Canadian, US & EuropeanStandards on Endoscope

Storage

Presentedby:

Doug Brown

Overview

Endoscope Storage• Review current Canadian, US and

European standards and guidelines forendoscopy storage.

• Overview of a number of studies thatback up these standards andguidelines.

• Review what healthcare facilities inCanada must follow to meet the CSAstandards.

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Standards andStudies

relating toEndoscopy

Storage

Image from AORN

CSGNA 2018

Studies Over the Past 16 Years• Riley R, Beanland C, Bos H. Establishing the shelf life of flexible colonoscopes. Gastroenterology Nursing.

2002;25(3):114-9.

• Rejchrt S, Cermak P, Pavlatova L, McKova E, Bures J. Bacteriologic testing of endoscopes after high- leveldisinfection. Gastrointestinal Endoscopy. 2004;60(1):76

• Muscarella LF. Inconsistencies in endoscope-reprocessing and infection-control guidelines: the importance

• of endoscope drying. Am J Gastroenterol 2006;101:2147-54.

• Osborne S, Reynolds S, George N, Lindemayer F, Gill A, Chalmers M. Challenging endoscopy reprocessingguidelines: a prospective study investigating the safe shelf life of flexible endoscopes in a tertiarygastroenterology unit. Endoscopy. 2007;39(9):825-30.

• Wardle, B. (2007). Endoscope storage cabinets. Journal Gastroenterological Nurses College of Australia,17(3): 5-11.

• Vergis AS, Thomson D, Pieroni P, Dhalla S. Reprocessing flexible gastrointestinal endoscopes after a periodof disuse: is it necessary? Endoscopy. 2007;

• 39: 737-9.

• Pineau L, Villard E, Duc DL, Marchetti : B. Endoscope drying/storage cabinet: interest and efficacy. Journalof Hospital Infection. 2008 Jan; 68(1):59-65.

• Foxcroft L., Monaghan, W., & Faoagali, J. (2008). Controlled study of the Lancer FD8 drying/storage cabinetfor endoscopes. Journal Gastroenterological Nurses College of Australia. 18, 5–11.

• Foxcroft L, Monaghan W, Faoagali: J. Controlled study of the Lancer FD8 Drying/Storage Cabinet forEndoscopes. J. GENCA. 2008;18(2):5-11.

• Wardle E. Endoscope storage cabinets. J.GENCA. 2007;17(3):7-12.

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Studies Over the Past 16 Years• Kovaleva J, Degener JE, van der Mei HC. Mimicking disinfection and drying of biofilms in contaminated

endoscopes. J Hosp Infect 2010; 76: 345-50.

• Courné, E. & Geyssens, S. (2011). Recommendations for good practice in use of storage cabinets for heatsensitive endoscopes]. Acta Endoscopica. 41(3), 153-159.

• Kovaleva J, Peters FTM, van der Mei HC et al. Transmission of Infection by Flexible GastrointestinalEndoscopy and Bronchoscopy. Clin Microbiol Revs 2013; 26: 231–254.

• Grandval, P., Hautefeuille, G., Marchetti, B., Pineau, L., & Laugier, R. (2013). Evaluation of a storagecabinet for heat-sensitive endoscopes in a clinical setting. Journal of Hospital Infection. 84(1), 71-6.

• Ingram, J., Gaines, P., Kite, R., Morgan, M., Spurling, S., & Winsett, R. (2013). Evaluation of medicallysignificant bacteria in colonoscopies after 8 weeks of shelf life in open air storage. Gastroenterology Nursing.36(2), 106-11.

• Alfa M. Monitoring and improving the effectiveness of cleaning medical and surgical devices. Am J InfectControl 2013 May; 41 (5 Suppl):S56-S59.

• Alfa MJ, Fatima I, Olson N. Validation of ATP to audit manual cleaning of flexible endoscope channels. Am JInfect Control 2013 March; 41(3):245-248.

