mckesson medical-surgical clinical webinar series€¦ · 25/6/2015 · future us enteral feeding...
TRANSCRIPT
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
Thank You!
To reach any member of our Clinical
Resource Team, call us at
1-877-611-0081
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