key: cord-0963552-lnvc7mmf authors: Lichtenstein, David; Alfa, Michelle J. title: Cleaning and Disinfecting Gastrointestinal Endoscopy Equipment date: 2018-03-19 journal: Clinical Gastrointestinal Endoscopy DOI: 10.1016/b978-0-323-41509-5.00004-9 sha: 13ae8a94e3aa33ce8096d63929c352a56139c21c doc_id: 963552 cord_uid: lnvc7mmf Outbreaks of infection transmission due to contaminated flexible endoscopes have focused the attention of health care personnel, senior management, device manufacturers, and regulators on the need to improve the approach used to offer this valuable service. This chapter presents the principles of flexible endoscope reprocessing along with a pragmatic approach to the judicious selection and proper reprocessing of endoscopic equipment, as well as guidance for prevention and management of infection transmission inclusive of newer sterilization (e.g., hydrogen peroxide vapor) and disinfection (e.g., improved hydrogen peroxide) technologies. It also provides an outline of the Quality Systems approach that is applicable to flexible endoscope reprocessing and the need for ongoing staff competency and audits of endoscope cleaning, disinfection, and storage practices. Furthermore, the most current regulatory, expert organization, and manufacturer's recommendations are reviewed. The field of gastrointestinal (GI) endoscopy has expanded dramatically as new procedures, instruments, and accessories have been introduced into the medical community; more than 20 million GI endoscopies are performed annually in the United States. 1, 2 Although GI endoscopes are used as a diagnostic and therapeutic tool for a broad spectrum of GI disorders, more health care-associated infectious outbreaks and patient exposures have been linked to contaminated endoscopes than to any other reusable medical device. [3] [4] [5] [6] Failure to adhere to established reprocessing guidelines or the use of defective reprocessing equipment accounts for the majority of these cases. [7] [8] [9] [10] [11] [12] [13] In addition, complex endoscopes such as the duodenoscope and linear echoendoscope with elevator mechanisms can transmit bacterial infections even when reprocessing protocols are reportedly followed in accordance with manufacturer and societal guidelines. [14] [15] [16] The topic of endoscope reprocessing has largely been taken for granted by many endoscopists; however, standardized cleaning and disinfection protocols have been available for some time, and, with few exceptions, changes have been gradual. This slow evolution with a high safety profile may have engendered some complacency on the part of endoscopists, to the point that many endoscopists are only vaguely aware of what goes on "behind the curtain" of the endoscope reprocessing room. Instruments are used on patients, taken away by GI nurses or other health care personnel, reprocessed, and returned ready for patient use. As the complexity of reprocessing and recognition of its importance become a concern to the medical community and our patients, endoscopists must become more educated on these issues and thereby able to participate in informed discussions with their patients. This chapter presents a pragmatic approach to proper reprocessing of endoscopic equipment, with guidance for prevention and management of infection transmission, and includes newer sterilization and disinfection technologies. 2. Semicritical: semicritical devices contact intact mucous membranes and do not ordinarily penetrate sterile tissue. These instruments include endoscopes, bronchoscopes, transesophageal echocardiography probes, and anesthesia equipment. Reprocessing of these instruments requires a minimum of HLD. 3. Noncritical: noncritical devices contact intact skin (e.g., stethoscopes or blood pressure cuffs). These items should be cleaned by low-level disinfection. Endoscopes GI endoscopes are considered semicritical devices, and the resultant minimal standard for reprocessing is HLD. This standard is endorsed by governmental agencies including the Joint Commission (JC), the Centers for Disease Control and Prevention (CDC), 37 and the FDA. 38 It is also endorsed by gastroenterology societies such as the American Society for Gastrointestinal Endoscopy (ASGE), American College of Gastroenterology (ACG), and American Gastroenterological Association (AGA), as well as medical organizations, including the Association of Perioperative Registered Nurses (AORN), Society of Gastroenterology Nurses and Associates (SGNA), Association for Professionals in Infection Control and Epidemiology (APIC), and American Society for Testing and Materials (ASTM). [39] [40] [41] [42] HLD of endoscopes eliminates all viable microorganisms, but not necessarily all are alike, however. Steam is the most extensively utilized process and is routinely monitored by the use of biologic indicators (e.g., spore test strips) to show that sterilization has been achieved. When liquid chemical germicides (LCGs) are used to eradicate all microorganisms, they can be called chemical sterilants; however, the US Food and Drug Administration (FDA) and other authorities have stated that these processes do not convey the same level of assurance as other sterilization methods. [28] [29] [30] Other commonly used sterilization processes include low-temperature gas such as ethylene oxide (ETO), liquid chemicals, and hydrogen peroxide gas plasma. 31 Disinfection is defined broadly as the destruction of microorganisms, except bacterial spores, on inanimate objects (e.g., medical devices such as endoscopes). Three levels of disinfection are achievable depending on the amount and kind of microbial killing involved. These levels of disinfection are as follows: 1. High-level disinfection (HLD): the destruction of all viruses, vegetative bacteria, fungi, mycobacterium, and some, but not all, bacterial spores. 32, 33 For LCGs, HLD is operationally defined as the ability to kill 10 6 mycobacteria (a six-log reduction). The efficacy of HLD is dependent on several factors and includes the type and level of microbial contamination; effective precleaning of the endoscope; presence of biofilm; physical properties of the object; concentration, temperature, pH, and exposure time to the germicide; and drying after rinsing to avoid diluting the disinfectant. 32 2. Intermediate-level disinfection: the destruction of all mycobacteria, vegetative bacteria, fungal spores, and some nonlipid viruses, but not bacterial spores. 3. Low-level disinfection: a process that can kill most bacteria (except mycobacteria or bacterial spores), most viruses (except some nonlipid viruses), and some fungi. Although this categorization for disinfection levels generally remains valid, there are examples of disinfection issues with prions, viruses, mycobacteria, and protozoa that challenge these definitions. 34 Antiseptics are chemicals intended to reduce or destroy microorganisms on living tissue (e.g., skin), as opposed to disinfectants, which are used on inanimate objects (e.g., medical devices such as endoscopes). The difference in the way the same chemical is used to achieve different levels of disinfection and sterilization is important for endoscopy because the contact times for sterilization with any given LCG are generally much longer (hours) than for high-level disinfection (minutes) and may be detrimental to the endoscope. The relative resistance of various microorganisms to LCGs is shown in Box 4.1. More than 40 years ago, Earle H. Spaulding developed a rational approach to disinfection and sterilization of medical equipment based on the risk of infection involved with the use of these instruments. 35, 36 The classification scheme defined these categories of medical devices and their associated level of disinfection as follows: 1. Critical: critical devices or instruments come into contact with sterile tissue or the vascular system. These devices confer a high risk for infection if they are contaminated. This category includes biopsy forceps, sphincterotomes, surgical instruments, and implants, when used in sterile anatomic locations. Reprocessing of these instruments requires sterilization. disinfection at least once daily. The water bottle should be filled with sterile water. [49] [50] [51] [52] Because accessory items often do not have unique identification numbers, it is critical to ensure they are dedicated to and stored with the endoscope that they are used with. This is necessary to ensure that if there is an outbreak, it is possible to identify which accessory components were used. This may require the use of disposable accessory holders or holders such as mesh bags that are also reprocessed along with the accessories. Most accessory instruments used during endoscopy either contact the bloodstream (e.g., biopsy forceps, snares, and sphincterotomes) or enter sterile tissue spaces (e.g., biliary tract) and are classified as critical devices. As such, these devices require sterilization. 49, 50 These accessories may be available as disposable "single-use" or "reusable" instruments. Reuse of devices labeled single-use only remains controversial but has been commonly employed in many practices, primarily for economic benefits. 44, [53] [54] [55] [56] The FDA 57 considers reprocessing a used single-use device into a ready-for-patient-use device as "manufacturing," and as a result, hospitals or third-party reprocessing 58, 59 companies that reprocess these devices are required to follow the same regulations as the original equipment manufacturers (i.e., obtain 510[k] and premarket approval application; submit adverse event reports; demonstrate sterility and integrity of the reprocessed devices; and implement detailed quality assurance monitoring protocols). This includes the development of standards and policies to determine the maximum number of uses for the devices and the training of staff in the reprocessing procedures. [59] [60] [61] [62] The regulatory burden imposed by these requirements essentially eliminated the practice of the reprocessing of single-use devices by most hospitals. AERs were developed to replace some of the manual disinfection processes and standardize several important reprocessing steps, thereby eliminating the possibility of human error and minimizing exposure of reprocessing department personnel to chemical bacterial spores. 