International guidelines suggest different possibilities for drying of endoscopes during reprocessing. Clinical results of these available drying methods are not satisfactory. The aim of this study was to compare the drying cycle of a standard endoscope washer-disinfector (EWD) (standard drying method [SD]) with a shortened mandatory drying by the EWD followed by a special drying device using laminar and turbulent air flow (novel drying method [ND]).

Sixty endoscopes (duodenoscopes, colonoscocopes, and gastroscopes) from 3 different manufacturers underwent high-level disinfection and drying depending on the randomization group. Operational time of drying was measured for both groups. Residual fluid in the channels was measured using a laboratory scale. After a 14-day storage period, a sample of the endoscope channels was obtained to determine bacterial contamination.

ND had significantly fewer residual water in endoscope channels (SD: 90% vs ND: 0%; P < 0.001) after high-level disinfection and drying and less bacterial contamination after storage for 14 days (SD: 47% vs ND: 20%; P = 0.028). Time consumed for drying in ND was also significantly shorter (SD: 16 minutes 4 seconds vs ND: 5 minutes 59 seconds; P < 0.001).

Drying with a special automatic drying device was superior compared with an EWD's drying program as evidenced by no measurable residual water, reduced microbiological contamination, and a more than 2-fold decrease in operational time. Thus, drying by laminar and turbulent airflow may represent an attractive alternative to the currently used standard approach in the reprocessing process of flexible endoscopes.

There is a lack of a universally accepted standard or guideline for the frequency of disinfection in purified water pipelines. Furthermore, there is no standardized method for detecting microorganisms in the final rinse water utilized for endoscope cleaning.This study aims to examine the current management and microbial monitoring practices concerning the final rinse water used for flexible endoscope cleaning in medical institutions.

A questionnaire was designed using a convenience sampling method to gather data on the maintenance and microbial monitoring of final rinse water for flexible endoscopes in 290 medical institutions across Jiangsu Province, China.

Purified water is used for endoscope rinsing by 93.45% of institutions, with 78.62% employing centralized water supply. Membrane filtration devices at the terminal are installed by 82.07%, mainly with a 0.2μm pore size (76.47%), and are replaced quarterly (32.77%). Disinfection devices are present at 52.76% of terminals, with varied disinfection frequencies; chlorine-containing disinfectants (48.15%) and peracetic acid (34.92%) are predominant. Inadequate disinfection, filter membrane neglect, sampling contamination, and biofilm formation are identified as reasons for non-compliant final rinse water. Actions include filter replacement, pipeline disinfection, and flushing. Microbial mornitoring occurs quarterly (70.96%), with faucet outlets as primary sampling sites. Standards are based on 10cfu/100ml (87.58%), using membrane filtration (40.81%) and nutrient agar plates (82.72%). A cultivation period of 2 days predominated (72.43%), with a temperature range of 35-37°C (76.47%).

While purified water and terminal filters are common for final rinsing of endoscopes, there is variation in maintenance and supply line disinfection. Current microbiological methods' reliability is considered low, necessitating further research to establish unified standards for effective endoscope final rinse water management and monitoring.

The complex structure of endoscopes causes nonuniform drying conditions. However, current clinical drying practices lack precise guidance, leading to the insufficient drying of some endoscopes, which increases the risk of infection. The pressure of compressed air has been proven to affect the effectiveness of endoscope drying; however, specific requirements are absent. This study explored the time required for the sufficient drying of different endoscopes under various pressure conditions.

Six different types of commonly used Olympus flexible endoscopes were selected, and for each type, multiple drying time groups were set under pressures of 0.102 and 0.204 MPa, with 10 endoscopes observed in each group.

Drying times varied according to the type and pressure. At 0.102 MPa, the instrument channel drying ranged from 80 s to 160 s (avg. 123 s), while suction channel ranged from 260 s to 540 s (avg. 428 s). At 0.204 MPa, the instrument channel dried in 50 s to 90 s (avg. 72 s), and suction channel in 130 s to 230 s (avg. 186 s).

Optimal drying times for endoscopes differ according to the type and pressure. A higher pressure (0.204 MPa) efficiently removes moisture and speeds up drying. Longer endoscopes with the same biopsy channel diameter require longer drying time. In addition, the instrument channel dries faster than the suction channel.

A diagnostic flexible laryngoscopy using a flexible endoscope (FE) without a working channel can become contaminated when inserted through the nose to inspect the throat. Microbiological surveillance is necessary to ensure adequate reprocessing. A lack of knowledge exists about the most accurate way to assess microbiological contamination on the surface of FEs without a working channel. A scoping review of research on sampling techniques for FEs without a working channel was done to identify frequently used sampling techniques and to determine the best way to assess microbiological contamination.

PubMed, Embase, Cochrane Library, and CINAHL databases were searched. Data related to the sampling technique and bacterial contamination were extracted.

Twelve of the 378 studies met the inclusion criteria. None compared sampling techniques, most studies investigated the efficacy of several disinfection methods. Retrieved sampling techniques were immersion, swabbing, and wiping. Immersion and wiping could detect bacterial contamination on contaminated FEs without a working channel. Two out of six studies using a swabbing method found bacterial contamination on contaminated FEs without a working channel. Three studies using the swabbing method detected bacterial contamination after disinfection. One study did not retrieve microorganisms after disinfection using the swabbing method.

Three different sampling techniques were extracted: immersion, wiping, and swabbing, which could all detect microbiological contamination on contaminated FEs without a working channel. However, this scoping review identified significant gaps in literature. Additional research is needed to determine the best sampling technique(s) for FEs without a working channel to detect microbiological contamination.

To report the epidemiologic, microbiologic and genetic investigation of a large outbreak of carbapenem-resistant Klebsiella pneumoniae associated with gastrointestinal endoscopy, including infection control interventions.

