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endoscope manual cleaningPlease upgrade your browser to improve your experience. Our portfolio of products is designed to break down soils and protect the integrity of delicate devices. Registered in Ireland No 595593 Registered office: 70 Sir John Rogerson's Quay, Dublin 2 Ireland. Please upgrade your browser to improve your experience. Our products make it easy for you to quickly process your endoscopes, increasing throughput while maintaining the highest level of patient care and compliance to standards and guidelines. Our portfolio of products is designed to break down soils and protect the integrity of delicate devices.Registered in Ireland No 595593 Registered office: 70 Sir John Rogerson's Quay, Dublin 2 Ireland. For optimal results, our manual cleaning products and detergents are designed to be a critical first step to efficiently and effectively reduce the bacterial load on endoscopes prior to reprocessing. Thank you for your interest in Cantel Medical. By submitting the contact form I agree to the processing. Accedendo a tali pagine, l'utente dichiara di essere un operatore professionale.Some of all cookies are categorized as necessary. The necessary cookies are used to guarantee the operation and basic functionalities of the website and are stored on your browser. We also use third-party cookies, to help us analyze the use of the website. This enables us to improve the website and increase your ease of use. The cookies are stored in your browser, but only with your permission. You can decline these cookies at any time, but this could affect your experience. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information. All rights reserved.http://www.horb.com.cn/cms3/userfiles/fckFile/20200921004055.xml
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Moving Away From Manual Reprocessing of Endoscopes August 10, 2018 Relevant Topics By Sunny Vestal, MS, CST, CRCST, CHL, CIS, CER By Sunny Vestal, MS, CST, CRCST, CHL, CIS, CER Endoscopes are used for therapeutic or diagnostic procedures and are highly contaminated once used (Ofstead et al., 2015). The process to clean and disinfect endoscopes is complicated and involves numerous steps and knowledge. Furthermore, the cost of labor involved in the manual reprocessing of an endoscope leaves room for opportunity. For many years, the preferred method to high-level disinfection (HLD) was the manual soak method due to low upfront costs. However, it is becoming a more widely held belief that manual cleaning poses a threat to the safety of patients as steps in the cleaning and disinfection process can be missed (Ofstead et al., 2015). Many recommendations and manufacturer’s instructions for use are moving away from allowing manual high level disinfection as an option for device reprocessing. Countries all over the world are moving to AERs for their endoscope reprocessing needs as they understand the cost savings associated with using an AER versus manual cleaning (Funk and Reaven, 2014). The use of an automated endoscope reprocessor (AER) limits the potential for cross contamination and ensures that all steps in the cleaning and disinfection process are met. In addition, it protects the staff member from exposure to harsh and damaging chemicals. The driving force behind the transition to an automatic reprocessor versus manual disinfection is the increased potential for cross-contamination between patients with the manual disinfection method. Endoscopes pose a high risk to patients if not properly disinfected or sterilized. Automatic endoscope reprocessors decrease the risk for cross contamination. Some AERs have the ability to wash an endoscope nearly cutting out all of the manual reprocessing steps.http://suyogmaratha.com/editorimages/digital-photo-frame-manual-en-espa-ol.xml Furthermore, evidence proves that using an AER can help to reduce the bacterial growth in endoscopes as opposed to manual cleaning (Gavalda et al., 2015). Although the upfront cost of the AER and the consumables may pose a stark contrast to the cost of the manual disinfection process, the cost is ultimately offset by number of hours spent reprocessing and additional endoscopes that will be able to be processed as a result of the saved time. In a study by Ofstead, et al. (2015), viable microbes were found on endoscopes after the manual disinfection process took place. In addition to numerous other studies with similar results, AERs prove to be the better option. By switching from a manual cleaning method to an AER, practices are further aligned with patient safety measures to provide quality patient care to the population. As direct patient-care participants, nurses and technicians in the operating or procedure room have a high level of responsibility in ensuring that endoscopes are being disinfected properly. Additionally, the physicians have an investment in the way endoscopes are disinfected as they are primarily responsible for the outcome of the