Endoscope-Associated Infections (EAI): an Update and Future Directions

FRONTIERS IN ENDOSCOPY, SERIES #64 FRONTIERS IN ENDOSCOPY, SERIES # 64

Douglas G. Adler MD, FACG, AGAF, FASGE, Series Editor Endoscope-Associated Infections (EAI): An Update and Future Directions

Kapil Gupta Tara Keihanian Amaninder S. Dhaliwal

James H. Tabibian Mohit Girotra

I. INTRODUCTION he number of endoscopic and minimally- to mitigate nosocomial infections. Endoscope- invasive procedures performed has associated infections (EAIs), especially those exponentially increased in recent years, as the associated with the endoscope conventionally T 1 realm of endoscopy has expanded. Annually, around used for ERCP (i.e. the duodenoscope), has been 20 million endoscopic procedures are performed a growing concern in the healthcare system in in the United States, of which at least 600,000 are recent years and has garnered significant attention endoscopic retrograde cholangiopancreatographies in the mainstream news. When compared to a (ERCPs).2-3 The parallel upsurge in multi-drug standard flexible endoscope, the duodenoscope resistant organisms (MDRO) has augmented the has a more complicated structure that makes it worldwide attention to the study of and efforts more susceptible to infection; this is especially Kapil Gupta, MD Department of Medicine, University of Miami/JFK Medical Center Palm Beach Regional GME Consortium Internal Medicine Program, Atlantis, FL Tara Keihanian, MD Fellow, Division of Gastroenterology and Hepatology, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL Amaninder S. Dhaliwal, MD Fellow, Division of Gastroenterology and Hepatology, University of Nebraska Medical Center, Omaha, NE James H. Tabibian, MD, PhD Health Sciences Clinical Associate Professor, David Geffen SOM at UCLA, Director of Endoscopy, Olive View-UCLA Medical Center, Los Angeles, CA Mohit Girotra MD FACP Associate Professor of Clinical Medicine, Division of Gastroenterology and Hepatology, University of Miami Miller School of Medicine, Miami, FL

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the case at the distal tip of the scope as a result of the duodenoscope’s elevator mechanism, which is relatively difficult to clean/disinfect, and as such, tissue/fluid from one patient may remain when the device is used on a subsequent patient, thus leading to patient-to-patient transmission of infection. Although duodenoscope-associated infections are rare occurrences and procedures are in place to avoid them, most experts believe that the infection prevalence may be under-reported.2 The paradigm for cleaning endoscopes (including duodenoscopes), as recommended by the Figure 1. The distal tips of three endoscopes, from L United States Food and Drug Administration (FDA) to R: Linear echoendoscope (for therapeutic EUS), and Centers for Disease Control and Prevention duodenoscope (for ERCP) and gastroscope (for (CDC), encompasses comprehensive and extensive EGD). Linear echoendoscope and duodenoscope cleaning followed by high-level disinfection have elevator mechanism at distal tip, making (HLD).2 Heat-labile endoscopes are not able to reprocessing challenging. undergo the same sterilization method for surgical Image used with permission from Boston Scientific instruments, thus making HLD important. In 2013, the CDC alerted the FDA to a potential association immediately after the procedure, at patient bedside, between MDRO and duodenoscopes. The initial usually by the endoscopy technician/staff.3,5 Pre- obvious suspicion was placed on reduced effort in cleaning starts with wiping the insertion section of cleaning, missed steps and/or other lapses involved endoscope (with clean water or detergent solution), in duodenoscope cleaning and HLD.1 However, followed by aspiration of water through the channel upon further investigation, it became clear that for 30 seconds, while raising and lowering the these cases of infection were occurring despite user elevator, followed by aspiration of air for 10 seconds. adherence to multiple expert societies suggested After this, the AW channel-cleaning adapter is guidelines and manufacturer’s instruction for use attached to the air/water cylinder and flushed with (IFU), which had been previously considered to water and air, before detaching accessories from be adequate. Unfortunately, after the increases in the endoscope, and subjecting the scope to a leak the frequency of infection in healthcare centers test.2 Certain automated endoscope reprocessors despite adhering to the guidelines/IFU, the FDA (AERs) have automated cleaning before HLD, and and CDC began to re-evaluate the infection risk although it allows for standardization and reduces with duodenoscopes.1 error, this method has not been vindicated with There have not been well-established, specific adequate peer-reviewed evidence.5 guidelines for endoscopic disinfection strategies Once the endoscope/duodenoscope is to better ensure safety from EAIs.2,4 Furthermore, transferred to endoscopy suites’ designated scope the complexity of duodenoscope design makes reprocessing area, the five stages of endoscope it difficult to achieve efficient and effective reprocessing begin, as described in manufacturers’ disinfection and reprocessing.1 In this review, we IFUs, which include manual cleaning, HLD, focus on EAIs (particularly duodenoscope) and the rinsing, drying, and storage.5 The steps of manual challenges related to it, and additionally discuss cleaning of duodenoscope include (i) cleaning the the current standards of reprocessing as well as external surface of scope using medical grade, low- the changes proposed for reprocessing technique foaming, neutral pH detergent, (ii) brush clean the and their effect on future of EAIs. elevator and recess along with guidewire-locking groove, (iii) brush clean the suction channel, (iv) II. ENDOSCOPIC REPROCESSING PROCESS brush clean the instrument channel from suction Pre-cleaning is a crucial first step to prevent cylinder to distal end of insertion section (scope tip) drying of pathogens attached, and is performed and reverse, (v) brush clean the suction cylinder

