-
American Journal of Infection Control Apr 2024Over the past decade, infections linked to duodenoscopes have become a significant concern, primarily due to the intricate design of the elevator mechanism. Currently,...
Over the past decade, infections linked to duodenoscopes have become a significant concern, primarily due to the intricate design of the elevator mechanism. Currently, there is limited evidence regarding the bacterial contamination level of the elevator mechanism after clinical use and throughout its various reprocessing stages. This study utilized the swab culture technique to examine the bacterial contamination on the duodenoscope elevator mechanism after clinical use and after 3 reprocessing stages at a Center of tertiary hospital. Our findings revealed severe bacterial contamination after clinical usage, emphasizing that the effectiveness of manual cleaning greatly influences the subsequent high-level disinfection quality.
Topics: Humans; Duodenoscopes; Equipment Contamination; Bacteria; Disinfection
PubMed: 37838249
DOI: 10.1016/j.ajic.2023.10.003 -
Endoscopy Dec 2021
Topics: Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Humans; Intubation, Intratracheal
PubMed: 33540436
DOI: 10.1055/a-1327-1813 -
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 -
Gastrointestinal Endoscopy Dec 2021Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists...
BACKGROUND AND AIMS
Expert 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.
METHODS
Fourteen "expert" (>2000 lifetime ERCPs) and 5 "less-expert" endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events.
RESULTS
Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P = .131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P = .999), median ERCP completion time (25.0 vs 28.5 minutes, P = .130), mean cannulation attempts (2.8 vs 2.8, P = .954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P = .840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P < .001). Serious adverse events were reported in 13 patients (6.5%).
CONCLUSIONS
In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.).
Topics: Catheterization; Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Endoscopy, Gastrointestinal; Humans
PubMed: 34186052
DOI: 10.1016/j.gie.2021.06.017 -
Clinical Infectious Diseases : An... Oct 2017Carbapenem-resistant Klebsiella pneumoniae infections are increasingly prevalent in North American hospitals. We describe an outbreak of carbapenem-resistant K....
BACKGROUND
Carbapenem-resistant Klebsiella pneumoniae infections are increasingly prevalent in North American hospitals. We describe an outbreak of carbapenem-resistant K. pneumoniae containing the blaOXA-232 gene transmitted by contaminated duodenoscopes during endoscopic retrograde cholangiopancreatography (ERCP) procedures.
METHODS
An outbreak investigation was performed when 9 patients with blaOXA-232 carbapenem-resistant K. pneumoniae infections were identified at a tertiary care hospital. The investigation included 2 case-control studies, review of duodenoscope reprocessing procedures, and culture of devices. Carbapenem-resistant Enterobacteriacieae (CRE) isolates were evaluated with polymerase chain reaction analysis for carbapenemase genes, and isolates with the blaOXA-232 gene were subjected to whole-genome sequencing and chromosome single-nucleotide polymorphism analysis. On recognition of ERCP as a key risk factor for infection, targeted patient notification and CRE screening cultures were performed.
RESULTS
Molecular testing ultimately identified 17 patients with blaOxa-232 carbapenem-resistant K. pneumoniae isolates, including 9 with infections, 7 asymptomatic carriers who had undergone ERCP, and 1 additional patient who had been hospitalized in India and was probably the initial carrier. Two case-control studies established a point-source outbreak associated with 2 specific duodenoscopes. A field investigation of the use, reprocessing, and storage of deuodenoscopes did not identify deviations from US Food and Drug Administration or manufacturer recommendations for reprocessing.
CONCLUSIONS
This outbreak demonstrated the previously underappreciated potential for duodenoscopes to transmit disease, even after undergoing high-level disinfection according to manufacturers' guidelines.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Carbapenem-Resistant Enterobacteriaceae; Carbapenems; Case-Control Studies; Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Disease Outbreaks; Disinfection; Duodenoscopes; Equipment Contamination; Female; Humans; India; Klebsiella Infections; Klebsiella pneumoniae; Male; Middle Aged; Pathology, Molecular; Young Adult
PubMed: 29579235
DOI: 10.1093/cid/cix527 -
Gastrointestinal Endoscopy Dec 2016
Review
Topics: Disinfectants; Disinfection; Duodenoscopes; Endoscopes; Endoscopy, Gastrointestinal; Equipment Contamination; Humans; Patient Safety
PubMed: 27765382
DOI: 10.1016/j.gie.2016.08.025 -
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 -
Gastrointestinal Endoscopy Clinics of... Oct 2020Over the past 2 decades, in hospital centers worldwide, there have been numerous outbreaks of multidrug-resistant organisms that have since been attributed to... (Review)
Review
Over the past 2 decades, in hospital centers worldwide, there have been numerous outbreaks of multidrug-resistant organisms that have since been attributed to endoscopic transmission of the infections between patients, primarily from duodenoscopes. These outbreaks have focused the attention of endoscope manufacturers, professional societies, and regulatory agencies on improving the reprocessing of these devices. The key steps in this process are point-of-use precleaning, leak testing, manual cleaning, high-level disinfection, and finally drying and storage. The promise of these initial efforts suggest that the aim of minimizing and ultimately eliminating events of endoscope-/duodenoscope-associated transmission of infectious organisms between patients can be achieved.
Topics: Cross Infection; Disease Outbreaks; Disinfection; Duodenoscopes; Endoscopes; Fomites; Guideline Adherence; Humans; Infection Control
PubMed: 32891224
DOI: 10.1016/j.giec.2020.06.002 -
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 -
Endoscopy Sep 2020A newly designed duodenoscope with detachable distal cap may reduce bacterial contamination by allowing better access to the elevator. We compared bacterial...
BACKGROUND
A newly designed duodenoscope with detachable distal cap may reduce bacterial contamination by allowing better access to the elevator. We compared bacterial contamination and organic residue evaluated by rapid adenosine triphosphate (ATP) test and culture from duodenoscopes with detachable vs. fixed distal caps after high-level disinfection (HLD).
METHODS
During December 2018-April 2019, 108 used newly designed duodenoscopes were enrolled. In group A (n = 54), the distal cap of the duodenoscope was detached before manual cleaning. In group B (n = 54), the distal cap was not detached. After HLD, samples were collected from the elevator, submitted for culture, and evaluated using the ATP test, using the cutoff value of 40 relative light units (RLUs).
RESULTS
After HLD, the proportion of potential bacterial contamination and organic residue in group A was significantly lower than in group B (37.0 % vs. 75.9 %; < 0.001; relative risk 0.49, 95 % confidence interval 0.33-0.71), and also confirmed by median ATP values (45.2 vs. 141.0 RLU; < 0.001). In group B, one sample culture was positive for nonpathogenic bacteria. Pathogenic bacteria were not found in any culture from either group.
CONCLUSIONS
The detachable distal cap was more effective at eliminating bacterial contamination and reducing organic residue than a fixed cap. Nonpathogenic bacteria were detected in the fixed cap group after reprocessing. The ATP test with 40 RLU cutoff is a practical method to ensure the cleanliness of duodenoscope reprocessing without the need to wait for bacterial culture results.
Topics: Adenosine Triphosphate; Bacteria; Disinfection; Duodenoscopes; Equipment Contamination; Humans
PubMed: 32299115
DOI: 10.1055/a-1145-3562