Unveiling 8 years of duodenoscope contamination: insights from a retrospective analysis in a large tertiary care hospital.

OBJECTIVE: Contaminated duodenoscopes caused several hospital outbreaks. Despite efforts to reduce contamination rates, 15% of patient-ready duodenoscopes are still contaminated with gastrointestinal microorganisms. This study aimed to provide an overview of duodenoscope contamination over time, identify risk factors and study the effects of implemented interventions. DESIGN: Duodenoscope culture sets between March 2015 and June 2022 at a Dutch tertiary care centre were analysed. Contamination was defined as (1) the presence of microorganisms of oral or gastrointestinal origin (MGO) or (2) any other microorganism with ≥20 colony-forming units/20 mL (AM20). A logistic mixed effects model was used to identify risk factors and assess the effect of interventions, such as using duodenoscopes with disposable caps, replacing automated endoscope reprocessors (AER) and conducting audits in the endoscopy department. RESULTS: A total of 404 culture sets were analysed. The yearly contamination rate with MGO showed great variation, ranging from 14.3% to 47.5%. Contamination with AM20 increased up to 94.7% by 2022. For both MGO and AM20, the biopsy and suction channels were the most frequently contaminated duodenoscope components. The studied interventions, including audits, AER replacement and implementation of duodenoscopes with disposable caps, did not show a clear association with contamination rates. CONCLUSION: Duodenoscope contamination remains a significant problem, with high contamination rates despite several interventions. Reprocessing the biopsy and suction channels is especially challenging. Changes in the design of reusable duodenoscopes, such as enabling sterilisation or easily replaceable channels, are necessary to facilitate effective duodenoscope reprocessing and to eliminate the risk of duodenoscope-associated infections.

Initial experience with duodenoscopes with single-use end caps in pediatric ERCP: infection prevention comes at a cost.

BACKGROUND AND AIMS: Duodenoscopes with single-use end caps were introduced to minimize infection risk, but they are unstudied in pediatrics. METHODS: We collected clinical data and endoscopists' evaluations of duodenoscopes with single-use end caps versus reusable duodenoscopes over 18 months. RESULTS: A total of 106 ERCPs were performed for patients aged 1 to 18 (mean, 14.2) years. Forty-six involved single-use end caps, with 9 requiring crossover to reusable duodenoscopes. ERCPs involving single-use end caps resulted in more instances of mucosal trauma (10 vs 0; P < .05) and post-ERCP pancreatitis (4 vs 1; P < .05) and accounted for 8 of 9 ERCPs requiring advanced cannulation techniques. No post-ERCP infections occurred. Reported challenges included single-use end cap stiffness and difficulty with their alignment for cannulation. CONCLUSIONS: We report difficulty with advancement, greater reliance on advanced cannulation techniques, and higher rates of post-ERCP pancreatitis when using duodenoscopes with single-use end caps in pediatric ERCP. This area warrants further study.

Effect of a novel endoscope cleaning brush on duodenoscope contamination.

BACKGROUND: Current duodenoscope reprocessing protocols are insufficient to prevent contamination and require adaptations to prevent endoscopy-associated infections (EAIs). This study aimed to investigate the effect of a new endoscope cleaning brush on the contamination rate of ready-to-use duodenoscopes. METHODS: This retrospective before-and-after intervention study collected duodenoscope surveillance culture results from March 2018 to June 2022. Contamination was defined as ≥1 colony-forming unit of a microorganism of gut or oral origin (MGO). In December 2020, an endoscope cleaning brush with a sweeper design was introduced as an intervention in the manual cleaning of duodenoscopes. A logistic mixed-effects model was used to study the effects of this intervention. RESULTS: Data were collected from 176 culture sets before the new brush's introduction and 81 culture sets afterwards. Pre-introduction, culture sets positive with an MGO comprised 45.5% (95%CI 38.3%-52.8%; 80/176), decreasing to 17.3% (95%CI 10.6%-26.9%; 14/81) after implementation of the new brush. Compared with the former brush, duodenoscopes cleaned with the new brush had lower odds of contamination with MGOs (adjusted odds ratio 0.25, 95%CI 0.11-0.58; P=0.001) CONCLUSIONS: Use of the new brush in manual cleaning reduced contamination with MGOs and is expected to prevent EAIs. These findings should be confirmed in future prospective randomized studies.

