国内外软式内镜清洗消毒方式/流程现状

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Reprocessing a flexible endoscope is a complex multistep process. Attention to detail is essential for patient safety. Physicians need to empower their staff to function as guardians and advocates for best practices in endoscope reprocessing. Current best practice standards and guidelines for flexible endoscope reprocessing in the United States have been led by the Society of Gastroenterology Nurses and Associates, the Association for the Advancement of Medical Instrumentation, the Association of periOperative Registered Nurses, American Society for Gastrointestinal Endoscopy, and Multisociety Guideline. This article focuses on important aspects and current best practices for flexible endoscope cleaning and high-level disinfection.

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The practice of reprocessing endoscopes and its effectiveness was evaluated in 37 services. Contamination of at least 1 endoscope could be identified in 34 (91.6%) of 37 services. Bacteria, fungi, and/or mycobacteria were isolated from 84.6% (33/39) of the colonoscopes (110-32,000 colony-forming units [CFUs]/mL) and from 80.6% (50/62) of the gastroscopes (100-33,000 CFUs/mL). Not all services followed recommended guidelines. Therefore, patients who underwent gastrointestinal endoscopies were exposed to diverse pathogens.

Pathogen transmissions via flexible endoscopes have been documented in the literature and have been historically related to human error or omission of steps in the reprocessing cycle. The 2008 Centers for Disease Control and Prevention report challenged manufacturers of automated endoscope reprocessors to improve and advance technology to automate more of the reprocessing steps. A review and synthesis of the literature following the 2008 Centers for Disease Control and Prevention report was performed to evaluate whether advances in reprocessing technology have occurred and whether these have had an impact on pathogen transmission via flexible endoscopes. The Iowa Model of Evidence-Based Practice to Promote Quality Care was used to guide the project. The literature search regarding pathogen transmission related to flexible endoscopes yielded 10 documents citing infections from 2008 to 2015. A total of 353 patients were identified as having been infected with a contaminated gastroscope, bronchoscope, or duodenoscope. An evaluation of reprocessing technology identified 3 automated endoscope reprocessors with enhanced capabilities and flushing devices intended to automate portions of the manual cleaning step.

In March 2022, the Association for the Advancement of Medical Instrumentation (AAMI) released the American National Standards Institute (ANSI)/AAMI ST91:2021, their latest update on comprehensive, flexible, and semirigid endoscope reprocessing. These updated standards recommend the sterilization of high-risk endoscopes when possible and provide new recommendations for the precleaning, leak testing, manual cleaning, visual inspection, automated reprocessing, drying, storage, and transport of endoscopes. ANSI/AAMI ST91:2021 was compared with ANSI/AAMI ST91:2015 for major reprocessing differences that result in either time and/or cost increases. Time estimates were captured by explicit recommendation inclusion or taken from the literature. All the costs were estimated using publicly available resources. The updated standards represent a potential 24.3-minute and 52.35 to 67.57 United States dollars increase per procedure in terms of reprocessing time and spending, respectively, not including capital investments. Capital costs per procedure were highly dependent on the procedure volume of the facility. The new AAMI standards recommend several major changes, such as sterilization, for facilities to reprocess and manage endoscopes between uses. As more facilities increase their reprocessing methods to reflect the updated standards, they do so at a cost and introduce several delays. As the reprocessing landscape evolves, facilities should consider their true costs and alternative solutions, such as single-use endoscopes.

The routine sampling of environmental surfaces within a healthcare facility is generally not recommended by the Centers for Disease Control and Prevention (CDC), the Association for the Advancement of Medical Instrumentation (AAMI), and several other healthcare organizations. There are a few circumstances, however, for which some organizations do recommend this practice. For instance, the CDC and the Association for Professionals in Infection Control and Epidemiology (APIC) recommend environmental sampling as clinically required during an outbreak investigation. The CDC and AAMI also recommend routine sampling of the rinse water used during hemodialyzer (but not endoscope) reprocessing. The rationale for this recommendation is based in part on reports of pyrogenic responses, patient infections, and bacteremia due to waterborne, gram-negative bacteria during hemodialysis. To determine whether the basis for this rationale might similarly apply to the rinse water used during endoscope reprocessing, the Food and Drug Administration's medical device reporting database, the endoscope reprocessing literature, and other sources were reviewed. The results of this review indicate that nosocomial outbreaks linked to endoscopes contaminated with gram-negative bacteria have been frequently reported. As a result, for several reasons, including to minimize the risk of patient infection due to gram-negative bacteria following endoscopy, this article recommends routine microbiologic sampling of the rinse water used during endoscope reprocessing.

Proper reprocessing of endoscopes prevents the risk of transmission of infection between patients. Meticulous mechanical cleaning is the most important step as it removes the majority of the contaminating bacteria. It should be performed before manual or automatic disinfection. High-level disinfection involves total immersion of the endoscope in a liquid chemical germicide (LCG) at a preset temperature and concentration for a pre-determined period of time. Subsequent rinsing and drying are essential steps to remove the chemical solution and prevent bacterial colonization during storage. Endoscopy units that are used for more than 50 procedures per week may benefit from cleaning in an automatic endoscope reprocessor (AER). This allows automated exposure of the endoscope to the LCG with subsequent flushing and drying of the channels, and minimizes staff exposure to the LCG. Reprocessing should be performed by trained and accredited personnel according to written guidelines or standards of practice as defined by professional societies. Regular monitoring of the reprocessing process is important for quality control and in ensuring patients' safety.

Endoscope reprocessing is often ineffective, and microbes frequently remain on endoscopes after the use of high-level disinfectants (HLDs). Several factors impact reprocessing effectiveness, including non-adherence to guidelines, use of damaged endoscopes, use of insoluble products during endoscopy, insufficient cleaning, contaminated rinse water, and inadequate drying before storage. Our team suspected that issues with HLD chemistries and monitoring could also contribute to reprocessing failures. We conducted a mixed-methods analysis of published literature, our interviews with frontline personnel, and evidence from our previous studies. The evidence showed that reusable HLDs commonly failed tests for minimum effective concentration (MEC) before their maximum usage periods. MEC tests also detected failures associated with single-use HLDs that did not fully deploy. These failures were due to product issues, process complexities, and personnel non-adherence with guidelines and manufacturer instructions. HLDs will likely continue to be used for the foreseeable future. More research is needed to assess real-world practice patterns related to the high-level disinfection step and MEC testing and to establish more realistic usage periods for reusable HLD chemistries. Manufacturers and researchers should evaluate the ability of technological solutions and engineered safeguards to overcome human error. Recognition of the need for quality improvement is growing, and infection preventionists should take action to build on this momentum and collaborate with manufacturers, endoscopists, and reprocessing personnel to improve the effectiveness of high-level disinfection.

Unstandardised reprocessing procedures for flexible endoscopes can lead to infection outbreaks and threaten the lives of ICU patients. Despite recent updates to technical specification, there was a paucity of studies on the current status of flexible endoscopic reprocessing, particularly concerning flexible bronchoscopes (FB). This study aimed to assess the current practices of reprocessing FBs in ICUs in Hubei Province, China. A cross-sectional study was conducted utilizing convenience sampling from October 11, 2024, to December 6, 2024, in the ICUs of 216 hospitals in Hubei Province, China. A self-developed questionnaire was distributed through an online survey platform to either the person in charge of the ICU or the frontline technicians. The information regarding the reprocessing of FBs was collected, including general characteristics, personnel and training, layout and facilities, reprocessing operations, and reprocessing quality monitoring. The content validity index of the questionnaire was 0.94. There were 202 valid questionnaires collected with a validity rate of 93.52%, including 158 ICUs in tertiary hospitals and 44 in secondary and primary hospitals. The ICUs of tertiary hospitals were better than the ICUs of secondary and primary hospitals in terms of the number of FBs available, the number of dedicated technicians, the opportunity for training, the availability of some equipment and facilities (ultrasonic cleaners, whole tube irrigators, etc.), and some reprocessing operations (FB sterilisation method and storage cabinet sterilisation frequency) (P < 0.05). There were variations in FB reprocessing practices across ICUs in hospitals of all levels in Hubei, along with some common issues. Most ICUs were standardised in personnel training, operation, and recording, and ICUs in tertiary hospitals behaved better than in secondary and primary hospitals. However, there remained a need for improvement in the layout of the reprocessing environment, equipment configuration, and quality monitoring. Future research could apply implementation science to identify barriers and propose strategies to align practice with guidelines.

Stringent regulatory standards for reprocessing medical devices and equipment have proliferated in response to patient safety incidents in which improperly disinfected or contaminated endoscopes lead to large-scale disease transmission or outbreaks. This article details best practices in reprocessing reusable and single-use devices in otolaryngology, with particular attention to flexible fiberoptic endoscopes/nasophyarngoscopes, nasal speculums, and other clinic and operating room instruments. High-risk devices require sterilization, whereas lower risk devices may be reprocessed using various disinfection procedures. Reprocessing practices have implications for adequacy, efficiency, and cost. Nuanced understanding of procedures and their rationale ensures delivery of safe, ethical, and quality patient care.

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.

Adequate drying and proper storage of flexible endoscopes are essential for maintaining quality in their reprocessing. The aim of the present study was to evaluate the drying stages, storage, and channel conditions of endoscopes through borescope inspection. The personnel responsible for endoscope reprocessing were interviewed. Storage conditions at 10 endoscopy facilities were inspected and an internal examination of the channels and ports of the stored equipment was carried out, utilizing a borescope. A total of 74 stored endoscope channels were evaluated. Only 10% of the facilities inspected utilized transport cases for storage and only 10% had rooms exclusively used for storage. Sixty percent of the facilities did not perform any shelf-life control. All the channels evaluated were scratched and fluids were present on 69% of them. Endoscope reprocessing can be improved through the implementation of drying and storage control and validation tools, as well as the use of borescopes and periodic clinical audits.

Various guidelines recommend several sampling techniques to verify endoscope reprocessing, but a comparative study of the efficiency for recovering microorganisms was rare. Our goal was to compare different sampling techniques for the postreprocessing endoscope to assess residual bacterial contamination and analysis of the critical factors affecting the endoscope reprocessing failure. From 2016 to 2018, 3 techniques, the conventional flushing sampling method, flush-brush-flush sampling method (FBFSM), and pump-assisted sampling method (PASM), were compared covering all 59 endoscope units in Tianjin, China. A total of 237 (84.64%) flushing channel samples and 110 (61.11%) final rinse water samples met the Chinese national standard. The univariate analysis showed that the qualified rates of endoscope reprocessing sampled by PASM (65.52%) and FBFSM (75%) were significantly lower than those of the conventional flushing sampling method (91.38%). Five other factors, including the final rinse water, dry, and hospital level, were potential factors besides sample technique. The multivariate logistic analysis indicated only 2 factors (sampling technique and final rinse water) remained in the model. FBFSM, PASM, and the purified water were significantly associated with the odds of endoscope reprocessing failure, with the odds ratio (95% confidence interval) of which were 4.206 (1.757-10.067), 5.326 (2.463-11.645), and 0.309 (0.137-0.695), respectively. The problem of residual microorganisms of the postreprocessing endoscope was severe. Sampling technique and final rinse water were critical for endoscope reprocessing verification.

Microbiologic surveillance of flexible gastrointestinal endoscopes is recommended in several guidelines as the primary means of identifying reprocessing failures. This study aimed to evaluate the contamination level and prevalence of bacteria of post-reprocessing endoscopes and to access whether using a pump-assisted sampling method (PASM) improves the sensitivity of culture. All 59 endoscopy units in Tianjin, China, were investigated. The PASM and the conventional flushing sampling method (CFSM) were used to compare the results of the microbial culture. Logistic regression analysis was used to identify the influencing factors. One hundred four (56.52%) flushing channel samples of gastrointestinal endoscopes were positive for culture, and the maximum bacterial concentration was 14,100 colony-forming units (CFU)/channel. One hundred fifty-one (82.07%) flushing samples were qualified according to the national standard of China (≤ 20 CFU/channel). The qualified rate of the samples collected by PASM was significantly lower than the qualified rate by CFSM (65.52% vs 89.68%). Using PASM (odds ratio [OR]: 4.257; 95% confidence interval [CI]: 1.870-9.690) would increase the sensitivity of culture. The use of purified water (OR: 0.288; 95% CI: 0.102-0.814) could reduce the risk of endoscope reprocessing failure. Many endoscopes fail to meet the national standard for microbial culture after reprocessing. Our results suggest that using a pump-assisted method could increase the sensitivity of the test.

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The quality of reprocessing gastroscopes, colonoscopes and duodenoscopes in daily routine of 25 endoscopy departments in hospitals and 30 doctors with their own practices was evaluated by microbiological testing in the HYGEA interventional study. In 2 test periods, endoscopes ready for use in patients were found contaminated at high rates (period 1: 49 % of 152 endoscopes; period 2: 39 % of 154 endoscopes). Culture of bacterial fecal flora (E. coli, coliform enterobacteriaceae, enterococci) was interpreted indicating failure of cleaning procedure and disinfection of endoscopes. Detection of Pseudomonas spp. (especially P. aeruginosa) and other non-fermenting rods - indicating microbially insufficient final rinsing and incomplete drying of the endoscope or a contaminated flushing equipment for the air/water-channel - pointed out endoscope recontamination during reprocessing or afterwards. Cause for complaint was found in more than 50 % of endoscopy facilities tested (period 2: 5 in hospitals, 25 practices). Reprocessing endoscopes in fully automatic chemo-thermally decontaminating washer-disinfectors with disinfection of final rinsing water led to much better results than manual or semi-automatic procedures (failure rate of endoscopy facilities in period 2 : 3 of 28 with fully automatic, 8 of 12 with manual, 9 of 15 with semi-automatic reprocessing). The study results give evidence for the following recommendations: 1. Manual brushing of all accessible endoscope channels has to be performed even before further automatic reprocessing; 2. For final endoscope rinsing, water or aqua dest. should only be used disinfected or sterile-filtered; 3. Endoscopes have to be dried thoroughly using compressed air prior to storage; 4. Bottle and tube for air/water-channel flushing have to be reprocessed daily by disinfection or sterilization, and in use, the bottle have to be filled exclusively with sterile water. The HYGEA study shows that microbiological testing of endoscopes is useful for detection of insufficient reprocessing and should be performed for quality assurance in doctors' practices, too. The study put recommendations for reprocessing procedures in more concrete terms.

Numerous federal bodies and professional societies have produced guidelines and standards for the reprocessing of endoscopes, but few specifically address the reprocessing of cystoscopes. This document presents a summary of the current recommendations for reprocessing flexible cystoscopes, and highlights particular aspects of instrument reprocessing that are unique to cystoscopy. Cystoscopes are classified as "semi-critical" devices. Such devices require high-level disinfection or sterilization between patients. High-level disinfection differs from sterilization in that high-level disinfection does not kill large numbers of bacterial spores, while sterilization involves the complete destruction of all microbial life. In the office setting, high-level disinfection (using glutaraldehyde or another chemical disinfectant) is commonly employed for the reprocessing of flexible cystoscopes. During high-level disinfection, standard reprocessing steps should be followed to prevent contamination of the cystoscope between uses. These include precleaning, leak testing, cleaning, disinfection, rinsing, and drying. Recommended "soak times" for glutaraldehyde vary from 20 to 45 minutes, depending upon the degree to which these steps are followed. If no precleaning is performed, a 45-minute glutaraldehyde soak is required to achieve high-level disinfection. Conversely, a 20-minute soak is adequate to achieve high-level disinfection if recommended reprocessing steps are followed prior to immersion in the glutaraldehyde. One chemical disinfectant (ortho-phthalaldehyde) has been associated with anaphylaxis in bladder cancer patients, and should be avoided in these patients. This white paper provides a concise reference document for the reprocessing of flexible cystoscopes. In addition, references and links to more comprehensive resources are provided. This document may be useful for clinicians and others who are in search of guidance in this area.

Infections have been linked to inadequately reprocessed flexible bronchoscopes, and recent investigations determined that pathogen transmission occurred even when bronchoscope cleaning and disinfection practices aligned with current guidelines. This multisite, prospective study evaluated the effectiveness of real-world bronchoscope reprocessing methods, using a systematic approach. This study involved direct observation of reprocessing methods for flexible bronchoscopes, multifaceted evaluations performed after manual cleaning and after high-level disinfection, and assessments of storage conditions. Visual inspections of ports and channels were performed using lighted magnification and borescopes. Contamination was detected using microbial cultures and tests for protein, hemoglobin, and adenosine triphosphate (ATP). Researchers assessed reprocessing practices, and storage cabinet cleanliness was evaluated by visual inspection and ATP tests. Researchers examined 24 clinically used bronchoscopes. After manual cleaning, 100% of bronchoscopes had residual contamination. Microbial growth was found in 14 fully reprocessed bronchoscopes (58%), including mold, Stenotrophomonas maltophilia, and Escherichia coli/Shigella species. Visible irregularities were observed in 100% of bronchoscopes, including retained fluid; brown, red, or oily residue; scratches; damaged insertion tubes and distal ends; and filamentous debris in channels. Reprocessing practices were substandard at two of three sites. Damaged and contaminated bronchoscopes were in use at all sites. Inadequate reprocessing practices may have contributed to bioburden found on bronchoscopes. However, even when guidelines were followed, high-level disinfection was not effective. A shift toward the use of sterilized bronchoscopes is recommended. In the meantime, quality management programs and updated reprocessing guidelines are needed.

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The use of flexible fiberoptic laryngoscopes (FFLs) is ubiquitous in otolaryngology practices. As with any medical device, there exists a small risk for transmission of pathogenic microorganisms between patients, necessitating high-level decontamination between uses. Most of the literature to date has studied channeled scopes such as those used in esophagogastroduodenoscopy and colonoscopy. A recent study of nonchanneled flexible laryngoscopes suggested that current high-level decontamination practices in use at some institutions, including ours, may be overly aggressive. We sought to evaluate and compare the efficacy of varying techniques of high-level disinfection of FFLs. FFLs were used in routine clinical encounters and then disinfected with a variety of techniques. The FFLs were then cultured for bacteria and fungi, and the rates of positive cultures were compared between the techniques and the controls. In this study, we took FFLs following use in routine clinical practice and disinfected them using one of eight decontamination protocols. We compared the bacterial and fungal culture results to positive and negative controls. We demonstrated that each of the eight cleaning protocols was statistically efficacious at removing bacterial contamination. Our results for fungal cultures did not reach statistical significance. Using in vitro inoculation of FFLs, this study demonstrated that quicker and more cost-effective practices are equally efficacious to more time-consuming and expensive techniques with regard to bacterial contamination of FFLs. NA

Elevator-based endoscope-related infections from patient cross-contamination is a multifactorial problem related to device design, maintenance, and function, with additional risk incurred from a high-level disinfection process that lacks quality controls. This article reviews the historical context for these outbreaks, technical aspects of scope design contributing to this risk, and innovations in endoscope technology that have the potential to overcome these shortcomings. Also reviewed are interim solutions and the data that support use of some of these interventions. Still needed are a validated manufacturer-recommended schedule for routine duodenoscope and echoendoscope maintenance with reprocessing protocols that can be implemented in endoscopy units.

Endoscopes are used for visualization and biopsy of gastrointestinal lesions, as well as therapeutic procedures, such as foreign body retrieval. In the past, they were primarily used in large institutional settings where specialized personnel could focus on their maintenance. Today, they are becoming increasingly common in general practice. The maintenance of gastrointestinal endoscopes in the veterinary setting involves many challenges, including safe handling, reprocessing, and storage. Meeting these challenges requires well-trained personnel and strict protocols. Reprocessing, which includes cleaning and disinfection, offers the greatest challenge. The complex structure of flexible endoscopes, particularly the long, narrow channels, makes them difficult to clean. Gastrointestinal endoscopes operate in a contaminated environment, exposing them to high levels of organic matter and bacteria. High-level disinfection is necessary for infection control, but liquid germicides available for endoscope disinfection can be toxic to medical personnel and patients.

