ENFit is coming! We need a plan! Who is working on this?
If you have not heard these words yet, you will soon. Many changes are coming to the way we work with enteral feeding products, in the NICU and the entire general population in the acute and non-acute care setting.
The Association for the Advancement of Medical Instrumentation (AAMI) and the International Organization for Standardization (ISO) worked together to establish enteral connector guidelines in an effort to standardize all enteral feeding disposable products (NGT’s extension sets, syringes) and avoid misconnections.
The recommendations were:
- Enteral connector hubs have specific dimensions
- Enteral connectors should be a locking system
- Enteral connector color will not be specified – purple or orange is acceptable
These three recommendations may not sound like much, especially since color is not going to be changing. So that means the real changes are:
1) The enteral connectors will lock
2) Enteral connectors will have specific dimensions
What Does This Mean for Enteral Devices in Healthcare?
The Global Enteral Device Supplier Association (GEDSA) brought industry device manufacturers together to create an enteral feeding connector that would meet these standards, resulting in the ENFit connector. As an additional feature to prevent misconnections, the ENFit connector has the male and female connectors reversed.
The ENFit connector is now available through a handful of enteral medical device manufacturers, with the list growing every day.
Something to keep in mind: similar product changes will be adopted by every vendor manufacturing these products, and eventually every hospital in the US (and globally) will switch to an enteral system that meets these requirements. It is affecting every piece of feeding equipment in the clinical, pharmacy, and home care setting, and in some cases, requires some practice changes within these settings.
The Enteral Feeding Connector Change Process
The road to change is sometimes more difficult than we anticipated.
The process of changing over to a new system like ENFit is not as simple as just changing a list number and reviewing the two changes to these products. Clinicians and management need to talk to vendors, review their own practices surrounding enteral and PO feeding, and form committees between pharmacy, pediatrics, and NICU to make sure the correct decisions are being made.
With that said, I’ve listed some of the common misconceptions and issues, and reviewed some possible solutions to consider when making your plans for implementation:
Low Dose Syringe – The new ENFit design has left all enteral syringes (which now have a female end) with a larger dead space than the old design. This larger dead space makes smaller doses under 2 mL vulnerable to over/under dosing issues. These doses directly impact the NICU as most medications will be under 2 mL.
The FDA requires that each manufacturer have FDA clearance for this low dose design, and most designs are modeled after a GEDSA approved “Master File” design that is basically a male and female tipped syringe. Make sure your vendors have an approved design and that it will work for your NICU.
PO Syringes and the Pharmacy – Don’t forget the pharmacy uses many enteral/PO syringes, as they are filling medications for any patient getting meds via this route. They usually purchase these syringes in non-sterile, bulk orders, and many times from a different vendor than the one being used on the clinical unit. It’s important to get pharmacy involved in every decision surrounding ENFit products, because the syringes used in both areas must fit together.
That does not mean hospitals need to standardize to one vendor for both pharmacy and clinical units – that is not done now. But, these syringes need to be verified they will work together. Make a clinical decision (not an availability decision) when talking about pharmacy and clinical enteral syringes. NICU is a specialized place, and many vendors, like Medela, have products specific for this population that help improve delivery of milk. A manufacturer may be able to provide syringes to both NICU and pharmacy, but that may not address clinical advantages – it just means they have syringes.
Different Hospitals and Home Care – Only the state of California has enacted a law that requires enteral connectors not be capable of connecting to an application other than what it was intended for. This means hospitals in other states are transitioning as they see fit. Because of this, different forms of non-compatible enteral systems will be floating around between hospitals and other health care facilities – such as in home care.
I’ve personally heard stories from customers that have experienced a patient coming in with a non-compatible tube: they either switched to ENFit, or an ENFit tube came in while they had the old style. Ultimately the patient loses in this case because they need a new tube placed. I recommend planning for this by keeping old product around if you switch, or, an even better idea is to have some caps on hand that can make these tubes compatible. Medela can provide dual caps that will address fit issues during your transition.
In summary, to avoid many pitfalls, I recommend getting a committee together as soon as possible from NICU and Pediatrics. Also include the pharmacy, purchasing, management, and any other interested parties. Talk to your current vendor from your clinical unit and pharmacy, and ask them for details on their plans for ENFit, along with an opportunity to see the products.
Then talk to other vendors. This will be a change that could provide clinical improvements as products have changed. Ask to see a vendor’s low dose syringe, and inquire about their FDA approval status. This is also a good time to look at your current policies, as they could be outdated and will need ENFit updating. Talk about how you are going to deal with patients coming in or going out with non-compatible tubes. Ask other hospitals that have made the ENFit conversion how they planned and implemented, and what they learned by the process.
Remember ENFit is all about patient safety and avoiding misconnections. With a little planning and discussion, the road to change can be easy, and the outcomes positive, because this is all about improving patient care.
Looking for more information about ENFit connectors?
Learn more about the Medela Enteral Feeding System with ENFit connectors here.