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Infection Control and Hospital... Dec 2022Several clinical procedures utilize duodenoscopes, which are processed for reuse after the procedures are completed. However, infection outbreaks due to improper...
OBJECTIVE
Several clinical procedures utilize duodenoscopes, which are processed for reuse after the procedures are completed. However, infection outbreaks due to improper duodenoscope processing occur frequently. To address this, we aimed to assess the contamination rates of duodenoscopes after reprocessing in nonoutbreak settings.
DESIGN AND SETTING
Prospective study in 16 clinical sites in the United States.
METHODS
We sampled and cultured reprocessed duodenoscopes following the FDA/CDC/ASM guideline; "Duodenoscope Surveillance Sampling and Culturing - Reducing the Risks of Infection." High-concern (HC) organisms were those highly associated with disease, including gram-negative rods, , β-hemolytic , spp, and yeasts. We evaluated duodenoscopes with ≥1 CFU of organisms after reprocessing. The reprocessing environments were also sampled and cultured.
RESULTS
We assessed 859 newer-model (NM) duodenoscopes (TJF-Q180V) and 850 older-model (OM) duodenoscopes (TJF-160F/VF); of these, 35 NM samples (4.1%) and 56 OM samples (6.6%) were contaminated with HC organisms. We detected and classified the HC organisms as gastrointestinal (45.4%), human origin (16.7%), environmental (24.1%), waterborne (13.0%), and unidentified (0.9%).
CONCLUSIONS
We detected an overall HC contamination rate of 5.3% in nonoutbreak settings. Although the relationship between endoscopic contamination and the occurrence of infections remains unclear, attempts should continue to be made to further reduce contamination rates. Additional improvements to the manufacturer's instructions for use, human factors during the reprocessing procedure, ongoing training programs, cleanliness of reprocessing environments, and the design of the distal end of the duodenoscope should be considered.
Topics: Humans; Duodenoscopes; Prospective Studies; Equipment Contamination; Disease Outbreaks; Gram-Negative Bacteria; Disinfection
PubMed: 35300743
DOI: 10.1017/ice.2021.525 -
Gastrointestinal Endoscopy Apr 2019
Topics: Duodenoscopes
PubMed: 30902223
DOI: 10.1016/j.gie.2019.01.027 -
The Journal of Hospital Infection Feb 2023Microbiological cultures are the gold standard in the monitoring of duodenoscope reprocessing. However, many different sampling and culturing techniques are used, making...
AIM
Microbiological cultures are the gold standard in the monitoring of duodenoscope reprocessing. However, many different sampling and culturing techniques are used, making it difficult to compare results. The latest Centers for Disease Control and Prevention protocol advises the use of a neutralizer to deactivate any remaining disinfectants in the samples. This study compared culturing results of duodenoscope samples collected with and without addition of a neutralizer.
METHODS
Six duodenoscopes were soiled with gut bacteria in a non-clinical experimental setting and reprocessed afterwards. Samples of the tip and working channel were collected immediately after decontamination or after drying. Dey-Engley (DE) broth was added as a neutralizer to the samples of four duodenoscopes; samples for the other two duodenoscopes were collected without the addition of DE broth.
RESULTS
Post-decontamination cultures were significantly more likely to be positive for growth of the applied micro-organisms in the group of samples with DE broth (88.1% vs 20.2%; P<0.0001). Post-drying samples were significantly more likely to be positive in the group of samples without DE broth (75.7% vs 33.4%; P<0.001).
CONCLUSION
The addition of DE broth to samples collected from wet duodenoscopes increases the yield of those cultures. Remaining disinfectants in wet duodenoscopes can lead to false-negative results. This can be overcome by adding a neutralizer, such as DE broth, to the samples. The higher yield after drying in the group without neutralizer could be due to biofilm formation in these two duodenoscopes, but this was not investigated. Standardization of the sampling method can help to compare both clinical and study results regarding duodenoscope contamination.