For a germicide to obtain a high level disinfection (HLD) claim, FDA requires demonstration of a 6-log reduction of mycobacterial inoculum under worst case conditions. The purpose of this study was to assess the adequacy of current guidelines for high level disinfection of GI endoscopes using alkaline glutaraldehyde in simulated-use testing. Various gastrointestinal endoscopes were contaminated with Mycobacterium chelonae in 46 experiments. Quantitative cultures were obtained from each endoscope channel separately after each step: inoculation, standardized manual cleaning, immersion in 2% glutaraldehyde (Cidex) for 10, 20, or 45 min at room temperature, 70% isopropanol rinse, and drying. Manual cleaning alone achieved a 4-log reduction. After 10 min of glutaraldehyde exposure, but before alcohol rinse, two of 10 experiments failed to achieve a 6-log reduction. However, after alcohol rinse, all 10 experiments achieved HLD. After 20 min of glutaraldehyde exposure, but before alcohol rinse, one of 18 experiments failed to achieve a 6-log reduction. After alcohol rinse, all 18 experiments achieved HLD. After 45 min of glutaraldehyde exposure, but before alcohol rinse, one of 18 experiments failed to achieve a 6-log reduction. After alcohol rinse, all 18 experiments achieved HLD. Thus, if the entire reprocessing protocol including manual cleaning, glutaraldehyde exposure, alcohol rinse, and drying was taken into account, the required 6-log reduction of mycobacteria was achieved with a minimum of 10 min of glutaraldehyde exposure at room temperature. Current guidelines for high level disinfection using glutaraldehyde are appropriate. Alcohol rinse is a valuable adjunctive step for drying and for its bactericidal effects.

Duodenoscopes have been the source of serious infection, despite correct performance of high-level disinfection (HLD). This study aimed to observe the impact of performing HLD twice on the rate of positive cultures from duodenoscope elevators. We performed double HLD (DHLD; i. e. complete manual cleaning followed by automated reprocessing, with the entire process repeated) and then randomly cultured the elevators of our duodenoscopes on about 30 % of occasions. DHLD was associated with positive elevator cultures for any microorganism in 9.4 % of cases, with a 0.8 % rate of known pathogens (627 cultures) between May 2015 and February 2016. After February 2016, and in association with changing the precleaning fluid, as well as use of a new FDA-recommended cleaning brush, the rate of positive cultures for any microorganism after DHLD was 4.8 % and 0.2 % for known pathogens (420 cultures). In a third phase, characterized by a change in personnel performing DHLD and retirement of a duodenoscope with a high rate of positive cultures, the rate of positive cultures for any microorganism was 4.9 % (783 cultures) and the rate of positive culture for known pathogens was 0.3 %. To our knowledge, no duodenoscope transmission of infection occurred during the study interval. DHLD resulted in a low rate of positive cultures for known pathogens and for organisms of low pathogenic potential, but did not eliminate these, from duodenoscope elevators. Additional improvements in HLD protocols and/or duodenoscope design are needed.

Semicritical medical devices such as flexible endoscopes require high-level disinfection between each use, and glutaraldehyde is often used for this purpose because of its favorable materials compatibility. However, workplace safety and the relatively slow microbicidal activity of such formulations remain a concern. Although recently introduced substitutes based on 0.55% ortho-phthaldehyde (OPA), 7% to 14% hydrogen peroxide, and 0.1% to 0.3% peracids are considered less toxic than glutaraldehyde, OPA can be a potential respiratory sensitizer, and the materials compatibility profile of peroxide/peracids at effective concentrations remains an issue. This study describes a high-level disinfectant/sterilant based on 2% accelerated hydrogen peroxide (AHP). It is a blend of stabilized hydrogen peroxide with safe inerts, which act in synergy, and has a 14-day reuse, 5-minute high-level disinfection, and 6-hour sterilization claim at room temperature. Extensive testing of this formulation using nationally and internationally accepted protocols has found it to be a fast-acting and broad-spectrum microbicide in addition to being biodegradable, virtually nontoxic, and free from volatile organic compounds and alkyl phenol ethoxylates. In addition, materials compatibility testing has proven it to be compatible with flexible endoscopes. Therefore, this new chemistry represents a significant advancement in the design of safer and faster acting, high-level disinfectants.

The potential for transmission of pathogenic organisms is a problem inherent to the current reusable duodenoscope design. Recent outbreaks of multidrug-resistant pathogenic organisms transmitted via duodenoscopes has brought to light the urgency of this problem. Microbiologic culturing of duodenoscopes and reprocessing with repeat high-level disinfection (HLD) or liquid chemical sterilization (LCS) have been offered as supplemental measures to enhance duodenoscope reprocessing by the U.S. Food and Drug Administration. This study aims to compare the efficacy of reprocessing duodenoscopes with double HLD (DHLD) versus LCS. We prospectively evaluated 2 different modalities of duodenoscope reprocessing from October 23, 2017 to September 24, 2018. Eligible duodenoscopes were randomly segregated to be reprocessed by either DHLD or LCS. Duodenoscopes were randomly cultured after reprocessing for surveillance based on an internal protocol. During the study period, there were 878 post-reprocessing surveillance cultures (453 in the DHLD group and 425 in the LCS group). Of all cultures, 17 were positive for any organism (1.9%). There was no significant difference of positive cultures when comparing the duodenoscopes undergoing DHLD (8 positive cultures, 1.8%) with duodenoscopes undergoing LCS (9 positive cultures, 2.1%; P = .8). Both groups had 2 cultures that grew high-concern organisms (.5% vs .5%, P=1.0). No multidrug-resistant organisms, including carbapenem-resistant enterobacteriaceae, were detected. DHLD and LCS both resulted in a low rate of positive cultures, for all organisms and for high-concern organisms. However, neither process completely eliminated positive cultures from duodenoscopes reprocessed with 2 different supplemental reprocessing strategies.

Concern has been raised regarding the use of simethicone, a de-foaming agent, during endoscopic procedures. Following reports of simethicone residue in endoscope channels despite high level disinfection, an endoscope manufacturer recommended that it not be used due to concerns of biofilm formation and a possible increased risk of microorganism transmission. However, a detailed mucosal assessment is essential in performing high-standard endoscopic procedures. This is impaired by bubbles within the gastrointestinal lumen. The Gastroenterological Society of Australia's Infection Control in Endoscopy Guidelines (ICEG) Committee conducted a literature search utilizing the MEDLINE database. Further references were sourced from published paper bibliographies. Following a review of the available evidence, and drawing on extensive clinical experience, the multidisciplinary ICEG committee considered the risks and benefits of simethicone use in formulating four recommendations. Published reports have documented residual liquid or crystalline simethicone in endoscope channels after high level disinfection. There are no data confirming that simethicone can be cleared from channels by brushing. Multiple series report benefits of simethicone use during gastroscopy and colonoscopy in improving mucosal assessment, adenoma detection rate, and reducing procedure time. There are no published reports of adverse events related specifically to the use of simethicone, delivered either orally or via any endoscope channel. An assessment of the risks and benefits supports the continued use of simethicone during endoscopic procedures. Strict adherence to instrument reprocessing protocols is essential.

Natural orifice translumenal endoscopic surgery (NOTES) involves the use of flexible endoscopes to perform intra-abdominal or intra-thoracic surgeries. Surgery in the operating room usually involves sterile instrumentation, whereas in the endoscopy suite high-level disinfection seems to be sufficient. Our objective was to assess the necessity for endoscope sterilization for clinical NOTES and to develop an endoscope processing protocol based on a score for the available processing options. Score and processing protocol development for clinical NOTES endoscopes was based on a comprehensive review of the available relevant literature. Options for sterilization for flexible endoscopes in the Good Samaritan Hospital, Legacy Health in Portland, Oregon, were analyzed for patient safety, potential for recontamination, cost, and validation. Literature survey indicated that there is controversy surrounding the necessity for sterilization of surgical endoscopes. However, standard of practice seems to call for sterile instrumentation for surgery and it is possible to terminally sterilize flexible endoscopes. Within our institution, a score was created to rank the available sterilization options. We successfully introduced a protocol for sterilization of endoscopes for use in clinical NOTES procedures. The protocol involved mechanical cleaning and high-level disinfection per Multi-Society Guidelines, with subsequent terminal sterilization using a validated peracetic acid protocol. It remains controversial whether sterile instrumentation is truly needed for surgery. It is difficult but possible to terminally sterilize flexible endoscopes. We recommend sterile instrumentation for clinical NOTES until well-designed, randomized, clinical trials are available and guidelines are published.

Outbreaks of carbapenemase-producing Enterobacteriaceae clinical infections related to endoscopic transmission are well documented. The high morbidity and mortality associated with these infections emphasizes the need to reassess endoscopic reprocessing protocols. The Gastroenterological Society of Australia established a multi-society committee to formulate evidence-based consensus statements on the prevention and management of endoscopic transmission of carbapenemase-producing Enterobacteriaceae. A literature search was undertaken utilizing the MEDLINE database. Further references were sourced from published paper bibliographies. Nine statements were formulated. Using the Delphi methodology, the statements were initially reviewed electronically by the committee members and subsequently at a face-to-face meeting in Melbourne, Australia. After further discussion, four additional sub-statements were added resulting in a total of 13 statements. Each statement was assessed for level of evidence, recommendation grade and the voting on recommendation was recorded. For a statement to be accepted, five out of six committee members had to "accept completely" or "accept with some reservation." All 13 statements achieved consensus agreement. Eleven statements achieved 100% "accepted completely." Two statements were 83% "accepted completely" and 17% "accepted with some reservation." Of particular significance, automated flexible endoscope reprocessors were mandated for high-level disinfection, and the use of forced-air drying cabinets was mandated for endoscope storage. These evidence-based statements encourage preventative strategies with the aim of ensuring the highest possible standards in flexible endoscope reprocessing thereby optimizing patient safety. They must be considered in addition to the broader published guidelines on infection control in endoscopy.

Endoscopes are used frequently for the diagnosis and therapy of medical disorders. For example, greater than 10000000 gastrointestinal endoscopic procedures are performed each year in the United States. Failure to employ appropriate cleaning and disinfection/sterilization of endoscopes has been responsible for multiple nosocomial outbreaks and serious, sometimes life-threatening, infections. Flexible endoscopes, by virtue of the site of use, have a high bioburden of microorganisms after use. The bioburden found on flexible gastrointestinal endoscopes following use has ranged from 10(5) to 10(10)CFU/ml, with the highest levels being found in the suction channels. Cleaning dramatically reduces the bioburden on endoscopes. Several investigators have shown a mean log(10) reduction factor of 4 (99.99%) in the microbial contaminants with cleaning alone. Cleaning should be done promptly following each use of an endoscope to prevent drying of secretions, allow removal of organic material, and decrease the number of microbial pathogens. Because the endoscope comes into intimate contact with mucous membranes, high-level disinfection is the reprocessing standard after each patient use. High-level disinfection refers to the use of a disinfectant (e.g., FDA-cleared chemical sterilant or high-level disinfectant) that inactivates all microorganisms (i.e., bacteria, viruses, fungi, mycobacteria) but not high levels of bacterial spores. The disinfection process requires immersion of the endoscope in the high-level disinfectant and ensuring all channels are perfused for the approved contact time (e.g., for ortho-phthaladehyde this is 12 min in the US). Following disinfection, the endoscope and channels are rinsed with sterile water, filtered water, or tapwater. The channels are then flushed with alcohol and dried using forced air. The endoscope should be stored in a manner that prevents recontamination. A protocol that describes the meticulous manual cleaning process, the appropriate training and evaluation of the reprocessing personnel, and a quality assurance program for endoscopes should be adopted and enforced by each unit performing endoscopic reprocessing.

Gluteraldehyde-based high-level disinfection (HLD) poses significant safety risks for staff and patients as well as institutional cost concerns. A value analysis team reviewed HLD practices, available products, and environmental requirements in view of the literature and standards developed by the Occupational Safety and Health Administration (OSHA). Institutional areas were identified and standardized unit-specific educational and competency programs were established. The overall use of gluteraldehyde-based HLD was decreased in this institution based on the findings and policy and procedure modification.

Colonoscopy is a well recognized diagnostic and therapeutic tool. Endoscope reprocessing must be done correctly every time; a breach of protocol leading to transmission of infection has the potential to bring endoscopy to a halt. Standards exist that guide the practitioner in all health care settings to minimize the chance of transmission of infection. Safe injection practices and reprocessing of endoscopes using high-level disinfection and sterilization methods may help avert the risk of contracting possible infections during colonoscopy procedures.

Approximately 42-95% of working channels have been reported to show the presence of residual fluid despite endoscope reprocessing. The aim of this study was to design two novel protocols for cleaning residual simethicone and demonstrate its efficiency by evaluating the residual fluid and cleanliness in the working channels of patient-ready duodenoscopes. The designed protocol for cleaning residual simethicone was implemented in manual cleaning and/or high-level disinfection (HLD). The residual fluid inside the working channels was estimated by visual inspection. Adenosine triphosphate (ATP) values were evaluated to determine cleanliness after manual cleaning. Manual cleaning with novel simethicone cleaning protocol demonstrated a significant decrease in fluid droplets (14.6 ± 29.9 vs 0 ± 0, P < 0.001) and ATP values (157 ± 196 relative light units [RLUs] vs 52 ± 41 RLUs, P = 0.031). HLD with simethicone cleaning protocol, using either enzymatic detergent with effective for cleaning simethicone or cleaning time set in the automatic endoscope reprocessor program for 8 min, demonstrated significant decrease in the number of fluid droplets. Follow-up after the implementation of the simethicone cleaning protocol showed a significant decrease in fluid droplets (37.4 ± 41.0 vs 2.1 ± 5.5, P = 0.003) and ATP values (271 ± 268 RLUs vs 82 ± 136 RLUs, P = 0.021). Simethicone cleaning protocol is advantageous for significantly decreasing fluid droplets and ATP values within endoscope working channels. After manual cleaning with the simethicone cleaning protocol, in particular, no retained fluid droplet was observed in patient-ready duodenoscopes.

There has been recent public concern regarding the adequacy of current practices for flexible endoscope reprocessing. High-level disinfection is defined by the Food and Drug Administration (FDA) as a minimum of 6-log reduction of mycobacteria under a worst-case scenario. Several agents are currently approved by the FDA, but published data on their relative efficacies against mycobacteria are lacking. The objective of this study was to determine the efficacy of these agents for high-level disinfection. In simulated-use testing, video endoscopes (5 colonoscopes and 5 duodenoscopes) were each inoculated with 9.0 x 10(7) colony-forming units of Mycobacterium chelonae. Cleaning was performed by using a standardized protocol. Each endoscope was then subjected to chemical disinfection with Cidex (2.0% glutaraldehyde) at 20 degrees C for 20 minutes, Sporox (7.5% hydrogen peroxide) at 20 degrees for 30 minutes, and Steris 20 (0.2% peracetic acid) at 50 degrees C to 56 degrees C for 12 minutes using the Steris System 1 processor. Although not FDA-approved, tests were also conducted by using 70% isopropyl alcohol at 20 degrees C for 20 minutes. These results were compared with disinfection with ethylene oxide gas. All channels were sampled for M chelonae before and after manual cleaning and after disinfection. Cleaning alone resulted in an average log reduction of 3. Cidex, Sporox, Steris 20, ethylene oxide gas, and isopropyl alcohol, in combination with manual cleaning, each achieved a 6-log or greater reduction of the mycobacterial inoculum. No organisms were recovered from any channel after reprocessing with ethylene oxide and Steris 20. Commercially available high-level disinfectants are equally efficacious for reprocessing flexible GI endoscopes when used in conjunction with cleaning and in accordance with recommended guidelines.

Flexible endoscopes undergo repeated rounds of patient-use and reprocessing. Some evidence indicates that there is an accumulation or build-up of organic material that occurs over time in endoscope channels. This "buildup biofilm" (BBF) develops as a result of cyclical exposure to wet and dry phases during usage and reprocessing. This study investigated whether the BBF matrix represents a greater challenge to disinfectant efficacy and microbial eradication than traditional biofilm (TBF), which forms when a surface is constantly bathed in fluid. Using the MBEC (Minimum Biofilm Eradication Concentration) system, a unique modelling approach was developed to evaluate microbial survival in BBF formed by repetitive cycles of drying, disinfectant exposure and re-exposure to the test organism. This model mimics the cumulative effect of the reprocessing protocol on flexible endoscopes. Glutaraldehyde (GLUT) and accelerated hydrogen peroxide (AHP) were evaluated to assess the killing of microbes in TBF and BBF. The data showed that the combination of an organic matrix and aldehyde disinfection quickly produced a protective BBF that facilitated high levels of organism survival. In cross-linked BBF formed under high nutrient conditions the maximum colony forming units (CFU) reached ~6 Log(10)CFU/peg. However, if an oxidizing agent was used for disinfection and if organic levels were kept low, organism survival did not occur. A key finding was that once established, the microbial load of BBF formed by GLUT exposure had a faster rate of accumulation than in TBF. The rate of biofilm survival post high-level disinfection (HLD) determined by the maximum Log(10)CFU/initial Log(10)CFU for E. faecalis and P. aeruginosa in BBF was 10 and 8.6 respectively; significantly different compared to a survival rate in TBF of ~2 for each organism. Data from indirect outgrowth testing demonstrated for the first time that there is organism survival in the matrix. Both TBF and BBF had surviving organisms when GLUT was used. For AHP survival was seen less frequently in BBF than in TBF. This BBF model demonstrated for the first time that survival of a wide range of microorganisms does occur in BBF, with significantly more rapid outgrowth compared to TBF. This is most pronounced when GLUT is used compared to AHP. The data supports the need for meticulous cleaning of reprocessed endoscopes since the presence of organic material and microorganisms prevents effective disinfection when GLUT and AHP are used. However, cross-linking agents like GLUT are not as effective when there is BBF. The data from the MBEC model of BBF suggest that for flexible endoscopes that are repeatedly used and reprocessed, the assurance of effective high-level disinfection may decrease if BBF develops within the channels.

Effective drying of the internal channels of endoscopes is essential to prevent the growth of water-borne pathogens and to assure adequate sterilization with vaporized hydrogen peroxide or ethylene oxide. The aim of this study was to evaluate the dryness of endoscopes after a routine disinfection process in an automated endoscope reprocessor. Stripped endoscopes (SE) that allow for visual inspection of the inside channels were reprocessed per protocol in a large urban medical center, with a 3-minute or 10-minute air flush following reprocessing. SE was hung and observed for any water within the channels after reprocessing and after a week of ambient storage. Ready-for-use endoscopes were also randomly spot-checked for moisture visually and with moisture detection paper. All SE were grossly wet after HLD with a 3-minute air flush, despite alcohol flush and drying cycle. The 10-minute air flush was effective at drying the biopsy/suction channel, but not the air/water channels. Hanging had limited effect, being most effective in the biopsy/suction channels. Of the 77 ready-for-use respiratory and gastrointestinal endoscopes assessed, 37 (48.1%) showed evidence of retained moisture. Air flush cycles commonly used in the final steps of automated endoscope reprocessing may not adequately dry endoscope channels, particularly the narrower diameter air/water channels. An extended 10-minute air flush appears effective at drying the larger biopsy/suction channel, but has limited effect on the air/water channels.

