-
EClinicalMedicine Aug 2020Multiple infection outbreaks have been linked to contaminated duodenoscopes worldwide. However, the contamination rate of patient-ready duodenoscopes varies highly...
BACKGROUND
Multiple infection outbreaks have been linked to contaminated duodenoscopes worldwide. However, the contamination rate of patient-ready duodenoscopes varies highly amongst published studies testing this subject. We aimed to estimate the contamination rate of reprocessed patient-ready duodenoscopes for endoscopic retrograde cholangio-pancreatography (ERCP) based on currently available data.
METHODS
We searched the PubMed and Embase databases from January 1, 2010 until March 10, 2020, for citations investigating contamination rates of reprocessed patient-ready duodenoscopes. Studies not assessing other types of endoscopes than duodenoscopes were excluded from the analysis. Study eligibility and data extraction was evaluated by three reviewers independently. A random-effects model (REM) based on the proportion distribution was used to calculate the pooled total contamination rate of reprocessed patient-ready duodenoscopes. Subgroup analyses were carried out to assess contamination rates when using different reprocessing methods by comparing single high-level disinfection (HLD) with double HLD and ethylene oxide (EtO) gas sterilization. Additionally, we investigated the contamination rate between studies conducted following an outbreak compared to non-outbreak-initiated studies.
FINDINGS
We identified 15 studies that fulfilled the inclusion, which included 925 contaminated duodenoscopes from 13,112 samples. The calculated total weighted contamination rate was 15.25% ± 0.018 (95% confidence interval [Cl]: 11.74% - 18.75%). The contamination rate after only using HLD was 16.14% ± 0.019 (95% Cl: 12.43% - 19.85%) and after using either dHLD or EtO the contamination rate decreased to 9.20% ± 0.025 (95% Cl: 4.30% - 14.10%). Studies conducted following an outbreak (n=4) showed a 5.72% ± 0.034 (95% Cl: 0.00% - 12.43%) contamination rate, and non-outbreak-initiated studies (n=11) revealed a contamination rate of 21.50% ± 0.031 (95% Cl: 15.35% - 27.64%).
INTERPRETATION
This is the first meta-analysis to estimate the contamination rate of patient-ready duodenoscopes used for ERCP. Based on the available literature, our analysis demonstrates that there is a 15.25% contamination rate of reprocessed patient-ready duodenoscopes. Additionally, the analysis indicates that dHLD and EtO reprocessing methods are superior to single HLD but still not efficient in regards to cleaning the duodenoscopes properly. Furthermore, studies conducted following an outbreak did not entail a higher contamination rate compared to non-outbreak-initiated studies.
FUNDING
The authors received no financial support for the research, authorship, and/or publication of this article.
PubMed: 32954234
DOI: 10.1016/j.eclinm.2020.100451 -
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 -
Clinical Endoscopy Jan 2022Multiple outbreaks of multidrug-resistant organisms have been reported worldwide due to contaminated duodenoscopes. In 2015, the United States Food and Drug...
BACKGROUND/AIMS
Multiple outbreaks of multidrug-resistant organisms have been reported worldwide due to contaminated duodenoscopes. In 2015, the United States Food and Drug Administration recommended the following supplemental enhanced surveillance and reprocessing techniques (ESRT) to improve duodenoscope disinfection: (1) microbiological culture, (2) ethylene oxide sterilization, (3) liquid chemical sterilant processing system, and (4) double high-level disinfection. A systematic review and meta-analysis was performed to assess the impact of ESRT on the contamination rates.
METHODS
A thorough and systematic search was performed across several databases and conference proceedings from inception until January 2021, and all studies reporting the effectiveness of various ESRTs were identified. The pooled contamination rates of post-ESRT duodenoscopes were estimated using the random effects model.
