Safety, Efficacy & Microbiological Consideration

Safety, Efficacy & Microbiological Consideration Endoscope Cleaning and Disinfection System (With Optional Cleaning Cycle that Eliminates Manual Cleaning) 1

Medivators is a registered trademark of Minntech Corporation. Medivators ADVANTAGE is a trademark of Minntech Corporation. Olympus is a registered trademark of Olympus Corporation. Pentax is a registered trademark of Pentax Precision Instrument Corporation. Fujinon is a registered trademark of Fujinon Corporation. 50097-698 ADVANTAGE PLUS 2.0 2011, Minntech Corporation All rights reserved. This publication is protected by copyright. Copying, disclosure to others, or the use of this publication is prohibited without the express written consent of Minntech Corporation. Minntech reserves the right to make changes in the specifications shown herein without notice or obligation. Contact your Medivators representative or Medivators customer service for more information. 2

INTENDED USE The Medivators ADVANTAGE Plus Endoscope Reprocessing System is cleared by the Food and Drug Administration (FDA) to test, clean, disinfect, and rinse endoscopes, such as fiber-optic and video endoscopes, between patient uses. The ADVANTAGE Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is not required prior to placement in the ADVANTAGE Plus system. The scopes must be precleaned immediately after use. The ADVANTAGE Plus Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the direction for use. The system uses Intercept Detergent in the cleaning cycle at a concentration of 0.5%. PRODUCT DESCRIPTION The Advantage Plus automated endoscope reprocessor tests, cleans, and high-level disinfects endoscopes and related accessories between uses. This advanced system performs automated cleaning of endoscopes, a feature which eliminates the need for manual cleaning. Built-in continuous leak testing and channel blockage monitoring provide additional levels of safety to ensure consistent results. Results are then recorded in the sophisticated data management storage system. The Advantage Plus has two large, easy loading independent basins, which perform asynchronous reprocessing and accommodate most endoscope models. Endoscopes are connected to the ADVANTAGE Hook-up Connector Block*, which contains individual connectors for each endoscope channel. These validated hook-ups test for channel connectivity blockage and outer sheath leaks and provide perfusion of internal endoscope channels. Upon successful completion of the connectivity, blockage and leak tests, the system proceeds to rinse the instrument and start the cleaning and disinfection cycle. The Advantage Plus utilizes Intercept Detergent and the high level disinfectant Rapicide PA, a single-use peracetic acid. Both Intercept and Rapicide PA have been validated for use in the Advantage Plus system. Endoscopes will not require manual cleaning if the wash cycle utilizing Intercept Detergent is performed. For reprocessing cycles that will not include the wash cycle, manual cleaning of the endoscope is required. The ADVANTAGE Plus also has the ability to perform a 70% isopropyl alcohol flush with subsequent air purge to assist in drying of endoscope channels. *It is important to use the correct connections (hookups) for connecting the scope to the machine. A list of endoscope and corresponding hookups can be found on the online interactive hookup guide: www.minntech.com/medivators/hookuplookup. 3

PRODUCT FEATURES Asynchronous operation of two large independent basins A dedicated personal computer (PC) for cycle recording, powerful quality assurance reporting, easy backups, networking availability, and remote diagnostics Contains second hard drive for easy data backups Hook-up blocks dedicated to a family of endoscopes to ensure correct connectivity and flow rates to meet manufacturers specifications Individual channel identification and blockage monitoring Continuous endoscope leak testing throughout entire reprocessing cycle Remote diagnostics for operator assistance and troubleshooting Uses single-shot, environmentally friendly Rapicide PA High Level Disinfectant FDA-cleared optional cleaning claim cycle that eliminates manual cleaning Easy-to-fill detergent and alcohol reservoirs 4

REPROCESSING CYCLE The Advantage Plus has an average reprocessing cycle time of 35 minutes, which includes leak testing, washing, disinfecting, rinsing and a final alcohol and air purge. The Advantage Plus utilizes an advanced software program that continuously monitors all system sensors. This highly advanced program was designed specifically for the Advantage Plus System and monitors each phase of the reprocessing cycle. Each overall cycle on the Advantage Plus consists of a combination of fourteen possible phases: Phase Phase Usage Details Number 1 Leak Test 2 Flush Rinse approximately 5 liters of water 3 Wash 3.5 liters water plus 10.8 ml Intercept detergent 4 Flush Rinse approximately 5 liters of water 5 Post Rinse 10 liters of water 6 Wash 3.5 liters water plus detergent 7 Flush rinse approximately 5 liters of water 8 Post Rinse 10 liters of water 9 Disinfect 10 liters of Rapicide PA 10 Flush Rinse 5 liters of water 11 Post Rinse 5 liters of water 12 Post Rinse 5 liters of water 13 Final Rinse 5 liters of water 14 Alcohol Purge/Vent 10-30 ml per cycle depending on the scope channel configuration The minimum requirements for a cycle are 1, 2, 3, 4, 9, 10, 13, 14 which can be configured with any different combination of washes and rinses. 5

