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Commentary on the 2016 Multi-Society Task Force Endoscope Reprocessing Guidelines
Gastroenterology 2017;-:1–3
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Commentary on 2016 Multi-Society Task Force Endoscope Reprocessing Guidelines Q5 Q1
Susan M. Hutfless and Anthony N. Kalloo Division of Gastroenterology & Hepatology, Johns Hopkins University, Baltimore, Maryland
“Mrs. Joe was a very clean housekeeper, but had an exquisite art of making her cleanliness more uncomfortable and unacceptable than dirt itself.” — Charles Dickens, Great Expectations
T
he widespread media attention related to duodenoscope-related transmission of deadly antibiotic resistant infections prompted the Multi-Society Task Force to update the 2011 Endoscope Reprocessing Guidelines. The AGA Institute has officially endorsed the updated 2016 guidelines.1 The first guidelines in 2003 included 34 recommendations, the 2011 guidelines included 39 recommendations, and the most recent 2016 guidelines include 41 recommendations. Between 2003 and 2011 the changes in guidelines included to preclean the endoscope (2016 recommendation #2), transport the pre-cleaned covered endoscope (2016 #3) in a covered way. In spite of these guidelines, the recent outbreaks involving side-viewing duodenoscopes with “elevator” mechanisms occurred despite documentation of appropriate cleaning and highlevel disinfection at sites with confirmed outbreaks. Although evidence of outbreaks occurred despite adherence to 2011 guidelines, the 2016 guidelines are not dramatically different. The major changes include 1) language to maintain consistency with the 2015 FDA endoscope reprocessing communications; 2) statements suggesting greater monitoring and tracking of the endoscope throughout the clinical units and cleaning rooms including timing of events and who performs the key steps. There are surprisingly only 2 new recommendations, one of which (#24) is a suggestion to perform cultures or further disinfection if feasible. Furthermore, the 2003 guidelines discuss unresolved issues related to endoscope reprocessing. The majority of unresolved issues have remained constant in both the 2011 and 2016 guidelines. We discuss the major changes to the guidelines and their implications on practice.
Recommendations #5, #6, #8, #12, #16, #28, #32 These recommendations have been modified to include specific mention of adhering to information provided by the FDA and manufacturers. Recommendation #5 has been revised to recommend “strict adherence” to manufacturer guidance. This language change is consistent with the FDA’s 2015 interim guidance with the same language. The strict
adherence is meant to be device and manufacturer specific. The 2016 Guidelines specifically state that a “single standard work process within one institution may be insufficient, given differences among manufacturers’ instructions and varied instrument designs.” The expectation is that all personnel will remain up to date with the manufacturer guidelines and that there will be documentation of the training. “All staff involved with the use, cleaning and processing of flexible endoscopes should undergo documented brand and model-specific training at commencement of employment and at least annually.. Additional training, along with updated evaluation and documentation of competency, is required whenever a change in reprocessing guidance is received from the endoscope manufacturer or regulatory agencies, or guidance from professional organizations is incorporated into unit policies and procedures.” The training requirements for those responsible for endoscope reprocessing include training at hire, annually and “anytime a breach is identified, when a major technique or new endoscope or reprocessing equipment is introduced, and in the context of local quality control efforts.”
Implications for practice Many endoscopy units utilize a device-specific (but not manufacturer-specific) cleaning and disinfection protocol that takes into account the common elements across the manufacturers and modifies them for their environment. The recommendations are not permissive of such a training or cleaning system. Many units will need to revise their cleaning and training protocols. An individual or group of individuals may need to be identified to keep up with the FDA, CDC, manufacturer and professional societies in order to modify and implement the changes to the cleaning and training protocols and update the training of all individuals in the unit. It is unclear from the guidelines what the minimum time should be between change in recommendations and updated training. It is also unclear if “all staff involved in the use” should undergo the documented competency training includes the endoscopists. Depending on the frequency of manufacturer, regulatory and professional society updates this could become time-consuming for the many clinical staff who work in the endoscopy unit.
© 2016 by the AGA Institute 0016-5085/$36.00 http://dx.doi.org/10.1053/j.gastro.2016.12.030
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Gastroenterology Vol.
