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EClinicalMedicine Aug 2020Multiple infection outbreaks have been linked to contaminated duodenoscopes worldwide. However, the contamination rate of patient-ready duodenoscopes varies highly...
BACKGROUND
Multiple infection outbreaks have been linked to contaminated duodenoscopes worldwide. However, the contamination rate of patient-ready duodenoscopes varies highly amongst published studies testing this subject. We aimed to estimate the contamination rate of reprocessed patient-ready duodenoscopes for endoscopic retrograde cholangio-pancreatography (ERCP) based on currently available data.
METHODS
We searched the PubMed and Embase databases from January 1, 2010 until March 10, 2020, for citations investigating contamination rates of reprocessed patient-ready duodenoscopes. Studies not assessing other types of endoscopes than duodenoscopes were excluded from the analysis. Study eligibility and data extraction was evaluated by three reviewers independently. A random-effects model (REM) based on the proportion distribution was used to calculate the pooled total contamination rate of reprocessed patient-ready duodenoscopes. Subgroup analyses were carried out to assess contamination rates when using different reprocessing methods by comparing single high-level disinfection (HLD) with double HLD and ethylene oxide (EtO) gas sterilization. Additionally, we investigated the contamination rate between studies conducted following an outbreak compared to non-outbreak-initiated studies.
FINDINGS
We identified 15 studies that fulfilled the inclusion, which included 925 contaminated duodenoscopes from 13,112 samples. The calculated total weighted contamination rate was 15.25% ± 0.018 (95% confidence interval [Cl]: 11.74% - 18.75%). The contamination rate after only using HLD was 16.14% ± 0.019 (95% Cl: 12.43% - 19.85%) and after using either dHLD or EtO the contamination rate decreased to 9.20% ± 0.025 (95% Cl: 4.30% - 14.10%). Studies conducted following an outbreak (n=4) showed a 5.72% ± 0.034 (95% Cl: 0.00% - 12.43%) contamination rate, and non-outbreak-initiated studies (n=11) revealed a contamination rate of 21.50% ± 0.031 (95% Cl: 15.35% - 27.64%).
INTERPRETATION
This is the first meta-analysis to estimate the contamination rate of patient-ready duodenoscopes used for ERCP. Based on the available literature, our analysis demonstrates that there is a 15.25% contamination rate of reprocessed patient-ready duodenoscopes. Additionally, the analysis indicates that dHLD and EtO reprocessing methods are superior to single HLD but still not efficient in regards to cleaning the duodenoscopes properly. Furthermore, studies conducted following an outbreak did not entail a higher contamination rate compared to non-outbreak-initiated studies.
FUNDING
The authors received no financial support for the research, authorship, and/or publication of this article.
PubMed: 32954234
DOI: 10.1016/j.eclinm.2020.100451 -
Diagnostics (Basel, Switzerland) Dec 2023Endoscopic retrograde cholangiopancreatography (ERCP) is considered the preferred method for managing biliary obstructions. However, the prevalence of surgically... (Review)
Review
Endoscopic retrograde cholangiopancreatography (ERCP) is considered the preferred method for managing biliary obstructions. However, the prevalence of surgically modified anatomies often poses challenges, making the standard side-viewing duodenoscope unable to reach the papilla in most cases. The increasing instances of surgically altered anatomies (SAAs) result from higher rates of bariatric procedures and surgical interventions for pancreatic malignancies. Conventional ERCP with a side-viewing endoscope remains effective when there is continuity between the stomach and duodenum. Nonetheless, percutaneous transhepatic biliary drainage (PTBD) or surgery has historically been used as an alternative for biliary drainage in malignant or benign conditions. The evolving landscape has seen various endoscopic approaches tailored to anatomical variations. Innovative methodologies such as cap-assisted forward-viewing endoscopy and enteroscopy have enabled the performance of ERCP. Despite their utilization, procedural complexities, prolonged durations, and accessibility challenges have emerged. As a result, there is a growing interest in novel enteroscopy and endoscopic ultrasound (EUS) techniques to ensure the overall success of endoscopic biliary drainage. Notably, EUS has revolutionized this domain, particularly through several techniques detailed in the review. The rendezvous approach has been pivotal in this field. The antegrade approach, involving biliary tree puncturing, allows for the validation and treatment of strictures in an antegrade fashion. The EUS-transmural approach involves connecting a tract of the biliary system with the GI tract lumen. Moreover, the EUS-directed transgastric ERCP (EDGE) procedure, combining EUS and ERCP, presents a promising solution after gastric bypass. These advancements hold promise for expanding the horizons of comprehensive and successful biliary drainage interventions, laying the groundwork for further advancements in endoscopic procedures.