43 Although spores are more resistant to HLD than other bacteria and viruses, they are likely to be killed when endoscopes undergo thorough manual cleaning. In addition, survival of small numbers of bacterial spores with HLD is considered acceptable because the intact mucosa of the GI tract is resistant to bacterial spore infection. Endoscope sterilization, as opposed to HLD, is not required for "standard" GI endoscopy, as a reprocessing endpoint of sterilization has not been demonstrated to further reduce the risk of infectious pathogen transmission from endoscopes. 44 Sterilization of endoscopes is indicated when they are used as "critical" medical devices, such as intraoperative endoscopy when there is potential for contamination of an open surgical field. 45, 46 In addition, individual institutional policies may dictate sterilization of duodenoscopes and linear endoscopic ultrasound instruments due to elevator mechanisms that have been difficult to clean and eradicate all bacterial contaminants with HLD alone (see the later section on Duodenoscope-Related Infections). Despite the complex internal design (Fig. 4 .1) of endoscopes, HLD is not difficult to achieve with rigorous adherence to currently accepted reprocessing guidelines. 47 Endoscope features that challenge the reprocessing procedures include: • Complex endoscope design with several long, narrow internal channels and bends that make it difficult to remove all organic debris and microorganisms (e.g., elevator channel and elevator lever cavity of duodenoscopes). • A large variety of endoscope vendors and models require different cleaning procedures and devices and materials. • Occult damage (e.g., scratches, crevices) to the endoscope can sequester microorganisms and promote biofilm formation. All valves, caps, connectors, and flushing tubes need to be adequately cleaned, rinsed, and disinfected or sterilized at the same time the patient-used endoscope is being reprocessed. 48 The water bottle used to provide intraprocedural flush solution and its connecting tubing should be sterilized or receive high-level LCGs have inherent limitations; however, they are universally used to reprocess flexible endoscopes and accessories due to their relative convenience, safety, and rapid action. LCGs used as HLDs should ideally have the following properties: broad antimicrobial spectrum, rapid onset of action, activity in the presence of organic material, lack of toxicity for patients and endoscopy personnel, long reuse life, low cost, odorless, ability to monitor concentration, and nondamaging to the endoscope or the environment. 18, 32 HLD solutions can act as sterilants if an increased exposure time is used 28, 48, 78 ; however, the exposure time required to achieve sterilization with most LCG solutions is far longer than is practical, and therefore these formulations are only used for HLD. 48, 79 The efficacy of chemical disinfectants and sterilants is dependent on their physical properties including concentration and temperature; the length of exposure of the endoscope to the chemical solutions; the type and amount of microbial debris on the endoscope; and the mechanical components of the endoscope such as channels and crevices. Because the chemicals are toxic to humans and the environment, proper handling, thorough rinsing, and appropriate disposal are essential for human safety. 71 When selecting a HLD product, institutional requirements need to be taken into consideration with important variables including the number of endoscopes processed per day, training requirements, turnaround time, cost information, and regulatory issues regarding safe use of the HLD products. Health care workers who use HLDs need to be familiar with and have readily accessible, product/brand-specific Material Safety Data Sheets (MSDS) and keep current with regulatory changes and new product developments. 18 Users should consult with manufacturers of endoscopes and AERs for compatibility before selecting an LCG. The most commonly used FDA approved LCGs for disinfection of flexible endoscopes include glutaraldehyde, ortho-phthalaldehyde (OPA), peracetic acid, and hydrogen peroxide (Table 4 .1) 71,80,81 based chemicals in varying combinations and concentrations. Some formulations contain combinations of microbicidal agents, including glutaraldehyde and phenol/phenate, peracetic acid and hydrogen peroxide, and glutaraldehyde and isopropyl alcohol. The FDA periodically updates a list of approved HLD solutions along with some of their attributes, such as contact time and temperature required for HLD. 82 Sterilization of endoscopes is indicated on occasions when they are used as critical medical devices during open surgical procedures. The risk for contamination of the operative field exists when a nonsterile endoscope enters the abdomen through sterilants. [63] [64] [65] [66] [67] [68] [69] [70] AERs continuously bathe the exterior surface of the endoscope and circulate the LCG under pressure through the endoscope channels. The AER manufacturer identifies each endoscope (brand and model) that is compatible with the AER and specifies limitations of reprocessing models of endoscopes and accessories. Variations in AERs may require customization of the facility design to accommodate requirements for ventilation; water pressure, temperature, and filtration; plumbing; power delivery; and space. All models of AERs have disinfection and rinse cycles. In addition, the AERs may also have one or more of the following automated capabilities: 32,68,71 1. Some AERs utilize and discard small quantities of LCG per HLD cycle, whereas others have a reservoir of LCG that is reused over multiple cycles. The latter design results in gradual dilution of the LCG and requires intermittent testing to verify maintenance of the minimum effective concentration (MEC). Product-specific test strips need to be used regularly to monitor these solutions, 48 which should be discarded whenever they fall below the MEC or when the use-life expires, whichever comes first. 2. The temperature and cycle length can be altered to ensure HLD or sterilization based on the LCG and type of endoscope. 3. The AER should ensure circulation of LCGs through all endoscope channels at an equal pressure with flow sensors for automated detection of channel obstruction. 4. The AER should be self-disinfecting. 5. Vapor recovery systems are available. 6. Low intensity ultrasound waves are an option. 7. Variable number of endoscopes per cycle. 8. Some AERs flush the endoscope channels with forced air or with 70% to 80% ethyl or isopropyl alcohol followed by forced air to aid in drying the endoscope channels, thereby eliminating residual water, which reduces microbial growth during storage. 9. The AER should incorporate a self-contained or external water filtration system. LCGs and AERs must meet specified performance levels for HLD to receive FDA clearance. This is defined as a reduction in residual organic loads and a 6-log 10 killing of resistant indicator organisms (typically Mycobacterium bovis). All AERs marketed in the United States meet these criteria. The ASGE has published a summary of vendor-specific AERs and their compatible LCGs. 65 The FDA has approved labeling some AERs as washer-disinfectors due to the introduction of automated, brushless washing of endoscope channels prior to the disinfection cycle. Utilization of this AER washing cycle provides an extra margin of safety by providing redundancy of cleaning; however, the existing multisociety guideline 45 and other international standards emphasize that manual cleaning is still necessary when a washer-disinfector is used to assure the overall efficacy of HLD. 65, 72 One AER (Steris System 1E [SS1E]; Steris Corp, Mentor, OH) has received FDA approval for liquid chemical sterilization, as opposed to HLD, for heat-sensitive devices that cannot be sterilized by traditional means. 73 This system uses filtered, ultraviolettreated water that enters the AER and mixes with a peracetic acid-based formulation that is subsequently heated to 46°C to 55°C for liquid chemical sterilization. 74 This system is designed for "point of use" sterilization, as sterile storage is not possible. For flexible endoscopes processed through the SS1E, there is still a requirement for an alcohol rinse and drying prior to placing the endoscope into a storage cabinet. The FDA also requested that AER manufacturers conduct additional validation testing to evaluate AER reprocessing Agent/Action ever more complex GI flexible endoscopes. The combination of ultrasonic capability with flexible endoscopes has opened up a new tool to use for the diagnosis and staging of cancers. However, along with these improvements that enhance diagnostic capabilities comes the increasing complexity of the endoscope channels. These complexities include double instrument channels with connector bridges, ultrasound probe channels, auxiliary channels, and elevator lever wire channels (sealed and unsealed). These complexities in endoscopes have far-reaching impacts in terms of reprocessing of reusable flexible endoscopes. This has been painfully highlighted by the recent outbreaks of antibiotic resistant bacteria associated with fully reprocessed endoscopes that remain contaminated 15,28,93-104 and act as fomites that transmit bacteria to a high percentage of subsequent patients who are exposed to the contaminated endoscope (see later section on Infection Control Issues for more detailed information on infection transmission). Such outbreaks have focused attention on the cleaning and disinfection of flexible endoscopes. There has been a paradigm change in that it is now recognized that reprocessing of GI flexible endoscopes is an extremely complex process that requires a quality systems approach, which includes specific training for reprocessing personnel, adequate monitoring of various stages in the reprocessing cycle, and ongoing documentation of staff competency. 48, 95, [105] [106] [107] [108] [109] [110] [111] [112] [113] [114] Human factors play a critical role in compliance with reprocessing of GI endoscopes. 115 Ofstead et al (2010) demonstrated that compliance with all the reprocessing steps occurred for only an incision, as occurs with selected methods of intraoperative enteroscopy or postsurgical anatomy endoscopic retrograde cholangiopancreatography (ERCP). 