Reprocessing & Infections Control J.Patricia Burga.

An Endless Story…. Contamination and infection control are an ancient but also actual problem From Semmelweis to now days, it is a run-up between new technology and more resistant bacteria

Spaulding Classification EH Spaulding believed that how an object will be disinfected depended on the object’s intended use (developed 1968). CRITICAL - objects which enter normally sterile tissue or the vascular system or through which blood flows should be sterile. SEMICRITICAL - objects that touch mucous membranes or skin that is not intact require a disinfection process (high- level disinfection [HLD]) that kills all microorganisms but high numbers of bacterial spores. NONCRITICAL -objects that touch only intact skin require low- level disinfection (or non-germicidal detergent).

Goals Endoscopy has made progress in diagnosis and treatment of GI diseases It is the hospital Doctor’s, nurse’s and assistant’s responsibility to assure patient safety during this procedures This is the aim of infection control in endoscopy

Disinfection and Sterilization Rutala, Weber. Am J Infect Control. 2016;44:e1-e6; Rutala, Weber ICHE. 2015;36:643 EH Spaulding believed that how an object will be disinfected depended on the object’s intended use (modified). CRITICAL - objects which directly or secondarily (i.e., via a mucous membrane such as duodenoscope, cystoscope, bronchoscope) enter normally sterile tissue or the vascular system or through which blood flows should be sterile. SEMICRITICAL - objects that touch mucous membranes or skin that is not intact require a disinfection process (high-level disinfection [HLD]) that kills all microorganisms but high numbers of bacterial spores. NONCRITICAL -objects that touch only intact skin require low-level disinfection (or non-germicidal detergent).

Infection transmission in endoscopy Existing problem: The visceral cavity is inspected and it can contain pathogenous germs or been contaminated The endoscopes are structural complex, difficult to clean, and can be damaged by aggressive chemical agents or heat

What to Do ? Guide Lines Thecnical Standards National -Regulations

Most common pathogens CLOSTRIDIUM DIFFICILE (GRAM +) Colitis, diarrhea ACINETOBACTER BAUMANII (GRAM -) bacteremia, urinary tract infections (UTIs), secondary meningitis, infective endocarditis, and wound and burn infections NOROVIRUS (GRAM -) nausea, vomiting, diarrhea, and some stomach cramping VRE Vancomycin Resistant Enterococci (GRAM +) infections can occur anywhere in the body, common sites include the intestines, the urinary tract, and wounds PSEUDOMONAS AERUGINOSA (GRAM -) P. aeruginosa typically infects the airway, urinary tract, burns, wounds and also causes other blood infections blood infections KLEBSIELLA PNEUMONIAE (GRAM -) pneumonia, thrombophlebitis, urinary tract infection, cholecystitis, diarrhea, upper respiratory tract infection, wound infection, meningitis and septicemia MYCOBACTERIUM TUBERCULOSIS (GRAM -) usually attack the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain MRSA Methicillin-Resistant Staphylococcus Aureus (GRAM +) respiratory tract, open wounds, intravenous catheters and the urinary tract are potential sites for infection

Infection transmission in endoscopy The pathogenes transmission is a rare event.. ASGE Technology Assesment committee : 28 reported cases ( 1:1,8 mill. Procedures) 93-03: 5 reported cases CDCDivision of health care quality promotion : ( review): 0 cases FDA :7 reported cases 10 millions di procedures /year in USA (95) (With a compliance of the guide lines from 70-90% for the endoscopes and 25-70% for the accessories in USA Italy ( ASGE-SIED survey)

How the Numbers Changed EU The number of hospital admissions in the EU ( 498 million inhabitants) is approximately 8116,247 admissions per 100,000 inhabitants per year. The yearly number of patients with at least one nosocomial infection in the EU can thus be estimated at patients. Since patietns will often get more than one infection during the same hospitalization (average from national prevalence survey is 1.1 infections per infected patient) the yearly number of nosocomial infections can be estimated at

Transmission of Infection by Endoscopy Kovaleva et al. Clin Microbiol Rev : Based on outbreak data, if eliminated deficiencies associated with cleaning, disinfection, AER, contaminated water and drying would eliminate about 85% of the outbreaks.

RECENT ENDOSCOPY-RELATED OUTBREAKS OF Multy Drug resistant ( MRDO) WITHOUT REPROCESSING BREACHES MDROScopeNo. Recovered From ScopeMolecular Link Reference P. aeruginosa (VIM-2) Duodenoscop e 22Yes, under forceps elevator Yes Verfaillie CJ, 2015 E. coli (AmpC)Duodenoscop e 7Yes (2 scopes)Yes (PFGE) Wendort, 2015 K. pneumoniae (OXA) Duodenoscop e 5 No Kola A, 2015 E. coli (NDM-CRE)Duodenoscop e 39YesYes (PFGE) Epstein L, 2014 Additional Outbreaks (not published; news media reports) UCLA, 2015, CRE, 179 patients exposed (2 deaths), 2 colonized duodenoscopes CMC, 2015, CRE, 18 patients exposed (7 infected), duodenoscopes Cedars-Sinai, 2015, CRE, 67 patients exposed (4 infected), duodenoscopes Wisconsin, 2013, CRE, (5 infected), duodenoscopes University of Pittsburgh, 2012, CRE, 9 patients, duodenoscopes

