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ENFit enteral connections: Are you ready?

Presented by webinar:

March 11, 2015 and

March 17, 2015

Cathie Gosnell, RN, MS, MBAClinical consultant

Premier Safety Institute

Debby Kasper, RDN, LDNDirector, clinical nutrition

Premier, Inc.

Understand the background for 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 transition

• Incorporate new connections into all areas of

practice

After this webinar, the listener will:

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

The Problem

Photo courtesy of FDA

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

The Solution Small Bore Connector Standards

80369-1 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

80369-2 - breathing systems & driving gases – April, 2016*

80369-3 - enteral feeding – July, 2015*+

80369-4 - urinary collection - TBA

80369-5 - limb cuffs – October, 2015*

80369-6 - neuraxial (e.g., epidural, catheter) – July, 2015*

80369-7 - vascular (replaces ISO 594) – October, 2015*

*Estimated ISO publication date+Published as ANSI/AAMI provisional standard December, 2014

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Estimated Implementation Timeline

Q2’14 Q3’14 Q4’14 Q1’15 Q2’15 Q3’15 Q4’15 Q1’16

AWAREAwareness Campaign

PREPAREIn-Service &

Webinars

ADOPTProduct Launch

& Implementation

MEASUREAdoption & Adherence

Q2’15 Q3’15 Q4’15 Q1’16 Q2’16 Q3’16 Q4’16 Q5’17

AWAREAwareness Campaign

PREPAREIn-Service &

Webinars

ADOPTProduct Launch &

Implementation

MEASUREAdoption & Adherence

Q2’16 Q3’16 Q4’16 Q1’17 Q2’17 Q3’17 Q4’17 Q1’18

AWAREAwareness Campaign

PREPAREIn-Service &

Webinars

ADOPTProduct Launch &

Implementation

MEASUREAdoption & Adherence

PHASE I - Enteral

PHASE II - Neuraxial

PHASE III – Therapeutic Family TBD

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

US Enteral Estimated Launch Timelines

TransitionSet

Launch 

New SyringeLaunch Launch

ISO Tubes

Jan‘15

Feb‘15

Mar‘15

Apr ‘15

May ’15

Jun‘15

July ‘15

Aug ‘15

Sep ’15

Oct‘15

Nov‘15

Dec’15

Jan‘16

Connector Transition

Trasition Set 

Rampdown

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Nutrition End Connector

Introduced in 2012

Adopted across the market by enteral industry

Prevents inadvertent use of IV tubing as an administration set.

Will be an ISO 18250 Standard for reservoir connectors

FROM

TO

The Challenge…Connecting a System Designed Not to Connect

CURRENT NEW

Male Stepped or “Christmas Tree” Connector from

Administration Set

Female Feeding Tube Port

Female ENFit Connector from

Administration Set

Male ENFit Connector for Feeding Tube

ENFit Transition Connector

Temporary Transition NEWCurrent

Female ENFitConnector from Administration

Set

FemaleFeeding Tube

Port

Transition Connector

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ENFit Transition Connector

Allows fitment to current feeding ports until new enteral feeding tubes are available.

Available Q1 2015 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 Q2 - 2015

Enteral Syringes with ENFit Connectors

Reversed orientation from female to male port

Locking & forcing function features

All enteral and multi-purpose ports must have ENFit connector

Available Q3 2015

ENFit Feeding Tube

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 80369 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

Enteral connector development

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ENFit connector syringe – fluid displacement

Fluid in female ENFit on syringe may be displaced when connected to male ENFit on feeding tube

Up to 0.148 ml of additional fluid may be administered

Use of a fill adapter or tip cap mitigates the issue

Displacement is not an issue when ENFit syringe is used for oral administration

Fill Adapter

Tip Cap

Debby Kasper, RDN, LDNDirector, clinical nutrition

Premier, Inc.

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Completed

Feeding Set

Extension Set

Feeding Tube

Enteral SyringesNow what?

Coordination

Communication• Facility

• Supplier (s)

Designate a Champion

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

Assemble a Team

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?

Discovery

Includes feeding tubes, connectors, and enteral specific syringes

Check units

Storage areas

Drawers

Closets

Consolidate Inventory

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Identify Super Users

Education• Who, what, where, when, how

Communication• Orders

» Electronic

» Paper

• Education materials

• Other organizations/agencies involved

Inventory• Amount

• Physical space

• Labelling

Develop a Plan

How is the plan working?

Glitches in the system

Evaluation

Facilities

Nurse/Clinicians

Supply Chain

Pharmacies

Home Health

Patients / Caregivers

Checklists on GEDSA

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GEDSA Website www.stayconnected.org

For more information:

www.premierinc.com/tubingmisconnections

www.ismp.org

www.fda.gov

www.aami.org

Thank you for joining us

Connect with Premier

The enteral feeding system is transitioning to the ENFitconnectors 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

Conclusion