84, 85 Endoscopes, when sterilized, require low-temperature methods because they are heat labile and therefore, unlike most other medical or surgical devices, they cannot undergo steam sterilization. ETO is the most commonly employed low-temperature sterilization process and a valuable method of sterilizing flexible endoscopes. However, a lengthy aeration time is required following ETO sterilization to allow desorption of all residual toxic gas from the endoscope. Additional steps must be taken, such as the application of a venting valve or the removal of the water-resistant cap to ensure proper perfusion with the gas and to prevent damage to the endoscope due to excessive pressure build-up. In addition, there are potential hazards to staff, patients, and the environment related to ETO toxicities (Table 4 .2). 86 The International Agency for Research on Cancer has classified ETO as a known (group 1) human carcinogen. Within the past two decades, several new, low-temperature (< 60°C) sterilization systems have been developed, including hydrogen peroxide gas plasma, vaporized hydrogen peroxide, peracetic acid immersion, and ozone 87-92 (see Table 4 .2). endoscopes and are not trained on specific cleaning requirements. The use of different sizes and types of channel brushes for the various different channel sizes, the fact that some channels cannot be brushed, and the multitude of different types of cleaning brushes available makes duodenoscope reprocessing a confusing process prone to human error. Major changes in GI endoscope reprocessing over the past five years have occurred and include new regulatory requirements, 1.7% of flexible endoscopes reprocessed when cleaning steps were performed manually and disinfection was automated, compared to 75.4% compliance when both cleaning and disinfection were automated. 115 Fig. 4 .2 outlines the basic steps in reprocessing of a GI flexible endoscope. Until recently, the only aspect of this process that was monitored was to test the MEC of the high-level disinfectant to ensure it contained a sufficient concentration of the active ingredient. It is easy to see from the outline provided in Fig. 4 identified. 97, 98, 108, 110, 113, [118] [119] [120] [121] If biofilm forms, the ability of disinfectants to reliably kill microorganisms within biofilm is dramatically reduced. 118, 122 Although most published reports of infectious outbreaks related to flexible endoscopes have involved duodenoscopes, other endoscopes including colonoscopes, gastroscopes, bronchoscopes, cystoscopes, and ureteroscopes (see later sections on Reprocessing Errors and Outbreak Management and Infection Control Issues), have been shown to be contaminated and involved in infectious outbreaks. As such, every site offering flexible endoscopy procedures should ensure they have an established quality system for reprocessing these complex devices as recommended by the FDA 110 and CDC. 123 Table 4 .3 provides an overview of what components are needed for such a system. As recommended by the CDC, 123 the first step that all health care facilities should undertake is to perform an audit by reviewing their current endoscopy services to ensure they meet all aspects of a quality system approach. This requires input from administration, risk management, endoscopy staff, and infection prevention and control to ensure that all components are adequately assessed and the appropriate policies and procedures documented and implemented. Table 4 .4 provides an overview of the key steps in reprocessing and outlines where mistakes are frequently made, as well as the impact of such mistakes. It is important that audits done for endoscope reprocessing are observational and based on a specific checklist of critical components, as well as data to substantiate processes (e.g., time data to show contact time with detergent during cleaning, as well as transport times to determine how frequently it exceeds 1 hour). Table 4 .4 is a useful aid to review during initial training of staff, as well as during discussion of audit data on a yearly basis. The need to monitor the adequacy of cleaning 48 is a critical step in the Total Quality System approach (see Table 4 .3) to endoscope reprocessing. Appropriate benchmarks for cleaning markers have been established. 48, 54, 109, 118, 121, [124] [125] [126] There are a number of rapid cleaning tests (RCT) available for monitoring organic residuals such as hemoglobin, carbohydrate, and protein, as well as those that monitor ATP residuals. There are published data for some of these rapid test methods, 112,125-132 but when selecting a rapid cleaning monitor, it is important to request that the rapid test manufacturer provide their validation data. Review of the pros and cons of the testing method based on the validation data provided by the manufacturer is an important step when selecting the RCT. Examples of the considerations for selecting the RCT are shown in Table 4 .5. Once the RCT has been selected, a way to document the RCT results is needed (e.g., a record sheet that identifies the scope tested, the person doing the testing, date and time of testing, result of testing, and the result of retesting for those scopes that fail the RCT and require recleaning). Regardless of the method selected, the site should do initial testing for ALL endoscopes to determine the current baseline status. This should be performed on the next patient use of each endoscope after completion of manual cleaning and rinsing. If the initial RCT fails for the majority of the endoscopes, this device-reprocessing guidelines, and endoscope manufacturers' instructions for use. The key "domino" in this chain of changes was the 2015 FDA Guide to Manufacturers of Reusable Medical Devices (FDA, March 2015) that required manufacturers to validate that their cleaning instructions were effective and could achieve predetermined benchmarks. Cleaning validation for medical device reprocessing was not previously required; the focus was on validation of the disinfection or sterilization protocols recommended by manufacturers for their medical devices. When transmission of carbapenem-resistant Enterobacteriaceae (CRE) associated with contaminated duodenoscopes was recognized and first investigated and reported in the United States, 14 it was unclear why reprocessing of duodenoscopes was failing. However, it was clear that transmission rates from contaminated duodenoscopes were high (up to 45%) and that, in addition to causing infections, patients often became colonized with CRE and remained colonized long after the exposure to the CRE contaminated duodenoscope. Some health care facilities continued to report CRE transmission and suggested that the manufacturers' instructions for use (MIFUs) for endoscope reprocessing were inadequate 15, 103, 116 and that was why endoscope contamination was ongoing. Although there had been recent design changes by the three main duodenoscope manufacturers whereby the elevator wire channel was sealed, the transmission of CRE was reported for duodenoscopes with both sealed and unsealed elevator wire channels. 14,15,103 However, one thing was clear; it was very difficult to adequately clean the lever cavity in duodenoscopes, and visible patient debris under the elevator lever was detected in one published outbreak. 95 This has prompted new validated cleaning instructions for the lever cavity of duodenoscopes. 117 The CRE outbreaks linked to contaminated duodenoscopes prompted the FDA to convene an advisory panel meeting in May 2015, and on August 4, 2015, the FDA issued a Safety Communication 110 with the recommendations from the advisory panel meeting that included: 1. Establishing and implementing a comprehensive quality control program for endoscopy reprocessing to ensure meticulous adherence to MIFUs for duodenoscope reprocessing, adequate training of reprocessing personnel, and audits to ensure ongoing compliance. 2. Supplemental measures to be considered by sites offering ERCP procedures, including: • Microbiological culture with quarantine of contaminated endoscopes until culture results become available; • Meticulous cleaning and HLD followed by one of: • ETO sterilization, • Liquid chemical sterilization, or • Repeat HLD. The FDA safety alert was followed by a CDC Health Advisory in September 2015, that indicated an immediate need for sites utilizing duodenoscopes to undertake audits of the reprocessing protocol, as well as staff training and longitudinal audits to document ongoing staff competency. These events and actions have led to a "paradigm shift" regarding the reprocessing of flexible endoscopes, 113 whereby the need for a total quality systems approach has been recognized. It is no longer adequate to accept that endoscope cleaning is being done properly just because the MIFUs are available to staff; rather, there needs to be evidence of monitoring and ongoing audits of cleaning compliance for all staff who reprocess endoscopes. In addition, the need to ensure the endoscopes are truly dry during storage to prevent biofilm formation has been Another stage where monitoring of the endoscope can be done is post-HLD. A Rapid Post-Disinfection Test (RPDT) that could be completed just prior to the next patient use of the scope to confirm that the endoscope does not contain viable microorganisms would be ideal. However, there is little published data for indicates that there may already be build-up biofilm (BBF) in the scopes being used. Remedial action would be needed for the endoscopes, which may include a longer soak time in detergent followed by extended brushing and flushing (as per scope manufacturer's input). If the endoscope fails the RCT after the remedial action, then it should be sent to the manufacturer for further remedial action (e.g., change of channels, etc.). There must be documentation of all reprocessing components to ensure there is a way to link which endoscopes (and corresponding accessories) were used on which patient. • Document which endoscope was used in the patient's medical record • Document in the reprocessing area which personnel cleaned each endoscope, which patient the endoscope was used on, the date/time it was cleaned, and which AER (automated endoscope