Disinfection Research Articles

Cryogenic fracturing of synthetic coal specimens under true-triaxial loadings-An experimental study

Cryogenic fracturing with liquid nitrogen (LN2) has been recognized as a potential and promising waterless fracturing technique for coalbed methane extraction, owing to the environmental harmlessness and low-temperature feature. Though it showed spirited performances in some field pilots in the late 20th century, it remains poorly understood, especially when LN2 is used directly as the fracturing fluid. In this work, we evaluated the performance of LN2 fracturing on cubic synthetic coal specimens under true-triaxial loadings. The study also included two subtasks that examined the necessity of a pre-cooling step and the effect of water saturation. Hence, the specimens are classified into dry and wet specimens, and the LN2 treatments are divided into two modes based on whether being pre-cooled. The results showed that the pre-cooling improved the fracturing performance of LN2 such that the breakdown pressures of the pre-cooled specimen are about 40% lower than the non-precooled ones. Based on the semilog pressure–time analysis, the pre-cooled specimens showed higher permeability enhancement (2.9- to 7.9-fold) than the non-precooled ones (1.4- to 1.7-fold). The dry specimens after LN2 fracturing gave a fracture along the direction perpendicular to the minimum horizontal stress, whereas fractures of the wet ones deviated from the expected direction. It indicates that the expansion pressure caused by the frost heaving may change the fracture orientation. In addition, small thermal cracks were observed around the borehole in the open-hole section from the cross-section of the wet specimen, which agrees with the widely accepted thermal damage theory.

Reconstitution of the Climate in the Municipality of Guimarães (Northern Portugal): A Regional Approach Based on Historical Information and the Record of Measured Data

Climate change is a global phenomenon that has become a focus of concern for society, mainly due to its impacts on daily lives. Despite being a global issue that affects the entire planet, these effects are not felt in the same way in all regions, so the analysis of processes from a regional or local perspective allows a better adaptation of populations to the new reality, as well as being used as a supporting tool for decision making when implementing mitigation measures. For the present analysis, a region in Northern Portugal was chosen, which is in the Mediterranean region, considered one of the hot spots for climate change. In this region of Entre Douro e Minho, more specifically in the municipality of Guimarães, the climate of the last centuries was reconstructed based on documentary information and recent data collected and modeled for the region under study. The results show a successive alternation of hot and dry periods with colder and wetter ones, where climate instability seems to be the dominant trend over the last thousand years. Currently, with the advent of a new period of climatic instability, which, unlike the periods verified previously, now have an anthropic origin, there is a tendency for a new period to occur, in which conditions will tend to be hotter and drier. Knowing this trend in advance allows informed decisions to be made to mitigate some problems that can be associated with these conditions, such as the increase in the risk of wildfires, the proliferation of invasive species, the decrease in agriculture and forests productivity, or even the occurrence of extreme weather events.

Persistent contamination of a duodenoscope working channel in a non-clinical simulated ERCP setting.

Background To mitigate duodenoscope contamination, recent design enhancements have primarily focused on the distal tip. However, the working channels remain unchanged, which may be linked to biofilm formation. We assessed the persistence of microorganisms, indicative of biofilm formation, in reprocessed duodenoscopes in a non-clinical endoscopic retrograde cholangiopancreatography (ERCP) simulation setting. Methods Three new duodenoscopes were over-soiled in non-clinical ERCP simulations followed by reprocessing. After 40 tests, the Pseudomonas aeruginosa strain in the soil (Pa-type 1) was switched to a different P. aeruginosa strain (Pa-type 2) for 20 subsequent tests. Cultures of the tip and working channel were acquired after high level disinfection and overnight storage. Results One duodenoscope showed persistent growth of P. aeruginosa from the fifth test until the end of the study. Pa-type 1 remained present until the end of the study in the cultures of this duodenoscope, even after discontinuation of exposure to that specific strain. The other two duodenoscopes only showed incidental contamination. Conclusion Persistent contamination by Pa-type 1 was seen in one out of three duodenoscopes after exposure to supraphysiological levels of gut microorganisms. No clear explanation was found for this persistent contamination as exposure and handling were identical and no abnormalities of this particular duodenoscope were identified by borescope inspection.

