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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 -
Canadian Journal of Gastroenterology &... 2019Duodenoscope use in healthcare facilities has been associated with transmission of multidrug resistant pathogens between patients. To assist healthcare facilities in... (Comparative Study)
Comparative Study Randomized Controlled Trial
Duodenoscope use in healthcare facilities has been associated with transmission of multidrug resistant pathogens between patients. To assist healthcare facilities in monitoring the quality of their duodenoscope reprocessing procedures and limit patient risk of infection, the Centers for Disease Control and Prevention (CDC) deployed voluntary interim duodenoscope sampling and culturing surveillance protocols in 2015. Though the interim methods were widely adopted, alternative surveillance protocols were developed and implemented at individual institutions. Here, we compared two sampling methods-the 2015 CDC interim protocol and an alternative protocol developed by the University of Wisconsin Hospitals and Clinics (UWHC). We hypothesized that the UWHC protocol would detect a higher incidence of bacterial contamination from reprocessed duodenoscopes. A total of 248 sampling events were performed at UWHC. The CDC protocol ( = 129 sampling events) required culturing samples collected from each duodenoscope after brushing its terminal end and flushing its lumen with sterile water. The UWHC protocol ( = 119 sampling events) required culturing samples collected from each duodenoscope after swabbing its elevator, immersing its terminal end into broth and flushing its lumen with saline. With the CDC method, 8.53% ( = 11) of the duodenoscopes sampled were positive for bacterial growth with 15 isolates recovered. Using the UWHC method, 15.13% ( = 18) of cultures were positive for bacterial growth with 20 isolates recovered. The relative risk of identifying a contaminated duodenoscope using the CDC interim method, however, was not different than when using the UWHC protocol. Mean processing time (27.35 and 5.11 minutes, < 0.001) and total cost per sample event ($17.87 and $15.04) were lower using the UWHC method. As the UWHC protocol provides similar detection rates as the CDC protocol, the UWHC method is useful, provided the shorter processing time and lower cost to perform.
Topics: Disinfection; Duodenoscopes; Equipment Contamination; Equipment Reuse; Humans; Microbiological Techniques; Prospective Studies; Time Factors
PubMed: 31828050
DOI: 10.1155/2019/1959141 -
Gastrointestinal Endoscopy Dec 2022
Topics: Humans; Duodenoscopes
PubMed: 36007585
DOI: 10.1016/j.gie.2022.08.025 -
Current Opinion in Gastroenterology Sep 2020The elevator mechanism of the duodenoscope was the focus of endoscopically transmitted infections prior to the COVID-19 pandemic. Since that time, the 'suspicious... (Review)
Review
PURPOSE OF REVIEW
The elevator mechanism of the duodenoscope was the focus of endoscopically transmitted infections prior to the COVID-19 pandemic. Since that time, the 'suspicious suspects' in the endoscopy unit have grown in number in the eyes of both patients and endoscopists.
RECENT FINDINGS
This review summarizes the existing guidelines related to infection control in the endoscopy unit and emerging technologies to address gaps, identifies recommendations proposed during the COVID-19 pandemic, and reminds the reader that infection prevention has not changed since the emergence of COVID-19, only the importance of infection prevention has increased in visibility.
SUMMARY
Infection prevention has been and will always be necessary in the gastrointestinal endoscopy unit. Although outbreaks of antibiotic-resistant organisms and infectious diseases like COVID-19 raise the profile of infection control, there have been no major changes to infection control practice recommendations because of the global pandemic. The history of lapses in infection control, persistent contamination of reprocessed endoscopes, and failure of many endoscopy units to identify certain endoscopic procedures as aerosol-generating procedures prior to the pandemic emphasize the need for better knowledge and implementation of infection control practices within endoscopy units.
Topics: Betacoronavirus; COVID-19; Coronavirus Infections; Cross Infection; Disinfection; Duodenoscopes; Endoscopy, Gastrointestinal; Equipment Contamination; Humans; Infection Control; Pandemics; Pneumonia, Viral; Practice Guidelines as Topic; SARS-CoV-2
PubMed: 32739998
DOI: 10.1097/MOG.0000000000000669 -
BMJ Open Gastroenterology 2019Cleaning and high-level disinfection have been the standard in the USA and other countries for reprocessing flexible endoscopes, including duodenoscopes and other types... (Review)
Review
BACKGROUND
Cleaning and high-level disinfection have been the standard in the USA and other countries for reprocessing flexible endoscopes, including duodenoscopes and other types of gastrointestinal endoscopes. For decades, this practice has been a cornerstone for infection prevention in the endoscopic setting. However, amid recent reports associating the use of duodenoscopes with infections and outbreaks of carbapenem-resistant (CRE) and related multidrug-resistant organisms (MDROs), reasonable questions about the adequacy of current practices for reprocessing duodenoscopes have emerged.
