Sans Standardization: Effective Endoscope Reprocessing.

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.

Bronchoscope-Related "Superbug" Infections.

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.

Use of ethylene-oxide gas sterilisation to terminate multidrug-resistant bacterial outbreaks linked to duodenoscopes.

BACKGROUND: 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 Enterobacteriaceae (CRE) and related multidrug-resistant organisms (MDROs), reasonable questions about the adequacy of current practices for reprocessing duodenoscopes have emerged. OBJECTIVES: To review and evaluate the adequacy of current reprocessing practices for preventing duodenoscopes from transmitting CRE and related MDROs. METHODS: 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. RESULTS: 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 Klebsiella pneumoniae carrying the mcr-1 gene as the pathogen. For 12 of these 23 cases, it was reported or implied that the duodenoscope was being high-level disinfected at the time of the infections, consistent with published guidelines. For the remaining 11 cases, the associated report(s) did not clearly identify how the duodenoscope was being reprocessed at the time of the infections (although it may be reasonably concluded that at least some, if not all, of these 11 cases involved high-level disinfection).Further, eight of the 23 cases reported the duodenoscope was being reprocessed in accordance with the manufacturer's instructions for use (and professional guidelines) at the time of the infections. Seven of the cases discussed the design of the duodenoscope (eg, the forceps elevator mechanism) in the context of reprocessing and the infections. Three of the cases identified one or more reprocessing lapses, including inadequate cleaning, delayed reprocessing and improper drying and/or storage of the duodenoscope. Most of these 23 cases were associated with exposure to a duodenoscope model featuring a sealed elevator-wire channel. Six of the cases reported adopting (or in one case supplementing high-level disinfection with) ethylene oxide (EO) gas sterilisation of the duodenoscope, with at least three reporting this measure terminated the outbreak. Other measures adopted to prevent additional infections included removing the implicated duodenoscope from use, re-training staff about proper cleaning, microbiological culturing of the duodenoscope and returning the duodenoscope to the manufacturer for evaluation, maintenance and/or repair. CONCLUSIONS: 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 critical devices requiring sterilisation is currently unresolved.

Risk of transmission of carbapenem-resistant Enterobacteriaceae and related "superbugs" during gastrointestinal endoscopy.

To evaluate the risk of transmission of carbapenem-resistant Enterobacteriaceae (CRE) and their related superbugs during gastrointestinal (GI) endoscopy. Reports of outbreaks linked to GI endoscopes contaminated with different types of infectious agents, including CRE and their related superbugs, were reviewed. Published during the past 30 years, both prior to and since CRE's emergence, these reports were obtained by searching the peer-reviewed medical literature (via the United States National Library of Medicine's "MEDLINE" database); the Food and Drug Administration's Manufacturer and User Facility Device Experience database, or "MAUDE"; and the Internet (via Google's search engine). This review focused on an outbreak of CRE in 2013 following the GI endoscopic procedure known as endoscopic retrograde cholangiopancreatography, or ERCP, performed at "Hospital X" located in the suburbs of Chicago (IL; United States). Part of the largest outbreak of CRE in United States history, the infection and colonization of 10 and 28 of this hospital's patients, respectively, received considerable media attention and was also investigated by the Centers for Disease Control and Prevention (CDC), which published a report about this outbreak in Morbidity and Mortality Weekly Report (MMWR), in 2014. This report, along with the results of an independent inspection of Hospital X's infection control practices following this CRE outbreak, were also reviewed. While this article focuses primarily on the prevention of transmissions of CRE and their related superbugs in the GI endoscopic setting, some of its discussion and recommendations may also apply to other healthcare settings, to other types of flexible endoscopes, and to other types of transmissible infectious agents. This review found that GI endoscopy is an important risk factor for the transmission of CRE and their related superbugs, having been recently associated with patient morbidity and mortality following ERCP. The CDC reported in MMWR that the type of GI endoscope, known as an ERCP endoscope, that Hospital X used to perform ERCP in 2013 on the 38 patients who became infected or colonized with CRE might be particularly challenging to clean and disinfect, because of the complexity of its physical design. If performed in strict accordance with the endoscope manufacturer's labeling, supplemented as needed with professional organizations' published guidelines, however, current practices for reprocessing GI endoscopes, which include high-level disinfection, are reportedly adequate for the prevention of transmission of CRE and their related superbugs. Several recommendations are provided to prevent CRE transmissions in the healthcare setting. CRE transmissions are not limited to contaminated GI endoscopes and also have been linked to other reusable flexible endoscopic instrumentation, including bronchoscopes and cystoscopes. In conclusion, contaminated GI endoscopes, particularly those used during ERCP, have been causally linked to outbreaks of CRE and their related superbugs, with associated patient morbidity and mortality. Thorough reprocessing of these complex reusable instruments is necessary to prevent disease transmission and ensure patient safety during GI endoscopy. Enhanced training and monitoring of reprocessing staffers to verify the proper cleaning and brushing of GI endoscopes, especially the area around, behind and near the forceps elevator located at the distal end of the ERCP endoscope, are recommended. If the ERCP endoscope features a narrow and exposed channel that houses a wire connecting the GI endoscope's control head to this forceps elevator, then this channel's complete reprocessing, including its flushing with a detergent using a procedure validated for effectiveness, is also emphasized.