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Recommendation #24
Recommendation #31
This new recommendation includes a suggestion that is consistent with the FDA documents. “Beyond the reprocessing steps discussed in these recommendations, no validated methods for additional duodenoscope reprocessing currently exist. However, units should review and consider the feasibility and appropriateness for their practice of employing one or more of the additional modalities suggested by the FDA for duodenoscopes: intermittent or per procedure culture surveillance of reprocessing outcomes, sterilization with ethylene oxide gas, repeat application of standard high level disinfection, or use of a liquid chemical germicide.”
This new recommendation makes specifications to the physical environments where patient care is delivered versus the location of endoscope reprocessing. “Reprocessing facilities should be designed with attention to the optimal flow of personnel, endoscopes and devices to avoid contamination between entering dirty instruments and reprocessed clean instruments. Reprocessing of endoscopes (other than immediate pre-cleaning) should not be performed in patient care areas due to risk of patient exposure to contaminated surfaces and devices.”
Implications for Practice Each of these additional modalities has limitations. The per procedure culture surveillance modality suggested by the FDA is not cost-effective unless the unit’s transmission probability of carbapenem-resistant Enterobacteriaceae is 24% or greater.2 Sterilization with ethylene oxide is problematic because a unit that used this approach still encountered an endoscope with carbapenem-resistant Enterobacteriaceae detected by culture. This unit also incurred extra costs to purchase additional scopes due to the longer reprocessing time for sterilization and had a greater number of endoscopes with damage, although the damage was not directly attributable to sterilization.3 Repeat high level disinfection has the same potential limitations as sterilization. Liquid chemical germicides, such as 2% glutaraldehyde, will expose the staff responsible for reprocessing to known irritants and can cause colitis in patients if the endoscope is not properly rinsed between uses.4 These costs and risks to patients and staff should be evaluated by a unit before implementing these suggested modalities. Since 2003, the guidelines have described sterilization versus disinfection for endoscopes. In 2016, the majority of the FDA panel members recommended reclassifying endoscopes so that sterilization is required instead of high level disinfection. “Indeed, the FDA Advisory Panel concluded that duodenoscopes and AERs (automated endoscope reprocessors) do not provide a reasonable assurance of safety and effectiveness. While some panelists held that high level disinfection is adequate when done properly, the majority felt that duodenoscopes should be reclassified as critical devices in the Spaulding Classification, thus shifting expectations toward sterilization.“ However, according to the Centers for Disease Control & Prevention and a laparoscopy textbook, there is no evidence of differences in infection transmission when laparoscopes undergo sterilization versus high level disinfection.4,5 The surgical experience is similar to the endoscopy unit that performed disinfection yet still identified carbapenem-resistant Enterobacteriaceae in a sterilized endoscope. It appears that contamination may be unavoidable using the current reprocessing or sterilization paradigm and that at present, methods to rapidly identify and contain outbreaks are the highest priority for innovation.
Implications for Practice If there are endoscopy units that are currently cleaning endoscopes in patient care areas, these units will require a modification of workflow so that cleaning can occur in a separate area.
Recommendation #5 This recommendation has been modified to specify compliance with the manufacturer documentation including that “only model-specific cleaning devices (such as brushes) designed for the endoscope model being cleaned” should be used. It also indicates that “Manual cleaning should occur within 60 minutes of endoscope use and the intervals from use to cleaning should be monitored.”
Implications for Practice Endoscope-specific tracking will be required to monitor the time between use and cleaning. This may need to include a barcode scanning or other system with scanners within the clinical areas and the endoscope cleaning and reprocessing rooms. The modification of this recommendation will also require a means to indicate which brush brands match which brands of endoscopes for cleaning rather than using brushes that works best for the majority of brands used by the unit.
Recommendation #27 The recommendation to log each procedure by name, medical record number, the procedure, the serial number of the endoscope, and the automated reprocessor unit was modified to include the name of the person who cleaned and disinfected the endoscope and to log information about temporarily used/loaner endoscopes. This information is needed to assist in an outbreak investigation.
