Processing Flexible Endoscopes - daorn.org · dry to a dew point of ... AORN Guidelines for Processing Flexible Endoscopes, 2017 ANSI/AAMI ST91:2015 Flexible and ... Purge all channels

4/25/2017

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

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� Discuss recent significant reports of outbreaks related to

the use of flexible endoscopes

� 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

� Recent significant increase in reports of outbreaks related to the use of Duodenoscopes for ERCP

� Endoscopic retrograde

cholangiopancreatography (ERCP)

◦ Procedure that combines endoscopy

and fluoroscopy to diagnose and treat certain problems of the biliary or pancreatic ductal systems

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� Reprocessed Flexible Bronchoscopes Infections

� 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.htm4

1. Infusion Errors Can Be Deadly If Simple Safety Steps Are Overlooked

2. Inadequate Cleaning of Complex (such as endoscopes, cannulated drills, and arthroscopic shavers) Reusable Instruments Can Lead to Infections

3. Missed Ventilator Alarms Can Lead to Patient Harm

4. Undetected Opioid-Induced Respiratory Depression

5. Infection Risks with Heater-Cooler Devices Used in Cardiothoracic Surgery

6. Software Management Gaps Put Patients at Risk

7. Occupational Radiation Hazards in Hybrid ORs

8. Automated Dispensing Cabinet Setup and Use Errors May Cause Medication Mishaps

9. Surgical Stapler Misuse and Malfunctions

10. Device Failures Caused by Cleaning Products and Practices

SHC © 5https://www.ecri.org/Resources/Whitepapers_and_reports/Haz17.pdf

� 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

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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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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, HLDor sterilization

◦ Storage of endoscopes

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� Guidance for all types of reusable flexible endoscopes and accessories:◦ Perioperative

◦ Endoscopy, and

◦ Sterile 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

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� Ratings [in brackets at the end of the recommendation]:◦ regulatory requirements

◦ strong evidence

◦ high evidence

◦ moderate evidence

◦ limited evidence

◦ benefits balanced with harm

� 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]

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� 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.

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� May have automatic sliding doors or foot-operated doors◦ Hands free

� 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 2015

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◦

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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New New New New – AER with Pass thru.

� 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

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� Sufficient space for:◦ Appropriate sinks (decontamination, handwashing)

◦ Eyewash stations

◦ HVAC design parameters � Air exchanges

� Airflow patterns

� Humidity limitations

� Temperature controls

◦ Instrument air


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� 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)


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Utility Water = tap water

Critical Water

A multistep water treatment process may include:

• carbon bed,

• softening,

• deionization (DI),

• reverse osmosis (RO), and/or

• distillation

Final Rinse and Steam Generation

ANIS/AAMI TIR34:2014 Water for the reprocessing of medical devicesAORN Guidelines for Processing Flexible Endoscopes 2015

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� Minimum HVAC values are for new construction or major renovations

� 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)

AORN Guidelines for Processing Flexible Endoscopes, 2017 22

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� Should be under negative pressure to the surrounding areas

� If neg. pressure room is not available, supplemental air cleaning may be accomplished with:◦ portable, industrial grade high-efficiency particulate air (HEPA) filter

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� 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

AORN Guidelines for Processing Flexible Endoscopes, 2017

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� Should be provided in the:◦ Clean workroom

◦ Decontamination room (separate from the decontamination sinks)


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� Minimum two decontam sinks

◦ One for leak testing and 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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• 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 minutes,hands free

• Water temp. 60-100ºF

• Should not be 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.


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� Clean surgical attire and head coverings� Surgical masks and eye protection devices� Fluid-resistant gown� General purpose utility gloves with cuffs that extend beyond the cuff of the gown, and

� Fluid-resistant shoe covers.

• All head and facial hair (except for eyebrows and eyelashes) should be completely covered

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

AORN Guidelines for Processing Flexible Endoscopes, 2017 Guidelines for Surgical Attire. In: Guidelines for Perioperative Practices. Denver, CO: AORN, Inc; 2017

� 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, 2017 ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities

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� 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

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� 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

� An inventory of flexible endoscopes and accessories sufficient to meet the anticipated demand

� Procedures scheduled to allow sufficient time for cleaning and processing


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You cannot take shortcuts

or hurry the endoscope

cleaning and

decontamination process.

While Processing

“Do NOT disturb or interrupt”

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� 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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Reprinted with permission from Guidelines for Perioperative Practice. Copyright © 2016, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved. 35

� 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


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� 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


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� 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 (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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� 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.


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Reprinted with permission from Guidelines for Perioperative Practice. Copyright © 2016, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved 41

� 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

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Reprinted with permission from Guidelines for Perioperative Practice. Copyright © 2016, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved 43

◦ Clean, brush, rinse and HLD or sterilize

◦ Reusable parts� Valves, buttons, port covers, tubing, water bottles, and

� Cleaning implements such as brushes, channel cleaning adapters

� Single-Use parts discarded

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� 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.


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� Lighted magnification to inspect endoscopes

and accessories for cleanliness and damage.

� Internal channels of flexible endoscopes may be

inspected using an endoscopic camera or borescope.[2: High Evidence]

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• Researchers evaluated flexible endoscope damage and contamination levels at baseline and 2 months later.

