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3M Health Care AcademySM

© 3M 2016. All Rights Reserved


Processing Flexible Endoscopes:AORN’s Updated Evidence-Based Guideline

May 19, 2016

Rose Seavey



Welcome!Topic: Processing Flexible Endoscopes:

AORN’s Updated Evidence-Based GuidelineFacilitators: Christophe de Campeau, 3M Susan Flynn, 3M

Speaker: Rose Seavey MBA, BS, RN, CNOR, CRCST, CSPDT

For more information: www.3M.com/IPEd

© 3M 2016. All Rights Reserved 3

House Keeping

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House Keeping

Continuing EducationEach 1 hour web meeting is approved by IAHCSMM, CBSPD and is 3M Health Care Provider approved by the California Board of Registered Nurses CEP 5770 for one contact hour.

Post webinar email• Link to Course Evaluation• CS Tech CE Certificate Included• Forward eMail to others in attendance


Disclosure

• Rose Seavey• President/CEO of Seavey Healthcare Consulting, LLC

• Educational Consultant for 3M


Learning Objectives

• Describe AORN’s current guidelines for processing flexible endoscopes

• Identify steps to assist personnel in providing a safe environment for patients and health care workers

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Focus on Endoscopes• Recent significant increase in reports

of outbreaks related to the use of Duodenoscopes for ERCP

• Endoscopic retrograde cholangiopancreatography (ERCP)

• Procedure that combines endoscopyand fluoroscopy to diagnose and treat certain problems of the biliary or pancreatic ductal systems


CDC/FDA Safety Alert Sept. 17, 2015

• Infections - Reprocessed Flexible Bronchoscopes• FDA ongoing, comprehensive investigation

• 500,000 procedures annually• Represent a high risk of infection • Recommendations:

• Strictly adhere to IFU

• Staff competent and understand the importance

• Implement comprehensive reprocessing quality control program.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm462949.htm


ECRI Top 10 Health Technology HazardsYear Rate Hazard

2016 1 Inadequate cleaning of flexible endoscopes

2015 4 Inadequate reprocessing of endoscopes and surgical instruments

2014 6 Inadequate reprocessing of endoscopes and surgical instruments

2013 8 Inadequate reprocessing of endoscopic devices and surgical instruments

2012 4 Cross contamination from flexible endoscopes

2011 3 Cross-Contamination from flexible endoscopes

2010 1 Cross-Contamination from flexible endoscopes

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Endoscopes - Challenges

• Arguably the most difficult pieces of equipment to reprocess• Limited scopes

• Scopes cost from $25,000 to $100,000

• Repairs = $5,000 - $8,000

• Scheduling issues • Long narrow flexible channels • Difficult to clean• Cannot see inside of lumens


Processing Cycle – Over 120 steps just to process!

Reprinted with permission from Guidelines for Perioperative Practice.Copyright © 2016, AORN, Inc, 2170 S. Parker Road, Suite 400, DenverCO 80231. All rights reserved.


AORN Guidelines for Perioperative Practices

Guideline for Processing Flexible Endoscopes – February 2016• Provides evidence-based, detailed recommendations for:

• Processing room design

• Surgical attire and PPE

• Competencies

• Best practices for leak testing

• Cleaning, inspecting, high-level disinfectionor sterilization

• Storage of endoscopes

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AORN Guidelines - Evidence Based• Guidance for all types of reusable flexible endoscopes and

accessories:• Perioperative

• Endoscopy, and

• Sterile processing for processing

• Extensive Search for Endoscope Processing / Infection Transmission

• Reviewed approximately 3,400 published pieces of literature

• Used 418 documents with the strongest evidence

• Score assigned to recommendation(s):

• Level of strength, and Quality of the published findings


Appraisal Score

• Ratings:• regulatory requirements

• strong evidence

• high evidence

• moderate evidence

• limited evidence

• benefits balanced with harm

• Brackets at the end of the recommendation(s)

• Example:• I.h.1. Decontamination sinks should be

deep enough to allow complete submersion of the endoscope and large enough to allow the endoscope to be positioned in the sink without tight coiling. [2: High Evidence]


Classifications of Endoscope Families • Proposed by the European Society of Gastrointestinal Endoscopy (ESGE)

• Based on characteristics:• Construction,

• Purpose, and

• Clinical applications of the channels

• Groups:1) Gastroscopes, colonoscopes, and duodenoscopes with an encapsulated elevator channel.

2) Additional instrument channel, elevator channel and up to two control channels with an open elevator channel

3) One channel or less- bronchoscopes, laryngoscopes, and nasendoscopes.

