The outcomes and safety of patients undergoing endoscopic retrograde cholangiopancreatography combining a single-use cholangioscope and a single-use duodenoscope: A multicenter retrospective international study.

BACKGROUND: Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography (ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy. METHODS: This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score (1 to 10) on performance rating of the single-use duodenoscope, and adverse event (AE) rate. RESULTS: A total of 66 patients (26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47 (71.2%) grade 3 and 19 (28.8%) grade 4. The technical success rate was 98.5% (65/66). Procedural duration was 64 (interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66 (1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3 points. Four patients (6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis (PEP), 1 cholangitis and 1 bleeding. CONCLUSIONS: Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.

Global prospective case series of ERCPs using a single-use duodenoscope.

BACKGROUND: The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. METHODS: 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). RESULTS: Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis. CONCLUSIONS: In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.

Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial.

Importance: Infection transmission following endoscopic retrograde cholangiopancreatography (ERCP) can occur due to persistent contamination of duodenoscopes despite high-level disinfection to completely eliminate microorganisms on the instrument. Objective: To determine (1) contamination rates after high-level disinfection and (2) technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs. Design, Setting, and Participants: In this parallel-arm multicenter randomized clinical trial at 2 tertiary ERCP centers in Canada, all patients 18 years and older and undergoing ERCP for any indication were eligible. Intervention: The intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design. Main Outcomes and Measures: Coprimary outcomes were persistent microbial contamination of the duodenoscope elevator or channel, defined as growth of at least 10 colony-forming units of any organism or any growth of gram-negative bacteria following high-level disinfection (superiority outcome), and technical success of ERCP according to a priori criteria (noninferiority outcome with an a priori noninferiority margin of 7%), assessed by blinded reviewers. Results: From December 2019 to February 2022, 518 patients were enrolled (259 disposable elevator cap duodenoscopes, 259 standard duodenoscopes). Patients had a mean (SD) age of 60.7 (17.0) years and 258 (49.8%) were female. No significant differences were observed between study groups, including in ERCP difficulty. Persistent microbial contamination was detected in 11.2% (24 of 214) of standard duodenoscopes and 3.8% (8 of 208) of disposable elevator cap duodenoscopes (P = .004), corresponding to a relative risk of 0.34 (95% CI, 0.16-0.75) and number needed to treat of 13.6 (95% CI, 8.1-42.7) to avoid persistent contamination. Technical success using the disposable cap scope was noninferior to that of the standard scope (94.6% vs 90.7%, P = .13). There were no differences between study groups in adverse events and other secondary outcomes. Conclusions and Relevance: In this randomized clinical trial, disposable elevator cap duodenoscopes exhibited reduced contamination following high-level disinfection compared with standard scope designs, without affecting the technical performance and safety of ERCP. Trial Registration: ClinicalTrials.gov Identifier: NCT04040504.

Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study.

INTRODUCTION: Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States. METHODS: We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected. RESULTS: A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs. CONCLUSIONS: The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.

Analysis of reported adverse events related to single-use duodenoscopes and duodenoscopes with detachable endcaps.

BACKGROUND AND AIMS: Single-use duodenoscopes and duodenoscopes with detachable/disposable caps emerged in the market to mitigate the risk of ERCP-related infections. We aimed to investigate adverse events associated with these devices occurring after U.S. Food and Drug Administration (FDA) approval. METHODS: We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from July 2018 to June 2021. RESULTS: One hundred eighty-five reports comprising 201 device issues and 118 patient adverse events were identified from July 2018 through June 2021. Most device issues related to the single-use duodenoscope were due to optical problems (7 reports). Other reported device issues included difficulty in advancing the duodenoscope (2 reports), fluid leak (2 reports), and use-of-device problems (2 reports). Among the duodenoscopes with detachable/disposable caps, most device issues were related to bacterial contamination (53 reports), followed by issues with device use (31 reports), detachment/separation of the device (25 reports), and crack/dent in device material (16 reports). Overall, the most frequently reported patient adverse events were tissue injury (63 reports), perforation (8 reports), and bleeding (7 reports). Ninety reports of microbial contamination of duodenoscopes with detachable/disposable caps were identified, of which Pseudomonas aeruginosa was most common. CONCLUSIONS: Findings from the MAUDE database highlight patient and device adverse events that endoscopists should be aware of in using single-use duodenoscopes and duodenoscopes with detachable/disposable caps. Whereas these devices mitigate the risk of transmitting infection, they are associated with additional device-associated adverse events.

