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1 Slide 1 1 Contact Hour CNE Presentation MK-234 Rev. a Slide 2 Successful completion: Participants must attend the entire program, including any resulting Q & A, and submit required documentation. Conflict of interest: Planners disclose no conflict of interest. The speaker, as an employee of the commercial support entity, hereby declares a conflict of interest. Commercial company support: Fees are underwritten by education funding and commercial support provided by PENTAX Medical. Non-commercial company support: None. Non-endorsement of products: Educational Dimensions, the Accredited Provider for this activity, is dedicated to the provision of quality CNE and does not endorse products or services provided by the speaker's company. Off-label product use: None Alternative/Complementary Therapy :None Slide 3 Upon completion of this presentation, participants will be able to: Apply standards and regulations from recognized agencies to safe endoscope reprocessing Examine safety considerations in the reprocessing environment Analyze reprocessing activities which will contribute to the development of best practices

2 Slide 4 Slide 5 Dr. Earle H. Spaulding, Temple University, Philadelphia 1939 paper serves as basis for FDA, CDC and EPA guidelines Strategy for sterilization and disinfection of inanimate objects is based on the degree of risk involved in using them Slide 6 Critical Items Semi-critical Items Non-critical Items Penetrate skin or mucous membrane Must be sterilized Surgical instruments, biopsy forceps Contact intact mucous membrane Contact intact skin Require minimum Require intermediateor high-level disinfection low-level disinfection Endoscopes BP cuff

3 Slide 7 Kills all microorganisms including bacterial spores Sterilization expressed as Sterility Assurance Level (SAL) Probability of an item being contaminated is equal to or less than one in a million Slide 8 Timeline for Heat/Gas/Chemical Sterilization Number Log 6 1,000, , , , in in in 1, in 10, in 100, in 1,000,000 Slide 9 Kills all microorganisms except high numbers of bacterial spores Time, temperature, minimum effective concentration (MEC) Manual or automated cycles Relatively short (5-20 min.) exposure time

4 Slide 10 Intermediate-level disinfection Kills viruses, Mycobacteria, fungi, vegetative bacteria Does not kill bacterial spores Low-level disinfection Kills vegetative bacteria, some fungi, lipid viruses Does not destroy Mycobacteria, nonlipid viruses or bacterial spores Slide 11 BACTERIAL SPORES Bacillus subtilis Clostridium sporogenes MYCOBACTERIA Mycobacterium tuberculosis STER HLD NONLIPID OR SMALL VIRUSES Polio virus, Rhinovirus FUNGI Trichophyton Candida albicans Cryptococcus ILD LLD VEGETATIVE BACTERIA Pseudomonas, Staphylococci, Enterococci (MRSA, VRE) LIPID OR MEDIUM-SIZED VIRUSES HBV, HCV, HIV, HSV, EBOLA, CMV, SARS Slide 12 Association for the Advancement of Medical Instrumentation (AAMI) Association of PeriOperative Registered Nurses (AORN) Society of Gastroenterology Nurses and Associates (SGNA) Multi-Society Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011

5 Slide 13 Association for the Advancement of Medical Instrumentation (AAMI) ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities Addresses work area design, cleaning and decontamination, personnel considerations Slide 14 Association of PeriOperative Registered Nurses (AORN) AORN Standards and Recommended Practices The standards address high-level disinfection, cleaning and processing of flexible endoscopes, and safe environment of care Slide 15 Society of Gastroenterology Nurses and Associates (SGNA) SGNA Practice Guidelines and Position Statements Guidelines address standards of infection control in reprocessing of flexible gastrointestinal endoscopes and the use of high level disinfectants and sterilants for flexible scopes

6 Slide 16 Multi-Society Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011 Published in Gastrointestinal Endoscopy Input and endorsement from eleven professional organizations Slide 17 More than 20 million endoscopy procedures are performed in the US each year. Patient outcomes are not routinely tracked, however reports of pathogen transmission resulting from these procedures are rare. Between 1966 and 1992, the 281 cases of pathogen transmission were associated with a reprocessing guidelines breach. Since the adoption of specific reprocessing guidelines from 1988 to 1992, the incidence of pathogen transmission was approximately 1 in 1.8 million procedures. Slide 18