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Stay-up-to-date

• Sharon Van Wicklin, MSN, RN, CNOR, CRNFA(E), CPSN-R, PLNC,• Senior perioperative practice specialist at AORN, and

• Lead author of this guideline

• Processing staff must understand the most current evidence

• New AORN guidelines - changes that should be implemented immediately, for example no longer disinfecting flexible endoscopes manually (e.g., soaking in a pan of high-level disinfectant solution)

6 New Evidence-Based Practices For Implementing More Effective Processing Of Flexible Endoscopes in; AORN Periop Insider, 1/13/2016.


Recommendation 1: Flexible endoscopes should be processed in an area designed and constructed to support processing activities.

• May have automatic sliding doors or foot-operated doors• A single processing room, or• Two separate rooms (ie, decontam room, clean workroom)

• Door, or pass-through window between the two rooms

AORN Guidelines for Processing Flexible Endoscopes 2016


•

Reprinted with permission from Guidelines for Perioperative Practice. Copyright © 2016, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved.

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Endoscopy processing room • One-room design

• Minimum of 3 ft between decontam area and clean work area, and

• Separating wall or a barrier that extends a minimum of 4 ft above the sink rim


No Separation of Clean and Dirty


Space Requirements – Decontamination area

• Sufficient space should be allocated for:• Appropriate sinks (decontamination, handwashing) • Eyewash stations • HVAC design parameters

• Air exchanges

• Airflow patterns

• Humidity limitations

• Temperature controls

• Instrument air


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Instrument Air

• A medical gas that falls under the general requirements for medical gases as defined by the NFPA 99: Health Care Facilities Code, is not respired, is compliant with the ANSI/ISA S-7.0.01, Quality Standard for Instrument Air, and is:

• filtered to 0.01 micron • free of liquids and hydrocarbon vapors • dry to a dew point of -40º F (-40º C)



Endoscope Reprocessing Area


Endoscope Reprocessing Area

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Endoscopy Suite Heating, ventilation, and air conditioning (HVAC)

• Compliance with:• State and local building codes,

• Facilities Guideline Institute (FGI), and

• American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE)

• HVAC should be constructed and designed to meet the parameters shown in Table 1. (next slide)

• Minimum HVAC values are for new construction or major renovations

AORN Guidelines for Processing Flexible Endoscopes, 2016




Bronchoscopy Procedures

• Procedure room should be under negative pressure to the surrounding areas

• If negative pressure room is not available, supplemental air cleaning may be accomplished with:

• a portable, industrial grade high-efficiency particulate air (HEPA) filter, or

• portable anteroom system (PAS)-HEPA combination unit.

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Structural Surfaces - Frequent Cleaning

• Doors, floors, walls, ceilings, cabinets, shelves, work surfaces, furniture (e.g., tables) should be smooth and made of materials that are:

• Water resistant

• Stain resistant

• Able to withstand frequent cleaning

• Pipes and fixtures above work areas should be enclosed and tightly sealed

• Floor surfaces should be monolithic



Handwashing stations

• Should be provided in the:• Clean workroom • Decontamination room

(separate from the decontamination sinks)



Decontamination Sinks• Minimum two decontam sinks (or one sink with two divisions)

• One for leak testing and manual cleaning

• One for rinsing

• Deep enough to allow complete submersion

• Large enough to allow the endoscope to bepositioned without tight coiling

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Eyewash Stations • Plumbed or self contained

• Located in well lit area with a highly visible sign• Within 10 seconds travel time (travel free obstructions )

• Ability to flush both eyes simultaneously for 15 minuteshands free

• Water temp. 60-100ºF

• Should not be in a location that requires flushing of the eyes in a decontamination sink

• Flushing nozzles:• Between 33 and 45 inches from where user stands

• Minimum of 6 inches from the wall or nearest obstruction.



Procedure and Processing Attire and PPE• Clean scrubs

• Includes two-piece pantsuits, scrub dresses, cover jackets, head coverings, shoes, masks, and protective eyewear

• All head and facial hair (except for eyebrows and eyelashes) should be completely covered with a surgical-type hair covering

• Jewelry that cannot be contained or confined within the attire should not be worn

AORN Guidelines for Processing Flexible Endoscopes, 2016 Guidelines for Surgical Attire. In: Guidelines for Perioperative Practices. Denver, CO: AORN, Inc; 2016


Endoscopy Processing Room Handling Contaminated Flexible Endoscopes

• PPE:• Fluid resistant surgical masks AND

eye protection devices:• goggles

• glasses with solid side shields, or

• chin-length face shields;

• Fluid-resistant gowns

• Utility gloves with cuffs that extend beyond the cuff

• Fluid-resistant shoe covers.AORN Guidelines for Processing Flexible Endoscopes, 2016 ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities

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Instructions For Use (IFU)

• Endoscopes, accessories, and equipment used in the endoscopy suite should have manufacturer-validated IFU

