D. Packaging

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Instruments should be wrapped or placed into pouches designed for instrument sterilization prior to sterilizing to prevent re-contamination once they have been sterilized.

The following guidelines must be followed throughout the preparation & packaging process:

All proper PPE shall be worn, including HDUG, during this process.

Heat-resistant critical or semi-critical instruments

  1. Must be packaged in new pouches (never reuse sterile pouches) or wrapped before sterilization.
  2. A single layer of instruments shall be placed in each sterilization pouch, never overloading the package.
  3. Each package or wrapped cassette of instruments shall be labeled with the date of sterilization and the specific sterilizer used if more than one sterilizer is utilized in the facility.
  4. Each package (cassette or pouch) must have a heat indicator or indicator tape on it:
    1. This heat indicator changes color when one of three things happen to the pouch or cassette:
      • The pouch or cassette has come into contact with steam or chemical vapor
      • The pouch or cassette has been subjected to heat for a certain length of time
      • The pouch or cassette has been exposed to a certain amount of pressure
    2. The color change does not prove the instruments inside the package are sterile
  5. Each pouch or wrapped cassette must be sealed properly to maintain sterility: folded properly at the perforated line with no gaps or openings, or taped cassettes with proper tape and seal methods.
  6. These pouches and wrapped cassettes shall be labeled with the date of sterilization and the specific sterilizer used if more than one sterilizer is utilized in the facility.
  7. Once the sterilization process is complete, these pouches and wrapped cassettes shall remain sealed in their pouches or wrapped cassette and stored in a manner so as to prevent contamination (in a closed cabinet or drawer). 

Heat-sensitive critical or semi-critical instruments

  1. Process with high-level disinfection
  2. Packaged or wrapped upon completion of the disinfection process.
  3. These instruments, items, and devices, shall remain sealed and stored in a manner so as to prevent contamination, and shall be labeled with the date of sterilization and the specific sterilizer used if more than one sterilizer is utilized in the facility.