reprocessor) was used to disinfect the endoscope (or which sterilizer was used). • Ensure the MIFU for reprocessing is available in the reprocessing area • Create a site-specific set of instructions that are based on the MIFU but indicate specific detergent, brushes, etc. that are used for reprocessing of each make/model of endoscope used at that site • If pump-assisted flushing is used during manual cleaning, ensure instructions for use are available • For manual cleaning, a succinct visual "aide" consisting of a summary of the process posted above the reprocessing sink, counters, etc., is useful. Table 4 .2 for additional information) • Traceability of each endoscope and reusable accessories used • Documentation of all monitoring performed for cleaning and minimum effective concentration (MEC) testing • Timely reprocessing • Routine cleaning and decontamination protocol for AER, flushing pump, sinks, connector tubing, endoscope storage cabinets • Policy on disposable and reusable ancillary items (e.g., water bottles, connector tubing, etc.) • Preventative maintenance (PM) program for endoscopes, AERs, flushing pump with repair history records • Record keeping of preventative maintenance on all equipment • Regular audits to ensure ongoing adequacy of all stages of the program • Involvement of Infection Prevention and Control (IPAC) and workplace safety in all components of the endoscopy reprocessing is crucial • A structured management scheme with regular review of the endoscopy program that includes reprocessing considerations. • There should be regular review and reporting of monitoring data at appropriate management meetings to identify any potential issues The bedside clean reduces the load of organic material and microbes for the full manual cleaning step. Detergent or water solution (as per endoscope manufacturer's instructions) is used to: • Wipe exterior using sponge or lint-free cloth • Suction or flush ALL channels (Note: this may require use of specific endoscope flushing adaptors as per MIFU) • Place all accessory components in detergent or water to keep moist during transport. 1. Forget to wipe exterior or forget to suction or flush some channels after patient procedure. 1. Dismantle reusable components such as valves, caps, flushing connectors etc. and process along with endoscope. Ensure endoscope is totally immersed in detergent solution. 3. Ideally suction detergent through all channels and discard this material (not in the cleaning basin). Brush all openings including suction cylinder, air/water cylinder, instrument port, and outlets on umbilical end. 5. Adequate contact time with detergent (as per detergent manufacturer's instructions) to loosen debris. 6. Rinse away detergent using tap water. 1. Reusable components not properly cleaned. Performing brushing while endoscope is not immersed. into the detergent solution. 4. Inadequate brushing of channels due to improper brush size or confusion regarding which brush to use. Inadequate contact time with detergent. 6. Many detergents are protein solutions that need to be removed before the disinfection/sterilization step. 1. Increased risk of accumulation of organic material and biofilm forming. Increased risk to personnel and environment due to aerosols of infectious debris. Contamination of detergent solution with high levels of patient secretions increases the risk of high levels of organic material and microbes on exterior and in channels. Inadequate brushing leads to improper cleaning and risk of excessive organic and microbial load for HLD. of organic material and microbes. 6. If detergent is not adequately rinsed away this could lead to accumulation of protein and failure of HLD. 1. Once manual cleaning has been completed collect a sample from the channel(s) of the endoscope. Minimally a sample from the instrument port to the distal end should be collected and tested. Follow the MIFU for the rapid cleaning monitor. If the test result is below the manufacturer's cut-off for adequate cleaning, then the scope can be transferred to the AER for HLD (or manual HLD done) or sent for sterilization. If the test result is above the MIFU cut-off, then the endoscope needs to be fully recleaned and tested after the second manual clean. NOTE: For duodenoscopes there should also be a sample from the elevator lever recess. If the endoscope fails the rapid cleaning test after three rounds of cleaning it should be sent to the endoscope manufacturer for evaluation. Breach of any of the manual cleaning steps shown in Fig. 4 .1 can lead to patient-derived material remaining in the endoscope that is sent for HLD or sterilization. HLD or sterilization processes fix the organic residues to the channel surface leading to build-up biofilm formation (BBF). 1. Accumulation of BBF in the endoscope increases the risk of microbes in the BBF matrix surviving HLD and possibly being transmitted to subsequent patients. Disinfection or Sterilization HLD and sterilization are intended to kill any remaining microbes left after the cleaning step. HLD and sterilization can achieve 6 and 12 Log 10 microbial reductions, respectively. All reusable accessory items must also be exposed to HLD or sterilization along with the endoscope they are dedicated to. Ideally an automated endoscope reprocessor (AER) should be used for HLD or sterilization. Manual HLD instructions are available from manufacturers but the manual process is fraught with concerns including ensuring adequate vapor control to prevent staff exposure to toxic fumes, adequate channel perfusion when using manual syringe to inject HLD, dilution of HLD from water remaining in channels after manual cleaning, etc. When using an AER, it is necessary to change the sub-micron filter inside the AER as per MIFU. 3. Fully reprocessed endoscopes and accessory components need to be handled using clean gloves to ensure skin organisms from bare hands are not transmitted to the endoscope post-HLD. 1. Inadequate HLD contact due to poor manual perfusion of channels (e.g., bubbles or inadequate immersion). Breach in sub-micron filter inside AER leads to contaminated rinse water. Handling of endoscope post-HLD with un-gloved hands 1. Increased risk of microbes surviving the HLD process due to inadequate contact with HLD. Microbes on the endoscope when put into storage can facilitate biofilm formation. 3. Microbes on hands transferred to disinfected endoscope can survive and subsequently be transmitted to next patient that the endoscope is used for. Microbes transferred to endoscope from hands also increase the risk of biofilm formation if there is sufficient moisture. 1. Through drying of endoscope exterior and ALL channels is critical prior to storage. This can be done using appropriately filtered forced air. If a "channel-purge" storage cabinet is used the manual drying only needs to be done briefly to remove excess water prior to placing the endoscope in the cabinet (ongoing air purging once the endoscope is placed in the cabinet is preferred to ensure dryness is maintained as additional wet endoscopes are sequentially placed into the storage cabinet). There are also small air-flushing pumps that can be used to ensure channel drying prior to placing the endoscope in a regular storage cabinet. Ensure adequate time is used for air-flushing to ensure scope is totally dry before being placed in a regular storage cabinet. 2. Ensure fully reprocessed endoscopes are somehow labeled or identified so they can be easily differentiated from patient-used endoscopes that are contaminated. 1. The volume of alcohol flushed and the time for manual forced air drying is not specified in MIFU and is often sub-optimal when performed manually. 2. Contaminated endoscope may be mistaken for a fully reprocessed endoscope and accidentally used on a patient. 1. Inadequate drying during storage is one of the key factors that leads to biofilm formation. Once formed, the biofilm protects microbes from being adequately killed by HLD or sterilization and increases the risk of organisms being transmitted to patients exposed to this contaminated endoscope. Use of a contaminated endoscope can lead to transmission of infectious agents that result in colonization or infection. 2. Contamination of endoscope may lead to microbial replication and biofilm formation if moisture is also present. Valves inserted into the valve cylinders can lead to moisture retention that facilitates microbial replication and can lead to biofilm formation. endoscope reprocessing. As outlined by recent guidelines, 48, 107, 108, 123 initial training and ongoing competency assessment are critical to ensuring that staff can effectively reprocess flexible endoscopes. The compliance of reprocessing personnel with endoscope reprocessing protocols should be reviewed at least annually to document ongoing competency. 48 It is clear from some outbreaks that despite having adequate written protocols, staff may create breaches by not following some steps in the protocol. 95, 98, 115 As such, observational audits are a useful approach to determining if staff are fully compliant in following the site protocol. If ongoing cleaning monitoring is performed, the results of these tests can be included as part of documentation of ongoing competency. Transmission of exogenous pathogens (i.e., not derived from the patient) can be categorized as "nonendoscopic," which is related to care of intravenous lines and administration of medications and anesthesia, or "endoscopic," which is related to transmission by the endoscope, water bottles, and its accessories. Outbreaks of infection have been traced to process failures, including endoscopes that are damaged or difficult to clean; AER design problems or failures such as breakdowns in AER water filtration systems; and lack of adherence to reprocessing guidelines for endoscopes and accessories. There are also data that demonstrate that all the steps associated with manual endoscope reprocessing are rarely performed and some essential steps, such as brushing all endoscope channels and adequate drying prior to storage, are frequently deficient. 