Query: duodenoscope

title: Infection control in ERCP using a duodenoscope with a disposable cap (ICECAP) rationale for and design of a randomized controlled trial
abstract: Endoscopic retrograde cholangio pancreatography (ERCP) is commonly performed in the management of pancreatic and biliary disease. Duodenoscopes are specialized endoscopes used to perform ERCP, and inherent to their design, a high rate of persistent bacterial contamination exists even after automated reprocessing and disinfection. Consequently, in recent years, ERCP has been associated with infection transmission, leading to several fatal patient outbreaks. Due to increasing fears over widespread future duodenoscope related outbreaks, regulatory bodies have called for alterations in the design of duodenoscopes. A duodenoscope has recently been developed that employs a disposable cap. This novel design theoretically eliminates the mechanism behind persistent bacterial contamination and infection transmission. However, there are no data demonstrating persistent bacterial contamination rates, technical success rates, or clinical outcomes associated with these duodenoscopes.  A parallel arm randomized controlled trial will be performed for which 520 patients will be recruited. The study population will consist of consecutive patients undergoing ERCP procedures for any indication at a high volume tertiary care centre in Calgary, Alberta, Canada. Patients will be randomized to an intervention group, that will undergo ERCP with a novel duodenoscope with disposable cap, or to a control group who will undergo ERCP with a traditional duodenoscope. Co primary outcomes will include persistent bacterial contamination rates (post automated reprocessing) and ERCP technical success rates. Secondary outcomes include clinical success rates, overall and specific early and late adverse event rates, 30 day mortality and healthcare utilization rates, procedure and reprocessing times, and ease of device use.  The ICECAP trial will answer important questions regarding the use of a novel duodenoscope with disposable cap. Specifically, persistent bacterial contamination, technical performance, and relevant clinical outcomes will be assessed. Given the mortality and morbidity burden associated with ERCP related infectious outbreaks, the results of this study have the capacity to be impactful at an international level.

title: A novel and effective disposable device that provides 2 way protection to the duodenoscope from microbial contamination.
abstract: Duodenoscope contamination is associated with notable patient morbidity and mortality and can occur despite high level disinfection protocols, requiring a solution that protects against contamination of the endoscope in the first place.  We assess a newly cleared single use device to seal the distal end of duodenoscopes while preserving optics and other endoscope functionality and tested its ability to protect against contamination using dye immersion tests as well as microbial inoculation.  Dye immersion tests revealed a complete seal with no leakage. Rigorous microbial challenge tests showed that the device can both protect against contamination of the endoscope by external microbes "outside in" protection) as well as shield instruments from contact with pre existing microbial biofilm on or around the elevator that may have survived reprocessing (inside out protection) Optical and mechanical performance of the endoscope was not compromised by the addition of the device.  The results show that this disposable device provides 2 way protection to the duodenoscope from microbial contamination, without the potential for disrupting current equipment, technique, and work flow.

title: A newly designed duodenoscope with detachable distal cap significantly reduces organic residue contamination after reprocessing.
abstract: A newly designed duodenoscope with detachable distal cap may reduce bacterial contamination by allowing better access to the elevator. We compared bacterial contamination and organic residue evaluated by rapid adenosine triphosphate (ATP) test and culture from duodenoscopes with detachable vs. fixed distal caps after high level disinfection (HLD) METHODS During December 2018 April 2019, 108 used newly designed duodenoscopes were enrolled. In group A (n 54) the distal cap of the duodenoscope was detached before manual cleaning. In group B (n 54) the distal cap was not detached. After HLD, samples were collected from the elevator, submitted for culture, and evaluated using the ATP test, using the cutoff value of 40 relative light units (RLUs)  After HLD, the proportion of potential bacterial contamination and organic residue in group A was significantly lower than in group B (37.0 vs. 75.9 P 0.001; relative risk 0.49, 95 confidence interval 0.33 0.71) and also confirmed by median ATP values (45.2 vs. 141.0 RLU; P 0.001) In group B, one sample culture was positive for nonpathogenic bacteria. Pathogenic bacteria were not found in any culture from either group.  The detachable distal cap was more effective at eliminating bacterial contamination and reducing organic residue than a fixed cap. Nonpathogenic bacteria were detected in the fixed cap group after reprocessing. The ATP test with 40 RLU cutoff is a practical method to ensure the cleanliness of duodenoscope reprocessing without the need to wait for bacterial culture results.