PubMed: 38132207
DOI: 10.3390/diagnostics13243623 -
American Journal of Infection Control Sep 2016Several clusters of Carbapenem-resistant Enterobacteriaceae (CRE) infections associated with contaminated endoscopes have recently been reported. Interim guidelines for... (Review)
Review
BACKGROUND
Several clusters of Carbapenem-resistant Enterobacteriaceae (CRE) infections associated with contaminated endoscopes have recently been reported. Interim guidelines for mitigating endoscope-associated transmission have been proposed, but there has not been a systematic appraisal of CRE prevention practices.
METHODS
We conducted a systematic review of endoscope-associated CRE infection episodes, abstracting information on outbreak detection, mitigation, outcomes, and corrective steps taken to prevent recurrence.
RESULTS
Seven distinct outbreaks were identified in the published literature, and 5 of these were associated with duodenal endoscopy, with the remaining 2 associated with cystoscopy and ureteroscopy. Several investigators noted difficulties in cleaning protocols surrounding difficult to access components, such as the elevator on duodenoscopes. The published investigations did not report any failures of sterilization. It is unclear if routine reprocessing was ineffective, or difficult to execute properly.
CONCLUSIONS
Meticulous cleaning protocols and increased surveillance are necessary to prevent and detect future outbreaks of CRE and to determine whether more stringent measures, such as sterilization, are needed for duodenoscopes.
Topics: Anti-Bacterial Agents; Carbapenems; Disease Transmission, Infectious; Endoscopy; Enterobacteriaceae; Enterobacteriaceae Infections; Humans; beta-Lactam Resistance
PubMed: 27179395
DOI: 10.1016/j.ajic.2016.03.029 -
Annals of Clinical Microbiology and... Oct 2018During clinical use, gastrointestinal endoscopes are grossly contaminated with patient's native flora. These endoscopes undergo reprocessing to prevent infectious... (Review)
Review
INTRODUCTION
During clinical use, gastrointestinal endoscopes are grossly contaminated with patient's native flora. These endoscopes undergo reprocessing to prevent infectious transmission upon future use. Endoscopy-associated infections and outbreaks have been reported, with a recent focus on the transmission of multi-drug resistant organisms. This review aims to provide an update on endoscopy-associated infections, and the factors contributing to their occurrence.
METHODS
PubMed, ScienceDirect, and CINAHL were searched for articles describing gastrointestinal endoscopy-associated infections and outbreaks published from 2008 to 2018. Factors contributing to their occurrence, and the outcomes of each outbreak were also examined.
RESULTS
This review found 18 articles, 16 of which described duodenoscope-associated infections, and the remaining two described colonoscope- and gastroscope-associated infection respectively. Outbreaks were reported from the United States, France, China, Germany, the Netherlands and the United Kingdom. The causative organisms reported were Klebsiella pneumoniae, Pseudomonas aeruginosa, Escherichia coli and Salmonella enteritidis.
CONCLUSIONS
A number of factors, including lapses in reprocessing, biofilm formation, endoscope design issues and endoscope damage, contribute to gastrointestinal endoscopy associated infection. Methods of improving endoscope reprocessing, screening for contamination and evaluating endoscope damage may be vital to preventing future infections and outbreaks.
Topics: China; Cross Infection; Disease Outbreaks; Disinfection; Endoscopy, Gastrointestinal; Germany; Humans; Infection Control
PubMed: 30314500
DOI: 10.1186/s12941-018-0289-2 -
Endoscopy Dec 2023The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde... (Clinical Trial)
Clinical Trial
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.
