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Guideline for processing flexible endoscopes
PERIOP BRIEFING
GUIDELINE FIRST LOOK
Guideline for processing flexible endoscopes Kelly Putnam, Managing Editor
T
he updated “Guideline for processing flexible endoscopes” details how to minimize flexible endoscope contamination.1 According to a review of reported lapses, failing to preclean endoscopes before processing, using incorrect containers to transport contaminated endoscopes, and inadequate cleaning of channels and elevators were among the noncompliance events that may expose patients to contaminated scopes.2 The updated guideline provides evidence-based recommendations for endoscopy processing room design and best practices for leak testing, cleaning, inspecting, and storing flexible endoscopes.
Effective endoscopy processing room design After precleaning flexible endoscopes in the procedure room, perioperative team members should transport them to a designated processing area as soon as possible. Personnel should keep endoscopes damp, but not submerged in liquid that could spill or splash and contaminate other areas. To transport flexible endoscopes from the point of use to the processing room, team members should use a closed, leak-proof, puncture-resistant container or cart large enough to contain endoscopes coiled in large loops to prevent damage from tight coiling. Having a physically separate area for processing activities prevents contamination of procedure rooms and patient care areas. “The design of the endoscopy suite, the processes in place for maintaining and controlling the environment, and the procedures performed in the facility all affect processing of flexible endoscopes,” said Sharon Van Wicklin, MSN, RN, CNOR, CRNFA(E), CPSN-R, PLNC, senior perioperative practice specialist at AORN and lead author of the guideline. The minimum recommended design for an endoscope processing area is a single room with distinct decontamination and clean areas to minimize cross contamination; the updated guideline details the recommended design components of the processing area (e.g., automatic or foot-operated doors).1 http://dx.doi.org/10.1016/S0001-2092(15)01158-8
P10 | Periop Briefing
Personnel working in the endoscopy processing room should wear surgical masks, eye protection, fluid-resistant gowns, utility gloves that extend over the cuff of the gown, and fluid-resistant shoe covers to protect them from exposure to potentially infectious material when handling the endoscopes.
Key steps to minimize endoscope contamination Qualified personnel should clean and disinfect or sterilize flexible endoscopes according to the manufacturers’ instructions for use (IFU). Manually cleaning endoscopes as soon as possible after leak testing limits the formation of biofilm. Following manual cleaning and visual inspection, personnel should follow manufacturers’ IFU for packaging and sterilization or mechanical processing, which helps ensure consistency and limits personnel’s exposure to biohazardous materials. Leak testing Personnel should leak test all flexible endoscopes including those that are new, loaned, or repaired, or require processing before use.1 The purpose of the leak test is to identify any damage to the endoscope and prevent further damage that may occur throughout the cleaning process if it is not sealed. For endoscopes that require leak testing, personnel should remove all port covers and function valves, pressurize the endoscope while it is in a loose configuration, manipulate all moving parts, and actuate video switches. Pressurizing the endoscope to the manufacturer’s recommended pressure for at least 30 seconds increases the likelihood of detecting a leak and minimizes the risk of damaging the scope. Manual cleaning Cleaning uses friction, water, and cleaning solutions to remove organic material and soil; it does not directly kill microorganisms. Cleaning solutions may include general purpose cleaners, which act as detergents, and enzymatic cleaners, which contain a mixture of enzymes that each break down a specific target compound (e.g., lipids,
