6 CCR 1010-22-8 - INSTRUMENTS/STERILIZATION

8-801 Instrument Cleaning

(a) All instruments that penetrate body tissue shall be properly cleaned prior to packaging and sterilization. All other instruments shall be cleaned and disinfected after each use.

(b) All instruments placed in the procedure area shall be repackaged and re sterilized.

(c) Employees shall wear heavy-duty, multi-use, and waterproof gloves while cleaning instruments.

(d) Used instruments shall be soaked in a disinfectant until cleaning can be performed. The solution shall be changed in a time as recommended by the solution manufacturer.

(e) Instruments shall be disassembled for cleaning.

(f) All instrument components shall be cleaned, either manually or in an ultrasonic cleaner, using the appropriate cleaning agent specific to the type of cleaning performed.

8-802 Instrument packaging/wrapping

(a) Employees shall wear clean gloves while packaging/wrapping instruments.

(b) Instruments shall be wrapped or packaged with a sterilizer indicator on or in each package.

(c) All packages shall be labeled with the time and date of sterilization. Packages will no longer be considered sterile six months after the date of sterilization.

8-803 Instrument Sterilization

(a) The sterilizer shall be designed and labeled as a medical instrument sterilizer.

(b) The operators' manual for the sterilizer shall be available on the premise and the sterilizer shall be operated according to manufacturer's recommendations.

(c) The sterilizer shall be cleaned and maintained according to manufacturer's specifications.

(d) A sterilizer load log shall be maintained for a minimum of three years at the facility and made available for inspection. The log shall contain the following documentation for each load:

1. Description of instruments contained in the load;

2. Date of sterilization load, and time or other unique identifier if more than one load is processed during a single day;

3. Sterilizer cycle time and temperature;

4. Indication of proper sterilization of instruments, as evidenced by the appropriate color indicator change on each package. Indicator used shall be compatible with the sterilization process being used; and

5. Action taken when appropriate color indicator change did not occur.

(e) Sterilizer Monitoring

1. Sterilizer monitoring shall be performed at least monthly (unless more frequent monitoring is specified by the manufacturer) by using a commercial biological monitoring (spore) system.

2. All biological indicators shall be analyzed by a laboratory independent from the establishment.

3. Biological indicator test results shall be maintained on the premises for a minimum of three (3) years and must be available for inspection at all times.

8-804 Instrument Storage

(a) Hands shall be washed prior to handling sterilized instrument packs.

(b) After sterilization, the instruments shall be stored in a dry, clean area reserved for storage of sterile instruments.

8-805 Single Use Items

(a) Single use items shall not be used on more than one client and shall be disposed of after the procedure.

(b) Contaminated single use needles, razors and other sharps shall be disposed of immediately in approved sharps containers.

Notes

6 CCR 1010-22-8