• Alfa MJ, Olson N, Murray BL. Comparison of clinically relevant benchmarks and channel sampling methodsused to assess manual cleaning compliance for flexible gastrointestinal endoscopes. Am J Infect Control2014 Jan; 42(1):e1-5.

• Brock, A.S., Steed, L.L., Freeman, J., Garry, B., Malpas, P., & Cotton, P. (2014). Endoscope storage time:Assessment of microbial colonization up to 21 days after reprocessing. Gastrointestinal Endoscopy. 2014Dec 5 [cited 2014, Dec 22].

• Alfa M., Mock clinical study demonstrates that ATP cleaning monitoring combined with channel purgestorage reliably eliminates Escherichia Coli, but not environmental bacteria from duodenoscopes, Sept 2017

• Ofstead CL., Heyman OL, Quick MR., Eiland JE., Wetzler HP. Residual moisture and waterborne pathogensinside flexible endoscopes: Evidence from a multi-site study of endoscope drying effectiveness AJIC , March2018

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Commonalities of Study FindingsIn conclusion our mock clinical study demonstrated that,even with repeated soiling of duodenoscopes with highlevels of E.coli, the use of ATP to monitor MIFUcleaning combined with dry storage in channel-purgestorage cabinets eliminated E.coli from all 119duodenoscopes tested. (Alfa)

Inadequate reprocessing and insufficient dryingcontributed to retained fluid and contamination foundduring this multisite study. More effective methods ofendoscope reprocessing, drying, and maintenance areneeded to prevent the retention of fluid, organicmaterial, and bioburden that could cause patient illnessor injury. (Olstead) CSGNA 2018

Commonalities of Study Findings

Conclusion: HEPA filtered cabinets with channelpurge supplement the drying process and help inthe prevention of microorganism growth. This isonly after the optimal bedside clean, manual wash,and reprocessing procedure is complete, monitoredand documented

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CSA Standards: ScopeStorage

Z314.8-14: “Decontamination of reusable medicaldevices”

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“Decontamination of ReusableMedical Devices”

#Z314.8-14

11.7.12.1 GeneralEndoscopes shall be stored in adedicated, closed, ventilated cabinetoutside of the decontamination areaand procedure room. The cabinetshall be equipped with HEPAfiltration. Endoscopes shall not bestored in their transport cases. Theyshall be stored in a manner thatensures they remain dry andprotected from environmentalcontaminants or damage. Woodencabinets shall not be used forendoscope storage. If storageconditions cannot be met, scopesshould be reprocessed just prior touse.Note: Poorly constructed and poorlymaintained storage cabinets havebeen found to be a source of crosscontamination.

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“Decontamination of ReusableMedical Devices”

#Z314.8-14

11.7.12.4.2HEPA-filtered channel-purge storagecabinets with non-porous cleanablesurfaces should be used.• Notes:1. Auto purge cabinets do not require the

use of alcohol (fixative) to expeditedrying and ensure that all ports of anendoscope are presented with airflowat the same time. This ensures dryingin a timely manner to mitigate thegrowth of biofilm.

2. Channel purge storage cabinets useall-channel connectors and HEPA-filtered air to continually flush theconnected channels of a scope withfiltered air during storage.

3. In purge storage cabinets, verticalstorage is not compulsory because theHEPA purging of the lumens andcontinuous HEPA air flow over theexterior of the endoscope, whichensures prompt drying both inside andout.

4. Other validated methods that ensuredry storage may be used.

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“Infection Prevention and Control Guideline forFlexible Gastrointestinal Endoscopy and

Flexible Bronchospy”

Storage cabinets should meet the following criteria: made of material that can be disinfected weekly with anapproved low-level disinfectant, ventilated when doors are closed, not situated in a procedure room, reprocessing area, or a hightraffic area, easily accessible to ensure scopes can be placed inside withoutdamage and without putting the HCW at risk (e.g., HCW mustreach a high shelf where endoscope is stored), should accommodate a sufficient number of endoscope tosupport the patient volume, designed to allow scopes to be stored in the vertical uncoiledposition to facilitate drying.CSGNA 2018

“Infection Prevention andControl Standards”- 2016.

