A Global Industry Change
ENFit® is a trademark of Global Enteral Device Supplier Association, Inc. (GEDSA).
AMT ENFit® Adapters and Transition Pieces
AMT Now Offers Transition Adapters for Your Enteral Connection Needs.
ENFit Transition Stepped Adapter TRN102
Male ENFit Transition Adapter TRN101
Female ENFit Transition Adapter TRN201
Bolus Transition Adapter TRN202
Y-Port Transition Adapter TRN203
Y-Port Transition Adapter w/ Enhanced Med-Port TRN204
ENFit Y-Port Extension/Feed Set 8-1255-ISOSAF
ENFit Extension/Feed Set 8-1211-ISOSAF
What is ENFit®
The International Organization for Standardization (ISO) has created a new standard design for enteral connectors, termed the “ENFit Connector”; which will be adopted by all United States enteral device manufacturers according to the required timeline as regulated by the FDA.
These new ENFit Connectors are intended to improve patient safety and to decrease the risk of medical device misconnections. This new connector has been designed to be incompatible with Luer adapters, which are commonly used in IV applications. The ENFit connector will look & secure very similar to a Luer threaded lock system, although the design is larger and thus, incompatible with Luers.
Visit StayConnected.org for additional information on the ENFit System.
ENFit is a patient safety initiative, designed to ensure that feeding tube connectors are incompatible with the connectors for unrelated delivery systems such as trach tubes, IV lines, and catheters. Misconnections involving such medical devices may be relatively rare compared with the number of patients needing tubes or IVs, but such misconnections can have deadly consequences when they do occur.
ENFit is a global initiative that affects end users, manufacturers, and suppliers. The ENFit Connectors were developed as part of the Stay Connected initiative under the supervision of clinicians, manufacturers, and regulators.
What is AMT’s Role?
AMT will be in compliance with the enteral connector requirements of ISO 80369-3, better known as ENFit, established by the governing bodies to manage the changeover. During the interim period, AMT has made enteral feeding transition adapters available to smooth the transition while continuing to protect patients.
What Does this Mean for You?
What is changing is how you connect your food source to the feed set, which in turn connects to an enteral feeding device. The straight or right angle connectors, which attach and lock into low-profile feeding devices, will remain the same. The distal end of feed sets, which connect directly into the device, are not regulated at this time. However, the proximal side of the feed set, your bolus or y-port adapters, will begin to incorporate the ENFit design as mandated by the FDA, ISO, and GEDSA.
From where we are today, to where you’re going tomorrow!
Current Enteral Administration
The current administration sets to enteral feeding devices consist of: (1) Catheter Tip Syringes, (2) Stepped/Christmas Tree Adapters, (3) Luer Locking Syringes, (4) Luer Slip Syringes & (5) Oral Syringes.
ENFit Transition Adapters
ENFit male transitional adapters will be available to attach to the new administration sets with the ENFit female connectors. This will facilitate compatibility between the new ENFit system and the current existing part system as the market transitions.
Transition to Standard
The new ENFit system has been designed to reduce the misconnections between unrelated delivery systems (vascular, respiratory, epidural). Both enteral administrative sets and device sets will adjust to the ENFit standard.
ENFit® Frequently Asked Questions
What is the ENFit Connector ISO 80369-3 change?
In order to improve patient safety and to decrease the risk of medical device misconnections, the International Organization for Standardization (ISO) has created a new standard design for enteral connectors, termed the “ENFit Connector”; which will be adopted by all United States enteral device manufacturers. This new connector has been designed to be incompatible with Luer adapters, which are commonly used in IV applications. The ENFit connector will look & secure very similar to a Luer threaded lock system, although the design is larger and thus, incompatible with Luers.
What is the planned rollout for the ENFit Connector change?
Feeding bag manufacturers have started to make the giving set (food source) end with a female ENFit lock (instead of the current Christmas tree adapter). Syringe manufacturers will follow shortly thereafter – in Q1 of 2016 – making syringes specifically for enteral use, having tips with a female ENFit lock just like the feeding bag giving set (instead of the current catheter or luer tips typical of bolus syringes).
Once both the food source ends (bag and syringe) have implemented, the feeding set (device) manufacturers will start making feeding sets that have a male ENFit lock (instead of the traditional bolus or Y-port), beginning Q1 of 2016. Note, the end of the feeding (device) sets that connect to the device (straight & right angle adapters) will not change and will still be manufacturer specific (e.g. MiniONE® compatible).
During the changeover for each of the components above, transitional adapters will be made available by both the feeding bag and feeding device manufacturers that allow for backwards compatibility to older connectors.
How is AMT planning the rollout of this new product?
AMT will remain in compliance with all rules and regulations established through ISO 80369-3 and any applicable FDA regulations regarding the time frame release of the new ENFit connectors.
AMT enteral products, with the new ISO connectors, are targeted to be implemented starting in Q1 of 2016.
There will be a transitional period where AMT will continue to provide our current products, until we exhaust our existing inventory as we phase in the new ISO updated items. Transition feeding/extension set adapters will be available which will fit both current feeding tube connectors as well as the new ENFit connections. Transition pieces will be available for six months and up to one year, depending on market needs. Eventually, the FDA will require transition adapters no longer be made available.
Will there be samples available for product demonstrations?
Yes. AMT’s sales team will have product samples to perform in-servicing opportunities. We will also provide additional training tools as the new ENFit connectors come to market.
What is the timing of the new ENFit enteral connector transition?
The current plan is:
- Step 1) Starting Q1 of 2015
Feeding Bag / Giving Sets to start having New ENFit female lock adapter
(also includes backwards compatible transitional adapters)
- Step 2) Starting Q1 of 2016
Enteral specific Syringes to start having New ENFit female lock adapter
- Step 3) Starting Q1 of 2016
Feeding Device Sets and Feeding Devices to start having New ENFit male lock adapter
(also includes backwards compatible transitional adapters)
AMT will adhere to the guidelines and time frame provided by ISO. AMT enteral products, with the new ISO ENFit connectors, are targeted to be implemented starting in Q1 of 2016. We will cycle through our current inventory first as we begin to manufacture the new connectors.
When will the transition pieces be available?
Transition pieces will begin to be available when the new feeding bag / giving sets start rolling out in Q1 of 2016. AMT will also provide transition pieces, as we begin rolling out our new feeding sets with the ENFit connector starting in Q1 of 2016. The transition pieces will allow the use of both the current feeding tube connectors, as well as the new ENFit connectors.
How long will the transition piece be available?
AMT will supply transitional adapters with our new ENFit device sets as consumer needs adjust. The FDA however, requires that eventually the transitional adapter be discontinued, such that full ENFit integration occurs.
Will the transition piece be sold as a separate item?
Yes. As the ENFit connector rolls out, AMT will include a transition piece within our enteral device products for our customer convenience, and it will also be sold as a separate item.