7 Slide 19 Environment HVAC moves air from clean side of the room to contaminated area Minimum 10 air exchanges per hour 16 o to 18 o C (60 o to 65 o F), 30 to 60% humidity Storage of supplies Slide 20 Personal Protective Equipment PPE gown or apron, goggles or face shield, masks, heavy duty gloves Cleaning supplies brushes of various sizes and diameters, lint-free cloths, solutions Slide 21 Water Separate handwash area Use potable water unless specified by the manufacturer Seasonal differences in water quality Deionized or softened water removes detergent more efficiently

8 Slide 22 Eyewash station American National Standards Institute (ANSI) Accessible to workers within 10 seconds Continuous flush 0.4 gallons per minute for 15 minutes Slide 23 ph Best for inorganic soil Acid Best for stainless steel instruments Neutral Best for organic soil Alkaline Slide 24 Detergent solutions ph, enzymes, foaming/surfactant, temperature, rinsing Dilution Usage

9 Slide 25 Different types of enzymes Breakdown of proteins Several types of enzymes -- action against blood, protein, fats, carbohydrates Multiple enzymes addition of synthetic lipids remover Other cleaners Multipurpose cleaner and degreaser Slide 26 Pressure to turn rooms around quickly Failure to leak test or failure to correctly leak test Failure to dilute the detergent or properly dilute the detergent Failure to fully immerse the endoscope Failure to clean all channels or to fill all channels with detergent Failure to time the detergent contact Failure to rinse the endoscope completely Failure to purge all channels with air prior to disinfection Slide 27 Monitoring the cleaning process: is visual inspection adequate? The effectiveness of the cleaning process is dependent on adherence to the cleaning procedures and protocols established by SGNA and your facility.

10 Slide 28 EndoCheck : Swab inner surface of channel ChannelCheck : Irrigate channel and check fluid Products of Healthmark, used with permission, for information purposes only Slide 29 Disinfectants Selection criteria Usage MEC test strips Slide 30 Commonly used types Aldehydes Glutaraldehyde (GA) Ortho-phthalaldehyde (OPA) Peracetic acid Hybrid formulations Glutaraldehyde and alcohol (Aldahol)

11 Slide 31 70% Isopropyl Alcohol Every endoscope, every time Air flush, alcohol flush, air flush Slide 32 OSHA Bloodborne Pathogens Standard Part of Annual Safety Review Staff training Competencies Material Safety Data Sheets (MSDS) All chemicals Environmental cleaning Spill-containment plans Slide 33 Damage prevention Clean endoscopes Transport to patient room Contaminated endoscopes Transport to Decontamination Area

12 Slide 34 Ergonomics -- OSHA Ergonomics is the science of fitting workplace conditions and job demands to the capabilities of the working population. Risks for injury Work station design Posture and position Personal Protective Equipment Level of risk based on intensity, frequency, duration Slide 35 Slide 36 Pre-cleaning Wipe outside surfaces Aspirate Purge Special channels Disconnect Transport Impervious container Horizontal

13 Slide 37 Air channel 0.7 mm Water channel 0.7 mm Biopsy channel 4.2 mm Suction channel 4.2 mm CO 2 channel 0.7 mm Water jet channel 0.7 mm Elevator channel 0.15 mm Slide 38 Auxiliary water channel and water jet channel Elevator channel (source:johns Hopkins Endoscopy) Dual biopsy channels (source:pentax) Slide 39 Manual pre-cleaning at bedside Leak test Cleaning Rinsing Disinfection Rinsing Drying

14 Slide 40 Alcohol flush Rinse Pre-clean Leak test Mechanically Clean Disinfect Rinse Slide 41 Pressure to turn rooms around quickly Failure to use disinfectant compatible with scopes Failure to perform MEC test Failure to use a disinfectant that has potency above its MEC Failure to fully immerse endoscope and accessories Failure to fill all channels with disinfectant Failure to time disinfectant contact (no clock in the room) Failure to use disinfectant at proper temperature Lack of written competencies, personnel training and periodic review Slide 42 An automated endoscope reprocessor can replace part or all of the manual process Does not replace bedside cleaning Advantages Patient Staff Standardization Inspection and maintenance

