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Gastrointestinal Endoscopy Jan 2022
Review
Topics: Cholangiopancreatography, Endoscopic Retrograde; Disinfection; Duodenoscopes; Equipment Contamination; Humans
PubMed: 34487777
DOI: 10.1016/j.gie.2021.08.019 -
American Journal of Infection Control Jan 2020In 2018, the Food and Drug Administration/Centers for Disease Control and Prevention revised protocols for surveillance sampling and cultures of duodenoscopes. We...
In 2018, the Food and Drug Administration/Centers for Disease Control and Prevention revised protocols for surveillance sampling and cultures of duodenoscopes. We describe the recovery of the mold Curvularia from a duodenoscope processed according to the manufacturer's instructions using this revised sampling process. To our knowledge, this is the first time a mold has been recovered from a duodenoscope after following the Food and Drug Administration/Centers for Disease Control and Prevention protocol. This suggests that manufacturer's recommendation for scope reprocessing may be insufficient to adequately remove mold from these scopes.
Topics: Cross Infection; Curvularia; Disinfection; Duodenoscopes; Equipment Contamination; Equipment Reuse; Humans; Mycoses
PubMed: 31439371
DOI: 10.1016/j.ajic.2019.06.025 -
Gastrointestinal Endoscopy Jul 2017Recent reports of infectious outbreaks linked to duodenoscopes have led to proposals for duodenoscope surveillance culturing, which has inherent limitations. We aimed to...
BACKGROUND AND AIMS
Recent reports of infectious outbreaks linked to duodenoscopes have led to proposals for duodenoscope surveillance culturing, which has inherent limitations. We aimed to assess the feasibility of real-time adenosine triphosphate (ATP) testing after manual cleaning and its ability to predict reprocessing adequacy, as determined by terminal duodenoscope cultures.
METHODS
Clinically used duodenoscopes underwent reprocessing per current guidelines. After manual cleaning, ATP samples were obtained from the elevator, within the proximal biopsy port, and by flushing of the biopsy channel. After high-level disinfection (HLD), aerobic cultures of the elevator and biopsy channel were obtained using sterile technique. Duodenoscopes with any ATP sample ≥200 relative light units underwent repeated cycles of cleaning, ATP testing, HLD, and terminal culturing.
RESULTS
Twenty clinically used duodenoscopes were included; 18 underwent a second reprocessing cycle, and 6 underwent a third reprocessing cycle because of detection of high ATP. After the initial reprocessing cycle, 12 of 20 (60%) duodenoscopes had positive culture results, most commonly yielding gram-negative bacilli (GNB, n = 11 from 9 duodenoscopes), and catalase-positive gram-positive cocci (CP-GPC, n = 7 from 7 duodenoscopes), suggesting staphylococcal organisms. Ambient environmental controls also showed GNB and CP-GPC growth. The overall sensitivity and specificity of ATP testing compared with terminal cultures were 30% and 53%, respectively.
CONCLUSIONS
ATP sampling appears to correlate poorly with terminal culture results and cannot be recommended as a surrogate for terminal cultures. The performance and interpretation of cultures remains complicated by the potential recovery of environmental contaminants.
Topics: Adenosine Triphosphate; Bacteriological Techniques; Catalase; Disinfection; Duodenoscopes; Equipment Contamination; Feasibility Studies; Gram-Negative Bacteria; Gram-Positive Cocci; Guidelines as Topic; Pilot Projects; Sensitivity and Specificity
PubMed: 28396277
DOI: 10.1016/j.gie.2017.03.1544 -
Gastrointestinal Endoscopy May 2022Transmission of multidrug-resistant organisms by duodenoscopes during ERCP is problematical. The U.S. Food and Drug Administration recently recommended transitioning... (Clinical Trial)
Clinical Trial
BACKGROUND AND AIMS
Transmission of multidrug-resistant organisms by duodenoscopes during ERCP is problematical. The U.S. Food and Drug Administration recently recommended transitioning away from reusable fixed-endcap duodenoscopes to those with innovative device designs that make reprocessing easier, more effective, or unnecessary. Partially disposable (PD) duodenoscopes with disposable endcaps and fully disposable (FD) duodenoscopes are now available. We assessed the relative cost of approaches to minimizing infection transmission, taking into account duodenoscope-transmitted infection cost.
