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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 -
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 -
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 -
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 -
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 2022
Topics: Humans; Duodenoscopes; Equipment Contamination; Disinfection; Cholangiopancreatography, Endoscopic Retrograde
PubMed: 36253193
DOI: 10.1016/j.gie.2022.08.014 -
Current Opinion in Gastroenterology Sep 2021Given the growing concerns about infection transmission from use of contaminated reusable duodenoscopes, technological advancements have been made that vary from... (Review)
Review
PURPOSE OF REVIEW
Given the growing concerns about infection transmission from use of contaminated reusable duodenoscopes, technological advancements have been made that vary from modifications of existing designs to development of single-use devices.
RECENT FINDINGS
To circumvent mechanical limitations that preclude access to critical areas of a duodenoscope to perform thorough cleaning and disinfection, single-use disposable duodenoscopes have been developed. A thorough assessment of this technology is limited by the minimal published data that is currently available. This opinion assesses the current technical functionality of these devices, potential for further improvements, implications for healthcare economics and the future of gastrointestinal endoscopy.
SUMMARY
Currently available data suggest that majority of endoscopic retrograde cholangiopancreatography procedures can be safely performed using single-use duodenoscopes. The ability to improve technical functionality, incorporate futuristic technology and secure financial reimbursement from insurance carriers will largely define the future prospects of this recent innovation.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Disinfection; Duodenoscopes; Endoscopy, Gastrointestinal; Equipment Contamination; Humans
PubMed: 34010243
DOI: 10.1097/MOG.0000000000000755 -
World Journal of Gastrointestinal... Aug 2021Endoscopic retrograde cholangiopancreatography (ERCP) has evolved from a primarily diagnostic to therapeutic procedure in hepatobiliary and pancreatic disease. Most... (Review)
Review
Endoscopic retrograde cholangiopancreatography (ERCP) has evolved from a primarily diagnostic to therapeutic procedure in hepatobiliary and pancreatic disease. Most commonly, ERCPs are performed for choledocholithiasis with or without cholangitis, but improvements in technology and technique have allowed for management of pancreatic duct stones, benign and malignant strictures, and bile and pancreatic leaks. As an example of necessity driving innovation, the new disposable duodenoscopes have been introduced into practice. With the advantage of eliminating transmissible infections, they represent a paradigm shift in quality improvement within ERCP. With procedures becoming more complicated, the necessity for anesthesia involvement and safety of propofol use and general anesthesia has become better defined. The improvements in endoscopic ultrasound (EUS) have allowed for direct bile duct access and EUS facilitated bile duct access for ERCP. In patients with surgically altered anatomy, selective cannulation can be performed with overtube-assisted enteroscopy, laparoscopic surgery assistance, or the EUS-directed transgastric ERCP. Cholangioscopy and pancreatoscopy use has become ubiquitous with defined indications for large bile duct stones, indeterminate strictures, and hepatobiliary and pancreatic neoplasia. This review summarizes the recent advances in infection prevention, quality improvement, pancreaticobiliary access, and management of hepatobiliary and pancreatic diseases. Where appropriate, future research directions are included in each section.
PubMed: 34512875
DOI: 10.4253/wjge.v13.i8.260 -
Journal of Clinical Gastroenterology Apr 2024Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard in the endoscopic management of biliary disease. An average of 700,000 ERCPs are performed...
Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard in the endoscopic management of biliary disease. An average of 700,000 ERCPs are performed every year, and most are performed using a reusable flexible duodenoscope. The innovation of disposable duodenoscopes has changed the dynamic in the advanced endoscopy field of study to primarily reduce or eliminate the risk of cross-contamination between patients. Many factors affect whether institutions can convert from standard reusable duodenoscopes to single-use duodenoscopes including the cost of the devices, reimbursement from insurance companies for the new devices, and the overall environmental impact. However, the reduction of cross-contamination leading to active infection in patients, environmental waste produced with high-level disinfection procedures, staff and equipment required for reprocessing, and the inability to frequently upgrade duodenoscopes for optimal performance are all factors that favor transitioning to single-use duodenoscopes. As these devices are new to the field of gastroenterology, the purpose of this review is to analyze the advantages and disadvantages of transitioning to single-use devices and a brief mention of alternative options for institutions unable to make this change.
PubMed: 38567887
DOI: 10.1097/MCG.0000000000001994