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Hepatobiliary & Pancreatic Diseases... Feb 2024Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by...
The outcomes and safety of patients undergoing endoscopic retrograde cholangiopancreatography combining a single-use cholangioscope and a single-use duodenoscope: A multicenter retrospective international study.
BACKGROUND
Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography (ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy.
METHODS
This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score (1 to 10) on performance rating of the single-use duodenoscope, and adverse event (AE) rate.
RESULTS
A total of 66 patients (26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47 (71.2%) grade 3 and 19 (28.8%) grade 4. The technical success rate was 98.5% (65/66). Procedural duration was 64 (interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66 (1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3 points. Four patients (6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis (PEP), 1 cholangitis and 1 bleeding.
CONCLUSIONS
Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.
Topics: Humans; Female; Male; Cholangiopancreatography, Endoscopic Retrograde; Retrospective Studies; Catheterization; Duodenoscopes; Pancreatitis
PubMed: 37100688
DOI: 10.1016/j.hbpd.2023.04.002 -
Digestive Diseases and Sciences Jun 2019The duodenoscope is among the most complex medical instruments that undergo disinfection between patients. Transmission of infection by contaminated scopes has remained... (Review)
Review
The duodenoscope is among the most complex medical instruments that undergo disinfection between patients. Transmission of infection by contaminated scopes has remained a challenge since its inception. Notable risk factors for pathogen transmission include non-adherence to disinfection guidelines, encouragement of biofilm deposition due to complex design and surface defects and contaminated automated endoscope reprocessors. The most common infections following endoscopy are endogenous infections involving the patient's own gut flora. Exogenous infections, on the other hand, are associated with contaminated scopes and can theoretically be prevented by effective reprocessing. Pseudomonas aeruginosa is currently the most common organism isolated from contaminated endoscopes. Of note, reports of multidrug-resistant duodenoscopy-associated outbreaks have surfaced recently, many of which occurred despite adequate reprocessing. The FDA and CDC currently recommend comprehensive cleaning followed with at least high-level disinfection for reprocessing of flexible GI endoscopes. Reports of duodenoscope-related outbreaks despite compliance with established guidelines have prompted professional and government bodies to revisit existing guidelines and offer supplementary recommendations for duodenoscope processing. For the purposes of this review, we identified reports of duodenoscope-associated infections from 2000 till date. For each outbreak, we noted the organisms isolated, the number of cases reported, any possible explanations of contamination, and the measures undertaken to end each outbreak. We have also attempted to present an overview of recent developments in this rapidly evolving field.
Topics: Anti-Bacterial Agents; Antibiotic Prophylaxis; Bacterial Infections; Decontamination; Disease Outbreaks; Duodenoscopes; Duodenoscopy; Equipment Contamination; Equipment Reuse; Gastrointestinal Microbiome; Humans; Risk Assessment; Risk Factors
PubMed: 30569333
DOI: 10.1007/s10620-018-5431-7 -
Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography.Clinical Gastroenterology and... Aug 2020Disposable, single-use duodenoscopes might reduce outbreaks of infections associated with endoscope reuse. We tested the feasibility, preliminary safety, and performance...
BACKGROUND & AIMS
Disposable, single-use duodenoscopes might reduce outbreaks of infections associated with endoscope reuse. We tested the feasibility, preliminary safety, and performance of a new single-use duodenoscope in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).
METHODS
We conducted a case-series study of the outcomes of ERCP with a single-use duodenoscope from April through May 2019 at 6 academic medical centers. We screened consecutive patients (18 years and older) without alterations in pancreaticobiliary anatomy and enrolled 73 patients into the study. Seven expert endoscopists performed roll-in maneuvers (duodenoscope navigation and visualization of duodenal papilla only) in 13 patients and then ERCPs in the 60 other patients. Outcomes analyzed included completion of ERCP for the intended clinical indication, crossover from a single-use duodenoscope to a reusable duodenoscope, endoscopist performance ratings of the device, and serious adverse events (assessed at 72 hours and 7 days).