115 These deficient reprocessing practices can be summarized as follows: 32,96,115 1. Inadequate or absent mechanical cleaning of the endoscope and channels before disinfection. the two RPDT tests that are currently available (Table 4 .6). In the absence of validated rapid test methods, culture is the only well-studied method for detection of microbial contamination of flexible endoscopes postdisinfection/-sterilization. However, there are a number of considerations when culture is used. There have been a variety of published studies on culture results from endoscopes, but there is little data on the recovery efficiency of the various endoscope extraction methods that have been used. 137 If a patient-ready endoscope is extracted by flushing the channel with bacterial culture media or other harvesting fluids containing various proteins or buffers containing salt, then the endoscope requires recleaning and disinfection prior to being used on a patient. If sterile, high-quality water (i.e., reverse osmosis or deionized water) is used to flush endoscope channels, the endoscope can be dried and then still be safely used on the next patient. Personnel who reprocess flexible endoscopes must have thorough initial training regarding the reprocessing of all makes and models of endoscopes that they will be responsible for reprocessing (see Tables 4.3 and 4.4 ). The training process should be documented and new staff not allowed to reprocess endoscopes on their own until they have demonstrated, under supervision, that they are competent to perform reprocessing independently. The use of rapid cleaning monitor (RCM) tests for each endoscope reprocessed during training is an excellent way to document the adequacy of the trainee's ability to perform the cleaning process. Reprocessing errors are a common underlying problem for many of the reported outbreaks. 95, 97, 98, 123 The "human factors" study done by 115 showed that inadequate cleaning of channels related to the lack of adequate channel brushing (43% of scopes) and inadequate drying (45% of scopes) prior to storage of endoscopes were the two most common breaches in The CDC guidelines for safe injection practices include the following recommendations: 150 • Use aseptic technique when preparing and administering medications and fluids. • A sterile, single-use, disposable needle and syringe should be used for each injection on a single patient. • Do not administer medications from single-dose vials or use IV solutions as a common source of supply for multiple patients. • Do not keep multidose vials in the immediate patient treatment area. • Do not reuse a syringe to access or administer medications from a vial that may be used on multiple patients, even if the needle is changed. • In times of critical need, medications from unopened singledose/single-use vials can be subdivided for multiple patients. However, this should only be performed by qualified health care personnel in accordance with standards in the United States Pharmacopeia chapter on Pharmaceutical Compounding. 3. An inadequate disinfectant was used or used improperly at an incorrect concentration, temperature, or exposure period. 4. Flawed or malfunctioning AER units or use of incorrect connectors. 20,101,142 5. Failure to disinfect or sterilize the irrigation bottle of the endoscope regularly. 143,144 6. Endoscopic accessory instruments were not sterilized. 7. The endoscope and all channels were not dried adequately before storage. 8. Unrecognized problems with water supply. Outbreaks of hepatitis B and C viruses have occurred due to failure to follow fundamental principles of aseptic technique and safe injection practices. 145, 146 These included improper handling of intravenous sedation tubing, reuse of syringes and needles, and use of single-dose or single-use medical vials on multiple patients. 146 • Detects viable organisms of high concern including Gram negatives and Gram positives. • Allows assessment of whether the bacteria detected are multi-antibiotic resistant • For outbreak investigation allows for genetic typing methods (e.g., PFGE) to help identify a point-source outbreak • Requires 48 to 72 hrs before results of culture are reported. • During outbreak investigation, quarantine of the endoscope pending culture results is necessary. • For routine surveillance (i.e., not an outbreak investigation) the endoscope is often not quarantined and may be used on multiple patients before culture results are available. Sites need to have a response plan in place regarding notification if culture shows organisms of concern on an endoscope that has been used on multiple patients (i.e., notify the patient, the doctor or both?) not be detected after HLD as these organisms commonly result in a clinically significant infection including gram-negative bacteria (e.g., Escherichia coli, Klebsiella spp., Shigella spp., Salmonella spp., Pseudomonas aeruginosa, other Enterobacteriaceae) as well as Staphylococcus aureus, and Enterococcus spp. 159 LCO are less often associated with disease; these bacteria typically include coagulase-negative staphylococci, micrococci, diptheroids, and Bacillus spp. The levels of LCO on a surveillance endoscope culture can vary depending on the reprocessing, handling, and culturing practices in a facility. Typically, fewer than 10 colony forming units (CFU) of LCO does not require intervention as this most likely represents collection process contamination rather than a significant problem with the disinfection or cleaning process. 159 Interpretation of culture results with 10 or greater CFU of LCO should be considered in the context of typical culture results at the facility. 111 Any endoscope found to be contaminated with a HCO or unacceptable CFU of LCO should cause concern and lead to repeat endoscope reprocessing followed by post-reprocessing cultures. The endoscope should be quarantined until it has been demonstrated to be free of HCO and has an acceptable level of LCO. Positive cultures should also prompt a review of the endoscopy unit reprocessing procedures to ensure adherence to the manufacturer's reprocessing instructions and to ensure proper culture methodology. If a reprocessing breach is identified, appropriate facility personnel should be notified and corrective actions should be immediately implemented. When bacteria are persistently recovered by surveillance cultures, refer to the manufacturer's instructions 111, 159 for evaluating the endoscope for mechanical defects and consider having the endoscope evaluated by the manufacturer. In addition, when ineffective reprocessing is suspected based on surveillance cultures, it might be helpful to review positive cultures among affected patients to determine whether transmission of relevant pathogens could have occurred. 111, 159 The vast majority of exogenously acquired endoscope-related infections have been caused by bacterial transmission. The bacteria involved have been true pathogens, which always have the potential to cause infection (e.g., Salmonella spp.), or opportunistic pathogens that cause infection if the microbial load is sufficient and/or host-factors are permissive (e.g., Pseudomonas aeruginosa). In the hierarchy of relative resistance to HLD, vegetative bacteria such as Pseudomonas spp. and Salmonella spp. are the most susceptible to disinfectants, whereas the mycobacteria are less susceptible and bacterial spores (e.g., Bacillus subtilis and Clostridium difficile) are the most difficult to eliminate (see Box 4.1). Nevertheless, as previously stated, all bacteria with the exception of a few bacterial spores are highly sensitive and eliminated by HLD. Salmonella is a serious primary pathogen, and Pseudomonas is ubiquitous in many water sources, and although both these pathogens have been associated most frequently with endoscopic transmission, they are both sensitive to multiple agents, including glutaraldehyde, and other HLDs. Transmission of bacterial pathogens from flexible endoscopes has been rare since the adoption of the current 2011 multisociety reprocessing guideline, 45, 160 with the exception of duodenoscope-related infections (discussed later). The most commonly reported infectious agents transmitted during GI endoscopy have been Pseudomonas aeruginosa (45 cases) [161] [162] [163] and Salmonella spp. (84 cases). 17 Isolated reports of More health care-associated outbreaks and patient exposures have been linked to contaminated endoscopes than to any other reusable medical device. 32, 102 Nevertheless, endoscopy-related transmission of infection is very low and was originally estimated to have an incidence of approximately 1 infection per 1.8 million procedures. 3, 17 This is very likely an underestimate, as many endoscopy-related infections go unrecognized because of inadequate or nonexistent surveillance programs, the absence of clinical symptoms in many patients who are colonized, a long lag time between colonization and clinical infection, and the fact that the pathogens transmitted by endoscopy are often normal enteric flora. 151 Endoscope-related transmission of bacterial infection has been rare since the adoption of the current multisociety reprocessing guidelines. 45, 151 However, recent outbreaks have occurred with duodenoscopes even when the manufacturers and societal guidelines were reportedly followed correctly (see later section on Duodenoscope-Related Infections). 152 The primary concern raised by infectious outbreaks is that current reprocessing guidelines are not adequate to ensure patient safety when undergoing endoscopic procedures. Endoscopes can harbor between 10 9 and 10 12 enteric organisms at the completion of some patient procedures. This bioburden is reduced by cleaning (i.e., bedside precleaning followed by manual cleaning) by a factor of 2 to 6 log 10 and the HLD step is expected to provide a 6 log 10 reduction of any microbes remaining after cleaning. 124, 153 Therefore the margin of safety associated with cleaning and HLD of GI endoscopes is low, and any deviation from proper reprocessing could lead to failure to eliminate contamination, with a possibility of subsequent patient-to-patient transmission. Biofilms can contribute to reprocessing failure and endoscoperelated infectious outbreaks. 