15 Slide 43 Validate compatibility Endoscope manufacturers must validate the compatibility of the reprocessing solutions used on the endoscopes Medical facilities should confirm that the endoscope manufacture has validated all model endoscopes which will be reprocessed in the chemicals used by the AER the customer is considering. Slide 44 EVOTECH ECR First automated cleaning cycle 2 basins run asynchronously Cycle time 33 minutes Computerized leak and channel blockage test, channel connection security, channel pressure Alcohol flush automatic Solutions CIDEZYME GI Enzymatic Detergent Solution CIDEX OPA-C Solution Slide 45 System 83 Plus TM 9 Ultrasonic wash cycle Can reprocess 2 endoscopes Cycle time 28 minutes with GTA Keyboard and video monitor Manual alcohol flush Solutions Tergal 800 Detergent Disinfectant

16 Slide 46 Medivators Advantage Plus Automated cleaning cycle 2 asynchronous basins Cycle time 28 minutes Computerized cycle Continuous leak test and programmable alcohol flush Solutions Intercept Detergent Rapicide PA Slide 47 OER-Pro Modified manual cleaning Bedside cleaning and leak test One basin for 2 endoscopes Cycle time 29 minutes RFID technology for endoscope serial number, and data Alcohol flush automated Solutions FlexClean 895 Aldahol Slide 48 Reliance TM EPS Manual cleaning P rocess 2 scopes in single basin Cycle time 30 mins Touch-button controls Alcohol flush manual Solutions Klenzyme Detergent Reliance TM DG Dry Germicide

17 Slide 49 System 1E TM Manual cleaning One scope in basin Cycle time 23 minutes Microprocessor controls Manual alcohol flush Solutions S40 TM Sterilant Concentrate Slide 50 Automatic wash Solutions Automatic alcohol flush ASP Evotech Custom Ultrasonics System 83 Plus TM 9 Medivators Advantage Plus Olympus OER-Pro Steris Reliance TM EPS yes Yes yes yes no CIDEZYME GI, CIDEX OPA Tergal 800, Disinfectant Intercept, FlexClean Rapicide PA 895, Aldahol Klenzyme Reliance DG yes No yes yes no Cycle time 33 mins 28 mins with GA 28 mins 29 mins 30 mins Slide 51 Manual cleaning of endoscope not performed when indicated by reprocessor manufacturer Channels not rinsed and dried prior to placing endoscope into reprocessor Endoscope connectors or cleaning adapters not applied correctly All channels not connected Endoscope incompatible with disinfectant Water filters not changed as required Alcohol flush omitted

18 Slide 52 Clean, well-ventilated area Distal tip hanging free Security Transport cart Storage cabinet Slide 53 The Spaulding Classification System says that any instrument that penetrates the mucous membrane (like biopsy forceps) must be sterile. Biopsy forceps, snares or other devices that pass through an endoscope channel become contaminated immediately upon entering channel. Is it necessary to sterilize such devices or can they be reprocessed by high-level disinfection? Slide 54 How long can reprocessed endoscopes be stored without requiring repeat high-level disinfection just prior to patient use? Refer to the High Level Disinfectant manufacturers instructions for soaking times.

19 Slide 55 Slide 56 The Case: Veterans Administration Hospitals Blood in auxiliary water system tubing Investigation revealed errors One-way valve missing 2 system components not being disinfected properly Slide 57 Discussion Communications Patients from December 1 Colonoscopy patients since endoscope received Other VA facilities Actions taken Standard Operating Procedures (SOP) Competency evaluations Training by manufacturer

20 Slide 58 The Outcomes Follow-up visits 3 months after STEP UP WEEK Unannounced inspections in 42 facilities Low compliance Clinical Risk Assessment Advisory Board Recommendations 2010 Update Over 50 cases of infection Slide 59 Apply standards and regulations from recognized agencies to safe endoscope reprocessing Examine safety considerations in the reprocessing environment Analyze reprocessing activities which will contribute to the development of best practices Slide 60 Prepared by: Educational Dimensions, Claire Maguire, clairemaguire@educationaldimensions.com