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Table 1a. Reported ERCP Associated Infection Outbreaks Since 2002 in the United States # of Year Location Organism Cause Manufacturer Patients 200219 Illinois 5 MDR Pseudomonas aeruginosa N/A Not reported 201233 Pennsylvania 135 Carbapenem resistant Klebsiella N/A Olympus 2012-1311,24 Washington 32 AmpC-producing E. Coli N/A Olympus 201334 Illinois 39 NDM-producing N/A Pentax carbapenem-resistant E. Coli (CRE) 201335 Wisconsin 3 NDM producing E. Coli N/A Olympus 201431 Florida 9 Not reported Not reported Olympus 201436 California 7 CRE Not reported Olympus 201437 Connecticut 12 ESBL-producing Enterobacteriaceae N/A Olympus 201438 Massachusetts 28 Ceftriaxone resistant E. Coli N/A Not reported 201531 North Carolina 18 Carbapenem resistant enterococci N/A Olympus 201531 Pennsylvania 3 Carbapenem resident Klebsiella Improper drying; Fujifilm pneumoniae improper storage of duodenoscope 201531 Colorado 9 MDRO/ESBL E. Coli N/A Not reported 201531 Massachusetts 3 MDRO/ceftriaxone N/A Pentax resistant E. Coli 201739 Massachusetts 2 Mcr-1 positive Klebsiella Poor duodenoscope Not reported pneumoniae reprocessing “Distal cap defect” reported to endoscope connector, and reverse, (vi) brush flushing all channels and forceps elevator recess clean the suction cylinder, (vii) brush clean the with disinfectant solution using luer-lock/regular instrument channel port, (viii) aspirate detergent syringe; (iii) leave endoscope and accessories solution through the instrument channel and suction immersed in disinfectant solution for recommended channel, (ix) flush forceps elevator recess with contact time, temperature and concentration. detergent solution, (x) flush the air/water channel Rinsing includes extensive rinsing of the scope with detergent solution, (xi) immerse the endoscope and accessories, as well as using suction pump and accessories in detergent solution, (xii) remove to aspirate air through the instrument channel, detergent solution from all channels, (xiii) dry followed by alcohol flush (medical grade 70% ethyl external surfaces of the scope. Disinfectants for or 70% isopropyl alcohol) and then filtered with HLD (glutaraldehyde, orth-phthalaldehyde, per- air-drying. Alternately, units may use automated acetic acid) must have a broad range of activity endoscope reprocessor (AER), if available. If against microbes at a specific concentration. 5 drying is inadequate, the duodenoscope is at higher Glutaraldehyde is a less expensive choice; however risk of increased bacterial growth and biofilm with reported incidence of bacterial resistance.5 formation.5,6 The duodenoscope should be stored After deep cleaning, the next step is HLD, for a period that ranges from hours to 21 days which can be performed manually or through (exact time is not defined), but more importantly, AER.5 The steps of manual HLD include (i) it should be stored in a manner that shields it from immersing scope in high-level disinfectant after contamination, moisture, and damage.5 attaching channel plug and injection tube, (ii) Duodenoscopes are generally more susceptible

