
CATEGORY: Compliance

Feb 14, 2025
The Age of Quality Assurance: A Complete Guide to Quality Assurance in Endoscope Reprocessing
Albert Einstein once famously said, “Without changing our patterns of thought, we will not be able to solve the problems that we created with our current patterns of thought.” This perspective is fitting for a scientist who revolutionized our understanding of physics and the very fabric of nature. The hallmark of successful scientists, theorists, and professionals across all fields is their unyielding curiosity and willingness to ask new questions. These inquiries are the driving force behind groundbreaking discoveries, innovative methodologies, and lasting advancements. In the realm of instrument reprocessing, particularly with flexible endoscope reprocessing, there is a constant stream of new questions being posed. Recent discussions have highlighted the convergence of rising adverse events, a rapidly evolving gastroenterology landscape, and an impending surge in colonoscopy procedures. If we fail to adapt and rethink our current practices, we risk becoming entangled in a complex web of challenges. The Important of Quality Assurance in Endoscope Reprocessing This might be why the industry has embraced quality assurance in recent years. Its ability to ask questions and provide potential answers can help untangle this mess. Quality assurance is a formalized attitude and methodology to embrace safety, data, preventative activities, training, and a commitment to error-free reprocessing, and in endoscope reprocessing, takes on other unique characteristics. Quality assurance is a patient safety matter, firstly. Any means to prevent patient harm is a binding law. Cori Ofstead and associates also estimated in a 2017 study, that the impact is a financial one, too, with estimates to reprocess a single endoscope from $114.07 to $280.71. Hands-on time further estimated over 76 minutes of a technician or nurses time. The risk to patient, cost and labor all depend on quality. Major Areas of Quality Assurance in Endoscope Reprocessing Pre-Cleaning Pre-cleaning outcomes are the foundation to quality endoscope reprocessing outcomes. The Centers for Disease Control starts its Essential Steps for Flexible Endoscope Reprocessing at bedside, for its importance in preventing the formation of biofilm. Some of the most important investments that improve pre-cleaning quality outcomes is training and measures of accountability. When nurses and technicians have a harmonious relationship, pre-cleaning is often done effectively and consistently, reducing the demand on manual cleaning. The stronger the foundation, the stronger the building. Delays in the journey from pre-cleaning to manual cleaning also increase the risk of biofilm formation, lowering quality outcomes. Methods to ensure items move quickly from pre-cleaning to manual cleaning may include timers, trackers, and others means to ensure pre-cleaning happens within 60 minutes of the procedure. Tags and written reminders can also be a helpful, visual cue without compromising transport containers or bags. Leak Testing For endoscopes which require leak testing, this critical step ensures damage is caught before time is spent on further reprocessing, or further damage can be extended to the scope. ANSI/AAMI ST91:2021 offers a couple recommendations to ensure quality leak testing outcomes: “Automated leak testers should be placed on a calibration schedule to verify the leak tester is producing the correct pressure. Manual handheld leak testers and leak tester tubing should be inspected for damage, leakage, and pressure output (kPa). Pressure verification should be performed for each type of leak tester in the facility each day that endoscopes are used; calibration ensures that an endoscope will be challenged with the proper pressure each time when being tested for leaks. Documentation of testing results should be recorded. The manufacturer’s written IFU for testing each type of leak tester (manual or mechanical) used in the facility should be followed to ensure they are properly functioning.” 7.4.1 Leak Testing, ANSI/AAMI ST91:2021 Leak testing can be complicated in areas with poor lighting, particularly during wet leak testing. Investing in underwater lighting can enhance the ability to see small damages to endoscopes, and pull scopes for repair early, before damage gets worse. Investing in basins the right size for endoscopes is also important; over-coiling can hide holes, and result in false passes. ST91 also recommends manual dry leak testing for at least 30 seconds, and manual wet leak testing for 60 seconds. Rushing leak testing can result in lower quality outcomes. Manual Cleaning Manual cleaning should follow immediately after leak testing to further prevent biofilm formation, and the drying of soil. Three C’s form the backbone of effective manual cleaning outcomes: Copious amounts of fluid Contact time & correct use of detergents Correct brushing technique, prioritizing single-use brushes, when possible Endoscopy and sterile processing departments should consider investing in technologies, training, and improvements which focus on these 3 key areas. For example, investments in automated cleaning solutions which flush, leak test, or dispense detergent can be great for busy departments, so long as departments write in policies to verify equipment performance, and hence, quality outcomes. Brushing with tools that are validated to provide high-quality outcomes is a great potential enhancement. Brush technology and design varies widely. Try sourcing brush technologies that have validated performance from independent sources, and which fit the endoscope inventory. Quality begins with preventing lapses, not finding them. Other quality assurance measures include biochemical cleaning verification tests to ensure detergent is being dosed appropriately, with temperature gauges to ensure they operate within proper ranges. Visual Inspection In a 2024 Ofstead and Associates study, it was estimated that visual inspection was one driving reason for a facility to reduce repair costs from $1.2M per annum to $724k, and cut the average cost per repair in half. It’s one helpful argument to help departments prioritize spending on inspection technologies. Borescopes and task lights both have a place here. ANSI/AAMI ST91 references the following regarding visual inspection: “Flexible endoscopes, accessories, and associated equipment should be visually inspected for cleanliness, integrity, and function before use, during the procedure, after the procedure, after cleaning, and before disinfection or sterilization (AORN, 2018e [39]).” 7.8.2 Visual Inspection “The internal channels of a flexible endoscope that are accessible can be inspected by a borescope or other appropriate inspection method.” – 7.8.3 Borescopic Inspection, ANSI/AAMI ST91:2021 Investing in borescope technology…
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