patient. Accrediting bodies such as the Joint Commission and the Centers for Medicare and Medicaid Services (CMS) have high-level disinfection processes high on their radar, and rightfully so. This topic brings alarm to any healthcare provider, as there are many possibilities for human errors with a manual HLD method. It is an industry standard that processes involving high level disinfection require a quality measurement to assess the efficacy of steps being performed (Komanduri et al., 2014). Evaluating the steps performed by manual cleaning and automatic endoscope reprocessing and performing a risk assessment in your own departments can substantiate the claim that endoscope reprocessors are superior to manual cleaning. References: Funk S and Reaven N. (2014).http://www.jfvtransports.com/home/content/boss-metal-zone-owners-manual High-level endoscope disinfection processes in emerging economies: financial impact of manual process versus automated endoscope reprocessing. Journal Of Hospital Infection, 86:250-254. Gavalda L, Olmo AR, Hernandez R, Dominguez MA, Salamonsen MR, Ayats J, Alcaide F, Soriano A and Rosell A. (2015). Microbiological monitoring of flexible bronchoscopes after high-level disinfection and flushing channels with alcohol: Results and costs. Respiratory Medicine, 109:1079-1085. Ofstead CL, Wetzler HP, Doyle EM, Rocco CK, Visrodia KH, Baron TH and Tosh PK. (2015). Persistent contamination on colonoscopes and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines. Am J Infect Control, 43:794-801. Komanduri S, Abu Dayyeh BK, Bhat YM, Chauhan SS, Gottlieb KT, Hwang JH, Konda V, Lo SK, Manfredi M, Maple JT, Murad FM, Siddiqui UD, Wallace MB and Banerjee S. (2014). Report on emerging technology: Technologies for monitoring the quality of endoscope reprocessing. Find articles by Jin Su Kim Author information Article notes Copyright and License information Disclaimer Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. Corresponding author. Correspondence: Jin Su Kim. Division of Gastroenterology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea. This article has been cited by other articles in PMC. Abstract Gastrointestinal endoscopy is effective and safe for the screening, diagnosis, and treatment of gastrointestinal disease. However, issues regarding endoscope-transmitted infections are emerging. Many countries have established and continuously revise guidelines for endoscope reprocessing in order to prevent infections.http://myhouseboatamsterdam.com/images/comfar-user-manual.pdf While there are common processes used in endoscope reprocessing, differences exist among these guidelines. It is important that the reprocessing of gastrointestinal endoscopes be carried out in accordance with the recommendations for each step of the process. Keywords: Endoscopy, Reprocessing, Guideline INTRODUCTION Endoscopy is used worldwide for the screening, diagnosis, and treatment of gastrointestinal (GI) diseases and enables early detection and treatment of malignant GI diseases. Despite its efficacy, there are several reports that raise concerns about infections that are transmitted via endoscopy. 1, 2, 3 Consequently, several countries have revised evidence-based guidelines on endoscope reprocessing in order to reduce the number of infections and improve safety. In March 2015, the Korean Medical Association released its third revision of guidelines for endoscope reprocessing. Herein, we discuss reprocessing protocols for GI endoscopes including recently revised guidelines from medical associations around the world including the Multisociety guidelines, European Society of Gastrointestinal Endoscopy (ESGE) guidelines, European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) guidelines, British Society of Gastroenterology (BSG) guidelines, and World Gastroenterology Organization (WGO) guidelines. COMMON REPROCESSING PROTOCOL FOR GI ENDOSCOPES There are seven steps involved in the reprocessing of GI endoscopes: precleaning, cleaning, rinsing, disinfection, rinsing, drying, and storage. These steps are similar across various guidelines. 4, 5, 6, 7, 8 (1) Precleaning is the first step of reprocessing, and should be conducted at the bedside immediately after completing the endoscopic procedure. Precleaning involves the removal of visible debris by wiping the exterior of the endoscope with an appropriate detergent solution. Air and solution should be passed through the biopsy channel repeatedly. After precleaning, endoscopes need to be transported to another room for the disinfection process. If the room is not adjacent, the container for the endoscopes should be closed. (2) Cleaning is the next step. Before cleaning the endoscopes, a leak test should be performed, and all detachable parts should be separated. Clean the external surface of the endoscope with detergent using soft cloths, sponges, or brushes. Flush and brush all accessible channels to remove debris and other contaminants. Hard-to-clean areas or accessories should be cleaned with