Cost utility analysis of strategies for minimizing risk of duodenoscope-related infections.

BACKGROUND AND AIMS: Transmission of multidrug-resistant organisms by duodenoscopes during ERCP is problematical. The U.S. Food and Drug Administration recently recommended transitioning away from reusable fixed-endcap duodenoscopes to those with innovative device designs that make reprocessing easier, more effective, or unnecessary. Partially disposable (PD) duodenoscopes with disposable endcaps and fully disposable (FD) duodenoscopes are now available. We assessed the relative cost of approaches to minimizing infection transmission, taking into account duodenoscope-transmitted infection cost. METHODS: We developed a Monte Carlo analysis model in R (R Foundation for Statistical Computing, Vienna, Austria) with a multistate trial framework to assess the cost utility of various approaches: single high-level disinfection (HLD), double HLD, ethylene oxide (EtO) sterilization, culture and hold, PD duodenoscopes, and FD duodenoscopes. We simulated quality-adjusted life years (QALYs) lost by duodenoscope-transmitted infection and factored this into the average cost for each approach. RESULTS: At infection transmission rates <1%, PD duodenoscopes were most favorable from a cost utility standpoint in our base model. The FD duodenoscope minimizes the potential for infection transmission and is more favorable from a cost utility standpoint than use of reprocessable duodenoscopes after single or double HLD at all infection rates, EtO sterilization for infection rates >.32%, and culture and hold for infection rates >.56%. Accounting for alternate scenarios of variation in hospital volume, QALY value, post-ERCP lifespan, and environmental cost shifted cost utility profiles. CONCLUSIONS: Our model indicates that PD duodenoscopes represent the most favorable option from a cost utility standpoint for ERCP, with anticipated very low infection transmission rates and a low-cost disposable element. These data underscore the importance of cost calculations that account for the potential for infection transmission and associated patient morbidity/mortality.

Investigation of possible transmission of a susceptible microorganism through a contaminated duodenoscope; a case report.

BACKGROUND: Despite compliance to extensive reprocessing protocols, duodenoscopes have been linked to outbreaks of susceptible and multi-drug resistant organisms (MDRO) due to persistent duodenoscope contamination. Duodenoscope-associated infections (DAIs) based on transmission of susceptible microorganisms are likely to be underreported due to detection bias. CASE PRESENTATION: We describe the retrospective detection of a DAI case caused by a susceptible microorganism which at the time of clinical infection was not recognized as such. During 2017 and 2018, duodenoscopes were cultured on a daily basis due to research activities. While analyzing this data, it was found that a duodenoscope had been contaminated with Enterobacter cloacae complex over a period of 3 months. We checked whether patients treated with this duodenoscope had developed infections and found one patient with an E. cloacae cholangitis 3 months after the ERCP (Endoscopic retrograde cholangiopancreaticography) procedure. The isolates on the duodenoscope and in the patients' blood culture were indistinguishable by amplified fragment length polymorphism (AFLP). By classical multi-locus sequence typing (MLST), both strains were of the same (but novel) sequence type. Application of whole genome MLST showed 93 (out of 3757) allelic differences. CONCLUSION: This case report describes a plausible link between a contaminated duodenoscope and a patient infection with E. cloacae. Transmission of susceptible E. cloacae was highly suspected from AFLP and MLST results; by WGS, 93 allelic differences were found which proves closely related strains. This report shows that DAIs by susceptible microorganisms can be easily missed and therefore its true prevalence remains underscored.

Device profile of the EXALT Model D single-use duodenoscope for endoscopic retrograde cholangiopancreatography: overview of its safety and efficacy.

