Effective Sterilization Monitoring in Healthcare Facilities

1. به نام خدایی که در این نزدیکی است

2. Monitoring the Sterilization Process in healthcare facilities By:RonakBakhtiari

3. Key points 01 All invasive procedures involve contact by a medical device or surgical instrument with patients’ sterile tissue or mucous membrane 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 05 Failure to properly disinfect devices used in health care has led to many outbreaks 04 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. Low temperature sterilization Liquid immersion Health Care Application Methods for disinfection and sterilization of patient-care items Heat automated High temperature Method Liquid immersion HLD Method Process Low-level disinfection Health Care Application Method Heat-sensitive critical and semicritical patient-care items Heat automated Heat-sensitive semicritical items Heat-sensitive semicritical items Heat-tolerant critical and semicritical patient-care items Noncritical patient care item or surface with no visible blood Heat-sensitive critical and semicritical patient-care items that can be immersed

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

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

8. Methods of Monitoring according to CDC guidelines 01 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 Class I (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 V (Integrating Indicators) Class III (Temperature Specific Indicators) Strips that contain a chemical ink which reacts to all three sterilization parameters during the sterilization cycle Indicate attainment of specific minimum temoerature within sterilization chamber during a cycle; not sensitive to other Class IV (Multi-Paremeter Indicators) Class VI (emulating indicators) Provide integrated color change to the temperature, pressure, time sterilization parameters 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 subtilistested dry heat units. Recently the names of these organisms have changed to Geobacillusstearothermophilus (for autoclaves and chemical vapor units) • Bacillus atropaeus(for dry heat)

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

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 Sterilization 2 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 May prevent or retard thorough contact of the sterilizing agent with all items in the chamber. 3 4 5 26

27. K N T H Y A U O

28. References http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf Fassò A, Toccu M, Magno M. Functional Control Charts and Health Monitoring of Steam Sterilizers. Quality and Reliability Engineering International. 2016. 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. 2016. Infection Control In Practice Vol. Vol. 2,1, No. No. 7 October 2003 1 May 2002 http://www.osap.org https://www.azda.org/docs/default-source/infection-control/2015_may