Iatrogenic infections related to duodenoscopes remain a top concern for medical centers where ERCP is performed. We assessed the long-term results and impact of key interventions in the optimization of a rigorous "culture and quarantine" program for duodenoscope reprocessing. We reviewed a prospectively collected, quality assurance database of all duodenoscope cultures (n = 4307) obtained for the initial 3-year duration of culture and quarantine from 2014 to 2017 in a single U.S.-based, high-volume endoscopy center. All duodenoscopes were subject to manual cleaning and automated reprocessing and drying, followed by sampling using a modified protocol developed by the Centers for Disease Control and Prevention. Duodenoscopes were cultured per-use. A total of 4307 duodenoscope cultures were obtained during the study period. High-concern organisms were isolated from 33 of these cultures, resulting in a .697% high-level disinfection defect rate. Statistically significant interventions included withdrawal of a high-frequency culture-positive duodenoscope (scope A) from clinical service in addition to implementation of new manufacturer-recommended cleaning protocols. Withdrawal of a second high-frequency culture-positive duodenoscope (scope B) and a mandatory device retrofit had no effect on the observed rate of positive duodenoscope cultures. Withdrawal of duodenoscopes with a high rate of culture positivity and optimizing manual cleaning practices have contributed to an overall decline in the high-level disinfection defect rate. A stringent culture and quarantine protocol allowed identification of the culprit endoscopes. There remains a much-needed role for an inexpensive and highly reliable method to check on the adequacy of reprocessing given the inherent complexity of these tasks.

Because of their complex design, duodenoscopes have been long recognized to be difficult to fully disinfect and may play a role in transmission of bacteria between patients. Recent reports of duodenoscope-associated carbapenem-resistant enterobacteriaceae transmission have confirmed these suspicions. An outbreak of a multidrug resistant strain of Escherichia coli was recently reported at our institution. Herein we report the results of our investigation and the process improvements that we deployed in an effort to contain the outbreak. A full investigation into the environment, endoscopists, infection control practices, high-level disinfection process as well as endoscopes was undertaken in conjunction with the local county health authority and the Centers for Disease Control and Prevention. Duodenoscopes were cultured and quarantined for 48 hours until negative cultures were obtained. Ergonomic changes were made to the endoscope reprocessing area, duodenoscopes were returned for routine maintenance, and surveillance cultures were obtained from all patients undergoing ERCP. Between November 2012 and August 2013, 32 patients were found to harbor 1 of 2 clonal strains of multidrug-resistant E coli, all of whom had undergone ERCP or duodenoscopy. A total of 1149 ERCPs were performed during this time period. Seven patients died within 31 days of the organism being identified in culture, 16 patients died overall by March 2015. The exact contribution of E coli to death is unclear because most patients had underlying late-stage malignancy or other severe medical comorbidities. No breach in high-level disinfection protocol or infection control practices was identified. The clonal strain of E coli was identified in culture on 4 of 8 duodenoscopes, 3 of which required critical repairs despite lack of obvious malfunction. The defect rate in high-level disinfection of duodenoscopes was 2% over a 1-year period. The implemented quality improvements, subsequent to which 1625 ERCPs have been performed, were successful in halting the outbreak. The existing manufacturer-recommended high-level disinfection protocols for duodenoscopes are inadequate. Although the ultimate solution may be a design change to the instrument, the timeline for such a change appears long and potentially difficult to exact. In the interim, a reliable method to ensure that bacterial pathogens are not present on the duodenoscope after high-level disinfection is needed.

The cleaning of flexible endoscopes is difficult and time consuming. Any method of attempted sterilization or high level disinfection will fail if prior cleaning has been defective. Inadequate reprocessing of endoscopes may result in patient to patient transmission of serious bacterial and viral diseases or infection with endemic hospital pathogens. Antibiotic prophylaxis is required to prevent septicemia and bacterial endocarditis in high risk patients undergoing specific endoscopic procedures. Prevention of serious endoscopy-associated clinical infections requires strict compliance with detailed reprocessing protocols by specially trained nursing staff.

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.

Numerous published outbreaks, including one from our institution, have described endoscope-associated transmission of multidrug-resistant organisms (MDROs). Individual centers have adopted their own protocols to address this issue, including endoscope culture and sequestration. Endoscope culturing has drawbacks and may allow residual bacteria, including MDROs, to go undetected after high-level disinfection. To report the outcome of our novel protocol, which does not utilize endoscope culturing, to address our outbreak. All patients undergoing procedures with elevator-containing endoscopes were asked to permit performance of a rectal swab. All endoscopes underwent high-level disinfection according to updated manufacturer's guidance. Additionally, ethylene oxide (EtO) sterilization was done in the high-risk settings of (1) positive response to a pre-procedure risk stratification questionnaire, (2) positive or indeterminate CRE polymerase chain reaction (PCR) from rectal swab, (3) refusal to consent for PCR or questionnaire, (4) purulent cholangitis or infected pancreatic fluid collections. Two endoscopes per weekend were sterilized on a rotational basis. From September 1, 2015 to April 30, 2016, 556 endoscopy sessions were performed using elevator-containing endoscopes. Prompted EtO sterilization was done on 46 (8.3%) instances, 3 from positive/indeterminate PCR tests out of 530 samples (0.6%). No CRE transmission was observed during the study period. Damage or altered performance of endoscopes related to EtO was not observed. In this pilot study, prompted EtO sterilization in high-risk patients has thus far eliminated endoscope-associated MDRO transmission, although no CRE infections were noted throughout the institution during the study period. Further studies and a larger patient sample will be required to validate these findings.

Outbreaks of infections transmitted by duodenoscopes have prompted changes to duodenoscope cleaning protocols. However, little is known about effectiveness of clinical cleaning practices. We present culture data after duodenoscope manufacturer-recommended high-level disinfection (HLD) and quarantine. Our institution adopted a combination of manufacturer-recommended cleaning with the Centers for Disease Control and Prevention-recommended culture and quarantine in 2015. Duodenoscopes (models TJF-Q180V, TJF-160, and PJF-160; Olympus, Center Valley, Penn, USA) underwent HLD according to the manufacturer's reprocessing manual protocols after use. Two culture specimens were then obtained using a sterile brush from the distal tip, including elevator mechanism, and by flushing sterile water through the working channel. Duodenoscopes were quarantined until cultures resulted. Positive cultures were defined as >10 colony-forming units (CFUs) of low-concern organisms or any CFUs of high-concern organisms according to Centers for Disease Control and Prevention recommendations. If either culture specimen was positive, the process was repeated until cultures were negative. Data were collected from December 2015 to July 2018. There were 140 instances of duodenoscope cleaning with 280 specimens. Twenty-eight of 234 (12%) initial culture specimens (18% of cultured duodenoscopes) were positive. Five of 36 (14%) second cultures were positive. Two of 8 (25%) third cultures were positive. Ninety-eight percent of organisms cultured were gram positive. In 8 instances both culture methods (brushing and flush) were positive; otherwise, only 1 method was positive. In 11 instances (8%) duodenoscopes were removed from quarantine before final culture results. No patient had infections related to ERCP. Eighteen percent of duodenoscopes had a positive culture after initial HLD. Only 3% were gram-negative bacteria. Repeated HLD was 86% and 75% effective at eliminating initial and repeat positive cultures, respectively. Initial HLD per manufacturer recommendations is not always effective at eliminating bacterial contamination. Additional steps are necessary to decrease risks of duodenoscope-transmitted infections.

High-level disinfection (HLD) of GI endoscopes is readily achieved when published guidelines are observed. Contamination is linked to breakdowns in accepted procedure. However, there is no recognized method of verifying adequacy of endoscope reprocessing in routine practice and no data regarding current quality assurance (QA) practice. Prior reports have demonstrated a wide variation in routine clinical practice of GI endoscopy HLD. The goal of this study was to determine current practice at regional endoscopy centers with regard to endoscope cleaning and HLD, maintenance, and QA practice. An anonymous multiple-choice questionnaire was mailed to 367 SGNA members in Pennsylvania, Delaware, Virginia, Maryland, and District of Columbia and completed by 230 (63%). The majority of responders were hospital-based and 59% of the units performed over 3000 procedures per year. After use the endoscope was hand-carried or transported in a dry container (97%) to a separate cleaning room (85%) for HLD by technicians (40%). Wide variations existed in manual step procedures including use of disposable (50%) brushes and number of times channel brushed: once (21%), twice (35%), or three to five times (37%). Soaking duration in disinfectant (70% gluteraldehyde) was for <10 min (8%), 10-20 min (35%), 20-30 min (38%), 30-40 min (7%), and >40 min (3%). Sixty-seven percent had an active unit infection control (IC) service and 98% had a QA program. Monitoring of cleaning effectiveness was by visual inspection (50%) and culturing endoscopes (17%). Culture was done weekly (1%) and <biannually (6.5%) and performed by swabing the endoscope end (5%) or rinsing the biopsy channel (8%). If culture positive, most would remove the instrument from clinical use and reevaluate the protocol and personnel for technique lapses. Two respondents were aware of a procedure-related infection. Wide practice variations were noted in manual cleaning and in soaking time during automated HLD in this community. Fewer variations were noted in cleaning personnel and training, location and methods of cleaning, and presence of IC services and QA programs. Endoscope culturing was infrequently done and positive cultures were rare. While most units claim to have ongoing QA programs, few use objective criteria to monitor effective disinfection or lapses in technique. Iatrogenic infection is uncommonly recognized following GI endoscope procedures.

Endoscopes are used widely for the diagnosis and therapy of medical disorders. To prevent spread of nosocomial infection, all endoscopes should undergo thorough cleaning and high-level disinfection following each use. The Food and Drug Administration (FDA) has approved a user-friendly package label for one liquid chemical germicide that requires a 45-minute immersion at 25 degrees C to support a high-level disinfection label claim. Scientific data reviewed here suggest that one can achieve at least an 8-log reduction in M tuberculosis contamination with cleaning (4 logs) followed by chemical disinfection for 20 minutes (4 to 6 logs). The FDA should modify the label to state that if cleaning is accomplished using a standardized cleaning protocol, then a 20-minute immersion at 20 degrees C will be sufficient to achieve high-level disinfection.

The U.S. Centers for Disease Control and Prevention (CDC) recommends that only heat sterilization be used for all reusable devices entering the oral cavity. However, chemical disinfection is still employed for reprocessing dental devices in many areas of the world. In an analysis of a Florida dental practice responsible for nosocomial human immunodeficiency virus (HIV) transmissions, the possible role of contaminated devices was deemed unlikely in part because they were subjected to high-level disinfection with 2% glutaraldehyde. Disease transmissions have, however, been documented for endoscopes used in diagnostic and surgical procedures even after this treatment. In some dental devices, lubricants mix with potentially infectious patient materials, and organic debris has been observed in endoscopes after cleaning. We have investigated whether lubricants can render high-level chemical disinfection procedures ineffective and have addressed the role that some common devices may play in disease transmission. We report here that HIV in whole-blood samples and Pseudomonas aeruginosa in blood and plasma survived high-level disinfection when entrapped in lubricants used in dental handpieces and endoscopes. We also found that lubricated dental devices used to clean and polish teeth (prophylaxis angles) have the potential to transfer sufficient amounts of blood to infect human lymphocyte cultures with HIV. These results emphasize the need to subject reusable dental devices to a heat-sterilization protocol that penetrates the lubricant.

Flexible endoscopes are difficult to decontaminate, and endoscope-associated infections are increasing. This report describes an outbreak of multi-drug resistant Pseudomonas aeruginosa identified following an increase in incidence of clinical infections associated with flexible ureteroscopy at a tertiary care centre in the UK. Clinical, laboratory and central decontamination unit (CDU) records were reviewed to determine the extent of the problem, and links to the used endoscopes. Audits of the ureteroscopy procedure, endoscopy unit and CDU were performed. Endoscopes were sampled, cultured and examined for structural integrity. All available isolates were typed. Thirteen patients developed clinical infections linked to two flexible ureteroscopes. The first ureteroscope was likely colonized from a known infected patient and the second ureteroscope after use on another patient infected by the first. Risk factors identified include surface cuts, stretching and puckering of the outer cover in both ureteroscopes, absence of bedside cleaning, overnight delay between the ureteroscopy and decontamination, inadequate drying after decontamination and non-traceability of connector valves. The adequacy of flexible endoscope decontamination depends on numerous steps. With the increasing global incidence of multi-drug resistant organisms, stringent monitoring of the flexible endoscopy process by users and decontamination units is essential.

Inadequate drying of endoscope channels is a possible cause of replication and survival of remaining pathogens during storage. The presence during storage of potentially contaminated water in endoscope channels may promote bacterial proliferation and biofilm formation. An incomplete drying procedure or lack of drying and not storing in a vertical position are the most usual problems identified during drying and endoscope storage. Inadequate drying and storage procedures, together with inadequate cleaning and disinfection, are the most important sources of endoscope contamination and post-endoscopic infection. Flexible endoscopes may be dried in automated endoscope reprocessors (AERs), manually, or in drying/storage cabinets. Flushing of the endoscope channels with 70-90% ethyl or isopropyl alcohol followed by forced air drying is recommended by several guidelines. Current guidelines recommend that flexible endoscopes are stored in a vertical position in a closed, ventilated cupboard. Drying and storage cabinets have a drying system that circulates and forces the dry filtered air through the endoscope channels. Endoscope reprocessing guidelines are inconsistent with one another or give no exact recommendations about drying and storage of flexible endoscopes. There is no conclusive evidence on the length of time endoscopes can be safely stored before requiring re-disinfection and before they pose a contamination risk. To minimize the risk of disease transmission and nosocomial infection, modification and revision of guidelines are recommended as required to be consistent with one another.

Automated endoscope washer disinfectors are widely used for the decontamination of flexible endoscopes. They are more effective than manual techniques and reduce the likelihood of skin contact with irritant disinfectants. Suitable machines are those which effectively clean, disinfect and rinse all channels and external surfaces without damaging the instrument. If glutaraldehyde is used, fumes should be removed or contained to protect endoscopy and processing staff. Machines should also be equipped with a self-disinfect facility and the rinse water should be of a suitable microbiological quality for the instruments processed, i.e. bacteria-free (sterile or filtered) water should be used for bronchoscopes and all invasive endoscopes. The choice of machine and cycle will depend on the following: whether a mobile or fixed unit is required; the type of disinfectant used; instrument throughput; and whether or not it is necessary to process more than one endoscope at a time. Purchasers are advised to request independent test reports which substantiate manufacturers' claims.

A national survey was carried out to investigate the current UK practice for decontaminating flexible nasal endoscopes. A postal questionnaire was sent to Sisters in Charge of 200 ear, nose and throat (ENT) outpatient departments in the UK, with an overall response rate of 60.5%. Decontamination with chlorine dioxide wipes was the most favoured method, used in 58% of the hospitals that participated in this survey. Automated machines were also used in many places (34%). Only a few hospitals used flexible sheaths (7%). Many departments do not use a separate protocol for high-risk patients.

Despite adherence to standard protocols, residues including live micro-organisms may remain on the various surfaces of reprocessed flexible endoscopes. Prions are infectious proteins that are notoriously difficult to eliminate. To test the potential of cold atmospheric plasma (CAP) for the decontamination of various surfaces of flexible endoscopes, measuring total proteins and prion residual infectivity as indicators of efficacy. New PTFE endoscope channels and metal test surfaces spiked with test soil or prion-infected tissues were treated using different CAP-generating prototypes. Surfaces were examined for the presence of residues using very sensitive fluorescence epimicroscopy. Prion residual infectivity was determined using the wire implant animal model and a more sensitive cell infectivity assay. A CAP jet applied perpendicularly at close range on flat test surfaces removed soil within 3 min, but left microscopic residues and failed to eliminate prion infectivity according to the wire implant animal assay. The longitudinal gas flow from CAP prototypes developed for the treatment of long channels led to the displacement and sedimentation of residual soil towards the distal end, when applied alone. Observations of the plasma inside glass tubes showed temporal and spatial heterogeneity within a limited range. After the standard enzymatic manual pre-wash, 'CAP-activated' gas effluents prevented prion transmission from treated endoscope channels according to the prion infectivity cell assay. CAP shows promising results as a final step for decontamination of surgical surfaces. Optimizing CAP delivery could further enhance CAP efficacy, offering a safe, chemical-free alternative for the reprocessing of all luminal flexible endoscope surfaces.

The decontamination of flexible fibreoptic endoscopes has considerably improved in recent years. This is mainly due to the introduction of instruments with more accessible channels, the use of automated washer disinfectors and a greater awareness of the problems associated with disinfection. Unfortunately the most widely used and effective disinfectant is 2% glutaraldehyde and this is toxic, irritant and sensitizing. With the implementation of Control of Substances Hazardous to Health legislation, strict environmental controls are required to reduce skin contact and vapour inhalation. Alcohol is probably the most suitable alternative disinfectant at present but it is flammable and cannot be used in automated systems. Other agents are either insufficiently effective or corrosive. Autoclavable or heat tolerant rigid endoscopes are now available but flexible endoscopes will not tolerate heat disinfection temperatures.

To assess the efficiency of decontamination of flexible nasoendoscopes using a chlorine dioxide wipe system and assessing the risk of disease transmission during the COVID-19 pandemic. Prospective and retrospective review of 544 patient episodes of nasoendoscopy and a study of 41 patient procedures and 22 members of staff at an ENT Outpatient Department from September 2020 to March 2021. Among 41 randomly selected episodes of nasoendoscopy in the clinic, there was 93%-100% compliance with decontamination guidelines suggested by ENT UK. Among 544 patients who had nasoendoscopies, 20 had RT-PCR tests within two weeks and all yielded a negative result; no clusters of consecutive endoscopies were noted. None among the 22 clinic staff had symptoms of COVID-19 infection during the study period. Accepting the limitations of the study design, this audit found no evidence of nosocomial transmission of SARS-CoV-2 virus related to use or reprocessing of flexible nasoendoscopes among patients and staff following good compliance to ENT UK decontamination guidelines.

Microbiological surveillance of bronchoscopes and automatic endoscope reprocessors (AERs)/washer disinfectors as a quality control measure is controversial. Experts also are divided on the infection risks associated with bronchoscopic procedures. We evaluated the impact of routine microbiological surveillance and audits of cleaning/disinfection practices on contamination rates of reprocessed bronchoscopes. Audits were conducted of reprocessing procedures and microbiological surveillance on all flexible bronchoscopes used from January 2007 to June 2020 at a teaching hospital in France. Contamination rates per year were calculated and analyzed using a Poisson regression model. The risk factors for microbiological contamination were analyzed using a multivariable logistical regression model. In total, 478 microbiological tests were conducted on 91 different bronchoscopes and 57 on AERs. The rate of bronchoscope contamination significantly decreased between 2007 and 2020, varying from 30.2 to 0% ( Our results confirm that bronchoscopes can remain contaminated despite repeated reprocessing. Routine microbial testing of bronchoscopes for quality assurance and audit of decontamination and disinfection procedures can improve the reprocessing of bronchoscopes and minimize the rate of persistent contamination.