Section 11.8 (page 43)

Flexible endoscopes are stored in a manner thatminimizes contamination and damage.

Guidelines

The organization does not store flexibleendoscopes coiled or in their cases. Flexibleendoscopes with channels or lumens are storedwith channel valves stored separately. Flexibleendoscopes are stored in a validated drying andstorage cabinet.

Resources 314.8 & , 314.0, PIDAC, PHAC

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PIDAC: “Best Practices for Cleaning,

Disinfection and Sterilization ofMedical Equipment/Devices”

Revised May 2013.

• Storage procedures must include the following• Remove caps, valves and other detachable components

during storage and reassemble just before use; Store closeto the endoscope in a manner that minimizes contamination.

• Store endoscopes that have been sterilized in theirsterilization containers.

• Do not allow endoscopes to coil, touch the floor or bottom ofthe cabinet while handling, or be stored in their cases.

• Store semi critical endoscopes by hanging vertically in adedicated, closed, ventilated cabinet outside of thedecontamination area and procedure room.CSGNA 2018

PIDAC: “Best Practices for Cleaning,

Disinfection and Sterilization ofMedical Equipment/Devices”

Revised May 2013.

• HEPA –filtered channel purge drying cabinetsshould be used for storage.

• Ensure that endoscope storage cabinets areconstructed of non-porous material that canbe cleaned.

• Clean and disinfect endoscope storagecabinets at least weekly with an approved low-level disinfectant/cleaner.

• Colonoscopes have a maximum shelf life of 7days, if stored dry. There are no otherrecommendations regarding shelf life of othertypes of endoscopes.

Suggests readers refer to Z314.8 & PublicHealth Canada for more information

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AORN Guidelines for

Flexible Endoscopes-2016.

• Recommendation IX• Flexible endoscopes and endoscope accessories

should be stored in a manner that minimizescontamination and protects the device or item fromdamage.

• IX.a Cabinets used for storage of flexible endoscopesshould be situated in a secure location the clean workroomof the endoscopy processing room in a two-room design, orin a separate clean area close to, but not within, theendoscopy procedure room.

• IX.a.1 Storage cabinets should have doors, and be locatedat least three feet from any sink.

• Flexible endoscopes should be stored in accordance withthe endoscope and cabinet manufacturers’ IFU.

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AORN Guidelines for

Flexible Endoscopes-2016.

• Flexible endoscopes should be stored in a drying cabinet.• The collective evidence shows that optimal storage flexible

endoscopes facilitates drying, decreases the potential forcontamination, and provides protection from environmentalcontaminants.

• A wide variety of storage cabinets are available. Dryingcabinets include a system that circulates HEPA-filtered airthrough the cabinet while filtered air under pressure isforced through the endoscope channels. The internal andexternal surfaces of the endoscope are continuously dried,suppressing bacterial growth.

• Studies related to the efficacy of drying cabinets comparedwith other methods of storage showed that drying cabinetseffectively limited bacterial proliferation during storage.

• If a drying cabinet is not available, flexible endoscopes maybe stored in a closed cabinet with HEPA-filtered air thatprovides positive pressure and allows air circulation aroundthe flexible endoscopes.

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SGNAStandards of Infection

Prevention in ReprocessingFlexible Gastrointestinal

Endoscopes- 20159. STORAGE

Endoscopes must be stored in an area that isclean, well-ventilated and dust-free in order tokeep the endoscopes dry and free of microbialcontamination. An endoscope that is not drymust be reprocessed before use. Endoscopesshould also hang freely so that they are notdamaged by physical impact. Endoscopesshould be stored in accordance with theendoscope and storage cabinet manufacturers'IFU.

Two major types of storage cabinets exist:conventional cabinets and drying cabinets.Conventional cabinets are favored in the UnitedStates, and drying cabinets are used mainly inEurope and Australia.