Evaluation of the risk of transmission of bacterial biofilms and Clostridium difficile during gastrointestinal endoscopy.

Recent attention has focused on the potential for the transmission of bacterial biofilms, Clostridium difficile, and other types of pathogenic spore-forming bacteria during gastrointestinal (GI) endoscopy. This study investigates whether GI endoscopy is a risk factor for the transmission of bacterial biofilms and the endospores or vegetative cells of pathogenic spore-forming bacteria including C. difficile. The medical literature was reviewed to evaluate the risk of the transmission of these infectious agents during GI endoscopy. No cases of a GI endoscope transmitting the endospores or vegetative cells of C. difficile or another type of pathogenic spore-forming bacterium were identified during this review. Also, no studies were identified during this review that document a case of infection causally linked to a bacterial biofilm that formed on the internal surfaces of and was transmitted by a GI endoscope that was reprocessed in accordance with currently accepted and well-established reprocessing standards. Gastrointestinal endoscopy is not reported to be a risk factor for the transmission of bacterial biofilms, C. difficile, or the endospores (and vegetative cells) of any other type of pathogenic spore-forming bacterium (or any type of infectious agent). Strict adherence to currently accepted and well-established reprocessing standards is necessary to prevent transmission of biofilms, C. difficile, and other infectious agents during GI endoscopy.

Prevention of disease transmission during flexible laryngoscopy.

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.

Endoscopic shuffling, infection control, and the clinical practice of push enteroscopy.

Failure to identify and diagnose the site and cause of obscure bleeding or some other gastrointestinal disorder may be an indication for push enteroscopy. During this procedure, a long, narrow, flexible gastrointestinal endoscope, known as a push enteroscope, is advanced into the upper gastrointestinal tract to examine and evaluate the proximal section (first one third) of the small bowel. Because of limited funding and inadequate instrument availability, some gastrointestinal endoscopy units may perform this procedure using a colonoscope instead of a push enteroscope. Although not specifically designed for push enteroscopy, colonoscopes are less expensive than push enteroscopes and readily available for clinical use in virtually every gastrointestinal endoscopy unit. The use of a colonoscope or other lower gastrointestinal endoscope to perform push enteroscopy or another upper gastrointestinal procedure (or the use of an upper gastrointestinal endoscope to perform a lower gastrointestinal procedure) is defined in this article as endoscopic shuffling. Although it is arguably efficient and cost effective (and in some instances may improve clinical outcomes), endoscopic shuffling raises a number of economic, legal, medical, and ethical questions and concerns, several of which are discussed in this article, with a particular focus on infection control.

Recommendations to resolve inconsistent guidelines for the reprocessing of sheathed and unsheathed rigid laryngoscopes.

Neither a consensus statement nor a formal set of step-by-step guidelines for reprocessing rigid laryngoscopes have been published or endorsed by professional organizations. Several published guidelines, standards, and clinical reports were reviewed to evaluate the risk of nosocomial infection associated with the use of rigid laryngoscopes, to determine their minimum reprocessing requirements. This review found that the recommendations of some guidelines and standards for reprocessing rigid laryngoscopes are incomplete, inadequate, and inconsistent with one another, and that current practices for reprocessing rigid laryngoscopes are reported to be inadequate and lack standardization. It is recommended that a consensus statement be developed that standardizes the reprocessing of rigid laryngoscopes and requires cleaning followed by high-level disinfection (or sterilization) and drying of the rigid laryngoscope's blade and handle to prevent nosocomial infection, regardless of whether a protective barrier or sheath is used during the procedure.

Inconsistencies in endoscope-reprocessing and infection-control guidelines: the importance of endoscope drying.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. DISCUSSION AND CONCLUSION: 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.

Current issues in endoscope reprocessing and infection control during gastrointestinal endoscopy.

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.

Infection control and its application to the administration of intravenous medications during gastrointestinal endoscopy.

Several infection control practices and procedures crucial to the prevention of disease transmission in the health care setting are reviewed and discussed. Emphasis is placed on the importance of infection control to gastrointestinal endoscopy. Recommendations that minimize the risk of nosocomial infection during the preparation, handling, and administration of intravenous medications, particularly propofol, are provided. These recommendations include the labeling of predrawn syringes; use of sterile single-use syringes, needles, and administration sets for each patient; and, whenever feasible, administration of intravenous medications promptly after opening their prefilled syringes or after opening their ampoules or vials and filling the sterile syringes.

Dear Los Angeles Times: the risk of disease transmission during gastrointestinal endoscopy.

UNLABELLED: This is the second in a series of articles that review media reports investigating the risk of disease transmission associated with gastrointestinal flexible endoscopy. The first article in this series, " COMMENTARY: Do Scopes Spread Sickness?'' was published in this journal in 1999 (Gastroenterology Nursing, 22(4), 179-180).