12 PRACTICAL GASTROENTEROLOGY • JULY 2020 Endoscope-Associated Infections (EAI): An Update and Future Directions FRONTIERS IN ENDOSCOPY, SERIES #64 to bacterial contamination because of their long augmented attention during reprocessing process. channels and sophisticated design (as discussed Duodenoscopes have a moveable unique lever/ below in detail), but effective cleaning has the elevator mechanism at the tip, which allows the potential to exponentially remove microbes and endoscopist to orient guidewire/instruments into debris (almost as high as 99.99%). Healthcare the visual field;1 however, this exclusive design workers who are directly involved in duodenoscope is poorly accessible with the standard cleaning reprocessing should have dedicated device brushes and makes the disinfecting process disinfection training, scheduled competency challenging. Duodenoscopes also have an elevator testing, and routine quality measure inspections wire channel and a long, braided wire connecting to ensure adherence with all current protocols and the “elevator mechanism” to the control. These manufacturer IFUs.3,5,7 In 2009, the CDC began an channels can be unsealed and are susceptible infection control audit during the inspection of 68 to bacterial colonization, and recently, been ambulatory surgical centers, and they had found implicated in some outbreaks.1 The water and that 28% of the surveyed centers lacked a uniform air channels of duodenoscopes, both with small protocol for duodenoscope reprocessing.3,5,7 diameter than standard endoscopes, are may also harbinger infection in case of inferior cleaning. III. DUODENOSCOPE-ASSOCIATED The design of linear array echoendoscopes (used INFECTION for therapeutic EUS), also is very similar to duodenoscope, with distal elevator mechanism, a. General Information and is prone to similar challenges with cleaning Most EAIs are detected through the outbreak and reprocessing (Figure 1). investigations,5 with at least 35 outbreaks reported Biofilms are polysaccharide matrices that between 2012 until 2015.1 The estimated incidence allow bacterial colonies to attach to surfaces, are of duodenoscope contamination ranges in literature a specific pathogen-associated risk factor. Biofilms from 0.3–30%.8-13 Attack rate for duodenoscope- protect bacterial colonies from drying and inhibit associated infections, defined as number of infected disinfectants and antibiotics.2,26-28 To eradicate or colonized cases over the number of exposed biofilms, mechanical and ultrasonic cleaning is an cases, has been estimated between 12-41%.14 effective method comparing to chemical cleaning. In a recent international endoscopic processing The current disinfection and reprocessing protocol survey, one-fifth of the 165 responding institutions has not been found to eradicate biofilms efficiently, from 39 countries testified at least one EAI which further complicates the issue of efficient outbreak, despite presence of standard operating reprocessing of duodenoscopes, and has been procedure for endoscope cleaning 82% facilities.15 attributed to recent reported outbreaks.2,29-30 Main contributors to EAI outbreaks have been thought to be breaches in reprocessing standards, b. Outbreaks use of unapproved disinfectants, poor endoscope In late 2013, Virginia Mason in Seattle, and maintenance, lack of microbiologic surveillance Advocate Lutheran in Chicago, independently and contaminated automated endoscope linked an outbreak of antibiotic-resistant infections reprocessors (AERs).14,16-24 Additional risk factors to use of duodenoscopes, which first brought to that specifically predispose duodenoscopes to attention this growing problem. This led to further infection include, but not limited to inadequate investigation by Senator Patty Murray (Ranking disinfection due to their sophisticated design/ member of the Senate Health, Education, Labor elevator mechanism and acquired damage with and Pensions Committee) who concluded that frequent instrumentation.2,4,25 Moreover, there are these incidents were not isolated, but recognized a few patient-centric risk factors which may also that between 2012-2015 at least 25 different contribute to duodenoscope-associated infections, incidents of antibiotic-resistant infections had including bile duct obstruction/infection and sickened at least 250 patients worldwide, and immunocompromised host status.2,4,25 implicated duodenoscopes made by all three major Intricate designs of duodenoscopes require manufacturers (Olympus, Fujifilm and Pentax).31