Implications for Practice The endoscope-specific tracking system will need to document the entire lifecycle of the endoscope. Electronic health records systems may need to be modified to capture the serial number of the endoscope and reprocessing unit to facilitate patient-specific notification in the event an outbreak does occur. The 2011 and 2016 recommendations do not mention tracking the endoscopist that performs the procedure, however the 2003 recommendations do include
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endoscopist-level tracking. Cross-documenting the endoscope information in the patients’ medical record would facilitate endoscopist-specific tracking.
Conclusions The uncertainty of the source of the most recent outbreaks, the lack of clarity that there was any specific adherence issue or other problem with the 2013 guidelines and the minor changes in the most recent guidelines suggest that the 2016 guidelines themselves are, thus, unlikely to guarantee the prevention of future outbreaks. The prevention of future outbreaks is left to the manufacturers to modify their protocols and the endoscopy units to adopt the protocols rapidly. If followed, the guidelines will make it possible to better track the source of future outbreaks if the tracking and monitoring suggested is performed. As suggested by the FDA panel, the effectiveness of the current cleaning paradigm for duodenoscopes is ineffective and these guidelines reflect changes to contain, rather than prevent, future outbreaks. If the guidelines themselves cannot prevent transmission what are the alternatives? As suggested by recommendation #24, sterilization or the “culture and quarantine” process. However, sterilization does not prevent culturedetectable antibiotic resistant bacteria and the culture and quarantine process is not cost-effective until the pre-test probability of transmission is 1 in 4 patients or greater.2,3 An emerging option may be disposable endoscopes. In September 2016 the FDA approved the first disposable colonoscope. This product is expected to be available in the United States in early 2017 at the cost of around $250 per colonoscope. Although a disposable endoscope with an elevator mechanism is not available at this time, if such a device were available it may be a solution to several of the unresolved issues that were present in the 2003, 2011 and 2016 guidelines. These unresolved issues include interval of storage after reprocessing, microbiologic surveillance, and endoscope durability and longevity. If the outbreaks persist after the use of disposable endoscopes it is possible that it is some other product or procedure within the endoscopic procedure that is the source of the infectious transmission. Actively comparing transmission and cost-effectiveness of endoscope reprocessing versus disposable endoscopes will
3
be needed. It is possible that not all patients will require a disposable endoscope and those patients at highest risk of transmission and infection can be identified and prioritized for these devices. Prioritizing patients accurately may have implications for budgeting and reimbursement. We agree that the 2016 guidelines should be followed yet, at the same time, adherence with them cannot be relied upon as a guarantee to prevent transmission. We also note that the majority of unresolved issues from 2003 are the same unresolved issues in 2011 and 2016 guidelines. These unresolved issues could be the clue to the source of the recent outbreaks as there was adherence to the guidelines in the units with outbreaks. Actively addressing the unresolved issues may provide insight into the prevention of outbreaks.
References 1.
2.
3.
4.
5.
Bret Petersen, MD, FASGE, and Jon Cohen, MD, FASGE, Reprocessing Guideline Task Force Committee Chair: Glenn Eisen, MD, FASGEMulti-Society Guideline on Reprocessing Flexible Gastrointestinal Endoscopes– 2016. http://dx.doi.org/10.1016/j.gie.2016.10.002. Almario CV, May FP, Shaheen NJ, et al. Cost Utility of Competing Strategies to Prevent Endoscopic Transmission of Carbapenem-Resistant Enterobacteriaceae. Am J Gastroenterol 2015;110:1666–1674. Naryzhny I, Silas D, Chi K. Impact of ethylene oxide gas sterilization of duodenoscopes after a carbapenemresistant Enterobacteriaceae outbreak. Gastrointest Endosc 2016;84:259–262. Rutala W, Weber D, Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Available at: https://www.cdc.gov/hicpac/pdf/ guidelines/Disinfection_Nov_2008.pdf, 2008. Accessed XXXX Arregui ME, Fitzgibbons RJJ, Katkhouda N, McKernan JB, Reich H, ed. Principles of Laparoscopic Surgery: Basic and Advanced Techniques.
