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Review question/objective How long (in days) do flexible endoscopes that have undergone reprocessing with high‐level disinfection (HLD) maintain the same level of disinfection and remain safe to use when stored as recommended by the manufacturer? The objective of this review is to systematically review the best available evidence related to the safe hang time or storage time (in days) of flexible endoscopes that have undergone reprocessing with high‐level disinfection in order to determine when they can be safely used without posing any risk of contamination from pathogens. Background Endoscope definition and use Endoscopes are used worldwide to screen for colon cancer and provide diagnostic information for gastrointestinal (GI) and pulmonary conditions, as well as for therapeutic interventions (e.g. removing biliary tract stones, removing polyps, cauterizing blood vessels in bleeding ulcers) and for surveillance purposes. An estimated 55 million endoscopies were performed in the United States in 2009 and 50% were for colonoscopies.1 The exact number of endoscopic procedures performed worldwide is unknown. However, endoscopy is commonly used for early detection of three of the 20 leading causes of death worldwide.2 These include tracheal, bronchial and lung cancer (eighth leading cause at 1.3 million deaths); stomach cancer (17th at 0.8 million deaths); and colorectal cancer (20th at 0.6 million deaths). Endoscopy is also used to diagnose conditions such as peptic ulcer disease, inflammatory bowel disease, irritable bowel syndrome, celiac disease, diverticulosis, gastro‐esophageal reflux disease and other digestive diseases which may not have such high mortality rates, but still cause significant morbidity and loss of productivity. Endoscopes are mechanical instruments that are inserted through a natural orifice in the body in order to look directly at the internal organs.3 They can be inserted through the mouth or anus in order to look directly at the walls of the gastrointestinal tract (Figure 1). A specific endoscope, the bronchoscope, is inserted through the mouth or the nose in order to view the trachea and passageways to the lungs. The first endoscopes were very rigid, but innovations in technology have produced a more flexible instrument. Current endoscopes are flexible, have fiber‐optics to provide light and moveable parts that can be threaded around angles in the GI tract. The most advanced endoscopes now utilize computer technology to provide enhanced imagery, video recordings and final reports. The endoscope essentially has a camera attached to a long, thin tube which moves through the openings in the body and projects the images onto an external screen. The endoscope can be used to look at the trachea, bronchi and lungs (bronchoscopy); colon (colonoscopy and sigmoidoscopy); esophagus and stomach (upper gastrointestinal endoscopy); and biliary tract (endoscopic retrograde pancreatography). Figure 1: Parts of the Flexible Endoscope The flexible endoscope is a complex instrument with delicate parts which break or malfunction unless the endoscope is handled appropriately. As seen in Figure 1, the endoscope has four major parts: the control body, the insertion tube, the bending section (distal tip) and the light guide connector. The internal components of the endoscope include: (a) a mechanical system which permits the tip to be manipulated in different directions; (b) a plumbing system with suctioning to remove gas, secretions, irrigants and other fluids; and (c) an illumination system which allows the inside of the body to be seen on a monitor. The endoscope also has removal accessories which include valves and caps.4 Endoscopes are inserted through the upper respiratory tract or the gastrointestinal tract, which contain colonies of microorganisms (e.g. bacteria, viruses). Therefore, a used endoscope must be appropriately cleaned and reprocessed to remove all microorganisms in order to avoid infecting subsequent patients. Reprocessing is a standardized process of pre‐cleaning, leak testing, manual cleaning, rinse after cleaning, high‐level disinfection (manual or with automated reprocessors), rinsing to remove high‐level disinfectants, drying and storage. Strict adherence to reprocessing guidelines effectively removes all microorganisms and most spores from contaminated endoscopes, without damaging the scopes. Although sterilization is more effective at killing microorganisms and spores, it cannot be used because it damages the scopes. Need for and nature of reprocessing Proper reprocessing of endoscopes and accessories is critical to the safe and successful treatment of patients.5 The Society of Gastroenterology Nurses and Associates (SGNA),3 the American Society for Gastrointestinal Endoscopy (ASGE),5 and the European Society of Gastrointestinal Endoscopy,6 support increased research in the areas of endoscope design. They encourage manufacturers to develop flexible gastrointestinal endoscopes that are easily disassembled for reprocessing and verifying the effectiveness of both cleaning