Single-use accessories and endoscopes in the era of sustainability and climate change-A balancing act.

Gastrointestinal (GI) endoscopy is among the highest waste generator in healthcare facilities. The major reasons include production of large-volume non-renewable waste, use of single-use devices, and reprocessing or decontamination processes. Single-use endoscopic accessories have gradually replaced reusable devices over last two decades contributing to the rising impact of GI endoscopy on ecosystem. Several reports of infection outbreaks with reusable duodenoscopes raised concerns regarding the efficacy and adherence to standard disinfection protocols. Even the enhanced reprocessing techniques like double high-level disinfection have not been found to be the perfect ways for decontamination of duodenoscopes and therefore, paved the way for the development of single-use duodenoscopes. However, the use of single-use endoscopes is likely to amplify the net waste generated and carbon footprint of any endoscopy unit. Moreover, single-use devices challenge one of the major pillars of sustainability, that is, "reuse." In the era of climate change, a balanced approach is required taking into consideration patient safety as well as financial and environmental implications. The possible solutions to provide optimum care while addressing the impact on climate include selective use of disposable duodenoscopes and careful selection of accessories during a case. Other options include use of disposable endcaps and development of effective high-level disinfection techniques. The collaboration between the healthcare professionals and the manufacturers is paramount for the development of environmental friendly devices with low carbon footprint.

A Novel Dry Simulator Model for Learning Comprehensive Endoscopic Retrograde Cholangiopancreatography/Endoscopic Sphincterotomy Procedures while Minimizing Adverse Bleeding Events (with Video).

INTRODUCTION: Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic sphincterotomy (EST) are essential skills for performing endoscopic cholangiopancreatic procedures. However, these procedures have a high incidence of adverse events, and current training predominantly relies on patient-based approaches. Herein, we aimed to develop an ERCP/EST simulator model to address the need for safer training alternatives, especially for learners with limited ERCP experience. METHODS: The model was designed to facilitate the use of actual endoscopic devices, supporting learning objectives that align with the components of the validated Bethesda ERCP Skill Assessment Tool (BESAT). BESAT focuses on skills, such as papillary alignment, maintenance of duodenoscope position, gentle and efficient cannulation, controlled sphincterotomy in the correct trajectory, and guidewire manipulation. Thirty gastroenterology trainees used the simulator between May 2022 and March 2023, and their satisfaction was assessed using a visual analog scale (VAS) and pre- and post-training questionnaires. RESULTS: The novel simulator model comprised a disposable duodenal papillary section, suitable for incision with an electrosurgical knife, alongside washable upper gastrointestinal tract and bile duct sections for repeated use. The duodenal papillary section enabled reproduction of a realistic endoscope position and the adverse bleeding events due to improper incisions. The bile duct section allowed for the reproduction of fluoroscopic-like images, enabling learners to practice guidewire guidance and insertion of other devices. Following training, the median VAS score reflecting the expectation for model learning significantly increased from 69.5 (interquartile range [IQR]: 55.5-76.5) to 85.5 (IQR: 78.0-92.0) (p < 0.01). All participants expressed a desire for repeated simulator training sessions. CONCLUSIONS: This innovative simulator could serve as a practical educational tool, particularly beneficial for novices in ERCP. It could facilitate hands-on practice with actual devices, enhancing procedural fluency and understanding of precise incisions to minimize the risk of bleeding complications during EST.

Assessment of the Learning Curve for a Single-Use Disposable Duodenoscope.