Introduction: The management of pancreaticobiliary disorders relies heavily on endoscopic retrograde cholangiopancreatography, which is performed with a duodenoscope. Bacterial colonization of reusable duodenoscopes leading to subsequent infectious outbreaks is well recognized and remains an issue despite efforts to optimize best practices in high-level disinfection. The EXALT Model D duodenoscope (EXALT) (Boston Scientific Corporation, Marlborough, MA) is a single-use device, designed to achieve technical equivalency with reusable devices while eliminating the potential for device-related outbreaks.Areas covered: This review covers the challenges associated with reprocessing duodenoscopes and the development of duodenoscope-related infections, with an emphasis on the use of single-use duodenoscopes as a potential solution to this issue.Expert Opinion: Duodenoscope-related infections are an increasingly recognized problem. Infectious outbreaks harm patients, significantly affect providers and medical centers, and can erode patient trust in the health-care system. Single-use duodenoscopes eliminate both the risk of device-related infection transmission and the need for burdensome duodenoscope reprocessing. In clinical evaluations, the EXALT device has demonstrated an equivalent technical performance and provider satisfaction compared to reusable duodenoscopes. Increasing use of this device will clarify how it compares to reusable duodenoscopes in a variety of clinical settings among endoscopists of varying skills levels.

Duodenoscope as a Vector for Transmission.

Elevator-based endoscope-related infections from patient cross-contamination is a multifactorial problem related to device design, maintenance, and function, with additional risk incurred from a high-level disinfection process that lacks quality controls. This article reviews the historical context for these outbreaks, technical aspects of scope design contributing to this risk, and innovations in endoscope technology that have the potential to overcome these shortcomings. Also reviewed are interim solutions and the data that support use of some of these interventions. Still needed are a validated manufacturer-recommended schedule for routine duodenoscope and echoendoscope maintenance with reprocessing protocols that can be implemented in endoscopy units.

Methods for Endoscope Reprocessing.

Over the past 2 decades, in hospital centers worldwide, there have been numerous outbreaks of multidrug-resistant organisms that have since been attributed to endoscopic transmission of the infections between patients, primarily from duodenoscopes. These outbreaks have focused the attention of endoscope manufacturers, professional societies, and regulatory agencies on improving the reprocessing of these devices. The key steps in this process are point-of-use precleaning, leak testing, manual cleaning, high-level disinfection, and finally drying and storage. The promise of these initial efforts suggest that the aim of minimizing and ultimately eliminating events of endoscope-/duodenoscope-associated transmission of infectious organisms between patients can be achieved.

Novel Algorithms for Reprocessing, Drying and Storing Endoscopes.

After outbreaks of duodenoscope-transmitted infection with multidrug-resistant organisms, it has become clear that institutions must optimize their endoscope reprocessing programs. Standard endoscope reprocessing practices may not represent the ideal approach for preventing transmission of infection related to endoscopy. We discuss multiple approaches to enhance and optimize reprocessing, drying, and storage of standard duodenoscopes. The optimal enhanced duodenoscope reprocessing modality remains to be determined. Acknowledging the challenges and limitations in effectively reprocessing duodenoscopes, the FDA issued a safety communiqué recommending transitioning to either single use disposable duodenoscopes or duodenoscopes with innovative designs that allow more effective reprocessing.

Recent Actions by the US Food and Drug Administration: Reducing the Risk of Infection from Reprocessed Duodenoscopes.

In addition to technological advancements, engagement and collaboration among the wider community of stakeholders will be beneficial toward reducing the risk of infection from reprocessed duodenoscopes. Such a community can raise awareness of the importance of duodenoscope cleaning, work to improve reprocessing training, identify the most pressing unanswered questions that merit further research, and develop tools that can be used by health care facilities to improve the quality of reprocessing at their sites. The Food and Drug Administration looks forward to working with the community to further reduce the risk of infections from reprocessed duodenoscopes.

Society Guidelines-Where Is the Consensus?

With reports of ongoing duodenoscope contamination and pathogen transmission despite strict adherence to manufacturer reprocessing instructions, professional societies continue to release updated recommendations. Despite general guideline similarities, there are differences. Although adherence to guidelines does not entirely eliminate pathogen contamination or transmission, it is critical to strictly adhere to updated guidelines for maximum risk reduction. In the United States, the Food and Drug Administration and Centers for Disease Control and Prevention continue to offer updates regarding improved duodenoscope reprocessing techniques and endoscope design. This article critically analyzes currently available national and international duodenoscope reprocessing guidelines.

