Disinfection & Sterilization

1. Disinfection & Sterilization

2. Getting from here…

3. Back To Here:

4. Outline • 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

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)= 10-6thpower, or 1:1,000,000 chance that a single viable microorganism is present on a “sterilized” item.

8. 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) AORN Standards & Recommended PracticesRecommendation #1 “Items to be processed should be categorized as critical, semicritical, and noncritical.”

9. 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

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

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

14. Flush lumens & cannulas!!!

15. Cleaning & Decontamination • Soiled instruments need to be contained and confined for transportation to the soiled utility room or to SPD.

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

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 15-60 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

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%

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

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

26. Sterilization • Terminal Sterilization—sterilized in a package, has a shelf life • Point of UseSterilization—no shelf life, needs to be delivered to the sterile field at the completion of the sterilization cycle.

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

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

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

32. Hydrogen Peroxide Gas Plasma Sterilizer

33. Hydrogen Peroxide Gas Plasma • Cycles: • Non-lumen: 20-40 minute cycle for batteries & other non-lumened items. • Lumen cycle: 55-75 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

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.

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

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

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

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.

50. Sterilization Quality Control • Bowie Dick Test—used to assure the air removal system is working properly in a prevacuum sterilizer • Daily