LEAK TESTING The Advantage Plus automated endoscope reprocessor performs leak testing during the first phase of the reprocessing cycle by pressurizing the endoscope. The pressure level is maintained throughout each following cycle until reprocessing is complete. If a gross leak is detected, the Advantage Plus will automatically stop the reprocessing cycle so no fluid enters the endoscope preventing further damage. If a small leak is detected in the endoscope but its sheath remains pressurized, no fluid invasion can occur so the Advantage Plus will finish the disinfection cycle. Therefore, the leak testing capability of the Advantage Plus System minimizes associated endoscope repair costs while providing the endoscope manufacturer with a high-level disinfected endoscope. CHANNEL MONITORING & BLOCKAGE DETECTION The Advantage Plus uses specially designed Hook-up Connector Blocks, which are specific for each endoscope make and model. Individual connections are made via the Connector Block tubing to the endoscope channels: air, water, suction, biopsy, etc. Through these connections, the advanced software system performs continuous monitoring of each channel connection and will alert the operator if a connection is not secure or if there is blockage. These quality assurance procedures provide consistency not offered with manual reprocessing. AUTOMATED CLEANING The FDA has cleared the Medivators Advantage Plus Endoscope Reprocessing System with a new cleaning cycle claim that eliminates the need for manual cleaning of endoscopes. Automated cleaning of endoscopes must be performed using Medivators Intercept Detergent in the high performance cleaning cycle. This automated cleaning cycle has been shown to be equivalent to manual cleaning, achieving results that meet the AAMI TIR-30 standard for residual soil. The endoscope cleaning phase for the ADVANTAGE Plus consists of four phases: 1. Phase 2 Flush phase. This phase flushes the endoscope channels with fresh water. The outside of the endoscope is also sprayed with fresh water using the spray arm. This is the initial flush of the endoscope. This phase also flushes the water up to temperature. This phase is also part of cycles programmed without the cleaning claim wash phase. 2. Phase 3 Detergent Wash phase. This phase dispenses detergent into the basin to a detergent concentration of 0.5%. The basin is filled with 3.5 liters of fresh water. The endoscope channels are rigorously flushed with the detergent solution. The exterior soaks in the 3.5 liter solution and is sprayed with the solution using the spray arm and the hydrodynamic spray tower. 3. Phase 4 Second Flush phase. This phase is used to remove the bulk of the detergent solution from the basin and the endoscope. This phase flushes the endoscope channels with fresh water. The outside of the endoscope is also sprayed with fresh water using the spray arm and the hydrodynamic spray tower. The drain is open and the water level is not maintained in the basin. 4. Phase 5 Post rinse. This rinse fills the basin with 10 liters of water. The endoscope channels are flushed while the exterior soaks in 10 liters of water and the exterior is sprayed with using the spray arm and the hydrodynamic spray tower. Air is then blown through the channels to remove residual rinse water prior to the introduction of disinfectant. This ensures surface contact with disinfectant and minimizes dilution. 6

