Validation Strategy for an Automated Endoscope Reprocessor
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1 Validation Strategy for an Automated Endoscope Reprocessor November 16, 2010 Bradley Catalone AER Validation Strategy System Approach page 1
2 AER Validation Strategy AER Scope-specific connectors Requires prior manual cleaning User High turnover Resource and time constraints Endoscope Complex, multiple designs, new models consistently introduced Process Multiple steps Manual cleaning Device-specific adapters Validation Objectives Reduce manual steps Eliminate scope-specific adapters during manual cleaning Eliminate manual channel flushing Improve other cumbersome or unnecessary steps (eliminate bedside flush with detergent, reduce manual flush volumes, etc.) Reduces variability Less user dependent Improves compliance with instructions page 2
3 Modified Cleaning AER automates channel flushing External surface cleaning and channel brushing required Reduces manual steps Reduces labor Improves efficiency Improves compliance Improves consistency AER Validation Design page 3
4 AER Validation Strategy Simulated Use Testing Worst case for identified variables related to process efficacy Specific user-dependent steps not performed for testing In Use (Clinical) Testing Validate efficacy in clinical environment according to AER IFUs Repeat validation eliminating specific user-dependent steps page 4
5 Elevator-Wire Channel Partially Occluded Channel Small Channels Flow Resistance Long Channels Flow Resistance Large Channels Flow Velocity Multiple Channels Efficacy Elevator-Wire Channel Partially Occluded Channel Small Channels Flow Resistance Long Channels Flow Resistance Large Channels Flow Velocity Multiple Channels Efficacy page 5
6 Overall Performance AC Line Voltage(108 V) Detergent Action Manually Inject Minimum Amount Channel Purging Restrictor in Air Compressor Line Ultrasonic Cleaning Power to US Transducers Channel Flushing Pump Voltage to Simulate 2,500 Cycles of Use page 6
7 Overall Performance AC Line Voltage (108 V) Detergent Action Manually Inject Minimum Amount Channel Purging Restrictor in Air Compressor Line Ultrasonic Cleaning Power to US Transducers Channel Flushing Pump Voltage to Simulate 2,500 Cycles of Use page 7
8 Artificial Soil High Levels of Protein, Hemoglobin, Carbohydrate & Bioburden Inoculation Challenge Every Channel Completely Filled Delayed Reprocessing Wait 1 Hour Pre-Cleaning No Detergent Reduced Flush Volume Manual Cleaning Totally Eliminated No Channel Brushing Companion Scope Fully Contaminated Used Model with Largest Effect on Test Scope Artificial Soil High Levels of Protein, Hemoglobin, Carbohydrate & Bioburden Inoculation Challenge Every Channel Completely Filled Delayed Reprocessing Wait 1 Hour Pre-Cleaning No Detergent Reduced Flush Volume Manual Cleaning Totally Eliminated No Channel Brushing Companion Scope Fully Contaminated Used Model with Largest Effect on Test Scope page 8
9 Test Endoscopes Condition of the AER Process Conditions Test Endoscopes Condition of the AER Process Conditions page 9
10 Soil Simulated Use Simulated Use Clinical Use Clinical Use ATS ATS Patient Patient Pre-Clean Manual Clean Clean Rinse AER HLD Rinse Alcohol Simulated Use Cleaning IT - Insertion Tube IS - Instrument/Suction Channel AW - Air/Water Channels AUX - Auxiliary Water Channel EW - Elevator Wire Channel page 10
11 Simulated Use Cleaning 6.4 μg/cm 2 <LOD IT - Insertion Tube IS - Instrument/Suction Channel AW - Air/Water Channels AUX - Auxiliary Water Channel EW - Elevator Wire Channel Simulated Use Cleaning Test Devices <LOD IT - Insertion Tube IS - Instrument/Suction Channel AW - Air/Water Channels AUX - Auxiliary Water Channel EW - Elevator Wire Channel page 11
12 In Use - Cleaning Endpoints o Protein: < 6.4 μg/cm 2 o Bioburden: < 4 Log 10 CFU/cm 2 15 Endoscopes, 65 Samples Bronchoscope, Colonoscopes, Duodenoscopes Results Protein (µg/cm 2 ) Bioburden (Log 10 CFU/cm 2 ) Bronchoscopes <LOD Colonoscopes <LOD LOD Duodenoscopes = Limit of Detection <LOD In Use - Cleaning Endpoints o Protein: < 6.4 μg/cm 2 o Hemoglobin: < 1.8 μg/cm 2 14 endoscopes, 62 samples Bronchoscope, Colonoscopes, Duodenoscopes Results Protein (µg/cm 2 ) Hemoglobin (µg/cm 2 ) Bronchoscopes <LOD 1.39 <LOD Colonoscopes <LOD 4.33 <LOD LOD = Limit of Detection Duodenoscopes <LOD 0.88 <LOD page 12
13 Simulated Use Full Cycle Testing Endpoints o Protein: < 6.4 μg/cm 2 o Bioburden: 6 Log 10 reduction in M. terrae 13 endoscopes, 65 samples Gastroscope, Colonoscope, Duodenoscope and Ultrasound Endoscope Results o All samples < 6.4 μg/cm 2 residual protein o 62 of 65 samples 6 Log 10 reduction in M. terrae o 3 samples > 5.9 Log 10 reduction sample volume limitation Summary Covers all Olympus endoscopes Reduced dependence on scope-specific adapters Reduced burden on user Simplified instructions Effective endoscope reprocessing page 13
14 page 14
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