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Table 1b. Reported ERCP Associated Infection Outbreaks Since 2002 in the United States # of Year Location Organism Cause Manufacturer Patients 200540 Marseille, 1 Methylobacterium mesophilicum N/A Not reported France 200541 Lucknow, India 3 Pseudomonas aeruginosa Insufficient cleaning Not reported 200540 Groningen, 3 MDR Pseudomonas N/A Not reported Netherlands 2008-0917 Clemont- 16 ESBL Klebsiella Poor cleaning, Not reported Ferrand, France insufficient drying before storage 200942 Paris, France 13 KPC Klebsiella Insufficient drying Not reported 201043-44 Paris, France 13 Carbapenem resistant Klebsiella Delay in the pre- Not reported cleaning after usage, insufficient drying 201223 Rotterdam, 30 VIM2-producing pseudomonas Duodenoscope Olympus Netherlands obstructing proper cleaning of the elevator channel 2012-1345 Berlin, 12 Carbapenem-resistant Klebsiella N/A Olympus Germany 201546 Hangzhou, 3 MDR pseudomonas Failed cleaning and Olympus China disinfection 201747 Glasgow, 4 Salmonella enteritidis Poor adherence Olympus United to disinfection Kingdom protocols

In 2018, Rauwers et al. reported that 26 out of membranes and carry moderate infection risk2-3,49-50 73 Dutch ERCP centers (39%) had at least one and hence require high-level disinfection (HLD) contaminated duodenoscope, which was thought (all flexible endoscopes fall in this category). to be patient-ready, despite compliance with Critical instruments enter the sterile tissues, body reprocessing guideline and recommendations.32 cavities (peritoneum) and vasculature, and carry Table-1 is a comprehensive list of reported high risk for infection, and hence need detailed outbreaks, number of affected patients, the sterilization. cause (if determined) and the company of It is debatable if Spaulding classification is duodenoscope, both within the United States and dependable in the current era, when endoscopy outside.11,17,19,20,23,24,33-47 has shifted from a diagnostic to an interventional/ therapeutic procedure, with continued efforts to c. Spaulding Classification push the frontiers in pancreato-biliary system This classification, proposed in 1974, splits as well as the third space. Duodenoscopes are medical instruments into three different categories, typically classified as semi-critical instruments, based on the risk of infection.48 Non-critical but technically enters sterile portion of GI tract instruments come in contact with intact skin, (biliary system), and hence carries high risk of thus low infection risk, and hence require simple infection. FDA currently recommends intensive disinfection with water and possibly detergent cleaning and HLD for optimal disinfection, but one (stethoscopes, sphygmomanometers, etc.). Semi- could argue these require sterilization and would critical instruments come in contact with mucous not be wrong. The counter-arguments presented