Corona viruses are a group of medium-sized positive-sense single-stranded RNA viruses with crown-like structure due to projections noted over the surface of the virus. The infection has been declared as a pandemic by the world health organization (WHO) in March 2020. Health care professionals in endoscopy are at high risk of infection by novel corona virus disease 2019 (COVID-19) from inhalation of droplets, conjunctival contact, feces, and touch contamination. Upper gastrointestinal (GI) endoscopy is considered to be a high-risk aerosol-generating procedures (AGPs) and the live virus has been found in patient stool. Flexible endoscopes when contaminated have been considered as the vector for transmission of infections. Infections related to the side viewing endoscopes and endoscopic ultrasound scopes are more frequent than upper GI scope and colonoscopes. Stratifying patients needing endoscopy and deferral of elective procedures will help to decrease the virus spread. Planning and revision of workflows is necessary for safety of patient and staff and to successfully provide infection prevention and control measures, for this a "three zones and two passages" concept should be followed. Manual cleaning followed by high-level disinfection (HLD), effectively eliminates nearly all microorganisms from endoscopes during reprocessing. Transmission of viral infections during endoscopy is quite rare and, it is usually the result of noncompliance from the essential steps of reprocessing. Reuse of any disposable GI endoscopic device is strongly discouraged. Environmental decontamination is essential to reduce the risk of fomite transmission. Noncritical environmental surfaces frequently touched by hands (e.g., bedside tables and bed rails) and endoscopy furniture and floor should be considered heavily contaminated in patients with intermediate or high risk of COVID-19 and should be thoroughly disinfected at the end of each procedure. If available, negative pressure rooms are preferred for endoscopy, as has been advised by Centers for Disease Control and Prevention (CDC). Staff involved in reprocessing and the cleaning of endoscopy rooms should utilize personal protective equipment (PPE) including N95 mask. Reprocessing staff should undergo necessary training and ongoing annual assessment of competency.

The duodenoscope is among the most complex medical instruments that undergo disinfection between patients. Transmission of infection by contaminated scopes has remained a challenge since its inception. Notable risk factors for pathogen transmission include non-adherence to disinfection guidelines, encouragement of biofilm deposition due to complex design and surface defects and contaminated automated endoscope reprocessors. The most common infections following endoscopy are endogenous infections involving the patient's own gut flora. Exogenous infections, on the other hand, are associated with contaminated scopes and can theoretically be prevented by effective reprocessing. Pseudomonas aeruginosa is currently the most common organism isolated from contaminated endoscopes. Of note, reports of multidrug-resistant duodenoscopy-associated outbreaks have surfaced recently, many of which occurred despite adequate reprocessing. The FDA and CDC currently recommend comprehensive cleaning followed with at least high-level disinfection for reprocessing of flexible GI endoscopes. Reports of duodenoscope-related outbreaks despite compliance with established guidelines have prompted professional and government bodies to revisit existing guidelines and offer supplementary recommendations for duodenoscope processing. For the purposes of this review, we identified reports of duodenoscope-associated infections from 2000 till date. For each outbreak, we noted the organisms isolated, the number of cases reported, any possible explanations of contamination, and the measures undertaken to end each outbreak. We have also attempted to present an overview of recent developments in this rapidly evolving field.

Inadequate flexible endoscope reprocessing has been associated with infection outbreaks, most recently caused by carbapenem-resistant Enterobacteriaceae. Lapses in essential device reprocessing steps such as cleaning, disinfection/sterilization, and storage have been reported, but some outbreaks have occurred despite claimed adherence to established guidelines. Recommended changes in these guidelines include the use of sterilization instead of high-level disinfection or the use of routine microbial culturing to monitor efficacy of reprocessing. This review describes the current standards for endoscope reprocessing, associated outbreaks, and the complexities associated with both microbiological culture and sterilization approaches to mitigating the risk of infection associated with endoscopy.

No abstract

The Ear, Nose and Throat (ENT) and Oral and Maxillofacial Surgery (OMFS) departments at Glasgow's Southern General Hospital use their 21 flexible endoscopes on a daily basis for a variety of surgical and anaesthetic procedures, including difficult intubations and the examination of the throat and airway. This article will examine the possible risks to the patient with these procedures and some cost-effective methods of minimising those risks within these departments.

The complexity of medical devices has increased over the past 10 years, and outbreaks of infections due to contaminated devices have focused attention on the need to adequately clean medical devices in order to ensure the adequacy of disinfection and sterilization. There has been a paradigm shift in reprocessing of medical devices, with increased emphasis on a quality management systems approach that requires validated cleaning instructions from manufacturers and ongoing monitoring by reprocessing personnel to ensure adequacy of cleaning. This article reviews the current issues related to medical device reprocessing and summarizes the approaches used for monitoring cleaning efficacy for surgical instruments and flexible endoscopes.

The purpose of this article was to investigate bacterial biofilm formed on endoscopes and to explore the possible correlation between endoscope reprocessing procedures and bacterial biofilm growth on endoscope channels. Sixty-six endoscope suction and biopsy channels and 13 water and air channels were collected from 66 hospitals throughout China. Scanning electron microscopy was used to observe biofilm growth on the internal surface of these channels. Questionnaires were mailed to 66 endoscopy centers to investigate reprocessing procedures for endoscopes. Obvious biofilm growth was detected on 36 suction and biopsy channels (36/66, 54.6%) and 10 water and air channels (10/13, 76.9%). The percentage of manual cleaning in group B (n = 36, without detection of biofilms) was 92.3% (33/36), whereas it was 50.0% (15/30) in group A (n = 30, with detection of biofilms). Follow-up of group A (n = 30) showed that no biofilm was detected, whereas biofilm was detected in group B. The difference was statistically significant (P = .001). The proportion of detergent reuse in group B was 92.3% (33/36), and it was 61.5% in group A (18/30) (P = .005). The proportion of alcohol-air drying in group B was 38.9% (14/36), and it was 76.7% (23/30) in group A (P = .002). The formation of endoscopic biofilm during clinical practice may be related to reuse of detergent, manual cleaning, and incomplete drying.

[corrected] Endoscopes are routinely used in hospitals and clinics of the world and they can be potential sources of cross-infection when the decontamination process is unsuitable The routines of flexible endoscope (bronchoscopes, esophagogastroduodenoscopes and colonoscopes) disinfection procedures used in two Brazilian university hospitals were evaluated during a 3-year period Aleatory samples from internal channels of endoscopes were collected after patient examination and after cleaning/disinfection procedures A contamination >3 log10 was achieved in samples recovered from endoscopes after patient examination. These samples yielded gram-negative bacilli (n = 142: 56%), gram-positive cocci (n = 43: 17%), yeast cells (n = 43: 17%), and gram-positive bacilli (n = 26: 10%). Approximately, 72 out of 149 samples (48.32%) collected after undergoing the cleaning and disinfection procedures disclosed gram-negative bacilli (n = 55: 61%), gram-positive cocci (n = 21: 23%), gram-positive bacilli (n = 8: 9%) and yeast cells (n = 6: 7%). Esophagogastroduodenoscopes and colonoscopes were the most frequently contaminated devices. Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli, Enterobacter spp, Serratia marcescens, Proteus mirabilis, Citrobacter freundii, Staphylococcus aureus, Staphylococcus coagulase negative, Micrococcus luteus, Candida albicans, C. tropicalis, C. glabrata, C. guilliermondii, Bacillus spp and Corynebacterium spp were predominantly identified Inappropriate cleaning and low times of disinfection were respectively the major factors associated with the presence of microorganisms in colonoscopes and esophagogastroduodenoscopes. By analyzing the identified germs, hospital disinfection was considered of either intermediate or poor level. After this investigation, both university centers improved their previous protocols for disinfection and conditions for reprocessing endoscopes.

The flexible fiberoptic sigmoidoscope has gained widespread acceptance as a diagnostic tool in the detection and diagnosis of colorectal disease. Since its introduction nearly a decade ago, studies have thus far indicated that in the hands of experienced physicians, flexible sigmoidoscopy is a safe procedure affording greater patient comfort, greater depth of insertion, and a higher yield of neoplastic lesions than rigid sigmoidoscopy, with surprisingly few associated risks. Although reported infrequently, infection is an acknowledged risk of flexible sigmoidoscopy and other endoscopic procedures. The most efficient means of preventing endoscopy-associated infection is uncompromising aseptic practice. Clinical and experimental data obtained from studies designed to investigate endoscopic transmission of infectious organisms and from our own and others' experiences are reviewed. Guidelines for achieving high-level disinfection of the flexible fiberoptic sigmoidoscope are included.

The need to monitor manual cleaning of high-risk endoscopes is recommended or more so required by the current endoscope reprocessing guidelines. The objective of this study was to establish the optimal extraction volume for colonoscopes and bronchoscopes and demonstrate the extraction efficacy for the ChannelCheck™ rapid test. The test soil utilized as a positive control was ATS2015 containing 20% defibrinated bovine blood. The extraction from the instrument channel of a colonoscope and bronchoscope was evaluated to establish the optimal extraction volume and the extraction efficacy for protein, carbohydrate and haemoglobin. Of the extraction volumes tested, 10 mL was optimal for both colonoscopes and bronchoscopes. The extraction efficacy was 91% for carbohydrate, 83.7% for haemoglobin and 82.4% for protein. The limit of detection for these analytes by the ChannelCheck rapid test meet or exceed the established levels that correlate with adequate manual cleaning of flexible endoscopes.

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.

The medical literature was reviewed to evaluate the risk of disease transmission and nosocomial infection associated with flexible laryngoscopes. These instruments have been reported to be contaminated with blood, body fluids, organic debris, and potentially pathogenic microorganisms during routine clinical use. Failure to reprocess properly a flexible laryngoscope may, therefore, result in patient-to-patient disease transmission. Different types of biocidal agents, including 70% isopropyl alcohol, quaternary ammonium compounds, and 2% glutaraldehyde have been reported to be used to disinfect flexible laryngoscopes. A logic, or algorithm, was developed to evaluate the adequacy of these and other types of biocidal agents used during instrument reprocessing. This review determined that flexible laryngoscopes are semicritical instruments that require high-level disinfection (or sterilization) to prevent nosocomial infection. Whereas 70% isopropyl alcohol, quaternary ammonium compounds, and other products that achieve intermediate-level or low-level disinfection are contraindicated for reprocessing flexible laryngoscopes, 2% glutaraldehyde and other products that achieve high-level disinfection (or sterilization) are recommended for reprocessing these instruments to prevent nosocomial infection. A formal set of step-by-step guidelines for reprocessing flexible laryngoscopes is provided. Use of a disposable sheath to cover and protect the flexible laryngoscope from contamination during clinical use is discussed.

nasopharyngoscopes are essential tools in modern otolaryngology practice. Owing to their frequent and diverse use, it is important to ensure that they can be efficiently and thoroughly cleaned. To date, there are no official national guidelines provided by the Canadian Society of Otolaryngology-Head and Neck Surgery (CSOHNS) for decontamination of nasopharyngoscopes. to compare flexible nasopharyngoscope decontamination practices across Canada. a questionnaire regarding nasopharyngoscope cleaning procedures was distributed online to all otolaryngologists registered with the CSOHNS. The survey was anonymous. Topics addressed province, practice type, maintenance, operations, ventilation, and process development. thirty-five percent of the 505 Canadian otolaryngologists contacted participated in the survey. Automated sterilization of nasopharyngoscopes is employed by 16% of participants, of which the majority of this use is in hospital settings. Over 61.3% of participants use a multistep decontaminating soak for cleaning. Decontamination procedures were created within the department in 59% of cases, and over 28.3% of participants are unsure as to whether their procedures adhere to infectious disease and industry standards. various procedures are employed throughout Canada owing to a lack of standardization. Survey responses indicate that Canadian otolaryngologists would appreciate a national standard for the cleaning of flexible nasopharyngoscopes, particularly for nonhospital practices.

Flexible endoscopes are used to diagnose and treat gastrointestinal and pulmonary diseases. They have narrow, internal channels which are used to insert instruments, air and water into hollow organs and to remove tissues and secretions. Since endoscopes are contaminated during use and have heat sensitive components that cannot be sterilized, they are reprocessed with cleaning and high-level disinfection to destroy microorganisms. Knowing how long reprocessed endoscopes can be safely stored is essential for preventing infection and decreasing unnecessary costs. The objective was to systematically review the best available evidence related to safe storage time (in days) of flexible endoscopes that have undergone reprocessing in order to determine when they can be safely used again without posing any risk of contamination from pathogens. The types of equipment were flexible endoscopes that had been reprocessed according to recommended guidelines, stored for a specified period of time, and tested for microorganisms.The intervention was the length of time (in days) that reprocessed endoscopes were appropriately stored before use.This review included non-randomized controlled trials and prospective cohort studies.This review considered studies that included the outcome measure: microbial growth on endoscopes which was measured with microbiological cultures. The search strategy aimed to find studies in English and Spanish and included published and unpublished studies from 1990 to 2014. An initial search of CINAHL, MEDLINE/PUBMed and EMBASE was conducted followed by an analysis of the text words contained in the title and abstract and index terms used to describe the articles. Next, a search using all identified keywords and index terms was undertaken across all included databases. Then, the reference lists of all identified reports and articles were searched for additional studies. A citation search was performed in order to find additional studies that cited those already located. The Joanna Briggs Institute's critical appraisal instruments were used to assess methodological quality. Data were extracted from studies in the review using the Joanna Briggs Institute data extraction form. Since the findings were expressed using descriptive statistics, a meta-analysis was impossible. Therefore, the findings have been summarized in a narrative form with tables and a figure. Ten studies met the appraisal criteria and were included in the review. Storage time ranged from two to 56 days, and all 10 studies concluded that endoscopes could safely be stored for the time measured. Seven studies measured microbial growth in all channels; six involved storing the endoscopes for at least three days and five for at least seven days. The contamination rates were low (2% at three days and 4% at seven days) and pathogens were rare. The contamination rate remained consistent over time. Endoscopes can be stored for seven days if they have been effectively reprocessed and appropriately stored. Ongoing surveillance cultures are necessary to verify reprocessing effectiveness.

Flexible nasoendoscope is an important tool in otorhinolaryngology practice. The endoscope needs to be decontaminated prior to use in the next patient. The 2005 ENT-UK guidance for cleaning fibre-optic laryngoscopes stated that the ideal disinfecting agent and process should be effective and have low capital and maintenance costs. To compare the efficacy and cost-effectiveness of chlorine dioxide wipes versus automated washer, for decontamination of flexible nasendoscopes. A sequential cohort, in vitro study was performed to test the efficacy of chlorine dioxide wipes and automated washer. Costs were also calculated. After deliberate bacterial contamination of the nasendoscope and subsequent decontamination, swab samples from the endoscope showed Staphylococcus epidermidis growth in 2 per cent (1/50 swabs) of the chlorine dioxide wipe group and in 28 per cent (14/50 swabs) of the automated washer group (p = 0.00). Based on a projected 10-year cost calculation, the automated washer was cheaper. Further studies are required to test whether these results are replicable. A similar study should be performed using real patients, to check the significance of improper decontamination.

The presence and potential build-up of patient material such as proteins in endoscope lumens can have significant implications, including toxic reactions, device damage, inadequate disinfection/sterilization, increased risk of biofilm development and potential transmission of pathogens. To evaluate potential protein deposition and removal in the channels of flexible luminal endoscopes during a simple contamination/cleaning cycle. The level of contamination present on disposable endoscopy forceps which come into contact with the lumen of biopsy channels was evaluated. Following observations in endoscopy units, factors influencing protein adsorption inside luminal endoscope channels and the action of current initial cleaning techniques were evaluated using a proteinaceous test soil and very sensitive fluorescence epimicroscopy. Disposable endoscope accessories appear to be likely to contribute to the contamination of lumens, and were useful indicators of the amount of proteinaceous soil transiting through the channels of luminal endoscopes. Enzymatic cleaning according to the manufacturer's recommendations and brushing of the channels were ineffective at removing all proteinaceous residues from new endoscope channels after a single contamination. Rinsing immediately after contamination only led to a slight improvement in decontamination outcome. Limited action of current decontamination procedures and the lack of applicable quality control methods to assess the cleanliness of channels between patients contribute to increasing the risk of cross-infection of potentially harmful micro-organisms and molecules during endoscopy procedures.

Endoscopy-associated infection transmission is frequently linked to inadequate reprocessing. Residual organic material and moisture may foster biofilm development inside endoscopes. This study evaluated the effectiveness of endoscope drying and storage methods and assessed associations between retained moisture and contamination. Endoscope reprocessing, drying, and storage practices were assessed at 3 hospitals. Researchers performed visual examinations and tests to detect fluid and contamination on patient-ready endoscopes. Fluid was detected in 22 of 45 (49%) endoscopes. Prevalence of moisture varied significantly by site (5%; 83%; 85%; P < .001). High adenosine triphosphate levels were found in 22% of endoscopes, and microbial growth was detected in 71% of endoscopes. Stenotrophomonas maltophilia, Citrobacter freundii, and Lecanicillium lecanii/Verticillium dahliae were found. Retained fluid was associated with significantly higher adenosine triphosphate levels (P < .01). Reprocessing and drying practices conformed with guidelines at 1 site and were substandard at 2 sites. Damaged endoscopes were in use at all sites. Inadequate reprocessing and insufficient drying contributed to retained fluid and contamination found during this multisite study. More effective methods of endoscope reprocessing, drying, and maintenance are needed to prevent the retention of fluid, organic material, and bioburden that could cause patient illness or injury.

Endoscope reprocessing is a multi-stepped process that renders a contaminated endoscope safe for reuse. Its steps include meticulous cleaning, complete immersion in a liquid chemical sterilant (LCS) or disinfectant to achieve high-level disinfection (or "liquid sterilization"), water rinsing, and proper handling and storage. Surveys and reports indicate that not all health-care facilities dry their endoscopes after reprocessing. Endoscope drying can be easily, quickly, and inexpensively achieved by flushing the endoscope's internal channels, and wiping its external surfaces, with 70-90% ethyl or isopropyl alcohol, to facilitate drying after reprocessing, followed by compressed or forced air. The medical literature was reviewed to evaluate the importance of endoscope drying to the prevention of disease transmission. Several national and international endoscope-reprocessing and infection-control guidelines and a public health advisory were also reviewed and compared for consistency and to evaluate the emphasis each places on endoscope drying. If a guideline recommends endoscope drying, this study clarified whether this step is recommended after reprocessing throughout the day (i.e., between patient procedures), before storage, or both. These guidelines were also reviewed to determine whether any of them recommend reprocessing endoscopes before the first patient of the day. This review identified several published reports and clinical studies that demonstrate the significant contribution of endoscope drying to the prevention of disease transmission. This review also identified significant differences and inconsistencies regarding the emphasis different published guidelines and a public health advisory place on endoscope drying. Some guidelines recommend drying the endoscope after completion of every reprocessing cycle, both throughout the day and before storage, while others deemphasize its importance and recommend endoscope drying only before storage, if at all. Instead of recommending endoscope drying before storage, some guidelines recommend reprocessing endoscopes before the first patient of the day. The finding that several guidelines are inconsistent with one another and that some are remiss and fail to recommend endoscope drying is of concern. Endoscope drying is as important to the prevention of nosocomial infection as cleaning and high-level disinfection (or "liquid sterilization"). Whereas wet or inadequately dried endoscopes pose an increased risk of contamination and have been associated with transmission of waterborne microorganisms and nosocomial infection, thoroughly dried (and properly cleaned and high-level disinfected) endoscopes have not been linked to nosocomial infection. Moreover, inconsistent guidelines can confuse reprocessing staff members and result in noncompliance, variations in the standard of care, and ineffective reprocessing. To minimize the risk of disease transmission and nosocomial infection, modification and revision of guidelines are recommended as required to be consistent with one another and to unconditionally recommend endoscope drying after completion of every reprocessing cycle, both between patient procedures and before storage, no matter the label claim of the LCS or disinfectant, the label claim of the automated reprocessing system, or the microbial quality of the rinse water. According to the medical literature, adoption of this recommendation may reduce the importance of not only monitoring the microbial quality of the rinse water, but also reprocessing endoscopes before the first patient of the day, both of which can be costly practices that a few guidelines recommend.

The purpose of this article is to review the evidence regarding transmission of infection during gastrointestinal endoscopy, factors important in endoscope reprocessing and infection control, areas to focus on to improve compliance, and recent developments and advances in the field.