RESULTS
Thirteen (100%) roll-in maneuver cases were completed using the single-use duodenoscope. ERCPs were of American Society for Gastrointestinal Endoscopy procedural complexity grade 1 (least complex; 7 patients [11.7%]), grade 2 (26 patients [43.3%]), grade 3 (26 patients [43.3%]), and grade 4 (most complex; 1 patient [1.7%]). Fifty-eight ERCPs (96.7%) were completed using the single-use duodenoscope only and 2 ERCPs (3.3%) were completed using the single-use duodenoscope followed by crossover to a reusable duodenoscope. Median overall satisfaction was 9 out of 10. Three patients developed post-ERCP pancreatitis, 1 patient had post-sphincterotomy bleeding, and 1 patient had worsening of a preexisting infection and required rehospitalization.
CONCLUSIONS
In a case-series study, we found that expert endoscopists can complete ERCPs of a wide range of complexity using a single-use duodenoscope for nearly all cases. This alternative might decrease ERCP-related risk of infection. Clinicaltrials.gov no: NCT03701958.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Disease Outbreaks; Duodenoscopes; Endoscopy, Gastrointestinal; Humans; Pancreatitis
PubMed: 31706060
DOI: 10.1016/j.cgh.2019.10.052 -
The Journal of Hospital Infection Jul 2024Contamination rates reported in the literature for patient-ready flexible endoscopes vary from 0.4% to 49%. Unfortunately, the comparison and interpretation of these... (Comparative Study)
Comparative Study
BACKGROUND
Contamination rates reported in the literature for patient-ready flexible endoscopes vary from 0.4% to 49%. Unfortunately, the comparison and interpretation of these results is almost impossible since several factors including sampling and culturing methods, target levels for contamination, or definition of indicator micro-organisms vary widely from one study to the other.
AIM
To compare the efficacy of six duodenoscope sampling and culturing methods by means of extraction efficacy comparison, while at the same time identifying key parameters that provide optimal microbial recovery.
METHODS
The duodenoscope sample extraction efficacy of each method was assessed using the repetitive recovery method described in ISO 11737-1: 2018.
FINDINGS
Mean overall bioburden extraction efficacy varied from 1% for the Australian method to 39% for the French one. The lowest endoscope sample extraction efficacy was associated with the absence of any neutralizer, friction, or tensioactive agent, and when only a small portion of the sampling solution collected was inoculated on to culture media. The efficacy of the sampling and culturing methods also varied according to the nature of micro-organisms present in the endoscope, and the time between sampling and culturing.
CONCLUSION
This study supports the need for a harmonized and standardized sampling and culturing method for flexible endoscopes.
Topics: Humans; Specimen Handling; Equipment Contamination; Bacteria; Microbiological Techniques; Endoscopes; Duodenoscopes
PubMed: 38649121
DOI: 10.1016/j.jhin.2024.03.017 -
Antimicrobial Resistance and Infection... Dec 2021Duodenoscopy-associated infections occur worldwide despite strict adherence to reprocessing standards. The exact scope of the problem remains unknown because a... (Review)
Review
Duodenoscopy-associated infections occur worldwide despite strict adherence to reprocessing standards. The exact scope of the problem remains unknown because a standardized sampling protocol and uniform sampling techniques are lacking. The currently available multi-society protocol for microbial culturing by the Centers for Disease Control and Prevention, the United States Food and Drug Administration (FDA) and the American Society for Microbiology, published in 2018 is too laborious for broad clinical implementation. A more practical sampling protocol would result in increased accessibility and widespread implementation. This will aid to reduce the prevalence of duodenoscope contamination. To reduce the risk of duodenoscopy-associated pathogen transmission the FDA advised four supplemental reprocessing measures. These measures include double high-level disinfection, microbiological culturing and quarantine, ethylene oxide gas sterilization and liquid chemical sterilization. When the supplemental measures were advised in 2015 data evaluating their efficacy were sparse. Over the past five years data regarding the supplemental measures have become available that place the efficacy of the supplemental measures into context. As expected the advised supplemental measures have resulted in increased costs and reprocessing time. Unfortunately, it has also become clear that the efficacy of the supplemental measures falls short and that duodenoscope contamination remains a problem. There is a lot of research into new reprocessing methods and technical applications trying to solve the problem of duodenoscope contamination. Several promising developments such as single-use duodenoscopes, electrolyzed acidic water, and vaporized hydrogen peroxide plasma are already applied in a clinical setting.