14 PRACTICAL GASTROENTEROLOGY • JULY 2020 Endoscope-Associated Infections (EAI): An Update and Future Directions FRONTIERS IN ENDOSCOPY, SERIES #64 include sterilization being more time and resource difficult to eradicate even with HLD. Other consuming, and HLD is not clinically inferior to common microorganisms implicated in exogenous sterilization in preventing infections.51 However, infections are Mycobacteria, Helicobacter pylori, in the light of recent infection outbreaks, this field and Clostridium difficile.2 needs further investigation. e. Multi-drug Resistant Organism (MRDO) d. Microbiology of Duodenoscope-associated Infections: Infections: In addition, the recent outbreaks (as in Table-1) have been due to multi-drug resistant i. Endogenous Infections: organisms (MRDO), like multidrug resistant Endogenous infections involve intra-procedural Enterobacteriaceae infections, including Extended breach of mucosal barrier and subsequent infection Spectrum Beta- Lactamases/Carbapenem-resistant with gut’s flora52 and are most common of all Enterobacteriaceae (ESBL/CRE), despite strict infections associated with GI procedures. It is adherence of accepted standards of reprocessing well understood that therapeutic upper endoscopic and manufacturers’ IFUs. This is not only a procedures (viz. variceal ligation, esophageal significant healthcare concern, but also garnered dilation, or sclerotherapy) have significantly significant media attention, requiring urgent higher rates of infection, than general endoscopic attention by institutions.59-60 The mortality and procedures (EGD with biopsy/snare, colonoscopy morbidity from multi-drug resistant infection with biopsy/snare). ERCP also has significantly led to increased collaboration between device high infection related complications such as manufacturers, hospitals/health care centers, ascending cholangitis, cholecystitis, abscess, and and encouraged regulatory agencies to revisit bacteremia/sepsis.5,53-55 As endogenous infections duodenoscope reprocessing guidelines, mandate involve the gut’s flora, the underlying pathogens standards of reprocessing to be followed/reported by might differ depends on the examined area healthcare institutions and establish supplementary anatomical location, i.e. upper or lower GI tract recommendations (as discussed below). or biliary system. Most common pathogens in upper endoscopic procedures related infection are coagulase-negative Staphylococcus, Streptococcus; IV. EFFORTS TO DECREASE while Enterobacteriaceae, enterococci, and THE RISK OF INFECTION Streptococci are the most common pathogens in Since the outbreaks, in order to decrease infection lower GI procedures.5,56 The commonest organisms rate, the CDC and FDA have recommended increased implicated in ERCP include E. Coli, Klebsiella and reprocessing quality, with stringent adherence to Enterobacter.57 detailed reprocessing protocols. Duodenoscope reprocessing requires high compliance, along ii. Exogenous Infections: with knowledgeable and well-trained healthcare Exogenous infections are generally from workers, and lapses in attention or bypassing contamination (including EAIs) and should be steps in the processing must be curtailed. Rutala preventable with adequate disinfection strategies. and Weber reviewed most common attributors to As discussed above, insufficient pre-cleaning, increased risk of infection, which were incomplete manual/automated cleaning, and drying are well- cleaning or HLD, endoscopes internal damage, described potential missteps that lead to direct and flaws in automated endoscopic reprocessors/ transmission of microbial pathogens. Since the endoscopes.7 The authors also discussed advent of HLD, the exogenous most commonly unrecognized infections, which are attributed to implicated pathogen has changed from Salmonella inadequate surveillance due to long delay from to Pseudomonas.58 The reason for this is the colonization until infection.3,7 To overcome such high tendency of Pseudomonas aeruginosa to issues, FDA emphasizes on implementing a produce biofilms in moist environments (for quality control protocol at healthcare facilities, example, wet endoscopic channels); which are which encompasses a comprehensive list of written

PRACTICAL GASTROENTEROLOGY • JULY 2020 15 Endoscope-Associated Infections (EAI): An Update and Future Directions FRONTIERSNUTRITION ISSUES IN ENDOSCOPY, IN GASTROENTEROLOGY, SERIES #64 SERIES #174 documents of training, documents of adherence to cycles of HLD did not eradicate the bacteria guidelines, equipment tests, and quality measures that led to multiple outbreaks of duodenoscope- during reprocessing.2 associated infectious outbreaks.69 Notably, one The automated endoscope reprocessor (AER) specific prospective randomized study showed is FDA approved as an alternative for endoscope no significant differences in contamination rates disinfection, capable to remove proteins and between single HLD group, double HLD group, other bioburden efficiently. However, AERs are and single HLD followed by EtO sterilization susceptible to contamination and damage, which group.13 Considering the complex design and has been implicated in previous outbreaks also.2,61- 64 elevator mechanism of a duodenoscope, a universal Moreover, most AERs do not have adequately and improved reprocessing method is paramount high flushing pressure to adequately disinfect to reduce infection contamination. the elevator channel, hence manual reprocessing with 2-5 ml syringe is more reliable than AER. For b. Sterilization: these reasons, currently, the FDA advises using Sterilization of endoscopes can be performed AER only as a supplementary step to the current using gaseous (ethylene oxine, EtO) or liquid recommended manufacturer’s IFU, rather than a (per-acetic acid) sterilants. Gas sterilization with standalone reprocessing strategy. ethylene oxide (EtO) for reprocessing is performed In 2015, the FDA released four recommendations at low temperatures, however, due to its potential to supplement reprocessing protocols in order to flammability and possible carcinogenic risk to reduce contamination rates. These new supplements reprocessing personnel, EtO use has been limited include consideration of repeat HLD, sterilization in most facilities. Another major limitation of with ethylene oxide (EtO), liquid chemical sterilant, EtO sterilization is the long aeration time, which and culturing for surveillance.9-11,14, 65-68 Although increases scope downtime, and may become a major some of these studies demonstrated a reduction of financial burden for endoscopy units. Moreover, as contamination, but not a zero contamination rate, discussed above, EtO sterilization after single HLD even with double HLD. The flip sides of these steps has not shown to be any better than single HLD include increased cost and resources, and increased alone.13 In addition to Eto, other agents including scope downtime (thus need for purchase of more hydrogen peroxide and plasma-activated water scopes) and additionally exposure of toxic EtO to have been tried, and are under investigation.71,72 reprocessing personnel. On the other hand, liquid sterilant flushing of the endoscope is thought to potentially re-introducing a. Repeat HLD: microbes and hence not favored. For these reasons, HLD is believed to eradicate 105 bacteria in single sterilization of endoscopes is not a widely accepted processing, whereas endoscopes are usually practice. contaminated with 1010 bacteria.69 Theoretically, it would be expected that two consecutive HLD c. Microbiologic testing: cycles would effectively remove 99% of bacterial European and Australian societies for contamination, and this may have been the basis gastrointestinal endoscopy have favored use of FDA suggestion of two consecutive HLD cycles of routine culturing as a quality measure of a supplement to existing reprocessing protocols. duodenoscope reprocessing,73-74 and inspired FDA Many healthcare facilities readily adopted this in conjunction with CDC and American Society strategy, for the ease of implementation, minimal of Microbiology (ASM) to release standardized extra cost or financial burden, and acceptable protocols for duodenoscope culturing.75 However, increase in length of reprocessing time/scope this approach is not widely adopted across the downtime. However, there is little substantial United States due to several reasons, including the evidence to support the efficacy of 2 consecutive high cost associated with culturing process, unclear HLD cycles, and in areas without outbreaks, intervals at which culturing should be performed, there is little efficacy and utility for multiple and lack of adequate evidence of test performance 2,11,66,70 HLD cycles. More importantly, multiple (continued on page 18)