Drying cabinets are designed to control airquality and humidity, and access to endoscopes(Courné & Geyssens, 2011; Foxcroft,Monaghan, & Faoagali, 2008; Grandval,Hautefeuille, Marchetti, Pineau, & Laugier, 2013;Pineau, Villard, Luu & Marchetti, 2008). Theyhave bacteria-free air under pressure to keepsurfaces dry. High efficiency particulate air(HEPA) filters provide microbial-free air that isblown through the endoscope channels toensure that they remain dry.

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Key considerations in storage include:

a) Use storage cabinets that are made of amaterial that can be disinfected.

b) In conventional storage, hang endoscopes ina vertical position (with caps, valves, andother detachable components removed) toprevent moisture accumulation andsubsequent microbial growth. Make sure thatthey hang freely so they are not damaged bycontact with one another.

c) When using drying cabinets, follow thecabinet manufacturer’s instructions. Sincedrying does not rely on gravity, theendoscopes can be stored horizontally orvertically depending on the design of thecabinet.

d) Literature suggests that reusable buttons andvalves should be reprocessed and storedtogether with the endoscope as a unique setfor tracking purposes (BSG, 2014).

e) SGNA supports a 7-day storage interval forreprocessed endoscopes-but only if they werereprocessed and stored according toprofessional guidelines and manufacturerinstructions

CSGNA 2018

SGNAStandards of Infection

Prevention inReprocessing Flexible

GastrointestinalEndoscopes- 2015

• The endoscope should be hung vertically withthe distal tip hanging freely in a well-ventilated,clean area, following

• the endoscope manufacturer’s written IFU forstorage. For example, make sure that theinsertion tube hangs vertically and is asstraight as possible (no bends). If the scopehas an angulation lock, it should be in theopen position while in storage. There shouldbe sufficient space between and aroundscopes to prevent them hitting into oneanother, which can cause damage to thescopes. All removable parts (e.g., valves andcaps) should be detached from theendoscope. To keep the parts together withthe scope, a small bag or similar device can beused to attach the parts to the scope.

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ANSI/AAMIST91:2015

Flexible and semi-rigidendoscope processing in

health care facilities

• Rationale: When flexible and semi-rigid endoscopes are hung in thevertical position, coiling or kinking isprevented, allowing any remainingmoisture to drain out of theendoscope and decreasing thepotential development of anenvironment conducive to microbialgrowth in the endoscope. Followingrecommended storage practicesfacilitates drying and decreasespotential for contamination. All valvesand other accessories should beremoved in preparation for drying.The scope protector may create anenvironment favorable for microbialgrowth if the endoscope is not dryand cannot hang straight (Thomas,2005; Goldstine, 2005; Bisset et al.,2006). Storing endoscopes withvalves or on the scope will trapresidual moisture in the internalchannels and provide optimalconditions for microbial growth.

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ANSI/AAMIST91:2015

Flexible and semi-rigidendoscope processing in

health care facilities

a) Cupboards used to store endoscopes mustbe either designed to hold endoscopeshorizontally on a flat surface with continuousair flow through each channel, or be tallenough to allow endoscopes to hangvertically without touching the floor and bewell ventilated or have continuous air flowthrough each channel.

b) Cupboards with continuous air flow shouldprovide filtered air, flow monitoring andaudible alarms in the event of failure. If airflow fails, the connections to the cupboard airflow lines will impair fluid drainage andevaporation of residual moisture withinendoscope.

c) Cupboards should be made of animpermeable material that allows for thecupboard walls to be cleaned weekly.

