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Infection and Drug Resistance 2018Duodenoscopes have been widely used for both diagnostic and therapeutic endoscopic retrograde cholangiopancreatography procedures. Numerous outbreaks of...
INTRODUCTION
Duodenoscopes have been widely used for both diagnostic and therapeutic endoscopic retrograde cholangiopancreatography procedures. Numerous outbreaks of duodenoscope-associated infections involving multidrug-resistant bacteria have recently been reported. Plasma activated water (PAW) has been widely considered an effective agent for surface decontamination and is increasingly used for disinfection of medical equipment. The aim of this study was to evaluate whether the duodenoscopes currently on market are suited for the repeated use of PAW and to test the efficacy of PAW for their disinfection.
MATERIALS AND METHODS
In order to evaluate the disinfection efficacy and the required time of contact, the duodenoscope samples were contaminated by immersing them in fasted-state simulated intestinal fluid containing , , , and , prior to PAW exposure. In order to test the duodenoscope polymer compatibility with PAW, a challenge test was conducted by immersing the samples in PAW for 30 minutes daily for 45 consecutive days.
RESULTS
Significant reductions in bacterial populations were achieved after 30 minutes of PAW treatment, indicating a high-level disinfection. Atomic force microscopy and scanning electron microscopy were used to demonstrate that repeated PAW treatment of duodenoscope coating polymer samples did not result in significant differences in morphological surface between the treated and untreated samples. Energy-dispersive X-ray spectroscopy analysis also showed no significant differences between the elemental composition of the duodenoscope coating polymer samples before and after repeated PAW treatment.
CONCLUSION
Considering these preliminary results, PAW could be considered as a new alternative for duodenoscope reprocessing.
PubMed: 29844690
DOI: 10.2147/IDR.S159243 -
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 -
VideoGIE : An Official Video Journal of... Dec 2020
PubMed: 33024906
DOI: 10.1016/j.vgie.2020.08.011 -
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 -
World Journal of Gastroenterology Nov 2013Pseudocysts and biliary obstructions will affect approximately one third of patients with chronic pancreatitis (CP). For CP-related, uncomplicated, pancreatic... (Review)
Review
Pseudocysts and biliary obstructions will affect approximately one third of patients with chronic pancreatitis (CP). For CP-related, uncomplicated, pancreatic pseudocysts (PPC), endoscopy is the first-choice therapeutic option. Recent advances have focused on endosonography-guided PPC transmural drainage, which tends to replace the conventional, duodenoscope-based coma immediately approach. Ancillary material is being tested to facilitate the endosonography-guided procedure. In this review, the most adequate techniques depending on PPC characteristics are presented along with supporting evidence. For CP-related biliary obstructions, endoscopy and surgery are valid therapeutic options. Patient co-morbidities (e.g., portal cavernoma) and expected patient compliance to repeat endoscopic procedures are important factors when selecting the most adapted option. Malignancy should be reasonably ruled out before embarking on the endoscopic treatment of presumed CP-related biliary strictures. In endoscopy, the gold standard technique consists of placing simultaneous, multiple, side-by-side, plastic stents for a one-year period. Fully covered self-expandable metal stents are challenging this method and have provided 50% mid-term success.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Cholestasis; Drainage; Endosonography; Humans; Pancreatic Pseudocyst; Pancreatitis, Chronic; Patient Selection; Risk Factors; Stents; Treatment Outcome
PubMed: 24259962
DOI: 10.3748/wjg.v19.i42.7308 -
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 -
World Journal of Gastrointestinal... May 2015Peroral cholangioscopy (POC) is an important tool for the management of a selected group of biliary diseases. Because of its direct visualization, POC allows targeted... (Review)
Review
Peroral cholangioscopy (POC) is an important tool for the management of a selected group of biliary diseases. Because of its direct visualization, POC allows targeted diagnostic and therapeutic procedures. POC can be performed using a dedicated cholangioscope that is advanced through the accessory channel of a duodenoscope or via the insertion of a small-diameter endoscope directly into the bile duct. POC was first described in the 1970s, but the use of earlier generation devices was substantially limited by the cumbersome equipment setup and high repair costs. For nearly ten years, several technical improvements, including the single-operator system, high-quality images, the development of dedicated accessories and the increased size of the working channel, have led to increased diagnostic accuracy, thus assisting in the differentiation of benign and malignant intraductal lesions, targeting biopsies and the precise delineation of intraductal tumor spread before surgery. Furthermore, lithotripsy of difficult bile duct stones, ablative therapies for biliary malignancies and direct biliary drainage can be performed under POC control. Recent developments of new types of conventional POCs allow feasible, safe and effective procedures at reasonable costs. In the current review, we provide an updated overview of POC, focusing our attention on the main current clinical applications and on areas for future research.
PubMed: 25992189
DOI: 10.4253/wjge.v7.i5.510 -
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