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World Journal of Gastroenterology Jul 2020Patient-ready duodenoscopes were designed with an assumed contamination rate of less than 0.4%; however, it has been reported that 5.4% of clinically used duodenoscopes... (Review)
Review
BACKGROUND
Patient-ready duodenoscopes were designed with an assumed contamination rate of less than 0.4%; however, it has been reported that 5.4% of clinically used duodenoscopes remain contaminated with viable high-concern organisms despite following the manufacturer's instructions. Visual inspection of working channels has been proposed as a quality control measure for endoscope reprocessing. There are few studies related to this issue.
AIM
To investigate the types, severity rate, and locations of abnormal visual inspection findings inside patient-ready duodenoscopes and their microbiological significance.
METHODS
Visual inspections of channels were performed in 19 patient-ready duodenoscopes using the SpyGlass visualization system in two endoscopy units of tertiary care teaching hospitals (Tri-Service General Hospital and National Taiwan University Hospital) in Taiwan. Inspections were recorded and reviewed to evaluate the presence of channel scratches, buckling, stains, debris, and fluids. These findings were used to analyze the relevance of microbiological surveillance.
RESULTS
Seventy-two abnormal visual inspection findings in the 19 duodenoscopes were found, including scratches ( = 10, 52.6%), buckling ( = 15, 78.9%), stains ( = 14, 73.7%), debris ( = 14, 73.7%), and fluids ( = 6, 31.6%). Duodenoscopes > 12 mo old had a significantly higher number of abnormal visual inspection findings than those ≤ 12 mo old (46 findings 26 findings, < 0.001). Multivariable regression analyses demonstrated that the bending section had a significantly higher risk of being scratched, buckled, and stained, and accumulating debris than the insertion tube. Debris and fluids showed a significant positive correlation with microbiological contamination ( < 0.05). There was no significant positive Spearman's correlation coefficient between negative bacterial cultures and debris, between that and fluids, and the concomitance of debris and fluids. This result demonstrated that the presence of fluid and debris was associated with positive cultures, but not negative cultures. Further multivariate analysis demonstrated that fluids, but not debris, is an independent factor for bacterial culture positivity.
CONCLUSION
In patient-ready duodenoscopes, scratches, buckling, stains, debris, and fluids inside the working channel are common, which increase the microbiological contamination susceptibility. The SpyGlass visualization system may be recommended to identify suboptimal reprocessing.
Topics: Disinfection; Duodenoscopes; Endoscopes; Equipment Contamination; Humans; Taiwan
PubMed: 32774056
DOI: 10.3748/wjg.v26.i26.3767 -
Gut Mar 2024Contaminated duodenoscopes caused several hospital outbreaks. Despite efforts to reduce contamination rates, 15% of patient-ready duodenoscopes are still contaminated... (Review)
Review
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.
Topics: Humans; Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Duodenoscopes; Magnesium Oxide; Retrospective Studies; Tertiary Care Centers
PubMed: 38182137
DOI: 10.1136/gutjnl-2023-330355 -
Antimicrobial Resistance and Infection... Dec 2021Duodenoscopy-associated infections occur worldwide despite strict adherence to reprocessing standards. The exact scope of the problem remains unknown because a... (Review)
Review
Duodenoscopy-associated infections occur worldwide despite strict adherence to reprocessing standards. The exact scope of the problem remains unknown because a standardized sampling protocol and uniform sampling techniques are lacking. The currently available multi-society protocol for microbial culturing by the Centers for Disease Control and Prevention, the United States Food and Drug Administration (FDA) and the American Society for Microbiology, published in 2018 is too laborious for broad clinical implementation. A more practical sampling protocol would result in increased accessibility and widespread implementation. This will aid to reduce the prevalence of duodenoscope contamination. To reduce the risk of duodenoscopy-associated pathogen transmission the FDA advised four supplemental reprocessing measures. These measures include double high-level disinfection, microbiological culturing and quarantine, ethylene oxide gas sterilization and liquid chemical sterilization. When the supplemental measures were advised in 2015 data evaluating their efficacy were sparse. Over the past five years data regarding the supplemental measures have become available that place the efficacy of the supplemental measures into context. As expected the advised supplemental measures have resulted in increased costs and reprocessing time. Unfortunately, it has also become clear that the efficacy of the supplemental measures falls short and that duodenoscope contamination remains a problem. There is a lot of research into new reprocessing methods and technical applications trying to solve the problem of duodenoscope contamination. Several promising developments such as single-use duodenoscopes, electrolyzed acidic water, and vaporized hydrogen peroxide plasma are already applied in a clinical setting.
