3/26/2015. Debby Kasper, RDN, LDN Director, clinical nutrition Premier, Inc. Cathie Gosnell, RN, MS, MBA Clinical consultant Premier Safety Institute

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1 Debby Kasper, RDN, LDN Director, clinical nutrition Premier, Inc. ENFit enteral connections: Are you ready? Presented by webinar: March 11, 2015 and March 17, 2015 Cathie Gosnell, RN, MS, MBA Clinical consultant Premier Safety Institute After this webinar, the listener will: Understand the background for the initiative Plan for the three phases of the transition Enteral connection sets Q Enteral syringes Q Feeding tubes Q Be aware of Premier and industry tools to help with smooth transition Incorporate new connections into all areas of practice The Problem Tubing misconnection - an inadvertent connection of tubing from the medical device for one delivery system to a system that serves a completely different function A serious adverse patient safety event resulting in harm and possible death Universal connectors allow misconnections between unrelated systems Practice guidance, alerts by professional and regulatory organizations have not solved this problem Photo courtesy of FDA The Solution Reduce opportunity for wrong connections Changing design, shape, or size of the tubing connections Creation of incompatible connectors New standards International Standard Organization (ISO), and the Association for the Advancement of Medical Instrumentation (AAMI)» In collaboration with an international group of clinicians, manufacturers and regulators Designed to reduce the risk of tubing misconnections» Retain Luer connectors for hypodermic and IV applications» Develop unique connectors for each clinical delivery system California legislation Prohibits use of epidural, IV or enteral connector that fits into a connection port other than the type for which it was intended Effective date January, 2016 Small Bore Connector Standards General requirements December, 2010 restricts use of luers and sets standards for new connectors for specific applications six related standards identify specific requirements for connectors by application / clinical delivery system breathing systems & driving gases April, 2016* enteral feeding July, 2015* urinary collection - TBA limb cuffs October, 2015* neuraxial (e.g., epidural, catheter) July, 2015* vascular (replaces ISO 594) October, 2015* *Estimated ISO publication date + Published as ANSI/AAMI provisional standard December,

the initiative Plan for the three phases of the transition Enteral connection sets Q1 2015 Enteral syringes Q2 2015 Feeding tubes Q3 2015 Be aware of Premier and industry tools to help with smooth

2 Estimated Implementation Timeline PHASE I - Enteral Q2 14 Q3 14 Q4 14 Q1 Q2 Q3 Q4 Q1 16 Stay Connected Driven by Industry, Supply Chain, Clinician & Patient Partnership Developed by Global Enteral Device Supplier Association (GEDSA) in partnership with experts from leading industry organizations Product & Implementation PHASE II - Neuraxial Q2 Q3 Q4 Q1 16 Q2 16 Q3 16 Q4 16 Q5 17 Product & Implementation PHASE III Therapeutic Family TBD Q2 16 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17 Q4 17 Q1 18 Product & Implementation US Enteral Estimated Timelines Nutrition End Connector Connector Transition Introduced in 2012 FROM Adopted across the market by enteral industry Jan Feb Transition Mar Apr May New Syringe Jun July Aug ISO Tubes Sep Oct Nov Trasition Rampdown Dec Jan 16 TO Prevents inadvertent use of IV tubing as an administration set. Will be an ISO Standard for reservoir connectors 10 The Challenge Connecting a System Designed Not to Connect ENFit Transition Connector Male Stepped or Christmas Tree Administration CURRENT Female ENFit Administration NEW Current Female ENFit Administration Temporary Transition Transition Connector NEW Female Feeding Tube Port Male ENFit Connector for Female Port 2

Implementation PHASE III Therapeutic Family TBD Q2 16 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17 Q4 17 Q1 18 Product & Implementation US Enteral Estimated Timelines Nutrition End Connector Connector Transition

3 ENFit Transition Connector Enteral Syringes with ENFit Connectors Allows fitment to current feeding ports until new enteral feeding tubes are available. Available Q in all administration sets. Used during year of transition. Currently oral syringes are used to administer Medication Flushes Supplemental hydration Bolus feeding Enteral specific syringe with ENFit female connector will now be required Oral, Luer or cath-tip syringe will no longer fit Available Q ENFit Enteral connector development Reversed orientation from female to male port Locking & forcing function features All enteral and multi-purpose ports must have ENFit connector Available Q Enteral feedings are used in all age groups and all healthcare settings Development of the standard considered all patient populations across the continuum of care Multiple designs evaluated for misconnection risk Common connector and name across all suppliers - ENFit Testing results for the ENFit connector indicates Low risk of misconnection with other connectors Human factors testing with clinicians positive ease of use Large enough to administer blenderized diets Small and light enough for use on neonatal feeding tubes Female to male (reverse) connection may result in fluid displacement from syringe to feeding tube, which can be mitigated ENFit connector syringe fluid displacement Fluid in female ENFit on syringe may be displaced when connected to male ENFit on feeding tube Use of a fill adapter or tip cap mitigates the issue Fill Adapter Tip Cap Debby Kasper, RDN, LDN Director, clinical nutrition Premier, Inc. 17 Up to ml of additional fluid may be administered Displacement is not an issue when ENFit syringe is used for oral administration 3

Currently oral syringes are used to administer Medication Flushes Supplemental hydration Bolus feeding Enteral specific syringe with ENFit female connector will now be required Oral, Luer or cath-tip

4 Completed Feeding Enteral Syringes Now what? Extension Designate a Champion Coordination Communication Facility Supplier (s) Assemble a Team Who is going to be impacted? Nurses Medical Staff Pharmacy RD Unit Secretaries IT Materials Management Education Department Social Workers Risk Managers or Patient Safety Officers Units (ED, OR, ICU, GI Lab) Home Health Agencies Discovery Inservice Tools on GEDSA website Identify your current suppliers Outline your processes and protocols How do feeding tubes get ordered? How are they stocked? Are they on order sets or standing orders? Are they listed in EMR s? How is medication for use thorough tubes ordered/delivered? Patient education material Who needs to know what and when? Consolidate Inventory Includes feeding tubes, connectors, and enteral specific syringes Check units Storage areas Drawers Closets 4

Discovery Inservice Tools on GEDSA website Identify your current suppliers Outline your processes and protocols How do feeding tubes get ordered? How are they stocked?

5 Develop a Plan Identify Super Users Education Who, what, where, when, how Communication Orders» Electronic» Paper Education materials Other organizations/agencies involved Inventory Amount Physical space Labelling Evaluation How is the plan working? Glitches in the system Checklists on GEDSA Facilities Nurse/Clinicians Supply Chain Pharmacies Home Health Patients / Caregivers GEDSA Website 28 Thank you for joining us For more information: Conclusion The enteral feeding system is transitioning to the ENFit connectors in 2015 Facilities need to prepare and implement changes to assure no gap in patient care Premier is providing tools to help members in the transition Connect with Premier 5

stayconnected.org 28 Thank you for joining us For more information: www.premierinc.com/tubingmisconnections www.ismp.org www.fda.gov www.aami.

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