154 Biofilms form in endoscope channels, in AERs, and within municipal and hospital water supplies as multilayered bacteria within exopolysaccharide. These biofilms protect the bacteria against physical (e.g., brushing, fluid flow) and chemical (e.g., disinfectant) forces, making the microorganisms more difficult to remove or completely kill by HLD. 151, 155 There is evidence that accumulation of fixed material within endoscope channels occurs over repeated usage. Biofilms that develop in endoscopes and AERs may not be detectable by surveillance culture, as cleaning and disinfection may have destroyed bacteria within the superficial layers but not those within the deeper layers. Prompt, meticulous, manual cleaning to remove biologic material and strict adherence to reprocessing protocols is the optimal approach to reduce biofilm formation/accumulation. [155] [156] [157] [158] Better biofilm removal protocols are needed to address this issue. Pathogens of concern to the GI endoscopy community and general public include Clostridium difficile, Helicobacter pylori, Escherichia coli, norovirus, human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), and multidrug resistant organisms (MDROs) such as M. tuberculosis, vancomycin-resistant enterococcus (VRE), methicillin-resistant Staphylococcus aureus (MRSA), and CRE. All these established pathogens are susceptible to currently available chemical disinfectants and sterilants. 17, 32 Low Concern Organisms (LCO) versus High Concern Organisms (HCO) Surveillance cultures of endoscopes are assessed for two general categories of microbial growth, LCO and HCO. HCO should be changed to protect our patients from CJD, citing no reported cases of CJD transmission by endoscopy and the lack of exposure to high-risk CNS tissue during endoscopic procedures. 17, 183 vCJD is a rare but fatal condition caused by the consumption of beef contaminated with a bovine spongiform encephalopathy agent. It differs from CJD in that the mutated prion protein can be found in lymphoid tissue throughout the body, including the gut and tonsils. 182, 184 Only three cases of vCJD have been reported in the United States, and all three patients contracted the disease elsewhere. 184 As vCJD is resistant to conventional disinfectants and sterilants, endoscopy should be avoided, if at all possible, in patients known to harbor this agent. 17, 184 Endoscopes used in individuals with definite, probable, or possible vCJD should be destroyed after use or quarantined to be reused exclusively on that same individual if required. 182, 184 Between 2012 and 2015, duodenoscopes resulted in 25 international outbreaks (at least eight in the United States) of antibiotic-resistant infections with CRE and other MDROs that sickened a reported 250 patients and resulted in 20 deaths. 16, 97, 103, 138, [185] [186] [187] In addition, transmission resulting in a long-term carrier state has been recognized as a risk of exposure to contaminated duodenoscopes. Long-term carriage has important clinical implications due to the development of a delayed infectious complication weeks to months later or patient-topatient transmission of pathogens when these carriers are subsequently admitted to health care or chronic care facilities. Investigative cultures identified persistent contamination of duodenoscopes as the cause for patient infections with MDROs in most of the outbreaks. 185, 188 Furthermore, these duodenoscopeassociated infections occurred even though the sites reported strict adherence to reprocessing procedures according to manufacturer's instructions and professional guidelines. 14, 16, 97, 142, 189 It is likely that MDROs are acting as a marker for ineffective reprocessing due to the complex design of duodenoscopes that have difficultly reaching crevices and channels involving the elevator mechanism where persistent colonization was identified. 186, 190 Duodenoscopes that persistently yield positive cultures likely harbor biofilms that cannot be eradicated with standard reprocessing. 155 In October 2015 the FDA and the CDC released an official health advisory alerting health care facilities to review their reprocessing procedures. [191] [192] [193] [194] [195] [196] [197] [198] [199] [200] [201] [202] In response to the problems with duodenoscope reprocessing, the FDA requested all three duodenoscope manufacturers to revise and validate their reprocessing instructions with provisions for additional duodenoscope reprocessing measures. 191 This led to the modification of manufacturers' reprocessing protocols with a larger emphasis on precleaning and manual cleaning before HLD. 117, [192] [193] [194] One duodenoscope manufacturer (Olympus; Center Valley, PA) subsequently modified the design of the closed elevator channel to create a tighter seal. 195, 196 In addition, the FDA has recommended that health care facilities performing ERCP consider employing supplemental measures for duodenoscope reprocessing when facilities have the resources to do so. 110 Most sites where outbreaks have occurred have chosen per procedure ETO sterilization after HLD as its primary reprocessing method, and in all reported instances, ETO has prevented further MDRO transmission. 110, 185 However, one site reported failure to eliminate MDRO contamination of a duodenoscope after HLD and ETO. 116 Alternative reprocessing endoscopic transmission of other enteric bacteria include Klebsiella spp., 164 Enterobacter spp., 165 Serratia spp., 166 and Staphylococcus aureus. 164 The few reports of endoscopic transmission of Helicobacter pylori were related to inadequate reprocessing of endoscopes and biopsy forceps. [167] [168] [169] Current reprocessing guidelines are shown to inactivate Clostridium difficile spores, 170 and no cases of endoscopic transmission of this infection or mycobacteria have been reported. In summary, there have not been any observed GI endoscopy-related transmission of bacterial pathogens since introduction of the currently accepted reprocessing standards with the exception of duodenoscope-related outbreaks (discussed later). Much greater anxiety is associated with the possibility of transmission of viral infections. This anxiety is surprising because the viruses of greatest concern (HBV, HCV, and HIV) are among the easiest microorganisms destroyed with standard reprocessing. 171 Transmission of viral pathogens by GI endoscopy procedures is rare because these microorganisms are obligate intracellular microorganisms that cannot replicate outside living tissue. Thus, even when a flexible endoscope is contaminated with viral pathogens, the burden of virus cannot increase, as they are not capable of ex vivo replication. Enveloped viruses (e.g., HIV, HBV, HCV) die readily once dried and are more readily killed by HLD compared to nonenveloped viruses (e.g., enteroviruses, rotavirus), which can survive in dry conditions. There has been concern about the possibility of HIV transmission by flexible GI endoscopy; however, no cases have been reported to date. [171] [172] [173] There is only one well-documented case of HBV transmission by GI endoscopy that occurred in the setting of inadequate endoscope reprocessing. 174 However, transmission of HBV is very rare or does not occur when accepted reprocessing guidelines are followed. 175 The presence of fungi is associated with prolonged storage of flexible endoscopes. Although transmission of Trichosporon beigelii and Trichosporon asahii occurred in the 1980s, 176, 177 there are no documented cases of fungal infections by GI endoscopy when updated reprocessing guidelines are followed. A single publication in the 1970s reported circumstantial evidence of Strongyloides stercoralis transfer to four patients from a contaminated upper endoscope. No subsequent reports of parasite transmission by GI endoscopes have been identified. 178 Creutzfeldt Jacob Disease (CJD) and variant CJD (vCJD) are degenerative neurologic disorders transmitted by proteinaceous infectious agents called prions. All prions remain infectious for years in a dried state, and resist all routine sterilization and disinfection procedures commonly used by health care facilities. 17, [178] [179] [180] [181] CJD is confined to the central nervous system (CNS) and is transmitted by exposure to infectious tissues from the brain, pituitary, or eye, whereas tissues and secretions that come into contact with the endoscope during procedures, such as saliva, gingival tissue, intestinal tissue, feces, and blood, are considered noninfectious by the World Health Organization. 17, [179] [180] [181] [182] The CDC and other infection control experts conclude that current guidelines for cleaning and disinfecting medical devices need not will help with the investigation and lead to an expeditious correction of any deficiencies that are identified. • A user facility is not required to report a device malfunction, but it can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under FDA's Safety Information and Adverse Event Reporting Program. 201 However, if a device failure leads to a death or serious injury, the FDA and the manufacturer must be contacted, as outlined in facility policies, by the designated individual or department at the facility. 202 The FDA encourages health care professionals, patients, caregivers, and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch (https://www.accessdata.fda.-gov/scripts/ medwatch/), the FDA's Safety Information and Adverse Event Reporting Program • Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury or when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. 