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

Infection Risk: Endoscope Update

MARIA DONNELLEY BSN, RN, CGRN, CIC

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

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

The Culprit

Carbapenem-resistant Enterobacteriaceae (CRE)

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

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

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.

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

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

The Bigger IssueOutbreaks from multidrug-resistant organisms (MDROs) have been found to originate in endoscopes that have been reprocessed according to industry guidelinesCase control study in Illinois: 39 cases of exposure in 2013 in duodenoscopes

adequately reprocessed

Zero incidence after changing from HDL to gas sterilization

The Test Results Testing Results at all Steps of Endoscope Cleaning: Viable Organisms

or Organic Residue Detected

Microbial Cultures Rapid Testing (ATP) Bedside, post-procedure 92% 100% (> 200 RLU*)

Manual Cleaning 46% 92%

HLD** 64% 73%

Overnight Storage 9% 82%

*Relative Light Units: the greater the ATP, the greater the RLU **High Level Disinfection

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

scopeA 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

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

Limiting Liability, Increasing Patient Safety

Compliance Competency Certification Vigilance Expectation of excellence

Thank you!

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

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