Assessment of postmanual cleaning adenosine triphosphate tests to prevent the use of contaminated duodenoscopes and linear echoendoscopes: the DETECT study

We investigated whether the use of postmanual cleaning adenosine triphosphate (ATP) tests lowers the number of duodenoscopes and linear echoendoscopes (DLEs) contaminated with gut flora. In this single-center before-and-after study, DLEs were ATP tested after cleaning. During the control period, participants were blinded to ATP results: ATP-positive DLEs were not recleaned. During the intervention period, ATP-positive DLEs were recleaned. DLEs underwent microbiologic sampling after high-level disinfection (HLD) with participants blinded to culture results. Using 15 endoscopes of 5 different DLE types, we included 909 procedures (52% duodenoscopes, 48% linear echoendoscopes). During the intervention period, the absolute rate of contamination with gut flora was higher (16% vs 21%). The main analysis showed that contamination was less likely to occur in the intervention period (odds ratio, .32; 95% credible interval [CI], .12-.85). A secondary analysis showed that this effect was based on 1 particular duodenoscope type (estimated probability, 39% [95% CI, 18%-64%] vs 9% [95% CI, 2%-21%]), whereas no effect was seen in the other 4 DLE types. In detail, of the 4 duodenoscopes of this type, 2 had lower contamination rates (69% vs 39% and 36% vs 10%). During the control period, both these duodenoscopes had multiple episodes with ongoing contamination with the same microorganism that ended weeks before the start of the intervention period (ie, they were not terminated by ATP testing). Postmanual cleaning ATP tests do not reduce post-HLD gut flora contamination rates of DLEs. Hence, postcleaning ATP tests are not suited as a means for quality control of endoscope reprocessing.

Prospective Study Assessing Impact of Ethylene Oxide Sterilization on Endoscopic Ultrasound Image Quality

Duodenoscope-associated transmission of infections has raised questions about efficacy of endoscope reprocessing using high-level disinfection (HLD). Although ethylene oxide (ETO) gas sterilization is effective in eradicating microbes, the impact of ETO on endoscopic ultrasound (EUS) imaging equipment remains unknown. In this study, we aimed to compare the changes in EUS image quality associated with HLD vs HLD followed by ETO sterilization. Four new EUS instruments were assigned to 2 groups: Group 1 (HLD) and Group 2 (HLD+ ETO). The echoendoscopes were assessed at baseline, monthly for 6 months, and once every 3 to 4 months thereafter, for a total of 12 time points. At each time point, review of EUS video and still image quality was performed by an expert panel of reviewers along with phantom-based objective testing. Linear mixed effects models were used to assess whether the modality of reprocessing impacted image and video quality. For clinical testing, mixed linear models showed minimal quantitative differences in linear analog score (P= .04; estimated change, 3.12; scale, 0-100) and overall image quality value (P= .007; estimated change,-0.12; scale, 1-5) favoring ETO but not for rank value (P= .06). On phantom testing, maximum depth of penetration was lower for ETO endoscopes (P < .001; change in depth, 0.49 cm). In this prospective study, expert review and phantom-based testing demonstrated minimal differences in image quality between echoendoscopes reprocessed using HLD vs ETO+ HLD over 2 years of clinical use. Further studies are warranted to assess the long-term clinical impact of these findings. In the interim, these results support use of ETO sterilization of EUS instruments if deemed clinically necessary.

