1. Infection Risk: Endoscope Update MARIA DONNELLEY BSN, RN, CGRN, CIC

2. Objectives  1. Discuss the risk for infection and contamination transmission in endoscopy scopes  2. Recognize the common microbial threats in endoscopy and the means of prevention in the endoscopy unit

3. The Background  Carbapenem-resistant Enterobacteriaceae (CRE) superbug outbreak in Los Angeles  cross-contamination from difficult to clean duodenoscopes  142 cases since 2010 – one half infected between 2013 and 2014  13 people died, 121 had serious complications, all had potential to infect others

4. The Culprit Carbapenem-resistant Enterobacteriaceae (CRE)

5. The Importance of CRE  Spectrum of bacteria that have a broad resistance to antibiotic therapy  Once CRE becomes an invasive bloodstream infection, the mortality rate exceeds 40%  Can be found in the intestinal tract without any symptoms of illness  Free-standing endoscopy centers are not immune to the threat

6. Transmission of Infection by Endoscopy  Endogenous: caused by the patient’s own microbial flora  cannot be prevented by disinfection procedures  Exogenous: transmitted from previous patients through contaminated equipment  Pseudomonas aeruginosa causing pneumonia, sepsis, lung abscesses, and bacteremia  H. pylori causing gastritis  Salmonella causing gastroenteritis and urinary tract infections  Hepatitis BV and Hepatitis CV  CRE  VRE  Mycobacteria (TB) from bronchoscopy

7. Endoscopes  Colonoscopes and gastroscopes are complex instruments with multiple areas for contamination risk.  Duodenoscopes hold a unique challenge for disinfection because of the intricate mechanism at the distal end to accommodate the elevator guidewire.

8. The Other Culprit  The elevator wire channel used to be exposed  In 2010, Olympus changed the design to make it safer  This has added to the difficulty of cleaning the already intricate device

9. The Basics of Disinfection  Biofilm: Bacteria begin to irreversibly adhere to the interior surfaces of the scope channels within 15 minutes after procedures are complete.  Pre-cleaning: adequate pre-cleaning can reduce the number of microorganism and debris by 99.99% if done thoroughly  Hang times: 5 days? 7 days? 21 days?  After-market compatible devices: Where did you read the device you are using is compatible with what the manufacturer requires?  Make sure you know where that information is

10. The Bigger Issue  Outbreaks from multidrug-resistant organisms (MDROs) have been found to originate in endoscopes that have been reprocessed according to industry guidelines  Case control study in Illinois:  39 cases of exposure in 2013 in duodenoscopes adequately reprocessed  Zero incidence after changing from HDL to gas sterilization

11. The Test Results Testing Results at all Steps of Endoscope Cleaning: Viable Organisms or Organic Residue Detected

12. Interim Protocol  CDC recognized incidents when no breach in reprocessing was determined  Surveillance Protocol: monthly, after 60 uses. Centers are testing weekly or after each procedure  Limitations:  A negative culture does not exclude the possibility of a contaminated scope  A positive test leads to another level in the protocol algorithm  Scopes being tested are taken out of rotation  Culture for a month to obtain baseline for unit

13. To Culture or Not to Culture  Industry standard to perform cultures during an outbreak  ATP shows presence of residual organic burden, but not specific microbes  Unrealistic for facilities to take scopes out of circulation  When a positive result is determined, an action needs to be taken; further testing  Need to trust epidemiological investigation; culture results can fail to detect offending organism

14. Limiting Liability, Increasing Patient Safety  Compliance  Competency  Certification  Vigilance  Expectation of excellence

15. Thank you!

16. References American Society for Gastrointestinal Endoscopy. (2015). Transmission of CRE bacteria through Endoscopic Retrograde Cholangiopancreatography (ERCP). Retrieved from http://www.asge.org/press/press.aspx?id=17917 Brock, A. S., Steed, L. L., Freeman, J., Garry, B., Malpas, P., & Cotton, P. (2015). Endoscope storage time: Assessment of microbial colonization up to 21 days after reprocessing. Gastrointestinal Endoscopy, 81(5), 1150-1154. doi: http://dx.doi.org/10.1016/j.gie.2014.09.053 Centers for Disease Control and Prevention. (2015). Interim duodenoscope surveillance protocol. Healthcare-associated Infections (HAIs). Retrieved from http://www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol.html# Costerton, B. (n.d.). Microbial diversity. Retrieved from http://www.learner.org/courses/biology/units/microb/experts/costerton.html#top Epstein, L., Hunter, J. C., Arwady, M. A., Tsai, V., Stein, L., Gribogiannis, M., Frias, M.,…Kallen, A. J. (2014). New Delhi Metallo-β- Lactamase–Producing Carbapenem-Resistant Escherichia coli associated with exposure to duodenoscopes. The Journal of the American Medical Association, 312(14), 1447-55. doi: 10.1001/jama.2014.12720. Jacob, J. T., Klein, E., Laxminarayan, R., Beldavs, Z., Lynfield, R., Kallen, A. J., Ricks, P.,…Cardo, D. (2013). Vital signs: Carbapenem- resistant Enterobacteriaceae. Morbidity and Mortality Weekly Report, 62(9), 165-170. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6209a3.htm Kovaleva, J., Peters, F. T. M., van der Mei, H. C., & Degener, J. E. (2013). Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clinical Microbiology Reviews, 26(2), 231-254. doi: 10.1128/CMR.00085-12

17. References Manning, M. L. (2015). Re: Docket No. FDA-2015-N-0722; Gastroenterology and Urology Devices Panel meeting on reprocessing of duodenoscopes and other endoscopes. Retrieved from http://www.apic.org/Resource_/TinyMceFileManager/Advocacy- PDFs/Duodenoscope_reprocessing_--_Final_4-29-15.pdf O’Connor, D. (2015). Deadly Superbug-Related Scopes Sold Without FDA Approval. Outpatient Surgery. Retrieved from http://www.outpatientsurgery.net/outpatient-surgery-news-and-trends/general-surgical-news-and-reports/deadly-superbug- related-scopes-sold-without-fda-approval--03-05-15 Ofstead, C. L., Wetzler, H. P., Doyle, E. M., Rocco, C. K., Visrodia, K. H., Baron, T. H., & Tosh, P. K. (2015). Persistent contamination on colonoscopes and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines. American Journal of Infection Control, 43(8), 794-801. http://dx.doi.org/10.1016/j.ajic.2015.03.003 Terhune, C., & Petersen, M. (2015, August 17). FDA reveals 142 cases of tainted scopes. Los Angeles Times. Retrieved from http://www.latimes.com/business/la-fi-fda-scopes-20150507-story.html