201,202 6. Patient notification and counseling: 200, 203 in instances where a breach in the reprocessing protocol or damaged equipment poses a risk to patients for adverse events, it becomes the institution's ethical obligation to notify patients in a timely manner. Notification may be accomplished by a direct meeting, telephone call, and letter sent by registered mail. The content should include an assessment of the risk, possible adverse events that may occur, symptoms and signs of the adverse event, time range for the adverse event, risk to other contacts, possible prophylactic therapy (including benefits and risks), and recommended medical follow-up. Prompt notification allows patients to take precautions to minimize the risk of transmitting infection to others and allows for early serologic testing. This may help distinguish chronic infections from those potentially acquired at the time of endoscopy and to permit earlier initiation of treatment for newly acquired infections. On the other hand, adverse publicity associated with the reporting of a reprocessing error might lead patients to avoid potentially life-saving endoscopic procedures because of an unwarranted fear of infection. Personal counseling should be offered to all patients. The risk of infection should be discussed and placed in context to minimize patient anxiety. Patients should be advised against donating blood and tissue products and engaging in sexual contact without barrier protection until all serologic testing is complete. A toll-free helpline should be established to provide information to all patients at risk. 7. Develop a long-term follow-up plan (e.g., long-term surveillance, changes in current policies and procedures) and prepare an after action report. There are risks related to infection transmission to personnel who handle patient-used endoscopes as well as to patients. Sites offering endoscopy procedures need to ensure the risk to personnel and patients is minimized. Flexible GI endoscopes are expensive and easily damaged. Unlike surgical instruments where the microbial load is less than 100 methods employed have included double HLD after each procedure 110, 185 or HLD with duodenoscope quarantine until negative culture results are obtained. 15 Another supplemental option for reprocessing endorsed by the FDA includes the use of a liquid chemical sterilant processing system. 110, 197 Surveillance microbiological culturing should be considered in addition to these supplemental reprocessing measures. This involves sampling the duodenoscope channels and the distal end of the scope to identify any bacterial contamination that may be present on the scope after reprocessing. 159, 198 It must be recognized that the sensitivity of surveillance culturing of the elevator channel, the elevator lever cavity, or other scope channels is unknown. Until there are evidence-based guidelines, individual hospitals should choose from these different options based on available information and feasibility for their medical practice. However, at a minimum, there should be an audit of all facilities offering duodenoscope procedures to ensure the site has a quality system in place and is compliant with current MIFUs and guidelines. Breaches of disinfection guidelines and device failures (e.g., endoscopes or AERs) are common in health care settings, resulting in potential patient injury or infection transmission. 31 The identification of such a problem may stem from the result of microbiologic surveillance cultures, an infectious outbreak within an institution or isolation of a pathogen from individuals having a recent endoscopic procedure, identification of a break in reprocessing protocol, or a visibly faulty device. Endoscopy facilities should have written policies on the roles and responsibilities within the organization to identify, report, and analyze these failures. 81 The investigation of a breach in reprocessing or resultant outbreak should be undertaken using a standardized approach. It should focus on the identification of factor(s) that led to the exposure and protect patients from potential adverse events. The investigation should not be punitive and not attempt to assign blame to any particular individual. Rutala et al (2007) 199 described a process for exposure investigation, and the ASGE has published guidelines for patient assessment and notification when there is a suspected failure in the disinfection or sterilization protocol. 200 These can be summarized as follows: 199, 200 1. Confirm that the reprocessing failure occurred and assess the duration of exposure (e.g., review sterilization methods and AER records of biological parameters). 2. Quarantine any endoscopes or associated accessories that malfunctioned or are at risk for inadequate reprocessing. 3. Do not use the devices in question, such as the endoscope or AER, until proper functioning is confirmed. 4. Prepare a list of potentially exposed patients, dates of exposure, and inadequately reprocessed or malfunctioning devices used. 5. Reporting: • Inform facility leadership: breaches in patient safety with serious potential infection risks should be reported to facility leadership, including infection control, risk management, public relations, legal department, and selectively to local/state public health agencies, the FDA, CDC, and the manufacturers of the involved equipment. 200, 203 This The workflow should proceed from "dirtiest to cleanest" in the reprocessing area, and there should be physical separation of "dirty" reprocessing areas and "clean" areas. 48, 107, 108 This requires appropriate removal of PPE and hand hygiene when leaving the dirty reprocessing area to enter any of the clean areas. Staff should take every precaution to reduce the generation of aerosols during reprocessing of GI endoscopes. This includes total immersion of the endoscope during cleaning. 48, 108 This ensures that any patient material removed from the channels during cleaning is contained within the detergent cleaning solution. Care is needed to ensure all brushing steps are done underneath the water surface to reduce aerosols. Holding the control head above water to insert the channel brush and then pulling the brush out of the channel while the control head is above the water generates significant aerosols of the contaminated detergent solution. In addition, during the air-flushing process after cleaning is completed, a piece of gauze should be placed over the distal end of the endoscope channel prior to placing it in an AER to prevent creation of aerosols when flushing out residual rinse water. A final, often overlooked step, is rinsing and decontamination of the sink after EACH endoscope is cleaned. This ensures that the sink does not accumulate microbial contamination over time and act as a reservoir within the reprocessing area to contaminate reprocessing personnel or other endoscopes. If flushing pumps are used as part of the manual cleaning step, they also require routine (usually daily) decontamination as per MIFU to ensure they do not become a reservoir of microbes that develop biofilm and subsequently contaminate endoscopes that they are used on. Any single-use disposable sharps used in the procedure room should be disposed of in appropriate sharps containers in the procedure room. There should be no single-use disposable sharps transported to the reprocessing area. If there are reusable sharps (e.g., biopsy forceps) used for patient procedures, these should be appropriately transported to the reprocessing area in a labeled, rigid, sealed container that ensures separation from the endoscope. This reduces the risk that the biopsy forceps (or other sharp accessory device) could damage the endoscope during transit. Reprocessing of reusable sharps requires specific MIFU and adequate staff training to reduce the risk of sharps injuries to reprocessing personnel. Single-use, disposable accessories are preferred to eliminate the risks associated with reprocessing of reusable sharps. 14 bacteria for 75% of instruments, 139, 204 the load of microorganisms in channels of flexible endoscopes can be as high as 10 10 bacteria 124 per instrument channel (e.g., for colonoscopes). During transport from the procedure room to the reprocessing area, 48 flexible GI endoscopes require a rigid, sealed container that is appropriately labeled as biohazardous. This protects the endoscope from accidental damage and also ensures that any patient-derived secretions and microorganisms are adequately contained and cannot drip out and contaminate the environment. All reusable accessory items (valves, flushing adaptors, cleaning valves, etc.) should be transported along with the associated endoscope. During transport, the endoscope and all accessory items should be kept moist to prevent drying of patient-derived material. If endoscopes are transported to a central reprocessing facility, evaluation of the time of transport should be conducted to determine the frequency of excessive transit times. There are risks to reprocessing personnel being exposed to patient-derived infectious materials. Endoscopes contacting the GI tract can have very high levels of infectious organisms (including bacteria, viruses, fungi, etc.) in channels or on the endoscope surface. To mitigate these risks, reprocessing personnel need to be trained regarding standard precautions, personal protective equipment (PPE), hand hygiene, disposal of sharps, and dealing with chemical and/or infectious material spills. Standard precautions are required when reprocessing any patient-used medical device. This means that staff treat all patient-used endoscopes as potentially infectious regardless of the underlying known illnesses that patients might have (e.g. Clostridium difficile infection, VRE colonization, human papilloma virus infection, candidiasis, etc.). Any handling of GI endoscopes should be done with due consideration to the potential to transmit infectious microorganisms to reprocessing personnel. Staff must be trained in appropriate PPE and reprocessing considerations aimed at reducing the generation of aerosols. It is critical that appropriate PPE be available 48,107,108 and include a gown (preferably a water-resistant gown), gloves (appropriate to the task), and a face shield/mask. Reprocessing personnel must be adequately trained in the proper donning and doffing of all PPE. Gowns, gloves, and a full-face shield (or combined face shield/mask) are required for cleaning of flexible endoscopes. The reprocessing staff needs to be trained in the appropriate use of protective gloves, as well as hand hygiene after removing gloves. Utility gloves used for cleaning of endoscopes should never be used at other stages in endoscope reprocessing (i.e., they are dedicated to the cleaning sinks). Disposable examination gloves must be available for handling cleaned endoscopes during connection to the AER. Fresh disposable gloves are needed for removing and handling fully reprocessed endoscopes from the AER and during manual channel drying and placing the endoscope into the clean storage cabinet. Fresh disposable gloves should also be used whenever an endoscope is removed from the clean storage cabinet. The use of gloves helps protect both the reprocessing personnel from contamination with patientderived microorganisms and the fully reprocessed endoscope from contamination with skin-derived microorganisms from reprocessing personnel. 