Cleaning Validation Validation of the automated cleaning by the Advantage Plus was done both with Artificial Test Soils (ATS) and with clinically soiled endoscopes. The endoscopes chosen were representative of the most complex scopes in three different classes: bronchoscopes, gastroscopes, and colonoscopes. The scopes in the simulated use testing were soiled in the channel lumens and on the surface with ATS, to the worst case limits reported (Alfa, 1999). The soils used were the Alfa test soil (Alfa, 2002) for the gastroscopes and colonoscopes, and a respiratory test soil (based on published reports of respiratory soil composition) for the bronchoscopes. The test markers followed were the total protein, total carbohydrate, and total hemoglobin. The total protein detection was done using the BCA assay (Smith et al., 1985), a standard method widely used in biochemistry and medicinal chemistry. The total carbohydrate detection was done using the anthrone/acid method (Morris, 1948), which produces a very stable color change and does not require prior hydrolysis of the polysaccharides. The hemoglobin quantitation was performed using cation exchange on a PolyCAT HPLC column, after cyano-derivatizing the hemoglobin. All of the methods were validated with the soils, including matrix validation. The quantitation for each analyte was reported in total (per scope) and also normalized to the total surface area that was soiled. The target criteria were taken from AAMI TIR-30. The goal of the cleaning phase was to achieve more than 90% reduction of protein, more than 90% reduction of carbohydrate, and a residue of <6.4 µg protein/cm 2, <1.8 µg carbohydrate/cm 2, and <2.2 µg hemoglobin/cm 2. All criteria were required to be met in all cases. A minimum of 5 repetitions were completed for each scope, in addition to 5 positive control (soiled but not cleaned, then recovered) and 5 negative control (not soiled, recovered) repetitions. The simulated studies were performed on scopes from three different manufacturers; in each case, the scopes used were representative of the most complicated and difficult to clean instruments in their class. The scopes were soiled in all lumens and on the surface, and dried for 1 hour. The total amount of soiling was determined both by dry weight difference and by the use of positive controls (where the soil was immediately recovered without being cleaned). Negative controls were performed in each case by performing soil recoveries on the scopes prior to the soiling/cleaning tests (i.e., on unsoiled scopes). This demonstrated that the scopes used did not have residual soil from previous use. Soiled/cleaned scopes were processed on the cleaning cycle of the Advantage Plus, using 0.3% Intercept cleaner, which is worst-case (the normal cycle uses 0.6% Intercept); this worst-case condition insures that variation in dilution is accounted for. After cleaning, the residual soil was recovered by brushing and flushing the channels and scrubbing the surface; all cleaning brushes and scrubs were recovered as well, using sonication and extraction. The recovery method for all cases (positive controls, negative controls, and soiled/cleaned scopes) was validated by demonstrating that >90% of the soil was recovered, and that successive soil recoveries of the same scope did not produce significant residuals of the analytes. The recovered soil was analyzed for the markers, and the data were totaled for each scope, and also normalized to the total surface area inoculated. The data, shown in tables 1,2, and 3, show that the target residual criteria were met in all cases. 7

Table 1. Residual soil recovered after cleaning, Olympus scopes Residuals Endoscope Channel protein carbohydrate hemoglobin Olympus Bronchoscope B/S 0.95 0.63 0.38 BF-P30 Out 0.68 0.87 0.23 Whole 1.95 1.36 0.67 Olympus Gastroscope B/S 0.43 0.13 0.13 GIF 2T-160 B2 0.65 0.13 0.14 Air 0.39 0.11 0.12 water 0.34 0.10 0.11 Elevator 0.41 0.12 0.13 Out 0.45 0.12 0.05 Whole 0.53 0.15 0.13 Olympus Colonoscope B/S 0.33 0.12 0.11 XCF-H160AYL Air 0.45 0.15 0.15 water 0.49 0.16 0.16 Elevator 0.48 0.15 0.16 Out 0.34 0.12 0.03 Whole 0.45 0.17 0.12 8

Table 1. Residual soil after cleaning, Pentax scopes. Residuals Endoscope Channel protein carbohydrate hemoglobin Pentax B/S 3.20 0.75 0.74 Bronchoscope Valve 1.48 0.46 0.44 VB 1530 Out 1.50 0.52 0.55 Whole 2.14 0.59 0.59 Pentax B/S 0.43 0.13 0.14 Gastroscope Air 0.32 0.10 0.10 EG 3830K water 0.34 0.11 0.12 Elevator 1.26 0.30 0.30 Out 0.17 0.05 0.05 Whole 0.48 0.14 0.15 Pentax B/S 0.25 0.07 0.08 Colonoscope Air 0.26 0.08 0.09 EC 3830FK water 0.28 0.09 0.09 Elevator 0.72 0.23 0.23 Out 0.10 0.02 0.03 Whole 0.32 0.09 0.10 9

