McKesson Medical-Surgical

Clinical Webinar Series

Getting Prepared: New Enteral Connectors June 10th, 2015

Lisa Logan RD,CNSC

McKesson Clinical Support

Manager

Getting Prepared: New

Enteral Connectors

Peggi Guenter, PhD, RN, FAAN

Senior Director for Clinical Practice, Quality, and Advocacy

American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.)

Silver Spring, MD

Learning Objectives 1. Explain why new enteral connector

design standards are needed

2. Describe features of the new enteral

connector standards and their safety

implications

3. Outline the timeline for new connector

design implementation and transition

What is a Small-bore Connector (SBC)?

A small-bore connector is a connector with

• an inner diameter of less than 8.5 mm

• used to link or join medical devices, components, and accessories

• for the purpose of delivering fluids or gases.

A Luer connector is a classic type of a small-bore connector used commonly in the healthcare setting- a universal connector.

? Central Venous Catheter

? Gastrostomy Tube ?Arterial Catheter

? Epidural Catheter

2/7/00

Enteral Misconnection

Definition: An inadvertent connection

between an enteral feeding system and

a non-enteral system such as an

intravascular catheter, peritoneal

dialysis catheter, tracheostomy, medical

gas tubing,etc.

Also known as a wrong route error or small

bore misconnection

Guenter et al. The Joint Commission Journal on Quality and Patient Safety May 2008;34:285-292.

Impact of Misconnections

A 24-year-old woman was 35 weeks pregnant hospitalized for vomiting

and dehydration. A bag of ready to hang enteral feeding was brought

to the floor, and the nurse, assuming it was total parenteral nutrition,

which the woman had received on previous admissions, pulled

regular intravenous tubing from floor stock, spiked the bag, and

started the infusion of tube feeding through the patient’s peripherally

inserted central catheter line. The fetus died—and then the mother. Guenter et al. The Joint Commission Journal on Quality and Patient Safety May 2008;34:285-292.

Following a routine carpal tunnel surgical procedure, a PACU

nurse hooked the BP monitor to the patients IV which caused

an air embolus and killed the patient. The patients’ daughter

was a PACU nurse at a different facility.

Misconnections: Two Sets of

Victims

In all of these misconnections reports,

there are two sets of victims, the patient

and family, and the clinician involved.

Clinicians never mean to make these

mistakes, but they do- because they can.

Enteral Misconnection- How Can

this Happen? Obvious Not so obvious

FDA Medical Device Safety Calendar, 2009

Enteral Misconnections: Contributing

Factors

Human Factors

• Healthcare clinician fatigue

• Distraction

• Lighting

Physical and Design Factors

– Compatible tubing between unlike systems

– Luer connectors

– Use of IV syringes for oral meds

– Universal Spike for bags

Enteral Misconnections:

Published Cases

116 published cases as of 2011 Like most errors, highly under-reported

Reported Enteral Misconnections

and Related Factors (Jan. 2000–Dec. 2006 USP data)

Guenter et al. The Joint Commission Journal on Quality and Patient Safety (2008).

Enteral Misconnections: Points of

Concern

Enteral Misconnections: What

About Color? • Manufacturers have introduced color to try to

trigger clinicians to prevent misconnections.

• However, color does not prevent the misconnection.

• Colors are not standardized across device types.

• May have a green connector for an EN device, an IV device, and a respiratory device so this defeats the purpose of color

• Color is not required in the new connector standard

Enteral Nutrition Connector

Call for Design Changes

• Product manufacturers are urged to implement

“incompatibility by design” features. 1

• “Forcing function” design changes would make

incorrect connections impossible.

• A physical barrier is the most effective preventive

tool when inappropriate connections are

attempted.

• The entire line of connections must be unique to

prevent mistakes in connection.

The Joint Commission Sentinel Event Alert. Tubing Misconnections—A Persistent and Potentially Deadly Occurrence. March 27, 2006.

Who is ISO and why them…

• ISO: International Organization of

Standardization

– Is recognized by many countries, organizations

and other entities as “THE” resource to drive

conformity

• Examples:

– Luer fittings are an ISO standard 594

– Syringes are in ISO standard 7886

– As such, ISO sets voluntary global standards for

various governments, purchasing organizations,

manufacturers and users to subscribe to.

