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BMC Gastroenterology Apr 2023Endoscopic retrograde cholangiography (ERC) possesses a translocation risk of microbes to the biliary system. We studied bile contamination during ERC and its impact on...
BACKGROUND
Endoscopic retrograde cholangiography (ERC) possesses a translocation risk of microbes to the biliary system. We studied bile contamination during ERC and its impact on patients' outcome in a real-life-situation.
METHODS
Ninety-nine ERCs were analyzed and microbial samples were taken from the throat before and from bile during ERC and from irrigation fluid of the duodenoscope before and after ERC.
RESULTS
91.2% of cholangitis patients had detectable microbes in the bile (sensitivity 91%), but the same was true for 86.2% in the non-cholangitis group. Bacteroides fragilis (p=0.015) was significantly associated with cholangitis. In 41.7% of ERCs with contaminated endoscopes these microbes were found in the bile after the procedure. Analysis of duodenoscopes' irrigation liquid after ERC matched the microbial bile analysis of these patients in 78.8%. Identical microbial species were in throat and in bile samples of the same ERC in 33% of all cases and in 45% in the non-cholangitis group. Transmission of microbes to the biliary tract did not result in more frequent cholangitis, longer hospital stays, or worse outcome.
CONCLUSIONS
During ERC bile samples are regularly contaminated with microbes of the oral cavity but it did not affect clinical outcome.
Topics: Humans; Cholangiopancreatography, Endoscopic Retrograde; Biliary Tract; Cholangiography; Biliary Tract Surgical Procedures; Cholangitis; Microbiota
PubMed: 37013522
DOI: 10.1186/s12876-023-02721-7 -
Gastrointestinal Endoscopy Jul 2023
Topics: Humans; Duodenoscopes; Disinfection; Cross Infection; Equipment Contamination
PubMed: 37004813
DOI: 10.1016/j.gie.2023.03.025 -
Digestive and Liver Disease : Official... Jan 2024Single use duodenoscopes were developed to reduce the risk of infection transmission from contaminated reusable duodenoscopes. To this end, we examined various biliary... (Meta-Analysis)
Meta-Analysis Review
Cannulation rates and technical performance evaluation of commericially available single-use duodenoscopes for endoscopic retrograde cholangiopancreatography: A systematic review and meta-analysis.
BACKGROUND
Single use duodenoscopes were developed to reduce the risk of infection transmission from contaminated reusable duodenoscopes. To this end, we examined various biliary interventions using single use duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).
METHODS
Medline, Embase, Scopus, and Cochrane databases were searched from inception through Aug 2022 to identify studies reporting on the performance of single use duodenoscopes for ERCP.
RESULTS
Seven articles were included in the final analysis that included 642 patients (318 males). The Exalt Model D duodenoscope was used in most cases (88.8%) followed by the aScope Duodeno (11.2%) for ERCP. Most ERCPs had a complexity grade of 2 (n = 303) and 3 (n = 198). The pooled cumulative rate of successful cannulation was 95% (95% Confidence Interval (CI): 93-96%, I2=0%, P = 0.46). Sphincterotomy was successfully performed in all cases. The pooled cumulative rate of PEP was 2% (95% CI: 0.4-3.4%, I2=0%, P = 0.80). The pooled cumulative rate of total adverse events was 7% (95% CI: 4-10%, I2=47%, P = 0.08).
CONCLUSIONS
The results of this systematic review and meta-analysis show that single use duodenoscopes are associated with high cannulation rates, technical performance, and safety profile.
Topics: Male; Humans; Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Catheterization
PubMed: 37003844
DOI: 10.1016/j.dld.2023.02.022 -
The Science of the Total Environment Jun 2023Despite advances in medicine and innovations in many underpinning fields including disease prevention and control, the Spaulding classification system, originally... (Review)
Review
A review of Spaulding's classification system for effective cleaning, disinfection and sterilization of reusable medical devices: Viewed through a modern-day lens that will inform and enable future sustainability.