• Readily available for each model• Vary widely for makes and models• Validated cleaning and processing instructions

AORN Guidelines for Processing Flexible Endoscopes, 2016 ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities


Dedicated Processing Personnel • Processed by individuals who have received education and

completed competency verification activities related to endoscope processing

• A dedicated team of individuals responsible for processing may also allow endoscopy nurses to focus on clinical responsibilities


Processing of Flexible Endoscopes

• Performed in the same manner (e.g., bedside procedures and procedures performed outside of normal operating hours) in all locations

• Sufficient time and numbers of personnel should be provided• Procedures scheduled to allow sufficient time for cleaning and

processing • An inventory of flexible endoscopes and accessories sufficient to

meet the anticipated demand


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You cannot take shortcuts or hurry the endoscope cleaning and

decontamination process.

While Processing “Do NOT disturb or interrupt”


1st Step: Precleaning at Point of Use

• Biofilm formation process can begin within minutes after completion of a procedure

• Precleaning of flexible endoscopes andaccessories should occur:

• As soon as the procedure is completed• Before organic material has a chance to dry on

surface or in channels


.



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Point of Use Precleaning

• Fresh solution of recommended cleaning product

• Wipe exterior with soft, lint-free cloth or sponge saturated with the cleaning solution

• Suction cleaning solution through all channels

• Flush air, water, and other channels alternately with the cleaning solution and finishing with air

• Place distal end in the cleaning solution and suction solution

• Visually inspect for damage

• Discard cleaning solution and cleaning cloth after use



Transporting Contaminated Endoscopes

• ASAP

• Keep wet or damp but not submerged in liquid during transport

• Closed container or closed transport cart

• leak proof

• puncture resistant

• large enough to contain all contents

• Labeled with label container with biohazard label

• Transported in a horizontal position and not suspended



Process ASAP After Transport

• If not processed within manufacturer's recommended time to process - follow delayed processing procedures per the IFU

• Develop a procedure for recording the time: • The procedure was completed, and

• Cleaning is initiated

• Transport carts or containers cleaned and disinfected after each use


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Leak Testing• Leak (pressure) testing should be performed on flexible

endoscopes before cleaning• Usually under water – (check IFU)

• Checks for holes in the external surfaces and internal channels

• Control knobs should be manipulated in all directions during leak testing.

• If a leak is detected –• Leak testing device should remain attached to the

endoscope and under pressure until the endoscope is removed from the water

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Manual Cleaning

• Following leak testing and before HLD or sterilization manually clean endoscope

• Follow specific IFU for :• Type of water

• Type of cleaning solution (freshly prepared)

• Concentration, temperature, contact time, etc.

• Detach removable parts

• Completely submerge in cleaning solution

• Use soft, lint-free cloth or sponge

• Flush all internal channel etc.



Reprinted with permission from Guidelines for Perioperative Practice. Copyright © 2016, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved

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Clean Channels and Distal End of Scope• Brushes – length, width and material

recommended in IFU• Valves actuated manually while cleaning

• Remove debris from brush before retracting back through channel

• Flush cleaning solution into all channels• Use automatic flushing system (if compatible)

• Dry exterior with soft, lint-free cloth or sponge• Purge all channels with instrument air


Figure 8. Distal End of Flexible Endoscope and Duodenoscope

Reprinted with permission from Guidelines for Perioperative Practice. Copyright © 2016, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved


Reusable Parts and Accessories

• Clean, brush, rinse and HLD or sterilize• Reusable parts

• Valves, buttons, port covers, tubing, water bottles• Accessories, and • Cleaning implements such as brushes, channel cleaning adapters

• Single-Use parts discarded

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Mechanically Clean and Mechanically Process (VIII)

• AORN now recommends after manual cleaning mechanical processing should be conducted (when compatible).

• Mechanical cleaning

• Mechanical high-level disinfection or sterilization, and

• Mechanical rinsing

• Why?• Improved cleaning

• Improved rinsing of disinfectants (reduce potential for residual disinfectant)

• Reduces potential for human error and noncompliance.



Polling Question Does your facility mechanically clean flexible endoscopesfollowing manual cleaning?

A. NoB. YesC. Not yet, but we hope to implement in 2016


Inspect for Cleanliness

• Endoscopes, accessories and equipment should be visually inspected

• Cleanliness

• Missing parts

• Clarity of lenses

• Integrity of seals and gaskets

• Moisture

• Physical or chemical damage

• Function

• Cleaning verification tests• Periodically verify cleaning process

and microbial contamination

• Quality check at established intervals:• ATP (adenosine triphosphate)

• Chemical reagent tests for detecting clinically relevant soils (e.g., protein, carbohydrate)

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Polling Question• Does your facility periodically verify the cleaning process?