Comparison of the sporicidal activity of a UV disinfection process with three FDA cleared sterilants

Endocavitary probes are semi-critical devices and must undergo, at least, high level disinfection (HLD) between uses. Therefore, they should be high level disinfected between uses (i.e., with a product/process that kills all forms of microbial life; bacteria, fungi, mycobacteria, and virus, and in some countries, a demonstrated potential for sporicidal activity). In this study, the sporicidal activity of three common Food and Drug Administration cleared sterilants (CIDEX OPA Solution, SPOROX II Sterilizing and Disinfection Solution and CIDEX Activated Dialdehyde Solution) was compared with the sporicidal activity of an ultraviolet disinfection technology (Hypernova Chronos, Germitec) against Bacillus subtilis ATCC 19659 spores spread on silicone flat carriers in the presence of inorganic and organic soil. The results indicate that the UV disinfection process presented within a 35 seconds exposure time a sporicidal efficacy substantially higher than the chemical sterilants used according to manufacturer instructions for HLD. This study demonstrated that even if it cannot be tested/approved as a sterilant according to AOAC 966.04, the UV unit is much more effective than usual Food and Drug Administration approved chemical HLD products to kill spores in real use conditions. This finding questions the relevancy of evaluating product efficacy within extended conditions giving results that could mislead users to select the most effective HLD product/process for the reprocessing of their medical devices.

Correspondence Between Model Structures and Hydrological Signatures: A Large‐Sample Case Study Using 508 Brazilian Catchments

AbstractDaily streamflow dynamics can be accurately simulated by conceptual models as simple as a single bucket in some catchments, while they require more complex configurations in other catchments. However, without resorting to calibration, anticipating where and why a given model structure may be appropriate remains difficult. In this work, we explored the feasibility of relating suitable model structures to the climate and streamflow characteristics of 508 catchments in Brazil. Specifically, we tested four model structures using up to three reservoirs, where each reservoir is intended to represent a catchment function: the rainfall‐runoff threshold, the fast, and the slow hydrograph response. We hypothesized a relationship between suitable model structures and hydrological signatures of aridity (IA) and baseflow index (IB). Our results show that different classes of signatures resulted in distinct patterns of model performance. Wet catchments (IA &lt; 0.9) with low baseflow (IB &lt; 0.4) were the easiest to model, with a single‐reservoir model presenting a relatively good performance. In the case of low baseflow, adding a rainfall‐runoff threshold reservoir resulted in better performance than adding a slow response reservoir, whereas in the case of high baseflow (IB &lt; 0.6) the opposite occurred. In the case of low baseflow, the inclusion of a slow response reservoir helped the simulation of dry catchments (IA &lt; 1.1), but not of wet ones, which we attributed to the impact of permeability in dry catchments. These results indicate a path toward model structure identification from streamflow signatures and potentially from landscape features.

On the Disinfection of Electrochemical Aptamer-Based Sensors.

Electrochemical aptamer-based (EAB) sensors encompass the only biosensor approach yet reported that is simultaneously: (1) independent of the chemical or enzymatic reactivity of its target, rendering it general; (2) continuous and real-time; and (3) selective enough to deploy in situ in the living body. Consistent with this, in vivo EAB sensors supporting the seconds-resolved, real-time measurement of multiple drugs and metabolites have been reported, suggesting the approach may prove of value in biomedical research and the diagnosis, treatment, and monitoring of disease. However, to apply these devices in long-duration animal models, much less in human patients, requires that they be free of any significant pathogen load. Thus motivated, here we have characterized the compatibility of EAB sensors with standard sterilization and high-level disinfection techniques. Doing so, we find that, while many lead to significant sensor degradation, treatment with CIDEX OPA (0.55% ortho-phthalaldehyde) leads to effective disinfection without causing any detectable loss in sensor performance.