RESULTS
A total of seven studies using various ESRTs were incorporated in the analysis, which included a total of 9,084 post-ESRT duodenoscope cultures. The pooled contamination rate of the post-ESRT duodenoscope was 5% (95% confidence interval [CI]: 2.3%-10.8%, inconsistency index [I2]=97.97%). Pooled contamination rates for high-risk organisms were 0.8% (95% CI: 0.2%-2.7%, I2=94.96).
CONCLUSION
While ESRT may improve the disinfection process, a post-ESRT contamination rate of 5% is not negligible. Ongoing efforts to mitigate the rate of contamination by improving disinfection techniques and innovations in duodenoscope design to improve safety are warranted.
PubMed: 34974676
DOI: 10.5946/ce.2021.212 -
Endoscopy International Open Jun 2022Duodenoscopes that are contaminated due to inadequate reprocessing are well-documented. However, studies have demonstrated poor reprocessing of other kinds of... (Review)
Review
Duodenoscopes that are contaminated due to inadequate reprocessing are well-documented. However, studies have demonstrated poor reprocessing of other kinds of endoscopes as well, including echoendoscopes, gastroscopes, and colonoscopes. We estimated the contamination rate beyond the elevator of gastrointestinal endoscopes based on available data. We searched PubMed and Embase from January 1, 2010 to October 10, 2020, for studies investigating contamination rates of reprocessed gastrointestinal endoscopes. A random-effects model was used to calculate the contamination rate of patient-ready gastrointestinal endoscopes. Subgroup analyses were conducted to investigate differences among endoscope types, countries, and colony-forming unit (CFU) thresholds. Twenty studies fulfilled the inclusion criteria, including 1,059 positive cultures from 7,903 samples. The total contamination rate was 19.98 % ± 0.024 (95 % confidence interval [Cl]: 15.29 %-24.68 %; I = 98.6 %). The contamination rates of colonoscope and gastroscope channels were 31.95 % ± 0.084 and 28.22 % ± 0.076, respectively. Duodenoscope channels showed a contamination rate of 14.41 % ± 0.029. The contamination rates among studies conducted in North America and Europe were 6.01 % ± 0.011 and 18.16% ± 0.053 %, respectively. The contamination rate among studies using a CFU threshold > 20 showed contamination of 30.36 % ± 0.094, whereas studies using a CFU threshold < 20 showed a contamination rate of 11 % ± 0.026. On average, 19.98 % of reprocessed gastrointestinal endoscopes may be contaminated when used in patients and varies between different geographies. These findings highlight that the elevator mechanism is not the only obstacle when reprocessing reusable endoscopes; therefore, guidelines should recommend more surveillance of the endoscope channels as well.
PubMed: 35692921
DOI: 10.1055/a-1795-8883 -
European Journal of Gastroenterology &... Apr 2023Treatment is a challenge in Irritable Bowel Syndrome (IBS) and fecal microbiota transplantation (FMT) has attracted significant interest. Network meta-analysis (NWM) has... (Meta-Analysis)
Meta-Analysis
A systematic review, pairwise meta-analysis and network meta-analysis of randomized controlled trials exploring the role of fecal microbiota transplantation in irritable bowel syndrome.
BACKGROUND
Treatment is a challenge in Irritable Bowel Syndrome (IBS) and fecal microbiota transplantation (FMT) has attracted significant interest. Network meta-analysis (NWM) has been established as an evidence-synthesis tool that incorporates direct and indirect evidence in a collection of randomized controlled trials (RCTs) comparing therapeutic intervention competing for similar therapeutic results. No NWM exists concerning the comparative effectiveness and safety of various FMT modalities for IBS.
AIM
We updated pairwise meta-analyses published in the past and assessed the comparative effectiveness and safety of various FMT delivery modalities for IBS.
METHODS
Pairwise meta-analyses and Bayesian NWM were performed. Heterogeneity, consistency of results and publication bias were explored.
