LEFT BEHIND Despite reprocessing in accordance with guidelines, organic residue and viable microbes can remain on endoscopes.

You can brush and flush with precision, for just the right amount of time and with just the right amount of touch, and still there's no guarantee that you'll deliver an endoscope free of bacteria and bioburden. Such is the lot of the reprocessing tech and the degree of difficulty of the manual clean, a rather thankless chore that requires amazing stamina and attention to detail.

The job recently got a lot more daunting with the publication of a study that found that rigorous, by-the-book cleaning of flexible endoscopes before disinfection doesn't ensure that scopes are free of contamination, particularly when the scopes have scratches and dents that could harbor blood, tissue and bacteria. The study, published in the February American Journal of Infection Control (osmag.net/C8WRex), raised the frightening possibility that you can't count on current reprocessing practices to consistently decontaminate your scopes — even if, and it's a mighty big if, your techs meticulously follow reprocessing guidelines and don't take shortcuts.

"The study was kind of chilling, but I was not shocked by it," says Chris Lavanchy, the engineering director of ECRI Institute's Health Devices Group. "Many people have long been suspicious that the manual cleaning process is not 100% reliable."

Twelve of the 20 reprocessed scopes examined during the 7-month study tested positive for microbial growth, indicating a failure of the disinfection process, despite being disinfected using the current guidelines. Researchers found that all 20 endoscopes had visual irregularities, such as fluid, discoloration and debris in the channels. The finding of residual fluid was significant because any bacteria present will flourish in a moist environment and lead to the development of biofilm — which can be difficult or impossible to remove, says lead study author Cori Ofstead, MSPH, an epidemiologist and president and CEO of Ofstead & Associates in St. Paul, Minn.

"If the scope's not clean, it can't be disinfected or sterilized. If the scope is damaged, it can't be disinfected or sterilized," says Ms. Ofstead.

In implicating the critical point-of-use precleaning and cleaning steps that precede the disinfection cycle as the weak links in the reprocessing chain, the study hammers home the point that you can't disinfect a dirty scope.

"Ever tried to wash a plate that has a bit of dried egg on it?" asks Mr. Lavanchy in a fitting dishwashing analogy. "There's so much emphasis on the disinfection process that we often overlook the cleaning step. But if you don't clean properly, you can't ensure that you can effectively disinfect a device."

VISUALIZATION AND INSPECTION A borescope can give you a view of the inside of an endoscope.

How to verify cleanliness
The study's findings support the need for careful visual inspection and cleaning verification tests to ensure that endoscopes are free of damage and debris before they are high-level disinfected or sterilized, says Ms. Ofstead. She also suggests an increased emphasis on drying before storage.

Increased visual inspection. After the manual clean, a tech should visually inspect the scope for debris before placing it in the automated endoscope reprocessor (AER). You can use a lighted magnifying glass to inspect the scope's components. You can also examine the inside of the scope for damage and debris with a borescope, a very small-diameter scope that lets you look with a camera inside endoscope channels.

Cleaning verification tests. Routine monitoring for biochemical markers of residual contamination can identify suboptimal reprocessing. A tech can collect samples from a scope to test for protein, hemoglobin and ATP, a marker that identifies organic matter, to tell you if you failed to achieve a level of cleanliness needed for disinfection and sterilization to work.

"ECRI hesitates to advocate the use of validation tests as a quality control measure because they're still largely unproven," says Mr. Lavanchy. "Tests can be useful to periodically check how you're doing, but we don't see the benefit of using them routinely to verify that you've cleaned the scope correctly."

Drying before storage. Does gravity pull moisture out of scopes in drip-dry cabinets? Not likely. "The scope's channels are almost like capillary tubes, and moisture's not likely to drain by gravity," says Mr. Lavanchy. He prefers a drying cabinet design that blows warm filtered air through it and, even better, a drying cabinet that has connections for each of the channels to force air through them.

Studies have demonstrated that a final drying step that includes flushing all channels with alcohol, followed by purging the channels with compressed air (to remove the alcohol), greatly reduces the possibility of recontamination of the endoscope by any residual microorganisms, says Mr. Lavanchy.

DINGS AND DENTS Damaged scopes are difficult to thoroughly clean. Notice the scratched, scaly lens and dents, and brown debris around the channel outlets.