Topics: Adult; Male; Humans; Female; Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Endoscopy, Gastrointestinal; Pancreatitis
PubMed: 37463599
DOI: 10.1055/a-2131-7180 -
World Journal of Gastroenterology Jan 2016Duodenal polyps or lesions are uncommonly found on upper endoscopy. Duodenal lesions can be categorized as subepithelial or mucosally-based, and the type of lesion often... (Review)
Review
Duodenal polyps or lesions are uncommonly found on upper endoscopy. Duodenal lesions can be categorized as subepithelial or mucosally-based, and the type of lesion often dictates the work-up and possible therapeutic options. Subepithelial lesions that can arise in the duodenum include lipomas, gastrointestinal stromal tumors, and carcinoids. Endoscopic ultrasonography with fine needle aspiration is useful in the characterization and diagnosis of subepithelial lesions. Duodenal gastrointestinal stromal tumors and large or multifocal carcinoids are best managed by surgical resection. Brunner's gland tumors, solitary Peutz-Jeghers polyps, and non-ampullary and ampullary adenomas are mucosally-based duodenal lesions, which can require removal and are typically amenable to endoscopic resection. Several anatomic characteristics of the duodenum make endoscopic resection of duodenal lesions challenging. However, advanced endoscopic techniques exist that enable the resection of large mucosally-based duodenal lesions. Endoscopic papillectomy is not without risk, but this procedure can effectively resect ampullary adenomas and allows patients to avoid surgery, which typically involves pancreaticoduodenectomy. Endoscopic mucosal resection and its variations (such as cap-assisted, cap-band-assisted, and underwater techniques) enable the safe and effective resection of most duodenal adenomas. Endoscopic submucosal dissection is possible but very difficult to safely perform in the duodenum.
Topics: Adenomatous Polyps; Ampulla of Vater; Biopsy; Cholangiopancreatography, Endoscopic Retrograde; Duodenal Neoplasms; Duodenoscopes; Duodenoscopy; Endosonography; Equipment Design; Female; Humans; Intestinal Mucosa; Intestinal Polyps; Male; Middle Aged; Postoperative Complications; Sphincterotomy, Endoscopic; Treatment Outcome
PubMed: 26811610
DOI: 10.3748/wjg.v22.i2.600 -
Current Opinion in Gastroenterology Sep 2021Given the growing concerns about infection transmission from use of contaminated reusable duodenoscopes, technological advancements have been made that vary from... (Review)
Review
PURPOSE OF REVIEW
Given the growing concerns about infection transmission from use of contaminated reusable duodenoscopes, technological advancements have been made that vary from modifications of existing designs to development of single-use devices.
RECENT FINDINGS
To circumvent mechanical limitations that preclude access to critical areas of a duodenoscope to perform thorough cleaning and disinfection, single-use disposable duodenoscopes have been developed. A thorough assessment of this technology is limited by the minimal published data that is currently available. This opinion assesses the current technical functionality of these devices, potential for further improvements, implications for healthcare economics and the future of gastrointestinal endoscopy.
SUMMARY
Currently available data suggest that majority of endoscopic retrograde cholangiopancreatography procedures can be safely performed using single-use duodenoscopes. The ability to improve technical functionality, incorporate futuristic technology and secure financial reimbursement from insurance carriers will largely define the future prospects of this recent innovation.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Disinfection; Duodenoscopes; Endoscopy, Gastrointestinal; Equipment Contamination; Humans
PubMed: 34010243
DOI: 10.1097/MOG.0000000000000755 -
World Journal of Gastrointestinal... Aug 2021Endoscopic retrograde cholangiopancreatography (ERCP) has evolved from a primarily diagnostic to therapeutic procedure in hepatobiliary and pancreatic disease. Most... (Review)
Review
Endoscopic retrograde cholangiopancreatography (ERCP) has evolved from a primarily diagnostic to therapeutic procedure in hepatobiliary and pancreatic disease. Most commonly, ERCPs are performed for choledocholithiasis with or without cholangitis, but improvements in technology and technique have allowed for management of pancreatic duct stones, benign and malignant strictures, and bile and pancreatic leaks. As an example of necessity driving innovation, the new disposable duodenoscopes have been introduced into practice. With the advantage of eliminating transmissible infections, they represent a paradigm shift in quality improvement within ERCP. With procedures becoming more complicated, the necessity for anesthesia involvement and safety of propofol use and general anesthesia has become better defined. The improvements in endoscopic ultrasound (EUS) have allowed for direct bile duct access and EUS facilitated bile duct access for ERCP. In patients with surgically altered anatomy, selective cannulation can be performed with overtube-assisted enteroscopy, laparoscopic surgery assistance, or the EUS-directed transgastric ERCP. Cholangioscopy and pancreatoscopy use has become ubiquitous with defined indications for large bile duct stones, indeterminate strictures, and hepatobiliary and pancreatic neoplasia. This review summarizes the recent advances in infection prevention, quality improvement, pancreaticobiliary access, and management of hepatobiliary and pancreatic diseases. Where appropriate, future research directions are included in each section.
