1. Breakout Session: Preventing Enteral Misconnections Michelle Kozeniecki, MS, RD, CNSC Clinical Dietitian, Froedtert Hospital WiSPEN 2014 Fall Symposium September 18, 2014

2. Objectives Identify and prioritize devices and practices vulnerable to tubing misconnections Establish processes and device selection guidelines to help safeguard against enteral device misconnections

3. What is an Enteral Misconnection? Definition: “An inadvertent connection between an enteral feeding system and a non-enteral system such as an intravascular line, peritoneal dialysis catheter, tracheostomy, medical gas tubing, etc.” The Joint Commission Journal on Quality and Patient Safety 2008; 34(5): 285-292.

4. How Can Enteral Misconnections Happen? Contributing Factors Compatible tubing between unlike systems (universal design) Use of IV syringes for oral medications Universal Spike for bags

5. Devices Vulnerable to Tubing Misconnections Small-bore connectors (SBC): The Luer connector is a classic type of SBC that allows direct or functional connection between unrelated delivery systems (e.g. vascular, enteral, respiratory, epidural, and intrathecal medical devices, components and accessories) http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm127745.htm

6. Why is this Important? Case Report: A 24-year-old woman was 35 weeks pregnant and hospitalized for vomiting and dehydration. A bag of ready-to-hang EN was brought to the floor and the nurse erroneously gave the EN through her IV line, assuming it was PN. The fetus and mother died after several hours of excruciating pain An overall 33% rate of permanent patient harm or death has been reported. The Joint Commission Journal on Quality and Patient Safety 2008; 34(5): 285-292.

7. Call for Design Changes All product manufacturers were urged to implement “incompatibility by design” features to prevent inappropriate connections when attempted 1. The new design was a group effort – An international group of clinicians, practice experts, manufacturers, and regulators – International Organization of Standardization (ISO) – Association for the Advancement of Medical Instrumentation (AAMI) 1 The Joint Sentinel Event Alert. Tubing Misconnections – A Persistent and Potentially Deadly Occurrence. March 27, 2006.

8. Nutrition End Connection ISO standard connectors were universally adopted on the nutrition end of feeding/administration sets in 2012 Purpose: To prevent the inadvertent use of IV tubing as an enteral administration set.

9. Patient-Access End Connection (ENFit connector) Addresses “patient side” connections between feeding tubes and administration sets, medication, flush and bolus feeding syringes, and other enteral devices Purpose: To help reduce the risk of enteral tube feeding misconnections and improve patient safety

10. Patient-Access End Connection (ENFit connector) Unique design – Does not allow connectivity with any other connector for any other clinical use – Provides a locking feature that signals the appropriate connection and stays in place One-year transition timeline

11. Patient-Access End Connection: Administration Sets Administration sets will be available starting October-December 2014* Administration sets will have a transition adapter to facilitate compatibility between the new and existing designs, until new enteral tubes are available *All dates are projected estimates and subject to change

12. Patient-Access End Connection: Enteral Syringes Enteral-specific syringes will be introduced December 2014-March 2015* To be used for medications, flushes, and bolus feeding *All dates are projected estimates and subject to change Oral-tipped and Luer-tipped syringes will not fit the new ENFit Connector

13. Medication Administration: Best Practices Review current systems and practices: Communicating the order/route (prescribers) – In one study, 574 of 601 medications (96%) that were ordered as “PO” were administered by feeding tube Preparing and labeling syringes (pharmacists) – Ready-to-administer enteral drug products Preparing and administering enteral meds (nurses)

14. Patient-Access End Connection: Enteral Tubes New enteral feeding tubes with ISO standard connectors will be available starting April 2015* *All dates are projected estimates and subject to change

15. “What can I do?” Look for education opportunities (see next slides) Identify a champion or leader Make sure all stakeholders are aware and involved Review protocols on feeding tube placement, EN, and medication delivery for any needed revisions Revise patient education materials

16. Resources Timeline and FAQs: www.StayConnected2014.org* www.gedsa.org EN Safety Toolkit: www.nutritioncare.org/Guidelines_and_Clinical _Practice/Toolkits/Enteral_Nutrition_Safety_T oolkit/

17. *Stay Connected Stay Connected is a program designed to facilitate the transition from medical device applications that allow connection between unrelated delivery systems to new, safer connectors that ensure compatibility and consistency while reducing the likelihood of tubing misconnections. Stay Connected is organized by the Global Enteral Device Supplier Association (GEDSA) in partnership with leading industry organizations.

18. Stay Connected Sign up for the latest updates! – Email notifications when new tools and information is added Coming soon: – Set of checklists for clinicians, manufacturers, supply chain managers, etc. – Short (5 min) video with connector animation – In-service tool that can be used at your facility www.StayConnected2014.org