Automated Endoscope Reprocessors Research Articles

Special problems associated with reprocessing instruments in outpatient care facilities.

In the United States, more patients obtain health care in specialty clinics, ambulatory surgery centers, and physicians’ offices than in hospitals. In 2008, there were 1.2 billion ambulatory care visits in the United States, including physicians’ offices, outpatient hospitals, and emergency departments. Nearly 61% of those visits were to primary care physicians’ offices.1 Although many outbreaks of infection associated with instrument processing in outpatient care facilities go unreported, reported outbreaks occur with frequency. In 2003, Srinivasan et al2 reported an outbreak of Pseudomonas aeruginosa associated with bronchoscopes in an outpatient setting, apparently caused by loose biopsy ports on the bronchoscopes. Thirty-nine patients were infected. Sixty-seven percent of these 39 patients were infected with P aeruginosa. In 2012, a commentary by Weber and Rutala3 that looked back at bronchoscopies from the 12-year period between 2000 and 2012 found 25 outbreaks and pseudo-outbreaks in the literature. The outbreaks described in their commentary resulted in 82 infections and 4 deaths. Notably, single use, disposable bronchoscopes are available. In 2013, Kovaleva et al4 reported on transmission of infections via endoscopy and found, of the 98 outbreaks assessed, 1,113 patients were contaminated and 249 patients were infected. Kovaleva et al4 noted that if deficiencies related to cleaning, disinfection, automated endoscope reprocessors (AERs), contaminatedwater, and drying were eliminated, approximately 85% of outbreaks would be eliminated as shown in Table 1. Neither the work byWeber and Rutala3 nor Kovaleva et al4 distinguish between outbreaks associated with inpatient and outpatient facilities. This paper looks at 2 problems associated with instrument processing practices at a large university teaching hospital’s outpatient facilities: 1.) physical space problems and 2.) training and education problems related specifically to high-level disinfection (HLD) practices and attempts to offer solutions or at least improvements to these two problems. PROBLEM 1: PHYSICAL SPACE

Another Call to Switch Reprocessors

The FDA has reinforced its call for health facilities to stop using automated endoscope reprocessors (AER) from Custom Ultrasonics, of Ivyland, Pennsylvania, and find other methods to clean and disinfect endoscopes.

Comparison of the efficacy of disinfectants in automated endoscope reprocessors for colonoscopes: tertiary amine compound (Sencron2®) versus ortho-phthalaldehyde (Cidex®OPA).

Background/AimsTo 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).MethodsA 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.ResultsA 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.ConclusionsTAC 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.

Evaluation of the Quality of Reprocessing of Gastrointestinal Endoscopes

To evaluate the quality of gastrointestinal endoscope reprocessing and discuss the advantages of microbiological surveillance testing of these endoscopes. Retrospective analysis of the results of endoscope sampling performed from October 1, 2006, through December 31, 2014, in a gastrointestinal endoscopy unit of a teaching hospital equipped with 89 endoscopes and 3 automated endoscope reprocessors, with an endoscopy quality assurance program in place. The compliance rate was defined as the proportion of the results classified at target or alert levels according to the French guidelines. A multivariate analysis (logistic regression) was used to identify the parameters influencing compliance. A total of 846 samples were taken. The overall compliance rate was 86% and differed significantly depending on the sampling context (scheduled or not scheduled), the type of endoscope, and the season. No other parameter was associated with compliance. A total of 118 samples carried indicator microorganisms such as Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Enterobacteriaceae, and Candida sp. The systematic use of an automated endoscope reprocessor does not provide totally satisfactory compliance. Microbiological surveillance is indispensable to monitor reprocessing, reinforce good practices (endoscopes, reprocessing units), and detect endoscopes requiring early technical maintenance.

High-level disinfection of gastrointestinal endoscope reprocessing.

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.

Survey of endoscope reprocessing in Korea.