proteins, carbohydrates). In a study comparing the effectiveness of various cleaning solutions and disinfectants to remove biofilm, enzymatic cleaners were more effective than detergents; aldehyde agents not only failed to remove biofilm but also made it more difficult to remove.3 Personnel should follow the manufacturers’ IFU regarding water quality, hardness, pH, and temperature; cleaning solution concentration, storage, and shelf life; and contact time between the device and solution. In addition, personnel should use brushes of the recommended size and material, especially for the channel lumens; the brush needs to have maximal contact with endoscope surfaces without damaging them. Advances in brush technology (e.g., elastomer discs, microfiber brushes) aim to optimize contact between the brush and surfaces to help ensure bioburden removal. Visual inspection Before high-level disinfection or sterilization, personnel should visually inspect cleaned flexible endoscopes and accessories to identify any residual debris or defects that warrant removal from use and repair.1 The guideline recommends using lighted magnification to inspect endoscopes for damage and suggests inspecting internal channels (Figure) with a camera or borescope. Visual inspections should assess cleanliness, missing parts, clarity of lenses, integrity of seals and gaskets, moisture, and correct functioning.1 High-level disinfection and sterilization According to the Spaulding classification, critical items that enter sterile tissue or the vascular system should be sterilized, whereas semicritical items that come in contact with broken skin or mucous membranes can be sterilized or high-level disinfected.4 A recently proposed modification to the Spaulding classification system would expand the definition of critical items to include devices that secondarily enter sterile tissue
or the vascular system via a mucous membrane (e.g., a bronchoscope enters the bronchi through the mouth or nose).5 Adopting this modification would mean that all flexible endoscopes should be sterilized; this could help prevent patient infections because sterilization eliminates all microorganisms and bacterial spores, which can linger even after high-level disinfection. The modification would also address the issue of critical endoscope accessories that pass through the endoscope and may be exposed to residual pathogens in an endoscope that has not been sterilized.
Requirements for endoscope storage Personnel should store endoscopes in cabinets with doors that are located near, but not in, the endoscopy procedure room, and at least three feet from any sink to reduce potential contamination. Endoscopes should be stored in a drying cabinet that circulates filtered air and also forces the filtered air through the endoscope channels. If a drying cabinet is not available, endoscopes should be stored in a closed cabinet with positive pressure that allows circulation of filtered air around the endoscopes.1 “Our previous recommendation for a maximum storage time of five days before reprocessing has gone away,” said Van Wicklin. “We are now
Inner channels
of flexible endoscopes. Reprinted with permission
from Guidelines for Perioperative Practice. Copyright 2016, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved.
January 2016 Vol 103 No 1 • Periop Briefing | P11
PERIOP BRIEFING
FLEXIBLE ENDOSCOPES
PERIOP BRIEFING
FLEXIBLE ENDOSCOPES
recommending that a multidisciplinary team that includes infection preventionists, endoscopy RNs, endoscopy processing personnel, endoscopists, and other involved personnel establish a policy to determine the maximum storage time that processed flexible endoscopes are considered safe to use without reprocessing.” This team should consider facility-specific factors that may dictate the storage time, such as processing effectiveness, storage conditions (e.g., restricted access, drying cabinet), frequency of use, and patient population.
Conclusion Perioperative team members and sterile processing personnel should follow the evidence-based recommendations in the updated guideline to maximize the effectiveness of their processing procedures. Personnel should follow the manufacturer’s IFU for each device to help ensure effective cleaning without damage to the device. A carefully designed processing area and mindful execution of each cleaning and disinfection or sterilization step minimize the potential spread of pathogens among devices and patients.
P12 | Periop Briefing
References 1. Guideline for processing flexible endoscopes. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2016:675-758. 2. Dirlam Langley AM, Ofstead CL, Mueller NG, Tosh PK, Baron TH, Wetzler HP. Reported gastrointestinal endoscope reprocessing lapses: the tip of the iceberg. Am J Infect Control. 2013;41(12):1188-1194. 3. Merritt K, Hitchins VM, Brown SA. Safety and cleaning of medical materials and devices. J Biomed Mater Res. 2000;53(2):131-136. 4. Spaulding EH, Lawrence Carl A Block Seymour Stanton Reddish George F. Chemical disinfection of medical and surgical materials. In: Lawrence Carl A Block Seymour Stanton Reddish George F, ed. Disinfection, sterilization, and preservation. Philadelphia: Lea & Febiger; 1968:517-531. 5. Rutala WA. ERCP scopes: a need to shift from disinfection to sterilization? Meeting of the FDA Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee [transcript]. Annapolis, MD: Free State Reporting, Inc.; Meeting date May 15, 2015.
