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Verification of Washing

Verification of Washing. Strategies for RMDs. Presented By:. Lon Bruso Vice President, SteriTec Products. 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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Verification of Washing

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  1. Verification of Washing Strategies for RMDs

  2. Presented By: Lon Bruso Vice President, SteriTec Products

  3. Verification of Washing • Quality system basics • Importance of washing verification • Blood residual as a test soil • Verification methods • Verification frequency • Prions

  4. 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?

  5. 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

  6. 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

  7. 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

  8. Microscopic Fibrin Filaments

  9. Blood Components • Primarily proteins • Albumin (water soluble) • Hemoglobin (water soluble) • Fibrin (non-water soluble) • Whitish residue • 2-4% in blood

  10. How do you verify? Challenge the washer Test the items for cleanliness

  11. 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

  12. 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

  13. Washing PCDs

  14. Wash Checks

  15. Wash Checks H

  16. Wash Checks H

  17. Wash Checks H

  18. Ultrasonic Cleaner PCD

  19. Test the Item for Cleanliness • Look at it • Visibly clean • Microscopic examination • Test for residuals • Protein • ATP • Transient • Expensive • Need equipment

  20. Protein Test

  21. Protein Test

  22. 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?

  23. Prions

  24. Alpha Helix

  25. Beta Pleated Sheet

  26. Tissue Particle

  27. Tissue Particle After Heating A hard shell is created, protecting a core of prions from destruction

  28. After Biological Digestion When the hard shell is dissolved away through metabolic action, the prions are released

  29. 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

  30. 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

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