BACKGROUND AND AIMS: In response to documented duodenoscope-related infectious outbreaks of multidrug-resistant organisms, the Food and Drug Administration has recommended a transition to duodenoscopes with innovative designs, including duodenoscopes with disposable components or fully disposable duodenoscopes. We aim to characterize the learning curve (LC) for a single-use disposable duodenoscope. METHODS: We performed a retrospective analysis of a prospectively collected database from 31 patients who underwent ERCP by a single, experienced operator using the EXALT Model D® (Boston Scientific, Marlborough) disposable duodenoscope at a single tertiary referral center. The LC for this device was described by the number of cases needed to achieve proficiency using cumulative sum (CUSUM) analysis. Number of attempts to cannulate and time to cannulate the desired duct were assessed as separate endpoints. The overall mean number of attempts and overall mean time to cannulation were used as the target values in the respective CUSUM analyses. Proficiency was defined as the number of procedures where an inflection point was reached in the CUSUM graph. This observation indicates improving operator performance as shown by a decrease in the number of attempts and shortening of cannulation time after the defined number of procedures. RESULTS: Overall, 31 patients underwent ERCP using the EXALT Model D disposable duodenoscope by a single experienced endoscopist. 6 (19%) patients had a native papilla and the majority of these procedures were classified as ASGE complexity level 2 or above. The procedure was completed using solely the disposable duodenoscope in 27 patients (87%), while a reusable duodenoscope was required for procedure completion in 4 patients (13%). The cross-overs were distributed evenly across the performance period. Procedure-related adverse events included: post-ERCP pancreatitis (3%), bleeding (3%) and no perforations. In the analyses of both endpoints, an inflection of the CUSUM curves is achieved at 10 cases, indicating sustained reduction of cannulation attempts and time to cannulation. CONCLUSION: Among experienced pancreaticobiliary endoscopists, approximately 10 ERCPs is the threshold whereby procedure-related factors including cannulation success and procedural time improves. Procedure-related adverse events are consistent with those expected with reusable duodenoscopes. The need to cross-over from single-use duodenoscope to reusable duodenoscope did not appear to be related to the learning curve, as they were evenly distributed across the study period. These results can be used to guide adoption of single-use duodenoscopes into clinical practice.

Advanced trainee perceptions of disposable duodenoscopes and disposable endcaps: results of a nationwide survey.

INTRODUCTION: Disposable duodenoscopes and duodenoscopes with disposable endcaps are being used in clinical practice to reduce or eliminate the risk of transmitting infections. The study aim was to assess perceptions and experiences regarding the use of these duodenoscopes among advanced endoscopy fellows in a nationally representative sample. METHODS: A 17-item electronic survey was sent to 74 advanced endoscopy training programs. The survey was completed by 50 participants and their responses were included for analysis. RESULTS: Most participants were from academic training programs (82.7%) and identified as being in their 7th year of post graduate training (92%; PGY-7). Participants performed an average of 414 ERCPs. 29% reported difficulty with cannulation using disposable duodenoscopes versus 15.7% with duodenoscopes with disposable endcaps (vs. standard duodenoscope). 96% of trainees perceived disposable duodenoscopes as not cost effective and 92% stated they would not use this device during independent practice. 100% of trainees stated that they would use duodenoscopes with disposable endcaps during independent practice. For their most challenging cases, 90% of trainees preferred using standard reprocessable duodenoscopes while no trainee indicated they would prefer using a disposable duodenoscope in this scenario. 82% of participants stated that disposable duodenoscopes and disposable endcaps should be used exclusively or preferentially for high-risk patients citing cost, functionality, and concerns regarding environmental impact. DISCUSSION: Advanced endoscopy fellows perceive disposable duodenoscopes as impacting technical maneuverability. Concerns about functionality, cost effectiveness and environmental impact are barriers to adoption.

The 90% effective dose (ED90) of remimazolam for inhibiting responses to the insertion of a duodenoscope during ERCP.