Topics: Anti-Bacterial Agents; Cross Infection; Disinfection; Drug Resistance, Multiple, Bacterial; Duodenoscopes; Enterobacteriaceae; Enterobacteriaceae Infections; Equipment Contamination; Equipment Reuse; Humans; Infection Control; United States; United States Food and Drug Administration
PubMed: 34949217
DOI: 10.1186/s13756-021-01037-z -
Surgical Laparoscopy, Endoscopy &... Jun 2024Endoscopes are an essential tool in the diagnosis, screening, and treatment of gastrointestinal diseases. In 2019, the Food and Drug Administration issued a news...
OBJECTIVE
Endoscopes are an essential tool in the diagnosis, screening, and treatment of gastrointestinal diseases. In 2019, the Food and Drug Administration issued a news release, recommending that duodenoscope manufacturers and health care facilities phase out fully reusable duodenoscopes with fixed endcaps in lieu of duodenoscopes that are either fully disposable or those that contain disposable endcaps. With this study, we systematically reviewed the published literature on single-use disposable gastrointestinal scopes to describe the current state of the literature and provide summary recommendations on the role of disposable gastrointestinal endoscopes.
MATERIALS AND METHODS
For our inclusion criteria, we searched for studies that were published in the year 2015 and afterward. We performed a literature search in PubMed using the keywords, "disposable," "reusable," "choledochoscope," "colonoscope," "duodenoscope," "esophagoscope," "gastroscope," and "sigmoidoscope." After our review, we identified our final article set, including 13 articles relating to disposable scopes, published from 2015 to 2023.
RESULTS
In this review, we show 13 articles discussing the infection rate, functionality, safety, and affordability of disposable gastrointestinal scopes in comparison to reusable gastrointestinal scopes. Of the 3 articles that discussed infection rates (by Forbes and colleagues, Ridtitid and colleagues, and Ofosu and colleagues), each demonstrated a decreased risk of infection in disposable gastrointestinal scopes. Functionality was another common theme among these articles. Six articles (by Muthusamy and colleagues, Bang and colleagues, Lisotti and colleagues, Ross and colleagues, Kang and colleagues, and Forbes and colleagues) demonstrated comparable functionality of disposable scopes to reusable scopes. The most reported functionality issue in disposable scopes was decreased camera resolution. Disposable scopes also showed comparable safety profiles compared with reusable scopes. Six articles (by Kalipershad and colleagues, Muthusamy and colleagues, Bang and colleagues, Lisotti and colleagues, Luo and colleagues, and Huynh and colleagues) showed comparable rates of AEs, whereas 1 article (by Ofosu and colleagues) demonstrated increased rates of AEs with disposable scopes. Lastly, a cost analysis was looked at in 3 of the articles. Two articles (by Larsen et al and Ross and colleagues) remarked that further research is needed to understand the cost of disposable scopes, whereas 1 article (by Kang and colleagues) showed a favorable cost analysis.
CONCLUSIONS
After a review of the literature published since the 2015 Food and Drug Administration safety communication, disposable scopes have been shown to be effective in decreasing infection risks while maintaining similar safety profiles to conventional reusable scopes. However, more research is required to compare disposable and reusable scopes in terms of functionality and cost-effectiveness.
Topics: Disposable Equipment; Humans; Equipment Reuse; Endoscopes, Gastrointestinal; Equipment Design; Gastrointestinal Diseases; Endoscopy, Gastrointestinal; Duodenoscopes
PubMed: 38767593
DOI: 10.1097/SLE.0000000000001278 -
American Journal of Infection Control Sep 2016Several clusters of Carbapenem-resistant Enterobacteriaceae (CRE) infections associated with contaminated endoscopes have recently been reported. Interim guidelines for... (Review)
Review
BACKGROUND
Several clusters of Carbapenem-resistant Enterobacteriaceae (CRE) infections associated with contaminated endoscopes have recently been reported. Interim guidelines for mitigating endoscope-associated transmission have been proposed, but there has not been a systematic appraisal of CRE prevention practices.