Topics: Humans; Duodenoscopes; Equipment Contamination; Disinfectants; Bacteria; Disinfection
PubMed: 36414167
DOI: 10.1016/j.jhin.2022.11.008 -
Gastrointestinal Endoscopy Aug 2018After recent outbreaks of duodenoscope-related infections from multidrug-resistant organisms (MDRO), the United States Food and Drug Administration (FDA) recommended...
BACKGROUND AND AIMS
After recent outbreaks of duodenoscope-related infections from multidrug-resistant organisms (MDRO), the United States Food and Drug Administration (FDA) recommended implementing 1 or more of 4 enhanced reprocessing measures in addition to updated manual cleaning methods and high-level disinfection (HLD). The implementation of these techniques in endoscopy facilities and provider opinions regarding reprocessing priorities remain unknown.
METHODS
Physicians, nurse managers, nurses, and infection control staff at endoscopy units performing ERCP in the United States were surveyed to assess current institutional practices and individual opinions regarding future reprocessing solutions.
RESULTS
A total of 249 distinct institutions participated in the survey. Of these, 223 (89.6%) implemented at least 1 of the 4 supplemental reprocessing methods after MDRO outbreaks. Overall, 63% of centers used repeat HLD, 53% performed surveillance microbiological culturing, 35% used liquid chemical sterilization, and 12% used ethylene oxide sterilization. Thirty-seven centers (15%) routinely screened patients for MDRO. Forced-air drying after reprocessing was used by 47.8% of centers. Fifty percent of individual respondents, including 58.6% of physicians, believed that redesign of the duodenoscope is the best long-term reprocessing solution. The majority (55.1%) identified efficacy to be the single most important factor in selecting a reprocessing technique.
CONCLUSIONS
Although most endoscopy centers have implemented enhanced duodenoscope reprocessing techniques, there is a large variation in practice. Most providers believe that duodenoscope redesign and identifying reprocessing techniques with maximal efficacy are the long-term priorities. Improved adherence to forced-air drying in duodenoscope reprocessing is needed.
Topics: Attitude of Health Personnel; Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Cross-Sectional Studies; Disinfection; Duodenoscopes; Equipment Contamination; Equipment Design; Equipment Reuse; Ethylene Oxide; Humans; Infection Control; Surveys and Questionnaires; United States
PubMed: 29684387
DOI: 10.1016/j.gie.2018.04.2340 -
Gastrointestinal Endoscopy Aug 2018Iatrogenic infections related to duodenoscopes remain a top concern for medical centers where ERCP is performed. We assessed the long-term results and impact of key...
BACKGROUND AND AIMS
Iatrogenic infections related to duodenoscopes remain a top concern for medical centers where ERCP is performed. We assessed the long-term results and impact of key interventions in the optimization of a rigorous "culture and quarantine" program for duodenoscope reprocessing.
METHODS
We reviewed a prospectively collected, quality assurance database of all duodenoscope cultures (n = 4307) obtained for the initial 3-year duration of culture and quarantine from 2014 to 2017 in a single U.S.-based, high-volume endoscopy center. All duodenoscopes were subject to manual cleaning and automated reprocessing and drying, followed by sampling using a modified protocol developed by the Centers for Disease Control and Prevention. Duodenoscopes were cultured per-use.
RESULTS
A total of 4307 duodenoscope cultures were obtained during the study period. High-concern organisms were isolated from 33 of these cultures, resulting in a .697% high-level disinfection defect rate. Statistically significant interventions included withdrawal of a high-frequency culture-positive duodenoscope (scope A) from clinical service in addition to implementation of new manufacturer-recommended cleaning protocols. Withdrawal of a second high-frequency culture-positive duodenoscope (scope B) and a mandatory device retrofit had no effect on the observed rate of positive duodenoscope cultures.
