1. 19 november 2017
Potpourri (Decontamination, Sterilization and Sterility Assurance Principles)
Welcome to the Principles of Cleaning and Disinfection Training Course.
Presented by Fred Alston, CSPDT
Eastern Regional Clinical Support Manager

2. Disclosure
I am an employee of Healthmark Industries Fraser, Michigan USA
I am involved with the manufacture and distribution of medical products to healthcare facilities and healthcare professionals
No compensation has been received for this presentation or for travel to and from the seminar
All opinions are those of the presenter

3. Healthmark Policy
Healthmark’s Policy is to provide our customers and the healthcare community with the highest quality, state of the art medical products and support services in a timely and cost effective manner.
This goal is supported by a staff committed to individual accountability, professionalism, mutual respect, collaboration and service excellence. This presentation is part of that commitment, educating our customers.

4. Agenda Introduction Cleaning Water Quality Sterilization
Sterility Assurance
Load Release Protocol

5. Introduction Why Do We Clean? What Residues Are We Removing?
What Substrates Are We Cleaning?

6. Decontamination
“The use of physical or chemical means to remove, inactivate or destroy bloodborne pathogen on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is safe for handling, use, or disposal.”
OSHA CFR

7. The Four Factors of Cleaning
Time
Action
Concentration [Chemical]
Temperature

8. The Four Factors of Cleaning

9. “Turkey Pan” Theory of Cleaning

10. Washer Disinfector

11. Soil Types
ORGANIC (Acidic)
Blood
Tissue
Fats
Feces
PROTEINS

12. Soil Types INORGANIC (Alkaline) Urine Scale Water Hardness
Lime Deposits
Rust
MINERALS

13. Substrates Stainless Steel (s) Plated Steel Aluminum Glass
Plastics (wide variety)
Rubber or Synthetics

14. This pH scale shows a variety of common household items.
Common Items by pH
This pH scale shows a variety of common household items. 6 5 4 3 2 1
Battery Acid 8 9 10 11 12 13 14
Bleach
Lemon Juice
ALKALINITY INCREASE
Acidic
Milk of Magnesia
Alkaline
ACIDITY INCREASE
Common Items by pH
This pH scale shows a variety of common household items. Please note the relationship between the types of chemicals and their placement on the scale.
Pure water is listed in the center of the scale with a pH of 7.
Acidic chemicals include items like skin (5), lemon juice (2), and battery acid (0).
Basic or alkaline chemicals include items like seawater (8), milk of magnesia (11), and bleach (13).
Skin
Seawater
Pure Water 7

15. INTRODUCTION TO DETERGENTS AND DISINFECTANTS
pH Ranges
Detergents are generally categorized by the use of pH ranges. 6 5 4 3 2 1 8 9 10 11 12 13 14
ALKALINITY INCREASE
Acidic
Cleans Alkaline
Soils
Alkaline
Cleans Acidic
Soils
ACIDITY INCREASE
pH Ranges
Detergents are generally categorized by the use of pH ranges.
Neutral detergents have a pH range from 5 through 9.
Acidic detergents have a pH range from 0 through 5.
Alkaline detergents have a pH range from 9 through 14.
Neutral 7

16. Section 3.4 defines three different categories of medical devices:
19 november 2017
Water for the reprocessing of medical devices
AAMI TIR34:2014
Section 3.4 defines three different categories of medical devices:
Critical Devices: “Instruments or objects that are introduced directly into the human body, either into or in contact with the bloodstream or into other normally sterile areas of the body, and products with sterile fluid pathways.”
Semicritical Devices: “ Instruments or objects that contact intact mucosal membranes or non-intact skin of the patient during use but do not usually penetrate the blood barrier or other normally sterile areas of the body.”
Noncritical Devices: “ Instruments or objects that usually contact only the intact skin of the patient.”
In this course, we will present the following topics:
Review of decontamination
What defines cleaning/disinfection
Cleaning Process
Four Factors of Cleaning
Disinfection Process
Steps in the Cleaning Process
Methods for Cleaning and
Health and Safety Considerations