• Yes• No• Don’t know


• Mechanical processing should be performed using critical water

• Following disinfection, scope and channels should be mechanically rinsed and flushed with critical or sterile water

Critical Water

A multistep water treatment process:

• Carbon bed

• Softening

• Deionization (DI)

• Reverse osmosis (RO)

• Distillation

AORN Guidelines for Processing Flexible Endoscopes, 2016 ANIS/AAMI TIR34:2014 Water for the reprocessing of medical devices, Section 4.2

Water Requirements


Drying • Multidisciplinary team should conduct a risk assessment to determine

whether endoscope lumens should be flushed with 70% to 90% ethyl or isopropyl alcohol

• After mechanical processing, exterior surfaces should be dried with a soft, lint-free cloth or sponge

• Channels should be dried by:• Purging with instrument air

• Mechanically dried with a mechanical processor drying system

• Removable parts and endoscope accessories should be dried


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Low Temperature Sterilization High Level Disinfection (HLD)

•

After Cleaning, High-level Disinfect or Sterilize


Spaulding’s Classification Scheme Determine the correct processing methods for items

1968 Earl Spaulding

Items that come in contact with:

Nature of item Processing required Examples

Sterile tissue or vascular system

Critical Sterilization Surgical instruments, cutting endoscopic accessories, catheters, needles

Nonintact skin or mucus membranes

Semi-critical Minimum of high level disinfection Respiratory therapy equipment, bronchoscopes and GI scopes

Intact skin Noncritical items Intermediate-level disinfection, low-level disinfection, or cleaning

Tourniquets, blood pressure cuffs, linens, and OR furnishings


Modified Classification

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HLD or Sterilize

• A multidisciplinary team • Infection Preventionists

• Endoscopy RNs

• Sterile processing personnel

• Endoscopists

• Other involved personnel

• Risk assessment - items that secondarily enter sterile tissue or the vascular system (i.e., via a mucous membrane) should be sterile



Enhanced Methods for Processing Duodenoscopes

• VIII.i. Multidisciplinary team consider enhanced methods for processing

• Enhanced processing methods include HLD followed by: • Quarantining of the endoscope until it is culture-negative

• Use of a liquid chemical sterilant processing system

• A second high-level disinfection process

• Ethylene oxide sterilization

• Use of another FDA-cleared, low-temperature sterilization process



Polling Question Has your facility initiated ‘enhanced’ methods for processing flexible duodenoscopes?

A. NoB. Yes, HLD then quarantine until culture-negativeC. Yes, HLD followed by ethylene oxide sterilizationD. Yes, HLD, followed by LCS processing system E. Yes, HLD followed by a second HLD

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Flexible Endoscope Storage• In a manner that protects the device from damage

and minimizes microbial contamination• Terminally sterilized: stored in sterile storage area to

protect packaging

• HLD or Liquid chemical sterilization:• Cabinet with doors

• Clean and secure location

• Not in procedure room

• At least 3 ft. from any sink



HLD/LCS Flexible Endoscopes Storage• Should be stored in a drying cabinet:• If not available:

• May be stored in a closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the endoscopes

• Cabinet that is either:• Designed by the cabinet manufacturer for

horizontal storage

• Vertical: sufficient height, width, and depth to allow flexible endoscopes to hang without coiling and without touching the bottom of the cabinet


HLD/LCS Flexible Endoscope Storage• Valves open and removable parts detached but stored with endoscope

• Clearly identified as processed and ready for use

• Cabinets visually inspected for cleanliness before placed into or removed

• Wear clean gloves when handling or transporting:• Low-protein

• Powder-free

• Natural rubber latex or latex-free

• Cabinet cleaned and disinfected when visibly soiled and on a regular (e.g., daily, weekly) basis


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“Hang Time”• AORN no longer recommends a specific maximum storage

time, such as five days

• Multidisciplinary team determines how long the scopes can be stored without being reprocessed prior to use

• Infection preventionists

• Endoscopy nurses

• Processing personnel

• Endoscopists, etc.

• Consider variables:• How and where the scopes are stored

• Results of cleaning verification tests

• Requirement to wear gloves when handling etc.

• AORN provides an extensive evidence review to assist the team


AORN Guidelines and Tools for the Sterile Processing Team• March 2015 electronic format• 8 guidelines related to reprocessing• Customizable templates for:

• Policy and procedures • Job descriptions• Competency verification tools

• Being updated to reflect changes in Flex Endo at no charge to those who've already purchased:

• P&P template• Competency verification tool




Additional Questions?

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Next Live Webinar

Date: Thursday June 16, 2016

Title: A Review of Sterilization Methods and Recommended Practices for Healthcare Facilities (Part 1)



Thank you

May 2016 Sterile U Webinar AORN Endo - 3M - 3M...

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