ОБРАБОТКА УЛЬТРАЗВУКОВЫХ ДАТЧИКОВ ПРИ РАЗЛИЧНЫХ РИСКАХ ИНФИЦИРОВАНИЯ

Everywhere in clinics of different countries, there is an insufficiently adequate processing of sensors and other elements of ultrasound (US) equipment, and this often happens due to lack of awareness of US diagnostics specialists. The purpose of the given work was to analyze the literature data on the principles of processing US probes. To prevent the transmission of microorganisms, the choice of the probe processing option is regulated by the general rules for disinfection of reusable medical devices in accordance with regulatory documents. US probes that come into contact with intact skin are non-critical devices. Such equipment should be cleaned and processed with the help of low to moderate disinfection. US probes that come into contact with damaged skin, blood, body fluids and mucous membranes are considered to be semi-critical and require high-level disinfection and the use of special disposable coatings. Critical devices include US probes that are used for invasive procedures. Sterilization, if possible, or high-level disinfection are used to clean these probes. Furthermore, the use of special disposable coatings is mandatory when examining patients from the risk group. The best option for choosing a disinfection mode, from the point of view of maintaining the operability of the probe, is the recommendation of the US equipment manufacturer.

Uniaxial Compression Damage Mechanical Properties and Mechanisms of Dolomite Under Deep High-Humidity Condition

The paper studies the uniaxial compression mechanical properties of pillars under the deep and high-humidity environment. We make the pillars cored from the −750 m mine room of Wengfu Phosphate Mine into the standard dolomite samples and test with a humidity control device developed by ourselves. Combining with uniaxial compression tests and microstructure inspections, we study the mechanical deterioration rule and damage mechanism of the dry samples and the wet ones that have been placed in a high-humidity condition (90% RH) for 30, 60 and 90 d, respectively. The results show that: 1) When the sample is placed in the humidity device, its original layered or sheet crystal morphology will change into sponge-like or flocculent morphology. As the placement time increases, the structure of the sample becomes looser and the boundaries between layers become blurred. The numbers of micro-cracks and micro-pores increase. 2) In the initial stage of water molecule intrusion (0–30 d), the strength and mass damages of the rock sample are less, and the damage rate is low. As high-humidity action time increases (30–90 d), the damage rates of both strength and mass gradually grow. 3) The failure modes of dolomites include shear failure and tensile/shear mixed failure, which are controlled by the storage time under high-humidity condition. As time goes by, more macroscopic cracks appear and the failure mode of the rock changes from shear to tensile. 4) Based on the X-ray diffraction and scanning electron microscopy analysis on mineral components, together with the principle of chemical kinetics, we discuss the chemical reaction process between dolomite and gaseous water molecules, and summarize the chemical damage mechanism of rocks during the water-rock interaction. The research has a certain guiding significance for the durability and stability prediction of pillars under deep high-humidity conditions.

Cost utility analysis of strategies for minimizing risk of duodenoscope-related infections

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. 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. 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. 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.

Contamination Rates in Duodenoscopes Reprocessed Using Enhanced Surveillance and Reprocessing Techniques: A Systematic Review and Meta-Analysis.

Background/AimsMultiple 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.MethodsA 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. ResultsA 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). ConclusionsWhile 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.

Storage of gastrointestinal endoscopes: when is the safe time for re-use?

to identify the safe storage time for the use of flexible gastrointestinal endoscopes after high-level disinfection, as well as the defining criteria for this time. an integrative literature review was carried out in the Virtual Health Library, PubMed, Scopus, and Web of Science, considering original articles published since 2000. eleven articles were selected, whose storage times ranged from 1 to 56 days, with a predominance of one to seven days (73%). Several criteria were used to define this time, predominantly the premise of efficient processing (100%), use of alcohol flush (64%), use of drying cabinets (18%), among others. the criteria for determining the storage time did not show a consensus for clinical practice. Expanding the discussion of this theme with the definition of the minimum necessary conditions is of fundamental importance for the reduction of risks and safety of the procedure and the patient.