title: Transmission of Mobile Colistin Resistance (mcr 1) by Duodenoscope
abstract: Clinicians increasingly utilize polymyxins for treatment of serious infections caused by multidrug resistant gram negative bacteria. Emergence of plasmid mediated, mobile colistin resistance genes creates potential for rapid spread of polymyxin resistance. We investigated the possible transmission of Klebsiella pneumoniae carrying mcr 1 via duodenoscope and report the first documented healthcare transmission of mcr 1 harboring bacteria in the United States.  A field investigation, including screening targeted high risk groups, evaluation of the duodenoscope, and genome sequencing of isolated organisms, was conducted. The study site included a tertiary care academic health center in Boston, Massachusetts, and extended to community locations in New England.  Two patients had highly related mcr 1 positive K. pneumoniae isolated from clinical cultures; a duodenoscope was the only identified epidemiological link. Screening tests for mcr 1 in 20 healthcare contacts and 2 household contacts were negative. Klebsiella pneumoniae and Escherichia coli were recovered from the duodenoscope; neither carried mcr 1. Evaluation of the duodenoscope identified intrusion of biomaterial under the sealed distal cap; devices were recalled to repair this defect.  We identified transmission of mcr 1 in a United States acute care hospital that likely occurred via duodenoscope despite no identifiable breaches in reprocessing or infection control practices. Duodenoscope design flaws leading to transmission of multidrug resistant organsisms persist despite recent initiatives to improve device safety. Reliable detection of colistin resistance is currently challenging for clinical laboratories, particularly given the absence of a US Food and Drug Administration cleared test; improved clinical laboratory capacity for colistin susceptibility testing is needed to prevent the spread of mcr carrying bacteria in healthcare settings.

title: Concept of disposable duodenoscope: at what cost?
abstract: Although most postendoscopic retrograde cholangiopancreatography (ERCP) biliary tract infections are attributed to suboptimal ductal drainage, transmission of infection by contaminated reusable duodenoscopes has been reported. To overcome this limitation, a disposable duodenoscope has been recently developed. However, given the widespread use and large volume of ERCPs being performed worldwide, the financial viability of this novel concept is unclear. Utilising an activity based costing and financial model, we estimated that the per procedure cost of a disposable duodenoscope in the United States can vary from $797 to $1547 for centres performing at the 75th percentile of ERCP procedure volume and from $1318 to $2068 for centres performing at the 25th percentile of procedure volume, based on infection rates of 0.4% to 1% respectively. However, when infection was not factored, the per procedure cost decreased to $818 and $297 for centres performing at the 25th and 75th percentiles, respectively. Given the recent reports on infection outbreaks, including carbapenem resistant Enterobacteriaceae (CRE) caused by contaminated duodenoscopes used at ERCP,1 4 a disposable duodenoscope (ExaltTM, Single Use Duodenoscope, Boston Scientific Corporation, Natick, Massachusetts, USA) has been developed to circumvent this problem.5 To determine the adaptability of this innovation in clinical practice, we estimated the per procedure cost of ERCP using a reusable duodenoscope in order to assess the break even costs for transitioning to disposable duodenoscopes. An activity based costing and financial model was constructed based on the current clinical practice of ERCP at a tertiary medical centre in the USA. The annual procedure volume was 1752 ERCPs in 2018. Nine duodenoscopes with lifetime usage of 3 years and a reprocessing turn over time of 40 min per scope were required to meet the clinical needs. The cost of an individual duodenoscope was $35 000 $11 667/year) with annual maintenance and repair costs of $1451 per scope. The annual cost

title: Results of duodenoscope culture and quarantine after manufacturer recommended cleaning process.
abstract: Outbreaks of infections transmitted by duodenoscopes have prompted changes to duodenoscope cleaning protocols. However, little is known about effectiveness of clinical cleaning practices. We present culture data after duodenoscope manufacturer recommended high level disinfection (HLD) and quarantine.  Our institution adopted a combination of manufacturer recommended cleaning with the CDC recommended culture and quarantine in 2015. Duodenoscopes (Olympus models TJF Q180V, TJF 160, PJF 160) underwent HLD according to the manufacturer's reprocessing manual protocols after use. Two culture specimens were then obtained using a sterile brush from the distal tip, including elevator mechanism, and by flushing sterile water through the working channel. Duodenoscopes were quarantined until cultures resulted. Positive cultures were defined as >10 colony forming units (CFUs) of low concern organisms, or any CFUs of high concern organisms according to CDC recommendations. If either culture specimen was positive, the process was repeated until cultures were negative. Data were collected from December 2015 to July 2018.  There were 140 instances of duodenoscope cleaning with 280 specimens. Twenty eight of 234 (12% initial culture specimens (18% of cultured duodenoscopes) were positive. Five of 36 (14% second cultures were positive. Two of 8 (25% third cultures were positive. Ninety eight percent of organisms cultured were gram positive. There were 8 instances when both culture methods (brushing and flush) were positive; otherwise only one method was positive. There were 11 instances (8% of duodenoscope removals from quarantine before final culture results. No patients had infections related to ERCP. CONCLUSIONS 18% of duodenoscopes had a positive culture after initial HLD. Only 3% were gram negative bacteria. Repeated HLD was 86% and 75% effective at eliminating initial and repeat positive cultures respectively. Initial HLD per manufacturer recommendations is not always effective at eliminating bacterial contamination. Additional steps are necessary to decrease risks of duodenoscope transmitted infections.