17. Section 4.2 in 2007 created four categories of water quality
19 november 2017
Water for the reprocessing of medical devices
AAMI TIR34:2014
Section 4.2 in created four categories of water quality
Potable Water: (water as it comes from the tap) requires no further treatment, provided that it meets some basic criteria. (described in Table 1 on pages 14,15)
Softened Water: “…water that received limited treatment (softening) to reduce scaling by replacing calcium and magnesium ions with more soluble sodium ions. This treatment process will not reduce microbial levels, nor will it remove organic material from the water.”
Deionized Water: “…water that receives limited treatment (deionization) to remove inorganic material from the water. This treatment process will not reduce microbial levels, nor will it remove organic material from the water.”
High-Purity Water: “…water that is extensively treated (usually by a multi step treatment process that may include a carbon bed, softening, DI, and RO or distillation) to insure that the microorganisms and the inorganic and organic material are removed from the water; a final submicron filtration may also occur as part of the treatment process.”
In this course, we will present the following topics:
Review of decontamination
What defines cleaning/disinfection
Cleaning Process
Four Factors of Cleaning
Disinfection Process
Steps in the Cleaning Process
Methods for Cleaning and
Health and Safety Considerations

18. Section 4.2 in 2014 has reduced it to TWO categories of water quality
19 november 2017
Water for the reprocessing of medical devices
AAMI TIR34:2014
Section 4.2 in 2014 has reduced it to TWO categories of water quality
Utility Water:
“Water as it comes from the tap that might require further treatment to achieve the specifications. This water is mainly used for flushing, washing, and rinsing.” “Tap Water” is referenced frequently.
Critical Water:
“ Water that is extensively treated (usually by a multistep treatment process that could include a carbon bed, softening, DI, and RO or distillation) to ensure that the microorganisms and the inorganic and organic material are removed from the water; a final submicron filtration could also be part of the treatment process. This water is mainly used for the final rinse or steam generation.”
In this course, we will present the following topics:
Review of decontamination
What defines cleaning/disinfection
Cleaning Process
Four Factors of Cleaning
Disinfection Process
Steps in the Cleaning Process
Methods for Cleaning and
Health and Safety Considerations

19. How does “Water Quality” affect me in my CS or OR Department?
19 november 2017
Water for the reprocessing of medical devices
Why is water treatment necessary?
How does “Water Quality” affect me in my CS or OR Department?
Ever notice a trend with intermittent occurrences of Wet packs or poor results in washer verification tests typically twice a year, April and October?
Sterilizers use a lot of water during a cycle. The harder the water the greater the chance for premature failure of valves, ejectors and clogged strainers.
Water Types: Utility
Sterilizers with integral Steam Generators are especially susceptible to Scale, Chlorides, Silica and Sodium levels.
As steam is generated the water is “Boiled” off and a greater concentration of these potentially dangerous and metal damaging precipitates remain.
Water Types: Utility, Critical (Softened, DI or RO only with additional treatment.)
In this course, we will present the following topics:
Review of decontamination
What defines cleaning/disinfection
Cleaning Process
Four Factors of Cleaning
Disinfection Process
Steps in the Cleaning Process
Methods for Cleaning and
Health and Safety Considerations

20. Water for the reprocessing of medical devices
19 november 2017
Water for the reprocessing of medical devices
Applications in my department
Cart Washers: use a large amount of water. As the quality of the water decreases, the greater the possibility of scale build up on the chamber walls and sump.
Water Types: Utility, Critical (Softened, DI or RO)
House Steam Quality: Often overlooked but if the chemical treatment is not properly managed, damage or discoloration of stainless instruments can occur as well as premature failure of sterilizer valves and check valves. Discoloration of Sterilizer chamber can occur as well.
Water Types: Utility, Critical (Softened, DI or RO, only with further treatment)
Scope Washers utilize Pre-Filters. The harder the water, the more frequently these sometimes expensive filters need changing.
Water Types: Utility, Critical Based on Manufacturers IFU.
In this course, we will present the following topics:
Review of decontamination
What defines cleaning/disinfection
Cleaning Process
Four Factors of Cleaning
Disinfection Process
Steps in the Cleaning Process
Methods for Cleaning and
Health and Safety Considerations

21. “Sterile is not Sterile until Clean is Clean”
What Do you think?
The Decontamination process is a very complex, vital component necessary for Sterilization and Sterility Assurance and ultimately Patient Safety.
“Sterile is not Sterile until Clean is Clean”
The foundation to sterilization begins in the OR.
Cleaning of instrumentation begins as soon as the item is finished being utilized in the case.

22. Review and Questions Know What You’re Cleaning
Alkaline or Acidic Soils?
Know Your Work Flow and Equipment
Know Your Water

23. Clean is now clean, so on to the next part, Sterility
Killer Mentality
Time to Kill
Clean is now clean, so on to the next part, Sterility
How do we help insure Sterility Assurance
Is it a Fred Said?
Chemistry and Biologics
Load Release Protocol

24. What is Sterilization? ster·il·i·za·tion (stĕr' ə-lĭ-zāshən) n.
Definitions
What is Sterilization?
ster·il·i·za·tion (stĕr' ə-lĭ-zāshən) n.
(1). The procedure of making an object free of viable bacteria or other microorganisms.
(2). A process used to render an object free from all forms of viable microorganisms.