• Microbial growth found in 47% of fully reprocessed endoscopes at baseline and 60% at follow-up.

• Borescope examinations identified:• scratches,

• discoloration,

• debris, and

• fluid inside endoscopes.

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Ofstead, CL., et. al, Assessing residual contamination and damage inside flexible endoscopes over time. In: Am J Infect Control. 2016 Dec 1;44(12):1675-1677.

� Borescopes allow damaged and contaminated endoscopes to be identified and re-reprocessed or sent for repairs.�Borescope examinations of lumens revealed defects requiring repair.

�Microbial growth was found on approximately half of patient-ready endoscopes.

�Internal damage and residual fluid may foster contamination and biofilm formation.

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Ofstead, CL., et. al, Assessing residual contamination and damage inside flexible endoscopes over time. In: Am J Infect Control. 2016 Dec 1;44(12):1675-1677.

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� Periodically verify cleaning process and microbial contamination

� Quality check at established intervals (eg. after each use, daily):◦ ATP (adenosine triphosphate), and

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

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� Mechanical processing should be performed using critical water

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

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Critical Water

A multistep treatment process:

� Carbon bed

� Softening

� Deionization (DI)

� Reverse osmosis (RO)

� Distillation

AORN Guidelines for Processing Flexible Endoscopes, 2017 ANIS/AAMI TIR34:2014 Water for the reprocessing of medical devices, Section 4.2

� 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 (psi per manufacture IFU)

◦ 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, HighAfter Cleaning, HighAfter Cleaning, HighAfter Cleaning, High----level Disinfect or Sterilizelevel Disinfect or Sterilizelevel Disinfect or Sterilizelevel Disinfect or Sterilize

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

1968 Earl Spaulding 1968 Earl Spaulding 1968 Earl Spaulding 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

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� 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


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� 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


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� Residual fluid after reprocessing and drying.

� Photographs and laboratory analysis – fluid contained simethicone (used to reduce foam and bubbles).

� May impact reprocessing effectiveness.

Fig 1. Fluid observed in endoscope channels and ports. (A) Cloudy fluid partially occluding suction-biopsy channel. (B) Shimmery, opaque fluid inside biopsy port. (C) Viscous, white, shimmery fluid inside biopsy port.

Ofstead, C. et al. Simethicone residue remains inside gastrointestinal endoscopes despite reprocessing. Am J Infect Control Aug.3, 2016. Available at: http://www.ajicjournal.org/article/S0196-6553(16)30581-8/abstract

� 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

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� Should be stored in a drying cabinet:

� If not available:◦ A closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the endoscopes.

� Cabinet that is either:◦ Designed for horizontal storage, or◦ Vertical - hang without coiling and without touching the bottom of the cabinet.

Drying cabinets

Vertical Horizontal

HEPA-filtered air

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� Valves open and removable parts detached but stored with scope

� Clearly identified as processed and ready for use

� Cabinets visually inspected for cleanliness

� 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

� AORN no longer recommends a specific maximumstorage time

� Multidisciplinary team determines how long the scopescan 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

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� Manual cleaning verification tests routinely◦ eg, after each use, daily

� Mechanically clean and processed - HLD or LCS

� Store in drying cabinet

� Multidisciplinary team: ◦ Establish policy on max. storage time

◦ Evaluate need to implement regular microbiological culturing:

� Flexible endoscopes, and

� Mechanical processors

Guideline Implementation: Processing Flexible EndoscopesMarie Bashaw DNP, RN, NEC-BC - AORN Journal Sept 2016, Vol. 104, No 3

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� Failure to measure enzymatic cleaner to water ratios

� Hand carrying dirty scopes

� Missing biohazard labeling

� Failure to ID your clinical practice guideline for HLD

� No oversight of HLD by infection control

� Mixing clean and dirty instruments

� No temperature monitoring of chemical used in HLD

� Failure to document competency

News from TJC and CMS. Patton Healthcare Consulting Newsletter Nov. 2015

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Meets

Recommendation?

Comments/Actions Yes No

Recommendation 1: Flexible endoscopes should be processed

in an area designed and constructed to support processing

activities.

Does endoscope processing occur in a room where only processing

activities are performed and away from patient care areas?

Is the decontamination area separate from the clean area (either a

two-room design or a one-room design with minimum of 3 ft [0.9 m]

between these areas and a wall or physical barrier that extends 4 ft

[1.2 m] above the sink rim)?

Are the heating, ventilation, and air conditioning (HVAC) systems

designed in compliance with state and local building codes?

Are HVAC systems set at the appropriate parameters for the

endoscopy suite?

Is the airflow direction for the endoscopy suite negative in the

decontamination room and positive in the clean workroom (for a two-

room processing area)?

Is the bronchoscopy procedure room (if applicable) under negative

pressure to surrounding areas?

Are the structural surfaces in the endoscopy processing area smooth

and made of materials that are water resistant, stain resistant, and

able to withstand frequent cleaning?

Is lighting adequate for endoscope inspection?

Documents

Processing Flexible Endoscopes - daorn.org · dry to a dew point of ... AORN Guidelines for Processing Flexible Endoscopes, 2017 ANSI/AAMI ST91:2015 Flexible and ... Purge all channels