GUIDELINE FIRST LOOK
Guideline for processing flexible endoscopes Kelly Putnam, Managing Editor
T
he updated “Guideline for processing flexible endoscopes” details how to minimize flexible endoscope contamination.1 According to a review of reported lapses, failing to preclean endoscopes before processing, using incorrect containers to transport contaminated endoscopes, and inadequate cleaning of channels and elevators were among the noncompliance events that may expose patients to contaminated scopes.2 The updated guideline provides evidence-based recommendations for endoscopy processing room design and best practices for leak testing, cleaning, inspecting, and storing flexible endoscopes.
Effective endoscopy processing room design After precleaning flexible endoscopes in the procedure room, perioperative team members should transport them to a designated processing area as soon as possible. Personnel should keep endoscopes damp, but not submerged in liquid that could spill or splash and contaminate other areas. To transport flexible endoscopes from the point of use to the processing room, team members should use a closed, leak-proof, puncture-resistant container or cart large enough to contain endoscopes coiled in large loops to prevent damage from tight coiling. Having a physically separate area for processing activities prevents contamination of procedure rooms and patient care areas. “The design of the endoscopy suite, the processes in place for maintaining and controlling the environment, and the procedures performed in the facility all affect processing of flexible endoscopes,” said Sharon Van Wicklin, MSN, RN, CNOR, CRNFA(E), CPSN-R, PLNC, senior perioperative practice specialist at AORN and lead author of the guideline. The minimum recommended design for an endoscope processing area is a single room with distinct decontamination and clean areas to minimize cross contamination; the updated guideline details the recommended design components of the processing area (e.g., automatic or foot-operated doors).1 http://dx.doi.org/10.1016/S0001-2092(15)01158-8
P10 | Periop Briefing
Personnel working in the endoscopy processing room should wear surgical masks, eye protection, fluid-resistant gowns, utility gloves that extend over the cuff of the gown, and fluid-resistant shoe covers to protect them from exposure to potentially infectious material when handling the endoscopes.
Key steps to minimize endoscope contamination Qualified personnel should clean and disinfect or sterilize flexible endoscopes according to the manufacturers’ instructions for use (IFU). Manually cleaning endoscopes as soon as possible after leak testing limits the formation of biofilm. Following manual cleaning and visual inspection, personnel should follow manufacturers’ IFU for packaging and sterilization or mechanical processing, which helps ensure consistency and limits personnel’s exposure to biohazardous materials. Leak testing Personnel should leak test all flexible endoscopes including those that are new, loaned, or repaired, or require processing before use.1 The purpose of the leak test is to identify any damage to the endoscope and prevent further damage that may occur throughout the cleaning process if it is not sealed. For endoscopes that require leak testing, personnel should remove all port covers and function valves, pressurize the endoscope while it is in a loose configuration, manipulate all moving parts, and actuate video switches. Pressurizing the endoscope to the manufacturer’s recommended pressure for at least 30 seconds increases the likelihood of detecting a leak and minimizes the risk of damaging the scope. Manual cleaning Cleaning uses friction, water, and cleaning solutions to remove organic material and soil; it does not directly kill microorganisms. Cleaning solutions may include general purpose cleaners, which act as detergents, and enzymatic cleaners, which contain a mixture of enzymes that each break down a specific target compound (e.g., lipids,
proteins, carbohydrates). In a study comparing the effectiveness of various cleaning solutions and disinfectants to remove biofilm, enzymatic cleaners were more effective than detergents; aldehyde agents not only failed to remove biofilm but also made it more difficult to remove.3 Personnel should follow the manufacturers’ IFU regarding water quality, hardness, pH, and temperature; cleaning solution concentration, storage, and shelf life; and contact time between the device and solution. In addition, personnel should use brushes of the recommended size and material, especially for the channel lumens; the brush needs to have maximal contact with endoscope surfaces without damaging them. Advances in brush technology (e.g., elastomer