an ultrasonic cleaner. After cleaning, rinse with clean water to remove the detergent on the endoscopes. (3) Rinsing includes flushing the endoscope, channels, and all accessories with sterile water. (4) High-level disinfection is recommended after the cleaning and rinsing processes. The endoscope and its components should be completely immersed in a high-level disinfectant solution, ensuring that all channels are well perfused. The appropriate exposure time and temperature for high-level disinfection are specific to each disinfectant and its concentration. An automated endoscope reprocessor can be used for high-level disinfection. (5) After disinfection, the endoscope, channels, and all accessories receive a final rinse with sterile water. (6) The endoscopic channels are dried by flushing with forced air and ethyl or isopropyl alcohol (70 to 90). (7) Storage requires keeping the endoscopes in a safe and sterile environment, usually hanging the endoscopes in a vertical position without touching the floor. KOREAN GUIDELINES FOR ENDOSCOPE REPROCESSING In 1995, the Korean Society of Gastrointestinal Endoscopy established the first endoscope reprocessing guideline. Since then, the guidelines have been revised in August 2009, August 2012, and March 2015. The most recent 3rd revision included the criteria to assess reprocessing for not only the certification of individual medical facilities but also the quality assessment of national cancer endoscopic screening. The overall process of endoscope reprocessing is the same as the common reprocessing protocol. The main change in the recently updated guidelines addressed the issue of reprocessing endoscopic accessories. It is no longer acceptable to reuse single-use (disposable) forceps or needles after sterilization. However, thus far, the Korean National Health Insurance Service has not provided appropriate reimbursement for single usage of forceps. Therefore, owing to practical limitations, many clinicians have needed to use single-use forceps. As stated above, the Korean Society of Gastrointestinal endoscopy updated and clarified the recommendation regarding endoscopic accessories in their third revision. Thanks to their efforts, the reasonable cost of the biopsy forceps can be recovered. There are several different details from other guidelines for reprocessing endoscopes. For example, unlike the BSG and ESGE-ESGENA guidelines, there is no recommendation for microbiological surveillance. Also, the water bottle and connectors should undergo high-level disinfection every day and the water should be sterilized. MULTISOCIETY GUIDELINES In 2003, the American Society for Gastrointestinal Endoscopy and the Society for Healthcare Epidemiology of America developed an initial set of guidelines for reprocessing GI endoscopes. Updated guidelines were published in 2011 along with additional discussions on evolving issues and the latest literature citations. Also, the minimum effective density of the active ingredient should be present in high-level disinfectants and the solution must be checked every day before use. The solution should be discarded when the concentration of the solution is less than the minimal effective density. 7, 9, 10, 11 Unlike other guidelines, these guidelines include recommendations that emphasize protection from exposure to hazards and chemicals for those who participate in reprocessing. All participants should wear personal protective equipment and work in a safe environment (category IB and IC). Also, they should be educated properly about hazards (category IC). 7, 9, 10, 12 In addition, these guidelines use the Spaulding classification of medical devices, which is used by the FDA, the Centers for Disease Control and Prevention, epidemiologists, and many other international organizations to determine the effectiveness of disinfection or sterilization. High-level disinfection is the destruction of mycobacteria, microorganisms, viruses, fungal spores, and some, but not all, bacterial spores. In addition, the following four unresolved issues are discussed: (1) How long can endoscopes be stored between use. The Association of periOperative Registered Nurses recommends 5 days, while the Association for Professionals in Infection Control and Epidemiology recommends 7 days before reprocessing. (2) How long can water bottles, tubing for air insufflation, lens wash water, waste vacuum canisters, and suction tubing be used before being replaced. The Association of periOperative Registered Nurses recommends replacing all items after each procedure. (3) How long can endoscopes be used before replacement. Determining the durability and longevity of endoscopes requires additional research. (4) Is microbiological surveillance testing required after reprocessing, during storage, or before use of endoscopes. The Gastroenterological Society of Australia and the guidelines of the combined ESGE and the ESGENA committee recommend this measure. However, this has not been advised in the current American standards. The necessity of environmental microbiological testing of endoscopes for quality assurance has not been established but warrants further study. ESGE-ESGENA GUIDELINES In 1994, the ESGE-ESGENA Guideline Committee of the ESGE and the ESGENA established guidelines for infection control of GI endoscopes. In 2008, ESGE-ESGENA updated the guidelines for cleaning and disinfection of GI endoscopes. 