1. Sterilization Standards & Processes
Wallace Puckett, Ph.D.
STERIS Corporation
April 25, 2009

2. Topics for Today’s Presentation
A High Level Summary of Standards related to Sterilization and the instrument reprocessing loop
A detailing of AORN’s Recommended Practices for Sterilization in the Perioperative Practice Setting
A Brief Summary of Aspects of Quality Systems and their application

3. Organizations Involved in Standards Setting (partial list)
Association for the Advancement of Medical Instrumentation (AAMI)
World Health Organization (WHO)
Association of periOperative Registered Nurses (AORN)
European Union (CEN standards)
International Standards Organization (ISO standards)
Center for Disease Control (CDC)

4. Standards for Sterilization in the Healthcare Setting
Definition of Standard
something established by authority, custom, or general consent as a model or example : <quite slow by today's standards>

5. ANSI/AAMI ST79:2006 and Attachment 1:2008 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities
ANSI/AAMI ST46, Steam sterilization and sterility assurance in health care facilities*
ANSI/AAMI ST42, Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care medical, surgical, and dental facilities*
ANSI/AAMI ST37, Flash sterilization: Steam sterilization of patient care items for immediate use*
ANSI/AAMI ST35, Safe handling and biological decontamination of medical devices in health care facilities and in non-clinical settings (with respect to steam sterilization only)*
ANSI/AAMI ST33, Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities*
(*All withdrawn and incorporated into ST79)

12. ANSI/AAMI/ISO 11138-2006 Sterilization of health care products - Biological Indicators
Part 1: General requirements
Part 2: Biological indicators for ethylene oxide sterilization processes
Part 3: Biological indicators for moist heat sterilization processes
Part 4: Biological indicators for dry heat sterilization processes
Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

13. ANSI/AAMI/ISO 11140-2005 Sterilization of healthcare products - Chemical Indicators
Part 1: General requirements
Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test (2007)
Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration (2007)
Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs, 2ed (2007)
Part 6: Class 2 indicators and process challenge devices for use in performance testing for small steam sterilizers (Draft)

14. Various Related Standards and Guidance Documents
AAMI TIR34:2007 Water for the reprocessing of medical devices
AAMI TIR30:2003 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
ANSI/AAMI ST77:2006 Containment devices for reusable medical device sterilization
ANSI/AAMI ST58:2005 Chemical sterilization and high-level disinfection in health care facilities
AAMI TIR31:2003 Process challenge devices/test packs for use in health care facilities

15. Sterilization Equipment Standards
ANSI/AAMI ST24:1999/(R)2005 Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities
ANSI/AAMI ST50:2004 Dry heat (heated air) sterilizers
ANSI/AAMI ST55:2003 Table-top steam sterilizers
ANSI/AAMI ST8:2008 Hospital steam sterilizers

16. AORN Recommended Practices for the Instrument Reprocessing Loop
Instrument Transport
and Storage
Instrument Use
Instrument Sterilization
Instrument Pre-cleaning
Instrument Packaging
Instrument Cleaning

17. AORN Recommended Practices for the Instrument Reprocessing Loop
Definition of Recommended-
1 a: to present as worthy of acceptance or trial <recommended the medicine>
b: to endorse as fit, worthy, or competent <recommends her for the position>
2: entrust, commit<recommended his soul to God>
3: to make acceptable <has other points to recommend it>
4: advise<recommend that the matter be dropped>
Definition of Practice-
a: to perform or work at repeatedly so as to become proficient <practice the act>
b: to train by repeated exercises <practice pupils in penmanship>

18. Recommendation I
Items to be sterilized should be cleaned, decontaminated, sterilized, and stored in a controlled environment and in accordance with AORN’s “Recommended practices for cleaning and caring of instruments and powered equipment” and the device manufacturer’s written instructions.

19. Recommendation I (continued)
Effective sterilization cannot take place without effective cleaning. The process of sterilization is negatively affected by the amount of bioburden and the number, type, and inherent resistance of microorganisms, including biofilms, on the items to be sterilized. Soils, oils, and other materials may shield microorganisms on items from contact with the sterilant or combine with, and inactivate, the sterilant.

20. Recommendation II
Items to be sterilized should be packaged in accordance with AORN’s Recommended practices for selection and use of packaging systems for sterilization.
Appropriate packaging ensures that sterility can be achieved and maintained to the point of use.

21. Recommendation III
Saturated steam under pressure should be used to sterilize heat- and moisture-stable items unless otherwise indicated by the device manufacturer.
Saturated steam under pressure is the preferred sterilization method. It is an effective, inexpensive and relatively rapid sterilization method for most porous and nonporous materials.

22. Recommendation IV
Use of flash sterilization should be kept to a minimum. Flash sterilization should be used only in selected clinical situations and in a controlled manner.
Flash sterilization may be associated with increased risk of infection to patients because of pressure on personnel to eliminate one or more steps in the cleaning and sterilization process.

23. Recommendation V
Ethylene oxide (EO) sterilization is a low-temperature process that is appropriate for heat- and moisture-sensitive surgical items when indicated by the device manufacturer.
Ethylene oxide at sterilizing temperatures kills microbes in hard-to-reach areas, and it does so with no damage to devices. Ethylene oxide is an alkylating agent that results in microbial death under controlled parameters.

