Important Information About Receiving CE

You must attend the entire webinar. No partial credit is awarded for this activity. If attending as part of a group, you must sign-in and the group leader must send the sign-in sheet to the email address or fax number provided on the form. The evaluation survey URL is provided at the conclusion of the webinar.

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Adopting New Enteral

Connectors

Adopting 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.)

Thomas Hancock

Executive Director, Global Enteral

Device Supply Association (GEDSA)

September 30, 2015

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Disclosure

This continuing education webinar is provided by Elsevier/Mosby*

To earn 1 contact hour* for this presentation, you MUST :

1) Attend the entire webinar.

No partial credit is awarded for this activity.

2) Log-in to the webinar or sign-in if participating in a group. The group leader submits the sign-in sheet to the email address or fax number provided on the form.

3) Complete and submit an evaluation of this presentation by the designated deadline.

The evaluation survey URL is provided at the conclusion of the webinar.

Speakers Peggi Guenter, PhD, RN, FAAN and Thomas J. Hancock and planner, Marilu Kelly, MSN, RN, CNE have disclosed no relevant financial relationships.

*Elsevier/Mosby is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s

Commission on Accreditation

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Speaker Profile

Peggi Guenter, PhD, RN, FAAN is the Senior Director of Clinical Practice, Quality, and Advocacy for the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). She is an expert in the field of nutrition support as a clinical nurse specialist, researcher, author of over 120 peer-reviewed publications, and was a former Editor-in-Chief of Nutrition in Clinical Practice. Dr. Guenter served as a clinical member of the ISO workgroup to design new enteral connectors, she won the 2012 Cheers Award from the Institute of Safe Medication Practices, and was recently inducted into the American Academy of Nursing.

Thomas J. Hancock — Executive Director, Global Enteral Device Supply Association (GEDSA) leads the development, coordination and execution of the Stay Connected initiative in collaboration with several industry-leading organizations. Tom has been involved with the small-bore connector initiative since 2009 and he has worked more than 15 years in healthcare as a marketer, business leader, and consultant.

The speakers have nothing to disclose. A.S.P.E.N. and GEDSA are not endorsing any brand of product that you may see in this presentation.

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Learning Objectives

• Recall the purpose for the implementation of

new enteral connector design standards.

• Identify key components necessary for the

transition to the new enteral connectors.

• Explain the application of new enteral connector

standards to current patient care protocols.

What is a Small-bore Connector (SBC)? A small-bore connector: • Has an inner diameter of less

than 8.5 mm • Is used to link or join medical

devices, components, and accessories

• Developed 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 woman was 35 weeks pregnant when she was 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, pulled regular intravenous tubing from floor stock, spiked the bag, and started the infusion of tube feeding through the patient’s PICC. The fetus died—and then the mother.*

Following a routine carpal tunnel surgical procedure, a PACU nurse hooked the BP monitoring device up to the patient’s IV which caused an air embolism and the patient died.

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

Misconnections:

Two Sets of Victims

In all of these misconnections reports, there are two sets of victims:

1. The patient and the family

2. 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

Enteral Nutrition Workaround

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.

ISO 80369-3 • Now an approved ISO draft international standard

• Published as an AAMI provisional standard in the US as AAMI/CN3(PS):2014

• FDA Final Guidance Feb. 11, 2015

Safety Considerations To Mitigate the Risks of Misconnections With Small-Bore Connectors Intended for Enteral Applications; Guidance for Industry and Food and Drug Administration Staff; Availability

• To be used by FDA to approve devices with the new enteral connectors

Patient-Access Connector (ENFit)

Timeline- One year transition

• Jan- March 2015: administration sets

• Jan-March 2016: enteral syringes and feeding tubes

Patient-Access ENFit 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 require a specific syringe, can no longer use luer or cath-tip syringe.

• Available Jan-March 2016

US Enteral Patient Access Estimated Launch Timelines

Transition Set Launch

New Syringe Launch

Launch ISO Tubes

Oct ‘14

Dec ’14

Jan ‘15

Feb ‘15

Mar ‘15

Apr ’15

May ‘15

June ‘14

July ‘15

Sep ’15

Jan ‘16

CA Deadline

Stayconnected2015.org

Enteral Feeding Tube Nursing Procedures

• Verify tube position

• Check gastric residuals

• Flush tube

• Administer feeding formula or HBM

• Administer medications

• Vent or drain tube as needed

• Clean the external end of the tube – new procedure with ENFit

*Note: Workflow may be different during the transition period than it will be when the change is completed.

www.nutritioncare.org

Enteral Nutrition Nursing Procedures

• Verify tube position- checking to ensure the enteral tube tip is correctly in the GI tract (either in the stomach or small bowel).

• Currently nurses insert a syringe to aspirate GI contents; often combined with auscultation using the syringe to push GI contents and air back into the stomach or testing of pH of stomach contents

• Change with this procedure: use the ENFit syringe with the ENFit tube or ENFit syringe with the Transition Adapter to a current feeding tube.