RESULTS
Of 510 titles raised by initial search, seven RCTs were entered into meta-analyses and NWM. They included 470 patients and controls, in whom four FMT delivery modalities were used, that is via colonoscopy, nasojejunal tube, duodenoscope and capsules per os. In the pairwise meta-analysis, the pooled results showed that overall FMT was not superior to placebo, whereas the subgroup analyses showed that FMT via duodenoscope and nasojejunal tube was superior. The NWM showed that 60-g FMT via duodenoscope had the highest efficacy (OR, 26.38; 95% CI, 9.22-75.51) and was by far the highest in the efficacy ranking (SUCRA, 98.8%).
CONCLUSION
The pooled results showed no overall advantage of FMT over placebo in IBS. However, upper GI delivery (via duodenoscopy or nasojejunal tube) proved to be effective. Consequently, well-designed RCTs are needed to ensure the efficacy and safety profile before FMT can be applied in everyday clinical practice for IBS patients.
Topics: Humans; Fecal Microbiota Transplantation; Irritable Bowel Syndrome; Network Meta-Analysis; Randomized Controlled Trials as Topic; Duodenoscopy; Treatment Outcome; Feces
PubMed: 36719820
DOI: 10.1097/MEG.0000000000002519 -
Endoscopy Feb 2022The risk of exogenous infections from endoscopic procedures is often cited as almost negligible (1 infection in 1.8 million procedures); however, this risk is based on...
BACKGROUND
The risk of exogenous infections from endoscopic procedures is often cited as almost negligible (1 infection in 1.8 million procedures); however, this risk is based on older literature and does not seem to match the number of infectious outbreaks due to contaminated duodenoscopes reported after endoscopic retrograde cholangiopancreatography (ERCP). Using Dutch data, we aimed to estimate the minimum risk of duodenoscope-associated infection (DAI) and colonization (DAC) in patients undergoing ERCP.
METHODS
A systematic literature search identified all DAI outbreaks in the Netherlands reported between 2008 and 2019. Included cases were confirmed by molecular matching of patient and duodenoscope cultures. Risk ratios were calculated based on the total number of ERCPs performed during the study period.
RESULTS
Three outbreaks were reported and published between 2008 and 2018, including 21 confirmed DAI cases and 52 confirmed DAC cases. The estimated number of ERCPs performed during the same period was 181 209-227 006. The calculated minimum estimated DAI risk was approximately 0.01 % and the minimum estimated DAC risk was 0.023 %-0.029 %.
CONCLUSIONS
The estimated risk of DAI in Dutch ERCP practice was at least 180 times higher than previously published risk estimates. The actual risk is likely to be (much) higher due to underreporting of infections caused by multidrug-resistant organisms and sensitive bacteria. Greater awareness by healthcare personnel involved in endoscopy and endoscope cleaning is required, as well as innovative technical solutions to contain and ultimately eliminate DAIs.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Disease Outbreaks; Duodenoscopes; Equipment Contamination; Humans; Netherlands
PubMed: 33915575
DOI: 10.1055/a-1467-6294 -
Digestive and Liver Disease : Official... Jan 2024Single use duodenoscopes were developed to reduce the risk of infection transmission from contaminated reusable duodenoscopes. To this end, we examined various biliary... (Meta-Analysis)
Meta-Analysis Review
Cannulation rates and technical performance evaluation of commericially available single-use duodenoscopes for endoscopic retrograde cholangiopancreatography: A systematic review and meta-analysis.
BACKGROUND
Single use duodenoscopes were developed to reduce the risk of infection transmission from contaminated reusable duodenoscopes. To this end, we examined various biliary interventions using single use duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).
METHODS
Medline, Embase, Scopus, and Cochrane databases were searched from inception through Aug 2022 to identify studies reporting on the performance of single use duodenoscopes for ERCP.
RESULTS
Seven articles were included in the final analysis that included 642 patients (318 males). The Exalt Model D duodenoscope was used in most cases (88.8%) followed by the aScope Duodeno (11.2%) for ERCP. Most ERCPs had a complexity grade of 2 (n = 303) and 3 (n = 198). The pooled cumulative rate of successful cannulation was 95% (95% Confidence Interval (CI): 93-96%, I2=0%, P = 0.46). Sphincterotomy was successfully performed in all cases. The pooled cumulative rate of PEP was 2% (95% CI: 0.4-3.4%, I2=0%, P = 0.80). The pooled cumulative rate of total adverse events was 7% (95% CI: 4-10%, I2=47%, P = 0.08).