Conflicts of interest The authors disclose the following: ---
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Commentary on 2016 Multi-Society Task Force Endoscope Reprocessing Guidelines Q5 Q1
Susan M. Hutfless and Anthony N. Kalloo Division of Gastroenterology & Hepatology, Johns Hopkins University, Baltimore, Maryland
“Mrs. Joe was a very clean housekeeper, but had an exquisite art of making her cleanliness more uncomfortable and unacceptable than dirt itself.” — Charles Dickens, Great Expectations
T
he widespread media attention related to duodenoscope-related transmission of deadly antibiotic resistant infections prompted the Multi-Society Task Force to update the 2011 Endoscope Reprocessing Guidelines. The AGA Institute has officially endorsed the updated 2016 guidelines.1 The first guidelines in 2003 included 34 recommendations, the 2011 guidelines included 39 recommendations, and the most recent 2016 guidelines include 41 recommendations. Between 2003 and 2011 the changes in guidelines included to preclean the endoscope (2016 recommendation #2), transport the pre-cleaned covered endoscope (2016 #3) in a covered way. In spite of these guidelines, the recent outbreaks involving side-viewing duodenoscopes with “elevator” mechanisms occurred despite documentation of appropriate cleaning and highlevel disinfection at sites with confirmed outbreaks. Although evidence of outbreaks occurred despite adherence to 2011 guidelines, the 2016 guidelines are not dramatically different. The major changes include 1) language to maintain consistency with the 2015 FDA endoscope reprocessing communications; 2) statements suggesting greater monitoring and tracking of the endoscope throughout the clinical units and cleaning rooms including timing of events and who performs the key steps. There are surprisingly only 2 new recommendations, one of which (#24) is a suggestion to perform cultures or further disinfection if feasible. Furthermore, the 2003 guidelines discuss unresolved issues related to endoscope reprocessing. The majority of unresolved issues have remained constant in both the 2011 and 2016 guidelines. We discuss the major changes to the guidelines and their implications on practice.
Recommendations #5, #6, #8, #12, #16, #28, #32 These recommendations have been modified to include specific mention of adhering to information provided by the FDA and manufacturers. Recommendation #5 has been revised to recommend “strict adherence” to manufacturer guidance. This language change is consistent with the FDA’s 2015 interim guidance with the same language. The strict
adherence is meant to be device and manufacturer specific. The 2016 Guidelines specifically state that a “single standard work process within one institution may be insufficient, given differences among manufacturers’ instructions and varied instrument designs.” The expectation is that all personnel will remain up to date with the manufacturer guidelines and that there will be documentation of the training. “All staff involved with the use, cleaning and processing of flexible endoscopes should undergo documented brand and model-specific training at commencement of employment and at least annually.. Additional training, along with updated evaluation and documentation of competency, is required whenever a change in reprocessing guidance is received from the endoscope manufacturer or regulatory agencies, or guidance from professional organizations is incorporated into unit policies and procedures.” The training requirements for those responsible for endoscope reprocessing include training at hire, annually and “anytime a breach is identified, when a major technique or new endoscope or reprocessing equipment is introduced, and in the context of local quality control efforts.”
Implications for practice Many endoscopy units utilize a device-specific (but not manufacturer-specific) cleaning and disinfection protocol that takes into account the common elements across the manufacturers and modifies them for their environment. The recommendations are not permissive of such a training or cleaning system. Many units will need to revise their cleaning and training protocols. An individual or group of individuals may need to be identified to keep up with the FDA, CDC, manufacturer and professional societies in order to modify and implement the changes to the cleaning and training protocols and update the training of all individuals in the unit. It is unclear from the guidelines what the minimum time should be between change in recommendations and updated training. It is also unclear if “all staff involved in the use” should undergo the documented competency training includes the endoscopists. Depending on the frequency of manufacturer, regulatory and professional society updates this could become time-consuming for the many clinical staff who work in the endoscopy unit.
© 2016 by the AGA Institute 0016-5085/$36.00 http://dx.doi.org/10.1053/j.gastro.2016.12.030
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Hutfless and Kalloo
Gastroenterology Vol.
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No.
