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Are Your Endoscopes Really Clean?
Don't bet on it. A study shows just how difficult the devices are to disinfect.
Jim Burger, Cori Ofstead
Publish Date: May 7, 2018   |  Tags:   Infection Prevention
Skin Prep
TO THE LETTER Make sure endoscope reprocessing guidelines are always followed and document that your scopes are clean and in good working order.

Is there a medical device that's harder to reprocess than a flexible endoscope? You can do everything right — wipe it down at the bedside, manually clean it with the properly sized brush and run it through an automatic endoscope reprocessor — and still find bacteria in its channels.

Those were the findings of an eye-opening study conducted at a surgery center specifically chosen for the quality of its endoscope care protocols (osmag.net/J3eSDm). Staff members at the facility did an impeccable job of following reprocessing guidelines. Moreover, the study took place over the course of 7 months, and during that time, members of the research team dropped in for 9 unannounced audits. Not a single deficiency was seen. Staff carefully followed all the recommended steps thoroughly and timely, and yet their scopes still showed signs of microbial growth, visible irregularities, discoloration and debris in channels.

It's particularly bad news that their scopes still fared so poorly, but there's a silver lining to the report: It should increase your awareness of just how challenging endoscope reprocessing is to get right and hammer home the importance of constantly monitoring the integrity and cleanliness of your scopes.

Plenty of problems

The surgery center was using 17 endoscopes when the study was initiated. Over the 7-month study period, they also brought in 5 loaners. In all, those 22 scopes included 7 adult colonoscopes, 8 pediatric colonoscopes and 7 gastroscopes. All were less than 2 ? years old and most had been used between 400 and 500 times.

For the study, 11 of the scopes were designated as an intervention group and were given extra-special attention. Along with the usual bedside precleaning, leak-testing and manual cleaning, the intervention scopes were run through an automated endoscope reprocessor (AER). They were also disinfected with 5% peracetic acid, which is a stronger antimicrobial than the 2.5% glutaraldehyde that was being used with the control scopes. On top of that, the reprocessing technicians conducted biochemical tests for adenosine triphosphate (ATP) on the intervention scopes and recleaned them when they exceeded what's considered the "clean" benchmark of 200 relative light units. Then, if their ATP levels were still too high, they put the scopes through 2 additional AER cycles.

Dirty Job\
DIRTY JOB Provide your staff with the tools they need to properly care for notoriously tough-to-clean flexible endoscopes.

During the final assessment, 10 scopes from the control group and 10 from the intervention group were included. Admittedly, those numbers are pretty small, but there were some very disturbing trends:

? Microbial growth. For starters, despite the intense efforts of the reprocessing techs, microbial growth was detected in 12 of the 20 scopes, including 7 in the intervention group. It's worth noting that the microbial growth didn't always appear immediately. In fact, if the samples taken from the scopes had been incubated for only 48 hours, instead of 5 to 7 days, 4 positive readings and 2 potential pathogens would have been missed. A third of the contaminated scopes showed nothing until after 48 hours, and the potential pathogens (Corynebacterium spp and Methylobacterium extorquens) didn't appear until day 5 or 6.

? Bacteria presence. Additionally, and somewhat surprisingly, 5 of the 6 gastroscopes tested not only showed bacterial presence, they also generally had much higher bacteria counts than the colonoscopes. Who would guess that you can treat a colonoscope and gastroscope exactly the same way and end up with a clean colonoscope and a dirty gastroscope?

Add to that the fact that even the more rigorous reprocessing routine applied to the intervention group failed to make much of a difference, and it's clear that peace of mind can only be achieved through visual inspection and routine monitoring for biochemical markers of residual contamination.

? Visible irregularities. All 20 scopes had fluid, discoloration and debris in their channels, and 17 of the 20 showed enough damage that they had to be sent out for repair. Among the defects found by the manufacturer were failed leak tests, chipped or cracked lenses and insulation damage. It's clear that regularly used scopes take a beating, and it's important to recognize that damaged scopes are more likely to harbor organic debris and bio?-?lm.

The findings underscore the importance of preventive maintenance and regular assessments to determine the integrity of scopes, and the need to have them repaired or refurbished when they're damaged. It's an expensive proposition, especially when you need loaners to sustain your volume, but early in the study, damage was seen inside scopes that had been used for as little as 2 months.

? Mystery fluid. Though it wasn't part of the original study design, another finding aroused concern and curiosity. Early on during the study, after residual fluid was found in several endoscopes, the researchers ramped up the AER drying cycle by putting more alcohol through the scopes and increasing the air-purge cycle from 1 minute to 6 minutes. The scopes were hung vertically in closed, ventilated cabinets to dry.

At the final assessment, several scopes contained visible droplets of a cloudy fluid. It didn't appear to be water or alcohol, which left a variety of sobering possibilities. Lab tests eventually identified the mystery fluid as simethicone, which is often injected into scopes to reduce bubbles and improve visibility during colonoscopies and other procedures.

That's a concern, because simethicone isn't water soluble; it actually repels water. But it does love to stick to any other surface, such as the inside of a scope, where it may actually form a protective barrier between cleaning solutions or disinfectants and biofilm or bioburden. In other words, it might effectively ensure that the scope can't be adequately cleaned.

Now you know

Endoscope-related outbreaks are rare, right? It might seem that way. In the last few years, you may have heard about the few deadly superbug-related outbreaks that were related to duodendoscopes. But now that more institutions are conducting scope surveillance, the number of reports of outbreaks related to every kind of scope is escalating rapidly. The more people are looking, the more issues they're finding.

Handle with Car\e
HANDLE WITH CARE Too few facilities verify that every endoscope is free of debris and bacteria before it's used on another patient.

The problem isn't going to go away. We need more and better research to establish the best methods for assessing endoscopes for visual abnormalities, residual contamination and microbial growth, as well as for figuring out how frequently we should be performing those assessments.

Flexible endoscopes can't tolerate the heat of autoclaving, but low-temperature sterilization has been shown effective for smaller, less complex scopes. The problem is that colonoscopes, gastroscopes and duodenoscopes have multiple channels and are longer, which makes it difficult to reach every nook and cranny with sterilants.

Improved drying cabinets are another potential solution because theoretically they should be able to get all channels and ports completely dry. The idea makes sense, but more data are needed.

In the meantime, your facility should be scrupulously following the most recent reprocessing guidelines from AORN, SGNA and AAMI. You need to have documented proof that your endoscopes are both in good working order and not contaminated.

The more you know about how challenging it is to adequately reprocess endoscopes, the clearer it becomes that trusting your processes is not enough. Every reprocessed scope should be verified — shown to be free of damage and debris — before it's permitted to touch another patient. If that's not being done in your facility — and it isn't being done in most — it's never been clearer that you're flirting with danger. OSM

Cori Ofstead, MSPH, president and CEO of Ofstead and Associates in Saint Paul. Minn., contributed.