Table 2. Residual soil after cleaning, Fuji scopes. Residuals Endoscope Channel protein carbohydrate hemoglobin Fuji Bronchoscope B/S 1.27 0.57 0.42 EB-470S Valve 1.06 0.44 0.35 Out 0.92 0.59 0.23 Whole 1.54 0.78 0.47 Fuji Gastroscope B/S 0.32 0.14 0.10 ED-530XT Air 0.27 0.14 0.09 water 0.36 0.16 0.12 Out 0.31 0.15 0.04 Whole 0.41 0.18 0.11 Fuji Colonoscope B/S 0.31 0.14 0.10 EC-450LS5 Air 0.28 0.13 0.09 water 0.36 0.19 0.12 Elevator 0.79 0.34 0.26 Out 0.41 0.16 0.05 Whole 0.47 0.20 0.12 The cleaning, indicated by the markers followed, achieved >99.9% removal of organic soil, and the average of residual soil was well below the target levels identified in AAMI TIR-30. This demonstrates that the Advantage Plus system was effective in removing the organic load from flexible endoscopes. 10

Clinically Soiled Scopes In addition to the simulated soiling/recovery, clinically soiled endoscopes were also cleaned, in order to evaluate the cleaning efficacy on actual patient soil, and also to demonstrate that the automated cycle achieves that same level of soil removal/residual as manual cleaning. Scopes were obtained from 2 different endoscopy clinics, representing multiple manufacturers, models, and classes (bronchoscopes, gastroscopes, and colonoscopes). The manual cleaning was performed by the clinical staff, in accordance with their normal cleaning methods. The scopes for automated cleaning were picked up from the clinics immediately after use and brought to the laboratory for processing on the Advantage Plus cleaning cycle (cleaning cycle only). Both the manually cleaned scopes and the scopes cleaned on the automated cycle of the Advantage Plus were harvested for residual soil by the same method that was validated and used in the simulated soiling. The same markers for residual soil (protein, carbohydrate, and hemoglobin) were followed. Three colonoscopes of each model and type were performed by each method (automated and manual). The results are shown in table 4. Both of the cleaning processes met the criteria set in AAMI TIR-30, for all scopes tested. In all cases the automated cycle of the Advantage Plus performed comparably to manual cleaning. Table 3. Cleaning of clinically soiled scopes, by automated and by manual cleaning. Scope Channels Protein residual, Carbohydrate residual, Hemoglobin residual, Automated Clean Manual Clean Automated Clean Manual Clean Automated Clean Bron. Biopsy 1.80 2.81 1.01 0.62 1.63 1.42 BF-P40 Out 0.78 0.74 0.68 1.01 0.82 0.65 Manual Clean Whole 1.76 2.02 1.04 1.02 1.72 1.44 Gastro B/S 0.73 0.63 0.69 0.32 0.73 0.46 GIF-H180 Air 0.39 1.31 0.29 0.35 0.29 0.27 Water 0.70 0.51 0.36 0.30 0.38 0.29 Out 0.62 1.36 0.32 0.31 0.14 0.11 Whole 0.73 1.10 0.45 0.35 0.43 0.31 Colon B/S 0.42 0.34 0.17 0.16 0.30 0.34 PCF- H180AL Air 0.77 3.83 0.36 0.41 0.39 0.50 Water 0.67 0.85 0.33 0.27 0.57 0.48 Elevator 0.56 1.75 0.28 0.32 0.51 0.51 Out 0.24 0.39 0.13 0.15 0.09 0.06 Whole 0.44 0.90 0.21 0.22 0.29 0.28 All of the cleaning processes met the criteria set in AAMI TIR-30. These data show that the automated cleaning cycle on the Advantage plus performs as effectively as manual cleaning in removing the organic load of even the most complicated endoscopes. 11

HIGH LEVEL DISINFECTION High level disinfection is achieved with Rapicide PA High Level Disinfectant, a single-use environmentally friendly peracetic acid. Rapicide PA enters the basin and is perfused through internal endoscope channels via hookups. Rapicide PA Solutions A and B are combined to produce a single use-solution for High-Level Disinfection (HLD) of endoscopes with peracetic acid (PAA) as the biocidal active agent. Rapicide PA also contains corrosion inhibitors and water conditioning agents. The Advantage Plus System is constructed with high-grade components compatible with peracetic acid. The characteristics of the single use-solution are: Active Ingredient: Peracetic Acid PAA Concentration: 1000-1300 ppm Minimum Recommended Concentration (MRC): 850 ppm Reuse Period: Single use High-Level Disinfection Claim: 5 Minutes @ 30ºC (Use conditions may vary by country. Please contact your Minntech distributor for information) Dilution Required: 1:1 to 48 water Activation Required: No Corrosion Inhibitors: Yes Rapicide PA has been shown to be effective in killing vegetative bacteria, M. tuberculosis, fungi and viruses, MRSA, VRE C. difficile and other spores of Bacillus and Clostridium species (36). Test strips are used to determine whether an effective concentration of active ingredient is present following reprocessing. TESTS Antimicrobial Activity Results Sporicidal Clostridium sporogenes spores Total Kill Sporicidal Bacillus subtilis spores Total Kill Tuberculocidal Mycobacterium bovis (BCG) Total Kill Virucidal Polio virus type 2 Complete Inactivation Virucidal Herpes Simplex virus type 1 Complete Inactivation Virucidal Human Immunodeficiency Virus type 1 Fungicidal Trichophyton mentagrophytes Total Kill Bactericidal Pseudomonas aeruginosa Total Kill Bactericidal Staphylococcus aureus Total Kill Bactericidal Salmonella enterica Total Kill Complete Inactivation Simulated Use Mycobacterium terrae >6 log Reduction In-Use GI Tract Normal Flora Total Kill 12