25. Sterilization vs. sterility assurance
If the microorganisms are weak, sterilization might be achieved by weak methods
Sterility assurance
Having a process that can even handle a large population of strong microorganisms
Setting cycle parameters that are 2X a biological kill.
Typical ºC (2X) is 4 132ºC or
15 or ºC
A process that has only a one in a million chance that something is unsterile in that load

26. Non Toxic Easy to Control Readily Available Economical Highly
Steam sterilization
Temperatures ranging from °F ( °C) at pressures of psi are generally recommended to sterilize wrapped or unwrapped surgical instruments.
Why Steam?
Non Toxic
Easy to Control
Readily Available
Economical
Highly
Effective

27. STEAM QUALITY and EQUIPMENT
WHAT FACTORS AFFECT STERILITY?
STEAM QUALITY and EQUIPMENT
Steam Quality
Wet Steam
Dryness value should be between 97% - 100% (i.e. 98% steam 2% water)
Excess moisture can cause wet packs and uneven temperature distribution on non-porous loads
Superheated steam – may occur during sterilization of extremely dry packs
Causes dry heat conditions that hamper sterilization and can damage textiles
Presence of non-condensable gases
Inhibits steam penetration
Properly maintained equipment
Daily inspection of charts, printers, printer ribbons, door gaskets, chamber drain screen and the internal chamber
Qualified Preventive Maintenance performed by factory trained technicians
Calibration by qualified personnel
Records of all maintenance and service

28. HOW DO WE MEASURE STERILITY ASSURANCE?

29. BIOLOGICAL INDICATORS
FDA –Class II Medical Device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package.
Biological Indicators are intended to demonstrate whether or not conditions were adequate to achieve sterilization. A negative BI does not prove that all items in the load are sterile or that they were exposed to adequate sterilization conditions.
A positive BI indicates that there has been a sterilization failure. Ask the question what changed or was different about this cycle that caused microorganisms to survive?

30. AAMI ST 79:2010 2.118 definition note
“It is generally accepted that a SAL of 10-6 is appropriate for items intended to come into contact with compromised tissue (that is, tissue that has lost the integrity of the natural body barriers).
A SAL of (a one in a thousand chance of a surviving microorganism) is considered acceptable for items not intended to come into contact with compromised tissue.”

31. What does one in a million mean?
106 Geobacillus stearothermophilus
(one million spores)
6 log reduction when killed
Anything less than a 6 log reduction means non-sterile
Sterility assurance level of 100
Accepted sterility assurance level is 10-6
12 log reduction
one in a million chance of having non-sterile conditions
Doubling of time to achieve 6 log reduction
An instrument might actually be sterile before it goes into the sterilizer. Maybe it was soaking in bleach. Hospitals cannot rely on “maybe”. Hospitals must be sure. Sterilizer cycles are designed to kill a known, standardized biological spore which is heat resistant. It must expose instruments to twice the amount of time necessary to kill one million of these heat resistant spores.

32. Sterility assurance level of 10-6 at 134oC
106
D134Value =.30 min.
Population of living spores
103 1 2
3 minutes
100
Kill point
10-3
Increasing Sterility Assurance Levels
106 is one million, D134 Value is the number of minutes needed to kill 90% of the spores min is 18 seconds. It takes 1.8 minutes to kill all 1 million spores. This is the BI kill point (BI is biological indicator)
10-6

33. Time vs. sterility assurance
Start
BI kill
S.A.L. 10-6
1 minute
2 minutes
3 minutes
Not sterile
Some sterility assurance
An easier way to think of this is the following: In the sterilizer, the standard biological indicator containing one million spores should die half way through the cycle.
Assuming steam quality is good

34. Performance of 20 BIs in saturated steam
134oC
Start
BI kill
S.A.L. 10-6
2 minutes
3 minutes
1 minute
Kill points of individual BIs in a group of 20

35. Steam quality is important
How does liquid water (excess condensate) affect sterilization and sterility assurance?

36. Performance of 20 BIs in saturated steam
Start
BI kill
S.A.L. 10-6
2 minutes
3 minutes
1 minute
Kill points of individual BIs in a group of 20

37. BI performance under condensate
Start
Former BI kill
Former S.A.L. 10-6
1 minute
2 minutes
3 minutes
It takes twice as long to kill BIs under water

38. Integrator…What is it?
An indicator that is as strong as or stronger than a BI
Cleared by the FDA as an Integrator

39. Integrator…How is it used?
To verify that the inside of packs and trays have seen the correct amount of steam, with correct steam quality for the correct amount of time
To assist in load release decisions inside of PCDs (Process Challenge Devices)
What or who determines which integrator to use and when?

