1. KING KHALID HOSPITAL INFECTION PREVENTION AND CONTROL MANUALENDOSCOPY Dr. Nahla Abdel Kader, MD, PhD. Infection Control Consultant, MOH Infection Control CBAHI Surveyor Infection Prevention Control Director KKH.

2. DEFINITION To provide recommendations for cleaning, disinfecting and sterilizing endoscopes/accessories in order to minimize the risk of infection transmission from one patient to another.COMMENTS Flexible endoscopy has become an invaluable diagnostic and therapeutic tool. As with all diagnostic and therapeutic procedures, there are always intrinsic and extrinsic risks of complications. To minimize the risk of infection, healthcare providers must ensure that equipment is designed and maintained properly and that guidelines for reprocessing are strictly followed. Reprocessing requires meticulous cleaning and high-level disinfection or sterilization of internal channels, external surfaces, openings, valves and caps. Accessory equipment used to biopsy, brush, or cut tissue must be cleaned and sterilized, or if disposable, discarded. Some disinfectants are inactivated by organic material. Organic soil including blood, excretions, and embedded microbes may contribute to disinfectant failures and prevent the penetration of germicides 3. DEFINITIONS Chemical sterilants refer to liquid chemical agents cleared by the Food and Drug Administration (FDA) for reprocessing reusable medical devices. These products are considered high-level disinfectants or sterilants depending upon time, temperature, concentration, and sporicidal activity. Manufacturers instructions must be followed. Cleaning refers to the physical removal of organic and inorganic material from objects and surfaces. Endogenous Infection occurs when the microflora colonizing the mucosal surfaces of GI or respiratory tract gain access to the blood stream or other normally sterile body sites as a consequence of the endoscopic procedure. (e.g., cholangitis, pneumonia) Endoscope refers to a flexible device use to visualize the interior of a hollow organ. 4. NextDEFINITIONS Endoscopic accessory refers to biopsy forceps, brushes, snares, or other devices introduced through the internal channel of the endoscope during procedures. Exogenous Infection occurs when micro- organisms are transferred from previous patients or the inanimate environment via contaminated endoscopes or accessories. Most common factors associated with transmission include inadequate manual cleaning, inadequate exposure of all endoscopy surfaces to the sterilant, inadequate rinsing and drying, and use of automated endoscope reprocessors. High-level disinfection is the elimination of all forms of microbial life with the exception of large numbers of bacterial spores. Reprocessing refers to the cleaning and high-level disinfection or sterilization of reusable endoscopic devices by either manual or automated methods. Sterilization is the complete elimination or destruction of all forms of microbial life 5. RECOMMENDATIONS A. Processing endoscopes and accessories: 1. If an Automated Endoscope Washer Disinfector (AEWD) is used, ensure that the endoscopes and its components can be effectively reprocessed in the AEWD. Obtain and review model-specific reprocessing protocols from the endoscope and AEWD manufacturers and check for compatibility. 2. Reusable endoscopic accessories (e.g., biopsy forceps or other cutting instruments) that break the mucosal barrier should be mechanically cleaned as described earlier and then sterilized between each patient use (high-level disinfection is not appropriate). 3. Endoscopes (and accessories) that come in contact with mucous membranes are classified as Semicritical items and should receive at least high-level disinfection after each patient use. 6. Next..RECOMMENDATIONS4. All endoscopes received for reprocessing must have the following information on the Endoscope Nursing Record Sheet: a. patient name b. medical record number c. procedure, endoscopist d. identifier number of endoscope used (serial number) 5. Perform pressure/leak testing after each use according to manufacturer guidelines. a. Observe the instrument carefully for continuous bubbling. If continuous bubbling is observed from a given area, this indicates a leak. Remove instrument from water immediately after leak test cycle. Do not use the instrument. b. Dry and clean instrument and place in plastic bag and pack into transport case. Contact appropriate department for repairs. 6. Disconnect and disassemble endoscope components (e.g., air/water and suction valves) as far as possible and completely immerse the endoscope and components in the enzymatic detergent. 7. Next..RECOMMENDATIONS7. Cleaning is essential before manual or automated disinfection. a. Meticulously clean the entire endoscope immediately after use, including valves, channels, connectors, and all detachable parts, according to the manufacturers instructions, using an enzymatic detergent compatible with the endoscope. b. Flush and brush all accessible channels to remove all organic (e.g., blood, tissue) and other residues. Repeatedly actuate the valves during cleaning to facilitate access to all surfaces. c. Clean the external surfaces and components of the endoscope using a soft cloth, sponge, or brushes. 8. Use brushes appropriate for the size of the endoscopes channel, parts, connectors, and orifices (e.g., bristles should contact all surfaces) for cleaning. Cleaning items should be disposable or thoroughly cleaned and disinfected/ sterilized between uses. 8. Next..RECOMMENDATIONS9. Ultrasonic cleaning of reusable endoscopic accessories and endoscope components may be used to remove soil and organic material from hard to clean areas. 10. Select a disinfectant/sterilant that is compatible with the endoscope. Exposure time, concentration, and temperature for disinfection the scope must be followed as per manufacturers recommendations. 11. After high-level disinfection, rinse the endoscope and flush the channels with sterile, filtered, or tap water to remove the disinfectant/sterilant. Discard the rinse water after each use/cycle. a. Flush the channels with 7090% ethyl or isopropyl alcohol and dry using forced-air. The final drying steps greatly reduce the possibility of recontamination of the endoscope by waterborne microorganisms. For storage refer to section: G. Storage of Clean/Sterile Endoscopes 12. High-level disinfect or sterilize the water bottle (used for cleaning the lens and irrigation during the procedure), and its connecting tube at least daily. Sterile water should be used to fill the water bottle. 