AUTOMATED ALCOHOL FLUSH & AIR PURGE After the high-level disinfection cycle is completed, the endoscope is given a final rinse and purged with alcohol and air to assist in drying all channels. This automated alcohol flush and air purge is an important step to sustaining a high-level disinfected endoscope. Table 3. Total Residues Extracted from Colonoscopes after ADVANTAGE Plus Processing Disinfectant Safe residual level (mg) Range of total extracted residuals from 3 endoscopes (mg) Required Endoscope Rinses Rapicide PA 250 mg 0 2 Electrical Safety Testing All electrical safety aspects of the ADVANTAGE Plus have been tested by an outside testing service (Intertek Testing Services) for compliance with UL-61010-1 Standard for Safety Requirements for Electrical Equipment. It has also been tested for emissions that may affect other devices, and for immunity to the effects that other devices may have on the reprocessor. These test data meet the requirements of IEC 60601-1-2. Testing on file with shows the machine meets all required standards and will be safe under its labeled conditions. Reprocessor Self-Disinfection The ADVANTAGE Plus needs to be sanitized at regular intervals to ensure that water pathways and filters do not become contaminated. Testing was performed on the ADVANTAGE Plus using the self-disinfection cycle with Rapicide PA. Concentrations of both disinfectants relative to the MRC in the water filter were determined in three replicate runs during the selfdisinfection hold period. Results in Table 4 demonstrate that Rapicide PA disinfectant concentrations are within the normal use concentration and well above the MRC during the disinfection hold period. Table 4. Disinfectant Concentrations During ADVANTAGE Plus Self-Disinfection Cycles Disinfectant MRC Range of baseline disinfectant Range during selfdisinfection Rapicide PA 850 ppm 1060-1090 ppm 1413-1453 ppm 13

Material Compatibility Material compatibility testing has been performed on all components of the ADVANTAGE Plus that will be contacted by the labeled disinfectants. Metals, ceramics, plastics, composites and elastomers were exposed to Rapicide PA at full strength at recommended use temperatures. Components were exposed for 325 hours to meet the equivalent of 1.5 years of field use. All materials had parameter changes less than the 5% criterion and are acceptable for use with disinfectants under labeled use conditions. Software Verification Laboratory studies were conducted to verify that the ADVANTAGE Plus will perform its specified functions. Each system and sensor has been studied, and the complete integrated system has been shown to perform in an effective manner. Software system parameter verification testing included: Control of machine draining Control of the pre-rinse and final rinse requirements Execution of the proper self-disinfection cycle Software detection of error conditions verification testing included: Compromised endoscope sheath (leak detection) Disconnected or improperly connected channels Endoscope channel blockage Reservoir temperatures above or below labeled parameters Open/ajar basin lids Low water or disinfectant level in basin Deviation from maximum/minimum cycle step times Disinfectant overflow sensor Disinfectant low level sensor Electrical power supply at incorrect cycle phase Disinfection contact times inadequate Unsatisfactory completion of self-disinfection phase 14

References AAMI TIR 30 (2003). A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. Alfa, MJ, Degagne, P, Olson, N (1999), Worst-case soiling levels for patient-used flexible endoscopes before and after cleaning. Am J. Infection Control 27:5, 392-401. Alfa, MJ (2002). Artificial Test Soil. US Patent 6,447,990. Morris, DL (1948). Quantitative determination of carbohydrates with Dreywood s anthrone reagent. Science 107:254-5 Smith, P.K. et al. (1985). Measurement of protein using bicinchonic acid. Anal. Biochem. 150: 76-85. 15

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