40. CHEMICAL INDICATORS - CI
ANSI/AAMI/ISO :2005 defines 6 classes of CIs. The classification has no hierarchical significance.
Class 1 Process indicators: Indicates the unit (pack/container) has been exposed to the process. Ex) Steam tape, pouch indicator spots
Class 2 Indicators for use in specific tests: CI designed for use in a specific test procedure (Bowie-Dick test indicator).
Class 3 Single-variable indicators: Indicator designed to react to one of the critical parameters of sterilization. Ex) Time or temperature.
Class 4 Multi-variable indicators: Indicator designed to react to 2 or more of the critical parameters of sterilization. Ex) Time and temperature.
Class 5 Integrating integrators: Indicators designed to react to all critical variables. The stated values are generated to be equivalent to or exceed BI performance.
Class 6 Emulating indicators: Cycle verification indicators designed to react to all critical variables for specified sterilization cycles. The stated values are generated from the critical values for the specified sterilization process.

41. Who else is involved in categorizing Integrators?
ISO (International Standards Organization)
:1995
:2005
FDA (Food and Drug Administration)
They currently only recognize the following:
Class 1: Process Indicators
Class 2: Bowie Dick
Class 6: Emulating Indicator
Integrator, Stronger than BI
They do not currently recognize the New Class 3,4 or 5 Integrator)

42. What does sterility assurance actually mean and how do you measure it?

43. Process Challenge Devices and Their Uses

44. What are we trying to accomplish by monitoring our cycles?
We are verifying we have achieved a high level of sterility assurance

45. ST 79:2010 10.6.1 Routine load release, Process Monitoring Devices
Every load containing implants should be monitored with a PCD containing a BI (a BI challenge test pack). A Class 5 integrating CI or an enzyme-only indicator should be included in this PCD.
Rationale: a Class 5 CI or an enzyme-only indicator should be included with the BI in the PCD so that if an implant must be released on an emergency basis, additional information about the critical parameters of the sterilization process will be available and documented

46. When do I use a BI and/or a CI?

47. BI/CI FREQUENCY OF USE
External CI on the outside of every package/tray/container.
Internal CI inside every package/tray/container.
Optional monitoring of every load with a PCD containing a Class 5 integrating CI and/or a BI. The results from the PCD CI may be used as part of the criteria for release of non-implant loads.
A PCD containing a BI and a Class 5 integrating CI for monitoring every load containing an implant. The results of the integrator are used for emergency release of implants.
A BI in a PCD (may also contain a CI) for routine sterilizer efficacy monitoring at least weekly but preferably daily. Testing is done using a full load with the exception being Flash sterilizers which are tested using an empty chamber. (ANSI/AAMI ST79: )
A BI in a PCD (may also contain a CI) for sterilizer qualification testing after sterilizer installation, relocation, malfunctions and major repairs and after sterilization process failures (see ANSI/AAMI ST79: ). Need 3 consecutive tests in an empty chamber with passing results.
Periodic quality assurance testing of representative samples of actual products being sterilized (see ANSI/AAMI ST79: and 10.10). The BI is placed within a product test sample.
Bowie-Dick test for dynamic air removal sterilizers is performed daily. Three consecutive BD tests are required as part of sterilizer qualification testing after sterilizer installation, relocation, malfunctions and major repairs and after sterilization process failures.

48. RELEASE OF ITEMS Routine Loads without implants
Based upon all available data from the sterilization process for the particular load. (ANSI/AAMI ST79:2010 section 10.6)
Cycle printouts initialed by operator
External and internal chemical monitoring of packages - CI results
Results of PCD if used - Integrator Challenge Packs, BI/CI Challenge Packs
Loads containing Implants
Recommended quarantine of implantable device until BI results are known. (ANSI/AAMI ST79: )
Review of cycle printouts, results of external and internal CIs.
Monitor every load with a PCD containing a BI and a Class 5 integrating indicator. If immediate emergency release is required (prior to BI results) the results of the Class 5 CI are used.
Release of implant devices prior to BI results should be documented and the BI results documented when known. Documentation of implant release should be fully traceable to the patient.

49. The Circle of Life PATIENT Proper Cleaning Patient Use Cycle Selection
Biological Read
PCD / Biologicals
Documentation
Sterilization
Load Release

50. Thank You!
Questions?
On behalf of Healthmark, I would like to thank you all for the opportunity to be here today.
THANK YOU!