1. به نام خدایی که در این نزدیکی است

2. Monitoring the Sterilization Process in healthcare facilities
By:Ronak Bakhtiari

3. Key points
All invasive procedures involve contact by a medical device or surgical instrument with patients’ sterile tissue or mucous membrane 01 02
The level of disinfection or sterilization depends on the intended use of the object: critical, semicritical, and noncritical require sterilization, high-level disinfection, or lowlevel disinfection, respectively 03
Cleaning must precede high-level disinfection and sterilization 04
Failure to properly disinfect devices used in health care has led to many outbreaks 05
Health care providers should be familiar with current issues 3

4. Definitions Removal of all soil from objects/surfaces Cleaning
Removal of all pathogenic microorganisms from objects to ensure they are safe to handle
Decontamination
Elimination of many or all pathogenic organisms with the exception of bacterial spores
Disinfection
Complete elimination, destruction of all microbial life
Sterilization

5. Health Care Application
Methods for disinfection and sterilization of patient-care items
sterilization
Low-level disinfection
HLD
Process
Heat-sensitive semicritical items
Noncritical patient care item or surface with no visible blood
Heat-sensitive critical and semicritical patient-care items that can be immersed
Heat-sensitive critical and semicritical patient-care items
Heat-tolerant critical and semicritical patient-care items
Health Care Application
Heat automated
Method
Low temperature
Liquid immersion
High temperature

6. Who recommends Biological Monitoring?
CSA
Canadian Standards Association International
American Society for Healthcare Central Service Professionals
Association for the Advancement of Medical Instrumentation
ASHCSP
AAMI
Operating Room Nurses Association of Canada
Association of Operating Room Nurses
ORNAC
AORN
Laboratory Centre for Disease Control
LCDC
CDC
Centers for Disease Control and Prevention

7. Sterilization Process
Clean
Prep/Pack
Sterilize
Store
Issue/Use

8. Methods of Monitoring according to CDC guidelines01
Mechanical Techniques
cycle time, temperature, pressure 02
Chemical Indicators
heat or chemical sensitive inks that change color when germicidal-related parameters present 03
Biological Indicators (BIs)
Bacillus spores that directly measure sterilization

9. Physical Monitors
Physical monitoring provides real-time assessment of the sterilization cycle conditions
provides permanent records by means of chart recordings or digital printouts
Physical monitoring is needed to detect malfunctions as soon as possible

10. Chemical Indicators (CIs)
sterilization process monitoring devices that are designed to respond with a chemical or physical change to one or more of the physical conditions within the sterilizing chamber
assist in the detection of potential sterilization failures that could result from incorrect packaging, incorrect loading of the sterilizer, or malfunctions of the sterilizer

11. Classification of Chemical Indicators
(Process Indicators)
Tapes or strips used only as external indicators to distinguish processed from unprocessed items
Class II
(Bowie-Dick Indicators)
Used as quality control indicators for vacuum steam sterilizers to assess air removal during cycle
Class III
(Temperature Specific Indicators)
Indicate attainment of specific minimum temoerature within sterilization chamber during a cycle; not sensitive to other
Class IV
(Multi-Paremeter Indicators)
Provide integrated color change to the temperature, pressure, time sterilization parameters
Class V
(Integrating Indicators)
Strips that contain a chemical ink which reacts to all three sterilization parameters during the sterilization cycle
Class VI
(emulating indicators)
They are used for specific sterilization cycles
not widely used in dental processing due to their sophistication and ease of misuse.

12. Biological Indicators (BIs)
provide the only direct measure of the lethality of the sterilization process
All BIs should be used in accordance with the BI manufacturer’s instructions
monitoring devices consisting of a standardized, viable population of microorganisms known to be resistant to the mode of sterilization being monitored
Biological indicators are intended to demonstrate whether the conditions were adequate to achieve sterilization

13. How often should biological monitoring be performed?
Whenever a new type of packaging material or tray is used
After a sterilizer has been repaired
After training new sterilization personnel
at least weekly
After any change in the sterilizer loading procedures

14. perform biological monitoring
TEMPLATES
Pre-designed presentations with 22 slides 14

15. Types of spore tests
The type of spore used in sterilizer monitoring depends on the type of sterilization
Bacillus stearothermophilus was used to monitor autoclaves and chemical vapor sterilizers
Bacillus subtilis tested dry heat units. Recently the names of these organisms have changed to Geobacillus stearothermophilus (for autoclaves and chemical vapor units)
Bacillus atropaeus (for dry heat)

16. Process Monitoring Load Control Pack Control Equipment Control
Exposure Control
Record Keeping

17. Load Control
The sterilization reliability that only a biological indicator can deliver
How Often?
Every load

18. Pack Control The inside counts in sterilization process monitoring
How Often?
Every pack

19. Equipment Control
Keeping the mechanics of sterilization process monitoring running smoothly
How Often?
Air removal: Beginning of each day, after major repairs or for installation testing. Mechanical monitoring: Every load. Integrator test pack: Every load that does not have a BI test pack

20. Exposure Control
Seeing is believing in sterilization process monitoring
How Often?
Every load

21. Record Keeping
Documenting the evidence in sterilization process monitoring
lot or load control number
processing date
sterilizer number
cycle number
Expiration statement
How Often?
Label each pack so there is a traceable path to monitoring control records

22. Common Factors Influencing the Effectiveness of Sterilization
Improper cleaning of instruments 1 1 2
Protein and salt debris may insulate organisms from direct contact with the sterilizing agent and interfere with the efficacy of the sterilization agent. 3 4 5 22

23. Common Factors Influencing the Effectiveness of Sterilization2 1
Improper packaging 2
Prevents penetration of the sterilizing agent; packaging material may melt. 3 4 5 23

24. Common Factors Influencing the Effectiveness of Sterilization
Excessive packaging material 3 1 2 3
Retards penetration of the sterilizing agent. 4 5 24

25. Common Factors Influencing the Effectiveness of Sterilization
Improper loading of the sterilizer 4 1 2
Increases heat-up time and will retard penetration of the sterilizing agent to the center of the sterilizer load. 3 4 5 25

26. Common Factors Influencing the Effectiveness of Sterilization
No separation between packages or cassettes even without overloading 5 1 2 3
May prevent or retard thorough contact of the sterilizing agent with all items in the chamber. 4 5 26

27. N K T H Y A O U

28. References
Fassò A, Toccu M, Magno M. Functional Control Charts and Health Monitoring of Steam Sterilizers. Quality and Reliability Engineering International
Rutala WA, Weber DJ. Disinfection and Sterilization in Health Care Facilities: An Overview and Current Issues. Infectious Disease Clinics of North America. 2016;30(3):609-37
Flynn S, BESc C. Quality assurance for low-temperature sterilizers. self
Infection Control In Practice Vol. Vol. 2,1, No. No. 7 October May