1. (a) Instrument cleaning and sterilization.

   1. (1) Clean and heat-sterilize critical and semi-critical instruments and items before each use using only Food and Drug Administration-cleared medical devices for sterilization, and follow the manufacturer’s instructions for correct use.
   2. (2) Clean all visible debris from instruments and items before sterilization or disinfection using an automated cleaning process such as an ultrasonic cleaner or washer-disinfector.
   3. (3) Wear puncture-resistant and chemical-resistant/heavy duty utility gloves for instrument cleaning and decontamination procedures.
   4. (4) Wear appropriate PPE when splashing or spraying is anticipated during cleaning (i.e., mask, eye protection, or face shield).
   5. (5) Single-use disposable instruments are acceptable alternatives if they are used only once and disposed of correctly.
   6. (6) Ensure that noncritical patient-care items are barrier protected or cleaned and disinfected after each use with an Environmental Protection Agency-registered hospital disinfectant.

2. (b) Packaging of instruments.

   1. (1) Instruments should be sterilized inside packages with color-change markings or chemical indicator tape attached that verify that:

      1. (A) The package has been exposed to the sterilization process; and
      2. (B) Required parameters of time, temperature, and the presence of steam has been achieved.

   2. (2) Critical and semi-critical instruments intended for immediate reuse can be heat sterilized unwrapped if:

      1. (A) A chemical indicator such as autoclave tape is used for each cycle; and
      2. (B) The instruments are transported immediately and aseptically to the point of use.
   3. (3) Do not sterilize implantable devices unwrapped.

3. (c) Sterilization monitoring.

   1. (1)

      1. (A) Monitor each load with mechanical (e.g., time, temperature, and pressure) and chemical indicators.
      2. (B) Color-change markings on bags or autoclave tape are acceptable indicators.
   2. (2) Do not use instrument packs if mechanical or chemical indicators indicate inadequate processing.
   3. (3) Monitor sterilizers at least monthly by using a biological indicator (spore test) with a matching control.

   4. (4)

      1. (A) In case of a positive spore test, remove the sterilizer from service and retest.
      2. (B) If the repeat spore test is negative put the sterilizer back in service.
      3. (C) If the repeated spore test is positive:

4. (i) Remove the sterilizer from use until it has been inspected or repaired; and

   1. (ii) Recall and reprocess all items processed since the last negative test.

   2. (5) Maintain sterilization records or biological spore testing for three (3) years.

      1. (d) Storing sterile items.

   3. (1)

      1. (A) Place the date of sterilization and, if multiple sterilizers are used in the facility, the sterilizer used on the outside of the packaging material.
      2. (B) This will be critical in case of a failed spore test.
   4. (2) Reclean, repack, and resterilize any instrument package that has been compromised (torn, punctured, etc.).
   5. (3) Do not store sterile instruments where the packages might be contaminated by contact with nonsterile instruments or packages.
   6. (4) Do not store critical or semicritical instruments unwrapped.

Codification Notes: "PPE" means personal protective equipment.