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Scope of Scope Contamination Problem Remains Underestimated!

[echo2]

The problem for TSO3 is not that it's unique VP4 technology is not an affordable and efficient solution to a public health problem that is becoming more and more recognized!! The new sales team just needs to get this excellent product sold!

As previously noted here, the scope contamination issue exists not just for duodenoscopes, but for gastroscopes, ureterorscopes, colonoscopes, and bronchoscopes. Bronchoscopes represent a category of scopes with similar issues to ERCP duodenoscopes (though only TSO3's VP4 is FDA approved to terminally sterilize ERCP scopes). Though competitors may be able to sterilize some of these other scopes (just not duodenoscopes or colonoscopes), the VP4 remains much more efficient, effective, and timely because up to 3 scopes can be put through a fast cycle of under an hour.

And, while the forward looking country of Canada has recently mandated sterilization of bronchoscopes, the US has not, or at least not yet. (Will the AAMI make this recommendation in the near future, with support of the FDA when the latter's people return to work following the US government shutdown??) And, the overseas demand for terminal sterilization is enormous, not just in Europe but in the developing world such as in India where TB and other diseases are far more prevalent than in NA.

Present practices are continuing to fail to decontaminate bronchoscopes with an incredibly alarming 58% of bronchoscopes found contaminated in a recent study (not including fungal and viral culturing).

Ofstead: "even when [proper reprocessing] guidelines were followed, high-level disinfection was not effective. A shift toward the use of sterilized bronchoscopes is recommended". "To reduce patient exposure to contaminated bronchoscopes, institutions should consider shifting from HLD to sterilization."

From https://www.chestnet.org/News/Blogs/CHEST-Thought-Leaders/2018/11/Q-and-A-with-Author-Cori-L-Ofstead

Home  /  CHEST Thought Leaders /  Effectiveness of Reprocessing for Flexible Bronchoscopes and Endobronchial Ultrasound Bronchoscopes Q&A With Author Cori L. Ofstead, MSPH

"Effectiveness of Reprocessing for Flexible Bronchoscopes and Endobronchial Ultrasound Bronchoscopes Q&A With Author Cori L. Ofstead, MSPH

By: Vanessa Claude

November 29, 2018

What effect do you hope the findings of this study will have on flexible bronchoscope reprocessing methods?

This study found that the methods used in three hospitals to clean and disinfect bronchoscopes were not effective, in part because crucial steps were being skipped or done improperly. I hope the study serves as a wake-up call to pulmonologists, the teams of reprocessing, and infection prevention personnel who are responsible for ensuring that reusable instruments are safe for use. More stringent reprocessing is clearly necessary, and I hope the American College of Chest Physicians^® will take the lead on developing stronger guidelines, training programs, and quality management systems that reduce patient exposure.

What are some factors that could enhance this study further?

Although we found microbial growth in 58% of bronchoscopes, the proportion with growth was likely underestimated because the incubation period was only 5 to 7 days, and we did not use methods needed to identify Mycobacterium or viruses. Future studies should address this and include sufficient resources to support identification of all microbial growth.

More importantly, the clinical implications of our findings are unknown because we did not track patient outcomes. Research is needed to evaluate the link between contaminated bronchoscope use and outcomes. This could be done via a randomized trial that involves sampling both patients and bronchoscopes. Samples obtained during procedures with reprocessed bronchoscopes could be compared with procedures done with single-use sterile bronchoscopes. Alternately, baseline samples could be obtained using a sterile disposable bronchoscope for comparison with samples obtained using a reusable bronchoscope in the same patient.

How would you overcome some of the limitations of this study moving forward?

Multisite studies are needed to define the extent of the problem and determine the effectiveness of potential solutions. The involvement of multidisciplinary teams including pulmonologists, epidemiologists, infection preventionists, and frontline sterile processing personnel will be essential. 

Are there any findings that you’d like to expand on in the future? What results would you like to find?

We would like to determine how GI bugs (eg, E. coli/Shigella) got inside bronchoscopes. We believe that reprocessing bronchoscopes in the same sinks and automated endoscope reprocessing systems (AERs) used for colonoscopes and gastroscopes could have introduced these pathogens. If it turns out that contaminated sinks and AERs are contributing to the problem, more rigorous protocols for their decontamination will be needed."

Effectiveness of Reprocessing for Flexible Bronchoscopes and Endobronchial Ultrasound Bronchoscopes

Cori L. Ofstead, MSPHCorrespondence information about the author MSPH Cori L. OfsteadEmail the author MSPH Cori L. Ofstead

, 

Mariah R. Quick, MPH

, 

Harry P. Wetzler, MD, MSPH

, 

John E. Eiland, RN, MS

, 

Otis L. Heymann, BA

, 

David A. Sonetti, MD

, 

J. Scott Ferguson, MD, FCCP

PlumX Metrics

DOI: https://doi.org/10.1016/j.chest.2018.04.045

 

 

 

• Abstract

• Full Text

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Background

Infections have been linked to inadequately reprocessed flexible bronchoscopes, and recent investigations determined that pathogen transmission occurred even when bronchoscope cleaning and disinfection practices aligned with current guidelines. This multisite, prospective study evaluated the effectiveness of real-world bronchoscope reprocessing methods, using a systematic approach.

Methods

This study involved direct observation of reprocessing methods for flexible bronchoscopes, multifaceted evaluations performed after manual cleaning and after high-level disinfection, and assessments of storage conditions. Visual inspections of ports and channels were performed using lighted magnification and borescopes. Contamination was detected using microbial cultures and tests for protein, hemoglobin, and adenosine triphosphate (ATP). Researchers assessed reprocessing practices, and storage cabinet cleanliness was evaluated by visual inspection and ATP tests.

Results

Researchers examined 24 clinically used bronchoscopes. After manual cleaning, 100% of bronchoscopes had residual contamination. Microbial growth was found in 14 fully reprocessed bronchoscopes (58%), including mold, Stenotrophomonas maltophilia, and Escherichia coli/Shigella species. Visible irregularities were observed in 100% of bronchoscopes, including retained fluid; brown, red, or oily residue; scratches; damaged insertion tubes and distal ends; and filamentous debris in channels. Reprocessing practices were substandard at two of three sites.

Conclusions

Damaged and contaminated bronchoscopes were in use at all sites. Inadequate reprocessing practices may have contributed to bioburden found on bronchoscopes. However, even when guidelines were followed, high-level disinfection was not effective. A shift toward the use of sterilized bronchoscopes is recommended. In the meantime, quality management programs and updated reprocessing guidelines are needed.