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

2. 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.

3. 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
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4. Outline Safety Concerns of medical device connection ports
Changes and Anticipated Time line
Key stakeholders
Patient education and training
Summary
Citations

5. 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

6. 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

7. 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

8. Safety Concerns – Adverse Events
Source: FDA Website

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

10. Changes
ISO Standard
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

11. 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.

13. 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**

14. 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

15. Timeline
FY15 Q3: Kangaroo Pump Set and Transition Connector ISO
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

16. 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

17. 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

18. References: Copy & paste in browser to view video:

19. Questions?