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

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

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.
 

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”

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