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05 MAR 2020
If something looks clean, is it really clean?
Cleaning validations for reusable medical devices
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OVERVIEW
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Device use Clean
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Device use Clean
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Device use Clean
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How do you validated your cleaning procedure?
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How do you validated your cleaning procedure?
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Device Soil Clean evaluate
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Device Soil Clean evaluate
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KNOW YOUR DEVICE
Surface area’s
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KNOW YOUR DEVICE
Surface area’s
Disassembly
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Surface area’s
Disassembly
Simulated use
KNOW YOUR DEVICE
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KNOW YOUR DEVICE
Surface area’s
Disassembly
Family grouping Simulated use ISO 17664 / AAMI TIR 12
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KNOW YOUR DEVICE
Surface area’s
Disassembly
Family grouping Simulated use ISO 17664 / AAMI TIR 12
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Device Soil Clean evaluate
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SOIL
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SOIL COMPONENTS ISO 15883-5 / ASTM F3208
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CONTAMINATION
SOIL COMPONENTS ISO 15883-5 / ASTM F3208
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CONTAMINATION
SOIL COMPONENTS ISO 15883-5 / ASTM F3208
DRY TIME IS CRUCIAL
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Device Soil Clean evaluate
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MANUAL
Manual - Soaking - Brushing - Flushing - …. Mechanical - Ultrasonic cleaners
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AUTOMATED
Washer-disinfector - Pre-wash - Washing - Neutralization - Rinsing - Thermal disinfection - Final rinsing - drying
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MANUAL AUTOMATED
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MANUAL AUTOMATED
A validated method of manual cleaning and at least one cycle of automated cleaning in a
washer/disinfector must be validated
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Evaluate your cleaning procedure
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Evaluate your cleaning procedure
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Cleaning Procedures
IFU Validation Parameters
Prepare detergent per manufacturer recommendations (5 mL/L; 10 mL/L; 15 mL/L)
Prepare detergent using (5 mL/L)
Soak the device in detergent for 2-5 minutes
Soak the device in detergent for not more
than 2 minutes Flush the lumen with 60 mL of prepared detergent
Flush the lumen with 55 mL of prepared
detergent
Clean the devices in an enzymatic detergent at 45 ± 5°C
Clean the devices in an enzymatic
detergent at 40°C
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Selection of detergents
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Selection of detergents
Compatiblity
Chemical properties
AVAILABILITY EU vs US
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Device Soil Clean evaluate
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SOIL DETERGENTS
EVALUATE FOR TRACES OF…..
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Level 1 Level 2 Level 3
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VISUAL INSPECTION
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VISUAL INSPECTION
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Level 1: visual inspection
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EVALUATION
CLEANED
DEVICE
Extraction conditions
Extraction Solvents
ANALYSES
OF THE
EXTRACTS
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EVALUATION
Extraction conditions
ANALYSES
OF THE
EXTRACTS
CLEANED
DEVICE
Extraction Solvents
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Extraction methods - Sonication - Manual Shaking - Orbital Shaking - Flushing (lumen) - Swabbing - …
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Extraction methods - Sonication - Manual Shaking - Orbital Shaking - Flushing (lumen) - Swabbing - …
DETERMINE EXTRACTION EFFICIENCY
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EVALUATION
Extraction conditions
Extraction Solvents
ANALYSES
OF THE
EXTRACTS
CLEANED
DEVICE
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SOIL
DETERGENTS
Hemoglobine Protein Carbohydrates Total organic carbon Bioload reduction Endotoxin
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SOIL
DETERGENTS Select at least 2 parameters!
Hemoglobine Protein Carbohydrates Total organic carbon Bioload reduction (only in EU) Endotoxin
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ACCEPTANCE CRITERIA
AAMI TIR30: 2011
Analyte Recommended Level
Protein < 6.4 μg/cm²
Hemoglobin < 2.2 μg/cm²
Carbohydrate < 1.8 μg/cm²
Endotoxin < 2.2 EU/cm²
These acceptance criteria are for flexible endoscopes that contact mucosal surfaces
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CONTROLS Positive
device control
Soiled
Uncleaned
Extraction efficiency
Negative device control
unsoiled
Cleaned
Test control
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Level 1: visual inspection Level 2: analytical endpoints
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Detergent residues
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Level 1: visual inspection Level 2: analytical endpoints Level 3: Cytotoxicity test
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Ageing of the device
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Ageing of the device
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Host
Material Properties
Material Function
BIOCOMPATIBILITY
CAN THIS BE AFFECTED BY CLEANING AND DETERGENT
RESIDUES?
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THE GAP - Ageing of material - Type of detergent - Processing steps of the device
- Sterilization - Cleaning?
- …
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Level 1: visual inspection Level 2: analytical endpoints Level 3: Cytotoxicity test ?
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Lifecycle of a device
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Device use Clean
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Device Soil Clean evaluate
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Device Soil Clean evaluate
2 5 3 1 + 1 question / consideration
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