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For practitioners seeking to reduce the likelihood of hospital-acquired infections, no medical device should be considered too small to worry about. According to the healthcare researchers at Ofstead & Associates, that includes ureteroscopes.

“There has been a lot of focus on duodenoscopes and the elevator mechanism, and we’ve been concerned about other types of scopes,” says Cori Ofstead, president and CEO of the research organization. “And in the case of ureteroscopes, it seems to me they’re a high risk type of instrument if they’re not sterile before use.”

Ofstead notes the risks identified with duodenoscopes largely stem from the ways in which contamination on the device can easily be introduced into the bloodstream through procedures performed in the liver, the bile duct, or the pancreas.

While often overlooked as a risk, the ureteroscope can leave the patient prone to similar exposure. When the ureteroscope is threaded into the kidney to demolish stones, damage can be done.   

“When you go into the kidney and blast a stone, by the nature of it you're doing surgery and it will cause the patient to bleed,” Ofstead says. “And so now you’re having access to the bloodstream. It is absolutely essential to avoid introducing a contaminated scope to an area where you’re right in touch with the bloodstream.”

Because the ureteroscopes are so slender and fragile, they’re also prone to failure and breakage. Ofstead notes that the literature review conducted ahead of their most recent research pointed to damaged ureteroscopes as a common problem. 

When considering infection prevention, a broken scope stirs concerns about the ways the device might have been starting to wear down.

“In my mind, if they break during the procedure, what were they like in the last procedure?” Ofstead says. “Were they actually intact, or were they already on their way to breaking? Did they have bad scratches, or gouges, or leaks that caused them to fail during the procedure or during reprocessing? Maybe the doctor or technician just noticed that it was so bad that they couldn’t use the scope anymore.”

Ofstead and her team set out to determine the state of ureteroscopes before they experienced catastrophic failure.

To make certain the research was of the highest rigor, Ofstead partnered with healthcare facilities that were especially attentive to keeping ureteroscopes in the highest possible condition. Though most standards suggest it’s permissible to settle for high-level disinfection on flexible endoscopes, the hospitals included in the study were opting for full sterilization as a standard.

Despite the aggressive infection prevention measures undertaken, the results were alarming.

“The scopes failed all kinds of tests that we were doing,” says Ofstead. “We did protein, hemoglobin, and ATP tests. And we tested only patient-ready ureteroscopes, which are scopes that had been sterilized and ought to have been free of all those contaminants.”

Since there’s currently no guideline for reprocessing urology scopes, Ofstead’s team used the benchmarks established for gastrointestinal scopes. According to Ofstead, every single scope failed to clear the threshold.

“Stretch your mind around that,” she says. “We’re holding onto a standard for colonoscopes that are clean and the ureteroscopes that had supposedly been sterilized failed to meet that benchmark. The rhetoric in sterile processing is ‘If something isn’t clean, sterilization won’t work,’ and at the end of the day, we found microbial growth on these allegedly sterile scopes. That’s not good, but it was predictable because all the tests showed they weren’t even clean.”

Dire assessments like that aren’t entirely new. Concerns have been raised about the possibility scopes are persistently difficult to get disinfected or fully sterile, especially once they’ve suffered some physical wear. Healthcare professionals now need to determine what can be done about the identified problem.

“I don’t think we’ve pushed the edges of trying,” says Ofstead. “And so the new guidelines that were released by AORN and others over a year ago, they say that people should be doing visual inspection and cleaning verification tests routinely. The truth is that almost no one’s doing it. What would happen if they actually did follow every step of the guidelines, do visual inspection every time, do a cleaning verification test every time? Well, none of these scopes would have made it into patient care, because they would have failed and then that could have been addressed.”

Ofstead also notes that bedside pre-cleaning of the scopes should be taking place. It’s a step that’s often skipped by OR staff in the interest of efficiency or even a simple lack of awareness that it’s needed. But scopes that aren’t properly cleaned in the first place cannot then be successfully sterilized.

Expediency in moving equipment from the treatment space to sterile processing is also important.

“In our research, we found out the scopes often sit on the case cart until it goes down to central sterile processing,” says Ofstead. “The scope may be used in the beginning of the procedure, then they might do some other stuff. It can sit there for an hour or two. So there’s no bedside pre-cleaning, and then delayed preprocessing.”

A lack of communication between departments compounds the problem.

“The sterile processing department folks had no idea that there was no pre-cleaning, no idea there were delays,” explains Ofstead. “So they had no protocol for dealing with scopes that had been delayed in reprocessing. In the whole scheme of things, by the time you haven’t done pre-cleaning, now the biofilm and the organic material just hardened on the scope. We think that’s definitely a contributing factor and that's an actionable thing.”

Another common recommendation illustrates the ways in which the protocols don’t always take every detail into account. As various organizations have been stressing the need for surgeons to visually inspect scopes immediately before beginning a procedure, a simple aspect of the environment in which ureteroscopes are used has been overlooked.

“We talked to some of the urologists about it, and the urologists said something that completely surprised me,” Ofstead says. “They said, ‘Oh we would never do a visual inspection on a scope, because when we go into the room to do the procedure, the lights are off.’”

That means the responsibility for visual inspection falls upon the technicians or nurses who set up the room before the procedure.

These challenges to fulfilling recommended preventative measures in the space in which the ureteroscopes are being used only emphasizes the need to take extra steps to get the cleaning and sterilization process exactly right every time. As everyone knows, lives are on the line. 

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