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  • Jefferson Adams
    Jefferson Adams

    Duodenoscopes Often Contaminated with Dangerous Bacteria After Reprocessing

    Reviewed and edited by a celiac disease expert.

      Duodenoscopes made by companies Olympus, Fujifilm, and Pentax are facing pressure from the FDA to reduce risk of bacterial infection of reprocessed scopes.


    Caption: Image: CC--Andy G

    Celiac.com 12/26/2018 - The first wave of results are in from the 2015 FDA-mandated post-market surveillance studies of duodenoscopes, and they are not encouraging. The duodenoscopes are designed to be reprocessed, to be cleaned and disinfected, according to manufacturer guidelines. However, reprocessed scopes show "higher-than-expected" rates of contamination with dangerous bacteria.

    In a recent safety announcement, the FDA revealed that 3% of properly collected samples tested positive for more than 100 colony-forming units of "low-concern" organisms. These bacteria are not likely to cause serious infections, but they do indicate "reprocessing failure."

    Moreover, an additional 3% of properly collected samples tested positive for "high-concern" bacteria that are more often associated with disease, such as Escherichia coli or Staphylococcus aureus.

    In 2013, the FDA began to focus on a possible connection between multi‒drug resistant bacteria and reprocessed duodenoscopes.  In 2015, FDA ordered duodenoscope makers Olympus, Fujifilm, and Pentax to determine whether healthcare facilities were able to properly clean and disinfect the devices. The mandatory monitoring is part of the FDA’s effort to eliminate patient infections associated with bacteria from contaminated duodenoscopes.

    The FDA’s order required the companies to conduct two separate studies. First, they were required to sample and culture reprocessed duodenoscopes to learn more about issues that contribute to contamination. Second, they were required to evaluate the training of hospital staff in following the reprocessing instructions as part of a study of “human factors.” 

    When the companies  failed to carry out such studies promptly, The FDA sent warning letters citing their failure publicly. All three device makers have now begun collecting the required data. They recently completed testing for the initial human factors, and at least 10% of the samples have been collected for the sampling and culturing study.

    Initial findings from the human factors study of staff training indicate that staff finds the reprocessing instructions in current user manuals difficult to comprehend and follow, the FDA said. The FDA is working with the duodenoscope manufacturing companies to revise and clarify the user materials to improve reprocessing outcomes and to reduce contamination risk.

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    Not acceptable --   Hospitals and Surgery Centers have to do better.  These instruments should be spot checked (by the surgery centers themselves as well as the FDA/NIH/CDC etc.) for bacteria AND taken out of commission ALONG with the centers they are used in ---  if found to be contaminated, until they can prove they can be cleaned/properly sterilized between patients

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    Yikes. The thing someone like myself with a bio degree often thinks about as I  am going twilight before scope. Is it autoclave standard clean? Probably can't go in autoclave .....😳 Fade to twilight....

    Glad someone is checking and getting data, but I agree with Celiac mom -not acceptable.

    Edited by Awol cast iron stomach
    Autocorrect incorrect

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    As a retired Endoscopy nurse(RN), at a local hospital, who cleaned our scopes, we had frequent in services from our company that we bought our equipment from. Our hospital did fire some techs and and RN when they refused to clean ERCP scopes properly. My question, are the other 97% of tested scopes OK? If so, that is a good sign that staff is cleaning well. We kept our Steris machines updated and cleaned every day. Hope this info helps. PS. I do have celiac and have Endoscopy tests often.

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    Awol-

     You are right, they can't be autoclaved. There are critical parts (elastomer seals?) that would simply be destroyed by the heat. There is a similar issue going on with similar equipment from the same manufacturers, colonoscopes. Perhaps you heard about the VA "scandal" and notices sent out to patients for HIV and hepatitis testing recently because of that?

     The literature from one manufacturer (for colonoscopes) calls for about an hour of manual intense cleaning, followed by a ten to twelve hour bath in disinfectant, followed by more cleaning and drying. That means if you want to do more than one procedure per day, you need one piece of equipment for EACH procedure, and staff to hang around cleaning and soaking things all night. Kinda pricey, huh?

     And a major dental school recently made the news because for two years now, their students have similarly been "wiping down" a major instrument instead of giving it a long overnight treatment. Notices were sent out to patients. A hygienist I know, who graduated from that program a decade ago, said "WHAT?! THEY CAN'T DO IT THAT WAY!" but, they did. Students are now being required to buy two instruments, so one can soak overnight while the second is ready for use first thing the next day.

     Not to mention, "twilight sleep" is still anaesthesia, and that still has a largely undiscussed damage rate. A friend of mine who had routine anaesthesia for two surgeries (they waited several days after the first one to perform the second half) actually left the planet [sic] for three months. We were helping her children make plans in case she didn't come back, because after the first two months, there was no sign, no information, when or if she would.

     Apparently there is "anaesthetic induced dementia" that no one talks about, and even anesthesiologists are often unaware of. Simple put, a significant number of patients (especially those over 60) will wake up just fine--but totally unable to recognize people and things, requiring constant care for days to months afterward.

    Sometimes procedures and equipment are necessary, sometimes the doctors are simply UNEDUCATED as to the potential for collateral damage. In which case you have to put your foot down and ask, if a "gold standard" is really the only acceptable way to do things. Often, it is simply "the way we've always done it" and that's not satisfactory.

    Marcus Welby, where are you? (Oh, wait, he'd never heard of celiac either...)

     

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  • About Me

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in biology, anatomy, medicine, science, and advanced research, and scientific methods. He previously served as SF Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

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