OBJECTIVES
To review and evaluate the adequacy of current reprocessing practices for preventing duodenoscopes from transmitting CRE and related MDROs.
METHODS
The MEDLINE/PubMed database was searched to identify published cases associating confirmed (or suspected) infections of CRE or a related MDRO with exposure to a duodenoscope since 2012, when duodenoscopes became a recognised risk factor for the transmission of CRE. The Internet was also searched to identify news articles and other reports documenting eligible cases occurring during this same timeframe but not identified during the MEDLINE database's search. The Food and Drug Administration's (FDA) medical device database was queried to identify regulatory reports describing these same types of cases, also recorded since 2012. The clinical and reprocessing details of each eligible case were reviewed to identify (when possible): (a) the reprocessing method (e.g., high-level disinfection) performed at the time of the infections, (b) whether the facility's compliance with the manufacturer's reprocessing instructions was confirmed, and (c) the measure(s) or corrective action(s) the facility implemented to prevent additional multidrug-resistant infections.
RESULTS
Seventeen cases in the USA and six in other countries (primarily Europe) associating infections (and colonizations) of CRE or a related MDRO with exposure to a duodenoscope were reviewed. Fourteen of these 23 outbreaks were caused by CRE, and six by a related MDRO. Two of these six latter cases identified carrying the gene as the pathogen. For 12 of these 23 cases, it was reported or implied that the duodenoscope was being high-level disinfected at the time of the infections, consistent with published guidelines. For the remaining 11 cases, the associated report(s) did not clearly identify how the duodenoscope was being reprocessed at the time of the infections (although it may be reasonably concluded that at least some, if not all, of these 11 cases involved high-level disinfection).Further, eight of the 23 cases reported the duodenoscope was being reprocessed in accordance with the manufacturer's instructions for use (and professional guidelines) at the time of the infections. Seven of the cases discussed the design of the duodenoscope (eg, the forceps elevator mechanism) in the context of reprocessing and the infections. Three of the cases identified one or more reprocessing lapses, including inadequate cleaning, delayed reprocessing and improper drying and/or storage of the duodenoscope. Most of these 23 cases were associated with exposure to a duodenoscope model featuring a sealed elevator-wire channel. Six of the cases reported adopting (or in one case supplementing high-level disinfection with) ethylene oxide (EO) gas sterilisation of the duodenoscope, with at least three reporting this measure terminated the outbreak. Other measures adopted to prevent additional infections included removing the implicated duodenoscope from use, re-training staff about proper cleaning, microbiological culturing of the duodenoscope and returning the duodenoscope to the manufacturer for evaluation, maintenance and/or repair.
CONCLUSIONS
This study's findings suggest current reprocessing practices may not always be sufficiently effective to prevent a duodenoscope from transmitting CRE and related MDROs, at least in some circumstances including an outbreak setting. Factors this review identifed that may contribute to the device remaining contaminated after reprocessing include the device's design; breaches of recommended reprocessing guidelines (eg, inadequate manual cleaning, delayed reprocessing or improper device storage); damage to the device; lacking servicing, maintenance or repair; and/or the presence of biofilms. Measures that can mitigate the impact of these and other reprocessing challenges and reduce, if not eliminate, the risk of transmission of CRE or a related MDRO by a duodenoscope include the use of EO gas sterilization (or another comparably effective process or method). In 2015, the FDA suggested healthcare facilities consider performing at least one of four supplemental measures, which include EO gas sterilisation, to improve the effectiveness of duodenoscope reprocessing. Whether the FDA and Centers for Disease Control and Prevention might reclassify duodenoscopes as devices requiring sterilisation is currently unresolved.
PubMed: 31423318
DOI: 10.1136/bmjgast-2019-000282 -
Endoscopy International Open Sep 2023The costs of reusable endoscope reprocessing have been evaluated, yet external validity of the findings remains challenging. The aim of this study was to assess the...
The costs of reusable endoscope reprocessing have been evaluated, yet external validity of the findings remains challenging. The aim of this study was to assess the costs of purchase, maintenance, microbiological control, and reprocessing of a reusable duodenoscope per endoscopic retrograde cholangiopancreatography (ERCP) in France. Study findings exclude the costs of infection, downtime due to breakdown, reprocessing single-use material disposal, and device disposal, all of which should also be considered. The study encompassed both observational and theoretical approaches. Observational data were collected in four hospitals, from December 2019 to December 2020, with an ad hoc survey, based on 2016 and 2018 national guidelines for duodenoscope reprocessing. Costs were modeled, using the same guidelines, assuming a mean workload of 223 ERCP/duodenoscope/year. The mean observed cost of purchase, maintenance, microbiological control, reprocessing (human resources and consumables), and overhead (additional 35%) with a reusable duodenoscope was €80.23 (standard deviation €3.77) per ERCP. The corresponding mean theoretical cost was €182.71 for manual reprocessing without endoscope drying cabinet (EDC), €191.36 for manual reprocessing with EDC, €235.25 for automated endoscope reprocessing (AER) without EDC, and €253.62 for AER with EDC. Because procedures, equipment, volume activity, number of duodenoscopes, human resources, and internal work organizations are hospital-dependent, observed costs varied between hospitals. Theoretical costs were higher than observed costs, showing that the theoretical approach is not sufficient. Hypotheses to explain the difference between the two approaches include failing to measure some costs in the survey and challenges in guideline implementation.