Over 17.7 million gastrointestinal (GI) endoscopic procedures are performed annually, contributing to 68% of all endoscopic procedures in the United States. Usually, endoscopic procedures are low risk, but adverse events may occur, including cardiopulmonary complications, bleeding, perforation, pancreatitis, cholangitis, and infection. Infections after the GI endoscopies most commonly result from the patient's endogenous gut flora. Although many studies have reported infection after GI endoscopic procedures, a true estimate of the incidence rate of post-endoscopy infection is lacking. In addition, the infection profile and causative organisms have evolved over time. In recent times, multi-drug-resistant microorganisms have emerged as a cause of outbreaks of endoscope-associated infections (EAI). In addition, lapses in endoscope reprocessing have been reported, with some but not all outbreaks in recent times. This systematic review summarizes the demographical, clinical, and management data of EAI events reported in the literature. A total of 117 articles were included in the systematic review, with the majority reported from North America and Western Europe. The composite infection rate was calculated to be 0.2% following GI endoscopic procedures, 0.8% following ERCP, 0.123% following non-ERCP upper GI endoscopic procedures, and 0.073% following lower GI endoscopic procedures. Pseudomonas aeruginosa was the most common culprit organism, followed by other Enterobacteriaceae groups of organisms and Gram-positive cocci. We have also elaborated different prevention methods such as antimicrobial prophylaxis, adequate sterilization methods for reprocessing endoscopes, periodic surveillance, and current evidence supporting their utilization. Finally, we discuss disposable endoscopes, which could be an alternative to reprocessing to minimize the chances of EAIs with their effects on the environmental and financial situation.

With advancements in technology, flexible bronchoscopes have become thinner in diameter and in need of more thorough reprocessing to prevent infection transmission than ever before. Many experienced bronchoscopists are not aware of the critical steps involved in effective bronchoscope reprocessing and we hope to bridge this gap by describing this process in detail. Bronchoscope reprocessing includes several distinct steps (precleaning, leak testing, manual cleaning, visual inspection, terminal reprocessing, rinsing and drying). Each step is comprehensive and needs to be carried out systematically by trained personnel. Failure of any step can lead to serious downstream events such as outbreaks and pseudo-outbreaks. Some experts now recommend sterilization when feasible, although high-level disinfection remains the minimum standard. We also will review some literature on the utility of borescopes, automated endoscope reprocessors and disposable bronchoscopes. Our article will focus on the most recent recommendations for effective reprocessing and disinfection of reusable bronchoscopes.

Over the past 2 decades, in hospital centers worldwide, there have been numerous outbreaks of multidrug-resistant organisms that have since been attributed to endoscopic transmission of the infections between patients, primarily from duodenoscopes. These outbreaks have focused the attention of endoscope manufacturers, professional societies, and regulatory agencies on improving the reprocessing of these devices. The key steps in this process are point-of-use precleaning, leak testing, manual cleaning, high-level disinfection, and finally drying and storage. The promise of these initial efforts suggest that the aim of minimizing and ultimately eliminating events of endoscope-/duodenoscope-associated transmission of infectious organisms between patients can be achieved.

Bronchoscopy is a commonly performed procedure within thoracic and critical care medicine. Modern bronchoscopes are technologically advanced tools made of fragile electronic components. Their design is catered to allow maximum maneuverability within the semi-rigid tracheobronchial tree. Effective cleaning and reprocessing of these tools can be a challenge. Although highly functional, the design poses several challenges when it comes to reprocessing. It is a very important step, and lapses in the procedure have been tied to nosocomial infections. The process lacks universal standardization; several organizations have developed their own recommendations. Data have shown that key stakeholders are not fully versed in the essentials of endoscope reprocessing. A significant knowledge gap exists between those performing bronchoscopy and those who are stewards of effective endoscope reprocessing. To service as a resource for bronchoscopists, this study summarizes the steps of effective reprocessing, details the important elements within a health-care facility that houses this process, and reviews some of the current data regarding the use of disposable endoscopes.

Endoscope reprocessing and repair are important factors in regard to patient safety, optimal endoscope function, and costs. Endoscope reprocessing requires high level disinfection. There are three steps in reprocessing; mechanical cleaning, disinfection, and that is followed by rinsing and drying. The most critical step is mechanical cleaning which results in a 10 (4) reduction in microbial contamination or bioburden. Improper cleaning can overwhelm high-level disinfection regardless of subsequent steps and is the most susceptible to error. Endoscopy costs are dependent on costs of instruments, cleaning costs, and repair costs. The average repair costs at our endoscopy unit remained stable for more than 4 years suggesting a durable life of use. Consideration of endoscope accessories use should consider potential damage to endoscope use, cost to process re-useable items, sterility, and consideration of recent legislation on reprocessing of single-use devices.

Several recent cases associating cleaned and high-level disinfected duodenoscopes with outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) and related multidrug-resistant organisms (MDROs) may cause bronchoscopists, pulmonologists, and other stakeholders to inquire about the effectiveness of today's practices for reprocessing flexible bronchoscopes. The primary objectives of this study were to address this question and investigate the risk of bronchoscopes transmitting infections of CRE and related MDROs. The published literature and the US Food and Drug Administration's medical device database of adverse events were searched beginning in 2012, when endoscopy first emerged as a recognized risk factor for transmission of CRE. The Internet was also searched during this same time frame to identify other relevant cases. Several cases associating reprocessed bronchoscopes with infections of CRE or a related MDRO were identified. This study's findings suggest that bronchoscopes may pose an underrecognized potential for transmission of CRE and related MDROs, warranting greater public awareness, enhanced preventive measures, and updated reprocessing guidance. This study's data also suggest that the cleaning and high-level disinfection of bronchoscopes performed in accordance with published guidelines and manufacturer instructions may not always be sufficiently effective to eliminate this risk. Several factors were identified that can adversely affect a bronchoscope's reprocessing and pose a risk of transmission of these multidrug-resistant bacteria, including use of a damaged or inadequately serviced bronchoscope, and formation of an inaccessible biofilm. Recommendations are provided to improve the safety of flexible bronchoscopes, including supplementing their reprocessing with an enhanced measure such as sterilization when warranted, and strict adherence to a periodic servicing and maintenance schedule consistent with the bronchoscope manufacturer's instructions.

No abstract

It has been recommended that bronchoscopists familiarize themselves with national recommendations for bronchoscope reprocessing practices, but the extent of guideline awareness is unclear. We distributed a survey to practicing bronchoscopists at two meetings. Questions addressed infection control issues related to bronchoscopy and specific reprocessing recommendations. A total of 46 surveys were completed by medical directors of bronchoscopy suites (26%) and attending bronchoscopists (74%) who had graduated from medical school a median of 22 years ago and performed a median of 19 procedures per month. Sixty-five percent of respondents, including 55% of directors, were not familiar with national reprocessing recommendations, and 39% did not know the approach to reprocessing at their own institution. Respondents who did > 20 procedures per month trended toward being more likely to be aware of guidelines (54% vs 26%, p = 0.09) and were less likely to answer "do not know" to more than one question about specific reprocessing details (25% vs 70%, p = 0.003). Seventy-eight percent of respondents did not know local practices for at least one of the reprocessing details. Forty-six percent of respondents stated their institutions followed recommendations that records be kept of the specific bronchoscope used in each case. Many experienced bronchoscopists are unfamiliar with national guidelines and local practices related to bronchoscope reprocessing. Publication of bronchoscope-specific, comprehensive reprocessing guidelines in the pulmonary literature may help increase familiarity with this crucial process.

With reports of ongoing duodenoscope contamination and pathogen transmission despite strict adherence to manufacturer reprocessing instructions, professional societies continue to release updated recommendations. Despite general guideline similarities, there are differences. Although adherence to guidelines does not entirely eliminate pathogen contamination or transmission, it is critical to strictly adhere to updated guidelines for maximum risk reduction. In the United States, the Food and Drug Administration and Centers for Disease Control and Prevention continue to offer updates regarding improved duodenoscope reprocessing techniques and endoscope design. This article critically analyzes currently available national and international duodenoscope reprocessing guidelines.

Several outbreaks of severe infections due to contamination of gastrointestinal (GI) endoscopes, mainly duodenoscopes, have been described. The rate of microbial endoscope contamination varies dramatically in literature. The aim of this multicentre prospective study was to evaluate the hygiene quality of endoscopes and automated endoscope reprocessors (AERs) in Tyrol/Austria. In 2015 and 2016, a total of 463 GI endoscopes and 105 AERs from 29 endoscopy centres were analysed by a routine (R) and a combined routine and advanced (CRA) sampling procedure and investigated for microbial contamination by culture-based and molecular-based analyses. The contamination rate of GI endoscopes was 1.3%-4.6% according to the national guideline, suggesting that 1.3-4.6 patients out of 100 could have had contacts with hygiene-relevant microorganisms through an endoscopic intervention. Comparison of R and CRA sampling showed 1.8% of R versus 4.6% of CRA failing the acceptance criteria in phase I and 1.3% of R versus 3.0% of CRA samples failing in phase II. The most commonly identified indicator organism was Pseudomonas spp., mainly Pseudomonas oleovorans. None of the tested viruses were detected in 40 samples. While AERs in phase I failed (n = 9, 17.6%) mainly due to technical faults, phase II revealed lapses (n = 6, 11.5%) only on account of microbial contamination of the last rinsing water, mainly with Pseudomonas spp. In the present study the contamination rate of endoscopes was low compared with results from other European countries, possibly due to the high quality of endoscope reprocessing, drying and storage.

No abstract

Reprocessing of gastrointestinal (GI) endoscopes and accessories is an essential part of patient safety and quality control in GI endoscopy centers. However, current endoscopic reprocessing guidelines or procedures are not adequate to ensure patient-safe endoscopy. Approximately 5.4 % of the clinically used duodenoscopes remain contaminated with high-concern microorganisms. Thus, the Digestive Endoscopy Society of Taiwan (DEST) sets standards for the reprocessing of GI endoscopes and accessories in endoscopy centers. DEST organized a task force working group using the guideline-revision process. These guidelines contain principles and instructions of step-by-step for endoscope reprocessing. The updated guidelines were established after a thorough review of the existing global and local guidelines, systematic reviews, and health technology assessments of clinical effectiveness. This guideline aims to provide detailed recommendations for endoscope reprocessing to ensure adequate quality control in endoscopy centers.

Infection-control issues during gastrointestinal endoscopy, which are becoming increasingly important, can generally be divided into three major areas: (1) infectious complications resulting from a patient's own microbial flora (autologous), (2) infections transmitted from patient to patient by way of the endoscope (exogenous), and (3) infections transmitted between the patient and the health-care provider. The mean frequency of postprocedure bacteremia ranges from 0.5% for flexible sigmoidoscopy to 2.2% for colonoscopy, 4.2% for esophagogastroduodenoscopy, 8.9% for variceal ligation, 11% for endoscopic retrograde cholangiopancreatography, 15.4% for variceal sclerotherapy, and 22.8% for esophageal dilation. Although postprocedure bacteremia is not uncommon, it seldom results in infectious complications. Exogenous infections transmitted during endoscopy, which are extremely rare, generally result from failure to follow accepted guidelines for the cleaning and disinfection of gastrointestinal endoscopes, underscoring the importance of meticulous attention to endoscope reprocessing. Finally, although the risk of patient-staff transmission of infection is also rare, standard infection-control recommendations are important in protecting both patients and health-care providers.

After outbreaks of duodenoscope-transmitted infection with multidrug-resistant organisms, it has become clear that institutions must optimize their endoscope reprocessing programs. Standard endoscope reprocessing practices may not represent the ideal approach for preventing transmission of infection related to endoscopy. We discuss multiple approaches to enhance and optimize reprocessing, drying, and storage of standard duodenoscopes. The optimal enhanced duodenoscope reprocessing modality remains to be determined. Acknowledging the challenges and limitations in effectively reprocessing duodenoscopes, the FDA issued a safety communiqué recommending transitioning to either single use disposable duodenoscopes or duodenoscopes with innovative designs that allow more effective reprocessing.

This statement was written under the auspices of the World Gastroenterology Organization's Guidelines Committee. The authors are members of the Review Team of the WGO Endoscope Disinfection Guideline and have experience in endoscopy, endoscope reprocessing, and microbiology, including biofilms. During the preparation of the WGO Update on Endoscope Disinfection Guidelines, concerns about simethicone on endoscope channel surfaces compromising cleaning and disinfection were raised. Publications on simethicone, including modes of delivery, effectiveness, and risks, have been reviewed. The paper was written as a companion to the new guidelines with a focus on minimizing the risks of simethicone in endoscope reprocessing.

Flexible endoscopes require cleaning, high-level disinfection, and sterilization between each patient use to reduce risk of transmitting pathogens. Public health investigations have identified concerns, including endoscope damage, mishandling, and reprocessing deficiencies, placing patients at risk for transmission of bacterial, viral, and other pathogens. Findings from outbreak investigations and other studies have led to innovations in endoscope design, use, and reprocessing, yet infection risks related to contaminated or damaged endoscopes remain. Strict adherence to infection control guidelines and manufacturer instructions for use, utilization of supplemental guidance, and training and oversight of reprocessing personnel, reduce risk of pathogen transmission by flexible endoscopes.

to elaborate and apply a method to assess the efficacy of automated flexible endoscope reprocessors at a time when there is not an official method or trained laboratories to comply with the requirements described in specific standards for this type of health product in Brazil. the present methodological study was developed based on the following theoretical references: International Organization for Standardization (ISO) standard ISO 15883-4/2008 and Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária - ANVISA) Collegiate Board Resolution (Resolução de Diretoria Colegiada - RDC) no. 35/2010 and 15/2012. The proposed method was applied to a commercially available device using a high-level 0.2% peracetic acid-based disinfectant. the proposed method of assessment was found to be robust when the recommendations made in the relevant legislation were incorporated with some adjustments to ensure their feasibility. Application of the proposed method provided evidence of the efficacy of the tested equipment for the high-level disinfection of endoscopes. the proposed method may serve as a reference for the assessment of flexible endoscope reprocessors, thereby providing solid ground for the purchase of this category of health products. propor e aplicar um método para a avaliação da eficácia de processadoras automáticas de endoscópios flexíveis, em um momento em que ainda não existe no Brasil um método oficial, nem tampouco laboratórios capacitados que contemplem os requisitos das normas específicas aplicáveis a esse tipo de produto para a saúde. caracterizou-se como pesquisa metodológica e foi desenvolvido com base em três referenciais teóricos: norma técnica International Organization for Standardization (ISO) - ISO 15883-4/2008, Resolução de Diretoria Colegiada (RDC) nº35/2010 e RDC nº15/2012 da Agência Nacional de Vigilância Sanitária (ANVISA). Aplicou-se o método proposto em um equipamento específico, comercialmente disponível, utilizando desinfetante de alto nível à base de ácido peracético 0,2%. o método de avaliação proposto mostrou-se robusto, à medida que as recomendações das legislações pertinentes ao equipamento avaliado foram incorporadas, com algumas adaptações para sua exequibilidade. A aplicação do método proposto permitiu atestar a eficácia do equipamento utilizado na desinfecção de alto nível de endoscópios. o método pode servir de referência para a avaliação de reprocessadoras de endoscópios flexíveis, subsidiando a aquisição dessa categoria de produtos para a saúde. elaborar y aplicar un método para evaluar la eficacia de reprocesadores automatizados de endoscopios flexibles en un momento en el que no hay un método oficial o laboratorios capacitados para cumplir con los requisitos descritos en las normas específicas para este tipo de producto para la salud en Brasil. el presente estudio metodológico fue desarrollado en base a las siguientes referencias teóricas: Organización Internacional de Normalización (International Organization for Standardization - ISO) norma ISO 15883-4/2008 y Agencia Nacional de Vigilancia de la Salud de Brasil (Agência Nacional de Vigilância Sanitária - ANVISA) Resolución del Directorio Colegiado (Resolução de Diretoria Colegiada - RDC) № 35/2010 y 15/2012. El método propuesto se aplicó a un dispositivo comercialmente disponible usando un desinfectante al 0,2% a base de ácido peracético de alto nivel. el método de evaluación propuesto se evaluó como fuerte después de que las recomendaciones formuladas en la legislación pertinente se incorporaron con algunos ajustes para garantizar su factibilidad. La aplicación del método propuesto proporciona evidencia de la eficacia de los equipos de prueba para la desinfección de alto nivel de endoscopios. el método propuesto puede servir de referencia para la evaluación de reprocesadores de endoscopios flexibles, proporcionando de este modo bases sólidas para la compra de esta categoría de productos de salud.

The objective of this study was to perform simulated-use testing as well as a clinical study to assess the efficacy of the EVOTECH Endoscope Cleaner and Reprocessor (ECR) cleaning for flexible colonoscopes, duodenoscopes, gastroscopes and bronchoscopes. The main aim was to determine if the cleaning achieved using the ECR was at least equivalent to that achieved using optimal manual cleaning. Simulated-use testing consisted of inoculating all scope channels and two surface sites with Artificial Test Soil (ATS) containing 108 cfu/mL of Enterococcus faecalis, Pseudomonas aeruginosa and Candida albicans. Duodenoscopes, colonoscopes, and bronchoscopes (all Olympus endoscopes) were included in the simulated use testing. Each endoscope type was tested in triplicate and all channels and two surface sites were sampled for each scope. The clinical study evaluated patient-used duodenoscopes, bronchoscopes, colonoscopes, and gastroscopes (scopes used for emergency procedures were excluded) that had only a bedside flush prior to being processed in the ECR (i.e. no manual cleaning). There were 10 to 15 endoscopes evaluated post-cleaning and to ensure the entire ECR cycle was effective, 5 endoscopes were evaluated post-cleaning and post-high level disinfection. All channels and two external surface locations were sampled to evaluate the residual organic and microbial load. Effective cleaning of endoscope surfaces and channels was deemed to have been achieved if there was < 6.4 microg/cm2 of residual protein, < 1.8 microg/cm2 of residual hemoglobin and < 4 Log10 viable bacteria/cm2. Published data indicate that routine manual cleaning can achieve these endpoints so the ECR cleaning efficacy must meet or exceed these to establish that the ECR cleaning cycle could replace manual cleaning In the clinical study 75 patient-used scopes were evaluated post cleaning and 98.8% of surfaces and 99.7% of lumens met or surpassed the cleaning endpoints set for protein, hemoglobin and bioburden residuals. In the simulated-use study 100% of the Olympus colonoscopes, duodenoscopes and bronchoscopes evaluated met or surpassed the cleaning endpoints set for protein, and bioburden residuals (hemoglobin was not evaluated). The ECR cleaning cycle provides an effective automated approach that ensures surfaces and channels of flexible endoscopes are adequately cleaned after having only a bedside flush but no manual cleaning. It is crucial to note that endoscopes used for emergency procedures or where reprocessing is delayed for more than one hour MUST still be manually cleaned prior to placing them in the ECR.

The air/water, auxiliary water, and elevator wire channels of endoscopes are narrow (0.06-0.14 cm), long (129-345 cm), and cannot be brushed manually. These 'unbrushable' channels depend solely on flushing during reprocessing, and are prone to residual debris and biofilm accumulation. This study evaluated the efficacy of cleaning of these channels in automated endoscope reprocessors (AERs), and assessed compliance with detergent instructions for use (IFUs). Endoscopes were reprocessed in an AER using a standardized protocol with high-level disinfection at 20 °C using peracetic acid. The efficacy of cleaning was verified using the FlexiCheck system with stainless steel test coupons coated with standardized blood and polysaccharide soils. Three detergents - one non-enzymatic (Product A) and two enzymatic (Products B and C; IFU: 25-60 °C) - were tested at 1:200 dilution for 1, 5 and 10 min under summer and winter conditions. A nationwide survey of 19 endoscopy centres assessed real-world AER cleaning practices and IFU compliance. In winter, low water temperatures impaired enzymatic activity, reducing the efficacy of cleaning. Product A achieved effective cleaning at ≥5 min across all temperatures. Product B showed temperature- and time-dependent efficacy, while Product C failed under all tested conditions. Survey data revealed substantial variability in detergent use, cleaning duration, and temperature control, with frequent non-compliance with IFUs. Only two centres (10.5%) performed in-AER cleaning verification. Effective reprocessing of unbrushable channels requires detergent compatibility with AER settings, temperature monitoring, adequate cleaning time, and routine verification of the efficacy of cleaning.

