A Novel Flocked Swab Protocol Proves to Be an Effective Method for Culturing Elevator-Containing Endoscopes.

BACKGROUND: The challenging disinfection process for the elevator mechanism on duodenoscopes and linear echoendoscopes has been identified as a source of clinically significant bacterial transmission. Despite increased awareness, there continues to be a lack of definitive guidelines for bacterial culturing protocols for elevator-containing endoscopes. AIMS: To compare two different prospective bacterial surveillance protocols for duodenoscopes and linear echoendoscopes with regard to accuracy, efficiency, and cost. METHODS: Consecutive duodenoscopes and linear echoendoscopes used at a single tertiary care center were reprocessed following hospital and manufacturer guidelines, dried using an automatic endoscope-drying machine, and hung overnight in an upright position. Following reprocessing, culture samples were sequentially obtained from each endoscope using two methods, first, the brush protocol followed immediately by the swab protocol. RESULTS: A total of 532 primary cultures were collected from 17 duodenoscopes and eight linear echoendoscopes. Of these, 266 cultures gathered using the brush protocol were negative, while 266 cultures gathered using the swab protocol resulted in three positive cultures (1.1%). Positive cultures showed Enterobacter cloacae and Klebsiella pneumoniae from one duodenoscope and two linear echoendoscopes. Yearly, the brush protocol amounts to approximately 520 nursing hours, and the swab protocol takes an estimated 42 nursing hours. Annually, the swab protocol could save over $26,500 and 478 nursing hours. CONCLUSIONS: The proposed swab protocol was superior to the brush protocol when evaluating the presence of residual bacteria on elevator-containing endoscopes following reprocessing and saves cost and nursing hours.

A narrative review on current duodenoscope reprocessing techniques and novel developments.

Duodenoscopy-associated infections occur worldwide despite strict adherence to reprocessing standards. The exact scope of the problem remains unknown because a standardized sampling protocol and uniform sampling techniques are lacking. The currently available multi-society protocol for microbial culturing by the Centers for Disease Control and Prevention, the United States Food and Drug Administration (FDA) and the American Society for Microbiology, published in 2018 is too laborious for broad clinical implementation. A more practical sampling protocol would result in increased accessibility and widespread implementation. This will aid to reduce the prevalence of duodenoscope contamination. To reduce the risk of duodenoscopy-associated pathogen transmission the FDA advised four supplemental reprocessing measures. These measures include double high-level disinfection, microbiological culturing and quarantine, ethylene oxide gas sterilization and liquid chemical sterilization. When the supplemental measures were advised in 2015 data evaluating their efficacy were sparse. Over the past five years data regarding the supplemental measures have become available that place the efficacy of the supplemental measures into context. As expected the advised supplemental measures have resulted in increased costs and reprocessing time. Unfortunately, it has also become clear that the efficacy of the supplemental measures falls short and that duodenoscope contamination remains a problem. There is a lot of research into new reprocessing methods and technical applications trying to solve the problem of duodenoscope contamination. Several promising developments such as single-use duodenoscopes, electrolyzed acidic water, and vaporized hydrogen peroxide plasma are already applied in a clinical setting.

Methods for Endoscope Reprocessing.

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.

Novel Algorithms for Reprocessing, Drying and Storing Endoscopes.

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.

Recent Actions by the US Food and Drug Administration: Reducing the Risk of Infection from Reprocessed Duodenoscopes.

In addition to technological advancements, engagement and collaboration among the wider community of stakeholders will be beneficial toward reducing the risk of infection from reprocessed duodenoscopes. Such a community can raise awareness of the importance of duodenoscope cleaning, work to improve reprocessing training, identify the most pressing unanswered questions that merit further research, and develop tools that can be used by health care facilities to improve the quality of reprocessing at their sites. The Food and Drug Administration looks forward to working with the community to further reduce the risk of infections from reprocessed duodenoscopes.

Society Guidelines-Where Is the Consensus?

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.

Performance characteristics and optimal cut-off value of triple adenylate nucleotides test versus adenosine triphosphate test as point-of-care testing for predicting inadequacy of duodenoscope reprocessing.

