Presented by Doug Brown Overview Endoscope Storage Review current Canadian US and European standards and guidelines for endoscopy storage Overview of a number of studies that back up these standards and guidelines ID: 815077
Download The PPT/PDF document "Canadian, US & European Standards on..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
Canadian, US & European Standards on Endoscope Storage
Presented by: Doug Brown
Slide2Overview
Endoscope StorageReview current Canadian, US and European standards and guidelines for endoscopy storage.Overview of a number of studies that back up these standards and guidelines.Review what healthcare facilities in Canada must follow to meet the CSA standards.
CSGNA 2018
Slide3Standards and Studies relating to Endoscopy StorageImage from AORNCSGNA 2018
Slide4Studies 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- level disinfection. Gastrointestinal Endoscopy. 2004;60(1):76Muscarella
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 reprocessing guidelines: a prospective study investigating the safe shelf life of flexible endoscopes in a tertiary gastroenterology 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 period of disuse: is it necessary? Endoscopy. 2007; 39: 737-9.Pineau L, Villard E, Duc DL, Marchetti : B. Endoscope drying/storage cabinet: interest and efficacy. Journal of Hospital Infection. 2008 Jan; 68(1):59-65.Foxcroft L., Monaghan, W., & Faoagali, J. (2008). Controlled study of the Lancer FD8 drying/storage cabinet for 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 for Endoscopes. J. GENCA. 2008;18(2):5-11.Wardle E. Endoscope storage cabinets. J.GENCA. 2007;17(3):7-12.
CSGNA 2018
Slide5Studies 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 heat sensitive endoscopes].
Acta
Endoscopica. 41(3), 153-159.
Kovaleva
J, Peters FTM, van der Mei HC et al. Transmission of Infection by Flexible Gastrointestinal Endoscopy and Bronchoscopy.
Clin
Microbiol
Revs 2013; 26: 231–254. Grandval, P., Hautefeuille, G., Marchetti, B., Pineau, L., & Laugier, R. (2013). Evaluation of a storage cabinet 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 medically significant 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 Infect Control 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 J Infect Control 2013 March; 41(3):245-248. Alfa MJ, Olson N, Murray BL. Comparison of clinically relevant benchmarks and channel sampling methods used to assess manual cleaning compliance for flexible gastrointestinal endoscopes. Am J Infect Control 2014 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. 2014 Dec 5 [cited 2014, Dec 22]. Alfa M., Mock clinical study demonstrates that ATP cleaning monitoring combined with channel purge storage reliably eliminates Escherichia Coli, but not environmental bacteria from duodenoscopes, Sept 2017Ofstead CL., Heyman OL, Quick MR., Eiland JE., Wetzler HP. Residual moisture and waterborne pathogens inside flexible endoscopes: Evidence from a multi-site study of endoscope drying effectiveness AJIC , March 2018
CSGNA 2018
Slide6Commonalities of Study Findings
In conclusion our mock clinical study demonstrated that, even with repeated soiling of duodenoscopes with high levels of E.coli, the use of ATP to monitor MIFU cleaning combined with dry storage in channel-purge storage cabinets eliminated E.coli from all 119 duodenoscopes tested. (Alfa)
Inadequate reprocessing and insufficient drying contributed to retained fluid and contamination found during this multisite study. More effective methods of endoscope reprocessing, drying, and maintenance are needed to prevent the retention of fluid, organic material, and bioburden that could cause patient illness or injury. (
Olstead
)
CSGNA 2018
Slide7Commonalities of Study Findings
Conclusion: HEPA filtered cabinets with channel purge supplement the drying process and help in the prevention of microorganism growth. This is only after the optimal bedside clean, manual wash, and reprocessing procedure is complete, monitored and documented
CSGNA 2018
Slide8CSA Standards: Scope Storage
Z314.8-14: “Decontamination of reusable medical devices”
CSGNA 2018
Slide9“Decontamination of Reusable Medical Devices
”#Z314.8-1411.7.12.1 GeneralEndoscopes shall be stored in a dedicated, closed, ventilated cabinet outside of the decontamination area and procedure room. The cabinet shall be equipped with HEPA filtration. Endoscopes shall not be stored in their transport cases. They shall be stored in a manner that ensures they remain dry and protected from environmental contaminants or damage. Wooden cabinets shall not be used for endoscope storage. If storage conditions cannot be met, scopes should be reprocessed just prior to use.
