1. Amsino Your Medical Device Partner

2. Tubing Misconnections: Adverse Events
A feeding tube connected to an in-line ventilator suction catheter, delivering feeding contents into the patient’s lungs, resulting in death
A feeding tube was coupled with a peripheral line of a pregnant woman, resulting in enteral nutrition delivered directly into the bloodstream; neither the 35-week-old fetus nor the woman survived
Connection of a feeding tube to a tracheostomy tube, delivering milk into an infant’s lung, resulting in death
2The Joint Commission is an independent, not-for-profit organization, which accredits and certifies more than 19,000 health care organizations and programs in the United States.

3. Presently there are universal connectors that allow fitment between physiologically incompatible systems.
What is being done?
FDA collaborated with International Organization for Standardization (ISO) and the Association for the Advancement of Medical Instrumentation (AAMI) to develop the ISO series of standards.
ISO specifies the dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used as connections in enteral applications of medical devices and accessories to ensure non-inter-connectability.
California Senate Bill No.158: “Prohibit the use of intravenous, epidural, or enteral feeding connections that would fit into a connection port other than the type it was intended for…”. Mandate takes effect January 1, 2016
Global Enteral Device Supplier Association (GEDSA) is a nonprofit trade association made up of manufacturers, distributors, and suppliers —helps educate and introduce the new international standards in medical device tubing connectors to enhance patient safety.

4. Stay Connected
The Stay Connected initiative for using safer connectors is a three-phase program. Through the Aware, Prepare, and Adopt phases, GEDSA will help facilitate a successful transition to safer connectors.
Website: StayConnected2015.org

5. Aware
• Generate awareness of impending changes across the organizations to all impacted clinicians, administrators, supply chain, health technology management and other support staff. • Identify a leader within the organization to stay informed as plans progress and communicate updates to others in the organization early and often.

6. Prepare 
• Form teams to assess existing systems, processes, and protocols that may need to change, focusing on areas of highest risk which have the most immediate need to convert to the new connectors. • Work with supplier representatives and adopt their product-specific transition plan. • Train clinicians and materials/inventory management staff for impending changes.

7. Adopt
• Introduce new connectors into work stream to reduce tubing misconnections and improve patient safety. • Remind the organization of the long-term benefits vs. the short-term hassles of transitioning to new connectors.

8. Current Enteral Feeding System
Phase 1: 2012
Change of proximal-end connector for closed system containers
New design for closed system containers compatible with the new proximal-end connector
Purpose: incompatible with IV ports

9. Phase 2: Traditional Male Distal Connector New Female Distal Connector.

10. What is ?
It’s a new enteral connector that will be phased in across the enteral device industry.
CHANGES
Administrative Sets
Enteral Syringes
Feeding Tubes
Traditional Male Distal Connector
ENFit Female Distal Connector
Traditional Piston Syringe
Syringe with ENFit Tip
Traditional G-Tube
ENFit G-Tube

11. connector unique design
Female distal connector
Enteral Feeding set
Male distal connector
Feeding tubes

12. ALCOR® AMSure® enteral feeding systems
Phase 1
Phase 2
Phase 3
Traditional Sets
Administration Kits*
Administration Sets**
E-1004
Enteral feeding spike set for Sentinel Feeding Pump
ENF1004K
(1) Enteral Feeding Spike Set with ENFit Connector
(1) Transition Connector
ENF1004
Enteral Feeding Spike Set with ENFit Connector
E-0500
Enteral feeding 500 mL bag set for Sentinel Feeding pump
ENF500K
(1) Enteral Feeding Bag with attached pump set and Secure Lock Tip, 500mL with ENFit Connector
ENF500
Enteral Feeding Bag with attached pump set and Secure Lock Tip, 500mL with ENFit Connector
E-1200
Enteral feeding 1200 mL bag set
ENF1200K
(1) Enteral Feeding Bag with attached pump set and Secure Lock Tip, 1200mL with ENFit Connector
ENF1200
Enteral Feeding Bag with attached pump set and Secure Lock Tip, 1200mL with ENFit Connector
E-1203
Enteral feeding 1200 mL gravity bag get
ENF1203K
(1) Enteral Feeding Bag with attached gravity set, 1200mL with ENFit Connector
ENF1203
Enteral Feeding Bag with attached gravity set, 1200mL with ENFit Connector
E-0500M
Enteral feeding 500 mL bag set with magnet
E-1200M
Enteral feeding 1200 mL bag set with magnet
* Kit will include 1 administrative set and 1 transition connector (Transition connector will not be pre-attached)
** Sets will no longer include transition connector

13. Connector + Transition Connector
To attach transition connector for use with ENFit administration set, push and turn motion until the transition connector is firmly connected to the female connector.
Enteral Administrative Kit will contain:
(1) Enteral Administration Set (Spike, pump set or gravity)
(1) Transition Connector .
ENFit Connector & Transition Connector
Push ENFit Connector & Transition Connector together
Turn Transition Connector until it connects firmly together
ENFit Spike Set

14. Enteral feeding tubes ENFit G-Tube Traditional G-Tube ENFit connector
Transition connector
Securely fit the transition connector into the enteral feeding tube funnel
Transition Connector will not work on ENFit G-Tubes

15. AMSure® syringe product line with ENFit Tip
Phase 1
Phase 2
SYRINGES
Traditional Syringes
Syringes with ENFit Connector
AS016
Thumb Control Piston
ENS016
AMSure® 60cc Enteral Feeding Thumb Control Ring Syringe with ENFit Tip , Re-sealable Pole Bag
AS116
Piston Irrigation Syringe
ENS116
AMSure® 60cc Enteral Feeding Flat Top Piston Syringe with ENFit Tip, Re-sealable Pole Bag
IRRIGATION KITS
AS126
Piston irrigation kit
ENK126
AMSure® Enteral Feeding Irrigation Kit
500cc Graduated Container, 60cc Thumb control Ring Piston Syringe with ENFit Tip Irrigation Kit, Poly Bag
AS127
ENK127
500cc Graduated Container, 60cc Thumb control Ring Piston Syringe with ENFit Tip Irrigation Kit, Resealable Pole Bag
AS136
Thumb Control Piston Irrigation Tray, 500cc
ENK136
AMSure® Enteral Feeding Irrigation Tray
1000cc Outer Tray, 500cc Graduated Container, 60cc Thumb control Ring Piston Syringe Irrigation Tray
with ENFit Tip, Alcohol prep pad, moisture proof under pad.
NEW Purple Plunger
Syringes will not include transition connector

16. Enteral Connectors 2015 GEDSA RECOMENDATION
Manufactures commit to ENFit conversion:
ENFit Administrative Sets - Q (Now)
ENFit Enteral Syringes – Q1 2016
ENFit Feeding Tubes –Q1 2016
CALIFORNIA MANDATE TAKES EFFECT JANUARY 1, 2016
Senate Bill No.158: “Prohibit the use of intravenous, epidural, or enteral feeding connections that would fit into a connection port other than the type it was intended for…”.
AMSINO ENTERAL CONNECTORS
Will offer both Traditional & ENFit Connector Administrative Sets/Syringes
ENFit Administrative Kits & ENFit Syringes will be available third quarter of 2015

17. Amsino is committed to patient safety
GEDSA Member
Smooth transition for you and your customers