Internal and external audits of reprocessing procedure, systematic microbiological examination of reprocessed endoscopes, replacement of old endoscopes, investigation of channels of a dismantled endoscope, disinfectant efficacy testing on the outbreak strain's biofilm, and whole-genome sequencing (WGS) analysis were performed.

In the early phase of the outbreak, the outbreak strain was detected in 19 patients, 16 (84%) of whom had undergone gastrointestinal endoscopy. The strain was also isolated from a reprocessed endoscope. WGS confirmed clonal relatedness of isolates and suggested transmission between patients via contaminated endoscopes. The reprocessing was audited, old endoscopes were replaced with new ones, and systematic microbiological examination of new endoscopes was introduced. In the follow-up, the outbreak strain was isolated from a new endoscope after reprocessing. Repeat audit revealed residual moisture in endoscope channels after reprocessing. Inspection of a dismantled endoscope revealed debris and scratches in channels. Disinfectant efficacy testing revealed tolerance of the outbreak strain's biofilm to peracetic acid. The outbreak strain was isolated from 32 patients and two reprocessed endoscopes. WGS suggested patient-to-patient as route of transmission in the outbreak's later phase.

A multi-stage strategy was required to contain this outbreak. Microscopic analysis showed evidence of biofilm formation in endoscope channels and the outbreak strain's biofilm showed tolerance to the disinfectant used for reprocessing. Our data underscores the need for continued vigilance in infection control practices and reprocessing protocols for endoscopes.

Single-use flexible bronchoscopes (SFBs) are increasingly used to minimize cross-infection risk, particularly in immunocompromised and intensive care unit patients. However, broader adoption requires cost analysis. We conducted a 1-year cost-minimization analysis comparing SFBs and reusable flexible bronchoscopes (RFBs) at a tertiary care university hospital.

We evaluated the costs per procedure, considering capital equipment, maintenance, repair, reprocessing, and overhead costs. We also analyzed the impact of annual procedure volume on costs and performed a sensitivity analysis to assess the effect of uncertainty on costs.

A total of 1394 bronchoscopies were performed. RFBs were less expensive for an annual volume of >50 bronchoscopies/year, with a 22% lower cost per procedure than that for SFBs (€203 vs. €259). This cost advantage became increasingly favorable with an increasing number of procedures, reaching a plateau after exceeding 250 bronchoscopies/year. The capital equipment, the annual number of bronchoscopies, and reprocessing were the major cost drivers for RFBs. During nonworking hours, the cost per procedure of RFBs ranged from €349.45 to €392.29. Using RFBs during interventions involving a high risk of bronchoscope damage (frequency of damage >10%) would increase the cost per bronchoscopy to >€263 (exceeding the cost of SFBs).

RFBs were 22% less expensive than SFBs for services with a moderate to high volume of bronchoscopies. However, this difference could not justify using RFBs in patients with a high cross-infection risk. SFBs might be less costly for procedures outside working hours and interventions involving a high risk of bronchoscope damage.

The storage of reusable medical devices (RMDs) is the final reprocessing phase and the step that directly precedes point-of-care delivery. Reusable medical devices, including surgical tools necessitating sterilization and semicritical devices such as endoscopes, undergo high-level disinfection. The rigorous reprocessing protocols and subsequent storage of RMDs are crucial in preserving their sterility and asepsis. This ensures they are available, clean, and safe for patient use, thereby significantly reducing the risk of surgical site infection. The stringent requirements for RMD storage are a testament to the critical role it plays in patient safety, making it a demanding task for health care organizations (HCOs) to comply with. These challenges are further amplified in austere environments. This integrative review aims to identify optimal storage practices, emphasize the critical importance of RMD storage in the Military Health System, and derive implications for policies and future considerations.

The authors performed an integrative review and comprehensive literature search in PubMed/MEDLINE, CINAHL, and Embase using the keywords "instrument storage," "surgical instruments," "sterile storage," "sterile wrap," and "flexible endoscope storage." Articles were limited to English from 1980 to 2024. Additionally, the authors reviewed international guidelines to support RMD storage.

The integrative review of 42 articles and 14 guidelines and articles identified 6 central themes supporting RMD storage, which include facility design, environmental considerations, sterile storage packaging systems, considerations for event-related sterile storage, point-of-care delivery, and endoscope storage best practices. The abundance of evidence-based recommendations and guidelines complicates adherence to optimal practices in HCOs, presenting significant challenges in austere environments. Integrating RMD storage considerations into training, exercises, and operations help promote a culture of RMD stewardship to ensure safe surgical and procedural care within the Military Health System.

Although surgical teams' capabilities are crucial in delivering effective care in a dynamic environment, the management and storage of RMDs are equally essential. Numerous organizations have outlined rigorous guidelines for HCOs to comply with, which can be intensified in austere conditions. Ultimately, a commitment to integrating the literature and developing the groundwork for clinical practice guidelines can improve the safe storage of RMDs in both standard and austere environments.

Ambu® aScope™ is a disposable flexible videoscope used for a wide range of medical procedures. However, adverse events associated with this device can occur. The Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was explored for patient-related adverse events associated with Ambu® aScope™ use between January 1, 2000 and December 15, 2023. Search terms included "Ambu" and "Ascope." Thirty unique adverse events were identified. Twenty-one of the events were associated with patient injury, and 9 with device malfunction. Eight patient-reported problems were documented as foreign bodies, 3 events as airway obstruction, desaturation, or hypoxic events, and 1 event as anxiety/cardiac arrest. The remaining 18 reported insufficient information other than associated with patient injury. We found that Ambu® aScope™ flexible nasolaryngoscopes and bronchoscopes are a common and effective tool for airway evaluations that may infrequently serve as a rare form of foreign body with potentially life-threatening consequences.