Since endoscopes are reusable apparatus classified as semicritical item, thorough reprocessing to achieve high-level disinfection is of utmost importance to prevent spread of infection. To improve disinfection efficacy and safety, disinfectants and endoscope reprocessors are continuously evolving. This study aimed to compare the efficacy of the combination of polyhexamethylenebiguanide hydrochloride-alkyldimethylbenzylammonium chloride (PHMB-DBAC) and orthophthalaldehyde (OPA) used respectively in ultrasonographic cleaning incorporated automated endoscope reprocessors: COOLENDO (APEX Korea) or OER-A (Olympus Optical). A total of 86 flexible upper endoscopes were randomly reprocessed with either COOLENDO/PHMB-DBAC or OER-A/OPA. Culture samplings were done at two sites (endoscope tip and working channel) which were later incubated on blood agar plate. Bacterial colonies were counted and identified. The culture-positive rate at the endoscope tip and working channel was 0% and 2.33% for COOLENDO/PHMB-DBAC and 4.65% and 0% for OER-A/OPA. Staphylococcus hominis was cultured from one endoscope reprocessed with COOLENDO/PHMB-DBAC and Pseudomonas putida was isolated from two endoscopes reprocessed with OER-A/OPA. The reprocessing efficacy of COOLENDO/PHMB-DBAC was non-inferior to that of OER-A/OPA (p=0.032; confidence interval, -0.042 to 0.042). During the study period, significant side effect of PHMB-DBAC was not observed.

To evaluate the effectiveness of a high-level disinfection solution generated inside an endoscope processing system for decontaminating external and internal surfaces of experimentally contaminated heat-sensitive medical devices. The American Society for Testing and Materials Simulated-Use Test protocol (E1837-02), which incorporates a soil load in each inoculum, was used to evaluate the efficacy of the system when processing 4 common types of endoscopes contaminated separately with 5 types of nosocomial pathogens: Pseudomonas aeruginosa (ATCC 15442), spores of Clostridium difficile (ATCC 9689), a glutaraldehyde-resistant strain of Mycobacterium chelonae, a vancomycin-resistant strain of Enterococcus faecalis, and a methicillin-resistant strain of Staphylococcus aureus. Rinse solution samples from channels and from surfaces of the processed endoscopes were tested for any microbicidal residues. For all organisms tested, the baseline level of contamination of the endoscopes ranged from 5 log(10) to greater than 7 log(10) at each external surface site and internal channel. All tests showed reductions in viability of the test organisms to undetectable levels. All rinse solution samples from external and internal sites of the endoscopes proved to be free of any residual microbicidal activity. The endoscope reprocessor, with its processor-generated high-level disinfection solution, successfully reduced the numbers of selected, clinically relevant pathogens to undetectable levels both in the channels and on the outside surfaces of the 4 representative endoscopes tested in this study.

High level disinfection (HLD) of the gastrointestinal (GI) endoscope is not simply a slogan, but rather is a form of experimental monitoring-based medicine. By definition, GI endoscopy is a semicritical medical device. Hence, such medical devices require major quality assurance for disinfection. And because many of these items are temperature sensitive, low-temperature chemical methods, such as liquid chemical germicide, must be used rather than steam sterilization. In summarizing guidelines for infection prevention and control for GI endoscopy, there are three important steps that must be highlighted: manual washing, HLD with automated endoscope reprocessor, and drying. Strict adherence to current guidelines is required because compared to any other medical device, the GI endoscope is associated with more outbreaks linked to inadequate cleaning or disinfecting during HLD. Both experimental evaluation on the surveillance bacterial cultures and in-use clinical results have shown that, the monitoring of the stringent processes to prevent and control infection is an essential component of the broader strategy to ensure the delivery of safe endoscopy services, because endoscope reprocessing is a multistep procedure involving numerous factors that can interfere with its efficacy. Based on our years of experience in the surveillance of culture monitoring of endoscopic reprocessing, we aim in this study to carefully describe what details require attention in the GI endoscopy disinfection and to share our experience so that patients can be provided with high quality and safe medical practices. Quality management encompasses all aspects of pre- and post-procedural care including the efficiency of the endoscopy unit and reprocessing area, as well as the endoscopic procedure itself.

The increasing reliance on automated endoscope reprocessors (AERs) for endoscope reprocessing has highlighted gaps in management systems. This study aimed to develop a comprehensive quality evaluation index system to optimize AERs management. Guided by the structure-process-outcome model, the Delphi method was employed across 2 consultation rounds involving 17 experts. Indicators were developed and refined through literature reviews, hospital data analysis, and consensus-building. Hospital data analysis identified key AERs management challenges: human errors (54.5%)-primarily improper leak detector installation (78.8% of human errors)-and component malfunctions (45.5%). The final system comprised 3 primary, 13 secondary, and 58 tertiary indicators. Expert consensus was robust (response rate: 100%; authority coefficient > 0.9; Kendall's W: P < .001). Outcome indicators linked reprocessing efficacy to clinical impacts, including microbiological pass rates and malfunction frequency. The structure-process-outcome-driven system integrates structural, procedural, and outcome standards, providing actionable benchmarks to mitigate risks and enhance reliability. While validated through expert consensus, further real-world validation is needed to assess long-term applicability across diverse settings. This comprehensive quality evaluation index system offers a standardized framework for AERs management and optimization of endoscope reprocessing workflows.

To prevent the transmission of pathogens by endoscopes, following established reprocessing guidelines is critical. An ideal reprocessing step is simple, fast, and inexpensive. Here, we evaluated and compared the efficacy and safety of two disinfectants, a tertiary amine compound (TAC) and ortho-phthalaldehyde (OPA). A total of 100 colonoscopes were randomly reprocessed using two same automated endoscope reprocessors, according to disinfectant. The exposure time was 10 minutes for 0.55% OPA (Cidex® OPA, Johnson & Johnson) and 5 minutes for 4% TAC (Sencron2®, Bab Gencel Pharma & Chemical Ind. Co.). Three culture samples were obtained from each colonoscope after reprocessing. A total of nine samples were positive among the 300 culture samples. The positive culture rate was not statistically different between the two groups (4% for OPA and 2% for TAC, P=0.501). There were no incidents related to safety during the study period. TAC was non-inferior in terms of reprocessing efficacy to OPA and was safe to use. Therefore, TAC seems to be a good alternative disinfectant with a relatively short exposure time and is also less expensive than OPA.

Adenosine triphosphate (ATP) bioluminescence assay is widely adopted in the West to allow rapid evaluation of endoscopes for bacteriologic/biologic residue, but this practice is rarely adopted in Asia. In this continuous quality improvement program, we evaluated the utility of ATP in bacteriologic surveillance on endoscope reprocessing. A total of 456 samples (304 ATP samples and 152 culture samples) of 38 flexible endoscopes were assessed after routine clinical use in a private hospital in Hong Kong. Endoscopes were assessed with an ATP system and bacterial cultures at different time points during the reprocessing. After pre-cleaning, the ATP values ranged from 228 to 65 163 relative light units (RLU) through all endoscope types. After manual cleaning, ATP values were decreased to 7-81 RLU (median, 19 RLU) for endoscope surface and 3-671 RLU (median, 12 RLU) for channel rinsate. There was a significant reduction in ATP levels between pre-cleaning and after manual cleaning. One of the 38 (2.6%) endoscopes (a duodenoscope) had an ATP value of 671 RLU from channel rinsate, which exceeded the benchmark for cleanliness of >200 RLU, and was sent back for re-cleaning. All endoscopes cultured no bacteria after high-level disinfection (HLD) by automated endoscope reprocessor (AER) and storage up to 24 h. ATP values were <200 RLU for all endoscopes after HLD and storage. Adenosine triphosphate bioluminescence assay offers a rapid, practical, and cost-effective alternative for detection of endoscope microbial residue as well as a routine monitoring tool for endoscope cleanliness in the clinical setting.

Flexible bronchoscopes (FBs) used in intensive care units (ICUs) frequently harbour pathogenic micro-organisms, creating early reprocessing risks for environmental contamination and staff exposure. In a six-month evaluation of 832 ICU FBs sampled immediately post-use with metagenomic next-generation sequencing, 55.4% carried one or more pathogens, including multi-drug-resistant bacteria, fungi and airborne agents. We instituted an enhanced reprocessing protocol centred on sealed transfer using double biohazard bags, a two-person dedicated handling method that separates contaminated-scope contact from support tasks, segregation of sinks and a dedicated automated endoscope reprocessor (AER) for ICU FBs, and rigorous terminal disinfection of equipment and work surfaces. Quality checks showed unchanged cleaning efficacy of FBs, whereas the environmental microbial burden on work surfaces after reprocessing was significantly reduced under the new protocol. These findings identify ICU FBs as a high-load reservoir at the point of receipt and demonstrate that targeted, standardized controls during the earliest reprocessing steps can mitigate environmental contamination and enhance sterile-processing worker protection without compromising device reprocessing outcomes.

Endoscopic examinations are essential for diagnosis and treatment of strangles (S equi infection) in horses. However, even after disinfection, endoscopes may retain viable bacteria or bacterial DNA. Twitches are commonly used during endoscopic examinations and can thus also potentially transmit the organism to other horses. To evaluate the efficacy of different disinfectant methods to eliminate S equi from experimentally contaminated endoscopes and twitches and the effectiveness of field disinfection of endoscopes used in sampling carriers of S equi. Experimental contamination and observational field study. One endoscope and 30 twitches were contaminated with standardised S equi broth solutions. The endoscope was disinfected following three protocols using various disinfectants for manual disinfection. A fourth protocol used an automated endoscope reprocessor (AER). The twitches (n = 30) were disinfected following eight different disinfecting protocols. Three endoscopes used in sampling for silent carriers were disinfected following a field-based protocol. After each protocol the endoscopes and twitches were sampled for S equi by culture and qPCR. Following experimental contamination all endoscope disinfection protocols, apart from 1/6 of the ethanol protocol were S equi culture negative. However, no endoscope disinfection protocol completely eliminated retention of S equi DNA. Field disinfection of endoscopes after sampling carriers yielded no culture positives and all but one (13/14) were qPCR negative. All twitches disinfected following experimental contamination were culture negative but sodium hypochlorite was the only disinfectant that completely eliminated detection of S equi DNA. Experimental contamination may not reflect the numbers of S equi transferred to endoscopes or twitches during use on silent carriers and purulent secretions from infected horses may influence survival of S equi. While most disinfection methods appear to ensure removal of cultivable S equi, residual DNA can remain on both endoscopes and twitches.

Compliance with cleaning of flexible endoscope channels cannot be verified using visual inspection. Adenosine triphosphate (ATP) has been suggested as a possible rapid cleaning monitor for flexible endoscope channels. There have not been published validation studies to specify the level of ATP that indicates inadequate cleaning has been achieved. The objective of this study was to validate the Clean-Trace (3M Inc, St. Paul, MN) ATP water test method for monitoring manual cleaning of flexible endoscopes. This was a simulated use study using a duodenoscope as the test device. Artificial test soil containing 10(6) colony-forming units of Pseudomonas aeruginosa and Enterococcus faecalis was used to perfuse all channels. The flush sample method for the suction-biopsy (L1) or air-water channel (L2) using 40 and 20 mLs sterile reverse osmosis water, respectively, was validated. Residuals of ATP, protein, hemoglobin, and bioburden were quantitated from channel samples taken from uncleaned, partially cleaned, and fully cleaned duodenoscopes. The benchmarks for clean were as follows: <6.4 μg/cm(2) protein, <2.2 μg/cm(2) hemoglobin, and <4-log10 colony-forming units/cm(2) bioburden. The average ATP in clean channel samples was 27.7 RLUs and 154 RLUs for L1 and L2, respectively (<200 RLUs for all channels). The average protein, hemoglobin, and bioburden benchmarks were achieved if <200 RLUs were detected. If the channel sample was >200 RLUs, the residual organic and bioburden levels would exceed the acceptable benchmarks. Our data validated that flexible endoscopes that have complete manual cleaning will have <200 RLUs by the Clean-Trace ATP test.

Cleaning of flexible endoscopes is most commonly performed using manual methods that are often performed inadequately. The aim of this study was to validate the sample collection protocol and the Rapid Use Scope Test (RUST) and then assess its usefulness in clinical use. The benchmarks for adequate cleaning were protein <6.4 μg/cm(2), hemoglobin <2.2 μg/cm(2), and carbohydrate <1.2 μg/cm(2). Sample collection consisted of flushing 10 mL of sterile reverse osmosis water through the suction-biopsy port to the distal end. Validation of the RUST audit tool included simulated-use and in-use testing in 43 endoscopy clinics across Canada. Simulated-use testing validated that improperly cleaned endoscopes that exceeded the cleaning benchmarks would be flagged by the RUST test. The clinical-use study indicated that 96.6% of 1,489 scope channels tested were RUST negative; however, 19% and 12% of elevator guide-wire channels and endoscopic retrograde colangiopancreatography channels, respectively, exceeded the benchmarks. The survey indicated that reprocessing personnel valued a rapid audit tool for assessing compliance with manual cleaning. The validated RUST test provides health care users with a rapid audit tool for manual cleaning that can be integrated into the quality program in endoscopy.

Patients should be informed about the benefits and risks of endoscopic retrograde cholangiopancreatography (ERCP)Only specially trained and competent personnel should carry out endoscope reprocessing.Manufacturers of duodenoscopes should provide detailed instructions on how to use and reprocess their equipment.In the case of modifications to their equipment, manufacturers should provide updated instructions for use.Detailed reprocessing protocols based on the manufacturer's instructions for use should clearly lay out the different reprocessing steps necessary for each endoscope model.Appropriate cleaning equipment should be used for duodenoscopes in compliance with the manufacturer's instructions for use. Only purpose-designed, endoscope type-specific, single-use cleaning brushes should be used, to ensure optimal cleaning. As soon as the endoscope is withdrawn from the patient, bedside cleaning should be performed, followed by leak testing, thorough manual cleaning steps, and automated reprocessing, in order to: · Remove debris from external and internal surfaces;. · Prevent any drying of body fluids, blood, or debris;. · Prevent any formation of biofilms.. In addition to the leak test, visual inspection of the distal end as well as regular maintenance of duodenoscopes should be performed according to the manufacturer's instructions for use, in order to detect any damage at an early stage.The entire reprocessing procedure in endoscope washer-disinfectors (EWDs) should be validated according to the European and International Standard, EN ISO 15883. Routine technical tests of EWDs should be performed according to the validation reports.Microbiological surveillance of a proportion of the department's endoscopes should be performed every 3 months, with the requirement that all endoscopes used in the unit are tested at least once a year.In the case of suspected endoscopy-related infection, the relevant device (e. g., endoscope, EWD) should be taken out of service until adequate corrective actions have been taken. Outbreaks should be managed by a multidisciplinary team, including endoscopy, hygiene, and microbiology experts, manufacturers, and regulatory bodies, according to national standards and/or laws. In the case of suspected multidrug-resistant organism (MDRO) outbreaks, close cooperation between the endoscopy unit and the clinical health provider is essential (including infection control departments and hospital hygienists).

The objectives of this study were to recommend sample collection method(s) based on relative soiling in patient-used gastrointestinal (GI) endoscopes and determine whether the published benchmarks for protein, bioburden, and adenosine triphosphate (ATP) remain relevant for pump-assisted manual cleaning. Patient-used gastroscopes, duodenoscopes, and colonoscopes were sampled before and after manual cleaning and assessed for protein, bioburden, and ATP levels. The biopsy port (BP) to distal end (D) sample was collected using 20 mL of sterile reverse-osmosis water. After a 200-mL flush, the umbilical (UM) to BP portion was sampled by flushing 40 mL from the UM to the D. The BP to D portion of the suction biopsy channel contained 83% of ATP residuals. Despite cleaning with brushing and a flushing pump, 25% of gastroscopes exceeded the ATP benchmark of 200 relative light units (RLU), whereas all duodenoscopes and colonoscopes had <200 RLU after cleaning. The protein and bioburden residuals after pump-assisted cleaning were consistently lower than existing benchmarks. Sampling the suction biopsy channel from BP to D detected the most residuals from patient-used GI endoscopes. The protein and bioburden benchmarks for pump-assisted cleaning can be lowered, but 200 RLU is still adequate for ATP.

The practice of flexible gastrointestinal endoscopy has matured significantly in recent years. Unfortunately, two long-standing problems still exist: the complex physical nature inherent to the endoscopes and accessories, and user compliance with established reprocessing guidelines. Improvements have been made, but newer instruments remain comparatively fragile, expensive, and physically complex, and validated data on reprocessing specific instruments is generally lacking. The practice of flexible gastrointestinal endoscopy today, however, is demonstrably safe and beneficial, provided established practice procedures for reprocessing, with emphasis on instrument cleaning, are followed meticulously in each endoscopy center.

In Europe, the evaluation of processing flexible endoscopes in washer-disinfectors (WDs) is performed in compliance with prEN ISO 15883-1 which includes determination of the efficacy of the cleaning process. Recent data suggest that cleaning processes show large differences when the prEN ISO 15883-1 German test model is applied. Hence, we analysed a total of 72 experiments in order to evaluate the test method. Transparent test tubes as test pieces (length 2 m, lumen 2 mm) were contaminated with a mixture of blood and Enterococcus faecium. Three set-ups were used: WD 425 with soft water, WD 425 with hard water and WD 440 with demineralized water. WDs were set to perform the cleaning stage of the programme alone. Seven cleaning agents were used according to the manufacturers' instructions (21 cleaning processes); in addition, three cleaning processes were carried out without a cleaning agent (i.e. with water alone). Each cleaning process was assessed by means of three experiments. Suspensions of test organism had 9.2x10(10) colony-forming units (cfu)/mL E. faecium (mean of 24 processes). Controls (recovery) contained 1.0x10(6) cfu/mL E. faecium (mean of 71 experiments). Mean log(10) reduction factors (RFs) for each process, i.e. the difference in microbial loads on the control and the processed tubes, were calculated. Cleaning processes led to RFs of 0-4.1, but no process led to residual bacterial loads below the limit of detection (1.8l gcfu/mL). Standard deviations for a cleaning process were small (< or =0.6 in 79% of the processes) indicating adequate reproducibility. The test model led to reproducible results and revealed large differences between the individual processes. If a cleaning process is intended to result in a bioburden reduction (i.e. RF> or =4), the control must carry a minimum bioburden of 6.5x10(5) cfu/mL. This was achieved in 58% of the processes. However, controls with a bioburden <6.5x10(5) cfu/mL never yielded a residual bacterial load below the limit of detection. We found that the prEN ISO 15883-1 German test method is suitable to determine the cleaning efficacy in WDs and leads to reproducible and valid results.