24. Recommendation VI
Low-temperature hydrogen peroxide gas plasma sterilization methods should be used for moisture-sensitive and heat-sensitive items and when indicated by the device manufacturer.
Low-temperature hydrogen peroxide gas plasma sterilization uses a combination of hydrogen peroxide vapor and low-temperature hydrogen peroxide gas plasma.

25. Recommendation VII
Sterilization systems using peracetic acid as a low-temperature liquid sterilant is appropriate for heat-sensitive surgical items that can be immersed and when indicated by the device manufacturer.
Peracetic acid sterilization is a system that uses a chemical formulation of 35% peracetic acid and water. The ability of peracetic acid to inactivate many different critical cell systems is responsible for its broad spectrum antimicrobial activity.

26. Recommendation VIII
Sterilization systems using ozone should be used for moisture and heat-sensitive items when indicated by the device manufacturer.
Ozone is a strong oxidizer, which makes ozone sterilization an effective low-temperature sterilization process. Ozone is generated within the sterilizer using only oxygen and water.

27. Recommendation IX
Dry-heat sterilization should be used to sterilize anhydrous (ie, waterless) items that can withstand high temperatures and when indicated by the device manufacturer.
Sharp instruments that would be damaged by the moisture of steam may be sterilized by dry-heat. Dry heat is an oxidation or slow burning process that coagulates protein in microbial cells.

28. Recommendation X
A formalized program between health care organizations and health care industry representatives should be established for the receipt and use of loaner instrumentation.
Implementation of tracking and quality controls and procedures are necessary to manage instrumentation and implants brought in from outside organizations and companies.

29. Recommendation XI
Sterilized materials should be packaged, labeled, and stored in a manner to ensure sterility, and each item should be marked with the sterilization date.
Limiting exposure to moisture, dust, excessive light or handling, and temperature and humidity extremes decreases potential contamination of sterilized items.

30. Recommendation XI (continued)
Note: Ambulatory surgery centers should refer to the Centers for Medicare and Medicaid Services State Operations Manual for Ambulatory Services that states, “Sterilized materials should be packaged, labeled, and stored in a manner to ensure sterility and that each item is marked with the expiration date.”

31. Recommendation XII
Transportation of sterile items should be controlled.
Sterility is event-related and depends on the amount of handling, conditions during transportation and storage, and the quality of the packaging material.

32. Recommendation XIII Competency
An introduction and review of policies and procedures should be included in personnel orientation to sterile processing of surgical instruments in the perioperative setting. Continuing education should be provided for employees when new equipment, instruments, and processes are introduced.

33. Recommendation XIV Documentation-
Sterilization records should be maintained for a time specified by the health care organization’s policies and in compliance with local, state, and federal regulations.
Every sterilization cycle and modality, should be documented. Documentation should include: the assigned lot number, contents of each load, and results of physical, chemical, and biological monitors.

34. Recommendation XV Policies and Procedures-
Policies and procedures for sterilization processes should be developed, reviewed periodically, and readily available in the practice setting.

35. Recommendation XVI Quality
A quality control program should be established and maintained.
Quality control programs that enhance personnel performance and monitor sterilization efficacy are established to promote patient and employee safety.

36. Sterilization Process Monitoring Recommendations’
Routine load release
Routine sterilizer efficacy monitoring
Sterilizer qualification testing
(after installation, relocation, malfunctions, major repairs, sterilization process failures)
Periodic product quality assurance testing
Nonimplants
Implants
Physical monitoring of cycle.
External and internal chemical indicator monitoring of packages.
Optional monitoring of the load with a process challenge device (PCD) containing one of the following:
a biological indicator (BI),
a BI and a Class 5 integrating indicator,
a BI and an enzyme-only indicator
a Class 5 integrating indicator,
an enzyme-only indicator.
Monitoring of every load with a PCD containing a BI and a Class 5 integrating indicator or a PCD containing a BI and an enzyme-only indicator.
Weekly, preferably daily (or each day the sterilizer is used), monitoring of a full load with a PCD containing a BI (The PCD may also contain a chemical indicator [CI]). In flash sterilization cycles, monitoring is done in an empty chamber.
For dynamic air removal sterilizers, daily Bowie-Dick testing in an empty chamber
For sterilizers larger than 2 cubic feet and for flash sterilization cycles, monitoring of three consecutive cycles in an empty chamber with a PCD containing a BI. (The PCD may also contain a CI.)
For table-top sterilizers, monitoring of three consecutive cycles in a fully loaded chamber with a PCD containing a BI. (The PCD may also contain a CI.)
For dynamic air removal sterilizers, monitoring of three consecutive cycles in a empty chamber with a Bowie-Dick test pack.
Placement of BIs and CIs within product test samples.

37. Professional Organizations
AAMI
JCAHO
AAAHC
CMS
OSHA
ANA
AORN
ACS
SGNA
ASGE
APIC
IAHCSMN
Lots of standard setting organizations

39. Summary
A High Level Summary of Standards related to Sterilization and the instrument reprocessing loop
A detailing of AORN’s Recommended Practices for Sterilization in the Perioperative Practice Setting
A Brief Summary of Aspects of Quality Systems and their application