The use of reusable flexible endoscopes has increased dramatically over the past decade, however despite improvements in endoscope reprocessing, the continued emergence of endoscopy-associated outbreaks as a result of multi-drug resistant bacteria has highlighted the need for a new approach to disinfection. Here, the use of plasma activated liquids (PALs) for the elimination of mixed species biofilm contamination within the working channels of endoscopes was evaluated. Cold atmospheric pressure plasma was used to chemically activate water and a commercially available pH buffered peracetic acid to create PALs. Polytetrafluoroethylene endoscope surrogate test pieces were contaminated with clinically relevant mixed species biofilms. The efficacy of PALs for the decontamination of narrow lumens was compared against the commercial disinfectant. Plasma activation was found to increase the antibiofilm capabilities of pH buffered peracetic acid by introducing reactive chemical species into the solution. Disinfection of endoscopic test pieces with plasma activated disinfectant (PAD) resulted in a 7.30 log10 reduction of biofilm contamination in 5 min, surpassing the 4.39 log10 reduction observed with the currently used endoscope disinfection method. PAD also resulted in reduced regrowth and recolonization of the surface of the endoscopic test pieces. Minimal changes to the surface morphology and composition were observed following exposure to PAD in comparison to the commercial disinfectant, suggesting the developed approach is no more aggressive than current disinfection approaches.

Objective This study aimed to evaluate the current status of cleaning and disinfection management for digestive endoscopy, provide data for standardization processing techniques, and improve the quality of cleaning and disinfection. Methods Two reviewers independently and comprehensively searched the PubMed, Cochrane Library, EMBASE, Web of Science, CNKI, Wanfang, and CBM databases on February 1, 2023. The inclusion and exclusion criteria were strictly followed during the literature survey and data extraction. All observational studies detailing the current cleaning and disinfection management status for digestive endoscopy in hospitals were included. Meta-analysis was performed using STATA 16.0 software. Results After removing different articles, the meta-analysis finally included 54 articles associated with multiple countries. The authors favor auditing staffers to confirm compliance with guidelines. The meta-analysis results indicated a configuration rate of 76% (95% CI: 68-83%) for separate rooms designated for reprocessing; 79% (95% CI: 72-84%) for reprocessing rooms with adequate ventilation; 30% (95% CI: 24-36%) for automated endoscope washer-disinfectors; 68% (95% CI: 55-81%) for complete protective equipment usage; 90% (95% CI: 83-95%) for the configuration rate of endoscope and accessory storage cabinets; 50% (95% CI: 38-61%) for changing enzymatic-type detergents after each use; 51% (95% CI: 30-71%) for the use of purified or sterilized water for final rinsing; 80% (95% CI: 70-88%) for monitoring disinfectant concentration; 87% (95% CI: 80-93%) for microbial monitoring; and 44% (95% CI: 26-62%) for the usage of protective equipment. Conclusion The configuration of the automated endoscope washer-disinfector, non-standard cleaning and disinfection procedures, and a lack of occupational protection awareness among personnel responsible for cleaning and disinfecting digestive endoscopy were all apparent issues. It was suggested that all departments enhance their levels of management and supervision, standardize reprocessing procedures and quality control details, upgrade hardware facilities and spatial layouts, reinforce personnel training, and increase staff awareness of nosocomial infection risks.

This study aimed to assess the impact of INTERCEPT Foam Spray (IFS) application on delayed endoscope reprocessing through microbiological surveillance culture (MSC).

A quasi-experimental, matched-comparison pilot study was conducted using gastrointestinal endoscopy. IFS was applied to the endoscopes after precleaning and before reprocessing the next day. An equal number of endoscopes, matched by endoscope type, were subjected to routine reprocessing. The MSC were subjected to high-level disinfection to detect any contamination. Data were analyzed using the chi-square test or Fisher exact test (categorical data) and Student t-test (continuous data).

In total, 150 MSCs were collected from 42 endoscopes. Positive MSCs were observed in 4.0% (4/75) of the sprayed group and 1.3% (1/75) of the control group (95% confidence interval, 30.34-0.31; p>0.05), all of which were contributed by colonoscopes. Colonoscope were more prone to positive MSC (mean difference in percentage, p<0.05). Mean spraying hours were not associated with detected growth (11.7% vs. 13.6%; 95% confidence interval, 1.43 to -5.27; p>0.05), with environmental and skin flora being the primary contaminants.

IFS may be applied when delayed endoscope processing is necessary, but with caution when applied to colonoscopes. However, further research is warranted to verify the result.

An increased incidence of Pseudomonas aeruginosa in microbiological surveillance (MS) cultures from gastrointestinal endoscopes was detected between March 2020 and March 2023 in Tan Tock Seng Hospital Singapore.

To describe the use of whole-genome sequencing (WGS) in this investigation.

WGS was performed for all P. aeruginosa isolates with pairwise comparison of isolates to assess for genomic linkage. Comprehensive review of reprocessing practices and environmental sampling was performed.

Twenty-two P. aeruginosa isolates were detected from endoscopic MS cultures. Fifteen (68%) isolates were available for WGS. Eighteen pairwise comparisons of isolates were made, of which 10 were found to be genomically linked. One endoscope had P. aeruginosa repeatedly cultured from subsequent MS that were genomically linked and persistent despite repeat endoscopic reprocessing, establishing the persistence of biofilm that could not be eradicated with routine reprocessing. All P. aeruginosa isolates cultured from other different endoscopes were genetically distinct. Investigation into reprocessing practices revealed the use of air/water valves connected to endoscopes during clinical use. Inspection of these valves revealed the presences of cracks and tears. All other environmental samples were negative.

The WGS findings helped to deprioritize common source contamination and supported the hypothesis of biofilm build-up within endoscopes, leading to repeatedly positive MS cultures that were genomically linked. This was possibly related to incomplete reprocessing of the damaged air/water valves, resulting in biofilm build-up. All faulty valves were changed and subsequently cleaned separately with ultrasonic cleaning followed by sterilization which resolved this incident.

