Tflexible endoscope certainly looks clean. As well it should. The reprocessing tech leak tested the scope, flushed and brushed the internal channels, and ran it through the automated endoscope reprocessor for the proper cycle. After an alcohol purge and air drying, it’s now back in the procedure room, ready to use on the next patient. Or is it?

Look closely at the scope’s distal tip. Closer. Closer still. There’s bioburden right there. Still don’t see it? What about the nicks, chips and discoloration? You probably can’t see those either. That’s because residual debris and damage that can harbor future microbes are often invisible to the naked eye. But more and more sterile processing departments are using cleaning verification tools such as handheld lighted magnifiers, tabletop microscopes and borescopes that let them examine and test areas that are difficult or impossible for the human eye to see into directly. Could your facility benefit from greater magnification, X-ray vision and high-tech microbial monitoring during visual inspections?

Standardizing a manual process

Of all the types of medical device reprocessing, flexible scope cleaning is one of the most manually intensive. Unfortunately, with manual processes can come variability, which is the chief threat to repeatable quality outcomes. This variability is often tied to human factors involved in everything from bedside cleaning and speed of transport to the reprocessing room to how techs manipulate their cleaning brushes and how closely they visually inspect the distal tip before disinfection.

The first key to creating a thorough scope cleaning verification program is to develop a standard cleaning process and defined verification program at the facility level. Because people are not machines, you must provide as much structure as possible to technicians regarding how they should clean and conduct cleaning verification testing. Never let individual preference trump standard facility practice. Regardless of the type of verification tests you use, you can develop standard cleaning and verification procedures in conjunction with manufacturers’ instructions for use, industry recommendations such as AAMI ST91:2015 (osmag.net/Y9NuQu) and department policies. For any quality assurance program to work, staff must be both competent and consistent in their application of the verification methods and documentation protocols.

Scope cleaning verification

Implementing a cleaning verification program for flexible scopes might seem like a daunting task, but the process is relatively straightforward as outlined in AAMI ST91:2015(12.4.2), and should consist of the following points:

• visual inspection combined with other verification methods that let you assess both external surfaces and internal housing and channels;
• testing of the cleaning efficacy of mechanical equipment; and
• monitoring key cleaning parameters, such as temperature.

Today we’ll focus on the first bullet: “visual inspection” and “other verification methods,” which include everything from borescopes and magnifiers, to adenosine triphosphate (ATP) and similar residual testing. Your scope cleaning verification program will need reasonable benchmarks for clean and user-friendly reliable tests to demonstrate you’re meeting that level.

When visually inspecting a scope, the benchmark for clean is fairly straightforward: no visible bioburden or damage to the scope’s external components or internal channels. This might sound obvious, but you should still educate your team to ensure all staff can identify bioburden and damage on their scopes when using magnification and borescope technologies. Nicks, chips or discoloration may be assumed as “normal” or “expected” wear and tear on devices if you don’t develop a clear visual inspection benchmark.

When addressing benchmarks for residual verification tests, review acceptable ranges and testing sensitivity from the test manufacturer’s instructions for use and current literature. While specific acceptable ranges have been published in various settings, advances in research and product capabilities, as well as the variation of test sensitivities, have made it difficult to set overarching industry benchmarks for these tests. Best advice: Take the test manufacturer’s recommended ranges and decide what is reasonably attainable and acceptable under your department’s current cleaning practices.

In terms of visual inspection, the current available technologies fall into 2 categories: external and internal visualization. A common external option is a handheld magnifier, which can range in power from 3x to 55x magnification, with some models also providing accessory lighting functions to assist with visual inspection. Additional magnification technologies include mountable LED-powered magnifiers with adjustable arms, as well as desktop USB microscopes that can provide up to 270x magnification so you can visualize even the smallest areas of concern on a flexible scope.

Small-diameter borescopes let you see inside of a device to visually verify cleanliness before high-level disinfection or terminal sterilization. Many of these borescopes can now fit into the smallest of internal channels and extend the length of most models of scopes, catching process breakdowns such as retained brush bristles, minute damage to internal channels, moisture and retained bioburden. Particular models can take photos and short videos as well, which you can document by serial number along with other aspects of your cleaning verification program.

Cleaning verification tests

The most common cleaning verification test in use for flexible scopes today uses ATP testing. Blood and bioburden contain large amounts of ATP, the universal energy molecule found in all animal, plant, bacterial, yeast and mold cells.

Damage or discoloration on a scope's distal tip, often invisible to the naked eye, can harbor microbes.

You can do an ATP swab on external surfaces of the device (such as the distal tip and control body) or run testing sponges through the length of a flexible scope channel to test internal cleanliness as well. You then insert these tests into a reading device, which gives a numerical measurement to be compared to your facility benchmark, letting you verify the efficacy of your cleaning protocols. Many ATP test manufacturers also provide software associated with their devices that allow for quality documentation management, including the ability to identify quality trends in particular devices or personnel.

Other testing options also measure the presence of residual hemoglobin or a combination of hemoglobin, protein and carbohydrates. You typically complete these tests by flushing prepackaged sterile water through a scope’s internal channel, recovering the water in a sterile container and inserting a test strip into the container to produce a color-coded reading.

Enzyme-specific detection is an increasingly popular testing method. These tests target the presence of Gram negative bacteria in a cleaned, high-level disinfected or terminally sterilized scope. Classified as an urgent threat by the CDC in 2013, carbapenem-resistant Enterobacteriaceae (CRE) is one such Gram-negative bacteria that enzyme-specific detection could identify. Similar to hemoglobin testing, you flush a scope channel with sterile water, recover the water and then incubate it for around 12 hours before reading the results. You can test devices at the end of a shift and have actionable results before the first patient the following day.

Cleaning failures

View cleaning verification failures as a “good catches” by the reprocessing team that provides you with invaluable feedback into what’s working and what’s not working. Be sure to specify the process in which you’ll document cleaning failures and route them in your facility.

Document each time a scope fails to meet the cleaning benchmark so that you have adequate data sets to review in cases of internal audits or potential infectious outbreaks. The technician’s goal should not be to only document scopes that “pass” — this can cause real process issues to become invisible in terms of your quality data. Set a limit on how many times a scope can fail in a day before you tag out the device for other corrective actions.

Many minds make safe scopes

A cleaning verification program leaves a documented trail of quality and compliance. Industry recommendations and manufacturers’ instructions for use serve as the foundation of your program, but successful implementation depends on the collaborative efforts of infection control practitioners, risk/quality professionals, physicians, nurses and scope technicians. They must team up to create the best process possible — and transparently verify that process, every scope, every time — in the name of patient safety. OSM