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• W3204104595 abstract "GI endoscopy carries a small but significant risk of transmission of infectious microorganisms. Flexible endoscopes are complex instruments with multiple channels and moving components, which cannot withstand sterilization with heat-based autoclaving.1Nelson D.B. Barkun A.N. Block K.P. et al.Technology status evaluation report. Transmission of infection by gastrointestinal endoscopy. May 2001.Gastrointest Endosc. 2001; 54: 824-828Abstract Full Text Full Text PDF PubMed Google Scholar Most flexible endoscopes, including duodenoscopes, are categorized by the U.S. Food and Drug Administration (FDA) as “semicritical devices,” meaning that they contact mucous membranes and require either sterilization or high-level disinfection if sterilization is not possible.2FDA Safety Communication. Reprocessing medical devices in health care settings: validation methods and labeling guidance for industry and food and drug administration staff. June 13, 2018. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-and-labeling. Accessed September 20, 2021.Google Scholar However, this seemingly rare problem of infection transmission came to the forefront in recent years when an outbreak of 65 cases of carbapenem-resistant Escherichia coli was reported at an Illinois Hospital.3Epstein L. Hunter J.C. Arwady M.A. et al.New Delhi metallo-β-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes.JAMA. 2014; 312: 1447-1455Crossref PubMed Scopus (268) Google Scholar These infections were traced back to exposure to duodenoscopes during ERCP. Additional reports of outbreaks in other countries and with different brands of duodenoscopes followed,4Wendorf K.A. Kay M. Baliga C. et al.Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak.Infect Control Hosp Epidemiol. 2015; 36: 634-642Crossref PubMed Scopus (145) Google Scholar highlighting the extent of the problem. The adequate reprocessing of flexible endoscopes requires strict compliance to cleaning protocols, including mechanical cleaning, chemical processing, and drying. Transmission of microbial infection is often due to lack of adherence to reprocessing guidelines.3Epstein L. Hunter J.C. Arwady M.A. et al.New Delhi metallo-β-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes.JAMA. 2014; 312: 1447-1455Crossref PubMed Scopus (268) Google Scholar Nevertheless, pathogenic transmission from duodenoscopes has been well documented in the absence of such lapses in cleaning protocol.3Epstein L. Hunter J.C. Arwady M.A. et al.New Delhi metallo-β-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes.JAMA. 2014; 312: 1447-1455Crossref PubMed Scopus (268) Google Scholar,4Wendorf K.A. Kay M. Baliga C. et al.Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak.Infect Control Hosp Epidemiol. 2015; 36: 634-642Crossref PubMed Scopus (145) Google Scholar Duodenoscopes are complex instruments that have a moving metallic component at the distal tip, termed the “elevator” for its ability to change the position of the guidewire during ERCP. The intricate elevator mechanism is of particular concern as a potential source of biofilm contamination because of its “microscopic hard-to-reach crevices,” which may retain “tissue or fluid and residual bacteria” that can be transferred from patient to patient if thorough cleaning and disinfection is not achieved.5FDA Safety Communication. Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning. February 23, 2015 .Available at: https://www.fdanews.com/ext/resources/files/03-15/03-02-15-endoscopes.pdf?1424972528. Accessed September 20, 2021.Google Scholar To address these challenges with duodenoscope design and reprocessing, the FDA has recommended the use of “innovative duodenoscope designs that make reprocessing easier, more effective, or unnecessary” and has cleared 6 devices, including 4 duodenoscopes with disposable endcaps (Fujifilm Corporation, Tokyo, Japan; Duodenoscope model ED-580XT; Olympus Medical Systems, Tokyo, Japan, Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus, Tokyo, Japan; Pentax Medical, Tokyo, Japan, Duodenoscope model ED34-i10T; Pentax Medical, Duodenoscope model ED34-i10T2) and 2 fully disposable duodenoscopes (Boston Scientific Corporation, Marlborough, Mass, USA, EXALT Model D Single-Use; Ambu Innovation GmbH, Augsburg, Germany, Duodenoscope model aScope Duodeno).6FDA Safety Communication Update. The FDA is recommending transition to duodenoscopes with innovative designs to enhance safety. July 24, 2020. Available at: https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication. Accessed September 20,2021.Google Scholar The use of sterile disposable duodenoscopes completely eliminates the need for reprocessing and, with that, the risk of transmitting microbial infection from patient to patient. With the recent development of these devices, data continue to emerge supporting their safety and usability. The first study examining disposable duodenoscope performance was published in 2020.7Muthusamy V.R. Bruno M.J. Kozarek R.A. et al.Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography.Clin Gastroenterol Hepatol. 2020; 18: 2108-2117.e3Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar In this multicenter case series, a total of 58 ERCP procedures were completed, with a success rate of 96.7%, with 2 procedures (3.3%) requiring crossover to a reusable duodenoscope. Bang et al8Bang J.Y. Hawes R. Varadarajulu S. Equivalent performance of single-use and reusable duodenoscopes in a randomised trial.Gut. 2021; 70: 838-844Crossref PubMed Scopus (20) Google Scholar recently published a randomized control trial (single-use n = 48 vs reusable n = 50) and showed no overall difference in cannulation rates, adverse events, or crossover to complete the procedure, although the single-use endoscope did have worse ease of passage into the stomach (P = .047), image quality (P < .001), image stability (P < .001), and air-water button functionality (P < .001). Slivka et al9Slivka A. Ross A.S. Sejpal D.V. et al.Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity.Gastrointest Endosc. 2021; 94: 1046-1055Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar have conducted a study aimed to determine the usability of a single-use duodenoscope (Exalt Model D, Boston Scientific Corporation, Marlborough, Mass, USA) in performing ERCP procedures of varying complexity by endoscopists of different experience levels. The study compared the performance of ERCP by 14 “expert” endoscopists (>2000 ERCP procedures) with 5 “less-expert” endoscopists (≤2000 ERCP procedures) and included 200 patients at 7 academic centers. The ERCP procedures encompassed all ASGE grades of complexity: grade 1 (10.3%), grade 2 (48.2%), grade 3 (30.3%), and grade 4 (11.3%). Overall, 19 cases (9.5%) required crossover from a single-use to a reusable duodenoscope, 16 of which were completed. When “expert” with “less expert” endoscopists were compared, no significant differences were found in procedural completion (96.3% vs 97.5%), procedure time (25 minutes vs 28.5 minutes), crossover rate (11.3% vs 2.5%), and proportion of high-complexity cases (43.6% vs 33.4%). On a scale of 1 to 10 (least satisfied to most satisfied), both endoscopist groups gave the single-use duodenoscope a median rating of 8. The mean procedure time was significantly shorter for less complex (ASGE 1 or 2) compared with more complex (ASGE 3 or 4) procedures, but no significant difference was seen in cannulation attempts, ERCP completion, or crossover rate. Serious adverse events were seen in 6.5% of patients, which is comparable to ERCP with a reusable duodenoscope. The authors of this study should be commended for adding to the existing literature on single-use duodenoscope use in a real-world clinical setting. Because data for disposable duodenoscopes are limited thus far, this is the largest series examining their use for ERCP. This study suggests that ERCP can successfully and safely be performed at all levels of procedural complexity across various endoscopist skill levels. However, the study also has several limitations that must be considered. Most importantly, the study does not include a control group, making it impossible to compare the performance of the disposable duodenoscope with that of reusable devices. The endoscopists were all performing ERCP in high-volume centers that may also have expert technicians and nurses assisting with cases that enabled ease of procedure performance. In addition, it was unclear how much experience each of the “less expert” endoscopists had. An endoscopist who has performed 1900 ERCPs may perform ERCP at an “expert” level compared with an endoscopist who has performed only 200 ERCPs and may still be at a novice level. One may argue that it would have been valuable to include novices in the study, because most academic centers train advanced endoscopy fellows in performing ERCP. It must also be noted that a crossover rate of 9.5% is not insignificant. This is higher than the 3.3% crossover rate documented in a previous clinical study,7Muthusamy V.R. Bruno M.J. Kozarek R.A. et al.Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography.Clin Gastroenterol Hepatol. 2020; 18: 2108-2117.e3Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar although it is difficult to compare across studies, considering the small sample size of the prior study. The median satisfaction score of 8 out of 10 is commendable but lower than the score of 9 out of 10 reported earlier.7Muthusamy V.R. Bruno M.J. Kozarek R.A. et al.Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography.Clin Gastroenterol Hepatol. 