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Der Gastroenterologe : Zeitschrift Fur... 2022Clinically relevant infections triggered by the use of flexible endoscopes and respective consumables have become the focus of clinical and scientific interest in the... (Review)
Review
Clinically relevant infections triggered by the use of flexible endoscopes and respective consumables have become the focus of clinical and scientific interest in the literature. Endoscopy-associated infections can be assigned to one of two groups: (i) endogenous infections are triggered by the spread of the patient's own local flora and (ii) exogenous infections result from transmission of contaminated material or endoscopes. The number of reported infectious complications in flexible endoscopy is low but likely underestimated due to inadequate surveillance strategies and lack of clinical symptoms. To prevent exogenous infections, single-use endoscopes were brought to the market. Single-use bronchoscope have been part of routine clinical care for years, while single-use duodenoscopes have only recently been approved. The increased patient safety and economic costs were clearly evaluated for the single-use bronchoscopes, but this still needs to be studied for single-use duodenoscopes. The use of single-use endoscopes-at first glance-represents an additional financial burden on the healthcare system. However, in addition to the material costs of disposable endoscopes, the costs that are avoided by them (e.g., prolonged hospitalization, intensive care treatment, and follow-up interventions) must also be included in the overall calculation.
PubMed: 35018195
DOI: 10.1007/s11377-021-00581-9 -
Endoscopy Dec 2023The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde... (Clinical Trial)
Clinical Trial
BACKGROUND
The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas.
METHODS
61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs).
RESULTS
Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis.
CONCLUSIONS
In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.
Topics: Adult; Male; Humans; Female; Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Endoscopy, Gastrointestinal; Pancreatitis
PubMed: 37463599
DOI: 10.1055/a-2131-7180 -
VideoGIE : An Official Video Journal of... Aug 2023Duodenal polyps have a reported incidence of 0.3% to 4.6%. Sporadic, nonampullary duodenal adenomas (SNDAs) comprise less than 10% of all duodenal polyps, and ampullary... (Review)
Review
BACKGROUND AND AIMS
Duodenal polyps have a reported incidence of 0.3% to 4.6%. Sporadic, nonampullary duodenal adenomas (SNDAs) comprise less than 10% of all duodenal polyps, and ampullary adenomas are even less common. Nonetheless, the incidence continues to rise because of widespread endoscopy use. Duodenal polyps with villous features or those that are larger than 10 mm may raise concern for malignancy and require removal. We demonstrate endoscopic resection of SNDAs and ampullary adenomas using some of our preferred techniques.
METHODS
The duodenum has several components that can make EMR of duodenal polyps technically challenging. Not only does the duodenum have a thin muscle layer, but it is also highly mobile and vascular, which may explain higher rates of perforation and bleeding of duodenal EMR reported in the literature compared with colon EMR. A standard adult gastroscope with a distal cap is commonly used for duodenal EMRs. Based on the location, however, side-viewing duodenoscopes or pediatric colonoscopes may be used. To prepare for EMR, a submucosal injection is performed for an adequate lift. The polyp is then resected via stiff monofilament snares and subsequently closed with hemostatic clips if feasible. The ampullectomy technique differs slightly from duodenal EMRs and carries the additional risk of pancreatitis. Submucosal injection in the ampulla may not lift well; thus, its utility is debatable. Biliary sphincterotomy should be performed, and based on endoscopist preference, the pancreatic duct (PD) guidewire can be left during resection to maintain access. After resection, a PD stent is placed to minimize pancreatitis risk.
RESULTS
The video shows the aforementioned duodenal EMR techniques. Two clips of ampullectomy are also shown in the video.
CONCLUSIONS
A few common techniques used to perform duodenal EMR and ampullectomy are highlighted in the video. It is important to understand and manage adverse events associated with these procedures and to have established surveillance plans.
PubMed: 37575136
DOI: 10.1016/j.vgie.2023.05.006 -
Current Opinion in Gastroenterology Sep 2003We are beginning to better understand the causes of chronic pancreatitis. This knowledge will hopefully lead to better diagnosis and treatment and abandonment of...
PURPOSE OF REVIEW
We are beginning to better understand the causes of chronic pancreatitis. This knowledge will hopefully lead to better diagnosis and treatment and abandonment of ill-conceived treatments. This review highlights contributions that moved the field toward these goals in the past year.
RECENT FINDINGS
Small steps have been made toward a better understanding of the molecular basis, particularly genetic causes, of the forms of chronic pancreatitis. Investigation of the role of stellate cells, an essential component of the fibrosis of chronic pancreatitis, has led to the finding that lovastatin inhibits stellate cell activation and could surface as a novel treatment of chronic pancreatitis. The clinical description of autoimmune pancreatitis has led to the realization that steroids are effective treatment for this form of chronic pancreatitis. Other treatments such as extracorporeal shock wave lithotripsy and endoscopic treatments have not been proved, because no controlled studies support these treatments over other treatments. The diagnosis of chronic pancreatitis may be enhanced by the new imaging technique of electronic pancreatoscopy whereby a 2.1-mm diameter scope can be advanced into the pancreatic duct through a duodenoscope. However, the data are too preliminary at this time to advocate this imaging procedure. A potential new endoscopic pancreatic function test may lead to more widespread use of function testing, but this test is not perfected and also cannot be advised for use at present.
SUMMARY
Ongoing basic and clinical research this past year has further characterized the genetic, molecular, and clinical aspects of chronic pancreatitis: efforts that may translate into novel therapies, once well-designed, controlled studies have been performed.
PubMed: 15703588
DOI: 10.1097/00001574-200309000-00003 -
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 -
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 -
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 -
VideoGIE : An Official Video Journal of... Dec 2020
PubMed: 33024906
DOI: 10.1016/j.vgie.2020.08.011 -
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 -
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