1© 2015 by Amsino: Confidential and Proprietary Data

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2© 2015 by Amsino: Confidential and Proprietary Data

Tubing Misconnections: Adverse Events

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TubingandLuerMisconnections/ucm313275.htm

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.

Connection of a feeding tube to a tracheostomy tube, delivering milk into an infant’s lung, resulting in death

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

3© 2015 by Amsino: Confidential and Proprietary Data

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 80369 series of standards.

ISO 80369-3 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© 2015 by Amsino: Confidential and Proprietary Data

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

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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.

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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.

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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.

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Current Enteral Feeding System

Phase 1: 2012Change 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

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Phase 2:

Traditional Male Distal Connector

New Female Distal Connector

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What is ?

Traditional Male Distal Connector

ENFit Female Distal Connector

It’s a new enteral connector that will be phased in across the enteral device industry.

Traditional Piston Syringe Syringe with ENFit Tip Traditional G-Tube ENFit G-Tube

Administrative Sets Enteral Syringes Feeding Tubes

CHANGES

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connector unique design

Female distal connectorEnteral Feeding set

Male distal connectorFeeding tubes

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ALCOR® AMSure® enteral feeding systems

Phase 1 Phase 2 Phase 3Traditional 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 (1) Transition Connector

ENF500Enteral 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(1) Transition Connector

ENF1200Enteral 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(1) Transition Connector

ENF1203Enteral 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

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Connector + Transition ConnectorTo 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

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Enteral feeding tubes

Securely fit the transition connector into the enteral feeding tube funnel

Transition connector

ENFit connector

Traditional G-Tube

ENFit G-Tube

Transition Connector will not work on ENFit G-Tubes

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AMSure® syringe product line with ENFit Tip

NEW Purple Plunger

Phase 1 Phase 2SYRINGES

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 KITSTraditional Syringes

Syringes with ENFit Connector

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 Piston irrigation kit ENK127

AMSure® Enteral Feeding Irrigation Kit 500cc Graduated Container, 60cc Thumb control Ring Piston Syringe with ENFit Tip Irrigation Kit, Resealable Pole Bag

AS136Thumb Control Piston Irrigation Tray, 500cc

ENK136AMSure® Enteral Feeding Irrigation Tray1000cc Outer Tray, 500cc Graduated Container, 60cc Thumb control Ring Piston Syringe Irrigation Tray with ENFit Tip, Alcohol prep pad, moisture proof under pad.

Syringes will not include transition connector

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Enteral Connectors2015 GEDSA RECOMENDATION

• Manufactures commit to ENFit conversion:• ENFit Administrative Sets - Q2 2015 (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

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Amsino is committed to patient safety GEDSA MemberSmooth transition for you and your customers