Background/AimsThere is a growing emphasis on quality management in endoscope reprocessing. Previous surveys conducted in 2002 and 2004 were not practitioner-oriented. Therefore, this survey is significant for being the first to target actual participants in endoscope reprocessing in Korea.MethodsThis survey comprised 33 self-filled questions, and was personally delivered to nurses and nursing auxiliaries in the endoscopy departments of eight hospitals belonging to the society. The anonymous responses were collected after 1 week either by post or in person by committee members.ResultsThe survey included 100 participants. In the questionnaire addressing compliance rates with the reprocessing guideline, the majority (98.9%) had a high compliance rate compared to 27% of respondents in 2002 and 50% in 2004. The lowest rate of compliance with a reprocessing procedure was reported for transporting the contaminated endoscope in a sealed container. Automated endoscope reprocessors were available in all hospitals. Regarding reprocessing time, more than half of the subjects replied that reprocessing took more than 15 minutes (63.2%).ConclusionsThe quality management of endoscope reprocessing has improved as since the previous survey. A national survey expanded to include primary clinics is required to determine the true current status of endoscope reprocessing.

Contamination of a purified water system by Aspergillus fumigatus in a new endoscopy reprocessing unit

Use of purified water for the final rinse stage of disinfected endoscopes is an important element of quality control. We describe the detection and management of Aspergillus fumigatus contamination of a new reverse osmosis unit supplying 10 automated endoscope reprocessor basins. Prompt detection and reaction to this contaminant were possible because of the introduction of a comprehensive program for microbiological monitoring of rinse waters, which included total viable counts, endotoxin, conductivity, and Pseudomonas spp.

218 Dramatic Improvement in Endoscope Cleanliness Using a Commercial Bioburden Detection System and Implementation of a Modified Cleaning Algorithm

and 2 upper endoscopes on days 0, 7, 14 and 21 following standard protocol for mechanical cleaning and high level disinfection using an automated endoscope reprocessor. Endoscopes were stored hanging per institutional practice. A 1mL aliquot of each sample was inoculated onto trypticase soy agar with 5% sheep blood (blood agar), thiogycollate broth, a CDC anaerobic blood agar plate, and Sabouraud dextrose agar (for yeast and molds). All media were incubated at 2535C for 7 days. Organisms were identified using standard microbiological techniques; results were reported in colony forming units. Results: There were 33 positive cultures from 28 out of the 96 sites tested (29.2% overall contamination rate). 30/33 isolates were typical skin or environmental contaminants, thus clinically insignificant (Table 1). Three potential pathogens were cultured, including

High-level endoscope disinfection processes in emerging economies: financial impact of manual process versus automated endoscope reprocessing

The use of flexible endoscopes is growing rapidly around the world. Dominant approaches to high-level disinfection among resource-constrained countries include fully manual cleaning and disinfection and the use of automated endoscope reprocessors (AERs). Suboptimal reprocessing at any step can potentially lead to contamination, with consequences to patients and healthcare systems. To compare the potential results of guideline-recommended AERs to manual disinfection along three dimensions - productivity, need for endoscope repair, and infection transmission risk in India, China, and Russia. Financial modelling using data from peer-reviewed published literature and country-specific market research. In countries where revenue can be gained through productivity improvements, conversion to automated reprocessing has a positive direct impact on financial performance, paying back the capital investment within 14 months in China and seven months in Russia. In India, AER-generated savings and revenue offset nearly all of the additional operating costs needed to support automated reprocessing. Among endoscopy facilities in India and China, current survey-reported practices in endoscope reprocessing using manual soaking may place patients at risk of exposure to pathogens leading to infections. Conversion from manual soak to use of AERs, as recommended by the World Gastroenterology Organization, may generate cost and revenue offsets that could produce direct financial gains for some endoscopy units in Russia and China.

Utilizing the Productivity Analysis Module

Utilizing the Productivity Analysis Module

Recent Update of Gastrointestinal Endoscope Reprocessing

As infection-related issues have become one of the most important concerns in endoscopy centers, proper reprocessing of endoscopes has attracted great interest. Compliance with established guidelines for reprocessing is critical to prevent pathogen transmission. However, hospital compliance with guidelines has not been satisfactory. To increase compliance, efforts have focused on developing new and more innovative disinfectants and an automated endoscope reprocessor. Reprocessing must be performed by appropriately trained personnel and regular monitoring of reprocessing is essential for quality assurance to improve compliance.

Surveillance cultures of samples obtained from biopsy channels and automated endoscope reprocessors after high-level disinfection of gastrointestinal endoscopes

BackgroundThe 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.MethodsWe 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.ResultsThe 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).ConclusionsCulturing 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.