Endemic Transmission of Infections Associated with GI Endoscopes Likely Go Unrecognized Rutala, Weber. Am J Infect Control. 2016;44:e1-e6; Rutala, Weber ICHE. 2015;36:643 Inadequate surveillance of outpatient procedures for healthcare-associated infections Long lag time between colonization and infection Low frequency of infection Pathogens “usual” enteric flora Risk of some procedures might be lower than others (colonoscopy versus ERCP where normally sterile areas are contaminated in the latter) Carbapenen resistant+Extended spectrumBeta-lactamoses Carbapenen resistant+Extended spectrumBeta-lactamosesCRE+ESBL

Reprocessing Channeled Endoscopes Cystoscope- “completely immerse” in HLD (J Urology :588

Reprocessing Channeled Endoscopes Rutala, Gergen, Bringhurst, Weber. ICHE. 2016;37: Exposure methodCRE ( K.pneumoniae) Inoculum before HLD ( glutaraldeide) CRE ( K,pneumoniae) Contamination after HLD Passive HLD (immersed not perfused) 3.2x x x x x x10 8 Active HLD ( perfused HLD into channel with syringe) 3.0x x x Immerse channeled flexible scope pathogens must have exposure to HLD for inactivation Simple immersion into HLD will not inactivate channel pathogens Completely immerse the endoscope in HLD and ensure all channels (ie. hysteroscopes, cystoscopes) are perfused Air pressure in channel stronger than fluid pressure at fluid-air interface

Cystoscope-HLD perfused through lumen with syringe (luer locks onto port and syringe filled and emptied until no air exits in the scope nor air in barrel of syringe-syringe and lumen filled with HLD) Reprocessing Channeled Endoscopes

Endoscope Reprocessing Microbial Load/Complex Instruments New Guidelines ESGE ESGENA multi-society guideline (in preparation) AORN-2016 AAMI-2015 SGNA-2015 Must educate/comply but will not prevent all infections and patient exposure due to microbial load and instrument complexity

Causes of Infections and endospic procedures Endoscopic procedures are well established in the diagnosis and therapy of gastrointestinal diseases. In addition to other procedure-related risks, the risk of infection due to endoscopic procedures has to be taken into consideration. Endoscopy-associated infection risks are categorized as follows: Endogenous: Bacterial translocation of endogenous bacterial flora into the blood stream may occur during an endoscopy because of mucosa trauma related to the procedure, depended on the procedure performed and the susceptibility of tissues An endoscopy may also result in local infections when typically sterile space, such as the bile duct or pancreatic cyst, is breached and contaminated by an endoscopic accessory. Placement of percutaneous gastrostomy tube is associated with the risk of peristomal infection Exogenous: caused by inadequately reprocessed equipment. (endoscopes and accessories can be vehicles for pathogenic or facultative-pathogenic germs that are transmitted from previous patients Cross infection: Non compliance to reprocessing guidelines due to error or negligence Use of syringes or contaminated water Non enough contact time with the HLD or a wrong disinfectant Wrong use of washer machines or the use of one not conform to the safety regulations Patient to patient – Asses the procedure that does risk management of privileges in those who are potentially infected

Guideline of the use of antibiotic prophylaxis in endoscopy highi/ low risk, patient at high / low risk Guideline about personnel protection (doctors / nurses from infections, from disinfectants Non standard regulations on how to proceed in the monitoring of HLD Few and limited warning or recomendations about traceability of the reprocessing What to do

Quality in endoscopy Rigor respect to the reprocessing guidelines Traceability of the whole process of the instrument (use and reprocessing) Organize and monitor the entire process of each endoscope: reprocessing, storage and use. In order to monitor, the procedure has to be measurable And to be measurable it has to be traceable

How to be protect Standard precautions: personnel should be aware of danger of blood or other body fluids, contaminated equipment and disease transmission Because a patient’s infection status is often unknown at time of an endoscopy,its prudent to apply standard procedures when interacting with patients. Precaution at the institutional level: all employees should be immunized against HBV, even though the risk is small Endoscopy suite: exposed surfaces should be thoroughly cleaned of visible contaminants Hands should be wash before and after each patient interaction. For some patients isolation may require an endoscopy at bed side rather than in the endoscopy unit. Have a separate areas for soiled and clean tasks and the handling of specimen,tissues soiled linens, and contaminated wastes.

Research and technology/ automation Sterilization Great huge margin of safety, modified Spaulding classification High level disinfection Endoscope related infections should promote automated research ( scopes) and sterilization Low level disinfection eliminate environmental causes as a source of health care associated pathogens

Disinfection and sterilization A challenge to meet goals Prevent all infectious disease transmission associated with the environment Via Research / automation/ technology/ competency

Technology and automation Giving the choice of changing human behavior (e.g improving aseptic technique) or designing a better device The device will always be more successful…… (Robert A. Weinstein)

Our Responsibility to the Future Prevent All Infectious Disease Transmission by Instruments and the Environment Via Research/Technology/Automation/Competency Disinfection and Sterilization: The Good, The Bad and The Ugly

The Good Sterilization-highly effective  Bioluminiscence (Bls), emerging technologies, sterilization endoscopes High-level disinfection  Endoscope-related infections will promote automation and sterilization Low-level disinfection  Eliminate environment as source-“No touch” room decontamination, new germicides, continuous room decontamination

The Bad Improve instrument reprocessing  Competency  Compliance with evidence- based guidelines  Research/Technology/ Automation

The Ugly Infection risks –Endoscopes –Infectious diseases