Despite advances in medicine and innovations in many underpinning fields including disease prevention and control, the Spaulding classification system, originally proposed in 1957, remains widely used for defining the disinfection and sterilization of contaminated re-usable medical devices and surgical instruments. Screening PubMed and Scopus databases using a PRISMA guiding framework generated 272 relevant publications that were used in this review. Findings revealed that there is a need to evolve how medical devices are designed, and processed by cleaning, disinfection (and/or sterilization) to mitigate patient risks, including acquiring an infection. This Spaulding Classification remains in use as it is logical, easily applied and understood by users (microbiologists, epidemiologists, manufacturers, industry) and by regulators. However, substantial changes have occurred over the past 65 years that challenge interpretation and application of this system that includes inter alia emergence of new pathogens (viruses, mycobacteria, protozoa, fungi), a greater understanding of innate and adaptive microbial tolerance to disinfection, toxicity risks, increased number of vulnerable patients and associated patient procedures, and greater complexity in design and use of medical devices. Common cited examples include endoscopes that enable non- or minimal invasive procedures but are highly sophisticated with various types of materials (polymers, electronic components etc), long narrow channels, right angle and heat-sensitive components and various accessories (e.g., values) that can be contaminated with high levels of microbial bioburden and patient tissues after use. Contaminated flexible duodenoscopes have been a source of several significant infection outbreaks, where at least 9 reported cases were caused by multidrug resistant organisms [MDROs] with no obvious breach in processing detected. Despite this, there is evidence of the lack of attention to cleaning and maintenance of these devices and associated equipment. Over the last few decades there is increasing genomic evidence of innate and adaptive resistance to chemical disinfectant methods along with adaptive tolerance to environmental stresses. To reduce these risks, it has been proposed to elevate classification of higher-risk flexible endoscopes (such as duodenoscopes) from semi-critical [contact with mucous membrane and intact skin] to critical use [contact with sterile tissue and blood] that entails a transition to using low-temperature sterilization modalities instead of routinely using high-level disinfection; thus, increasing the margin of safety for endoscope processing. This timely review addresses important issues surrounding use of the Spaulding classification system to meet modern-day needs. It specifically addresses the need for automated, robust cleaning and drying methods combined with using real-time monitoring of device processing. There is a need to understand entire end-to-end processing of devices instead of adopting silo approaches that in the future will be informed by artificial intelligence and deep-learning/machine learning. For example, combinational solutions that address the formation of complex biofilms that harbour pathogenic and opportunistic microorganisms on the surfaces of processed devices. Emerging trends are addressed including future sustainability for the medical devices sector that can be enabled via a new Quintuple Helix Hub approach that combines academia, industry, healthcare, regulators, and society to unlock real world solutions.
Topics: Humans; Artificial Intelligence; Cross Infection; Disinfectants; Disinfection; Endoscopes; Equipment Contamination
PubMed: 36963674
DOI: 10.1016/j.scitotenv.2023.162976 -
Gastrointestinal Endoscopy Apr 2023
Topics: Humans; Duodenoscopes; Cross Infection; Disinfection; Equipment Contamination
PubMed: 36958922
DOI: 10.1016/j.gie.2022.11.023 -
Gastroenterology Sep 2023
Topics: Humans; Cholangiopancreatography, Endoscopic Retrograde; Elevators and Escalators; Disposable Equipment; Duodenoscopes; Equipment Contamination
PubMed: 36940776
DOI: 10.1053/j.gastro.2023.03.209 -
Endoscopy International Open Mar 2023The contamination level of ready-to-use endoscopes published in the literature varies from 0.4 % to 49.0 %. Unfortunately, the comparison and the interpretation of...
The contamination level of ready-to-use endoscopes published in the literature varies from 0.4 % to 49.0 %. Unfortunately, the comparison and the interpretation of these results are quite impossible, given the limited number of samples and sites included and the differences observed between sampling, culturing methods, and interpretation criteria. The objective of this retrospective study was to analyze the results of 90,311 endoscope samples collected between 2004 and 2021 in 490 private or public hospitals in France. Through the full test period, the mean ratio of endoscopes at the action level was 12.6 % (19.5 % including alert level). Of the endoscopy units, 23.0 % had a ratio of compliant endoscopes ≤ 70.0 %. The overall microbial quality of gastroscopes, duodenoscopes, and colonoscopes is improving year by year, whereas an opposite trend is observed for ultrasound endoscopes and bronchoscopes. In 2021, following French guidelines, 13.0 % of the endoscopes should have been quarantined and 8.1 % were at the alert level, meaning that the contamination level of 21.1 % of the endoscopes exceeded what was defined as a maximum acceptable value. This study demonstrates that additional efforts, including implementation of microbial surveillance strategies using a standardized sampling method and periodic observational audits, must be made to improve the overall microbiological quality of endoscopes and reduce the risk associated with their use.
PubMed: 36937825
DOI: 10.1055/a-1991-1391 -
Digestive Endoscopy : Official Journal... Nov 2023Little is known about how to perform the endoscopic ultrasound (EUS)-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) in patients with... (Observational Study)
Observational Study
Risk factors of anastomosis-related difficult endoscopic retrograde cholangiopancreatography following endoscopic ultrasound-guided gastro-gastrostomy using a standardized protocol (with video).
OBJECTIVES
Little is known about how to perform the endoscopic ultrasound (EUS)-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) in patients with gastric bypass using lumen-apposing metal stents (LAMS). The aim was to assess the risk factors of anastomosis-related difficult ERCP.
