Posted on June 8, 2017 by Cogentix Medical

Battling the Bugs: Superbugs in Endoscopy

What are Superbugs?

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Superbugs are a growing problem that have affected all corners of the medical community. Superbug is the coined term for antibiotic resistant bacteria. This is a result of long term overuse of antibiotics, which has led to bacteria evolving and becoming stronger, to the point that even “last-resort” medications are of no longer effective in fighting them. According to the Review on Antimicrobial Resistance, approximately 700,000 people around the world die every year as a result of superbug infections; and that number is expected to rise to 10 million deaths per year by 2050 if solutions aren’t found. One of the most dangerous and untreatable superbugs, which has been in the news plenty in recent years, is Carbapenem-Resistant Enterobacteriacae (CRE). Carbapenem is an extremely strong antibiotic that is used to treat infections that are suspected to be caused by multidrug-resistant (MDR) bacteria. So basically, Carbapenem is an antibiotic we turn to when other antibiotics fail; so the fact that CRE is resistant to Carbapenem is what makes it so scary and very difficult to treat.

It is estimated that as many as 1 out of 2 patients who are infected with CRE will die as a result; although the actual statistics are much less clear. The two most notable recent outbreaks of CRE were closely linked to use of endoscopes. One outbreak, at UCLA, saw 179 patients infected with CRE with 2 patients dying from the infection. All patients were found to have undergone endoscopies at Ronald Reagan Hospital at UCLA. Prior to that, a series of infections occurred in Washington at Virginia Mason Medical Center, where 39 patients were infected between 2012 and 2014 with 18 patients dying. Although previous investigations of other outbreaks found that certain cleaning and reprocessing protocols were not followed, that was not necessarily the case with either of these outbreaks; in fact, investigators found that the endoscopes at UCLA were cleaned following well established guidelines each time, yet the virus was still passed.

Can We Clean the “Bugs” Away?

So, even if protocols are followed closely there is still a chance for a superbug infection? Unfortunately, yes. Due to the complicated design of flexible endoscopes, there are countless cracks, crevices, joints, and spaces where cells can collect. Even if the standard protocols and guidelines are followed, these spaces are very difficult to clean and often are not completely scrubbed, despite best efforts.  UCLA and Virginia Mason CRE outbreaks were associated with duodenoscopes with a specific part, the elevator section, which is considered nearly impossible to completely clean. Bioburden from a patient carrier of CRE cells can build up in those spaces and lead to the threat of widespread cross-contamination to future patients treated with that endoscope. These cells have even been shown to be resistant to even high level disinfectant (HLD) chemicals.

What is Being Done?

To combat these problems, the FDA, CDC and other organizations have made several changes to reprocessing and sterilization guidelines, in order to minimize the risk of these infections. Manufacturers of various types of endoscopes have changed some aspects of their designs, in order to make them easier to clean, and have also made updates to the listed reprocessing instructions in their user’s manuals. The topic was also discussed at the annual FDA Advisory Committee Meeting for Gastroenterology and Urology Devices on May 17 in Gaithersburg, MD.

Can the EndoSheath® Protective Barrier Help?

A way to mitigate the risk of these infections in Bronchoscopy, Cystoscopy, Esophagoscopy, and Laryngoscopy is the use of a single-use EndoSheath Protective Barrier with a PrimeSight Endoscope. The EndoSheath passed FDA-mandated testing to prove protection against microbes as small as 27 nanometers, which is the size of the Polio virus. There have been zero cases of cross-contamination out of over 5 million EndoSheath product sold, and the product goes through vigorous leak testing before being sterilized and shipped.

But, what if the EndoSheath gets a tiny puncture and the scope gets contaminated, won’t that spread infection to the next patient? Consider the results of this study in which a series of tiny (30 nanometers) holes were laser drilled into several EndoSheath barriers, which were then placed in a highly concentrated solution (titer) for 30 minutes. The amount of microbe buildup on the inside of the EndoSheath and the endoscope were noted, and the scope was immediately placed into another EndoSheath which had been laser drilled with even smaller (20 nanometers) holes. This second set-up was placed in a tracing liquid, which contained no bacteria, for another 30 minutes, and then the outside of the EndoSheath was tested to see if any of the bacteria had permeated out. In every trial, there were no traces of the virus on the outside of the second EndoSheath, which lead Baker to determine that “use of a sheath combined with intermediate level disinfection should provide a safe instrument.”

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