Enteral Nutrition Nursing Procedures

• Checking Gastric Residuals- aspirating stomach contents to check the residual volume of feeding previously delivered.

• Currently nurses insert a syringe to aspirate GI contents and then push those GI contents back into the stomach.

• Change with this procedure: use the ENFit syringe with the ENFit tube or ENFit syringe with the Transition Adapter to a current feeding tube.

Flushing Feeding Tubes

Use ENFit Syringes either through feeding port or medication port

When to Flush:

• After Verifying Placement

• After Bolus or Intermittent Feeding

• Before, After, and Between Multiple Medications

• Use of Automatic Flush Pumps

Flushing Feeding Tubes

How Much to Flush:

• Dependent on Age and Weight

• Dependent on Fluid Status

• Dependent on Inner Tube Volume

• Dependent on Viscosity of Feeding Formula

• Adults 30mL or 10mL if fluid restricted

• Pediatrics 2-5mL

• Neonates 1mL or minimal amount

Tube Feeding Formula Delivery

• Feedings are given either continuously or intermittently (bolus)

• Feedings can be given continuously via an administration set/bag which can be given via a pump or slow drip

Tube Feeding Formula Delivery

• Can be given via a syringe or bag in a bolus or intermittent fashion

Special Issues with Human Breast Milk

Clearly Label • Change syringe and extension

set every four hours

• Administer at an angle or with a syringe that has an offset tip to allow lipids/fat to be delivered

• Syringe needs to compatible with neonatal syringe pump

Cleaning the Proximal Tube End

• Proximal end of feeding tube now a male end

• Will need periodic cleaning to remove medication and formula debris

• Suggest a brush like a toothbrush or bottle brush and warm water daily and prn for tubes, particularly those in the home.

Drainage Through Multi-lumen Tubes

Venting and Drainage

Early Feeding Through a Salem Sump

Clinical Challenges

• Blenderized diets in the home

• Medication Delivery- particularly low doses often given in pediatric or neonatal populations

Blenderized Diet Testing Conclusion

• Blenderized formulas are not all the same and tubes vary as well.

• In this study, with these tubes and formulas, ENFit and Cath-tip syringes flow and pressure requirements were essentially equivalent.

• It is recommended that each company perform testing on it’s own line of tubes with a variety of formulas.

Used with permission from J. Boullata

TM

Introducing ENFit, the proposed new ISO 80369-3 design standard connector

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

Stayconnected2015.org Stayconnected.org

GOAL: Eliminate the Long Term Need for adapters

Check with your supplier regarding Transition Connectors from ENLock to ENFit

Female ENFit Syringe Tip

connects to

Male Feeding Tube or

Extension Set

Big Change with New ENFit

Syringes:

Male & Female Assignments Switched:

Stayconnected.org

Dead Space

• Volume of liquid left in tip not delivered to the

patient when the gradient marking is at zero.

• Most syringes feature tips that connect inside

the hub of the proximal device.

• For enteral applications, syringe tips were

male and feeding tubes/extension sets were

female.

Stayconnected.org

Dead Space & Accuracy with

Oral vs. ENFit Tip Syringe Dead space is taken into consideration when reading gradient markings

Dosing accuracy is not impacted by dead space alone.

Existing syringe has a

male tip that fits a female

feeding port or directly into

the mouth.

When drawing up and

when dispensing, the

entire tip is filled with

fluid. Delivering an

accurate dose

Stayconnected.org

Delivery w/ ENFit Tip Syringe

As long as an ENFit compatible connector is used during filling, plunger

operation, and delivery, the ENFit syringe tip is left almost empty once

the plunger position is at zero.

The syringe is filled using an

ENFit Straw or an ENFit style

pharmacy bottle adapter.

The tip is not filled with

fluid because volume was

displaced by the ENFit

connector used to fill the

syringe.

An ENFit Feeding

Tube/Extension Set is

used for delivery and it

re-occupies the space

within the tip.

There may be a small amount of

dead space (approximately

0.07 mL), but there is no

delivery error. This volume is

accounted for when the plunger

position is at zero.

Stayconnected.org

Delivery w/ ENFit Tip Syringe

When ENFit connectors are NOT used during filling, plunger operation, or

delivery once the plunger position is at zero the dosing accuracy is

acceptable

... extra volume in

the tip but no

delivery error.

ENFit filling device

NOT used to fill

syringe.

Example: Filling

straight from a cup.

Tip is filled with

extra volume.

NO ENFit

device used

for delivery...

