1. Disinfection & Sterilization

2. Getting from here…
How do we get from here….

3. Back To Here:

4. Outline Quality Assurance & Monitoring Cleaning & Decontamination
Disinfection
Prep & Pack
Sterilization
Terminal
Point of Use
Quality Assurance & Monitoring
Sterilization Process Failure

5. Good old Dr. Earle Spaulding
The selection of a disinfection or sterilization method depends on the intended use of the item.
Non-critical requires low level disinfection
Semi-critical requires high level disinfection
Critical requires sterilization
1968, microbiologist

6. Definitions
Cleaning—Removal of contamination from an item to the extent necessary for further processing or for intended use.
Decontamination—The use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infection and the item is rendered safe to handle with the ungloved hand.

7. Definitions
Disinfection—The process that kills pathogenic and other microorganisms by physical or chemical means.
Low
Intermediate
High Level
Sterilization—Free from viable microorganisms.
This is actually just a probability.
Sterility Assurance Level (SAL)= 10-6th power, or 1:1,000,000 chance that a single viable microorganism is present on a “sterilized” item.

8. AORN Standards & Recommended Practices Recommendation #1 “Items to be processed should be categorized as critical, semicritical, and noncritical.”
NonCritical: Contact with intact skin but not mucous membranes
Clean with low-level disinfectant : kill bacteria,fungi and some viruses, won’t kill spores
Ex Alcohol, quaternary ammonium (virex)
Intermediate level disinfectants are also mostlyt for environmental surfaces too they kill more things and have specific uses. Bleach kills C. Diff

9. Examples: Halogens (chlorine, iodine), Phenolics (carbolic acid)
Intermediate level disinfection is also mainly for environmental surfaces
Used on noncritical items that have been exposed to pathogens that aren’t killed by low level disinfection.
Examples: Halogens (chlorine, iodine), Phenolics (carbolic acid)
Relatively fast acting
Relatively broad spectrum
During bankers hours there is an infection control officer who will know if you have questions. Housekeeping can be a good resource. Usually online resources.
Bleach for c-Diff

10. Semi-Critical: Contact with mucous membranes or broken skin
Require high level disinfection but do not have to be sterile at point of use
Examples: Gluteraldehyde, Ortho-Phthaldehyde (OPA), Formaldehyde, Cidex OPA
All have a use life after opening package
May have an obnoxious odor
Use test strips to ensure MEC
Need proper venting
Need copious rinsing—particularly with OPA
Need documentation
Why these require high level disinfection
Some places sterilize when they can.
This is not something the nurse does unless you’re also an endo tech.

11. Critical Items
Object that carry a high risk for infection if contaminated, things that will enter sterile tissue. High level disinfection +sterilization

12. It all starts with cleaning
Items can’t be disinfected or sterilized unless they are properly cleaned.
AORN: “Cleaning and decontamination are the initial and most critical steps in breaking the chain of disease transmission.” 2011 pg 401

13. Cleaning & Decontamination
Cleaning begins at the point of use.
AORN RP: Care of Instruments Recommendation #4—Instruments should be kept free of gross soils during surgical procedures
Use enzymatic spray at the end of the procedure
Role of the Tech
Spray that S***t it should get on all the surfaces

14. Flush lumens & cannulas!!!
If blood is clogging up your tubing its probably doing so in your suction too

15. Cleaning & Decontamination
Soiled instruments need to be contained and confined for transportation to the soiled utility room or to SPD.
Think about the guys downstairs they’re at risk for stick too.
If you have to send down one dirty thing put it in biobag

16. Cleaning & Decontamination—after the procedure
The first step is to remove all visible and invisible soils
Must be done according to manufacturer’s guidelines
Neutral PH enzymatic detergent, mechanical friction
Next step is generally the mechanical washer
Basic Principles

17. Decontam
All items need to be decontaminated, even if just opened in the room.
One way flow of materials
AT ANMC IF NO PATIENT ENTERED THE ROOM THE EQUIPMENT IS CAN BE RE-STERILIZED (faster cheaper)

18. Cleaning & Decontamination
AORN RP: Care of Instruments, Recommendation #5—Cleaning and decontamination should occur as soon as possible after the instruments are used.
AAMI: Instruments are decontaminated within minutes after use.