METHODS
We conducted a systematic review of endoscope-associated CRE infection episodes, abstracting information on outbreak detection, mitigation, outcomes, and corrective steps taken to prevent recurrence.
RESULTS
Seven distinct outbreaks were identified in the published literature, and 5 of these were associated with duodenal endoscopy, with the remaining 2 associated with cystoscopy and ureteroscopy. Several investigators noted difficulties in cleaning protocols surrounding difficult to access components, such as the elevator on duodenoscopes. The published investigations did not report any failures of sterilization. It is unclear if routine reprocessing was ineffective, or difficult to execute properly.
CONCLUSIONS
Meticulous cleaning protocols and increased surveillance are necessary to prevent and detect future outbreaks of CRE and to determine whether more stringent measures, such as sterilization, are needed for duodenoscopes.
Topics: Anti-Bacterial Agents; Carbapenems; Disease Transmission, Infectious; Endoscopy; Enterobacteriaceae; Enterobacteriaceae Infections; Humans; beta-Lactam Resistance
PubMed: 27179395
DOI: 10.1016/j.ajic.2016.03.029 -
Annals of Clinical Microbiology and... Oct 2018During clinical use, gastrointestinal endoscopes are grossly contaminated with patient's native flora. These endoscopes undergo reprocessing to prevent infectious... (Review)
Review
INTRODUCTION
During clinical use, gastrointestinal endoscopes are grossly contaminated with patient's native flora. These endoscopes undergo reprocessing to prevent infectious transmission upon future use. Endoscopy-associated infections and outbreaks have been reported, with a recent focus on the transmission of multi-drug resistant organisms. This review aims to provide an update on endoscopy-associated infections, and the factors contributing to their occurrence.
METHODS
PubMed, ScienceDirect, and CINAHL were searched for articles describing gastrointestinal endoscopy-associated infections and outbreaks published from 2008 to 2018. Factors contributing to their occurrence, and the outcomes of each outbreak were also examined.
RESULTS
This review found 18 articles, 16 of which described duodenoscope-associated infections, and the remaining two described colonoscope- and gastroscope-associated infection respectively. Outbreaks were reported from the United States, France, China, Germany, the Netherlands and the United Kingdom. The causative organisms reported were Klebsiella pneumoniae, Pseudomonas aeruginosa, Escherichia coli and Salmonella enteritidis.
CONCLUSIONS
A number of factors, including lapses in reprocessing, biofilm formation, endoscope design issues and endoscope damage, contribute to gastrointestinal endoscopy associated infection. Methods of improving endoscope reprocessing, screening for contamination and evaluating endoscope damage may be vital to preventing future infections and outbreaks.
Topics: China; Cross Infection; Disease Outbreaks; Disinfection; Endoscopy, Gastrointestinal; Germany; Humans; Infection Control
PubMed: 30314500
DOI: 10.1186/s12941-018-0289-2 -
Gastroenterology Nursing : the Official... 2020A rise in duodenoscope-associated infections, especially in regard to multidrug-resistant organisms, has led to an increase in scrutiny regarding duodenoscope... (Review)
Review
A rise in duodenoscope-associated infections, especially in regard to multidrug-resistant organisms, has led to an increase in scrutiny regarding duodenoscope reprocessing. Endoscopic retrograde cholangiopancreatography scopes have a specialized elevator wire channel, allowing more flexible duct cannulation; however, this channel can be difficult to reprocess with standard techniques. Although strict adherence to manufacturer reprocessing protocols remains the primary means of infection prevention, periodic microbiological surveillance is a Food and Drug Administration-recommended practice that the Medical University of South Carolina has implemented to further prevent duodenoscope-associated infections. The Medical University of South Carolina obtains 2 separate cultures from 2 duodenoscopes every 2 months, which undergo standard speciation and sensitivity and are returned to use once negative at 48 hours. The initial results of the Medical University of South Carolina's surveillance cultures are negative for any multidrug-resistant organisms; however, other centers should consider implementing surveillance cultures into their reprocessing practices and closely monitoring for future endoscope infection prevention modalities.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Disinfection; Duodenoscopes; Equipment Contamination; Humans; Infection Control
PubMed: 33055545
DOI: 10.1097/SGA.0000000000000499 -
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