BACKGROUND: Compared to midazolam, remimazolam has a faster onset and offset of hypnotic effect, as well as cardiorespiratory stability, this study aims to determine the 90% effective dose (ED90) of remimazolam to inhibit responses to insertion of a duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP). METHODS: A dose-response study was carried out undergoing ERCP who received remimazolam-alfentanil anesthesia using 10 µg/kg of alfentanil between September 2021 and November 2021. The initial dose of remimazolam was 0.2 mg/kg. The dose was then decided based on the responses of earlier patients by exploiting the sequential ascend and descend according to a 9: 1 biased coin design. Upon failure, the dose of remimazolam was increased by 0.025 mg/kg in the next patient. When the insertion was successful, the succeeding patient was randomized to an identical dose or a dose that was lower by 0.025 mg/kg.The ED90 of remimazolam for inhibiting responses to the insertion of a duodenoscope during ERCP was calculated. Adverse events and complications of remimazolam were recorded. RESULTS: A total of 55 elderly patients (age > 65) were included in the study. 45 successfully anesthetized patients, and 10 unsuccessfully. The ED90 of remimazolam was 0.300 mg/kg (95% CI = 0.287-0.320). ED95 was 0.315 (95% CI = 0.312-0.323) and ED99 was 0.323 (95% CI = 0.323-0.325). Among the patients, 9 patients developed hypotension, 2 patients developed bradycardia and 1 patient developed tachycardia, and hypoxia occurred in 2 patients. CONCLUSIONS: A loading dose of 0.300 mg / kg of remimazolam for elderly patients undergoing ERCP can safely, effectively, and quickly induce patients to fall asleep and inhibit responses to the insertion of a duodenoscope. TRIAL REGISTRATION: The study protocol was registered at the website ClinicalTrials.gov on 22/09/2021(NCT05053763).

A therapeutic ERCP in an only 5.9 kg infant with obstruction jaundice using JF-260V duodenoscope.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) has found extensive use in pediatric patients; however, challenges persist in the application of therapeutic ERCP in infants. CASE PRESENTATION: This case report details the presentation of a 5.9-kilogram infant with obstructive jaundice and suspected hemolytic anemia who underwent ERCP to alleviate biliary obstruction. The infant was admitted due to clay-colored stools, jaundice, and liver injury. Ultrasound and magnetic resonance cholangiopancreatography (MRCP) revealed dilation of the common bile duct (CBD) accompanied by the presence of stones. ERCP was conducted using a JF-260V duodenoscope under general anesthesia. Successful stone extraction and biliary drainage were achieved. CONCLUSIONS: In centers with considerable expertise in ERCP and pediatric anesthesia, the use of a conventional adult duodenoscope for therapeutic ERCP in infants can be considered safe and feasible, provided careful and stringent patient selection criteria are applied. In the future, clear guidelines and standardized protocols for the indications and procedures of pediatric ERCP should be established.

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.

Efficacy of cap-assisted endoscopy for the visualization of the major duodenal papilla: a systematic review and meta-analysis.

BACKGROUND AND AIMS: The current standard of practice is to use a duodenoscope for the evaluation of the major duodenal papilla (MDP). Recently, cap-assisted endoscopy (CAE), which uses a transparent cap at the tip of a standard front-viewing endoscope, has emerged as an alternative. METHODS: A systematic literature search was performed in several databases from inception to January 2023 to identify studies evaluating the efficacy of CAE for the evaluation of the MDP. RESULTS: Nine studies including 806 patients met our inclusion criteria. The pooled rate of technical success for CAE was 93.2% (95% confidence interval, 85.6-96.9; I2 = 84.6%). A subgroup analysis comparing CAE with a standard endoscope showed higher odds for the evaluation of the MDP with CAE (but not a duodenoscope, which was better than CAE) with an odds ratio of 57.294 (95% confidence interval, 17.767-184.755; I2 = 45.303%). CONCLUSIONS: CAE offers a significant advantage with high rates of complete MDP evaluation compared with standard forward-viewing endoscopy. However, CAE is associated with lower rates of success when compared with side-viewing endoscopes.