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(continued from page 16) Table 2. FDA recommendations for Hospitals and characteristics.75-76 Furthermore, a negative and Endoscopy Facilities culture result of duodenoscope does not eliminate 1. Consider using duodenoscopes with the possibility of infection, as there are cases in disposable components, if available (this which duodenoscopes outbreak occurred despite design may lower but not eliminate risks of negative cultures.19 infection). V. Future Directions in the Prevention of 2. Ensure staff meticulously follows Duodenoscope-associated Infections reprocessing instructions. 3. Institute quality control program including a) Augmented manufacturer accountability: sampling and microbial culturing, and other In the light of these duodenoscope-associated monitoring methods. infection outbreaks, the FDA claimed post-market 4. Consider reprocessing with supplemental surveillance studies on the manufacturer IFU by measures such as sterilization or use of all three major manufacturers, Fujifilm, Olympus, liquid chemical sterilant processing system. and Pentax, which they all initially failed to provide.77 In 2018, the interim results demonstrated 5. Monitor reprocessing procedures. contamination rates of up to 3% for high concern 6. Develop schedules for routine inspection organisms, which was higher than expected.78 and periodic maintenance in accordance Further sampling and culturing studies by these with manufacturer’s IFU. companies showed presence of high risk organisms including E. Coli and P. aeruginosa. The FDA then ordered these companies to conduct post-market b) Augmented endoscopy unit accountability: surveillance studies to evaluate if the staff could Since these MRDO outbreaks associated with understand and follow manufacturer’s IFU in real- duodenoscope use, FDA and CDC have put in place world healthcare settings (called human factors many regulations, all aimed at preventing risk of studies), which showed users often had difficulty infection transmission and minimizing the patient understanding and following IFU, and hence unable risk. These measures include identification of risk to successfully complete reprocessing.79 These factors responsible for infection transmission, data ultimately encouraged FDA to recommend maintaining adequate communication to mitigate measures supplemental to existing reprocessing such occurrences, making process of reprocessing protocols, and also led to development of several efficient and creating quality control measures, endoscopy unit quality checks, as discussed below. which can serve as check points. FDA also has recently raised concerns regarding FDA and CDC recommend recognizing patient the practice of semi-automatic renewal of market specific and endoscope specific risk factors, authorization of new endoscope models, without which can lead to infection transmission. In case additional analysis, if the new modified design of duodenoscope, as previously discussed in this of new endoscope was sufficiently similar to the manuscript, they pertain to its complex design previously approved designs.80 As an example, and distal tip elevator mechanism. In addition, prior to these outbreaks, Olympus introduced TJF- a duodenoscope may have internal channel Q180V with sealed elevator channel, as opposed damage, which may be independent of age of the to the previous model with exposed elevator wire scope but dependent on use frequency and user channel, but after the outbreaks linked to this model, characteristics, which may render it more difficult FDA suspected a possible safety compromise due to clean, and currently there are no guidelines to changed design, leading to worldwide recall of regarding endoscope durability/longevity and this model of duodenoscope.81 optimal inspection frequency, and these needs to be These instances encourage manufacturers focus of future research. Some endoscopy centers, to assume greater accountability in this overall hence, maintain an endoscope specific log file to mission of minimizing EAI transmission. keep a track of number of procedures done, repair