Endoscope valve reprocessing

The safe and effective processing of endoscopy equipment is a critical part of any procedure. While much has been written on this topic in general, a recent medical device alert, published by the Medicines and Healthcare products Regulatory Agency (MHRA) has drawn attention to the specific issue of endoscope valve reprocessing. In it they state that the use of inappropriate valve holders within automated endoscope reprocessors (AERs) may lead to contamination of devices, equipment and processing media by retained soil and corroded material from the endoscope accessory holder (MHRA, 2012). Endoscopy units have until the 9th November 2012 to update their practices and respond to the Central Alerting System.

Aldehyde-resistant mycobacteria bacteria associated with the use of endoscope reprocessing systems

Bacteria can develop resistance to antibiotics, but little is known about their ability to increase resistance to chemical disinfectants. This study randomly sampled 3 automated endoscope reprocessors in the United States using aldehydes for endoscope disinfection. Bacterial contamination was found after disinfection in all automated endoscope reprocessors, and some mycobacteria isolates demonstrated significant resistance to glutaraldehyde and ortho-phthaldehyde disinfectants. Bacteria can survive aldehyde-based disinfection and may pose a cross-contamination risk to patients.

Swab culture monitoring of automated endoscope reprocessors after high-level disinfection

To conduct a bacterial culture study for monitoring decontamination of automated endoscope reprocessors (AERs) after high-level disinfection (HLD). From February 2006 to January 2011, authors conducted randomized consecutive sampling each month for 7 AERs. Authors collected a total of 420 swab cultures, including 300 cultures from 5 gastroscope AERs, and 120 cultures from 2 colonoscope AERs. Swab cultures were obtained from the residual water from the AERs after a full reprocessing cycle. Samples were cultured to test for aerobic bacteria, anaerobic bacteria, and mycobacterium tuberculosis. The positive culture rate of the AERs was 2.0% (6/300) for gastroscope AERs and 0.8% (1/120) for colonoscope AERs. All the positive cultures, including 6 from gastroscope and 1 from colonoscope AERs, showed monofloral colonization. Of the gastroscope AER samples, 50% (3/6) were colonized by aerobic bacterial and 50% (3/6) by fungal contaminations. A full reprocessing cycle of an AER with HLD is adequate for disinfection of the machine. Swab culture is a useful method for monitoring AER decontamination after each reprocessing cycle. Fungal contamination of AERs after reprocessing should also be kept in mind.

Emergence of Glutaraldehyde-Resistant Pseudomonas aeruginosa

In November 2009, routine sampling of endoscopes performed to monitor the effectiveness of the endoscope-cleaning procedure at our hospital detected Pseudomonas aeruginosa. Herein we report the results of the subsequent investigation. The investigation included environmental cultures for source investigation, molecular analysis by pulsed-field gel electrophoresis (PFGE) to reveal the identity of the strains, and determination of the bactericidal activity of the glutaraldehyde-based disinfectant used for automated endoscope reprocessing. In addition, patient outcome was analyzed by medical chart review, and incidence rates of clinical samples with P. aeruginosa were compared. The University Hospital of Basel is an 855-bed tertiary care center in Basel, Switzerland. Approximately 1,700 flexible bronchoscopic, 2,500 gastroscopic, 1,400 colonoscopic, 140 endoscopic retrograde cholangiopancreatographic, and 140 endosonographic procedures are performed annually. P. aeruginosa was detected in samples obtained from endoscopes in November 2009 for the first time since the initiation of surveillance in 2006. It was found in the rinsing water and in the drain of 1 of the 2 automated endoscope reprocessors. PFGE revealed 2 distinct P. aeruginosa strains, one in each reprocessor. The glutaraldehyde-based disinfectant showed no activity against the 2 pseudo-outbreak strains when used in the recommended concentration under standard conditions. After medical chart review, 6 patients with lower respiratory tract and bloodstream infections were identified as having a possible epidemiological link to the pseudo-outbreak strain. This is the first description of a pseudo-outbreak caused by P. aeruginosa with reduced susceptibility to an aldehyde-based disinfectant routinely used in the automated processing of endoscopes.

