetic and respiratory equipment, as well as being a member of ISO TC210 JWG4 and WG5 for small-bore connectors and reservoir connectors.
He has been involved with the subject of small-bore connectors since the beginning when a European committee (CEN BT TF123) was formed to develop a range of connectors, as alternatives to Luer connectors, for several different applications. Terry joined the ISO committee when it was formed in 2007.
Terry has a broad range of interests across a wide spectrum of medical devices and represents BAREMA, a UK based association of manufacturers of anaesthetic and respiratory medical devices, with some 60 members, many of whom are global companies.
 

 
 

“During the early days of this work it was interesting to hear a view expressed by International guests at one of our European small-bore connector meetings that misconnections are not a world-wide problem so there is no need for change. It is good that this view has since changed and that the patient environment, internationally, will be made a much safer place without such misconnections”

   
  Have you told?  
 

Supply Chain Leads

The transition to the new ENFit connectors will take a coordinated effort that includes your colleagues from purchasing, materials management, logistics, inventory management, demand planning, forecasting, and more

   
 

Where to find us

May 6-9

European Society of Paediatric Gastroenterology, Hepatology and Nutrition Annual Congress; Amsterdam, Netherlands

May 13-14

McKesson Surgical and Medical Sales Conference; Dallas, TX

June 5-8

Association for the Advancement of Medical Instrumentation (AAMI) 2015 Conference; Denver, CO

June 30-July 2

Oley Foundation Annual Conference; Saratoga Springs, NY

August 9-12

Association for Healthcare Resource & Materials Management (AHRMM) 2015 Conference & Exhibition; Indianapolis, IN

August 29-September 1

American Association of Nurse Anesthetists Annual Conference (AANA); Salt Lake City, UT

September 5-8

European Society for Parenteral & Enteral Nutrition (ESPEN) Annual Congress; Lisbon, Portugal

 
 

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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