4 Apart from the seven steps of endoscope reprocessing similar to other guidelines, they provided detailed information for three different available reprocessing methods: automated washer-disinfectors, automated disinfection devices, and manual reprocessing followed by precleaning and manual cleaning. Using the automated washer disinfector includes all the processing steps from the leakage test to drying. Using the automated disinfection device includes rinsing and disinfection, along with final rinsing and drying. The ESGE and ESGENA strongly recommend the use of washer-disinfectors including cleaning and disinfection. Compared with manual reprocessing, automated reprocessing provides a standardized and validated reprocessing cycle. In addition, it ensures highly reliable reprocessing and minimal staff hazard and lowers the risk of scope damage. According to European standard EN 14885, disinfectants are effective at room temperature when they are used manually or in automated disinfection devices. 15 They rely on an aldehyde group (glutaraldehyde, formaldehyde, and orthophthalaldehyde) or an oxidizing substance (chlorine dioxide, hypochlorous acid, and peracetic acid and its salts). Biliopancreatic procedures require the usage of sterile accessories. Reusable devices should be autoclavable. For example, balloons cannot be autoclaved and the use of reprocessed balloons increases the risk of biliopancreatic duct infection. Likewise, injection needles should be used only once, and in no circumstance should be reprocessed, because dismantling of needles is dangerous and the lumen of the needle is inaccessible for cleaning. They also recommend process validation and microbiological surveillance. Manufacturer's instructions should be followed when performing process validation for washer disinfectors. Regular microbiological surveillance testing, at intervals less than 3 months, is recommended. 16 Washer disinfector, endoscopes, and the water used in endoscopy should be tested at the same time. Moreover, regular quality control must include testing of water bottles. 6, 17 BSG GUIDELINES The 2008 guidelines were updated in 2014. The process of reprocessing is described in two parts. The first is manual cleaning, which includes precleaning, cleaning, and rinsing. The second is automated disinfection by using endoscope washer disinfectors (EWDs), followed by drying and storage. Guidelines for the reprocessing of endoscopes recommend almost the same process as other guidelines. However, several details differ from other guidelines. In the manual cleaning process, the use of enzymatic detergents to digest mucus and other biological material from endoscopic channels is no longer recommended, because of reports of occupational asthma and skin reactions. 18, 19 These guidelines do not recommend any manual disinfection method. The only recommended EWD is the automated disinfection device. Furthermore, they strongly recommend the EWD for the disinfection process after manual cleaning. Glutaraldehyde-based disinfectants, widely used disinfectants, are no longer used in the United Kingdom owing to two reasons: occupational safety concerns, an example of which is asthma, and the potential risk of residual cross-linked protein or prion material. There are four other disinfectants that can be used for reprocessing of endoscopes: orthophthalaldehyde (0.55), peracetic acid (0.2 to 0.35), chlorine dioxide, and electrolytically generated hypochlorous acid. 20 Accessories that pass through the working channel of endoscopes should be used only once, such as cytology brushes, polypectomy snares, injection needles, biopsy forceps, and most endoscopic retrograde cholangiopancreatography accessories. 21, 22 Currently, most biopsy forceps are reused but the discovery of variant Creutzfeldt-Jakob disease has caused a shift towards single use. Accessories that are not passed through the working channel can be reused when sterilized, such as bottles and bougies. Also, heater probes can be reused and should be sterilized. 21 BSG guidelines also recommend a microbiological surveillance test for assurance. The final rinse water should be sampled from the EWD and tested weekly for its microbiological quality in accordance with the current relevant European Standard, Health Technical Memorandum, or Choice Framework for local Policies and Procedures. 