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Recommendation #24
Recommendation #31
This new recommendation includes a suggestion that is consistent with the FDA documents. “Beyond the reprocessing steps discussed in these recommendations, no validated methods for additional duodenoscope reprocessing currently exist. However, units should review and consider the feasibility and appropriateness for their practice of employing one or more of the additional modalities suggested by the FDA for duodenoscopes: intermittent or per procedure culture surveillance of reprocessing outcomes, sterilization with ethylene oxide gas, repeat application of standard high level disinfection, or use of a liquid chemical germicide.”
This new recommendation makes specifications to the physical environments where patient care is delivered versus the location of endoscope reprocessing. “Reprocessing facilities should be designed with attention to the optimal flow of personnel, endoscopes and devices to avoid contamination between entering dirty instruments and reprocessed clean instruments. Reprocessing of endoscopes (other than immediate pre-cleaning) should not be performed in patient care areas due to risk of patient exposure to contaminated surfaces and devices.”
Implications for Practice Each of these additional modalities has limitations. The per procedure culture surveillance modality suggested by the FDA is not cost-effective unless the unit’s transmission probability of carbapenem-resistant Enterobacteriaceae is 24% or greater.2 Sterilization with ethylene oxide is problematic because a unit that used this approach still encountered an endoscope with carbapenem-resistant Enterobacteriaceae detected by culture. This unit also incurred extra costs to purchase additional scopes due to the longer reprocessing time for sterilization and had a greater number of endoscopes with damage, although the damage was not directly attributable to sterilization.3 Repeat high level disinfection has the same potential limitations as sterilization. Liquid chemical germicides, such as 2% glutaraldehyde, will expose the staff responsible for reprocessing to known irritants and can cause colitis in patients if the endoscope is not properly rinsed between uses.4 These costs and risks to patients and staff should be evaluated by a unit before implementing these suggested modalities. Since 2003, the guidelines have described sterilization versus disinfection for endoscopes. In 2016, the majority of the FDA panel members recommended reclassifying endoscopes so that sterilization is required instead of high level disinfection. “Indeed, the FDA Advisory Panel concluded that duodenoscopes and AERs (automated endoscope reprocessors) do not provide a reasonable assurance of safety and effectiveness. While some panelists held that high level disinfection is adequate when done properly, the majority felt that duodenoscopes should be reclassified as critical devices in the Spaulding Classification, thus shifting expectations toward sterilization.“ However, according to the Centers for Disease Control & Prevention and a laparoscopy textbook, there is no evidence of differences in infection transmission when laparoscopes undergo sterilization versus high level disinfection.4,5 The surgical experience is similar to the endoscopy unit that performed disinfection yet still identified carbapenem-resistant Enterobacteriaceae in a sterilized endoscope. It appears that contamination may be unavoidable using the current reprocessing or sterilization paradigm and that at present, methods to rapidly identify and contain outbreaks are the highest priority for innovation.
Implications for Practice If there are endoscopy units that are currently cleaning endoscopes in patient care areas, these units will require a modification of workflow so that cleaning can occur in a separate area.
Recommendation #5 This recommendation has been modified to specify compliance with the manufacturer documentation including that “only model-specific cleaning devices (such as brushes) designed for the endoscope model being cleaned” should be used. It also indicates that “Manual cleaning should occur within 60 minutes of endoscope use and the intervals from use to cleaning should be monitored.”
Implications for Practice Endoscope-specific tracking will be required to monitor the time between use and cleaning. This may need to include a barcode scanning or other system with scanners within the clinical areas and the endoscope cleaning and reprocessing rooms. The modification of this recommendation will also require a means to indicate which brush brands match which brands of endoscopes for cleaning rather than using brushes that works best for the majority of brands used by the unit.
Recommendation #27 The recommendation to log each procedure by name, medical record number, the procedure, the serial number of the endoscope, and the automated reprocessor unit was modified to include the name of the person who cleaned and disinfected the endoscope and to log information about temporarily used/loaner endoscopes. This information is needed to assist in an outbreak investigation.