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Infection Control inEndoscopy Guidelines

d) Provided storageconditions are as• recommended

above,endoscopes willneed to

• be disinfectedprior to use onlywhen the times inthe followingtable haveelapsed:

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Infection Control inEndoscopy Guidelines

e) Those endoscopes only used in emergency should be routinely reprocessed every 72hours to ensure they are ready to be used at any time.

f) Endoscopes must have a full disinfection process performed at the end of the list,using 70% alcohol and forced air drying to enhance the drying process prior tostorage. Methylated spirits is NOT suitable for this process.

g) Extended storage is only permitted if recent (within 12 months) routine microbiologicalsurveillance of the endoscope has shown negative culture results.

h) If recent culture results have been positive or if adequate storage facilities are notavailable, endoscopes should be disinfected prior to use if the storage time has beenlonger than 12 hours.

i) Endoscopes should not be stored in transport cases as these may have becomecontaminated and do not allow air flow to remove residual moisture from theendoscope.

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Infection Control inEndoscopy Guidelines

European Standard EN 16442:2015Controlled environment storage cabinetfor processed thermolabile endoscopes

This European Standard specifies storagecabinets which flush the channels and theexternal surfaces of endoscopes with air.

NOTE 1 The storage cabinet is one of themeans that can allow the safe use of theendoscope for an extended period from the timeof processing and improve availability foremergency use.

NOTE 2 Thorough drying of an endoscope in awasher-disinfector can require a prolonged cycletime; the use of a storage cabinet including adrying function can enhance throughput of theendoscopes.

The cabinet is not intended to provide anycleaning or disinfection function.

This European Standard does not include theuse of other chemicals for drying andmaintaining the quality of endoscopes duringstorage

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Whoa!

• Way too much information!• Way too many recommendations!• Way too many risks!How do we protect our staff and patients from cross contaminationwhile adhering to all these guidelines now and in the future?

Getting rid of those pesky little biofilm bugs is not easy that’s for sure!

But, as we have seen in all the recommendations and studies, HEPAfiltered ventilated cabinets with HEPA filtered purging of all endoscopechannels certainly helps.

CSGNA 2018

What do we need to know inCanada?As per CSA Z314.8-14, Canadian Healthcare Facilities shall

have cabinets that meet these standards:• Use an endoscope storage cabinet that has constant

positive pressure HEPA filtered ventilation.• Be made of a non-porous cleanable surface that is

impervious to micro-organism growth, such as stainlesssteel.

• In non-channel purge cabinets, endoscopes must hangvertically so they do not touch the bottom of the cabinet oreach other.

• Scopes can be hung for up to seven days if validated dryprior to storage. If not then they must be reprocessed priorto next procedure.

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Better World

Again, as per Z314.8-14 Canadian Healthcare Facilities, shouldhave cabinets with the following:• HEPA Filtered channel purge cabinets with non-porous

cleanable surfaces should be used.• Channel purge storage cabinets use all channel connectors to

flush HEPA filtered air through the connected channels duringstorage.

• Cabinets that store endoscopes horizontally can used, as longas the channels are connected and purged with HEPA filteredair.

• Alcohol flush is not required if an endoscope is stored in adedicated channel purge cabinet.

• Endoscopes stored in a dedicated channel purge cabinet forlonger than 7 days must be reprocessed.

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Best World

While not part of the CSA Standardsrequirement, the ability to track a endoscopewithin a channel purge storage cabinet,beginning from when it is stored, to when it istaken out, will help make sure you are using aclean, dry endoscope that is used before 7days for every procedure. Barcode and RFIDscanners are available.

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Other HEPA Cabinets

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In Conclusion• In Canada healthcare facilities, at a

minimum, must store their endoscopes in apositive pressure HEPA ventilated cabinet.

• The cabinet must be made of a non-porouscleanable surface.

• Endoscopes can be stored for up to 7 dayswithout reprocessing if verified dry prior tostorage in a non-channel purge cabinet.

In Conclusion• Endoscopes can be stored for 7 days in a

HEPA filtered channel purge cabinet,without prior drying.

• All studies point to the importance of dryingall channels of endoscopes in a timelymanner to eliminate the risk of micro-organism growth and generating bio-film.Most worldwide standards and guidelinesare recommending that now as well.

Let’s do what we can to get ridof those pesky bugs.

Questions?