Review: Disposable Duodenoscopes in the Era of Climate Change—A Global Perspective

AbstractEndoscopic retrograde cholangiopancreatography remains a major interventional procedure in gastroenterology clinical practice. There have been concerns of hospital related infections secondary to the reusable duodenoscopes despite optimal strategies for high-level disinfection. While there are have been potential changes in duodenoscope design with availability of disposable caps, the increased risk of infection has led to the advent of single-use duodenoscopes in clinical practice. This innovation may help reduce infections due to duodenoscope reprocessing, while ensuring optimal performance similar to reusable duodenoscopes. However, their impact on the environment and overall carbon footprint has not been discussed. Moreover, disposable duodenoscopes are costly equipments. In developing countries with low income and poor insurance coverage, the clinical utility of this equipment is yet to be ascertained. With major push for Go-Green initiatives by various governments, there has to be clarity on not just use but also disposal and recycling of disposable duodenoscopes. In this narrative review, we discuss the role of disposable duodenoscopes in clinical practice in this era of climate change from the Indian perspective.

960. Creation of an Infection Prevention and Control (IPAC) Elective for Infectious Disease (ID) Fellows

BackgroundID specialists often function as leaders of IPAC for healthcare systems, with variable training. Our graduates have noted feeling underprepared for this role despite completion of a computer-based training course on IPAC basics. We developed a 2-4 week IPAC elective (IPACe) rotation to address this gap to increase familiarity with key IPAC concepts, introduce learners to approaches to IPAC investigations, and develop understanding of common IPAC challenges and controversies. MethodsMethodology followed Kern’s 6-step approach. A reading list focusing on key areas in infection prevention was developed. Instructional methods included flipped classroom, learner led discussions, performing tracers, and integration with the IPAC team. Key hospital processes including High Level Disinfection (HLD) and Sterile Processing Department (SPD) were reviewed in detail with and observed by learners. In addition to an IPACe, periodic required IPAC essay questions on real-world investigations as they arose were delivered to the learners. Learner Assessment: Learners were assessed on elements of IPAC consistent with the ACGME 6 core competencies at the end of their rotation. Program Assessment: Anonymous narrative feedback was solicited post rotation completion and at semi-annual program evaluations. Additionally, learners were asked to rate the elective on a 5 point Likert scale (1 lowest, 5 highest) and specific feedback was solicited for improvement. Finally, feedback was solicited from graduates in IPAC roles.Results8 learners participated over from 2017-2021: 2 for 4 weeks, and 6 for 2 weeks. 4 of 8 surveys included a response to the questionnaire, all survey respondents (4/4) rated the elective 5: “rotation should be required of all trainees in the program.” Narrative assessments revealed the elective was highly valuable. Graduates reported feeling well-prepared after the IPACe for their roles as IPAC leaders. Highlights identified were: exposure to interdisciplinary teamwork, participation in tracers in identifying gaps, and using real-world IPAC challenges as cognitive frameworks for outbreak investigation.ConclusionAn IPACe was highly valued by fellow learners and narrative assessments identified key areas for further focus. Disclosures All Authors: No reported disclosures

Australasian emergency ultrasound: A survey on the current status.

Emergency ultrasound (EUS) has become an integral part of emergency medicine, and the core pillars of governance, infrastructure, administration, education and quality assurance (QA) are vital for its quality and continued growth. We aimed to assess the status of these vital pillars among Australasian EDs. A survey among the clinical leads in ultrasound (CLUS) in Australasian EDs from November 2020 to April 2021. We analysed a total of 98 responses from CLUS representing 98 EDs. Most CLUS (85%) held EUS qualifications (CCPU 57%, DDU 18%, other 9%) but 15% had none. Only 66% of CLUS had dedicated clinical support time, and a mere 5% had administrative personnel support. Up to three ultrasound machines in 62% of EDs, but only 26% of EDs had secured image archiving facilities. In-house credentialing and the Australasian College for Emergency Medicine (ACEM) trainee special skills placement were available in 50% and 32% of EDs, respectively. Only 11% of EDs had regular EUS training for FACEMs, and only 66% of EDs had regular EUS education for emergency medicine trainees. Only 20 EDs had sonographer educators. Regarding EUS QA, only 33% of EDs provided formal EUS report, 23% of EDs conducted regular image reviews and 37% of EDs audited EUS performance. Only 35% of EDs had high-level disinfection equipment, and 56% of EDs had formal transducer disinfection protocols. Despite ACEM recommendations for the practice of EUS, Australasian EDs still lack vital governance, administrative support, infrastructure, education and QA processes. Prompt actions such as ACEM mandating these recommendations are required to improve resource allocation by health services.