Implications for Practice The endoscope-specific tracking system will need to document the entire lifecycle of the endoscope. Electronic health records systems may need to be modified to capture the serial number of the endoscope and reprocessing unit to facilitate patient-specific notification in the event an outbreak does occur. The 2011 and 2016 recommendations do not mention tracking the endoscopist that performs the procedure, however the 2003 recommendations do include
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endoscopist-level tracking. Cross-documenting the endoscope information in the patients’ medical record would facilitate endoscopist-specific tracking.
Conclusions The uncertainty of the source of the most recent outbreaks, the lack of clarity that there was any specific adherence issue or other problem with the 2013 guidelines and the minor changes in the most recent guidelines suggest that the 2016 guidelines themselves are, thus, unlikely to guarantee the prevention of future outbreaks. The prevention of future outbreaks is left to the manufacturers to modify their protocols and the endoscopy units to adopt the protocols rapidly. If followed, the guidelines will make it possible to better track the source of future outbreaks if the tracking and monitoring suggested is performed. As suggested by the FDA panel, the effectiveness of the current cleaning paradigm for duodenoscopes is ineffective and these guidelines reflect changes to contain, rather than prevent, future outbreaks. If the guidelines themselves cannot prevent transmission what are the alternatives? As suggested by recommendation #24, sterilization or the “culture and quarantine” process. However, sterilization does not prevent culturedetectable antibiotic resistant bacteria and the culture and quarantine process is not cost-effective until the pre-test probability of transmission is 1 in 4 patients or greater.2,3 An emerging option may be disposable endoscopes. In September 2016 the FDA approved the first disposable colonoscope. This product is expected to be available in the United States in early 2017 at the cost of around $250 per colonoscope. Although a disposable endoscope with an elevator mechanism is not available at this time, if such a device were available it may be a solution to several of the unresolved issues that were present in the 2003, 2011 and 2016 guidelines. These unresolved issues include interval of storage after reprocessing, microbiologic surveillance, and endoscope durability and longevity. If the outbreaks persist after the use of disposable endoscopes it is possible that it is some other product or procedure within the endoscopic procedure that is the source of the infectious transmission. Actively comparing transmission and cost-effectiveness of endoscope reprocessing versus disposable endoscopes will
3
be needed. It is possible that not all patients will require a disposable endoscope and those patients at highest risk of transmission and infection can be identified and prioritized for these devices. Prioritizing patients accurately may have implications for budgeting and reimbursement. We agree that the 2016 guidelines should be followed yet, at the same time, adherence with them cannot be relied upon as a guarantee to prevent transmission. We also note that the majority of unresolved issues from 2003 are the same unresolved issues in 2011 and 2016 guidelines. These unresolved issues could be the clue to the source of the recent outbreaks as there was adherence to the guidelines in the units with outbreaks. Actively addressing the unresolved issues may provide insight into the prevention of outbreaks.
References 1.
2.
3.
4.
5.
Bret Petersen, MD, FASGE, and Jon Cohen, MD, FASGE, Reprocessing Guideline Task Force Committee Chair: Glenn Eisen, MD, FASGEMulti-Society Guideline on Reprocessing Flexible Gastrointestinal Endoscopes– 2016. http://dx.doi.org/10.1016/j.gie.2016.10.002. Almario CV, May FP, Shaheen NJ, et al. Cost Utility of Competing Strategies to Prevent Endoscopic Transmission of Carbapenem-Resistant Enterobacteriaceae. Am J Gastroenterol 2015;110:1666–1674. Naryzhny I, Silas D, Chi K. Impact of ethylene oxide gas sterilization of duodenoscopes after a carbapenemresistant Enterobacteriaceae outbreak. Gastrointest Endosc 2016;84:259–262. Rutala W, Weber D, Healthcare Infection Control Practices Advisory Committee (HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Available at: https://www.cdc.gov/hicpac/pdf/ guidelines/Disinfection_Nov_2008.pdf, 2008. Accessed XXXX Arregui ME, Fitzgibbons RJJ, Katkhouda N, McKernan JB, Reich H, ed. Principles of Laparoscopic Surgery: Basic and Advanced Techniques.
Conflicts of interest The authors disclose the following: ---
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