and high‐level disinfection. Flexible endoscopes reprocessed according to national and international standards pose virtually no risk of transmission of patient‐borne or environmental microorganisms when scopes are used soon after being reprocessed.3 Endoscopes which are not reprocessed following these standards may develop biofilm, a matrix of different types of bacteria that adhere to the endoscopes and are resistant to high‐level disinfection.7,8 Failure to adhere to established reprocessing guidelines, defective endoscopes and automated reprocessors, and contaminated water sources account for all of the reported cases of bacterial and viral transmissions.5 In the absence of defective equipment, every reported case of hospital acquired infection associated with a contaminated endoscope has been linked to a breach in the requisite reprocessing steps.5 The Spaulding classification system is universally used to choose the appropriate method of disinfection or sterilization for a particular class of medical device.5 Medical devices are classified as critical, semi‐critical or non‐critical, depending on how the device is used. Critical devices (e.g. reusable biopsy forceps) break the mucosal barrier and should be sterilized. Semi‐critical devices (e.g. endoscopes) come in contact with mucous membranes or non‐intact skin and should be sterilized or receive high‐level disinfection. Non‐critical devices (e.g. blood pressure cuffs and stethoscopes) touch intact skin and can be cleaned with soap and water or disinfected with a germicide. Steps in endoscope reprocessing (including high‐level disinfection) As a semi‐critical device, endoscope reprocessing includes cleaning, high‐level disinfection, high‐level rinsing and drying.5,9 1. Cleaning. Cleaning includes pre‐cleaning, leak testing and manual cleaning and rinsing. First, the endoscope is immediately pre‐cleaned after use in order to remove gross contamination before it can adhere and harden. Prompt efficient cleaning helps to prevent biofilm, a matrix of microorganisms and other debris that form on the endoscope surfaces and are resistant to high‐level disinfection. After removing the detachable parts, the endoscope is tested for leaks in order to determine whether it can be safely reprocessed. After leak testing, the endoscope is mechanically cleaned with brushes, detergents and rinses. All interior channels are cleaned with a low foaming enzymatic detergent and brushes. The scope is thoroughly rinsed with water after cleaning to remove all detergent and debris. 2. Disinfecting. Once an endoscope has been properly cleaned, it must be immersed in an approved high‐level disinfectant to kill microorganisms. A high‐level disinfectant is a type of germicide that is used only on inanimate objects because it damages human tissue. High‐level disinfectants destroy all viruses, vegetative bacteria, fungi, mycobacterium and most, but not all, bacterial spores.9 The endoscopes are placed in approved basins that allow full immersion in the disinfectant and remain immersed for the length of time recommended by the manufacturer. Although high‐level disinfection can be done manually, most American endoscopy units use automated endoscope reprocessors which can be programmed to provide the proper immersion and contact time. The use of non‐immersible endoscopes is no longer acceptable because endoscopes that cannot be completely immersed in liquid cannot be adequately cleaned and disinfected.10 3. Rinsing. Immediately after disinfection, the scope is rinsed with sterile, filtered or tap water that meets clean water standards. Thorough rinsing is essential to remove all traces of disinfectant which is toxic to body tissues. If there is any possibility that the water used for rinsing could reintroduce microorganisms into the scope, sterile water should be used. The World Gastroenterology Organisation recommends boiled water when other sources of safe water are unavailable.11 4. Drying. The final step in the process is drying of the endoscope. Alcohol is often utilized followed by forced air through the channels to completely dry the entire endoscope prior to storage. Alcohol is not used in all countries because of its fixative properties or when reprocessed scopes will not be subjected to overnight or longer storage.6 5. Storage. Endoscopes are stored (with detachable parts removed) in cabinets that allow them to hang freely in order to prevent the accumulation of moisture, a medium for growth of microorganisms (Figure 2). The endoscopes should be hung vertically and steps should be taken to avoid their recontamination. The storage area must be clean, dust free and well ventilated so that the scopes remain clean and dry. Examples of recontamination of an endoscope while in storage include incidental touching, dust, or airborne contaminants. Inadequate endoscope drying and improper storage

jbi database of systematic reviews and implementation reports

The length of time that flexible endoscopes which have undergone reprocessing with high-level disinfection can safely be stored before use: a systematic review protocol