Stayconnected.org

GEDSA RECOMMENDATION

1. Attach Filling Device (Fill Cap, Draw up Straw, Transition Connector) to ENFit tip syringe

2. Fill ENFit tip syringe with medication

3. Disconnect filling device from ENFit tip syringe

4. Cap ENFit tip syringe per hospital protocol

5. CAUTION: Do not purge air from the tip of the ENFit tip syringe

6. Administer Medication via ENFit feeding tube medication port

Enteral Delivery of Liquid Medication that require accuracy > 0.15mL

Stayconnected.org

GEDSA RECOMMENDATION:

ENFit tip syringes were designed specifically for enteral and not oral delivery of medications. Use oral tip syringes to avoid the potential of mis-dosing.

• Use oral tip syringe according to current institution protocols

• If using ENFit tip syringe orally, consult your syringe supplier representative on the most appropriate filling and administration methods

NOTE: When filling the ENFit tip syringe with a filling device and delivering orally directly from the ENFit tip syringe, the ENFit tip syringe under delivers a mean average of 0.148mL (ranging from 0.089mL to 0.179mL) of fluid.

Oral Delivery of Liquid Medication that require accuracy > 0.15mL

Stayconnected.org

Low Dose Syringe Problem Statement • Dosing Accuracy (2.0mL doses and under)

• 3mL Syringes and less (Greater than 3mL is currently acceptable)

• 0.2mL doses should be accurate within +/-10% connected enteral (priority)

• DESIGN CONSIDERATION – Minimize Recoil in either direction (when disconnected some of dose can go back into syringe)

• Syringe selection • Prefer 1 syringe for all application

• Do not want a new procedure to have to follow

• Challenges with communication between pharmacy & nursing

• Accommodate for route delivery changes

Stayconnected.org

Low Dose Syringe Tip

The information contained within this presentation is proprietary and confidential. Contents of this document are not to be reproduced or distributed without the express written consent

of NeoMed, Inc. Stayconnected.org

Control – ENFit Tip ENFit Low Dose - A ENFit Low Dose - B

Preliminary Performance Testing Results

• ENFit Low Dose Syringe Design A met all requirements

specified for dosing accuracy, 7886-1 dead space and

tolerance on graduated capacity

• Connection delivery accuracy is less variable and

shows improved accuracy with both designs A and B.

Additional Testing & Validation

Completed

• Misconnection Assessment

To Be Completed

• Additional Performance Testing

• Risk Analysis

• Human Factors/Usability

• Manufacturability

Website with Translated Resources

Stayconnected.org

• Visitors to the Stay Connected website may print and distribute

Learning Tools: Brochure

Checklists- Tools for Healthcare Clinicians and Home Care Providers

Staying Connected: E-Newsletter

www.StayConnected.org

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Questions and Answers

Thank You!

Peggi Guenter PhD, RN, FAAN :

peggig@nutritioncare.org

Thomas J. Hancock:

tom@gedsa.org

Elsevier Clinical Solutions

www.elsevierclinicalsolutions.com

elsevierclinicalsolutions@elsevier.com

1.866.416.6697

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References

Guenter P. New Enteral Connectors Raising Awareness. Nutr Clin Pract, 2014; 29(5):612-4.

Debora Simmons, Lene Symes, Peggi Guenter, and Krisanne Graves. Tubing Misconnections: Normalization of Deviance. Nutr Clin Pract, June 2011; vol. 26, 3: pp. 286-293

Guenter, P, Hicks RW, Simmons D. Enteral Feeding Misconnections: An Update. Nutr Clin Pract. 2009;24:325-334.

Sarah J. Miller. Enteral Feeding Misconnections: A Consortium Position Statement. Nutr Clin Pract. Dec. 2008-Jan. 2009; vol. 23, 6: pp. 664-665.

Guenter P, Hicks RW, Simmons D, et al. Enteral feeding misconnections: a consortium position statement. Jt Comm J Qual Patient Saf. 2008;34(5):285-292

Lindsey Getz. Enteral Misconnections — Changes in Pipeline to Prevent Deadly Errors.Today’s Dietitian. Feb 2010; 12 (2): 18.

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Association for the Advancement of Medical Instrumentation (AAMI). Small bore connectors. [Online]. Available at: http://www.aami.org/hottopics/connectors/

The Joint Commission. Sentinel Event Alert 53: Managing risk during transition to new ISO tubing connector standards. 2014. [Online]. Available at:

http://www.jointcommission.org/sea_issue_53/

GEDSA. Stay Connected. [Online]. Available at: http://www.stayconnected.org/index.html

US Food and Drug Administration. Preventing Tubing and Leur Misconnections. Website: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TubingandLuerMisconnections/default.htm

Additional References

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US Food and Drug Administration. Safety Considerations to Mitigate

the Risks of Misconnections with Small-bore Connectors Intended for

Enteral Applications.2015.[Online]. Available at:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandG

uidance/GuidanceDocuments/UCM313385.pdf

Institute for Safe Medication Practices. ENFit Enteral devices are n

their way: Important Safety Considerations for Hospitals. Acute Care

ISMP Medication Safety Alert! April 9, 2015.[Online]. Available at:

http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=105

Additional References