discs, microfiber brushes) aim to optimize contact between the brush and surfaces to help ensure bioburden removal. Visual inspection Before high-level disinfection or sterilization, personnel should visually inspect cleaned flexible endoscopes and accessories to identify any residual debris or defects that warrant removal from use and repair.1 The guideline recommends using lighted magnification to inspect endoscopes for damage and suggests inspecting internal channels (Figure) with a camera or borescope. Visual inspections should assess cleanliness, missing parts, clarity of lenses, integrity of seals and gaskets, moisture, and correct functioning.1 High-level disinfection and sterilization According to the Spaulding classification, critical items that enter sterile tissue or the vascular system should be sterilized, whereas semicritical items that come in contact with broken skin or mucous membranes can be sterilized or high-level disinfected.4 A recently proposed modification to the Spaulding classification system would expand the definition of critical items to include devices that secondarily enter sterile tissue
or the vascular system via a mucous membrane (e.g., a bronchoscope enters the bronchi through the mouth or nose).5 Adopting this modification would mean that all flexible endoscopes should be sterilized; this could help prevent patient infections because sterilization eliminates all microorganisms and bacterial spores, which can linger even after high-level disinfection. The modification would also address the issue of critical endoscope accessories that pass through the endoscope and may be exposed to residual pathogens in an endoscope that has not been sterilized.
Requirements for endoscope storage Personnel should store endoscopes in cabinets with doors that are located near, but not in, the endoscopy procedure room, and at least three feet from any sink to reduce potential contamination. Endoscopes should be stored in a drying cabinet that circulates filtered air and also forces the filtered air through the endoscope channels. If a drying cabinet is not available, endoscopes should be stored in a closed cabinet with positive pressure that allows circulation of filtered air around the endoscopes.1 “Our previous recommendation for a maximum storage time of five days before reprocessing has gone away,” said Van Wicklin. “We are now
Inner channels
of flexible endoscopes. Reprinted with permission
from Guidelines for Perioperative Practice. Copyright 2016, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231. All rights reserved.
January 2016 Vol 103 No 1 • Periop Briefing | P11
PERIOP BRIEFING
FLEXIBLE ENDOSCOPES
PERIOP BRIEFING
FLEXIBLE ENDOSCOPES
recommending that a multidisciplinary team that includes infection preventionists, endoscopy RNs, endoscopy processing personnel, endoscopists, and other involved personnel establish a policy to determine the maximum storage time that processed flexible endoscopes are considered safe to use without reprocessing.” This team should consider facility-specific factors that may dictate the storage time, such as processing effectiveness, storage conditions (e.g., restricted access, drying cabinet), frequency of use, and patient population.
Conclusion Perioperative team members and sterile processing personnel should follow the evidence-based recommendations in the updated guideline to maximize the effectiveness of their processing procedures. Personnel should follow the manufacturer’s IFU for each device to help ensure effective cleaning without damage to the device. A carefully designed processing area and mindful execution of each cleaning and disinfection or sterilization step minimize the potential spread of pathogens among devices and patients.
P12 | Periop Briefing
References 1. Guideline for processing flexible endoscopes. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2016:675-758. 2. Dirlam Langley AM, Ofstead CL, Mueller NG, Tosh PK, Baron TH, Wetzler HP. Reported gastrointestinal endoscope reprocessing lapses: the tip of the iceberg. Am J Infect Control. 2013;41(12):1188-1194. 3. Merritt K, Hitchins VM, Brown SA. Safety and cleaning of medical materials and devices. J Biomed Mater Res. 2000;53(2):131-136. 4. Spaulding EH, Lawrence Carl A Block Seymour Stanton Reddish George F. Chemical disinfection of medical and surgical materials. In: Lawrence Carl A Block Seymour Stanton Reddish George F, ed. Disinfection, sterilization, and preservation. Philadelphia: Lea & Febiger; 1968:517-531. 5. Rutala WA. ERCP scopes: a need to shift from disinfection to sterilization? Meeting of the FDA Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee [transcript]. Annapolis, MD: Free State Reporting, Inc.; Meeting date May 15, 2015.