Topics: Anti-Bacterial Agents; Cross Infection; Disinfection; Drug Resistance, Multiple, Bacterial; Duodenoscopes; Enterobacteriaceae; Enterobacteriaceae Infections; Equipment Contamination; Equipment Reuse; Humans; Infection Control; United States; United States Food and Drug Administration
PubMed: 34949217
DOI: 10.1186/s13756-021-01037-z -
Gastrointestinal Endoscopy Sep 2022
Topics: Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Equipment Contamination; Humans
PubMed: 35995465
DOI: 10.1016/j.gie.2022.03.010 -
Gastrointestinal Endoscopy Dec 2022
Topics: Humans; Duodenoscopes
PubMed: 36007585
DOI: 10.1016/j.gie.2022.08.025 -
Gastrointestinal Endoscopy Sep 2015
Topics: Cross Infection; Disinfection; Drug Resistance, Multiple, Bacterial; Duodenoscopes; Equipment Contamination; Escherichia coli; Escherichia coli Infections; Female; Humans; Male; Quarantine
PubMed: 26279349
DOI: 10.1016/j.gie.2015.07.004 -
Gastroenterology Nursing : the Official... 2017Transmission of carbapenem-resistant Enterobacteriaceae (CRE) via duodenoscopes, specialized endoscopes used during endoscopic retrograde cholangiopancreatography (ERCP)... (Review)
Review
Transmission of carbapenem-resistant Enterobacteriaceae (CRE) via duodenoscopes, specialized endoscopes used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, has attracted media attention since early 2015. This attention has placed increasing focus on the reprocessing of duodenoscopes. Current reprocessing recommendations for these endoscopes require either high-level disinfection or ethylene oxide sterilization. While reprocessing duodenoscopes, staff at endoscopy locations within the Mercy health system perform a single high-level disinfection cycle that is preceded by two cycles of manual cleaning. The Mercy system has 37 locations for gastrointestinal endoscopic procedures and nine that can accommodate patients requiring ERCP. In early 2016, the Mercy Oklahoma City location performed an ERCP on a patient known prior to the case to be a carrier of CRE. After the case, multiple departments located in both the Oklahoma City and St. Louis facilities partnered to culture and sterilize the duodenoscope used in that case to ensure its safety for use on subsequent patients. This case study presents the situation and discusses culturing of endoscopes. In light of the evidence presented, the importance of enhanced communication and cooperation to achieve patient safety should be paramount to all other factors.
Topics: Carbapenems; Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Drug Resistance, Bacterial; Duodenoscopes; Duodenoscopy; Enterobacteriaceae; Enterobacteriaceae Infections; Equipment Contamination; Female; Humans; Incidence; Male; Needs Assessment; Risk Assessment
PubMed: 28134720
DOI: 10.1097/SGA.0000000000000268 -
American Journal of Infection Control Sep 2022The objectives of this survey study were to assess duodenoscope precleaning and manual cleaning times, identify human factors issues in duodenoscope reprocessing...
BACKGROUND
The objectives of this survey study were to assess duodenoscope precleaning and manual cleaning times, identify human factors issues in duodenoscope reprocessing workflow or ergonomics, and ascertain any best practices in duodenoscope reprocessing.
METHODS
Researchers developed the confidential, qualitative, online Duodenoscope Reprocessing Workflow and Ergonomic Design Human Factors Survey with an intended audience of healthcare workers (HCWs) who routinely perform duodenoscope precleaning or manual cleaning. The unrestricted survey link was distributed to target HCW email addresses in December 2020; the survey closed in January 2021.
RESULTS
Three hundred and forty-one individuals completed the survey. Most respondents complete duodenoscope precleaning in 10 minutes or less and manual cleaning in 16-to-30 minutes. Most respondents' facilities use fixed distal endcap duodenoscopes. Most respondents experience pressure to work faster when cleaning duodenoscopes and reported that cleaning duodenoscopes caused fatigue or discomfort in at least one body part. Mentoring HCWs and retaining experienced staff were 2 primary duodenoscope reprocessing best practices identified by respondents.
DISCUSSION AND CONCLUSIONS
To enhance duodenoscope cleaning, facilities should provide ample reprocessing work spaces with incorporated height-adjustable work surfaces, train HCWs on validated duodenoscope reprocessing instructions, provide step-by-step instructions for HCWs when duodenoscope cleaning is performed, mentor reprocessing HCWs, and retain experienced staff.
Topics: Cross Infection; Disinfection; Duodenoscopes; Equipment Contamination; Ergonomics; Feedback; Health Personnel; Humans; Workflow
PubMed: 35108583
DOI: 10.1016/j.ajic.2022.01.012 -
Expert Review of Medical Devices May 2021: The management of pancreaticobiliary disorders relies heavily on endoscopic retrograde cholangiopancreatography, which is performed with a duodenoscope. Bacterial... (Review)
Review
: 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.: 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.: 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.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Disinfection; Duodenoscopes; Equipment Contamination; Humans; Product Surveillance, Postmarketing; Social Control, Formal
PubMed: 33855920
DOI: 10.1080/17434440.2021.1917990 -
Clinical Gastroenterology and... Aug 2020
Topics: Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Duodenoscopes; Humans; Infection Control
PubMed: 32302708
DOI: 10.1016/j.cgh.2020.04.026