23, 24, 25, 26 WGO GUIDELINES The committee of the WGO is composed of representatives from Europe, America, and Japan. In 2011, they updated the guidelines for reprocessing endoscopes. In order to improve compliance, WGO guidelines introduced the standard procedures with alternatives options that could be used when there are certain external limitations. For example, the cleaning process should be performed with an enzymatic detergent, but it can be performed with a non-enzymatic detergent in case of external limitations. Also, if personnel cannot rinse the endoscopes and valves with filtered water, they can rinse them under running tap water of drinking-water quality. Endoscopic accessories that penetrate the mucosal barrier should be used only once or sterilized between each use. However, single-use is preferred. If disposable accessories are to be reused despite external limitations, they should be perfectly sterilized. 9, 10, 27, 28, 29, 30, 31 Microbiological surveillance testing is recommended. Samples of the final rinse water from the automatic reprocessor should be subjected to microbiological testing at least weekly. 16, 23, 24, 25, 26 CONCLUSIONS Different organizational guidelines for reprocessing GI endoscopes are similar, but they include subtle differences ( Table 1 ). Reprocessing of GI endoscopes should be carried out according to recommendations for each step of the process, whether using manual or automated methods. Many associations are trying to develop evidence-based guidelines for the reprocessing of GI endoscopes. The evolution of disinfectants and automated machines for reprocessing are required to ensure endoscopic safety. Lastly, guidelines should reflect both new procedures and practical limitations. Table 1 Comparison of Different Details among Guidelines Open in a separate window ESGE, European Society of Gastrointestinal Endoscopy; ESGENA, European Society of Gastroenterology and Endoscopy Nurses and Associates; BSG, British Society of Gastroenterology; EWD, endoscope washer disinfector; WGO, World Gastroenterology Organization. Footnotes Conflicts of Interest: The authors have no financial conflicts of interest. References 1. Gorse GJ, Messner RL. Infection control practices in gastrointestinal endoscopy in the United States: a national survey. Petersen BT, Chennat J, et al. Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011. Epic3: national evidence-based guidelines for preventing healthcare-associated infections in NHS hospitals in England. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Association for Professionals in Infection Control. ASGE Standards of Practice Committee. Banerjee S, Shen B, et al. Infection control during GI endoscopy. Daniel G, Hoffman W, McDonald B. OSHA compliance: issues ethylene oxide in a commercial sterilization operation. Rutala WA, Clontz EP, Weber DJ, Hoffmann KK. Rutala WA, Weber DJ. Disinfection and sterilization in health care facilities: what clinicians need to know. Gebel J, Exner M, French G, et al. The role of surface disinfection in infection prevention. Beilenhoff U, Neumann CS, Rey JF, et al. Bader L, Blumenstock G, Birkner B, et al. HYGEA (Hygiene in gastroenterology: endoscope reprocessing): study on quality of reprocessing flexible endoscopes in hospitals and in the practice setting. Cobbold A, Lord S. A critical guideline appraisal overview: Choice Framework for local Policy and Procedures (CFPP) 01-06 Decontamination of flexible endoscopes 2013. Part 1: Policy and management and Part 3: Operational management manual. Heederik D, Houba R, Liss GM, Millerick-May M. Protecting the worker and modifying the work environment. In: Malo JL, Chan-Yeung M, Bernstein DI, editors. Bramble MG, Ironside JW. Spaulding E, Groschel D. Hospital disinfectants and antiseptics. In: Lennette EH, Spaulding EH, Truant JP, editors. Leung J, Vallero R, Wilson R. Surveillance cultures to monitor quality of gastrointestinal endoscope reprocessing. Moses FM, Lee J. Surveillance cultures to monitor quality of gastrointestinal endoscope reprocessing. Moses FM, Lee JS. Current GI endoscope disinfection and QA practices. Tunuguntla A, Sullivan MJ. SGNA Practice Committee. Reprocessing of endoscopic accessories and valves. Patient-to-patient transmission of hepatitis C virus during colonoscopy. BSG Endoscopy Committee Working Party. Cleaning and disinfection of equipment for gastrointestinal endoscopy. Association of periOperative Registered Nurses. Spach DH, Silverstein FE, Stamm WE. Transmission of infection by gastrointestinal endoscopy and bronchoscopy. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. Abstract 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.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. Principles of Reprocessing Cleaning Meticulous physical cleaning must always precede disinfection and sterilization procedures, because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. 18 Mechanical cleaning alone reduces microbial counts by approximately 10 3 to 10 6 (three to six logs), equivalent to a 99.9 to 99.9999 reduction in microbial burden. 19, 20, 21, 22, 23, 24, 25, 26 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 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.