Transitional Phase 1
EnFit transition system
Continuing innovation
New Twist on Enteral Nutrition
Current System
Educate • Transition • Relax
Current Original System
New Patient Safety Standards
Current Market Systems In Use
Projected January 2015 - To Early 2016
AMT’s ISO 80369-3 ENFit Connector Transition Guide
Current Enteral Administration
AMT: Leaders In Product Education
Food / Medication
Enteral feeding tubes with the new ISO 80369-3 standard
connector will be available from AMT, as well as the entire
enteral device industry, beginning in 2016. For additional
information please visit the following links:
Administration Sets
How do I find out more about this change?
Device Sets
(Patient End/ Feed Extension Sets)
Male Connector
With AMT’s Glow-In-The-Dark
Glow-In-The-Dark Connectors
AMT will abide by all ISO and FDA regulations regarding the
product release timeline. All dates are subject to change due
to regulatory review and market demands.
Applied Medical Technology, Inc.
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T: 1-800-869-7382
[email protected]
www.AppliedMedical.net
The Leader In Enteral Device Innovation
An ISO 13485 Registered Company
Patents Pending ©2014 Applied Medical Technology, Inc.
C4485-A
Made In USA
Device Sets
(Food/ Medication Source)
Female Connector
Patient End/ Feed Extension Sets
Administration Sets
2
3
4
As early as January 2015, the new ENFit
Administration sets will be available. Administration
sets will use ENFit female connectors as the new
enteral nutrition standard.
5
Administration sets and syringes
are scheduled to transition to
ENFit connectors first, followed
by device sets in the coming
months.
Several
transitional
adapters will be made available
during the phases inside. The
transitional phase (Phase 1) will
begin as early as January 2015.
See inside for details.
Transitional Adapters
Please let us know if we may be of any further assistance.
Email: [email protected]
Please include “ISO 80369-3 Change” in the subject line.
Toll Free: 800-869-7382
1
“Do I Need An ENFit
Adapter Now?”
Placeholder Image
http://www.amtinnovation.com/AMT_ISO.html
http://www.amtinnovation.com/pdf/ISO-Change-FAQs.pdf
http://www.amtinnovation.com/pdf/ENFit_2014.png
www.aami.org/hottopics/connectors/stay_connected_10152013
http://www.oley.org/New_Connectors_for_Enteral_Feedings.html
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.
New ENFit Administration Sets
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.
Example:
Current Market
Current Market Enteral Device Sets
Current Enteral Device Sets
These are AMT’s Current Market device sets that
are compatible with administration sets. The
estimated transition from these feed sets will start
to occur July of 2015.
There will be a transitional period where AMT
will continue to provide our current products, as
pictured below. We will transition to a complete
ENFit integration by 2016.
Not Actual Size
Applied Medical Technology, Inc.
Call Today 1-800-869-7382
As the market transitions to the new ENFit connectors,
you may encounter any of these possibilities.
Transitional Phase 2
A New Twist On Enteral Nutrition
July 2015 - January 2016
Current Market to ENFit
ENFit to Current Market
Female
ENFit
July 2015 - January 2016
July 2015 - January 2016
Final Enfit
ENFit Fully Integrated
January 2016 - Beyond
Future Enteral Administration
ENFit to ENFit
The new ENFit connectors will be the accepted ISO
80369-3 fittings for patients. ENFit is similar to a luer
adapter, but larger and thus incompatible.
Current
Female ENFit
Male
ENFit
Male ENFit End
Female ENFit
For a period of time, all
new AMT ENFit devices
will come with the appropriate ENFit transitional
adapters.
For a period of time, all
new AMT ENFit devices
will come with the appropriate ENFit transitional
adapters.
Not Actual Size
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.
Female ENFit
Male ENFit
Male ENFit
Current
Not Actual Size
Early Occurrence Likelihood
A
The new ENFit administration sets with female connectors will
require ENFit male transition adapters to facilitate compatibility
with existing port systems as the market transitions.
You will be able to use your current supply of device sets by
utilizing the ENFit male transition adapters to attach to the
ENFit female administration sets.Transitional adapters will
come with new ENFit administration sets, and AMT will have
these available as well, should you need them.
Applied Medical Technology, Inc.
Not Actual Size
Not Actual Size
Not Actual Size
Low Occurrence Likelihood
B
Later Occurrence Likelihood
C
An ENFit female transition adapter will be required with the
new ENFit male device sets.
The new ENFit administration sets with female connectors will
attach to the new ENFit device sets with male connectors.
You will be able to attach your current supply of enteral
administration sets (as pictured at the top) to the new ENFit
male device sets by utilizing the AMT ENFit female transition
adapters. AMT will supply transitional adapters with our
new ENFit device sets as consumer needs adjust. The FDA
however, requires that eventually the transitional adapters be
discontinued, such that full ENFit integration occurs.
Utilizing both ENFit connectors you will be able to attach your
administration sets to your device sets. This ENFit connection
will be the established medical standard created through ISO
80369-3. As the market transitions to the new ENFit connection
standard, you could encounter any of these possibilities listed
in our Transitional Phase 2 section.
Call Today 1-800-869-7382
Applied Medical Technology, Inc.
The ENFit Market
ENFit has been established as the new medical standard.
As pictured below, ENFit connectors provide a higher
degree of safety in food and medicine administration.
Transition adapters will be made available as the market
adjusts to the new ISO 80369-3 changes. The FDA
however requires that eventually the transition adapters
will be discontinued.
Not Actual Size
Applied Medical Technology, Inc.