Evaluating the virucidal activity of four disinfectants against SARS-CoV-2

BackgroundThe recent COVID-19 pandemic highlights the need for efficacious virucidal products to limit the spread of SARS-CoV-2. Several studies have suggested that alcohol-based sanitizers and some disinfectants are effective. While virucidal activity data of low-level disinfectants are lacking and some conclusions are not clear yet. MethodsWe evaluated the virucidal activity of 2 quaternary ammonium compounds (QAC) disinfectants (MICRO-CHEM PLUS and FWD), W30 (an amphoteric surfactant), and Medical EtOH against SARS-CoV-2. Suspension tests covering different concentration and contact time were performed using the integrated cell culture-qPCR method. ResultsEach of disinfectants was effective at inactivating SARS-CoV-2. MCP and FWD are highly effective within 15 seconds. W30 is also efficient within 2 minutes at concentration of 1%. Consistent with previous report, our results also demonstrated that 38% ethanol was sufficient to completely inactivate virus, which proved the method used in this study is feasible. Conclusions and DiscussionQAC disinfectants, MCP and FWD, are highly effective for the inactivation of SARS-CoV-2, which making them practical for use in health care setting and laboratories where prompt disinfection is important. The low-level disinfectant based on amphoteric surfactant, W30, which may present in commonly available household hygiene agents is also able to inactivate SARS-CoV-2.

Potential of an Eco-Sustainable Probiotic-Cleaning Formulation in Reducing Infectivity of Enveloped Viruses.

The COVID-19 pandemic has deeply influenced sanitization procedures, and high-level disinfection has been massively used to prevent SARS-CoV-2 spread, with potential negative impact on the environment and on the threat of antimicrobial resistance (AMR). Aiming to overcome these concerns, yet preserving the effectiveness of sanitization against enveloped viruses, we assessed the antiviral properties of the Probiotic Cleaning Hygiene System (PCHS), an eco-sustainable probiotic-based detergent previously proven to stably abate pathogen contamination and AMR. PCHS (diluted 1:10, 1:50 and 1:100) was tested in comparison to common disinfectants (70% ethanol and 0.5% sodium hypochlorite), in suspension and carrier tests, according with the European UNI EN 14476:2019 and UNI EN 16777:2019 standards. Human alpha- and beta-coronaviruses hCoV-229E and SARS-CoV-2, human herpesvirus type 1, human and animal influenza viruses, and vaccinia virus were included in the study. The results showed that PCHS was able to inactivate 99.99% of all tested viruses within 1–2 h of contact, both in suspension and on surface. Notably, while control disinfectants became inactive within 2 h after application, the PCHS antiviral action persisted up to 24 h post-application, suggesting that its use may effectively allow a continuous prevention of virus spread via contaminated environment, without worsening environmental pollution and AMR concern.