Future US Enteral Feeding System Opportunity: Patient Safe Enteral Connectors

Nutrition Source

ENFit Patient Access

Connector

PHASE I New Enteral Connectors

Solution:

Result of global collaboration including but not limited to government regulatory agencies, industry, quality improvement organizations and clinicians

Complete

Est. Q1 2015

Pending FDA Approval of Devices

Nutrition Source Connector • Introduced in 2012

• Adopted across the market by enteral industry working together.

• Prevents that inadvertent use of IV tubing as an administration set.

• Will be an ISO standard in 2015.

ENFit Patient-Access Connector

Timeline- One year

transition

• Jan.-March 2015

administration sets

• Q1 2016- enteral

syringes

• Q1 2016- feeding tubes

Patient-Access Transition Set

• Allows fitment to

current feeding ports

until new enteral

feeding tubes are

available.

• Will be available with

the administration set.

• Use during year of

transition.

Patient-Access End Syringe

• Syringes to administer medicine, flushes, supplemental hydration, or bolus feeding through the enteral tubes.

• Will now require this specific syringe, can no longer use luer or cath-tip syringe.

• Available early 2016

New Joint Commission Sentinel

Event Alert

• Issued August 20, 2014

• Also includes text and

list of particular

standards in all care

areas where this

applies

• http://www.jointcommiss

ion.org/sentinel_event.a

spx

Patient-Access Connector

• New connectors will modify

delivery of:

– Enteral nutrition

– Hydration

– Medication

Medication Port

Enteral Medications

Three processes

1. Medication order – prescriber

2. Medication dispensing- pharmacist

3. Medication administration- nurse

New connectors bring emphasis and

protocol change to each process

Crit Care Med 2009;37(Suppl):A122

Receiving EN

N = 82

21% Sm Bowel EFT

Active Drug Orders 1324 Orders for Injectable,

Topical, Local Drugs 610

Orders for Enteral Drugs 714

“PO” = 601

Total Doses of Drug Administered 1778

574 of the 601 meds (96%) that were ordered as “PO”

were administered by feeding tube

Only 22 of 138 meds (16%) administered into the small

bowel were appropriate for that route of administration

Only 56 of the 82 EN patients (68%) had “NPO” orders

Preparation Checklists

Checklists to Prepare for New EN Connectors

• For Nurses and Clinicians

• For Facilities and Administrators

• For Pharmacists

• For Supply Chain Personnel

• For Home Care Providers

• For Patients/Caregivers On www.nutritioncare.org on Enteral Nutrition Safety Toolkit and www.StayConnected2014.org

Patient-Access Connector

• New connectors will modify delivery of:

– Enteral nutrition

– Hydration

– Medication

– ?Drainage

Drainage Through Multi-lumen

Tubes

Communication: Partnership

Between Industry and Clinicians

• StayConnected 2014 Campaign www.StayConnected2014.org

• GEDSA- Global Enteral Device Supply Association- Tradegroup of Enteral Industry in US www.gedsa.org

• GEDSA also organizing Core group of clinical and supply organizations: A.S.P.E.N.,FDA, TJC, AAMI, Premier Safety, Novation, CMS

Communication and

Education:Timeline Four Phased Approach

Thru Summer 2014

Fall 2014

Early 2015

2015

AWARE

PREPARE

ADOPT

MEASURE

Communication and Education:

What Can You Do? Prepare

• Form teams to assess existing systems, processes, and protocols that may need to change, focusing on areas of highest risk which have the most immediate need to convert to the new connectors.

• Work with supplier representatives and adopt their product specific transition plan.

• Train clinicians and materials/inventory management staff for impending changes.

• Look for education opportunities

PREPARE

Communication and Education:

What Can You Do?

• Introduce new connectors into work stream to reduce tubing misconnections and improve patient safety.

• Remind the organization of the long-term benefits vs. the short-term hassles of transitioning to new small-bore connectors.

ADOPT

Summary

• Get the Facts - Access the FAQs

• Become an institutional champion for

change

• Go back and form awareness groups

including all stakeholders

• Watch for educational offerings

• Go to www.StayConnected2015.org

Resources Now

• FAQs –

www.StayConnected2015.org

• EN Safety Campaign: A.S.P.E.N.

Website www.nutritioncare.org

Additional Resources

Reducing the Risk of Medical Device

Tubing Misconnections https://www.youtube.com/watch?v=996YBH_JYtk&feature=youtu.be

Questions?

Lisa Logan R.D.,CNSC

Lisa.Logan@mckesson.com

Thank You!

To reach any member of our Clinical

Resource Team, call us at

1-877-611-0081

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