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PART IV. Issues related to reprocessing flexible endoscopes Food and Drug Administration: FDA-cleared sterilants and high level disinfectants with general claims for processing reusable medical and dental devices Food and Drug Administration: FDA-cleared sterilants and high level disinfectants with general claims for processing reusable medical and dental devices Sterilization, high level disinfection and environmental cleaning Public Health Agency of Canada (formerly Health Canada): Infection control guidelines: hand washing, cleaning, disinfection and sterilization in health care APIC guideline for selection and use of disinfectants. 1994, 1995, and 1996 APIC Guidelines Committee High-level disinfection or "sterilization" of endoscopes? 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A bacteriological evaluation Ethylene oxide sterilization of medical devices: a review Validation of low-temperature steam with formaldehyde sterilization for endoscopes, using validation device Comparison of ion plasma, vaporized hydrogen peroxide, and 100% ethylene oxide sterilizers to the 12/88 ethylene oxide gas sterilizer Comparison of liquid chemical sterilization with peracetic acid and ethylene oxide sterilization for long narrow lumens Comparative evaluation of the sporicidal activity of new low temperature sterilization technologies: ethylene oxide, 2 plasma sterilization systems, and liquid peracetic acid A comparative study of ethylene oxide gas, hydrogen peroxide gas plasma, and low-temperature steam formaldehyde sterilization Ethylene oxide sterilization of medical devices: a review Current practice of duodenoscope reprocessing Carbapenem-resistant Enterobacteriaceae and endoscopy: an evolving threat Early identification and control of carbapenemase-producing Klebsiella pneumoniae, originating from contaminated endoscopic equipment Reported gastrointestinal endoscope reprocessing lapses: the tip of the iceberg Multidrug-resistant Klebsiella pneumoniae outbreak after endoscopic retrograde cholangiopancreatography Control of a multi-hospital outbreak of KPC-producing Klebsiella pneumonia type 2 in France Outbreak of ertapenem resistant Enterobacter cloacae urinary tract infections due to a contaminated ureteroscope Duodenoscope-associated bacterial infections: a review and update Infectious diseases linked to cross-contamination of flexible endoscopes Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak A carbapenem-resistant Klebsiella pneumoniae outbreak following bronchoscopy AMMI TIR34 Water for reprocessing of medical devices TIR30 A compendium of processes, materials, test methods and acceptance 147. Muscarella LF: Recommendations for preventing hepatitis C virus infection: analysis of a Brooklyn endoscopy clinic's outbreak Prevention: Transmission of hepatitis B and C viruses in outpatient settings Viral hepatitis transmission in ambulatory health care settings Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings Evaluation of the risk of transmission of bacterial biofilms and clostridium difficile during gastrointestinal endoscopy ERCP scopes: what can we do to prevent infections? Disinfection, sterilization and antisepsis: principles and practices in healthcare facilities Is biofilm accumulation on endoscope tubing a contributor to the failure of cleaning and decontamination Effectiveness of current disinfection procedures against biofilm on contaminated GI endoscopes Modeling microbial survival in buildup biofilm for complex medical devices A study of the efficacy of bacterial biofilm cleanout for gastrointestinal endoscopes Evaluation of detergents and contact time on biofilm removal from flexible endoscopes Control and Prevention: Interim protocol for healthcare facilities regarding surveillance for bacterial contamination of duodenoscopes after reprocessing Antimicrobial efficacy of endoscopic disinfection procedures: a controlled, multifactorial investigation Pseudomonas aeruginosa cross-infection following endoscopic retrograde cholangiopancreatography Pseudomonas aeruginosa and Enterobacteriaceae bacteremia after biliary endoscopy: an outbreak investigation using DNA macrorestriction analysis Nosocomial infections from contaminated endoscopes: a flawed automated endoscope washer. An investigation using molecular epidemiology A prospective analysis of fever and bacteremia following ERCP Polymicrobial sepsis following endoscopic retrograde cholangiopancreatography Infection control practices in gastrointestinal endoscopy in the United States: a national survey Iatrogenic Campylobacter pylori infection is a cause of epidemic achlorhydria Development and validation of rapid use scope test strips (RUST) to determine the efficacy of manual cleaning for flexible endoscope channels Rapid method for the sensitive detection of protein contamination on surgical instruments The ATP test is a rapid and reliable audit tool to assess manual cleaning adequacy of flexible endoscope channels Validation of ATP to audit manual cleaning of flexible endoscope channels Persistent contamination on colonoscopes and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines Assessing residual contamination and damage inside flexible endoscopes over time Simulated-use validation of a sponge ATP method for determining the adequacy of manual cleaning of endoscope channels Validation and comparison of three adenosine triphosphate luminometers for monitoring hospital surface sanitization: a Rosetta Stone for adenosine triphosphate testing The use of rapid indicators for the detection of organic residues on clinically used gastrointestinal endoscopes with and without visually apparent debris The ATP test is a rapid and reliable audit tool to assess manual cleaning adequacy of flexible endoscope channels Hemoglobin assay for validation and quality control of medical device reprocessing Control and Prevention: Interim sampling method for the duodenoscope -distal end and instrument channel Detection of persistent vegetative bacteria and amplified viral nucleic acid from in-use testing of gastrointestinal endoscopes Natural bioburden levels detected on rigid lumened medical devices before and after cleaning Microbiological monitoring of endoscopes: 5-year review Is bacteriologic surveillance in endoscope reprocessing stringent enough? Surveillance cultures of samples obtained from biopsy channels and automated endoscope reprocessors after high-level disinfection of gastrointestinal endoscopes Pseudomonas aeruginosa sepsis following retrograde cholangiopancreatography (ERCP) Pseudomonas septicaemia after endoscopic retrograde cholangiopancreatography: an unresolved problem Acute hepatitis C virus infections attributed to unsafe injection practices at an endoscopy clinic-Nevada Nonhospital health care-associated hepatitis B and C virus transmission: United States News Release: FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities USA: Safety Communication -FUJIFILM Medical Systems validates revised reprocessing instructions Food and Drug Administration: PENTAX validates reprocessing instructions for ED-3490TK video duodenoscopes: FDA Safety Communication Olympus validates new reprocessing instructions for model TJF-Q180V duodenoscopes: FDA Safety Communication Food and Drug Administration: FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk. FDA News Release Urgent medical device removal and corrective action: elevator mechanism replacement, updated operation manual, and new reprocessing instructions for the Olympus TJF-Q180V duodenoscope Outbreaks of carbapenem-resistant Enterobacteriaceae infections associated with duodenoscopes: what can we do to prevent infections? Surveillance of guideline practices for duodenoscope and linear echoendoscope reprocessing in a large healthcare system How to assess risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines Reprocessing failure Food and Drug Administration: Medical device reporting (MDR) Food and Drug Administration: Mandatory reporting requirements: manufacturers, importers and device user facilities Assessing the risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines Analysis of microbial load on surgical instruments after clinical use and following manual and automated cleaning Patient-to-patient transmission of Campylobacter pylori infection by fiberoptic gastroduodenoscopy and biopsy Conventional cleaning and disinfection techniques eliminate the risk of endoscopic transmission of Helicobacter pylori Inactivation of Clostridium difficile spores by disinfectants Inactivation of hepatitis B virus by intermediate-to-high level disinfectant chemicals Viral transmission and fibreoptic endoscopy Elimination of high titre HIV from fiberoptic endoscopes Endoscopic transmission of hepatitis B virus Absence of transmission of hepatitis B by fiberoptic upper gastrointestinal endoscopy Contamination of an endoscope due to Trichosporon beigelli Transmission of trichosporon asahii oesophagitis by a contaminated endoscope Complications associated with esophagogastroduodenoscopy and with esophageal dilation Creutzfeldt-Jakob disease: recommendations for disinfection and sterilization Managing the risk of nosocomial transmission of prion diseases Creutzfeldt-Jakob disease: implications for gastroenterology Current issues in endoscope reprocessing and infection control during gastrointestinal endoscopy Guideline for disinfection and sterilization of prion-contaminated medical instruments Variant Creutzfeldt-Jakob disease (vCJD) and gastrointestinal endoscopy United States Senate; Health, Education, Labor, and Pensions Committee: Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients. Minority staff report Food and Drug Administration: Infections associated with reprocessed duodenoscopes Risk of transmission of carbapenem-resistant Enterobacteriaceae and related "superbugs" during gastrointestinal endoscopy Infection using ERCP endoscopes Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update Food and Drug Administration: Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede A complete reference list can be found online at ExpertConsult .com