Note:
Poorly constructed and poorly maintained storage cabinets have been found to be a source of cross contamination.
CSGNA 2018
Slide10“Decontamination of Reusable Medical Devices
”#Z314.8-1411.7.12.4.2HEPA-filtered channel-purge storage cabinets with non-porous cleanable surfaces should be used.Notes:
Auto purge cabinets do not require the use of alcohol (fixative) to expedite drying and ensure that all ports of an endoscope are presented with airflow at the same time. This ensures drying in a timely manner to mitigate the growth of biofilm.
Channel purge storage cabinets use all-channel connectors and HEPA-filtered air to continually flush the connected channels of a scope with filtered air during storage.
In purge storage cabinets, vertical storage is not compulsory because the HEPA purging of the lumens and continuous HEPA air flow over the exterior of the endoscope, which ensures prompt drying both inside and out.
Other validated methods that ensure dry storage may be used.
CSGNA 2018
Slide11“Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchospy”
Storage cabinets should meet the following criteria:
made of
material that can be disinfected weekly
with an approved low-level disinfectant,
ventilated when doors are closed,
not situated in a procedure room, reprocessing area, or a high traffic area,
easily accessible to ensure scopes can be placed inside without damage and without putting the HCW at risk (e.g., HCW must reach a high shelf where endoscope is stored),
should accommodate a sufficient number of endoscope to support the patient volume,
designed to allow scopes to be stored in the vertical uncoiled position to facilitate drying.
CSGNA 2018
Slide12“Infection Prevention and Control Standards”- 2016.
Section 11.8 (page 43)Flexible endoscopes are stored in a manner that minimizes contamination and damage.
Guidelines
The organization does not store flexible endoscopes coiled or in their cases. Flexible endoscopes with channels or lumens are stored with channel valves stored separately.
Flexible endoscopes are stored in a validated drying and storage cabinet.
Resources 314.8 & , 314.0, PIDAC, PHAC
CSGNA 2018
Slide13PIDAC: “Best Practices for Cleaning, Disinfection and Sterilization of Medical Equipment/Devices” Revised May 2013.
Storage procedures must include the followingRemove caps, valves and other detachable components during storage and reassemble just before use;
Store close to the endoscope in a manner that minimizes contamination.
Store endoscopes that have been sterilized in their sterilization containers.
Do not allow endoscopes to coil, touch the floor or bottom of the cabinet while handling, or be stored in their cases.
Store semi critical endoscopes by hanging vertically in a dedicated, closed, ventilated cabinet outside of the decontamination area and procedure room.
CSGNA 2018
Slide14PIDAC: “Best Practices for Cleaning, Disinfection and Sterilization of Medical Equipment/Devices” Revised May 2013.
HEPA –filtered channel purge drying cabinets should be used for storage.Ensure that endoscope storage cabinets are constructed of non-porous material that can be cleaned.
Clean and disinfect endoscope storage cabinets at least weekly with an approved low-level disinfectant/cleaner.
Colonoscopes have a maximum shelf life of 7 days, if stored dry. There are no other recommendations regarding shelf life of other types of endoscopes.
Suggests readers refer to Z314.8 & Public Health Canada for more information
CSGNA 2018
Slide15AORN
Guidelines for Flexible Endoscopes- 2016. Recommendation IX
Flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects the device or item from damage.
IX.a
Cabinets used for storage of flexible endoscopes should be situated in a secure location the clean workroom of the endoscopy processing room in a two-room design, or in a separate clean area close to, but not within, the endoscopy procedure room.
IX.a.1
Storage cabinets should have doors
, and be located at least three feet from any sink.
Flexible endoscopes should be stored in accordance with the endoscope and cabinet manufacturers’ IFU.