Introduction. Imipenemase (IMI) enzymes are an uncommon class A carbapenemases that have been isolated from aquatic environments and, occasionally, from clinical isolates of Enterobacterales.Aim. We describe a cluster of three patients infected by IMI-1 carbapenemase-producing Enterobacter ludwigii (IMI-1-Elud) in a tertiary university hospital in Gran Canaria, Spain.Methodology. Antimicrobial susceptibility was determined using the Vitek2 AST-N355 card and antibiotic gradient strips. The modified carbapenem inactivation method (CIM) test was performed in cases where the ertapenem MIC value was higher than 0.125 mg l-1. The carbapenemase was identified by PCR and DNA microarray and later characterized by whole-genome next-generation sequencing (NGS) with Illumina.Results. Three patients presented thoracic or abdominal infections caused by IMI-1-Elud ST1677 from 14 June 2022 to 14 July 2022. All patients underwent at least one gastroscopy during their admission, and two of them were located in adjoining rooms. Isolates were resistant to carbapenems, colistin and fosfomycin but susceptible to ciprofloxacin. IMI/NMC-A carbapenemase was detected by PCR and hybridization test and confirmed by NGS as IMI-1. All patients underwent at least one gastroscopy, and two of them were in nearby rooms. Patients showed microbiological and clinical improvement following focus drainage and targeted antibiotic treatment with a fluoroquinolone.Conclusions. This study reports the first documented global outbreak of patients infected with IMI-1-Elud. The source appeared to be related to endoscopes. Contact transmission may also have played a role. A screening method such as the modified CIM test is crucial for detecting less common carbapenemases that might not be identified by rapid molecular or immunochromatographic tests, as these often do not include bla IMI genes, which could lead to the undetected dissemination of carbapenemase-producing Enterobacterales. Effective infection source control and targeted treatment are essential for achieving a favourable clinical outcome.

Introduction. Simethicone is an over-the-counter product that is frequently used by clinicians during endoscopic procedures to reduce foaming and improve visualization. Published studies have found simethicone residue on endoscopes after cleaning and disinfecting the devices as per the manufacturer's instructions. Some literature suggests that simethicone residue may reduce disinfection efficacy and increase the risk of patient infections.Gap Statement. However, there appears to be a lack of direct evidence in the literature to either disprove this or correlate simethicone presence with an increased microbial risk.Aim: Research was conducted to evaluate the in vitro impact of simethicone on disinfection efficacy.Methodology. Bacteria were grown in a microtitre plate assay in the presence of a range of simethicone concentrations and then treated with a disinfectant. Bacterial growth was assessed by spotting each microtitre well onto an agar plate.Results. The results demonstrated that, under the conditions tested, simethicone did not reduce the efficacy of Cidex ortho-phthalaldehyde disinfectant, which demonstrated at least a 6-log unit reduction in bacterial viability. Additional experiments showed that direct exposure to 66 mg ml-1 of simethicone reduced bacterial viability.Conclusion. These results indicate that simethicone may not reduce the bactericidal efficacy of disinfectant during reprocessing, under certain conditions.

Point of use (POU) treatment is a critical first step of medical device reprocessing. Reusable instruments and flexible endoscopes require a minimum of terminal sterilization or high-level disinfection, neither of which can be guaranteed if POU is performed incorrectly. Compliance considerations for POU include hospital accreditation readiness, unique austere surgical mission requirements, and the transition of future conflict towards Large Scale Combat Operations. This integrative review aims to describe POU for reusable instruments and endoscopes, and extrapolate implications for Military Health System policies and future considerations.

The authors performed an integrative review and comprehensive literature search in PubMed and CINAHL with the keywords "point of use," "point of use cleaning," "POU," "instrument," "high-level disinfection," "endoscope," and "clean." Articles were limited to "English" and "human" from 2017 to 2023. The authors also performed a thorough review of the Defense Health Agency and service-specific doctrine, as well as national guidelines regarding POU adherence.

The literature review yielded 18 articles that discussed the transport and reprocessing of reusable medical devices. Regulatory standards and national guidelines were used to supplement the literature. Seventeen evidence-based criteria were extrapolated from the literature to generate two step-by-step guides for the POU treatment of endoscopes and reusable instruments (Tables I and II). Despite increased morbidity and mortality rates linked to inadequate device reprocessing, compliance with POU procedures remains low. Barriers to practice included complex POU processes, intricately designed surgical instruments and endoscopes, lack of healthcare worker (HCW) knowledge and competency, and inadequate or ambiguously written policies. Training, competency assessments, and clearly written policies and procedures can be cost-effective, evidence-based, and feasible solutions.

Completing POU treatment is critical to a successful surgical mission in both the hospital and austere environment. Implications to practice include implementing evidence-based POU programs that improve patient outcomes and readiness while decreasing costs.

The study was conducted to learn if the otoscope, a noncritical medical device, used by ENT residents harbor pathogenic organism. This study was conducted in a medical teaching hospital in India. Total of 38 otoscopes of ENT residents were examined after taking samples using sterile cotton swabs from otoscope speculum and otoscope head and both bacterial and fungal culture were studied. The study showed that 11 otoscope heads (28.94%) and 11 otoscope speculums (28.94%) out of the 38 otoscopes studied showed bacterial growth. Most commonly isolated bacteria were skin commensals followed by Klebsiella species. Fungal growth was seen in 3 out of 38 otoscope Speculums (7.89%). All 3 fungi isolated during the study belonged to Aspergillus species. Training residents regarding hygiene of medical equipments is necessary. Residents must be periodically assessed regarding their practice in handling medical equipments.

The online version contains supplementary material available at 10.1007/s12070-024-04695-8.

