What is ENFit?
Example of an ENFit extension set with locking ports
ENFit is a global change to make all enteral (tube feeding) devices specific to tube feeding. Every extension set, syringe, long tube/PEG, and NG-tube will be designed with a specific ENFit end so that you can only use products designed for enteral/tube feeding access. Button style G-tubes will not change at all – only the extension sets that connect to them.
Why are they doing this?
Way back in 2006, many in the enteral community expressed concern about the ability of medical devices to connect across systems. So, for example, syringes used for tube feeding would also fit into IV systems of TPN patients. There were numerous journal articles detailing the risks of compatible systems and the risk to patients. Here is one from 2008. Cases of misconnections are under-reported and many may show as medication errors. Several people did die from misconnections and many more were put at serious risk. You can read about some examples here.
In our pediatric community, there is also a very serious risk of disconnection. Current systems, particularly med ports, open easily, making it possible for our children to miss feeds for hours, particularly overnight. This is an inconvenience for most, but a serious problem for children who have issues maintaining their blood sugars.
It was a serious enough issue for patient safety that California passed a law mandating that all the enteral products be enteral specific. It took several years to get all manufacturers of enteral products around the world together to move to a standard connection. You can read more about it at the GEDSA website and sign up for updates. The roll out is worldwide with staggered timing. There is a lengthy transition period during which both the old and the new enteral products will be available.
If you have been tube feeding for a while, you may have heard about this before. There was a push to roll out ENFit in 2015 that was significantly delayed. Some of the delays stemmed from the fact that every product needs to go through FDA approval. There were also concerns over the accuracy of low-dose medication syringes and cracking with pump bag connectors, both of which led to delays in production, as corrections to syringe designs and feeding sets were made. You can read our earlier updates from January 2015 and February 2015 for more information.
What’s Feeding Tube Awareness Foundation’s role in this?
We found out about this change in February 2013, well after this movement was mandated and underway. We were horrified by the reported misconnection-related injuries and deaths, and by the risk to patient safety. In addition, we saw the possibility of a misconnection occurring with our own children and those in the community, particularly for those who use both tube feeding and IV nutrition.
Example of an ENFIt extension attached to a feeding set
We support the changes because they mean greater patient safety. Moreover, they mean the possibility of fewer disconnections from feeds. For the last few years, we have worked with GEDSA by providing feedback from the pediatric tube feeding community. We also try to help parents navigate the change by providing information and education.
We also use these products to feed our children, so we understand how challenging it can be to have them change. Feeding Tube Awareness Foundation does not have anything to do with the design of ENFit, specific product designs, or distribution of ENFit products.
Where are we now?
ENFit supplies have once again started to make their way into the supply chain. While it will still take some time for the majority of people who use home enteral nutrition to start receiving ENFit extension sets, a few people have started to see them.
What we don’t know:
- When we can expect the majority of people to start receiving ENFit extension sets, PEG tubes, and NG tubes. It will take time for all of these supplies to make their way through the supply chain.
- When MOOG will release ENFit feeding pump bags into the supply chain.
- How soon we will see ENFit syringes, low-dose medication syringes, and medication bottle adapter caps, and how they will be distributed.
Click to enlarge
What we DO know:
- AMT (makers of the Mini One and GJet) and Halyard (makers of the Mic-Key) are both ready to start releasing ENFit products into the market.
- AMT has released a series of adapters so that we can continue to use our current supplies and stockpiles.
- It will take time for supply companies to work through their stock of supplies with the old connectors before they start mass distribution of the new ENFit supplies.
- Low-dose ENFit syringes have been redesigned to prevent the medication errors that were a concern with preliminary designs. There will also be adapter caps to ensure accurate dosing.
- Mayo Clinic is doing extensive testing with ENFit connectors. The testing is still ongoing, so there are no results available yet, but the testing includes various commercial formulas and blenderized food products to ensure that tube feeders’ dietary choices will not be impacted by the move to ENFit.
- Your medical supply company and medical professionals SHOULD be aware of this change. GEDSA has been at conferences and industry events for years. However, the people you talk to may not be. It will be important for you to be educated on the change.
- Multiple companies have created special cleaning brushes to allow for thorough cleaning of all ENFit connectors.
One of our staff members was able to do a trial of Halyard ENFit extensions with MOOG ENFit pump bags. The connection itself was secure and never came apart unintentionally during the 10-day trial, despite being connected and disconnected multiple times per day. There was no increase in pump alarms, no leaking from the connection, no accidental G-tube pull-outs, and no difficulty taking the connection apart when needed, as opposed to the difficulty disconnecting a bolus extension from a MOOG pump bag with a red Christmas tree adapter. The connection is not any more bulky than the old design, and is actually less bulky than some of the old extension sets. That is pretty positive.
We will continue to update as we get information. You can also sign up for updates at the GEDSA site.
We will help people navigate the change in their supplies as best as we can. There will be a sizable transition window where old and new products are available. We are also using these products to feed our children, so we are just as concerned as you are about how these products will be rolled out.
What manufacturer resources and product information are available?
GEDSA has a compilation page of product and supply resources on its Stay Connected site, including resources listed by manufacturer or item.
Several companies have released information on ENFit and how it impacts their products.