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A Global Industry Change / ENFit® ISO-80369-3
ENFit® is a trademark of Global Enteral Device Supplier Association, Inc. (GEDSA).
Legacy Items, Hybrid Options, or All ENFit®?
AMT’s Hybrid Feed Set Available NOW – 2 Lengths!
8-1255-H & 8-2455-H
In light of the July 18th letter from the Global Enteral Device Supplier Association (GEDSA), stating that all “member manufacturers will phase out legacy feeding devices and transition adapters starting July 1st, 2020”, we would like to share that Applied Medical Technology, Inc. (AMT) will continue to offer a complete line of ENFit® products and a complete line of Legacy devices and accessories, pursuant to FDA regulations.
AMT Now Offers Transition Adapters for Your Enteral Connection Needs.
Male ENFit® Transition Adapter
TRN101
Female ENFit® Transition Adapter
TRN201
ENFit® Transition Stepped Adapter
TRN102
Bolus Transition Adapter
TRN202
Y-Port Transition Adapter
TRN203
Y-Port Adapter w/Enhanced Med-Port
TRN204
The International Organization for Standardization (ISO) has created a new standard design for enteral connectors, termed the “ENFit Connector.”
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.
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 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 into newly created product lines.
From where we are today, to where you’re going tomorrow!
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® 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.
The new ENFit® system has been designed to reduce the misconnections between unrelated delivery systems (i.e. vascular, respiratory, epidural). Both enteral administrative sets and device sets will adjust to the ENFit® standard.