BACKGROUND: Adenosine triphosphate (ATP) test based on one nucleotide has been applied as point-of-care testing (POCT) for bacterial contamination in the medical and food industries. Hypothetically, testing three adenylate nucleotides (A3) may provide better detection of duodenoscope bacterial contamination than ATP test. AIM: To evaluate performance characteristics and optimal cut-off value of A3 and ATP tests in predicting bacterial contamination of duodenoscopes. METHODS: Four hundred duodenoscope samples obtained after 100 endoscopic retrograde cholangiopancreatography procedures were randomized into group A (A3 test) or B (ATP test). Samples were collected from the elevator at the four-step cleaning process of duodenoscope. We defined the new cut-off value of the test for reaching 100% negative predictive value (NPV) from our receiver operating characteristic (ROC). FINDINGS: Using the cultures from the four-step cleaning process as the reference, the areas under ROC (AUROC) were 0.83 and 0.84 for group A (N = 200) and group B (N = 200), respectively. Using the cultures from post-high-level disinfection (HLD) as the reference, the AUROC were 0.35 and 0.74 for group A (N = 50) and group B (N = 50), respectively. We investigated ATP as a POCT after HLD with a new cut-off value of 40 RLU. However, this threshold did not allow detection of low numbers of bacteria. CONCLUSION: A3 and ATP tests provide good performances in predicting bacterial contamination of duodenoscopes for the four-step cleaning process. The ATP <40 RLU is helpful as a POCT after HLD; however, the limitation of this cut-off value is its inability to detect low numbers of bacteria.

Novel single-use duodenoscope compared with 3 models of reusable duodenoscopes for ERCP: a randomized bench-model comparison.

BACKGROUND AND AIMS: Multidrug-resistant infectious outbreaks associated with duodenoscope reuse have been documented internationally. A single-use endoscope could eliminate exogenous patient-to-patient infection associated with ERCP. METHODS: We conducted a comparative bench simulation study of a new single-use and 3 models of reusable duodenoscopes on a synthetic anatomic bench model. Four ERCP tasks were performed: guidewire locking (single-use and 1 reusable duodenoscope only), plastic stent placement and removal, metal stent placement and removal, and basket sweeping. The study schedule included block randomization by 4 duodenoscopes, 4 tasks, and 2 anatomic model ERCP stations. Ability to complete tasks, task completion times, and subjective ratings of overall performance, navigation/pushability, tip control, and image quality on a scale of 1 (worst) to 10 (best) were compared among duodenoscopes. RESULTS: All 4 ERCP tasks (total 14 subtasks) were completed by 6 expert endoscopists using all 4 duodenoscopes, with similar task completion times (median, 1.5-8.0 minutes per task) and overall performance ratings by task (median, 8.0-10.0). Navigation/pushability ratings were lower for the single-use duodenoscope than for the 3 reusable duodenoscopes (median, 8.0, 10.0, 9.0, and 9.0, respectively; P < .01). Tip control ratings were similar among all the duodenoscopes (median, 9.0-10.0; P = .77). Image quality ratings were lower for 1 reusable duodenoscope compared with the single-use and other 2 reusable duodenoscopes (median, 8.0, 9.0, 9.0, and 9.0, respectively; P < .01). CONCLUSIONS: A new single-use duodenoscope was used to simulate 4 ERCP tasks in an anatomic model, with performance ratings and completion times comparable with 3 models of reusable duodenoscopes.

Procedures in endoscope reprocessing and monitoring: an Italian survey.

BACKGROUND: The high diffusion of endoscopes worldwide and the need for effective reprocessing methods requested the development of guidelines and implementation of surveillance procedures at local level. STUDY DESIGN: In order to collect data on everyday's practice and adherence to available guidelines, endoscopy units from different public institutions were surveyed using a dedicated questionnaire. METHODS: Between July and November 2015 a survey was carried in 12 main hospitals from 10 different Italian regions, involving 22 endoscopy units. The state of the art of national and international guidelines was investigated to compare the protocols adopted at local level. RESULTS: In all the surveyed hospitals, the reprocessing activity is based on pre-established protocols in adherence with principal guidelines. Enzymatic detergents, which are recommended by the international guidelines, are used in 55.6% of units and peracetic acid is currently the most widely used chemical disinfectant. Discrepancies were observed in the application of periodic quality controls. CONCLUSION: Updated guidelines are generally applied in reprocessing practice. Quality controls may represent a critical issue to improve effectiveness and surveillance. The whole of acquired data can promote a positive trend towards the application of best practices.

Safely reprocessing duodenoscopes: current evidence and future directions.

Highly publicised outbreaks of various infections related to the use of duodenoscopes have increased public awareness of the once arcane and largely ignored subject of endoscope reprocessing. Since 2015, national professional societies, multiple federal agencies, and even the US Senate have written reports and guidelines on duodenoscope reprocessing. However, their recommendations are sometimes contradictory and difficult to implement, and new research on the topic is published regularly which further complicates the situation. With this flood of new and sometimes contradictory information, clinicians can feel confused about how to assure the safety of their patients undergoing duodenosocopy. This Review summarises the most salient current research on duodenoscope-associated outbreaks and reprocessing, and aims to provide clinicians with practical information applicable to their practice.

Optimizing duodenoscope reprocessing: rigorous assessment of a culture and quarantine protocol.

BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Prevention of multidrug-resistant infections from contaminated duodenoscopes: Position Statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates (ESGENA).

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).