A few questions
A time out, please, before you push that propofol. Mr. Lavanchy has a few questions about his favorite subject: endoscope reprocessing, his life's work for more than 20 years at ECRI Institute, the suburban Philadelphia laboratory where he tests medical products and investigates scope reprocessing failures. Mr. Lavanchy knows all too well how difficult it is to clean and disinfect the flexible endoscope you're about to use on him. He's peeled back the smooth black insertion tube and seen the fiber-optic light bundles, the camera cables, and the air, water and biopsy channels that run along its entire length. He knows that the slightest departure from recommended practices can lead to the survival of disease-causing organisms and the risk of infection. So he wants to ask about your facility's scope disinfection practices before you start his colonoscopy, just a few questions to assess the adequacy of your reprocessing equipment, staffing and workflow.

What kind of AER do you use? Some AER designs are more reliable than others. You'll find varying degrees of automation in today's AERs, says Mr. Lavanchy. In general, a more automated machine is going to provide you with a more consistent result than one that has more manual interventions. It's better, he says, to use a machine with an automatic timer than one in which you have to manually start and stop the processing cycle. "In that way, you're ensuring a consistent process from one scope to the next," he says. By the way, Mr. Lavanchy says you can cancel his case if you rely solely on manual disinfecting. "There is just too much uncertainty in a completely manual process for me to be comfortable," he says.

Fresh germicide with each cycle? Are you using fresh germicide each time you use your AER? Some AERs let you reuse the liquid chemical germicide multiple times. "You're supposed to test it each time you reuse it for proper concentrations, but I'd rather not rely on a manual process with the agents designed to kill microorganisms, particularly pathogenic organisms," says Mr. Lavanchy. "I'd rather you use fresh germicide each time you use the machine." You also want to select a disinfecting agent that is labeled for the appropriate germicidal level and is compatible with the reusable device you're disinfecting, he says.

Are your reprocessors certified? Connecticut, New Jersey, New York and Tennessee are the only 4 states that require sterile processors to be certified. No state requires special education or a degree. "But even if your state doesn't require your reprocessors to be certified, maybe your facility should," says Mr. Lavanchy, who adds you should at the very least require mandatory continuing education for your sterile processing techs. "I know that techs are often overworked and underpaid, and that good ones are hard to find and keep. But if your facility doesn't invest in proper training and continuous documented competency, I might be concerned enough to go elsewhere for my colonoscopy."

CLEANING VERIFICATION A tech collects samples from a sterilized ureteroscope to test for the presence of protein, hemoglobin, ATP and microbes.

It's a backbreaking job
Cleaning endoscopes might look easy, but it's a particularly challenging task. Ms. Ofstead once observed techs cleaning scopes and tallied the number of steps in the process. "Depending on the kind of scope, 120 to 140 discrete steps have to be done in the right order," she says. "I don't have that attention to detail that I could sustain all day."

Plus, it's a physically demanding job. "Holding the scope, leaning over the sink and doing the brushing — I would have back, neck, shoulder and hand pain," she says.

Every scope has a different IFU, she adds. "If you know how to clean a cystoscope, it's a totally different process to do the colonoscopes — longer channels, different leak tester. All of the rules change with every single scope. I'm sure the people who do it all day, every day are better at it than me, but what about when they're pressured to go faster or interrupted?"

It's dangerously tempting for techs to think it's okay to cut the 5-minute flush-and-brush down to 3 minutes because the AER will clean what they miss, says Mr. Lavanchy. "The scope must be cleaned before you put it in the machine," he stresses. "Don't count on the AER to take care of cleaning. It's not intended to do that. Some models have cleaning stages in them, but you need to put a manually cleaned scope into the machine to ensure you get a good result. Shortcutting the process can potentially risk infections down the line."

Time to sterilize?
The patient was nervous about his upcoming colonoscopy, not about the prep or the propofol or the procedure, but about the risk of infection from the scope.

"Don't worry. All of our scopes are sterile," you assure him.

"Sterile?" he asks.

"Yes, we sterilize all of them."

But if high-level disinfection is as unreliable and unpredictable as many make it out to be and if flexible scopes are fundamentally difficult to decontaminate, maybe scopes should be sterilized.

"We should be moving away from high-level disinfection and going toward sterilization due to uncertainty in the process," says Mr. Lavanchy. "A gaseous approach is more reliable because it can get to surfaces within the endoscope that liquid germicides may not be able to reach."

Theoretically, he says you could sterilize endoscopes with ethylene oxide, but this can be dangerous for technicians because the gas may be carcinogenic. "That's not the only problem," says Mr. Lavanchy. "Ethylene oxide may degrade the devices."

Many consider flexible scopes to be surgical devices, no longer used solely for diagnosis, but to snare polyps and biopsy lesions. "Would you use instruments that aren't sterile for surgery?" asks Ms. Ofstead.

It's a question, unfortunately, her study has already answered. OSM