19. How fast do microorganisms reproduce??
12:00 1
12:20 2
12:40 4
13:00 8
14:00 64
15:00 512
16:00 4,096
17:00 32,768
18:00 262,144
19:00 2,097,152

20. Final point on cleaning and decontamination
Anything that can be disassembled must be disassembled for cleaning, decontamination, and sterilization
Copious rinse with RO, DI or distilled water

21. What’s next? Disinfection Use a germicidal solution
Follow manufacturer’s guidelines regarding dilution
Must come in contact with all surfaces
Must remain in wet contact for the prescribed amount of time—read the label
Different levels of disinfection

22. Disinfection Thermal!!! Using Mechanical Washer-Sterilizer
Washes with cold water then fills chamber with steam
Heat denatures proteins at lower temperatures if steam is present
Pressure is used to achieve temp of 270 deg.
Goal is steam saturation of 100%
That’s why its so hot

23. Most items are mechanically washed
Process time is 43 minutes—longer if a bunch of patients are taking showers
Only hand wash items that cannot be submersed
Pressured to hand wash—takes longer to do it properly (friction to all surfaces, disinfectant stand time) than to put it in the washer
((Please do not pressure us to handwash))
Daily QA tests

24. Inspect & Assemble
Regardless of who is processing the instruments, they need to be inspected to make sure they’re clean and in good working order before they go into a sterilizer
After the washer-sterilizer stuff is safe to handle but its not ready for Surgery yet.

25. Packaging
Instruments that are terminally sterilized are placed into some kind of package before they go into a sterilizer
Rigid container
Flat wrapped
Peel pouch
Instruments on stringers in order neatly arranged

26. Sterilization
Terminal Sterilization—sterilized in a package, has a shelf life
Point of Use Sterilization—no shelf life, needs to be delivered to the sterile field at the completion of the sterilization cycle.
Package should have a date of when it was sterilized, good for a year.
Dust covers extend shelf life
POU is flash, also called immediate use and is only for emergencies.

27. Steam Sterilization Most common method of sterilization
Has been used for many years
Relatively safe
Relatively inexpensive
Can be used for the majority of surgical instruments
Can’t be used for instruments that are heat and pressure sensitive

29. Steam Sterilization Phases Condition Sterilize Exhaust
Dry—needs to cool to room temperature before handling (sterility assurance and condensation)
Need to make sure all parameters for sterilization have been met prior to releasing the instruments for patient use.

30. Steam Sterilization
Cycle selection needs to be in accordance with manufacturer’s guidelines
Terminal sterilization cycles all take around an hour.
Common Cycles
Prevacuum 270’ 4 minutes
Prevacuum 270’ 8 minutes
Gravity 250’ 30 minutes
Policy not the same everywhere

31. Hydrogen Peroxide Gas Plasma
Used for heat and pressure sensitive instruments
Relatively safe
More expensive than steam sterilization
Fast cycle times—48-75 minutes
Good for batteries, shavers, fiber optic scopes
Not for use with paper or cloth
Sterrad

32. Hydrogen Peroxide Gas Plasma Sterilizer
Rigid containers, tyvek peel packs, regular wrap

33. Hydrogen Peroxide Gas Plasma
Cycles:
Non-lumen: minute cycle for batteries & other non-lumened items.
Lumen cycle: minutes for items containing lumens, mixed loads, complex items
Flexible scope cycle: 75 minutes, allows for terminal sterilization of selected flexible endoscopes

34. Point of Use Sterilization
Immediate use steam (“Flash”) sterilization
Paracetic Acid Sterilizers
Hydrogen Peroxide Sterilizers
Automated Endoscope Reprocessors

35. Flash Sterilizer
In the core, find out your policy is on using this, it is subject to the same quality controls and traceability standards as any other

36. Immediate Use Steam Sterilization
Will sterilize an item in 10 minutes.
Item will come out of the sterilizer hot and wet;
need to be transported to the sterile field at the end of the cycle in a manner that doesn’t compromise sterility
Items need to cool before coming in contact with the patient—force cooling can cause instruments to crack & break

37. Immediate Use Steam Sterilization
Need to review load printout to make sure all parameters for sterilization were met
Processing implants in an immediate use sterilizer should be avoided at all costs.
If using a “Flashguard” container, read instructions carefully!