9. Next..RECOMMENDATIONS13. Perform routine testing of the liquid sterilant/high-level disinfectant to ensure minimal effective concentration (MEC) of the active ingredient. a. Check the solution at the beginning of each day of use (or more frequently) and document the results. If the chemical indicator shows that the concentration is less than the MEC, the solution should be discarded. 14. Discard the liquid sterilant/high-level disinfectant at the end of its reuse life (which may be single use) regardless of the MEC. If additional liquid sterilant/ high-level disinfectant is added to an AEWD (or basin, if manually disinfected), the reuse life should be determined by the first use/activation of the original solution (i.e., the practice of topping off of a liquid sterilant/high-level disinfectant pool does not extend the reuse life of the liquid sterilant/high-level disinfectant). 15. Discard enzymatic detergents after each use, as these products are not microcidal and will not retard microbial growth. 10. Next..RECOMMENDATIONSB. Safety and Quality Control: 1. Policy and procedure on device-specific reprocessing instructions must be written and followed by all CSSD personnel. 2. Operate AEWD or Automated Endoscope Reprocessor systems as per manufacturers recommendations. 3. A regular schedule basis, the CSSD technician must carry out a biological test. 4. Diagnostic test must be carried out and passed prior to instruments being loaded. 11. Next..RECOMMENDATIONS5. Material and Safety Data Sheets must be obtained for each chemical used and stored in the department. 6. Use to correct amount or dilution of chemicals required for each load. 7. A Chemical indicator must be used on each instrument. 8. Filters must be changed as per the manufacturer instructions. 9. Healthcare facilities should develop protocols to ensure that users can readily identify whether an endoscope is contaminated or is ready for patient use. 12. Next..RECOMMENDATIONSC. Quality Control Sampling: 1. Quantitative microbiologic cultures may be taken randomly from the endoscopes and washing machines for quality assurance. The criterion of acceptability is absence of growth of vegetative bacteria. Depending on the results of monitoring, the need for ongoing routine microbiologic culturing should be discussed with the Infection Control Staff. 2. Cultures of endoscopes are indicated only where clinical or epidemiological findings suggest endoscopy-related transmission of infection. 3. Brushings should be obtained from the suction and biopsy channels with a sterile brush, and sent for culture and sensitivity. The criterion of acceptability is the absence of growth of vegetative bacteria 13. Next..RECOMMENDATIONSD. Design of the endoscopy suite: There are a number of factors to be considered in the design and use of space for endoscopic procedures and the cleaning, disinfection, sterilization and storage of endoscopes and endoscopic equipment. 1. Separate space used for the performance of procedures from the space used for cleaning, and sterilization equipment. 2. Provide separate designated sinks for hand hygiene and utility. 3. Air exchanges in the suite should meet the latest CDC guidelines to prevent the transmission of Tuberculosis, 12 air changes per hour. 4. The area should be planned to allow for sound infection control practices e.g., avoidance of proximity of clean and contaminated equipment. 5. Do not allow eating or drinking in procedure and utility rooms 14. Next..RECOMMENDATIONSE. Reprocessing Technicians: 1. Personal protective equipment (gloves, gowns, eyewear, respiratory protection devices, etc.) should be readily available and should be used, as appropriate, to protect workers from exposure to chemicals, blood, or other potentially infectious material. 2. Strict use of hand hygiene by all healthcare workers. 3. All healthcare personnel assigned to reprocess endoscopes should be trained in, and adhere to, standard infection control recommendations, including those to protect both patients and healthcare workers. a. Personnel should receive device-specific reprocessing instructions to ensure proper cleaning and high-level disinfection or sterilization. b. Competency testing of personnel should be done regularly (e.g. annually) c. Temporary personnel should not be allowed to reprocess endoscopes until competency has been established. 4. All personnel using chemicals should be educated about the biological and chemical hazards present while performing procedures that use disinfectants 15. Next..RECOMMENDATIONSF. Cleaning and disinfection area: 1. Space used for the cleaning, disinfecting, and sterilizing should have adequate ventilation to exhaust toxic vapors. 2. Air-exchange equipment (ventilation system, exhaust hoods, etc) should be used to minimize the exposure of all persons to potentially toxic vapors released from chemical sterilants. 3. The air system should provide at least 12 air change per hour for negative room pressure. 4. The utility sink used to clean instruments should be functionally separate from the hand hygiene sink, and be large enough to accommodate the endoscope and accessories. 5. Adequate space should be designated for the storage of chemical sterilant, with consideration given to their special handling requirements as hazardous materials. 6. Cleaning/disinfection and sterilization will be carried out by trained personnel only. 16. Next..RECOMMENDATIONSG. Storage of Clean/Sterile Endoscopes: 1. Examine and test endoscope for proper angulation before storing. Hold fiberscope with both hands when storing to prevent banging against cupboard and therefore damaging fiberoptic bundles. a. When storing the endoscope, hang it in a vertical position to facilitate drying (with caps, valves and other detachable components removed as per manufacturer instructions). 2. Endoscopes should be stored in a vertical manner that will protect the endoscope and minimize the potential for residual moisture accumulation; and allow for proper airing to ensure endoscopes are kept dry. 3. Cabinets used for drying and storage of endoscopes should be constructed of material that can be cleaned easily. 4. Endoscopes should not be stored in foam-lined cases, as foam lining is impossible to clean and harbors contamination. 5. Endoscopes should be stored in a manner that will protect the endoscope from contamination 17.