METHODS
Observational single-center study. All patients who underwent an EDGE procedure in 2020-2022 following a standardized protocol were included. Risk factors for difficult ERCP, defined as the need of >5 min LAMS dilation or failure to pass a duodenoscope in the second duodenum, were assessed.
RESULTS
Forty-five ERCPs were performed in 31 patients (57.4 ± 8.2 years old, 38.7% male). The EUS procedure was done using a wire-guided technique (n = 28, 90.3%) for biliary stones (n = 22, 71%) in most cases. The location of the anastomosis was gastro-gastric (n = 24, 77.4%) and mainly in the middle-excluded stomach (n = 21, 67.7%) with an oblique axis (n = 22, 71%). The ERCP technical success was 96.8%. There were 10 difficult ERCPs (32.3%) due to timing (n = 8), anastomotic dilation (n = 8), or failure to pass (n = 3). By multivariable analysis adjusted by two-stage procedures, the risk factors for a difficult ERCP were the jejuno-gastric route (85.7% vs. 16.7%; odds ratio [OR ] 31.875; 95% confidence interval [CI] 1.649-616.155; P = 0.022), and the anastomosis to the proximal/distal excluded stomach (70% vs. 14.3%; OR 22.667; 95% CI 1.676-306.570; P = 0.019). There was only one complication (3.2%) and one persistent gastro-gastric fistula (3.2%) in a median follow-up of 4 months (2-18 months), with no weight regain (P = 0.465).
CONCLUSIONS
The jejunogastric route and the anastomosis with the proximal/distal excluded stomach during the EDGE procedure increase the difficulty of ERCP.
Topics: Aged; Female; Humans; Male; Middle Aged; Cholangiopancreatography, Endoscopic Retrograde; Endosonography; Gastric Bypass; Gastrostomy; Observational Studies as Topic; Retrospective Studies; Risk Factors; Stents; Ultrasonography, Interventional
PubMed: 36872440
DOI: 10.1111/den.14544 -
JGH Open : An Open Access Journal of... Feb 2023Adenosine triphosphate (ATP) bioluminescence assay is widely adopted in the West to allow rapid evaluation of endoscopes for bacteriologic/biologic residue, but this...
BACKGROUND AND AIM
Adenosine triphosphate (ATP) bioluminescence assay is widely adopted in the West to allow rapid evaluation of endoscopes for bacteriologic/biologic residue, but this practice is rarely adopted in Asia. In this continuous quality improvement program, we evaluated the utility of ATP in bacteriologic surveillance on endoscope reprocessing.
METHODS
A total of 456 samples (304 ATP samples and 152 culture samples) of 38 flexible endoscopes were assessed after routine clinical use in a private hospital in Hong Kong. Endoscopes were assessed with an ATP system and bacterial cultures at different time points during the reprocessing.
RESULTS
After pre-cleaning, the ATP values ranged from 228 to 65 163 relative light units (RLU) through all endoscope types. After manual cleaning, ATP values were decreased to 7-81 RLU (median, 19 RLU) for endoscope surface and 3-671 RLU (median, 12 RLU) for channel rinsate. There was a significant reduction in ATP levels between pre-cleaning and after manual cleaning. One of the 38 (2.6%) endoscopes (a duodenoscope) had an ATP value of 671 RLU from channel rinsate, which exceeded the benchmark for cleanliness of >200 RLU, and was sent back for re-cleaning. All endoscopes cultured no bacteria after high-level disinfection (HLD) by automated endoscope reprocessor (AER) and storage up to 24 h. ATP values were <200 RLU for all endoscopes after HLD and storage.
CONCLUSIONS
Adenosine triphosphate bioluminescence assay offers a rapid, practical, and cost-effective alternative for detection of endoscope microbial residue as well as a routine monitoring tool for endoscope cleanliness in the clinical setting.
PubMed: 36852145
DOI: 10.1002/jgh3.12863 -
Infection Control and Hospital... Oct 2023We report 2 outbreaks of genetically unrelated carbapenem-resistant New Delhi metallo-β-lactamase-producing caused by contaminated duodenoscopes. Using endoscopes with...
We report 2 outbreaks of genetically unrelated carbapenem-resistant New Delhi metallo-β-lactamase-producing caused by contaminated duodenoscopes. Using endoscopes with disposable end caps, adherence to the manufacturer's reprocessing instructions, routine audits, and manufacturer evaluation are critical in preventing such outbreaks.
Topics: Humans; Escherichia coli; beta-Lactamases; Carbapenem-Resistant Enterobacteriaceae; Duodenoscopes; Disease Outbreaks; Carbapenems; Microbial Sensitivity Tests; Anti-Bacterial Agents
PubMed: 36815278
DOI: 10.1017/ice.2023.21