2020; 18: 2108-2117.e3Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar Finally, it must be noted that the majority of the authors are paid consultants or have received research funding from the study sponsor, which may have introduced bias into the study. Single-use endoscopes provide several practical and theoretical advantages, first and foremost being the potential safety benefit to the patient. The ability to use a sterile instrument and completely prevent exogenous pathogenic infection transmission between patients is a clinical advantage. Disposable devices could have a practical impact in certain circumstances. Examples could include performing procedures in sterile environments, such as intraoperative ERCP, or in low-volume centers where additional cleaning or culturing protocols may not be feasible. The patient populations that would benefit most from single-use instruments remain yet unknown. It seems intuitive that patients at high risk for infection, for example, the immunosuppressed such as liver transplantation patients, would be the major beneficiaries, although there is a lack of data to support this. Another potential advantage would be the ability to customize endoscopes specific to the endoscopist (adjusting dial or handle size) or clinical scenario (slimmer scope diameters for strictures or pediatric patients). Despite these possible benefits, multiple other factors will play a large role in whether or not single-use duodenoscopes are adopted on a wider scale. The financial implications of using these instruments must be examined. Overall, the use of disposable instruments will certainly increase the cost to our healthcare system. The cost of use of disposable instruments may be somewhat offset by decreases in the cost of reprocessing, although this impact may be minimal if these devices are used only in certain patient populations, given that reprocessing staff and equipment cannot be eliminated completely. Another study, by Bang et al,10Bang J.Y. Sutton B. Hawes R. et al.Concept of disposable duodenoscope: at what cost?.Gut. 2019; 68: 1915-1917Crossref PubMed Scopus (43) Google Scholar examined the cost effectiveness of single-use duodenoscopes and found that the break-even price point for a duodenoscope at a high-volume center (≥$800) is much lower than at a low-volume center (≥$1300) because the fixed costs of reprocessing at high-volume centers are spread out over a larger number of procedures. Comparison of fully disposable duodenoscopes with those that have disposable endcaps will be useful to determine the most cost-effective system. If disposable endcaps prove to be effective in preventing microbial transmission, they will certainly put competitive pressure on their fully disposable counterparts. Furthermore, the current disposable duodenoscopes have been shown to be suboptimal in terms of ease of endoscope passage and image quality compared with reusable endoscopes.8Bang J.Y. Hawes R. Varadarajulu S. Equivalent performance of single-use and reusable duodenoscopes in a randomised trial.Gut. 2021; 70: 838-844Crossref PubMed Scopus (20) Google Scholar Improvements must continue to be made if disposable endoscopes are to gain widespread use. Finally, we must consider the additional waste that will be created by disposable endoscopes. If the use of disposable endoscopes grows, maximizing the recycling of these instruments will be paramount in minimizing the environmental impact. Initial data on single-use duodenoscopes show that they can be used safely and effectively by endoscopists of varying levels of expertise. As the quality and functionality of these devices improve over time, their role in GI endoscopy will continue to evolve. The main issue that remains is how they would integrate into our current endoscope systems and in which patient populations or clinical scenarios they would have additional benefit. Future randomized comparative studies with cost and environmental impact analyses will be crucial to understanding their utility compared to disposable scopes. Dr Sahakian is a consultant for Boston Scientific, Cook Medical, and Medtronic. Dr Siddiqui is a consultant for Boston Scientific, Olympus, Medtronic, and Cook Medical; a speaker for Boston Scientific, Olympus, Medtronic, Cook Medical, Ovesco, and Pinnacle Biologics; and the recipient of research funding from Boston Scientific. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexityGastrointestinal EndoscopyVol. 94Issue 6PreviewExpert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience. Full-Text PDF Open Access" @default.
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• W3204104595 title "Single-use duodenoscopes: The next disruptor or passing fad?" @default.
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