Update on Duodenoscope Related CRE Transmission. Disclosures. Outline 9/2/2016. None

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1 Update on Duodenoscope Related CRE Transmission Mary Beth Graham, MD, FIDSA,FACP Professor of Medicine Medical College of Wisconsin None Disclosures Outline Overview of multidrug resistant organisms including CRE Review reports of endoscopic transmission of CRE Review current recommendations for scope processing to prevent transmission Discuss novel approaches and interventions to prevent spread of CRE 1

2 Antibiotic Resistance Each year in the US, at least 2 million people acquire serious infections with bacteria that are resistant to one or more antibiotics designed to treat t them. At least 23,000 people die each year as a result of an antibiotic resistant infection. The use of antibiotics is the single most important factor leading to antibiotic resistance in the world. Antibiotic Resistance Per CDC ~50% of the time antibiotics are not optimally prescribed, often done so when not needed, incorrect dosing or duration. Another major factor in the growth of antibiotic resistance is spread of the organisms person to person, or spread from non-human sources in the environment 2

3 What is an MDRO? MDRO Multi-Drug Resistant Organism No consensus definition Various definitions used in the literature: Resistance to 1 or more antibiotics Resistance to 1 or more classes of antibiotics Resistance to all but one antibiotic or class Resistance to all antibiotics or classes Clinical Importance of MDROs Options for treatment are limited MDROs have been associated with Increased lengths of stay Increased cost Increased morbidity and mortality Worse outcomes for resistant organisms has been reported MDRO Control Successful control of MDROs has been documented in the United States and abroad using a variety of combined interventions: improvements in hand hygiene use of Contact Precautions until patients are culture- negative for a target MDRO active surveillance cultures (ASC) Education enhanced environmental cleaning improvements in communication about patients with MDROs within and between healthcare facilities. 3

4 Superbug = CRE Carbapenem Resistant Enterobacteriaceae Klebsiella species, Escherichia coli (E. coli), and Enterobacter species are examples of Enterobacteriaceae Currently in the United States, CRE are primarily identified among patients with healthcare exposure Potential for CRE to spread outside of healthcare settings, given that Enterobacteriaceae are a common cause of community-associated infections such as UTIs 4

5 CRE Uncommon in the US prior to 1992 Much of the increase in CRE since 2000 has been due to the spread of CRE that produce the carbapenemase Klebsiella pneumoniae carbapenemase (KPC) Several other types of carbapenemases have been identified in the United States since 2009 New Delhi Metallo-β-lactamase (NDM-1) Verona Integron-encoded Metallo-β- lactamase (VIM) Oxacillinase-48-type carbapenemases (OXA-48) Imipenemase (IMP) Metallo-β-lactamase. CRE CRE have been associated with high mortality rates (up to 40 to 50% in some studies). In addition to β-lactam/carbapenem resistance, CRE often carry genes that confer high levels of resistance to many other antimicrobials, often leaving very limited therapeutic options Pan-resistant KPC-producing strains have been reported. 5

6 Historical View of GI Endoscopy and Infection Despite the large number and variety of GI endoscopic procedures performed, documented instances of infectious complications remain rare, with an estimated frequency of 1 in 1.8 million procedures Microorganisms may be spread from patient to patient by contaminated equipment (exogenous) Microorganisms may spread from the GI track through the blood stream during an endoscopy (endogenous) Microorganisms transmitted from patients to endoscopy personnel Gastrointestinal Endosc 2008; 67(6): Healthcare-Acquired Outbreaks via GI Endoscopes Infections Associated with Accessories Infections associated with biopsy forceps Contaminated biopsy forceps. (Dwyer DM. Gastroint Endosc 1987;33:84) Contaminated biopsy forceps (no cleaning between cases). Graham DY. Am J Gastroenterol 1988;83:974) Biopsy forceps not sterilized (glut exposed,? time) Bronowicki JP. NEJM 1997;334:237) Reusable endoscopic accessories that break the mucosal barrier should be mechanically cleaned and sterilized between patients Transmission of Infection During GI Endoscopy Viruses - Attributable 8 cases of HCV (possible contamination of multi-dose vials) 5 cases of HBV suboptimal reprocessing practices Bacteria 48 cases of Salmonella ( ) colonization to death 216 cases of Pseudomonas aeruginosa water, elevator channel, failure to dry all channels (70% alc.) 12 cases of H. pylori Miscellaneous Gram-negatives (<20 cases) - ERCP M. tuberculosis, atypical Mycobacteria - bronchoscopy Nelson DB, Muscarella LF. World J Gastroenterology 2007;12:

7 Healthcare-Associated Infections via GI Endoscopes Observations Number of reported infections is small, suggesting g a very low incidence Endemic transmission may go unrecognized (e.g. inadequate surveillance, low frequency, asymptomatic infections) Spach DH. Ann Int Med 1993 Weber DJ, Rutala, WA. Gastroint Dis 2002 Healthcare-Associated Infections via GI Endoscopes Infections traced to: Inadequate cleaning (clean all channels) Inappropriate/ineffective disinfection (time exposure, perfuse channels, test concentration, ineffective disinfectant, inappropriate disinfectant) Failure to follow recommended disinfection practices (tap water rinse) Flaws and complexity in design of endoscopes or AERs Wm A. Rutala, PhD FDA Reports Olympus ERCP Endoscope Reported 12/ patients developed Klebsiella pneumoniae infections after ERCP Problem related to difficulty in reliably cleaning and disinfecting the elevator Response Reprocessing changed from automated highlevel disinfection to gas sterilization 7