METHODS
We developed a Monte Carlo analysis model in R (R Foundation for Statistical Computing, Vienna, Austria) with a multistate trial framework to assess the cost utility of various approaches: single high-level disinfection (HLD), double HLD, ethylene oxide (EtO) sterilization, culture and hold, PD duodenoscopes, and FD duodenoscopes. We simulated quality-adjusted life years (QALYs) lost by duodenoscope-transmitted infection and factored this into the average cost for each approach.
RESULTS
At infection transmission rates <1%, PD duodenoscopes were most favorable from a cost utility standpoint in our base model. The FD duodenoscope minimizes the potential for infection transmission and is more favorable from a cost utility standpoint than use of reprocessable duodenoscopes after single or double HLD at all infection rates, EtO sterilization for infection rates >.32%, and culture and hold for infection rates >.56%. Accounting for alternate scenarios of variation in hospital volume, QALY value, post-ERCP lifespan, and environmental cost shifted cost utility profiles.
CONCLUSIONS
Our model indicates that PD duodenoscopes represent the most favorable option from a cost utility standpoint for ERCP, with anticipated very low infection transmission rates and a low-cost disposable element. These data underscore the importance of cost calculations that account for the potential for infection transmission and associated patient morbidity/mortality.
Topics: Cost-Benefit Analysis; Cross Infection; Disinfection; Duodenoscopes; Equipment Contamination; Humans
PubMed: 35026281
DOI: 10.1016/j.gie.2022.01.002 -
Digestive Endoscopy : Official Journal... Feb 2024
Topics: Humans; Duodenoscopes; Immersion; Adenomatous Polyps; Colonic Polyps; Colonoscopy
PubMed: 38148732
DOI: 10.1111/den.14731 -
Digestive Diseases and Sciences Jun 2024In response to documented duodenoscope-related infectious outbreaks of multidrug-resistant organisms, the Food and Drug Administration has recommended a transition to...
BACKGROUND AND AIMS
In response to documented duodenoscope-related infectious outbreaks of multidrug-resistant organisms, the Food and Drug Administration has recommended a transition to duodenoscopes with innovative designs, including duodenoscopes with disposable components or fully disposable duodenoscopes. We aim to characterize the learning curve (LC) for a single-use disposable duodenoscope.
METHODS
We performed a retrospective analysis of a prospectively collected database from 31 patients who underwent ERCP by a single, experienced operator using the EXALT Model D® (Boston Scientific, Marlborough) disposable duodenoscope at a single tertiary referral center. The LC for this device was described by the number of cases needed to achieve proficiency using cumulative sum (CUSUM) analysis. Number of attempts to cannulate and time to cannulate the desired duct were assessed as separate endpoints. The overall mean number of attempts and overall mean time to cannulation were used as the target values in the respective CUSUM analyses. Proficiency was defined as the number of procedures where an inflection point was reached in the CUSUM graph. This observation indicates improving operator performance as shown by a decrease in the number of attempts and shortening of cannulation time after the defined number of procedures.
RESULTS
Overall, 31 patients underwent ERCP using the EXALT Model D disposable duodenoscope by a single experienced endoscopist. 6 (19%) patients had a native papilla and the majority of these procedures were classified as ASGE complexity level 2 or above. The procedure was completed using solely the disposable duodenoscope in 27 patients (87%), while a reusable duodenoscope was required for procedure completion in 4 patients (13%). The cross-overs were distributed evenly across the performance period. Procedure-related adverse events included: post-ERCP pancreatitis (3%), bleeding (3%) and no perforations. In the analyses of both endpoints, an inflection of the CUSUM curves is achieved at 10 cases, indicating sustained reduction of cannulation attempts and time to cannulation.
CONCLUSION
Among experienced pancreaticobiliary endoscopists, approximately 10 ERCPs is the threshold whereby procedure-related factors including cannulation success and procedural time improves. Procedure-related adverse events are consistent with those expected with reusable duodenoscopes. The need to cross-over from single-use duodenoscope to reusable duodenoscope did not appear to be related to the learning curve, as they were evenly distributed across the study period. These results can be used to guide adoption of single-use duodenoscopes into clinical practice.