PubMed: 37942444
DOI: 10.1055/a-2153-7016 -
Techniques and Innovations in... 2021Over 16 million cases worldwide, severe acute respiratory syndrome coronavirus 2 has profoundly affected healthcare as we know it. Given reports of gastrointestinal... (Review)
Review
Over 16 million cases worldwide, severe acute respiratory syndrome coronavirus 2 has profoundly affected healthcare as we know it. Given reports of gastrointestinal involvement and viral shedding in the stool, it is unsurprising there are concerns that endoscopic equipment may be a potential vector of viral transmission. Here, we provide an overview of existing practices for endoscope reprocessing, recent developments in the field, and challenges in the COVID-19 environment. Current multi-society guidelines do not advise any change to endoscope disinfection protocols but emphasize strict adherence to recommended practices. However, endoscopy reprocessing staff may benefit from supplemental personal protective equipment measures, especially in high risk situations. Because thorough endoscope reprocessing is highly operator dependent, adequate training of personnel is critical for proper manual cleaning and disinfection of endoscopes that have potential to harbor virus. Bacterial contamination of duodenoscopes has caused outbreaks of infection from multidrug-resistant organisms, highlighting vulnerable areas. The emphasis of current studies is on optimization of disinfection and drying, minimization of simethicone use, and on quality control of endoscope reprocessing with sampling and microbiological culturing. Recent advances include novel approaches to endoscope sterilization, infection barrier methods, and design of partially or fully disposable duodenoscopes. Overall, the available data indicate that, when correctly executed, current reprocessing practices are sufficient in preventing SARS-COV-2 transmission.
PubMed: 33103131
DOI: 10.1016/j.tige.2020.10.001 -
Clinical Endoscopy Nov 2022Endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y gastric bypass anatomy is a well-documented challenge. Traditionally, this problem has... (Review)
Review
Endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y gastric bypass anatomy is a well-documented challenge. Traditionally, this problem has been overcome with adjunctive techniques, such as device-assisted ERCP, including double-balloon or single-balloon enteroscopy and laparoscopy-assisted transgastric ERCP. Endoscopic ultrasound-directed transgastric ERCP (EDGE) is a novel technique that enables access to the ampulla using a duodenoscope without surgical intervention and has shown high clinical and technical success rates in recent studies. However, this approach is technically demanding, necessitating a thorough understanding of the gastrointestinal anatomy as well as high operator experience. In this review, we provide a technical overview of EDGE in parallel with our personal experience at our center and propose a simple algorithm to select patients for its appropriate application. In conjunction, the outcomes of EDGE compared with those of device-assisted and laparoscopy-assisted transgastric ERCP will be discussed.
PubMed: 36464820
DOI: 10.5946/ce.2022.114 -
Endoscopy Oct 2020
Topics: Betacoronavirus; COVID-19; Cholangiopancreatography, Endoscopic Retrograde; Coronavirus Infections; Duodenoscopes; Humans; Pandemics; Pneumonia, Viral; SARS-CoV-2
PubMed: 32967025
DOI: 10.1055/a-1194-4745 -
Revista Espanola de Enfermedades... Feb 2022The performance of an endoscopic procedure involves introducing an endoscope through the mouth or the anus, which may potentially lead to lethal infection. The risk...
The performance of an endoscopic procedure involves introducing an endoscope through the mouth or the anus, which may potentially lead to lethal infection. The risk increases when complex and difficult-to-clean scopes are used, as in the case of duodenoscopes. Side-viewing duodenoscopes are complex in design, with the camera and working channel exit located on one side of the endoscope's distal end, and with an elevator nail also located at this point for catheter redirection. This complex design may facilitate the presence of blind areas not easy to access for cleaning, resulting in suboptimal disinfection of the duodenoscope and therefore a higher risk of bacterial infection. This is of particular importance in particularly vulnerable patients like those who are immunosuppressed (e.g., transplanted patients) or have a malignant disease and are receiving chemotherapy. Moreover, in the era of ¨superbugs¨, like carbapenem-resistant Enterobacteriaceae, infection outbreaks related to endoscopic retrograde cholangiopancreatography (ERCP) have been reported with a significant mortality rate.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Costs and Cost Analysis; Delivery of Health Care; Disinfection; Duodenoscopes; Humans
PubMed: 35045718
DOI: 10.17235/reed.2022.8570/2021