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Verification of Washing
Strategies for RMDs
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Presented By:
Lon BrusoVice President, SteriTec Products
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Verification of Washing
• Quality system basics• Importance of washing verification• Blood residual as a test soil• Verification methods• Verification frequency• Prions
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Quality System Basics
• Who did it?• When did they do it?• How did they do it?– Did they follow procedures?
• How effective was it?– Is it verified?
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Why is verification of washing so important?
• If it isn’t clean, you can’t sterilize it– Sterilization process specifications are based upon
the assumption that the instruments are clean• What soil is most important to remove?– Blood
• Prions– Washing may be more important than sterilizing
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Blood Contamination• Can contain pathogens• Starts as a liquid then coagulates– Flows into hinges and hidden areas– Cleaners must also flow into those areas and
dissolve blood away– Direct impingement and indirect
impingement
• What component of blood is most difficult to remove?– Fibrin
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What is fibrin?
• Fibrous protein that is generated as blood clots– Knits a wound together– Generates a water-insoluble covering– White
• Generated by fibrinogen in blood– Fibrinogen polymerizes and forms fibrin as blood clots
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Microscopic Fibrin Filaments
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Blood Components
• Primarily proteins– Albumin (water soluble)– Hemoglobin (water soluble)– Fibrin (non-water soluble)• Whitish residue• 2-4% in blood
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How do you verify?
Challenge the washerTest the items for cleanliness
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Challenge the Washer
• Is it functioning properly?– Are the spray arms clogged?– Are the spray arms rotating properly?– Are the spray arms installed properly?
• Is it loaded properly?– Shadows
• Is the detergent working properly?– Temperature– Time– Dosing
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Challenge the Washer
• Smear test soil on the item– Check for residuals• Visibly clean• Inoculate and culture• Protein test
– Still have to clean again before reuse• Adulterated
• Use a pre-made test soil challenge– A washing PCD…Process Challenge Device
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Washing PCDs
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Wash Checks
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Wash Checks H
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Wash Checks H
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Wash Checks H
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Ultrasonic Cleaner PCD
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Test the Item for Cleanliness
• Look at it– Visibly clean– Microscopic examination
• Test for residuals– Protein– ATP• Transient• Expensive
– Need equipment
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Protein Test
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Protein Test
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Frequency of Monitoring
• Traceability to the patient– Each tray?– Each shelf?– Each load?– Once a day?– Once a week?– Once a month?
• Each load is the minimum for traceability to the patient
• What does it cost?
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Prions
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Alpha Helix
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Beta Pleated Sheet
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Tissue Particle
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Tissue Particle After Heating
A hard shell is created, protecting a core of prions from destruction
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After Biological Digestion
When the hard shell is dissolved away through metabolic action, the prions are released
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Prions
• Washing may be more important than sterilizing– Sterilizing methods must hydrolyze (cut) the prion
protein chain– Sodium hydroxide methods– Enzymatic methods
• Alpha helix • Beta pleated sheet
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What have we learned?
• Cleaning needs to be monitored• Effectiveness of cleaning needs to be verified– Challenge the washer with a washing PCD– Test the items for cleanliness• Protein test or ATP test
• Frequency of monitoring needs consideration– Each load is minimum for traceability to patient
• Prions are much more difficult to sterilize– Washing might be more important than sterilizing