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.
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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 is just one means to ensure quality outcomes in endoscope reprocessing. While its not enough to determine soil levels, it can identify residual water and poor drying technique, brush fibers and failing brush quality, or damage, potentially resulting in negative patient outcomes.
Determining where and how to inspect using borescope technology is also important. ST91 offers multiple recommendations for when
in the process borescopes can be helpful. Creating a clinical team of stakeholders to do a risk assessment can help make this decision clearer for your team. Regardless of where, investing in the power requirements and organizational tools to get borescope stations ready is key. Borescopes can either sit cluttered and messy in a corner, or be fully integrated into stations with other quality assurance tools such as ATP testing.
ANSI/AAMI further recommends testing duodenoscopes with a 10x magnifier. Elevator channels continue to present cleaning risks. Be prepared to address this recommendation with enhanced visualization technology.
Cleaning Verification Testing
With the 2021 update for ST91, a new category emerged; high-risk endoscopes:
“High-risk endoscopes…and/or those that are of complex design (e.g., duodenoscopes, linear ultrasound (EUS) endoscopes, bronchoscopes, endobronchial ultrasound (EBUS) endoscopes, ureteroscopes, cystoscopes and as determined by the facility) shall be monitored with cleaning verification tests after each cleaning. Manual cleaning of flexible endoscopes that are not determined to be high-risk should be verified using cleaning verification tests when new endoscopes are purchased and at established intervals (e.g., at a statistically significant frequency based on the number of procedures performed).” 7.8.4 Cleaning Verification, ANSI/AAMI ST91:2021
Visual inspection alone is not enough to ensure high-risk endoscopes have undergone quality cleaning practices. Organic soil and microbial contamination lead to biofilm formations on and within endoscopes. Regular use of technologies such as protein testing, adenosine triphosphate tests (ATP) and others help test that minimum benchmarks of contamination are controlled. They can also provide trending data over time, to show if cleaning outcomes are improving.
Departments also need to verify that testing equipment is working and effective. Having this step written in department SOP’s is critical.
High-level Disinfection / Sterilization
Whether liquid chemical high-level disinfection (HLD) or low-temperature sterilization practices are in effect, both require monitoring. Have all valves and caps underwent consistent HLD processes? Is there a spill kit plan in case of accident? Is the process for using solution test strips or chemical monitoring systems well trained, effective, and accurate?
Drying
Endoscopes should never be stored wet. Biofilm and microorganisms thrive in dark, damp and undisturbed environments, leading to potential infection hazards. Ensuring pressure-related instrument air or HEPA-filtered air are used according to IFU is critical here. When storing, methods that circulate filtered air through channels are preferred.
Taking the Next Steps in Quality Assurance Improvements
There is no shortage of questions to ask when it comes to improving quality cleaning outcomes in endoscope reprocessing. Where to start? How much to invest? Who can I count on to believe in the changes I want to make?
Putting together a group of stakeholders who might be impacted by quality assurance programs is a great place to start. Identify needs, opportunities and the implications of certain QA program components.
Measure and assess data points to identify where in the endoscope reprocessing cycle QA improvements will have the biggest impact. Starting with the most impactful change can be powerful to earn additional resources for other QA initiatives. Starting small is another approach, particularly if departments are anxious about additional steps or new technologies.
Putting together means to measure the quality outcomes before and after QA initiates are implemented is also essential. Don’t enter the journey without the end destination in mind. Set goals with stakeholders and revisit them often to ensure the compass’ needle hasn’t moved.
The foundation of great answers lies in the power of asking great questions, and quality assurance programs provide a prime platform to do just that:
- Where is this quality issue arising?
- Could additional training in this area enhance cleaning outcomes?
- How can quality assurance programs empower and support my team in achieving their goals?
There are numerous starting points for this journey, but the most crucial step is choosing to begin. Leverage available resources, consult with experts, engage stakeholders, and collaborate with peers to navigate this path to success. By fostering a culture of inquiry and continuous improvement, you’ll be well-equipped to elevate your practices and achieve outstanding results.
Looking to explore more topics related to endoscope reprocessing? Explore all our Reprocessing Reports related to GI, here!
