E. Sterilization

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The next step is the process of sterilization. This is the process that destroys all microorganisms including viruses, bacteria, fungi and spores. Items are either sterile or they are not. All reusable items that come in contact with patient blood, mucous membranes, or saliva must be heat-sterilized either through steam, chemical vapor, or dry heat.

Any of the following methods will meet the requirements for sterilization.

  1. Steam: Sterilizing instruments using steam under pressure. The equipment used in steam sterilization is the autoclave or Statim.
  2. Chemical Vapor: In chemical vapor sterilization, instruments are exposed to chemical vapors including alcohol, formaldehyde, ketone, and acetone. Formaldehyde is considered a carcinogen = can possibly cause cancer.
  3. Dry Heat: Dry heat is the process of heating air at high temperatures approximately 375 degrees and transferring that air to the contaminated instruments, for a certain length of time.
  1. All instruments that have been precleaned, inspected, dried, and placed in pouches or wrapped in FDA approved wrapped, may now be placed in the sterilizer.
  2. Never overload the sterilizer unit.
  3. Place a single layer of instruments on each tray.
  4. Pay attention to the manufacturer’s “instructions for use” when placing pouches in the sterilizer (paper side up or paper side down).
  5. Be certain the sterilizing unit is turned on, water levels are appropriate (if applicable), and is working properly.
  6. Run the proper sterilization time according to the IFUs.
  7. All proper PPE including HDUG shall be worn during this process.

Spore testing is the method used to check correct functioning of sterilization equipment and cycles. Spore testing should be verified for each sterilizer by the periodic use (at least weekly).

  1. Biological Indicators (BIs) (i.e., spore tests) are the most accepted method for monitoring the sterilization process because they assess it directly by killing known highly resistant microorganisms
  2. Spore testing products are placed in the sterilizing unit and processed along with a normal load of instruments.
  3. Should the spore test fail:
    1. The spore test should be repeated immediately after correctly loading the sterilizer and using the same cycle that produced the failure.
    2. Sterilizer operating procedures should be reviewed, including packaging, loading, and spore testing, with all persons who work with the sterilizer to determine whether operator error.
    3. If there was no human error the sterilizer should remain out of service until it has been inspected, repaired, or replaced.