CSGNA 2018
Slide16AORN
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 for contamination, and provides protection from environmental contaminants.
A wide variety of storage cabinets are available. Drying cabinets include a system that circulates HEPA-filtered air through the cabinet while filtered air under pressure is forced through the endoscope channels. The internal and external surfaces of the endoscope are continuously dried, suppressing bacterial growth
.
Studies related to the efficacy of drying cabinets compared with other methods of storage showed that drying cabinets effectively limited bacterial proliferation during storage.
If a drying cabinet is not available, flexible endoscopes may be stored in a closed cabinet with HEPA-filtered air that provides positive pressure and allows air circulation around the flexible endoscopes.
CSGNA 2018
Slide17SGNA
Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes- 20159. STORAGE
Endoscopes must be stored in an area that is clean, well-ventilated and dust-free in order to keep the endoscopes dry and free of microbial contamination. An endoscope that is not dry must be reprocessed before use. Endoscopes should also hang freely so that they are not damaged by physical impact. Endoscopes should be stored in accordance with the endoscope and storage cabinet manufacturers' IFU.
Two major types of storage cabinets exist: conventional cabinets and drying cabinets. Conventional cabinets are favored in the United States, and drying cabinets are used mainly in Europe and Australia.
Drying cabinets are designed to control air quality and humidity, and access to endoscopes (
Courné
&
Geyssens
, 2011;
Foxcroft
, Monaghan, & Faoagali, 2008; Grandval, Hautefeuille, Marchetti, Pineau, & Laugier, 2013; Pineau, Villard, Luu & Marchetti, 2008). They have bacteria-free air under pressure to keep surfaces dry. High efficiency particulate air (HEPA) filters provide microbial-free air that is blown through the endoscope channels to ensure that they remain dry.CSGNA 2018
Slide18Key considerations in storage include:
Use storage cabinets that are made of a material that can be disinfected.In conventional storage, hang endoscopes in a vertical position (with caps, valves, and other detachable components removed) to prevent moisture accumulation and subsequent microbial growth. Make sure that they hang freely so they are not damaged by contact with one another. When using drying cabinets, follow the cabinet manufacturer’s instructions. Since drying does not rely on gravity, the endoscopes can be stored horizontally or vertically depending on the design of the cabinet.
Literature suggests that reusable buttons and valves should be reprocessed and stored together with the endoscope as a unique set for tracking purposes (BSG, 2014).
SGNA supports a 7-day storage interval for reprocessed endoscopes-but only if they were reprocessed and stored according to professional guidelines and manufacturer instructions
CSGNA 2018
SGNA
Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes- 2015
Slide19The endoscope should be hung vertically with the distal tip hanging freely in a well-ventilated, clean area, following
the endoscope manufacturer’s written IFU for storage. For example, make sure that the insertion tube hangs vertically and is as straight as possible (no bends). If the scope has an angulation lock, it should be in the open position while in storage. There should be sufficient space between and around scopes to prevent them hitting into one another, which can cause damage to the scopes. All removable parts (e.g., valves and caps) should be detached from the endoscope. To keep the parts together with the scope, a small bag or similar device can be used to attach the parts to the scope.
CSGNA 2018
ANSI/AAMI
ST91:2015
Flexible and semi-rigid
endoscope processing in
health care facilities
Slide20Rationale:
When flexible and semi-rigid endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential development of an environment conducive to microbial growth in the endoscope. Following recommended storage practices facilitates drying and decreases potential for contamination. All valves and other accessories should be removed in preparation for drying. The scope protector may create an environment favorable for microbial growth if the endoscope is not dry and cannot hang straight (Thomas, 2005; Goldstine, 2005; Bisset et al., 2006). Storing endoscopes with valves or on the scope will trap residual moisture in the internal channels and provide optimal conditions for microbial growth.