Implant-related infections (IRIs) represent a significant challenge to modern surgery. The occurrence of these infections is due to the ability of pathogens to aggregate and form biofilms, which presents a challenge to both the diagnosis and subsequent treatment of the infection. Biofilms provide pathogens with protection from the host immune response and antibiotics, making detection difficult and complicating both single-stage and two-stage revision procedures. This narrative review examines advanced chemical antibiofilm techniques with the aim of improving the detection and identification of pathogens in IRIs. The articles included in this review were selected from databases such as PubMed, Scopus, MDPI and SpringerLink, which focus on recent studies evaluating the efficacy and enhanced accuracy of microbiological sampling and culture following the use of chemical antibiofilm. Although promising results have been achieved with the successful application of some antibiofilm chemical pre-treatment methods, mainly in orthopedics and in cardiovascular surgery, further research is required to optimize and expand their routine use in the clinical setting. This is necessary to ensure their safety, efficacy and integration into diagnostic protocols. Future studies should focus on standardizing these techniques and evaluating their effectiveness in large-scale clinical trials. This review emphasizes the importance of interdisciplinary collaboration in developing reliable diagnostic tools and highlights the need for innovative approaches to improve outcomes for patients undergoing both single-stage and two-stage revision surgery for implant-related infections.

Outbreaks linked to inadequate endoscope drying have infected numerous patients, and current standards and guidelines recommend at least 10 minutes of forced air for drying channels. This study evaluated a new forced-air drying system (FADS) for endoscopes.

Drying was assessed using droplet detection cards; visual inspection of air/water connectors, suction connectors, and distal ends; and borescope examinations of endoscope interiors. Assessments were performed after automated endoscope reprocessor (AER) alcohol flush and air purge cycles and after 10-minute FADS cycles.

Researchers evaluated drying during encounters with 22 gastroscopes and 20 colonoscopes. After default AER alcohol and air purge cycles, 100% (42/42) of endoscopes were still wet. Substantial fluid emerged from distal ends during the first 15 seconds of the FADS cycle, and droplets also emerged from air/water and suction connectors. Following FADS cycle completion, 100% (42/42) were dry, with no retained fluid detected by any of the assessment methods.

Multiple endoscope ports and channels remained wet after AER cycles intended to aid in drying but were dry after the FADS cycle. This study reinforced the need to evaluate the effectiveness of current drying practices and illustrated the use of practical tools in a real-world setting.

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.

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.

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.

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.

To investigate factors related to the risk of developing irritable bowel syndrome (IBS) or Helicobacter pylori infection.

This cross-sectional, questionnaire-based study analysed the responses from participants that completed an online questionnaire, which asked about their knowledge of the causes and risk factors associated with IBS and H. pylori infection.

The study analysed responses from 230 participants: 181 females (of 227 participants; 79.7%) and 190 aged 18-40 years (of 228; 83.3%). Of the 230 participants, 40 (17.4%) had been diagnosed by a physician with IBS and 57 (24.8%) had been diagnosed with H. pylori infection. Of 226 participants, 93 (41.2%) had self-medicated with antibiotics in the past 6 months for various reasons. The overall mean ± SD knowledge score about IBS and H. pylori infection for the study cohort (n = 230) was 35.8 ± 19.2%. Wald χ2-test analysis demonstrated that chronic diseases, antibiotic use and having an endoscopy were significantly associated with developing IBS. Male sex and chronic diseases were significantly associated with H. pylori infection. Logistic regression analysis showed no relationship between IBS and H. Pylori infection.

Chronic diseases was the only risk factor common for IBS and H. pylori infection.

Duodenoscope-associated infections (DAIs) are exogenous infections resulting from the use of contaminated duodenoscopes. Though numerous outbreaks of DAI have involved multidrug-resistant micro-organisms (MDROs), outbreaks involving non-MDROs are also likely to occur. Detection challenges arise as these infections often resolve before culture or because causative strains are not retained for comparison with duodenoscope strains.

To identify and analyse DAIs spanning a seven-year period in a tertiary care medical centre.

This was a retrospective observational study. Duodenoscope cultures positive for gastrointestinal flora between March 2015 and September 2022 were paired with duodenoscope usage data to identify patients exposed to contaminated duodenoscopes. Analysis encompassed patients treated after a positive duodenoscope culture and those treated within the interval from a negative to a positive culture. Patient identification numbers were cross-referenced with a clinical culture database to identify patients developing infections with matching micro-organisms within one year of their procedure. A 'pair' was established upon a species-level match between duodenoscope and patient cultures. Pairs were further analysed via antibiogram comparison, and by whole-genome sequencing (WGS) to determine genetic relatedness.

Sixty-eight pairs were identified; of these, 21 exhibited matching antibiograms which underwent WGS, uncovering two genetically closely related pairs categorized as DAIs. Infection onset occurred up to two months post procedure. Both causative agents were non-MDROs.

This study provides crucial insights into DAIs caused by non-MDROs and it highlights the challenge of DAI recognition in daily practice. Importantly, the delayed manifestation of the described DAIs suggests a current underestimation of DAI risk.

Contamination of duodenoscopes is a significant concern due to the transmission of multidrug-resistant organisms (MDROs) among patients who undergo endoscopic retrograde cholangiopancreatography (ERCP), resulting in outbreaks worldwide. In July 2020, it was determined that three different patients, all had undergone ERCP with the same duodenoscope, were infected. Two patients were infected with blaCTX-M-15 encoding Citrobacter freundii, one experiencing a bloodstream infection and the other a urinary tract infection, while another patient had a bloodstream infection caused by blaSHV-12 encoding Klebsiella pneumoniae. Molecular characterization of isolates was available as every ESBL-producing isolate undergoes Next-Generation Sequencing (NGS) for comprehensive genomic analysis in our center. After withdrawing the suspected duodenoscope, we initiated comprehensive epidemiological research, encompassing case investigations, along with a thorough duodenoscope investigation. Screening of patients who had undergone ERCP with the implicated duodenoscope, as well as a selection of hospitalized patients who had ERCP with a different duodenoscope during the outbreak period, led to the discovery of three additional cases of colonization in addition to the three infections initially detected. No microorganisms were detected in eight routine culture samples retrieved from the suspected duodenoscope. Only after destructive dismantling of the duodenoscope, the forceps elevator was found to be positive for blaSHV-12 encoding K. pneumoniae which was identical to the isolates detected in three patients. This study highlights the importance of using NGS to monitor the transmission of MDROs and demonstrates that standard cultures may fail to detect contaminated medical equipment such as duodenoscopes.