18 PRACTICAL GASTROENTEROLOGY • JULY 2020 Endoscope-Associated Infections (EAI): An Update and Future Directions FRONTIERS IN ENDOSCOPY, SERIES #64 history, report regarding their borescope channel examinations, and infection/culture results. FDA and CDC also recommend all endoscopy centers to maintain transparent communication between endoscopists, reprocessing personnel and medical devise and infection control experts as a core strategy to minimize EAIs. Appropriate reporting of any adverse events, in regards to infection control, which would include any infection outbreaks, device failures and reprocessing lapses, is paramount to minimize patient risk. If an outbreak is detected, then a detailed investigation of root- Figure 2. Single use disposable duodenoscope by cause analysis by experts, along with dismantling Boston Scientific (EXALT Model D) of alleged duodenoscope is advised. In addition, Image used with permission from Boston Scientific endoscopy centers are encouraged to maintain protocols regarding endoscopy/reprocessing staff corresponding negative cultures. This led authors education and examination on a periodic basis, as to propose re-education of endoscopy staff and 2 measures of quality control. cycles of cleaning and HLD to minimize the risk Refer to Table-2 for a comprehensive list of of transmission of infections by duodenoscopes. FDA recommendations for hospitals and endoscopy Barakat and Girotra then utilized ultrathin units. flexible inspection endoscope to inspect working channels of 68 endoscopes in their unit, and c) ATP bioluminescence as an alternative correlated to ATP bioluminescence values from to microbiologic surveillance and use of working channel rinsates.83 They noted superficial borescope: scratches (98.5%) and scratches with adherent Adenosine triphosphate (ATP) is present in peel (76.5%) and few small drops of fluid in microorganisms and human cells, and its detection 42.6% endoscopes after reprocessing and drying. in endoscope allows as a surrogate of bacteriologic/ The authors noted that presence of residual fluid biologic residue. A few recent studies from Stanford predicted higher ATP bioluminescence values, interventional group led by Subhas Banerjee and hence proposed periodic visual surveillance have explored the use of ATP bioluminescence of duodenoscope, using borescope, for working as a surrogate of microbiologic culturing. In channel damage (standard wear and tear/ study by Sethi et al., ATP bioluminescence was debris/water), and taking remedial actions on measured after pre-cleaning, manual cleaning, duodenoscope with extensive damage to achieve and HLD on rinsates from suction-biopsy additional benefits in overall infection reduction channels of all endoscopes and elevator channels strategy. Barakat et al. further demonstrated fewer of duodenoscopes/linear echoendoscopes.82 The water droplets and delayed ATP bioluminescence authors noted that ideal ATP bioluminescence values within endoscope working channels after benchmark of <200 relative light units (RLUs) automated drying compared with manual drying, after manual cleaning was achieved from suction- thus favoring automated drying to decrease risk of biopsy channel rinsates of all endoscopes, but 9 of infection transmission.84 The group also showed that 10 duodenoscope elevator channel rinsates failed use of medium/high concentrations of simethicone to meet this benchmark. Re-education reduced was associated with increased retention of fluid RLUs in duodenoscope elevator channel rinsates droplets and higher ATP bioluminescent values in after pre-cleaning (23,218.0 vs. 1340.5 RLUs, P < endoscope working channels, compared to when .01) and HLD (177.0 vs. 12.0 RLUs, P < .01).82 water or lower concentrations of simethicone was Also authors noted that after 2 cycles of manual used.85 The group hence proposed using lowest cleaning/HLD, duodenoscope elevator channel possible concentration of simethicone, if needed RLUs achieved levels similar to sterile water, with at all, and Facilities may consider 2 automated