Hospital acquired infections stemming from contaminated reusable medical devices are of increasing concern. This issue is exaggerated with the introduction of complex medical devices like endoscopes and robotic instrumentation. Although medical device manufacturers validate their cleaning instructions for use, evidence in the literature demonstrates that effective device processing is not being performed consistently within sterile processing departments in clinical settings. The result is increased risks to patient safety. As a solution to this problem, focused one-on-one training increases compliance to the medical device manufacturer's processing instruction. However, often this is not a practical solution for the volume of healthcare staff responsible for device processing activities. This constitutes the first paper to address the blended use of educational and digital technologies to address these challenges and as a result inform safety and sustainability for the medical device sector. Cognitive learning theory is an evidence-based framework for learning. It supports the use of immersive educational experiences using emerging extended reality technologies (e.g., virtual or augmented reality) to increase learning comprehension. The delivery of educational content via these technologies provides an innovative option for repeatable leaning and training outcomes. The motivation is to decrease patient risk of contaminated reusable medical devices. The proposed approach while primary motivated by safety can also enhance sustainability and efficiency enabled by artificial intelligence and robotic instrumentation.

Biofilm formation has been shown to be associated with damaged areas of endoscope channels. It was hypothesized that the passage of instruments and brushes through endoscope channels during procedures and cleaning contributes to channel damage, bacterial attachment and biofilm formation. To compare surface roughness and bacterial attachment in used and new endoscope channels in vivo and in vitro. Surface roughness of 10 clinically used (retired) and seven new colonoscope biopsy channels was analysed by a surface profiler. For the in-vitro study, a flexible endoscope biopsy forceps was passed repeatedly through a curved 3.0-mm-diameter Teflon tube 100, 200 and 500 times. Atomic force microscopy was used to determine the degree of inner surface damage. The number of Escherichia coli or Enterococcus faecium attached to the inner surface of the new Teflon tube and the tube with 500 forceps passes in 1 h at 37 The average surface roughness of the used biopsy channels was found to be 1.5 times greater than that of the new biopsy channels (P=0.03). Surface roughness of Teflon tubes with 100, 200 and 500 forceps passes was 1.05-, 1.12- and 3.2-fold (P=0.025) greater than the roughness of the new Teflon tubes, respectively. The number of E. coli and E. faecium attached to Teflon tubes with 500 forceps passes was 2.9-fold (P=0.021) and 4.3-fold (P=0.004) higher compared with the number of E. coli and E. faecium attached to the new Teflon tubes, respectively. An association was found between endoscope usage with damage to the biopsy channel and increased bacterial attachment.

Biofilm contributes significantly to bacterial persistence in endoscope channels. Enhanced cleaning methods capable of removing biofilm from all endoscope channels are required to decrease infection risk to patients. This head-to-head study compared cyclic build-up biofilm removal of an automated endoscope channel cleaner (AECC) with standard manual cleaning according to instructions for use (IFU) in polytetrafluorethylene channels. Cyclic build-up biofilm was grown in 1.4-mm (representing air/water and auxiliary channels) and 3.7-mm (representing suction/ biopsy channels) inner diameter polytetrafluorethylene channels. All channels were tested for residual total organic carbon, protein, and viable bacteria. Internationally recognized ISO 15883-5:2021 alert levels were used as cleaning benchmarks for protein (3 μg/cm The automated cleaner significantly outperformed manual cleaning for all markers assessed (protein, total organic carbon, viable bacteria) in 1.4-mm and 3.7-mm channels representing air/water/auxiliary and suction/biopsy channels, respectively. Manual cleaning failed to remove biofilm from the air/water and auxiliary channels. According to the IFU, these channels are not brushed, suggesting a potential root cause for a portion of the numerous endoscopy-associated infections reported in the literature. AECC shows potential to deliver enhanced cleaning over current practice to all endoscope channels and may thereby address infection risk.

Studies have indicated that endoscope reprocessing failure might be attributed to internal damage or residual liquid in endoscopes. However, large-sample survey data on the internal conditions of endoscopic channels after reprocessing are lacking. This study used a borescope to investigate the internal cleanliness and damage of 213 endoscopic biopsy channels after reprocessing at the endoscopy center of the First Affiliated Hospital of Nanchang University, provided in theoretical basis for the efficacy of endoscope reprocessing and maintenance. A borescope was used to observe and analyze the inside of the endoscopic biopsy channel of 213 reprocessed endoscopes (in accordance with the Chinese health industry standard "Regulation for cleaning and disinfection technique of flexible endoscope (WS 507-2016). Each endoscope was observed for at least 10 minutes, and the results were recorded and evaluated by 5 researchers independently. In all, 2504 images and 109 videos were recorded, and abnormal findings were classified into 10 categories: scratches (91.5%, 195/213), scratches with adherent peel (46.0%, 98/213), discolored areas (49.3%, 105/213), transparent drops (28.2%, 60/213), milky drops (23.9%, 51/213), white particles (46.9%, 100/213), attached materials (37.6%, 80/213), wear on metal parts (41.3%, 88/213), rust (23.9%, 51/213), and black spots (35.7%, 76/213). Among scratches, those in Teflon from 0-10 cm at the apex of the biopsy channel outlet and in metal from 0-5 cm at the biopsy channel inlet accounted for 58.4% (114/195) and 96.4% (188/195), respectively. Scratches were the most common form of damage in the endoscopic biopsy channels investigated and were related to the use of endoscopic accessories and cleaning brush materials. The incidence of other abnormalities gradually increased with the duration of use and began to increase significantly after 18 months. All abnormalities have a certain impact on the quality of endoscope reprocessing. We recommend that a borescope be used to check the inside of endoscopic biopsy channels regularly to determine the damage and cleaning conditions and that these channels be reprocessed, repaired, or replaced in a timely manner.

to analyze the cleaning process of gastroscopes, colonoscopes and duodenoscopes in eight in-hospital health services. a cross-sectional study conducted with 22 endoscopes (eight gastroscopes, eight colonoscopes and six duodenoscopes), and microbiological analysis of 60 samples of air/water channels (all endoscopes) and elevator (duodenoscopes), in addition to protein testing. Descriptive statistics with calculation of frequencies and central tendency measures was used in data analysis. the processing of 22 endoscopes was monitored with microbiological analysis for 60 channels. In the pre-cleaning procedure, in 82.3% (14/17) of the devices, gauze was used in cleaning the insertion tube. Incomplete immersion of the endoscope in detergent solution occurred in 72.3% (17/22) of the cases, and in 63.6% (14/22) there was no standardization of filling-in of the channels. Friction of the biopsy channel was not performed in 13.6% (3/22) of the devices. In the microbiological analysis, 25% (7/32) of the samples from the stored endoscopes were positive for microbial growth (from 2x101 to 9.5x104 CFU/mL), while after processing, contamination was 32% (9/28). Protein residues in the elevator channel were detected in 33% of duodenoscopes. the results indicate important gaps in the stages of pre-cleaning and cleaning of endoscopes that, associated with presence of protein residues and growth of microorganisms of epidemiological importance, indicate limitations in safety of the processing procedures, which can compromise the disinfection processes and, consequently, their safe use among patients subjected to such tests. analizar el proceso de limpieza de gastroscopios, colonoscopios y duodenoscopios en ocho servicios de salud intrahospitalarios. estudio transversal con 22 endoscopios, de los cuales ocho eran gastroscopios, ocho colonoscopios y seis duodenoscopios, y análisis microbiológico de 60 muestras de los canales de aire/agua (todos los endoscopios) y elevador (duodenoscopios), además de prueba de proteínas. En el análisis de los datos se utilizó estadística descriptiva, con cálculo de frecuencias y medidas de tendencia central. el procesamiento de los 22 endoscopios fue monitoreado con el análisis microbiológico de 60 canales. En la prelimpieza, en el 82,3% (14/17) de los equipos se utilizó gasa para limpiar el tubo de inserción. En el 72,3% (17/22) de los casos la inmersión del endoscopio en solución detergente fue incompleta y en el 63,6% (14/22) no hubo estandarización del llenado de los canales. La fricción del canal de biopsia no se realizó en el 13,6% (3/22) de los equipos. En el análisis microbiológico, el 25% (7/32) de las muestras endoscópicas almacenadas dio positivo para crecimiento microbiano (2x10 los resultados indican que hay importantes lagunas en las etapas de prelimpieza y limpieza de los endoscopios que, junto con la presencia de residuos de proteínas y del crecimiento de microorganismos de importancia epidemiológica, indican limitaciones en la seguridad del procesamiento, que pueden comprometer los procesos de desinfección y, por ende, el uso seguro en los pacientes que se someten a esos procedimientos.

No abstract

Assess the accumulation of protein and biofilm on the inner surfaces of new flexible gastroscope (FG) channels after 30 and 60 days of patient use and full reprocessing. Clinical use study of biofilm accumulation in FG channels. Endoscopy service of a public hospital. First, we tested an FG in clinical use before the implementation of a revised reprocessing protocol (phase 1 baseline; n = 1). After replacement of the channels by new ones and the implementation of the protocol, 3 FGs were tested after 30 days of clinical use (phase 2; n = 3) and 3 FGs were tested after 60 days of clinical use (phase 3; n = 3), and the same FGs were tested in phase 2 and 3. Their biopsy, air, water, and air/water junction channels were removed and subjected to protein testing (n = 21), bacteriological culture (n = 21), and scanning electron microscopy (SEM) (n = 28). Air-water junction channels fragments were subjected to SEM only. For the FGs, the average number of uses and reprocessing cycles was 60 times. Extensive biofilm was detected in air, water, and air-water junction channels (n = 18 of 28). All channels (28 of 28) showed residual matter, and structural damage was identified in most of them (20 of 28). Residual protein was detected in the air and water channels of all FG evaluated (phases 1-3), except for 1 air channel from phase 2. Bacteria were recovered from 8 of 21 channels, most air or water channels. The short time before damage and biofilm accumulation in the channels was evident and suggests that improving the endoscope design is necessary. Better reprocessing methods and channel maintenance are needed.

Flexible endoscopes are complex medical instruments that are easily damaged. To maintain the flexible endoscope in optimum working condition, the user must have a thorough understanding of the structure and function of the instrument. This is the second in a series of articles presenting an in-depth look at the care and handling of the flexible endoscope. The first article discussed the air and water system. This article will focus specifically on the suction and biopsy channel system. The flexible endoscope is constructed of several systems that operate simultaneously to produce a highly technical, yet effective diagnostic and therapeutic medical device. These systems include the air and water system, the suction or operating channel system, the mechanical system, the endoscopic retrograde cholangiopancreatography (ERCP) elevator system, the optical system, and the electrical system. A review of the internal and external structure of the flexible endoscope and the functions of the channel system, including infection control issues, potential problems and evaluation, and prevention of minor problems to avoid expensive repairs, will be addressed.

It has been suggested that single-use biopsy forceps prevent interpatient transmission of infection during endoscopy. Passage of sterile forceps through the accessory channel of the endoscope may lead to contamination, however, if the endoscope has been inadequately processed. The potential for contamination of single-use biopsy forceps at various stages of endoscope reprocessing was prospectively evaluated. A total of 50 disposable biopsy forceps were passed through the accessory channels of 10 colonoscopes at the following stages of reprocessing: (1) before use in patients to establish a baseline of high-level disinfection, (2) directly after colonoscopy to confirm contamination with use, (3) after manual cleaning and flushing of the accessory channel to support the claim that manual cleaning significantly decreases bioburden, (4) after manual cleaning and a 2-minute soak in 2% glutaraldehyde to assess for contamination after an inadequate cleaning time, and (5) after manual cleaning and a 20-minute soak in 2% glutaraldehyde. The forceps were then sealed in sterile plastic bags after adding 20 mL of thioglycollate broth medium. The suspension was passed through a 0.2-micron vacuum filter and the filters were cultured. All cultures were incubated more than 48 hours. Biopsy forceps underwent a total of 50 aerobic and 50 anaerobic cultures. Colony-forming units too numerous to count of GI flora, including Escherichia coli, Klebsiella, Pseudomonas, and Clostridium species, grew on 19 of 20 culture plates from biopsy forceps passed through colonoscopes immediately after use. One plate in this group grew 3 colony-forming units of E coli. Persistence of GI flora was noted on 5 of 20 plates after manual cleaning of the colonoscopes. No GI flora were found on forceps after the colonoscopes after soaking in gluteraldehyde for 2 and 20 minutes. Environmental contaminants including diptheroids, Staphylococcus, and Streptococcus species grew on 16 culture plates. (1) Single-use biopsy forceps are highly susceptible to contamination during passage through the accessory channels of improperly cleaned endoscopes. (2) Disinfection of the colonoscopes in this study prevented contamination of the forceps at baseline and after reprocessing. (3) Proper endoscope reprocessing may be the most important factor in preventing biopsy forceps-related interpatient infection.

The purpose of this study was to evaluate the disinfection efficacy of peracetic acid disinfectant (Type III) on gastrointestinal endoscopy. Endoscopes were disinfected, respectively, by 2% glutaraldehyde and peracetic acid disinfectant (Type III) according to the procedures stipulated by the 2016 version of "Regulation for cleaning and disinfection technique of flexible endoscope," then samples were collected through biopsy channel at the specified steps. The bacterial count and pathogenic bacteria of these samples were detected, and hepatitis B virus surface antigen, hepatitis C virus antibody, and Treponemiapallidum antibody were detected by chemiluminescent microparticle immunoassay in peracetic acid disinfectant (Type III) group. The samples from the peracetic acid disinfectant (Type III) group were collected for 5 days continuously. In total, 56 gastroscopes and 16 colonoscopes were disinfected by 2% glutaraldehyde (GA Group), 46 gastroscopes, and 15 colonoscopes were disinfected by peracetic acid disinfectant (Type III) (PAA Group). After disinfection, the bacterial count was significantly reduced in the 2 groups (P<0.05). In terms of the qualified rate of gastroscopes and total qualified rate, the PAA Group was better than GA Group [the qualified rate of gastroscopes: 97.83% (45/46) vs. 92.86% (52/56), P>0.05; total qualified rate: 98.36% (60/61) vs. 94.44% (68/72), P>0.05], the qualified rate of colonoscopes in the 2 groups were both 100.00% (15/15, 16/16). After disinfecting by peracetic acid disinfectant (Type III), hepatitis B virus surface antigen, anti-hepatitis C virus, and Treponemiapallidum antibody were negative. In term of colonies number detected for 5 days continuously, there was no significant difference at different collection steps (P>0.05). Peracetic acid disinfectant (Type III) can be well applied to clinical with meeting the standard of high-level disinfection for gastrointestinal endoscopy, and after disinfecting by peracetic acid disinfectant (Type III), there was no obvious bacterial residue in the biopsy channel.

To evaluate variables that affect risk of contamination for endoscopic retrograde cholangiopancreatography and endoscopic ultrasound endoscopes. Observational, quality improvement study. University medical center with a gastrointestinal endoscopy service performing ∼1,000 endoscopic retrograde cholangiopancreatography and ∼1,000 endoscopic ultrasound endoscope procedures annually. Duodenoscope and linear echoendoscope sampling (from the elevator mechanism and instrument channel) was performed from June 2020 through September 2021. Operational changes during this period included standard reprocessing with high-level disinfection with ethylene oxide gas sterilization (HLD-ETO) was switched to double high-level disinfection (dHLD) (June 16, 2020-July 15, 2020), and duodenoscopes changed to disposable tip model (March 2021). The frequency of contamination for the co-primary outcomes were characterized by calculated risk ratios. The overall pathogenic contamination rate was 4.72% (6 of 127). Compared to duodenoscopes, linear echoendoscopes had a contamination risk ratio of 3.64 (95% confidence interval [CI], 0.69-19.1). Reprocessing using HLD-ETO was associated with a contamination risk ratio of 0.29 (95% CI, 0.06-1.54). Linear echoendoscopes undergoing dHLD had the highest risk of contamination (2 of 18, 11.1%), and duodenoscopes undergoing HLD-ETO and the lowest risk of contamination (0 of 53, 0%). Duodenoscopes with a disposable tip had a 0% contamination rate (0 of 27). We did not detect a significant reduction in endoscope contamination using HLD-ETO versus dHLD reprocessing. Linear echoendoscopes have a risk of contamination similar to that of duodenoscopes. Disposable tips may reduce the risk of duodenoscope contamination.

Channel-cleaning brushes are an important tool in the reprocessing of endoscopes. To investigate the efficacy of cleaning brushes composed of various materials in removing organic matter from the biopsy channels of flexible endoscopes. In total, 168 cleaned gastroscopes were divided at random into six groups (A, B, C1, C2, C3 and D) based on the specific characteristics of four different types of cleaning brush. A suspension containing 12% bovine serum and 10 Cleaning brushes with a metal shaft demonstrated superior performance in removing organic matter from flexible endoscopes compared with cleaning brushes with a plastic shaft (P<0.05). Similarly, brushes with bristles made of cylindrical DuPont fibres exhibited superior cleaning efficacy compared with those made of strip microfibres or caterpillar polyolefins (P<0.05). Better results were achieved when the cleaning brush was passed through the biopsy channel four times compared with once or twice (100%). From the perspective of cleaning outcomes and economic benefits, the use of a cleaning brush with a metal shaft and cylindrical DuPont fibre bristles during the reprocessing of flexible endoscopes, combined with a cleaning technique involving four brush passes through the biopsy channels, can remove organic matter more effectively compared with the use of a cleaning brush made of microfibres, polyolefins and plastics.

Contaminated duodenoscopes caused several hospital outbreaks. Despite efforts to reduce contamination rates, 15% of patient-ready duodenoscopes are still contaminated with gastrointestinal microorganisms. This study aimed to provide an overview of duodenoscope contamination over time, identify risk factors and study the effects of implemented interventions. Duodenoscope culture sets between March 2015 and June 2022 at a Dutch tertiary care centre were analysed. Contamination was defined as (1) the presence of microorganisms of oral or gastrointestinal origin (MGO) or (2) any other microorganism with ≥20 colony-forming units/20 mL (AM20). A logistic mixed effects model was used to identify risk factors and assess the effect of interventions, such as using duodenoscopes with disposable caps, replacing automated endoscope reprocessors (AER) and conducting audits in the endoscopy department. A total of 404 culture sets were analysed. The yearly contamination rate with MGO showed great variation, ranging from 14.3% to 47.5%. Contamination with AM20 increased up to 94.7% by 2022. For both MGO and AM20, the biopsy and suction channels were the most frequently contaminated duodenoscope components. The studied interventions, including audits, AER replacement and implementation of duodenoscopes with disposable caps, did not show a clear association with contamination rates. Duodenoscope contamination remains a significant problem, with high contamination rates despite several interventions. Reprocessing the biopsy and suction channels is especially challenging. Changes in the design of reusable duodenoscopes, such as enabling sterilisation or easily replaceable channels, are necessary to facilitate effective duodenoscope reprocessing and to eliminate the risk of duodenoscope-associated infections.

Forced-air drying (FAD) cabinets are recommended for storage of reprocessed endoscopes, but financial constraints prevent their universal application. The study aimed to determine bacterial contamination in flexible gastroscopes (FG) channels after storage, in a cabinet with filtered air and UV lights, but without FAD. Eight FG in clinical use in an endoscopy service of a large Brazilian hospital were sampled: immediately "Time zero" (N = 50), 12 h "Time 1" (N = 25), and 60 h "Time 2" (N = 25) after reprocessing. Following a flush-brush-flush of channels, 40-mL sterile water and 3 cm of the brush were collected. Each sample was divided, filtered onto two 0.22-μm membranes, and incubated in media without or with disinfectant neutralizer. Automated method was used for identification and antibiotic resistance test of isolated bacteria. Bacterial contamination in times "1" and "2" was 5.9 and 16.1 times greater than that of "Time zero," respectively. Number of positive cultures in media with and without neutralizer was similar at times "1" and "2," while media with neutralizer produced more positive cultures at "Time zero." Most bacteria isolated at "Time 2" were Gram-negative rods (52.3%) and showed resistance to one or more antibiotics (65%). Bacterial contamination was detected on reprocessed FG stored in non-FAD cabinets overnight (12 h) and increased with longer storage time (60 h). The contamination source is likely to be bacteria in biofilm which multiply in the absence of FAD. Evidence-based criteria should be available for storage time according to the cabinet available.