A central tenet in infection prevention is application of the Spaulding classification system for the safe use of medical devices. Initially defined in the 1950s, this system defines devices and surfaces as being critical, semi-critical or non-critical depending on how they will be used on a patient. Different levels of antimicrobial treatment, defined as various levels of disinfection or sterilization, are deemed appropriate to reduce patient risk of infection. However, a focus on microbial inactivation is insufficient to address this concern, which has been particularly highlighted in routine healthcare facility practices, emphasizing the underappreciated importance of cleaning and achieving acceptable levels of cleanliness. A deeper understanding of microbiology has evolved since the 1950s, which has led to re-evaluation of the Spaulding classification along with a commensurate emphasis on achieving appropriate cleaning. Albeit underappreciated, cleaning has always been important as the presence of residual materials on surfaces can interfere with the efficacy of the antimicrobial process to inactivate micro-organisms, as well as other risks to patients including device damage, malfunction and biocompatibility concerns. Unfortunately, this continues to be relevant, as attested by reports in the literature on the occurrence of device-related infections and outbreaks due to failures in processing expectations. This reflects, in part, increasing sophistication in device features and reuse, along with commensurate manufacturer's instructions for use. Consequently, this constitutes the first description and recommendation of a new cleaning classification system to complement use of the traditional Spaulding definitions to help address these modern-day technical and patient risk challenges. This quantitative risk-based classification system highlights the challenge of efficient cleaning based on the complexity of device features present, as an isolated variable impacting cleaning. This cleaning classification can be used in combination with the Spaulding classification to improve communication of cleaning risk of a reusable medical device between manufacturers and healthcare facilities, and improve established cleaning practices. This new cleaning classification system will also inform future creation, design thinking and commensurate innovations for the sustainable safe reuse of important medical devices.

Accurately detecting the quantity of microorganisms in hospital purified water is of significant importance for early identification of microbial contamination and reducing the occurrence of water-borne hospital infections. The choice of detection method is a prerequisite for ensuring accurate results. Traditional Plate Count Agar (PCA) belongs to a high-nutrient medium, and there may be limitations in terms of accuracy or sensitivity in detecting microorganisms in hospital purified water. On the other hand, Reasoner's 2A agar (R2A) has characteristics, such as low-nutrient levels, low cultivation temperature, and extended incubation time, providing advantages in promoting the growth of aquatic microorganisms. This study, through comparing the differences in total colony counts between two detection methods, aims to select the method more suitable for the growth of aquatic microorganisms, offering new practical insights for accurately detecting the total count of heterotrophic bacteria in hospital purified water.

The most commonly used plate count agar (PCA) method, and the R2A agar culture were adopted to detect microorganisms and determine the total number of bacterial colonies in the water for oral diagnosis and treatment water and terminal rinse water for endoscopes in medical institutions. The two water samples were inoculated by pour plate and membrane filtration methods, respectively. Using statistical methods including Spearman and Pearson correlation, Wilcoxon signed-rank sum test, paired-Chi-square test, and linear regression, we analyze the differences and associations in the bacterial counts cultivated through two different methods.

In 142 specimens of the water, the median and interquartile range of the heterotrophic bacterial colony number under the R2A culture method and under the PCA culture method were 200 (Q1-Q3: 25-18,000) and 6 (Q1-Q3: 0-3700). The total number of heterotrophic bacteria colonies cultured in R2A medium for 7 days was more than that cultured in PCA medium for 2 days (P < 0.05). The linear regression results showed a relatively strong linear correlation between the number of colonies cultured by the R2A method and that cultured by the PCA method (R2 = 0.7264). The number of bacterial species detected on R2A agar medium is greater than that on PCA agar medium.

The R2A culture method can better reflect the actual number of heterotrophic bacterial colonies in hospital purified water. After logarithmic transformation, the number of colonies cultured by the two methods showed a linear correlation.

Standard laparoscopes, which are widely used in minimally invasive surgery, have significant handling limitations due to their rigid design. This paper presents an approach for a bending section for laparoscopes based on a standard semi-finished tube made of Nitinol with laser-cut flexure hinges. Flexure hinges simply created from a semi-finished product are a key element for realizing low-cost compliant structures with minimal design space. Superelastic materials such as Nitinol allow the reversible strain required for this purpose while maintaining sufficient strength in abuse load cases. This paper focuses on the development of a bending section for single use laparoscopic devices (OD 10 mm) with a bending angle of 100°, which enables the application of 100 µm diameter Nitinol actuator wires. For this purpose, constructive measures to realise a required bending curvature and Finite Element Analysis for determining the strain distribution in the flexural region are applied and described for the design of the flexure hinges. In parallel, the influence of the laser-based manufacturing process on the microstructure is investigated and evaluated using micrographs. The deformation behavior of the bending section is experimentally determined using Digital Image Correlation. The required actuation forces and the failure load of the monolithic bending section is measured and compared to a state of the art riveted bending section made of stainless steel. With the developed monolothic bending section the actuation force could be reduced by 50% and the available inner diameter could be increased by 10% while avoiding the need of any assembly step.

Increasing infectious rate estimates and low microbiological surveillance affect safety of gastrointestinal endoscopy globally. Single use endoscopes and accessories have been claimed to improve safety, but there is lack of data on their indication and sustainability. We aimed to identify a series of best practice recommendations for the use of single use endoscopes and accessories using a modified Delphi.

Consensus statements for the use of single use endoscopy and accessories were developed using a modified Delphi process, utilizing an international endoscopist expert panel of 62 experts from 33 nations. The main steps in the process were selecting the consensus group, conducting systematic literature reviews, developing statements, and anonymous voting on the statements until consensus was reached. High-risk patients were defined as those with multi-drug-resistant infections, immunosuppressive medication or chemotherapy, post-transplantation, or with severe neutropenia.