Duodenoscope-associated infections: a review.

Flexible digestive endoscopes are used for the management of various conditions with hundreds of thousands of therapeutic procedures performed worldwide each year. Duodenoscopes are indispensable tools for the delivery of minimally invasive vital care of numerous pancreaticobiliary disorders. Despite the fact that nosocomial infections after endoscopic retrograde cholangiopancreatography (ERCP) have always been among the most frequently cited postprocedural complications, recent emergence of duodenoscope-transmitted multiple drug-resistant bacterial infections has led to intense research and debate yet with no clearly delineated solution. Duodenoscope-transmitted nosocomial infections have become one of the most visible topics in the recent literature. Hundreds of high-impact articles have therefore been published in the last decade. This review article discusses how such infections were seen in the past and what is the current situation in both research and practice and thus tries to solve some of the unanswered questions for the future. With the persistence of nosocomial infections despite strict adherence to both manufacturer-issued reprocessing protocols and international guidelines and regulations, an urgent and proper microbiologically driven common action is needed for controlling such nosocomial worldwide threat.

Duodenoscope-Associated Infections beyond the Elevator Channel: Alternative Causes for Difficult Reprocessing.

OBJECTIVES: Duodenoscopes have been widely used for both diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP) procedures, but recently, numerous outbreaks of multidrug-resistant organisms (MDRO) infections have been reported which has led to extensive research for their possible causes. Consequently, the aim of this study is to search for possible duodenoscope surface damages that could provide an alternative and plausible source of infections. MATERIALS AND METHODS: In order to assess both outer and inner surfaces, a duodenoscope was dismantled and samples were taken from the outer resin polymer and from the air/water, elevator, and working (biopsy) channels that were characterized by FTIR, DSC, TGA, AFM, SEM techniques and the antimicrobial activity were tested. RESULTS: Alterations were noticed on both the coating and working channel polymers, with external alterations increasing progressively from the proximal sample to the distal sample near the tip of the scope. However, the results showed that the coating surface was still efficient against bacterial adhesion. Changes in surface texture and also morphological changes were shown. CONCLUSIONS: The study describes the impact of routine procedural use and reprocessing cycles on the duodenoscope, showing that these may possibly make it susceptible to bacterial contamination and MDRO biofilm formation due to difficult reprocessing of the altered surfaces.

Independent root-cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to investigate an outbreak of multidrug-resistant Klebsiella pneumoniae.

BACKGROUND AND AIMS: Worldwide, an increasing number of duodenoscope-associated outbreaks are reported. The high prevalence rate of contaminated duodenoscopes puts patients undergoing ERCP at risk of exogenous transmission of microorganisms. The contributing factors of the duodenoscope design to contamination are not well understood. This article reports on the investigation after the outbreak of a multidrug-resistant Klebsiella pneumoniae (MRKP) related to 2 Olympus TJF-Q180V duodenoscopes. METHODS: We conducted a contact patient screening and microbiologic laboratory database search. Reprocessing procedures were audited, and both duodenoscopes were fully dismantled to evaluate all potential contamination factors. Outcomes were reviewed by an experienced independent expert. RESULTS: In total, 102 patients who had undergone an ERCP procedure from January to August 2015 were invited for screening. Cultures were available of 81 patients, yielding 27 MRKP-infected or -colonized patients. Ten patients developed an MRKP-related active infection. The 2 duodenoscopes had attack rates (the number of infected or colonized cases/number of exposed persons) of 35% (17/49) and 29% (7/24), respectively. Identical MRKP isolates were cultured from channel flushes of both duodenoscopes. The review revealed 4 major abnormalities: miscommunication about reprocessing, undetected damaged parts, inadequate repair of duodenoscope damage, and duodenoscope design abnormalities, including the forceps elevator, elevator lever, and instrumentation port sealing. CONCLUSIONS: Outbreaks are associated with a combination of factors, including duodenoscope design issues, repair issues, improper cleaning, and systemic monitoring of contamination. To eliminate future duodenoscope-associated infections, a multipronged approach is required, including clear communication by all parties involved, a reliable servicing market, stringent surveillance measures, and eventually new duodenoscope designs and reprocessing procedures with a larger margin of safety.