Safe Enteral Connection – ISO Standard Changes Tamara Passut, RN, MBA Patient Safety Manager, Fayetteville NC VA Medical Center 7/24/2015

Disclosure The presenter nor those in a position to control content have no relevant relationship or financial disclosures to make. There will not be discussion of any off-label, experimental, or investigational use of drugs or devices in this presentation This program is not being supported by any commercial funding.

Objectives Understand safety concerns of current medical device connections Have an understanding of the anticipated time line and objectives for change implementation Identify key personnel and responsibilities of those who will be affected by the changes Once your determine your topic, write down your “objectives” What should you accomplish with your presentation: The audience will be understand how to create a PowerPoint presentation The audience will be able to identify key elements of a good presentation. The audience will have hands-on practice building a presentation The audience will have a template for future use

Outline Safety Concerns of medical device connection ports Changes and Anticipated Time line Key stakeholders Patient education and training Summary Citations

Safety Concern: Adverse Events A patient’s oxygen tubing became disconnected from his nebulizer and was accidentally reattached to his IV tubing Y-site by a staff member who was completing a double shift The patient died from an air embolism, even though the connection was broken within seconds

Safety Concern: Adverse Events An anesthetist and a midwife mistakenly connected an epidural set to the patient’s IV tubing The epidural medicine was delivered to the IV The patient died For certain high-risk catheters (e.g., epidural, intrathecal, arterial), label the catheter and do not use catheters that have injection ports

Safety Concerns – Adverse Events A patient’s feeding tube was inadvertently connected to the instillation port on the ventilator in-line suction catheter Tube feeding was delivered into the patient’s lungs - The patient died

Safety Concerns – Adverse Events Source: FDA Website

Safety Concern Human Factors Physical Compatibility Lack of a Forcing Function Source: Stacy Connected 2015, Joint Commission,

Changes ISO Standard 80369-3 Global Enteral Device Supplier Assoication (GEDSA) Formed to introduce standards in medical device tubing connectors Stay Connected 2015 GEDSA’s communication source for changes and communication for global changes GEDSA http://www.gedsa.org/

What’s Happening? Current Administration Sets World-wide replacement of Tube feeding administration sets so that the connection will be with a leurlock or “screw on” system. New Connections Current Connections An adaptor or “connection set” will be available until patient feeding tubes can be surgically implanted (updated) to leurlocks.

Enteral Syringe Connection **Be Aware that other types of syringes that may be used to connect to Enteral Connections Currently will NO longer be compatible with Enteral Access Connections without the new design**

Changes Summary Industry-wide changes to the distal connection on all pump sets and a corresponding change to all feeding tube ports The “ENFit” connector tip will replace the stepped connector or “Christmas Tree” end of the feeding set that connects to the patient ENFit connector is a screw-on connector A white transitional connector will come in the feeding set bag (which will be transitioned out) Once the patient has the new device feeding tube surgically placed they will no longer be compatible with the current feeding bags/spike sets or syringes Source: Covidien Module 1 – Safe Enteral Connections

Timeline FY15 Q3: Kangaroo Pump Set and Transition Connector ISO 80368-3 Logistics to notify Nurse Educators, Prosthetics, PSM First in/First out practice of dissemination using older version first Use first arrivals as teaching aids/tools CACs to add to template for Tube Feeding Education FY15 Q4: Enteral –specific syringes – to administer medicine, flushes, supplemental hydration or bolus feeding (oral, luer or cath tip syringes will no longer fit) FY16 Q2/Q3: Patient Feeding Tube Replacement PCMs/Provider initiate consult to replace tube feeding unless contraindicated FY17/FY18: Transition Connector to be phased out

Key Personnel Providers: Prescribe Nutritional Support and Medications to be administered through enteral port, refer patient to surgery for placement of an updated ENFit feeding tube Pharmacy: Stocks Enfit Syringes, bottle adapters, light sensitive bags, and ENFit transition adapters. Processes enteral feedings, dispenses syringes for enteral medication administration, prepare medications via enteral syringe for inpatient use – POC: Barbara Windley Nurses: Home Based Primary Care, Long Term Care, and the Hospital will assist with education for patients on changes and may administer tube feedings and/or medications - Nurse POC: Wanda Jessie Prosthetics Department: Dispense tube feeding systems and pumps to established outpatients along with educational handouts - POC: Kimberly Nielson Logistics (SPD): Orders and distributes inpatient supplies to units – POC: Janis Hunter

Provider Summary Ensure patients with enteral feeding or medication needs are identified and provided education about the changes Ensure all medication orders and nutrition orders clearly identify the enteral route for administration (so they will be prepared appropriately- pharmacy will be dispensing liquid medications in the syringe) Conduct a risk/benefits analysis of patients who currently have an feeding tube to determine if they should receive an updated ENFit model in FY16

References: Copy & paste in browser to view video: http://www.healthstream.com/content/Covidien/ENFit/Module%201%20-%20Beta%20w%20Change%20Order/story.html http://www.jointcommission.org/assets/1/6/SEA_53_Connectors_8_19_14_final.pdf http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TubingandLuerMisconnections/ucm313275.htm http://www.jointcommission.org/joint_commission_alerts_organizations_to_tubing_misconnection_risks/ http://www.jointcommission.org/assets/1/6/SEA_Connectors_TJC_Requirements.pdf http://www.philly.com/philly/blogs/healthcare/New-connectors-coming-for-healthcare-tubing-and-catheters-.html https://www.premierinc.com/tubingmisconnections/ https://www.premierinc.com/quality-safety/tools-services/safety/safety-share/bulletin-tubing-misconnect-11132013.jsp

Questions?