Comparative cost-efficiency of the EVOTECH endoscope cleaner and reprocessor versus manual cleaning plus automated endoscope reprocessing in a real-world Canadian hospital endoscopy setting

BackgroundReprocessing of endoscopes generally requires labour-intensive manual cleaning followed by high-level disinfection in an automated endoscope reprocessor (AER). EVOTECH Endoscope Cleaner and Reprocessor (ECR) is approved for fully automated cleaning and disinfection whereas AERs require manual cleaning prior to the high-level disinfection procedure. The purpose of this economic evaluation was to determine the cost-efficiency of the ECR versus AER methods of endoscopy reprocessing in an actual practice setting.MethodsA time and motion study was conducted at a Canadian hospital to collect data on the personnel resources and consumable supplies costs associated with the use of EVOTECH ECR versus manual cleaning followed by AER with Medivators DSD-201. Reprocessing of all endoscopes was observed and timed for both reprocessor types over three days. Laboratory staff members were interviewed regarding the consumption and cost of all disposable supplies and equipment. Exact Wilcoxon rank sum test was used for assessing differences in total cycle reprocessing time.ResultsEndoscope reprocessing was significantly shorter with the ECR than with manual cleaning followed by AER. The differences in median time were 12.46 minutes per colonoscope (p < 0.0001), 6.31 minutes per gastroscope (p < 0.0001), and 5.66 minutes per bronchoscope (p = 0.0040). Almost 2 hours of direct labour time was saved daily with the ECR. The total per cycle cost of consumables and labour for maintenance was slightly higher for EVOTECH ECR versus manual cleaning followed by AER ($8.91 versus $8.31, respectively). Including the cost of direct labour time consumed in reprocessing scopes, the per cycle and annual costs of using the EVOTECH ECR was less than the cost of manual cleaning followed by AER disinfection ($11.50 versus $11.88).ConclusionsThe EVOTECH ECR was more efficient and less costly to use for the reprocessing of endoscopes than manual cleaning followed by AER disinfection. Although the cost of consumable supplies required to reprocess endoscopes with EVOTECH ECR was slightly higher, the value of the labour time saved with EVOTECH ECR more than offset the additional consumables cost. The increased efficiency with EVOTECH ECR could lead to even further cost-savings by shifting endoscopy laboratory personnel responsibilities but further study is required.

Current status of cleaning and disinfection for gastrointestinal endoscopy in China: A survey of 122 endoscopy units

Background Adequate compliance with the existing guidelines for cleaning and disinfection of gastrointestinal endoscopes and accessories is necessary to obtain high-level disinfection and prevent pathogen transmission. Aim To investigate cleaning and disinfection practice in China. Methods A questionnaire with 21 questions concerning gastrointestinal endoscopy reprocessing was sent by e-mail to 189 endoscopy units in China. Results One hundred and twenty-two (80.39%) of the 189 units responded. Compared with the low-workload units (<5000 procedures/year), the high-workload units (≥5000 procedures/year) had a significantly higher number of gastrointestinal endoscopes (25.8 ± 3.6 vs. 4.7 ± 1.8, p < 0.01) and the higher possessing rate of automated endoscope reprocessors (43.9% vs. 3.1%, p < 0.01). Glutaraldehyde was the most commonly employed disinfectant (88.5%) in all the units. In 23/122 (18.8%) units, the exposure time to glutaraldehyde was <45 min in the case of infectious disease patients. Eighty-six of 122 (70.5%) units reused disposable materials, of which 21/86 (24.4%) reused disposable forceps and disposable polypectomy hooks, and 2/86 (1.6%) reused disposable injection needles intermittently. Conclusion Although gastrointestinal endoscopy has developed rapidly in China in the past decade, there is still room for improvement in the practice of endoscopy reprocessing, especially in middle-sized and small cities.

Comparison on the Efficacy of Disinfectants Used in Automated Endoscope Reprocessors: PHMB-DBAC versus Orthophthalaldehyde

Background/AimsSince 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).MethodsA 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.ResultsThe 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.ConclusionsThe 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.

P08.13 Comparative efficacy of high level disinfectants: in-hospital evaluation with manual or automatic endoscope reprocessors

P08.13 Comparative efficacy of high level disinfectants: in-hospital evaluation with manual or automatic endoscope reprocessors