Topics: Humans; Duodenoscopes; Learning Curve; Retrospective Studies; Disposable Equipment; Cholangiopancreatography, Endoscopic Retrograde; Male; Female; Middle Aged; Aged; Clinical Competence; Equipment Design
PubMed: 38466461
DOI: 10.1007/s10620-024-08305-z -
IEEE Transactions on Bio-medical... Dec 2013A side-viewing duodenoscope capable of both optical and magnetic resonance imaging (MRI) is described. The instrument is constructed from MR-compatible materials and...
A side-viewing duodenoscope capable of both optical and magnetic resonance imaging (MRI) is described. The instrument is constructed from MR-compatible materials and combines a coherent fiber bundle for optical imaging, an irrigation channel and a side-opening biopsy channel for the passage of catheter tools with a tip saddle coil for radio-frequency signal reception. The receiver coil is magnetically coupled to an internal pickup coil to provide intrinsic safety. Impedance matching is achieved using a mechanically variable mutual inductance, and active decoupling by PIN-diode switching. (1)H MRI of phantoms and ex vivo porcine liver specimens was carried out at 1.5 T. An MRI field-of-view appropriate for use during endoscopic retrograde cholangiopancreatography (ERCP) was obtained, with limited artefacts, and a signal-to-noise ratio advantage over a surface array coil was demonstrated.
Topics: Animals; Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Equipment Design; Liver; Magnetic Resonance Imaging; Phantoms, Imaging; Signal-To-Noise Ratio; Swine
PubMed: 23807423
DOI: 10.1109/TBME.2013.2271045 -
Infection Control and Hospital... Feb 2016
Topics: Communicable Diseases; Cross Infection; Disinfection; Duodenoscopes; Equipment Contamination; Equipment Reuse; Ethylene Oxide; Health Care Surveys; Humans; Physicians
PubMed: 26503302
DOI: 10.1017/ice.2015.256 -
Gastrointestinal Endoscopy Feb 2020Multidrug-resistant infectious outbreaks associated with duodenoscope reuse have been documented internationally. A single-use endoscope could eliminate exogenous... (Comparative Study)
Comparative Study
BACKGROUND AND AIMS
Multidrug-resistant infectious outbreaks associated with duodenoscope reuse have been documented internationally. A single-use endoscope could eliminate exogenous patient-to-patient infection associated with ERCP.
METHODS
We conducted a comparative bench simulation study of a new single-use and 3 models of reusable duodenoscopes on a synthetic anatomic bench model. Four ERCP tasks were performed: guidewire locking (single-use and 1 reusable duodenoscope only), plastic stent placement and removal, metal stent placement and removal, and basket sweeping. The study schedule included block randomization by 4 duodenoscopes, 4 tasks, and 2 anatomic model ERCP stations. Ability to complete tasks, task completion times, and subjective ratings of overall performance, navigation/pushability, tip control, and image quality on a scale of 1 (worst) to 10 (best) were compared among duodenoscopes.
RESULTS
All 4 ERCP tasks (total 14 subtasks) were completed by 6 expert endoscopists using all 4 duodenoscopes, with similar task completion times (median, 1.5-8.0 minutes per task) and overall performance ratings by task (median, 8.0-10.0). Navigation/pushability ratings were lower for the single-use duodenoscope than for the 3 reusable duodenoscopes (median, 8.0, 10.0, 9.0, and 9.0, respectively; P < .01). Tip control ratings were similar among all the duodenoscopes (median, 9.0-10.0; P = .77). Image quality ratings were lower for 1 reusable duodenoscope compared with the single-use and other 2 reusable duodenoscopes (median, 8.0, 9.0, 9.0, and 9.0, respectively; P < .01).
CONCLUSIONS
A new single-use duodenoscope was used to simulate 4 ERCP tasks in an anatomic model, with performance ratings and completion times comparable with 3 models of reusable duodenoscopes.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Disposable Equipment; Duodenoscopes; Equipment Reuse; Humans; Models, Anatomic; Operative Time; Random Allocation
PubMed: 31679738
DOI: 10.1016/j.gie.2019.08.032 -
Endoscopy Sep 2022
Topics: Anastomosis, Roux-en-Y; Anastomosis, Surgical; Duodenoscopes; Gastrectomy; Humans; Jejunum; Stomach Neoplasms; Varicose Veins
PubMed: 34624920
DOI: 10.1055/a-1625-5369