Compare the effects of three sampling methods on the microbiological monitoring results after reprocessing of gastrointestinal endoscopes, providing scientific basis for improving the monitoring quality of gastrointestinal endoscope cleaning and disinfection. Gastrointestinal endoscopes after reprocessing were selected randomly at the gastrointestinal endoscopy center of a tertiary hospital in Shanghai from October 2018 to February 2019. The endoscopes selected were all sampled in three different methods under continuous sampling and intermittent sampling respectively. Methods used includes, the biopsy channel group (Group A), the entire channel group (Group B), and the disc brush group (Group C). Then the colony forming units (CFU/piece) were counted in the laboratory. A total of 12 endoscopes were sampled by using continuous sampling approach, in which the detection rate of bacteria in disc brush group (33.3%) and entire channel group (33.3%) was higher than biopsy channel group (8.3%). Among the 12 endoscopes sampled with intermittent approach, the detection rate of bacteria from high to low was the disc brush group (50%), the entire channel group (41.7%), and the biopsy channel group (8.3%). Different sampling methods will lead to the difference of microbiological culture results after reprocessing of gastrointestinal endoscope, indicating that the improved sampling method is beneficial to objectively reflect the endoscope cleaning and disinfection effect, and improve the monitoring quality of endoscope disinfection.

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.

The instrument channels of gastrointestinal (GI) endoscopes may be heavily contaminated with bacteria even after high-level disinfection (HLD). The British Society of Gastroenterology guidelines emphasize the benefits of manually brushing endoscope channels and using automated endoscope reprocessors (AERs) for disinfecting endoscopes. In this study, we aimed to assess the effectiveness of decontamination using reprocessors after HLD by comparing the cultured samples obtained from biopsy channels (BCs) of GI endoscopes and the internal surfaces of AERs. We conducted a 5-year prospective study. Every month random consecutive sampling was carried out after a complete reprocessing cycle; 420 rinse and swabs samples were collected from BCs and internal surface of AERs, respectively. Of the 420 rinse samples collected from the BC of the GI endoscopes, 300 were obtained from the BCs of gastroscopes and 120 from BCs of colonoscopes. Samples were collected by flushing the BCs with sterile distilled water, and swabbing the residual water from the AERs after reprocessing. These samples were cultured to detect the presence of aerobic and anaerobic bacteria and mycobacteria. The number of culture-positive samples obtained from BCs (13.6%, 57/420) was significantly higher than that obtained from AERs (1.7%, 7/420). In addition, the number of culture-positive samples obtained from the BCs of gastroscopes (10.7%, 32/300) and colonoscopes (20.8%, 25/120) were significantly higher than that obtained from AER reprocess to gastroscopes (2.0%, 6/300) and AER reprocess to colonoscopes (0.8%, 1/120). Culturing rinse samples obtained from BCs provides a better indication of the effectiveness of the decontamination of GI endoscopes after HLD than culturing the swab samples obtained from the inner surfaces of AERs as the swab samples only indicate whether the AERs are free from microbial contamination or not.

Recent outbreaks of duodenoscope-transmitted infections underscore the importance of adequate endoscope reprocessing. Adenosine triphosphate (ATP) bioluminescence testing allows rapid evaluation of endoscopes for bacteriologic/biologic residue. In this prospective study we evaluate the utility of ATP in bacteriologic surveillance and the effects of endoscopy staff education and dual cycles of cleaning and high-level disinfection (HLD) on endoscope reprocessing. ATP bioluminescence was measured after precleaning, manual cleaning, and HLD on rinsates from suction-biopsy channels of all endoscopes and elevator channels of duodenoscopes/linear echoendoscopes after use. ATP bioluminescence was remeasured in duodenoscopes (1) after re-education and competency testing of endoscopy staff and subsequently (2) after 2 cycles of precleaning and manual cleaning and single cycle of HLD or (3) after 2 cycles of precleaning, manual cleaning, and HLD. The ideal ATP bioluminescence benchmark of <200 relative light units (RLUs) after manual cleaning was achieved from suction-biopsy channel rinsates of all endoscopes, but 9 of 10 duodenoscope elevator channel rinsates failed to meet this benchmark. Re-education reduced RLUs in duodenoscope elevator channel rinsates after precleaning (23,218.0 vs 1340.5 RLUs, P < .01) and HLD (177.0 vs 12.0 RLUs, P < .01). After 2 cycles of manual cleaning/HLD, duodenoscope elevator channel RLUs achieved levels similar to sterile water, with corresponding negative cultures. ATP testing offers a rapid, inexpensive alternative for detection of endoscope microbial residue. Re-education of endoscopy staff and 2 cycles of cleaning and HLD decreased elevator channel RLUs to levels similar to sterile water and may therefore minimize the risk of transmission of infections by duodenoscopes.

There have been reported outbreaks of carbapenem-resistant Enterobacteriaceae infections linked to endoscopes with elevator mechanisms. Adenosine triphosphate (ATP) testing has been used as a marker for bioburden and monitoring manual cleaning for flexible endoscopes with and without an elevator mechanism. The objective of this study was to determine whether routine ATP testing could identify areas of improvement in cleaning of endoscopes with an elevator mechanism. ATP testing after manual cleaning of TJF-Q180V duodenoscopes and GF-UCT180 linear echoendoscopes (Olympus America Inc, Center Valley, PA) was implemented. Samples were tested from the distal end, the elevator mechanism, and water flushed through the lumen of the biopsy channel. Data were recorded and compared by time point, test point, and reprocessing technician. Overall failure rate was 6.99% (295 out of 4,219). The highest percentage of failed ATP tests (17.05%) was reported in the first quarter of routine testing, with an overall decrease in rates over time. The elevator mechanism and working channel lumen had higher failure rates than the distal end. Quality of manual cleaning between reprocessing technicians showed variation. ATP testing is effective in identifying residual organic material and improving quality of manual cleaning of endoscopes with an elevator mechanism. Cleaning efficacy is influenced by reprocessing technicians and location tested on the endoscope. Close attention to the working channel and elevator mechanism during manual cleaning is warranted.

Since the late 1970s there have been sporadic reports of nosocomial infections linked to endoscopic procedures. Infections by multidrug-resistant organisms (MDRO) have an increasing impact on healthcare systems worldwide. Since 2010 outbreaks involving MDRO have been reported as a result of endoscopic retrograde cholangiopancreatography (ERCP) from the USA, France, Germany and the Netherlands. This article evaluates the recent outbreaks and developments and demonstrates a structural approach to how to prevent future infections. Current national and international guidelines were used as a basis for discussions. In some cases insufficient cleaning or drying supported the outbreak. In the majority of cases, outbreaks occurred despite the apparently appropriate reprocessing protocols being in use. Microlesions were identified on a number of endoscopes, which supported the growth of bacteria and represented a vehicle for the transmission of infectious material. National official bodies responded with warnings. Manufacturers informed their customers accordingly. Separate, purpose-designed reprocessing rooms and a sufficient number of competent staff provide the structural quality for a safe reprocessing. The process quality includes a thorough cleaning of all endoscope channels and crucial instrument components, followed by an automated and validated reprocessing procedure. Strict adherence to manufacturers' recommendations is essential. The outcome quality should be evaluated by regular audits, validation of reprocessing procedures and microbiological surveillance. If outbreaks occur, a close co-operation with official bodies and manufacturers is essential. Health care professionals and manufacturers should be aware of their responsibility to ensure patient safety. A structural approach is key in prevention of endoscopy-associated infections.

Considering the physiological contamination of skin and mucous membranes in the ear, nose, and throat region by facultative pathogen microorganisms, as well as the increase in multidrug resistant organisms (MDRO), it is mandatory that hygienic procedures be observed in ENT institutions, in order to prevent transmission of bacteria and infections in patients. General guidelines for hygiene in otorhinolaryngology are presented based on the recommendations published by the German Commission on Hospital Hygiene and Infection Prevention (KRINKO). These encompass hand hygiene, surface disinfection, and reprocessing of medical devices. The correct reprocessing of the various components of ENT treatment units (including endoscopes, water bearing systems) is reported. Although law requires and KRINKO recommends that manufacturers of medical devices publish instructions for reprocessing their products, these reprocessing recommendations are often insufficient. Manufacturers should thus be called upon to improve their recommendations. In this paper, the requirements for handling of ENT treatment units are compared with the observations made by the Public Health Department in 7 ENT clinics and 32 ENT practices in Frankfurt/Main, Germany, in 2014.

No abstract

Recovery of multidrug-resistant (MDR) Pseudomonas aeruginosa and Klebsiella pneumoniae from a cluster of patients in the medical intensive care unit (MICU) prompted an epidemiologic investigation for a common exposure. Clinical and microbiologic data from MICU patients were retrospectively reviewed, MICU bronchoscopes underwent culturing and borescopy, and bronchoscope reprocessing procedures were reviewed. Bronchoscope and clinical MDR isolates epidemiologically linked to the cluster underwent molecular typing using pulsed-field gel electrophoresis (PFGE) followed by whole-genome sequencing. Of the 33 case patients, 23 (70%) were exposed to a common bronchoscope (B1). Both MDR P. aeruginosa and K. pneumonia were recovered from the bronchoscope's lumen, and borescopy revealed a luminal defect. Molecular testing demonstrated genetic relatedness among case patient and B1 isolates, providing strong evidence for horizontal bacterial transmission. MDR organism (MDRO) recovery in 19 patients was ultimately linked to B1 exposure, and 10 of 19 patients were classified as belonging to an MDRO pseudo-outbreak. Surveillance of bronchoscope-derived clinical culture data was important for early detection of this outbreak, and whole-genome sequencing was important for the confirmation of findings. Visualization of bronchoscope lumens to confirm integrity should be a critical component of device reprocessing.

Clinicians increasingly utilize polymyxins for treatment of serious infections caused by multidrug-resistant gram-negative bacteria. Emergence of plasmid-mediated, mobile colistin resistance genes creates potential for rapid spread of polymyxin resistance. We investigated the possible transmission of Klebsiella pneumoniae carrying mcr-1 via duodenoscope and report the first documented healthcare transmission of mcr-1-harboring bacteria in the United States. A field investigation, including screening targeted high-risk groups, evaluation of the duodenoscope, and genome sequencing of isolated organisms, was conducted. The study site included a tertiary care academic health center in Boston, Massachusetts, and extended to community locations in New England. Two patients had highly related mcr-1-positive K. pneumoniae isolated from clinical cultures; a duodenoscope was the only identified epidemiological link. Screening tests for mcr-1 in 20 healthcare contacts and 2 household contacts were negative. Klebsiella pneumoniae and Escherichia coli were recovered from the duodenoscope; neither carried mcr-1. Evaluation of the duodenoscope identified intrusion of biomaterial under the sealed distal cap; devices were recalled to repair this defect. We identified transmission of mcr-1 in a United States acute care hospital that likely occurred via duodenoscope despite no identifiable breaches in reprocessing or infection control practices. Duodenoscope design flaws leading to transmission of multidrug-resistant organsisms persist despite recent initiatives to improve device safety. Reliable detection of colistin resistance is currently challenging for clinical laboratories, particularly given the absence of a US Food and Drug Administration-cleared test; improved clinical laboratory capacity for colistin susceptibility testing is needed to prevent the spread of mcr-carrying bacteria in healthcare settings.

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.

Cleaning and high-level disinfection have been the standard in the USA and other countries for reprocessing flexible endoscopes, including duodenoscopes and other types of gastrointestinal endoscopes. For decades, this practice has been a cornerstone for infection prevention in the endoscopic setting. However, amid recent reports associating the use of duodenoscopes with infections and outbreaks of carbapenem-resistant To review and evaluate the adequacy of current reprocessing practices for preventing duodenoscopes from transmitting CRE and related MDROs. The MEDLINE/PubMed database was searched to identify published cases associating confirmed (or suspected) infections of CRE or a related MDRO with exposure to a duodenoscope since 2012, when duodenoscopes became a recognised risk factor for the transmission of CRE. The Internet was also searched to identify news articles and other reports documenting eligible cases occurring during this same timeframe but not identified during the MEDLINE database's search. The Food and Drug Administration's (FDA) medical device database was queried to identify regulatory reports describing these same types of cases, also recorded since 2012. The clinical and reprocessing details of each eligible case were reviewed to identify (when possible): (a) the reprocessing method (e.g., high-level disinfection) performed at the time of the infections, (b) whether the facility's compliance with the manufacturer's reprocessing instructions was confirmed, and (c) the measure(s) or corrective action(s) the facility implemented to prevent additional multidrug-resistant infections. Seventeen cases in the USA and six in other countries (primarily Europe) associating infections (and colonizations) of CRE or a related MDRO with exposure to a duodenoscope were reviewed. Fourteen of these 23 outbreaks were caused by CRE, and six by a related MDRO. Two of these six latter cases identified This study's findings suggest current reprocessing practices may not always be sufficiently effective to prevent a duodenoscope from transmitting CRE and related MDROs, at least in some circumstances including an outbreak setting. Factors this review identifed that may contribute to the device remaining contaminated after reprocessing include the device's design; breaches of recommended reprocessing guidelines (eg, inadequate manual cleaning, delayed reprocessing or improper device storage); damage to the device; lacking servicing, maintenance or repair; and/or the presence of biofilms. Measures that can mitigate the impact of these and other reprocessing challenges and reduce, if not eliminate, the risk of transmission of CRE or a related MDRO by a duodenoscope include the use of EO gas sterilization (or another comparably effective process or method). In 2015, the FDA suggested healthcare facilities consider performing at least one of four supplemental measures, which include EO gas sterilisation, to improve the effectiveness of duodenoscope reprocessing. Whether the FDA and Centers for Disease Control and Prevention might reclassify duodenoscopes as

The aim of this position statement is to reinforce the key points of hygiene in digestive endoscopy. The present article details the minimum hygiene requirements for reprocessing of endoscopes and endoscopic devices, regardless of the reprocessing method (automated washer-disinfector or manual cleaning) and the endoscopy setting (endoscopy suite, operating room, elective or emergency procedures). These minimum requirements are mandatory for patient safety. Both advanced diagnostic and therapeutic endoscopies should be carried out in an environment that is safe for patients and staff. Particular attention is given to contaminants. Procedural errors in decontamination, defective equipment, and failure to follow disinfection guidelines are major factors contributing to transmission of infection during endoscopy. Other important risk factors include inadequate cleaning, use of older endoscopes with surface and working channel irregularities, and contamination of water bottles or irrigating solutions. Infections by multidrug-resistant organisms have become an increasing problem in health-care systems worldwide. Since 2010, outbreaks of multidrug-resistant bacteria associated with endoscopic retrograde cholangiopancreatography have been reported from the USA, France, Germany, and The Netherlands. In many endoscopy units in Asia and the Middle East, reprocessing procedures have lagged behind those of Western countries for cultural reasons or lack of financial resources. This inconsistency in standards is now being addressed, and the World Endoscopy Organization has prepared this position statement to highlight key points for quality assurance in any endoscopy unit in any country.

Duodenoscopes have been implicated in the transmission of multidrug-resistant organisms (MDRO). We compared the frequency of duodenoscope contamination with MDRO or any other bacteria after disinfection or sterilization by 3 different methods. We performed a single-center prospective randomized study in which duodenoscopes were randomly reprocessed by standard high-level disinfection (sHLD), double high-level disinfection (dHLD), or standard high-level disinfection followed by ethylene oxide gas sterilization (HLD/ETO). Samples were collected from the elevator mechanism and working channel of each duodenoscope and cultured before use. The primary outcome was the proportion of duodenoscopes with an elevator mechanism or working channel culture showing 1 or more MDRO; secondary outcomes included the frequency of duodenoscope contamination with more than 0 and 10 or more colony-forming units (CFU) of aerobic bacterial growth on either sampling location. After 3 months of enrollment, the study was closed because of the futility; we did not observe sufficient events to evaluate the primary outcome. Among 541 duodenoscope culture events, 516 were included in the final analysis. No duodenoscope culture in any group was positive for MDRO. Bacterial growth of more than 0 CFU was noted in 16.1% duodenoscopes in the sHLD group, 16.0% in the dHLD group, and 22.5% in the HLD/ETO group (P = .21). Bacterial growth or 10 or more CFU was noted in 2.3% of duodenoscopes in the sHLD group, 4.1% in the dHLD group, and 4.2% in the HLD/ETO group (P = .36). MRDOs were cultured from 3.2% of pre-procedure rectal swabs and 2.5% of duodenal aspirates. In a comparison of duodenoscopes reprocessed by sHLD, dHLD, or HLD/ETO, we found no significant differences between groups for MDRO or bacteria contamination. Enhanced disinfection methods (dHLD or HLD/ETO) did not provide additional protection against contamination. However, insufficient events occurred to assess our primary study end-point. ClinicalTrials.gov no: NCT02611648.

Duodenoscopes have been implicated in the transmission of multidrug-resistant organisms (MDROs). Echoendoscopes could potentially transmit infection. The aim of this study was to assess the effectiveness of standard high-level disinfection (HLD) for radial and linear echoendoscopes and to compare it with that of duodenoscopes. We performed a prospective single-center study sampling echoendoscopes immediately before use, from the working channel (radial and linear echoendoscopes) and the transducer (radial echoendoscope) or elevator mechanism and transducer (linear echoendoscope). The primary outcome was the proportion of echoendoscopes with any culture showing ≥1 MDRO; secondary outcomes included bacterial growth >0 colony forming units (CFUs) and ≥10 CFUs on either sampling location. We compared these findings with duodenoscope cultures from the previously published DISINFECTS trial. During the study period, 101 echoendoscopes were sampled (n = 50 radial echoendoscopes, n = 51 linear echoendoscopes). No MDROs were recovered. Bacterial growth >0 CFUs was noted in 6% and ≥10 CFUs in 3% of all echoendoscopes. There was no significant difference in growth between radial and linear echoendoscopes (P = .4 for >0 CFU growth; P = .6 for ≥10 CFUs growth). The proportion of transducer and/or elevator mechanism positive for bacterial growth was significantly higher in duodenoscopes as compared with echoendoscopes (P = .02). After standard HLD, no echoendoscope showed MDRO growth, 6% showed >0 CFUs, and 3% showed ≥10 CFUs bacterial growth. Bacterial growth was higher in duodenoscopes at the level of the transducer and/or elevator mechanism when compared with echoendoscopes.

Most cases of microbial transmission to patients via contaminated endoscopes have resulted from nonadherence to reprocessing guidelines. We evaluated the occurrence, features, and implications of reprocessing lapses to gauge the nature and breadth of the problem in the context of widely available and accepted practice guidelines. We examined peer-reviewed and non-peer-reviewed literature to identify lapses reported in North America during 2005 to 2012 resulting in patient exposure to potentially contaminated gastrointestinal endoscopes. Lapses occurred in various types of facilities and involved errors in all major steps of reprocessing. Each lapse continued for several months or years until the problem was discovered except for one that was described as a single incident. There were significant implications for patients, including notification and testing, microbial transmission, and increased morbidity and mortality. Only 1 reprocessing lapse was found in a peer-reviewed journal article, and other incidents were reported in governmental reports, legal documents, conference abstracts, and media reports. Reprocessing lapses are an ongoing and widespread problem despite the existence of guidelines. Lack of publication in peer-reviewed literature contributes to the perception that lapses are rare and inconsequential. Reporting requirements and epidemiologic investigations are needed to develop better evidence-based policies and practices.