A Cost-Effectiveness Analysis of Exalt Model D Single-Use Duodenoscope Versus Current Duodenoscope Reprocessing Methods

Background and AimsThe spread of duodenoscope-related infections has led to the recognition that reprocessing of duodenoscopes using high-level disinfection (HLD), if done perfectly, narrowly meets the advised thresholds of endoscope decontamination. In 2019, the US Food and Drug Administration (FDA) recommended a transition to duodenoscopes designed to pose less risk, including the use of disposable duodenoscopes. The Exalt Model D (Boston Scientific Corp, Marlborough, MA) single-use duodenoscope (EXALT) has been shown to be substantially equivalent to reusable duodenoscopes for clinical use. The aim of this study was to estimate the cost-effectiveness of EXALT in the United States healthcare system. MethodsA cost-effectiveness model was developed comparing HLD, culture-and-quarantine (CQ), Ethylene oxide sterilization (ETO), and EXALT in a simulated cohort undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) for choledocholithiasis. Published information was leveraged describing clinical estimates, infectious outbreaks, and hospital costs. ResultsIn a base analysis, HLD was the least costly ($962), and EXALT was the costliest ($3000), but yielded the most QALYs (0.0172 incremental QALYs). The incremental cost-effectiveness ratio was $38,461 for ETO gas sterilization and $62,185 for EXALT. However, with the availability of device-specific reimbursement for EXALT in the US in the form of transitional pass-through payment (TPT) and new technology add-on payment (NTAP), EXALT provided the highest cost-savings to the hospital versus alternative strategies by maintaining QALY gains while decreasing estimated net costs. Probabilistic sensitivity analyses showed EXALT to be preferred compared to HLD over a range of willingness-to-pay. ConclusionEXALT is a viable and cost-effective strategy that should be strongly considered for ERCP.

S970 New Automated Cleaning System Is More Effective in Reducing Bioburden vs Standard Manual Clean in Duodenoscopes

Introduction: Multiple recent outbreaks of multidrug resistant organisms (MDRO) related to contaminated duodenoscopes have led to increased scrutiny of duodenoscope standard reprocessing methods. A key component of duodenoscope reprocessing is the cleaning step that occurs before high-level disinfection (HLD) or sterilization. Perfect adherence to manufacturer Instructions for Use (IFU) for manual cleaning can be difficult to achieve due to technical complexity and is open to human factor error. Adequate cleaning is measured against FDA and industry maximum allowed contaminants post cleaning of protein < 6.4 ug/cm^2 and carbohydrates < 2.2 ug/cm^2. Inadequate cleaning increases the risk for inadequate high-level disinfection and the possibility of procedures being performed with contaminated duodenoscopes. A new cleaning process has been developed to fully automate the cleaning step using turbulent flow technology. Methods: A total of 48 therapeutic ERCP procedures were performed utilizing Olympus TJF-Q180V duodenoscopes. After bedside point of use cleaning, 21 duodenoscopes were manually cleaned by trained technicians following the manufacturer IFU. 27 duodenoscopes were cleaned using the automated cleaning system. Duodenoscope instrument channels and distal elevator areas were sampled for residual protein and carbohydrates after cleaning. Results: The automated cleaning process resulted in a lower average level of residual protein and carbohydrate compared to standard manual cleaning (Table 1). Using FDA and industry standards as a benchmark, the automated cleaning process reduced levels of protein and carbohydrate below safety threshold levels on all study duodenoscopes, while manual cleaning resulted in 4/21 (19%) duodenoscopes having protein or carbohydrate levels above FDA standards (p = 0.03). Conclusion: Recent outbreaks of MDRO organisms transmitted after ERCP have brought to light the risk to patients when reusable duodenoscopes are not sufficiently reprocessed. The complex design of the device – involving multiple channels and an elevator mechanism at the distal tip – makes proper cleaning difficult. Without sufficient cleaning, subsequent HLD or sterilization can fail to adequately remove contaminants. As seen in this study, manual cleaning can be prone to error. With no incidents of elevated bioburden post cleaning, a fully automated cleaning technology appears to be a viable alternative for replacement of manual cleaning of duodenoscopes.Table 1.: Residual Protein and Carbohydrate Post Manual Versus Automated Clean *One manually cleaned duodenoscope had levels of both protein and carbohydrate above FDA threshold.