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.

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.

The management of endoscopic retrograde cholangio- pancreatography-related infections risk: results of an italian survey at regional level.

Background and aim: Among the Endoscopic retrograde cholangiopancreatography (ERCP) adverse events, an increasingly arising problem is the transmission of Multi Drug Resistant (MDR) Bacteria through duodenoscopes. The aim of this survey was to evaluate the current clinical practice of management of ERCP associated infections in Emilia-Romagna, Italy. Methods: An online survey was developed including 12 questions on management of ERCP associated infections risk. The survey was proposed to all 12 endoscopy centers in Emilia Romagna that perform at least > 200 ERCPs per year. Results: 11 centers completed the survey (92%). Among all risk factors of ERCP infections, hospitalization in intensive care units, immunosuppressant therapies, and previous MDR infections have achieved a 80 % minimum of concurrence by our respondents. The majority of them did not have a formalized document in their hospital describing categories and risk factors helpful in the detection of patients undergoing ERCP with an high-level infective risk (9/11, 82%). Most centers (8/11, 72%) do not perform screening in patients at risk of ERCP infections. Post procedural monitoring is performed by 6 of 11 centers (55%). Conclusion: Our survey showed that, at least at regional level, there is a lack of procedures and protocols related to the management of patients at risk of ERCP infections.

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.

Bacterial contamination and organic residue after reprocessing in duodenoscopes with disposable distal caps compared with duodenoscopes with fixed distal caps: a randomized trial.

BACKGROUND AND AIMS: Newly designed duodenoscopes with disposable distal caps have been developed for better cleaning and preprocessing to reduce the risk of bacterial contamination (BC). We compared BC and organic residue of duodenoscopes with disposable distal caps and duodenoscopes with fixed distal caps after manual cleaning and high-level disinfection (HLD). METHODS: Four hundred duodenoscopes were randomized into group A (fixed distal caps, n = 200) and group B (disposable distal caps, n = 200). After manual cleaning, samples from the elevator were submitted for culture. An adenosine triphosphate (ATP) test was performed for organic residue evaluation. Based on our previous data, ATP < 40 relative light units (RLUs) had 100% sensitivity with 100% negative predictive value to confirm no BC after reprocessing. RESULTS: After manual cleaning, group A had a higher BC rate (14% vs 7%, P = .02), a higher proportion of duodenoscopes with ATP ≥ 40 RLUs (73.5% vs 57%, P = .001), and a higher mean of ATP level (226.6 vs 82.0 RLUs, P < .001) compared with group B. After HLD, the proportion of potential BC (ATP ≥ 40 RLUs) in group A was 2.7 times higher than group B (4% vs 1.5%, P = .13). Mean ATP level after HLD in the 2 groups was significantly lower than before the HLD procedure (group A, 24.2 vs 226.6 RLUs [P < .001]; group B, 20.4 vs 82.0 RLUs [P < .001], respectively). CONCLUSIONS: After manual cleaning, duodenoscopes with disposable distal caps had significantly lower BC and organic residue than duodenoscopes with fixed distal caps. Only a few duodenoscopes from each group did not pass the ATP threshold after HLD.

Environmental and health outcomes of single-use versus reusable duodenoscopes.

BACKGROUND AND AIMS: The large-scale effects of duodenoscopes on the environment and public health have not been quantified. Our aim was to perform an exploratory life cycle assessment comparing environmental and human health effects of single-use duodenoscopes (SDs) and reusable duodenoscopes (RDs). METHODS: We evaluated 3 duodenoscopes: conventional RDs, RDs with disposable endcaps, and SDs. The primary outcomes were impacts on climate change and human health, complemented by multiple environmental impacts. RESULTS: Performing ERCP with SDs releases between 36.3 and 71.5 kg of CO2 equivalent, which is 24 to 47 times greater than using an RD (1.53 kg CO2) or an RD with disposable endcaps (1.54 kg CO2). Most of the impact of SDs comes from its manufacturing, which accounts for 91% to 96% of its greenhouse gas emission. The human health impact of RDs becomes comparable with the SD lower bound if disposable endcaps or other design modifications can reduce serious infection rates below a target rate of 23 cases per year (.0046%). CONCLUSIONS: Although SDs may provide incremental public health benefit compared with RDs, it comes at a substantially higher cost to the environment. As infection rates continue to decrease from more regimented cleaning protocols and enhanced designs such as disposable endcaps to facilitate cleaning, the negative impact to human health from contaminated RDs could be comparable with SDs.