PRACTICAL GASTROENTEROLOGY • JULY 2020 19 Endoscope-Associated Infections (EAI): An Update and Future Directions FRONTIERS IN ENDOSCOPY, SERIES #64 endoscope reprocessor cycles for reprocessing of with median overall endoscopist satisfaction of endoscopes when simethicone has been used. 9/10. Although this study supports performance characteristics of this single-use disposable d) Advances in duodenoscope design: duodenoscope, its wide adoption will depend on Lessons learnt from these outbreaks, which its cost effectiveness, which must take into account were clearly attributable to the complex design not only the face value of the procedure cost and of the distal tip of duodenoscope, especially the disposable equipment cost, but also balance it elevator mechanism, and particular difficulty in against several factors associated with reusable cleaning these, and persistence of infection despite duodenoscopes, including maintenance cost and reprocessing, served as fulcrum for research and reprocessing cost after each use. In addition, there development towards endoscope redesign, and will are several hidden costs which need to be taken open new frontiers in endoscopic research. What into consideration, including cost of managing started with introduction of single use parts of colonized/infected patients, associated litigation duodenoscope (disposable protection caps and air/ costs, and costs of remedial actions (discarding the water channel plugs)86 led to models with disposable infected duodenoscope away, downtime costs and or sterilizable forceps elevators.87 Till date, the cost of new duodenoscope, etc.). This is an area that FDA has cleared 5 duodenoscopes with disposable needs detailed studies, but is extremely promising. components that facilitate reprocessing, including Boston Scientific EXALT Model D single-use (fully VI. CONCLUSIONS disposable duodenoscope), Fujifilm ED-580XT In summary, the upsurge in EAIs, in particularly (disposable endcap duodenoscope), Olympus multi-drug resistant infections, noted in the Evis Exera III TJF-Q190V (disposable endcap last decade, despite adherence to reprocessing duodenoscope), Pentax ED34-i10T (disposable protocols, has not only directed worldwide endcap duodenoscope) and Pentax ED34-i10T2 attention to this issue but also led the FDA and (disposable elevator duodenoscope). 79 Disposable CDC to regularize several aspects at the ends of designs may reduce between-patient duodenoscope endoscope manufacturers and the endoscopy units. contamination by half as compared to reusable, or This also commanded potent research focused fixed endcaps, and are hence being advocated by at improving reprocessing protocols including the FDA. Other devices are also in development, increased automation to decrease human errors in including ScopeSeal (GI Scientific LLC, Arlington, reprocessing and introduction of checkpoints and VA), which is a single-use device cleared by surrogates to detect potential bacteriologic/biologic FDA for Olympus TJF-Q180V, which provides a residue in the duodenoscopes. This research is now sealed barrier for the distal end of duodenoscope, taking a direction towards advancements in design while maintaining the superior optical capability of duodenoscopes, including use of disposable and other performance attributes of reusable distal attachments to facilitate cleaning, and even duodenoscopes.88 introduction of fully disposable duodenoscopes. More recently, reusable single use duodenoscope These exciting advances instill a strong hope has been introduced by Boston Scientific amongst the endoscopy community that we will Corporation (Figure-2), which has garnered be able to put the issue of EAIs behind us and significant clinical attention and positive press.89 thereby minimize patient risk while provide high A clinical evaluation of single-use duodenoscope level endoscopic services was recently conducted at 6 academic medical centers and included ERCPs with a wide range References of complexity (ASGE complexity grade 1 = 7, 1. Rubin ZA, Murthy RK. Outbreaks associated with duodenoscopes: new 90 challenges and controversies. Curr Opin Infect Dis. 2016;29(4):407-414. grade 2 = 26, grade 3 = 26 and grade 4 = 1). 2. Rahman MR, Perisetti A, Coman R, Bansal P, Chhabra R, Goyal H. The results suggests that 96.7% (58/60) ERCPs Duodenoscope-Associated Infections: Update on an Emerging Problem. Dig Dis Sci. 2019;64(6):1409-1418. were successfully completed using single-use 3. Petersen BT, Cohen J, Hambrick RD 3rd, Buttar N, Greenwald DA, duodenoscope and another 3.3% (2/60) completed Buscaglia JM, et al. Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update. Gastrointest Endosc. 2017;85(2):282-294.e281. after crossover to reusable duodenoscopes, 4. Kovaleva J, Peters FT, van der Mei HC, Degener JE. Transmission of

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