Of the 26 statements that were voted upon through two rounds, 17 statements reached consensus. Category 1: single use accessories (8 statements), related to defining recommendations for the use of single use accessories in all patient populations or high-risk patients. Category 2: clinical indication for single use endoscopes (9 statements), including indications to high-risk patients, protecting the endoscope apparatus and contamination measures in endoscopy units. Category 3: technical factors (4 statements), related to superior performance and technical specifications with the new innovation. Category 4: environmental issues (2 statements), concerning mechanisms that reduce the detrimental burden to the environment. Category 5: financial implications (3 statements), related to healthcare policies, cost neutrality and other financial associations of single use endoscopy.

This is the first international initiative in determining clinical indications for single use endoscopy and accessories. The study's findings should serve as a framework for future physicians to guide future research and aid the proper evidence-based indications for the implementation of single use endoscopes in clinical practice.

Cetaceans, including beluga whales (Delphinapterus leucas), have high morbidity and mortality rates due to bacterial or fungal lower respiratory infections. Bronchoalveolar lavage fluid (BALF) collection by bronchoscopy is beneficial for detecting pathogenic microorganisms in the lower respiratory tract. Efficient and safe bronchoscopy requires characterizing the bronchial tree systems of beluga whales, as no reports exist on bronchial length and bifurcation. In this study, bronchoscopy was performed on five captive beluga whales (9-44 years old) to detect bronchial length and bifurcation. The lengths from the blowhole to the scope impassable points due to the minimized bronchi diameters of the left principal bronchus (LPB), right principal bronchus (RPB), and tracheal bronchus (TB) were 110-155, 110-150, and 80-110 cm, respectively, and were correlated with the body length. Bronchoscopy identified more than 10, 10, and 6 bifurcated bronchi from the LPB, RPB, and TB, respectively. This is the first report to clarify the differences in bronchial tree systems between beluga whales and other cetaceans, as well as the differences for each individual beluga whale. These results could be useful for obtaining BALF via bronchoscopy to detect pathogenic microorganisms causing infections in the lower respiratory tract of beluga whales.

As well as preventing nosocomial and healthcare-associated infections, a reliable and eco-friendly washer for medical equipment would also be safe for the global environment. The aim of this study was to evaluate the efficacy of a newly developed automatic washing system (Nano-washer) that uses electrolyzed water and ultrasonication without detergent for washing endoscopes.

Patients who underwent laparoscopic lobectomy or laparoscopic colectomy at Nagasaki University between 2018 and 2022 were included. A total of 60 cases of endoscope use were collected and classified according to endoscope washing method into the Nano-washer group (using no detergent) (n = 40) and the manual washing group (n = 20). Protein and bacterial residues were measured before and after washing, using absorbance spectrometry and 16S rRNA polymerase chain reaction. The effectiveness of protein and bacterial removal and endoscope surface damage after washing were compared under specular vision between the groups.

Nano-washer did not use detergent unlike manual washing. There was no difference in demographic or clinical characteristics between the groups except for the presence of comorbidities in the lobectomy group (Nano-washer, 85%; manual washing, 40%, P = .031). Compared with the manual washing group, residual protein levels in the Nano-washer group were significantly reduced after washing (lobectomy, 0.956 mg/mL vs 0.016 mg/mL, P < .001; colectomy, 0.144 mg/mL vs 0.002 mg/mL, P = .008). Nano-washer group showed a significant reduction in bacteria between before and after lobectomy (9437 copies/cm2 vs 4612 copies/cm2 , P = .024).

Nano-washer is a promising, effective, and eco-friendly automatic washing device that is safer and more efficient than manual washing.

A pseudo-outbreak of bronchoscopy-associated Mycobacterium chelonae and M. mucogenicum was traced to contaminated ice machine water and ice. A nonsterile ice bath was used to cool uncapped, sterile, saline syringes used to slow procedural bleeding. Joining the growing evidence of bronchoscopy pseudo-outbreaks, our investigation describes several lessons for future prevention.

In this summary of US Centers for Disease Control and Prevention (CDC) consultations with state and local health departments concerning their bronchoscope-associated investigations from 2014 through 2022, bronchoscope reprocessing gaps and exposure to nonsterile water sources appeared to be the major routes of transmission of infectious pathogens, which were primarily water-associated bacteria.

Contamination due to failures or omissions in the reprocessing steps of gastrointestinal endoscopes is common in clinical practice. Ensuring the proper execution of each step is a challenge for reprocessing personnel. This cross-sectional study was conducted in an endoscopy setting between March and May 2021. We performed interviews about reprocessing practices, analyzed the life history of the equipment, and performed inspections through a borescope video of gastrointestinal endoscope channels that were stored and ready for use. A borescope is a complementary tool used to validate endoscope reprocessing, evaluate the internal visualization of channels, and identify changes that can compromise the safety of its use, which are often not detected in the leak test. Thirteen biopsy channels from stored gastrointestinal endoscopes were inspected. We found that 85% had stains and grooves, 69% contained moisture, and 46% had debris. There was at least one noncompliance issue in all of the channels inspected.

Semicritical medical devices are defined as items that come into contact with mucous membranes or nonintact skin (e.g., gastrointestinal endoscopes, endocavitary probes). Such medical devices require minimally high-level disinfection.

Analyze the methods used to reprocess semicritical medical devices and identify methods and new technologies to reduce the risk of infection.

The reprocessing methods for semicritical medical devices is described as well as a shift from high-level disinfection to sterilization for lumened endoscopes.

Strict adherence to current guidelines and transition to sterilization for endoscopes is required as more outbreaks have been linked to inadequately disinfected endoscopes and other semicritical items than any other reusable medical devices.

