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

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Presentation on theme: "Verification of Washing Strategies for RMDs. Presented By: Lon Bruso Vice President, SteriTec Products."— Presentation transcript:

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

17

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

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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