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.

Assessment of postmanual cleaning adenosine triphosphate tests to prevent the use of contaminated duodenoscopes and linear echoendoscopes: the DETECT study.

BACKGROUND AND AIMS: We investigated whether the use of postmanual cleaning adenosine triphosphate (ATP) tests lowers the number of duodenoscopes and linear echoendoscopes (DLEs) contaminated with gut flora. METHODS: In this single-center before-and-after study, DLEs were ATP tested after cleaning. During the control period, participants were blinded to ATP results: ATP-positive DLEs were not recleaned. During the intervention period, ATP-positive DLEs were recleaned. DLEs underwent microbiologic sampling after high-level disinfection (HLD) with participants blinded to culture results. RESULTS: Using 15 endoscopes of 5 different DLE types, we included 909 procedures (52% duodenoscopes, 48% linear echoendoscopes). During the intervention period, the absolute rate of contamination with gut flora was higher (16% vs 21%). The main analysis showed that contamination was less likely to occur in the intervention period (odds ratio, .32; 95% credible interval [CI], .12-.85). A secondary analysis showed that this effect was based on 1 particular duodenoscope type (estimated probability, 39% [95% CI, 18%-64%] vs 9% [95% CI, 2%-21%]), whereas no effect was seen in the other 4 DLE types. In detail, of the 4 duodenoscopes of this type, 2 had lower contamination rates (69% vs 39% and 36% vs 10%). During the control period, both these duodenoscopes had multiple episodes with ongoing contamination with the same microorganism that ended weeks before the start of the intervention period (ie, they were not terminated by ATP testing). CONCLUSIONS: Postmanual cleaning ATP tests do not reduce post-HLD gut flora contamination rates of DLEs. Hence, postcleaning ATP tests are not suited as a means for quality control of endoscope reprocessing.

Risk evaluation of duodenoscope-associated infections in the Netherlands calls for a heightened awareness of device-related infections: a systematic review.

BACKGROUND: The risk of exogenous infections from endoscopic procedures is often cited as almost negligible (1 infection in 1.8 million procedures); however, this risk is based on older literature and does not seem to match the number of infectious outbreaks due to contaminated duodenoscopes reported after endoscopic retrograde cholangiopancreatography (ERCP). Using Dutch data, we aimed to estimate the minimum risk of duodenoscope-associated infection (DAI) and colonization (DAC) in patients undergoing ERCP. METHODS: A systematic literature search identified all DAI outbreaks in the Netherlands reported between 2008 and 2019. Included cases were confirmed by molecular matching of patient and duodenoscope cultures. Risk ratios were calculated based on the total number of ERCPs performed during the study period. RESULTS: Three outbreaks were reported and published between 2008 and 2018, including 21 confirmed DAI cases and 52 confirmed DAC cases. The estimated number of ERCPs performed during the same period was 181 209-227 006. The calculated minimum estimated DAI risk was approximately 0.01 % and the minimum estimated DAC risk was 0.023 %-0.029 %. CONCLUSIONS: The estimated risk of DAI in Dutch ERCP practice was at least 180 times higher than previously published risk estimates. The actual risk is likely to be (much) higher due to underreporting of infections caused by multidrug-resistant organisms and sensitive bacteria. Greater awareness by healthcare personnel involved in endoscopy and endoscope cleaning is required, as well as innovative technical solutions to contain and ultimately eliminate DAIs.