CONCLUSIONS
The results of this systematic review and meta-analysis show that single use duodenoscopes are associated with high cannulation rates, technical performance, and safety profile.
Topics: Male; Humans; Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Catheterization
PubMed: 37003844
DOI: 10.1016/j.dld.2023.02.022 -
United European Gastroenterology Journal Feb 2020Endoscopic papillectomy (EP) is a viable therapy in ampullary lesions (AL). Many series have reported low morbidity and acceptable outcomes. We performed a systematic...
Endoscopic papillectomy (EP) is a viable therapy in ampullary lesions (AL). Many series have reported low morbidity and acceptable outcomes. We performed a systematic review with pooled analysis to assess the safety and efficacy of EP for AL. Electronic databases (Medline, Scopus and EMBASE) were searched up to September 2018. Studies that included patients with endoscopically resected AL were eligible. The rate of adverse events (AEs; primary outcome) and the rates of both technical and clinical efficacy outcomes were pooled by means of a random- or fixed-effects model to obtain a proportion with a 95% confidence interval (CI). Twenty-nine studies were included (1751 patients). The overall AE rate was 24.9%. The post-procedural pancreatitis rate was 11.9%, with the only factor affecting this outcome being prophylactic pancreatic stenting. The complete resection rate was 94.2%, with a rate of oncologically curative resection of 87.1%. The recurrence rate was 11.8% (follow-up: 9.6-84.5 months). EP is a relatively safe and effective option for AL. Our study might definitively suggest the protective role of prophylactic pancreatic stenting against post-procedural pancreatitis.
Topics: Adenoma; Ampulla of Vater; Asymptomatic Diseases; Common Bile Duct Neoplasms; Endoscopy, Digestive System; Follow-Up Studies; Humans; Neoplasm Recurrence, Local; Pancreatitis; Postoperative Complications; Stents; Treatment Outcome
PubMed: 32213054
DOI: 10.1177/2050640619868367 -
Gastrointestinal Endoscopy Dec 2023The current standard of practice is to use a duodenoscope for the evaluation of the major duodenal papilla (MDP). Recently, cap-assisted endoscopy (CAE), which uses a... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND AIMS
The current standard of practice is to use a duodenoscope for the evaluation of the major duodenal papilla (MDP). Recently, cap-assisted endoscopy (CAE), which uses a transparent cap at the tip of a standard front-viewing endoscope, has emerged as an alternative.
METHODS
A systematic literature search was performed in several databases from inception to January 2023 to identify studies evaluating the efficacy of CAE for the evaluation of the MDP.
RESULTS
Nine studies including 806 patients met our inclusion criteria. The pooled rate of technical success for CAE was 93.2% (95% confidence interval, 85.6-96.9; I = 84.6%). A subgroup analysis comparing CAE with a standard endoscope showed higher odds for the evaluation of the MDP with CAE (but not a duodenoscope, which was better than CAE) with an odds ratio of 57.294 (95% confidence interval, 17.767-184.755; I = 45.303%).
CONCLUSIONS
CAE offers a significant advantage with high rates of complete MDP evaluation compared with standard forward-viewing endoscopy. However, CAE is associated with lower rates of success when compared with side-viewing endoscopes.
Topics: Humans; Ampulla of Vater; Endoscopy, Gastrointestinal; Endoscopes; Duodenoscopes
PubMed: 37544335
DOI: 10.1016/j.gie.2023.07.050 -
Digestive and Liver Disease : Official... Feb 2022
Topics: Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Disposable Equipment; Duodenoscopes; Equipment Contamination; Humans; Treatment Outcome
PubMed: 34838478
DOI: 10.1016/j.dld.2021.11.003