PubMed: 34512875
DOI: 10.4253/wjge.v13.i8.260 -
Annals of Gastroenterology 2022Despite the standardization and optimization of disinfection protocols, duodenoscope-related infections (DRIs) remain an emerging threat for patients undergoing...
BACKGROUND
Despite the standardization and optimization of disinfection protocols, duodenoscope-related infections (DRIs) remain an emerging threat for patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Single-use duodenoscopes could represent a potential alternative avenue to circumvent the problem of reprocessing and thus risk of exogenous patient-to-patient transmission. The aim of our study was to test the feasibility and technical success rate of a recently made available single-use duodenoscope.
METHODS
We carried out a thorough and standardized evaluation of the usability, performance and safety of a recently developed single-use duodenoscope in 52 consecutive patients scheduled for ERCP in a single center. Outcomes included performance ratings of the single-use duodenoscopes, adverse events (assessed at 3 days and 1 week), and crossover rate to a reusable duodenoscope.
RESULTS
The ERCP completion rate with a single-use duodenoscope was 90.4%, rising to 94.2% after crossover to reusable duodenoscope. The mean American Society for Gastrointestinal Endoscopy (ASGE) grade was 2.7, with 27 procedures (51.9%) considered as advanced level complexity (ASGE grade 3 & 4). Performance rating found that 94% of the therapeutic treatments were comparable to those using a traditional reusable duodenoscope. Overall satisfaction amounted to 80%. No major adverse events were attributable to the single-use endoscope.
CONCLUSIONS
Single-use duodenoscopes can provide an alternative to avoid the intensive and often inconsistent results of cleaning and disinfection procedures. We confirmed the feasibility, adequate performance characteristics and safety of a recently developed first-generation single-use duodenoscope over a broad range of ERCP procedures, in terms of both indication and complexity.
PubMed: 35784631
DOI: 10.20524/aog.2022.0723 -
Der Gastroenterologe : Zeitschrift Fur... 2022Clinically relevant infections triggered by the use of flexible endoscopes and respective consumables have become the focus of clinical and scientific interest in the... (Review)
Review
Clinically relevant infections triggered by the use of flexible endoscopes and respective consumables have become the focus of clinical and scientific interest in the literature. Endoscopy-associated infections can be assigned to one of two groups: (i) endogenous infections are triggered by the spread of the patient's own local flora and (ii) exogenous infections result from transmission of contaminated material or endoscopes. The number of reported infectious complications in flexible endoscopy is low but likely underestimated due to inadequate surveillance strategies and lack of clinical symptoms. To prevent exogenous infections, single-use endoscopes were brought to the market. Single-use bronchoscope have been part of routine clinical care for years, while single-use duodenoscopes have only recently been approved. The increased patient safety and economic costs were clearly evaluated for the single-use bronchoscopes, but this still needs to be studied for single-use duodenoscopes. The use of single-use endoscopes-at first glance-represents an additional financial burden on the healthcare system. However, in addition to the material costs of disposable endoscopes, the costs that are avoided by them (e.g., prolonged hospitalization, intensive care treatment, and follow-up interventions) must also be included in the overall calculation.
PubMed: 35018195
DOI: 10.1007/s11377-021-00581-9