38. Paracetic Acid Sterilizer
Steris System 1E
Relatively safe for staff
Relatively fast—38-43 minutes
Sensitive to water temperature & pressure fluctuations
Use for choledochoscope, bronchoscope, etc.
Btw all these times are for the sterilizer, the don’t include cleaning, decontam, disinfect and assembly. Turnover is easily over an hour on these items

39. Steris System 1E

40. Point of Use Hydrogen Peroxide Gas Sterilization
Sterrad NX
Used for terminal sterilization of scopes
Able to use for instruments that are moisture sensitive
Cycle time: 28 minutes
Requires packaging
Chamber is small

41. Automated Endoscope Reprocessor
Automated equipment designed to clean, disinfect, and rinse flexible scopes
“High level decontam”, not sterile
AER’s are a chemical process; Gluteraldehyde, OPA, and Paracetic acid are the most common chemicals
If you work in endoscopy.

42. Automated Endoscope Reprocessor

43. Sterilization Quality Control
How do I know my item is safe for the patient???

44. Sterilization Quality Control
Physical monitoring—instruments within the sterilizer that tell us the temperature, pressure, and duration of a sterilization cycle.
Process indicators—let us know whether or not the item has been processed
Count sheets and packaging have initals, lot numbers, etc. people need feedback to improve

45. External Chemical Indicator Tape
Before Processing
After Processing

46. Sterilization Quality Control
Tamper evident device—container locks, tape, arrows
Internal Pack Control—chemical indicators placed inside the tray, let us know that several parameters for sterilization have been met

47. Examples of Internal Chemical Indicators
You may see several. Indicators tell you what the indicator was exposed to

48. Sterilization Quality Control
Biological Monitoring—spores inside a test package that measure the lethality of a sterilization cycle
Always run a BI with implants

49. Biological Indicators
Contain Geobacillus stearothermophillus- Highly heat resistant, spore-forming bacteria does not produce toxins and is non-pathogenic.
Change colors and are cultured for best results

50. Sterilization Quality Control
Bowie Dick Test—used to assure the air removal system is working properly in a prevacuum sterilizer
Daily
Makes sure steam is displacing the air but not assure sterilization.

51. Sterilization Quality Control
Lot control number—includes sterilizer identification, cycle number, date of sterilization
This is how we achieve lot traceability
It’s up to the clinical staff to record lot control number in the patient’s record.

52. Load Control Information*
S-1
L-5
Sterilizer Number
Load Number
Date Sterilized
Note date sterilized, not exp date
*Must be placed on each item Sterilized in the Central Service Department.

53. Sterilization Quality Control
In order for a sterilizer load to be released for patient use:
Sterilizer tests complete
Parameters for sterilization must be met
Process indicator (tape) must pass
Tamper evident devices present
Lot control present & accurate
Packages cooled to room temperature if terminally sterilized
If implants, BI must pass

54. Sterilization Quality Control
What can go wrong???

55. Parameters for sterilization not met
Parameters: Time, Temperature, Pressure, Concentration
Reprocess the load in another sterilizer
Take the sterilizer out of service until the cause can be identified and corrected
Usually something has gone wrong with the sterilizer & sometimes the plant

56. Sterilization Process Failure
Positive Biological Indicator
Need to recall back to the last negative biological
Take the device out of service until the cause of the problem can be identified and corrected
Most of the time it’s user error
The rest of the time it’s caused by a problem with the sterilizer or the plant

57. Sterilization Process Failure
Wet load/wet pack
May be inside the chamber
User error—improper loading of the chamber
Sterilizer—valve or trap problem
Plant—steam too wet
Reprocess the load in another sterilizer; take the sterilizer out of service until the cause can be identified and corrected

58. Sterilization Process Failure
Wet load/wet pack
May be inside the packages—can’t tell until they are opened.
Usually a condensation issue
Items moved before they have cooled to room temperature
Improper configuration of tray
Improper configuration of sterilizer load
Excessively heavy tray
Mixed metals and plastic
Trays with moisture are considered contaminated—notify SPD and replace the tray. SPD needs lot control # in order to conduct a recall

59. Internal Pack Moisture

60. Other things that can go wrong
Hole in wrapper
Items get handled many times and every time they are touched, there’s a chance the wrapper may get damaged
Lift—don’t drag
Watch out for trays that have feet or are very heavy
Rigid Container Defect
All parts have to be intact

61. Other things that can go wrong
Peel pack has wrinkles in the seal
Tamper evident device comes off
Indicators missing
Item falls on the floor
Indicators are on the count sheet to remind you

63. Questions??