The emergence of disinfectant-resistant microorganisms poses a significant threat to public health. These resilient pathogens can survive and thrive in hospital settings despite routine disinfection practices, leading to persistent infections and the potential for outbreaks. In this study, we investigated the impact of 11 different commercial sanitizers at various concentrations and exposure times on biofilms consisting of clinical and nosocomial environmental isolates of Candida parapsilosis and Staphylococcus aureus. Among the sanitizers tested, 0.5% and 2.0% chlorhexidine (CLX), 10% polyvinyl pyrrolidone (PVP-I), a disinfectant based on quaternary ammonium compound (QAC), 2% glutaraldehyde, and 0.55% orthophthalaldehyde (OPA) demonstrated efficacy against both C. parapsilosis and S. aureus in monospecies and mixed biofilms. Analysis showed that 0.5% CLX and 10% PVP-I had fungicidal and bactericidal activity against all biofilms. However, the sanitizer based on QAC and 0.55% OPA proved to be bacteriostatic and fungicidal against both monospecies and mixed biofilms. In mixed biofilms, despite the last four sanitizers exerting fungicidal action, the reduction of fungal cells was approximately 4 log10 CFU/mL compared to monospecies biofilms, showing that the interaction provided more resistance of the yeast to the sanitizer. Formation of mixed biofilms in hospital settings can create an ecological niche that enhances the survival of pathogens against routine sanitization procedures. Therefore, effective sanitization practices, including regular cleaning with effective sanitizers, should be implemented to prevent C. parapsilosis/S. aureus biofilm formation in healthcare settings.

Transmission of infections via contaminated endoscopes is a common problem. Manual cleaning, using at least a detergent, is an important step in endoscope processing and should be performed as soon as possible to avoid drying of organic residues that might interfere with high-level disinfection and promote biofilm formation.

To assess the efficacy of two detergent-disinfectants, enzymatic and non-enzymatic, and of an enzymatic detergent used during the manual cleaning against a Klebsiella pneumoniae biofilm.

A 24 h biofilm statically formed in a Tygon tube was exposed to detergent-disinfectants at 20 °C and 35 °C for 10 mn, and to enzymatic detergent at 45 °C for 60 mn. The logarithmic reduction in bacteria in the Tygon tube and the number of bacteria in the product supernatant were calculated.

Biofilm formation was reproducible between assays. After exposure to detergent-disinfectants, the logarithmic reduction was between 6.32 and 6.71 log10 cfu/cm2 in the Tygon tubes. No bacteria were found in their supernatants. Results in the detergent-disinfectant group were not affected by the exposure temperature or the addition of enzymes. No decrease in the bacterial load was observed in the Tygon tubes after exposure to the enzymatic detergent. Bacteria were found in its supernatant.

These results show the importance of the choice of products used during the manual cleaning phase. They also show the potential benefit of combining detergent and disinfectant activity to decrease the bacterial load during the manual cleaning step of endoscope processing.

Outbreaks of infection related to flexible endoscopes are well described. However, flexible endoscopy also requires the use of ancillary equipment such as irrigation plugs. These are potential vectors of infection but are infrequently highlighted in the literature. This paper reports a cystoscopy-associated outbreak of Pseudomonas aeruginosa from contaminated irrigation plugs in a UK tertiary care centre.

Laboratory, clinical and decontamination unit records were reviewed, and audits of the decontamination unit were performed. Flexible cystoscopes and irrigation plugs were assessed for contamination. Retrospective and prospective case finding was performed utilizing the microbiology laboratory information management system. Available P. aeruginosa isolates underwent variable nucleotide tandem repeat (VNTR) typing. Confirmed cases were defined as P. aeruginosa infection with an identical VNTR profile to an outbreak strain.

Three strains of P. aeruginosa were isolated from five irrigation plugs but none of the flexible cystoscopes. No acquired resistance mechanisms were detected. Fifteen confirmed infections occurred, including bacteraemia, septic arthritis and urinary tract infection. While failure of decontamination likely occurred because the plugs were not dismantled prior to reprocessing, the manufacturer's reprocessing instructions were also incompatible with standard UK practice. The Medicines and Healthcare Products Regulatory Agency was informed. A field safety notice was issued, and the manufacturer issued updated reprocessing instructions.

Ancillary equipment can represent an important vector for infection, and should be considered during outbreak investigations. Users should review the manufacturer's instructions for reprocessing ancillary equipment to ensure that they are compatible with available procedures.

Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States.

We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected.

A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs.

The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.

Prevention of spread of Streptococcus equi subspecies equi (S. equi) after an outbreak is best accomplished by endoscopic lavage of the guttural pouch, with samples tested by culture and real time, quantitative polymerase chain reaction (qPCR). Disinfection of endoscopes must eliminate bacteria and DNA to avoid false diagnosis of carrier horses of S. equi.

Compare failure rates of disinfection of endoscopes contaminated with S. equi using 2 disinfectants (accelerated hydrogen peroxide [AHP] or ortho-phthalaldehyde [OPA]). The null hypothesis was that there would be no difference between the AHP and OPA products (based on culture and qPCR results) after disinfection.

Endoscopes contaminated with S. equi were disinfected using AHP, OPA or water (control). Samples were collected before and after disinfection and submitted for detection of S. equi by culture and qPCR. Using a multivariable logistic regression model-adjusted probability, with endoscope and day as controlled variables, the probability of an endoscope being qPCR-positive was determined.

After disinfection, all endoscopes were culture-negative (0%). However, the raw unadjusted qPCR data were positive for 33% AHP, 73% OPA, and 71% control samples. The model-adjusted probability of being qPCR-positive after AHP disinfection was lower (0.31; 95% confidence interval [CI], -0.03-0.64) compared to OPA (0.81; 95% CI, 0.55-1.06), and control (0.72; 95% CI, 0.41-1.04).

Disinfection using the AHP product resulted in significantly lower probability of endoscopes being qPCR-positive compared to the OPA product and control.