CONCLUSIONS
Withdrawal of duodenoscopes with a high rate of culture positivity and optimizing manual cleaning practices have contributed to an overall decline in the high-level disinfection defect rate. A stringent culture and quarantine protocol allowed identification of the culprit endoscopes. There remains a much-needed role for an inexpensive and highly reliable method to check on the adequacy of reprocessing given the inherent complexity of these tasks.
Topics: Bacteriological Techniques; Cross Infection; Disinfection; Drug Resistance, Multiple, Bacterial; Duodenoscopes; Equipment Contamination; Humans; Quarantine
PubMed: 29476846
DOI: 10.1016/j.gie.2018.02.015 -
Case Reports in Gastroenterology 2021The Food and Drug Administration (FDA) has recently released a safety communication recommending transition to duodenoscopes with innovative designs that facilitate or...
The Food and Drug Administration (FDA) has recently released a safety communication recommending transition to duodenoscopes with innovative designs that facilitate or eliminate the need for reprocessing. Thus, there has been a significant amount of development into disposable duodenoscope components and single-use duodenoscopes, with variable tactile feedback. We describe a case of esophageal perforation after using a single-use disposable duodenoscope (EXALT Model D; Boston Scientific Corporation, Marlborough, MA, USA). To our knowledge, this is the first reported case of an esophageal perforation since FDA approval of this device in December 2019. ERCP was performed with the EXALT Model D single-use duodenoscope (Boston Scientific Corporation) by an experienced gastroenterologist. During the procedure, gentle force applied through the gastroesophageal junction caused a liner perforation in the distal esophagus. An esophageal stent was placed with satisfactory wound healing and no fistula formation. There have been a few reports in the last 2 years showing promising results using this device; however, the differences in the tactile feedback, navigation, and pushability of the device may make it prone to unintended consequences.
PubMed: 35110984
DOI: 10.1159/000519685 -
Gastrointestinal Endoscopy Sep 2020Contaminated duodenoscopes and linear echoendoscopes (DLEs) pose a risk for infectious outbreaks. To identify DLEs and reprocessing risk factors, we combined the data...
BACKGROUND AND AIMS
Contaminated duodenoscopes and linear echoendoscopes (DLEs) pose a risk for infectious outbreaks. To identify DLEs and reprocessing risk factors, we combined the data from the previously published nationwide cross-sectional PROCESS 1 study (Prevalence of contamination of complex endoscopes in the Netherlands) with the follow-up PROCESS 2 study.
METHODS
We invited all 74 Dutch DLE centers to sample ≥2 duodenoscopes during PROCESS 1, and all duodenoscopes as well as linear echoendoscopes during PROCESS 2. The studies took place 1 year after another. Local staff sampled each DLE at ≤6 sites according to uniform methods explained by online videos. We used 2 contamination definitions: (1) any microorganism with ≥20 colony-forming units (CFU)/20 mL (AM20) and (2) presence of microorganisms with GI or oral origin, independent of CFU count (MGOs). We assessed the factors of age and usage by performing an analysis of pooled data of both PROCESS studies; additional factors including reprocessing characteristics were only recorded in PROCESS 2.
RESULTS
Ninety-seven percent of all Dutch centers (72 of 74; PROCESS 1, 66; PROCESS 2, 61) participated in one of the studies, sampling 309 duodenoscopes and 64 linear echoendoscopes. In total, 54 (17%) duodenoscopes and 8 (13%) linear echoendoscopes were contaminated according to the AM20 definition. MGOs were detected on 47 (15%) duodenoscopes and 9 (14%) linear echoendoscopes. Contamination was not age or usage dependent (all P values ≥.27) and was not shown to differ between the reprocessing characteristics (all P values ≥.01).
CONCLUSIONS
In these nationwide studies, we found that DLE contamination was independent of age and usage. These results suggest that old and heavily used DLEs, if maintained correctly, have a similar risk for contamination as new DLEs. The prevalence of MGO contamination of ∼15% was similarly high for duodenoscopes as for linear echoendoscopes, rendering patients undergoing ERCP and EUS at risk for transmission of microorganisms.