title: Preliminary experience of hybrid endoscopic submucosal dissection by duodenoscope for recurrent laterally spreading papillary lesions
abstract: The management strategies for recurrent ampullary adenoma after endoscopic papillectomy are still controversial. Patients with the recurrent papillary lesions need to receive repetitive endoscopic interventions due to the limitations of conventional endoscopic techniques.  To assess the feasibility, efficacy, and safety of hybrid endoscopic submucosal dissection (ESD) by duodenoscope for recurrent, laterally spreading papillary lesions.  We enrolled two patients with recurrent, laterally spreading, duodenal papillary adenomas with no intraductal extension confirmed by follow up between March 2017 and September 2018. After marking the resection borders of the lesion using a dual knife, a submucosal cushion was created by injecting a mixture of saline solution, methylene blue, and adrenaline. A total circumferential incision and submucosal excision was performed by dual knife combined with insulated tip diathermic knife, and then the lesion was ligated and resected using an electric snare. Endoscopic hemostasis was applied during the endoscopic procedures. Moreover, the endoscopic retrograde cholangiopancreatography (ERCP) procedures, including selective cannulation and stent implantation of biliary and pancreatic ducts, were performed. Additionally, we performed endoclip closure for mucosal defect after ESD.  Hybrid ESD using a duodenoscope and biliary and pancreatic stent placement were performed successfully in two patients. The endoscopic size of recurrent papillary lesions was no more than 2 cm. Generally, the average total procedure time was 95.5 min, and the procedure time of ESD and ERCP was 38.5 min and 15.5 min, respectively. No serious complications occurred during the intraoperative and postoperative periods. The histopathological examination revealed tubulovillous adenoma negative for neoplastic extension at the cut margin in both patients. The duodenoscopic follow up and histopathology of biopsy specimens at 3 mo after ESD showed no residual or recurrent lesions in ampullary areas in both cases. Both cases have been followed up with no recurrence to June 2020.  Hybrid ESD by duodenoscope is technically challenging, and may be curative for recurrent, laterally spreading papillary adenomas 2 cm. It should be performed cautiously in selected patients by experienced endoscopists.

title: Comparing Duodenoscope Disinfection Regimens
abstract: Duodenoscope related infection transmission continues to be a vexing problem. New duodenoscopes with disposable tips and fully disposable duodenoscopes

title: Duodenoscope as a Vector for Transmission.
abstract: 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.

title: Remote video auditing in the endoscopy unit for evaluation of duodenoscope reprocessing in a tertiary care center.
abstract: A significant proportion of duodenoscope transmitted infections have resulted from errors related to reprocessing. Remote video auditing (RVA) is a tool that can monitor reprocessing compliance but it has not been previously evaluated in a tertiary care setting. The aims of this study were to evaluate: 1) RVA feasibility in a tertiary care setting (defined as the ability to audit every step of duodenoscope reprocessing without delaying the next procedure due to unavailability of duodenoscopes) and 2) the use of RVA as a compliance monitoring tool.  This was a prospective study at a tertiary care center. A video camera with offsite monitoring was installed in March 2018. Auditors delivered a compliance score after each procedure. The duodenoscope was not used until it passed the audit. Feasibility and compliance data were collected from April 2018 to August 2019 after a 1 month run in phase. Both per step compliance and overall 100 compliance rates were measured.  Of 743 duodenoscope reprocessing procedures, 32 666 individual steps were audited and 99.9 of the steps were fully viewable. The mean time per audit was 38.3 minutes, the mean duodenoscope turnover time was 76.1 minutes, and there were no delays to the next procedure due to unavailability of duodenoscopes. The per step compliance rate was 99.5 but the overall 100 compliance rate was 90.3  The use of RVA in duodenoscope reprocessing was feasible and promoted sustained high level compliance in a tertiary care center.