CSGNA 2018
ANSI/AAMI
ST91:2015
Flexible and semi-rigid
endoscope processing in
health care facilities
Slide21Cupboards used to store endoscopes must be either designed to hold endoscopes horizontally on a flat surface with continuous air flow through each channel,
or be tall enough to allow endoscopes to hang vertically without touching the floor and be well ventilated or have continuous air flow through each channel.Cupboards with continuous air flow should provide filtered air, flow monitoring and audible alarms in the event of failure. If air flow fails, the connections to the cupboard air flow lines will impair fluid drainage and evaporation of residual moisture within endoscope.Cupboards should be made of an impermeable material that allows for the cupboard walls to be cleaned weekly.
CSGNA 2018
Infection Control in Endoscopy Guidelines
Slide22d) Provided storage conditions are as
recommended above, endoscopes will need tobe disinfected prior to use only when the times in the following table have elapsed:CSGNA 2018
Infection Control in Endoscopy Guidelines
Slide23Those endoscopes only used in emergency should be routinely reprocessed every 72 hours to ensure they are ready to be used at any time.
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 to storage. Methylated spirits is NOT suitable for this process.Extended storage is only permitted if recent (within 12 months) routine microbiological surveillance of the endoscope has shown negative culture results.
If recent culture results have been positive or if adequate storage facilities are not available, endoscopes should be disinfected prior to use if the storage time has been longer than 12 hours.
Endoscopes should not be stored in transport cases as these may have become contaminated and do not allow air flow to remove residual moisture from the endoscope.
CSGNA 2018
Infection Control in Endoscopy Guidelines
Slide24European Standard EN 16442:2015
Controlled environment storage cabinet for processed thermolabile endoscopes
This European Standard specifies storage cabinets which flush the channels and the external surfaces of endoscopes with air.
NOTE 1 The storage cabinet is one of the means that can allow the safe use of the endoscope for an extended period from the time of processing and improve availability for emergency use.
NOTE 2 Thorough drying of an endoscope in a washer-disinfector can require a prolonged cycle time; the use of a storage cabinet including a drying function can enhance throughput of the endoscopes.
The cabinet is not intended to provide any cleaning or disinfection function.
This European Standard does not include the use of other chemicals for drying and maintaining the quality of endoscopes during storage
CSGNA 2018
Slide25Whoa! Way too much information!
Way too many recommendations!Way too many risks!How do we protect our staff and patients from cross contamination while 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, HEPA filtered ventilated cabinets with HEPA filtered purging of all endoscope channels certainly helps.
CSGNA 2018
Slide26What do we need to know in Canada?
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 stainless steel.In non-channel purge cabinets, endoscopes must hang vertically so they do not touch the bottom of the cabinet or each other.Scopes can be hung for up to seven days if validated dry prior to storage. If not then they must be reprocessed prior to next procedure.
Slide27CSGNA 2018
Slide28Better World
Again, as per Z314.8-14 Canadian Healthcare Facilities, should have 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 during storage.Cabinets that store endoscopes horizontally can used, as long as the channels are connected and purged with HEPA filtered air.Alcohol flush is not required if an endoscope is stored in a dedicated channel purge cabinet.Endoscopes stored in a dedicated channel purge cabinet for longer than 7 days must be reprocessed.
Slide29CSGNA 2018
Slide30Best WorldWhile not part of the CSA Standards requirement, the ability to track a endoscope within a channel purge storage cabinet, beginning from when it is stored, to when it is taken out, will help make sure you are using a clean, dry endoscope that is used before 7 days for every procedure. Barcode and RFID scanners are available.
Slide31CSGNA 2018
Slide32Other HEPA Cabinets
CSGNA 2018
Slide33In ConclusionIn Canada healthcare facilities, at a minimum, must store their endoscopes in a positive pressure HEPA ventilated cabinet.
The cabinet must be made of a non-porous cleanable surface.Endoscopes can be stored for up to 7 days without reprocessing if verified dry prior to storage in a non-channel purge cabinet.
Slide34In ConclusionEndoscopes can be stored for 7 days in a HEPA filtered channel purge cabinet, without prior drying.
All studies point to the importance of drying all channels of endoscopes in a timely manner to eliminate the risk of micro-organism growth and generating bio-film. Most worldwide standards and guidelines are recommending that now as well.
Slide35Let’s do what we can to get rid of those pesky bugs. Questions?