Topics: Cross Infection; Cross-Sectional Studies; Disinfection; Duodenoscopes; Equipment Contamination; Humans; Netherlands; Risk Assessment
PubMed: 32502549
DOI: 10.1016/j.gie.2020.05.030 -
Gastrointestinal Endoscopy Clinics of... Oct 2020With reports of ongoing duodenoscope contamination and pathogen transmission despite strict adherence to manufacturer reprocessing instructions, professional societies... (Review)
Review
With reports of ongoing duodenoscope contamination and pathogen transmission despite strict adherence to manufacturer reprocessing instructions, professional societies continue to release updated recommendations. Despite general guideline similarities, there are differences. Although adherence to guidelines does not entirely eliminate pathogen contamination or transmission, it is critical to strictly adhere to updated guidelines for maximum risk reduction. In the United States, the Food and Drug Administration and Centers for Disease Control and Prevention continue to offer updates regarding improved duodenoscope reprocessing techniques and endoscope design. This article critically analyzes currently available national and international duodenoscope reprocessing guidelines.
Topics: Centers for Disease Control and Prevention, U.S.; Cholangiopancreatography, Endoscopic Retrograde; Consensus; Cross Infection; Duodenoscopes; Duodenoscopy; Guidelines as Topic; Humans; Infection Control; Societies, Medical; United States; United States Food and Drug Administration
PubMed: 32891231
DOI: 10.1016/j.giec.2020.06.008 -
Digestive Endoscopy : Official Journal... May 2019
Topics: Cholangiopancreatography, Endoscopic Retrograde; Choledocholithiasis; Duodenoscopes; Humans; Infant, Newborn; Magnetic Resonance Imaging
PubMed: 30803055
DOI: 10.1111/den.13380 -
Digestive Endoscopy : Official Journal... Jan 2022A single-use duodenoscope (SUD) has been recently developed to overcome issues with endoscopic retrograde cholangiopancreatography (ERCP)-related cross-infections. The...
OBJECTIVES
A single-use duodenoscope (SUD) has been recently developed to overcome issues with endoscopic retrograde cholangiopancreatography (ERCP)-related cross-infections. The aim was to evaluate SUD safety and performance in a prospective multi-centre study.
METHODS
All consecutive patients undergoing ERCP in six French centers were prospectively enrolled. All procedures were performed with the SUD; in case of ERCP failure, operators switched to a reusable duodenoscope. Study outcomes were the successful completion of the procedure with SUD, safety and operators' satisfaction based on a VAS 0-10 and on 22 qualitative items. The study protocol was approved by French authorities and registered (ID-RCB: 2020-A00346-33). External companies collected the database and performed statistical analysis.
RESULTS
Sixty patients (34 females, median age 65.5 years old) were enrolled. Main indications were bile duct stones (41.7%) and malignant biliary obstruction (26.7%). Most ERCP were considered ASGE grade 2 (58.3%) or 3 (35.0%). Fifty-seven (95.0%) procedures were completed using the SUD. Failures were unrelated to SUD (one duodenal stricture, one ampullary infiltration, and one tight biliary stricture) and could not be completed with reusable duodenoscopes. Median operators' satisfaction was 9 (7-9). Qualitative assessments were considered clinically satisfactory in a median of 100% of items and comparable to a reusable duodenoscope in 97.9% of items. Three patients (5%) reported an adverse event. None was SUD-related.
CONCLUSIONS
The use of a SUD allows ERCP to be performed with an optimal successful rate. Our data show that SUD could be used for several ERCP indications and levels of complexity.
Topics: Aged; Bile Duct Diseases; Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Duodenoscopes; Female; Humans; Prospective Studies
PubMed: 33666280
DOI: 10.1111/den.13965