8 Early identification and control of carbapenemase-producing Klebsiella pneumoniae, originating from contaminated endoscopic equipment. AJIC 2013;41:562-4 Florida 2 hospitals 7 cases of carbapenem resistant K. pneumoniae identified between June 2008 and Jan All 7 patients had ERCP at the same endoscopy center 46 additional patients who were seen at the same endoscopy center were screened 3 additional patients were found to be colonized with CRE Institution blamed episode on inadequate cleaning of the complex terminal part of the ERCP scope that contains the scope elevator 39 case patients were identified from January 2013 through December 2013, 35 with duodenoscope exposure in an Illinois hospital. No lapses in duodenoscope reprocessing were identified; however, NDM-producing Escherichia coli was recovered from a reprocessed duodenoscope and shared more than 92% similarity to all case patient isolates by PFGE. JAMA 2014;312(14): NDM-Producing CRE Associated With Duodenoscope Exposure Infection Prevention During October 2013, the hospital changed its duodenoscope reprocessing procedure from automated a high-level e disinfection to gas sterilization with ethylene oxide. The hospital completed 3 rounds of postreprocessing cultures on all duodenoscopes in service. All cultures were negative for Enterobacteriaceae 8

9 Recent Endoscopy Related Outbreaks of MDRO No breaches in reprocessing documented in any of the following reports: Endoscopy 2015 Jun;47(6): VIM-2-producing Pseudomonas aeruginosa Infect Con and Hosp Epi 2015 Jun;36(6): AmpC E coli Antimicrobial Resistance and Infec Cont :8 OXA-48 Klebsiella pneumoniae Gastrointestinal Endoscopy (4): NDM-1 E coli And many more. CDC Response CDC released Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing Facilities should review all steps in duodenoscope reprocessing quarterly to ensure strict adherence to manufacturer s instructions Inspection / Manual cleaning Drying» including alcohol flush followed by forced air drying if compatible CDC Response Use of Duodenoscope Culturing The sensitivity of the interim protocol has not been determined A negative culture does not completely exclude the possibility of a contaminated duodenoscope Positive culture should lead to some action Non-Culture methods (e.g. ATP) will detect residual organic material after cleaning but lack consistent correlation to bacterial concentrations 9

10 FDA Response Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate i it. Recommendations for Facilities and Staff that Reprocess ERCP Duodenoscopes: Follow closely all manufacturer instructions for cleaning and processing. Refer to the Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011 consensus document for evidence-based recommendations for endoscope reprocessing. Report problems with reprocessing the device to the manufacturer and to the FDA Dilemma Are current endoscope reprocessing guidelines adequate to ensure a GI endoscope devoid of potential pathogens? Is it impossible to ensure that high-level disinfection (HLD) of endoscopes will lead to a scope devoid of potential pathogens? Especially scopes with long, narrow channels, and components that are difficult to clean and disinfect such as elevator channels ICHE 2015, vol. 36, no. 6 10

11 ENDOSCOPE SAFETY Quality Control Issues Ensure protocols equivalent to guidelines from professional organizations (APIC, SGNA, ASGE) Ensure that the manufacturer guidelines are being followed EXACTLY Are the staff who reprocess the endoscope specifically trained in that job? Are the staff competency tested at least annually? Conduct IC rounds to ensure compliance with policy Consider microbiologic sampling of the endoscope ENDOSCOPE SAFETY Quality Control Issues Keep track of updates from CDC and FDA htm FDA Safety communication - Updated reprocessing instructions from Olympus for duodenoscope models TJF- 160F and TJF-160VF CDC Interim Duodenoscope Surveillance protocol searchoption=all AAMI endoscope reprocessing standard no free access 11

12 What We Know HLD alone is not sufficient based on recent ERCP outbreaks Although a second HLD cycle may reduce or eliminate microbial contaminants from the first cycle, no enhancement to reduce infection risk with ERCP scopes has been shown HLD with microbiologic surveillance Post-HLD cultures may not be sensitive enough to identify scopes which may be colonized What We Know Ethylene oxide (ETO) sterilization Some data demonstrate reduced infection risk with HLD followed by ETO No microbicidal efficacy data proving sterility assurance level (SAL) of 10-6 ETO is toxic, a carinogen, flammable Requires aeration time to remove ETO residue Limited availability of ETO on site May damage endoscope Novel Approach Microbiology lab developed and verified a technique to screen patients (rectal swab) for KPC and NDM-1 (PCR test) All patients undergoing any ERCP or EUS procedure in GI clinic screened prior to the procedure Micro lab runs test in real time, so result of testing available within hours of reaching the lab 12

13 Novel Approach Specimens screening positive for KPC or NDM-1 set up for culture confirmation Any scope used on a patient screening positive for KPC or NDM-1 is quarantined Scopes with elevator channel undergoes HLD and then is sent for terminal sterilization with ETO Novel Approach Purchase / rental of additional ERCP and EUS scopes to ensure availability of instruments for patient care All ERCP and EUS (and any other scope with an elevator) are on a rotating schedule to undergo ETO sterilization at least once a month 13

14 Other Resources Volume 73, No. 6 : 2011 GASTROINTESTINAL ENDOSCOPY 14

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