(1) All nondisposable instruments used for tattooing or body piercing that can come into contact with blood or body fluids must be individually wrapped and sterilized by an autoclave. All disposable instruments that come into contact with blood or body fluids must come from the supplier individually wrapped and sterile.

(2) All jewelry must be sterilized by one of the following methods:

(a) individually wrapped and autoclaved; or

(b) come from the supplier individually wrapped and sterile.

(3) Whenever an autoclave is used, the following requirements apply:

(a) Autoclave packaging and a testing indicator for verifying temperatures must be used each time the autoclave is used.

(b) The autoclave must be allowed to run a complete cycle for 20 minutes at 15 pounds of pressure at a temperature of 250°F (121°C), or in accordance with the autoclave manufacturer's instructions.

(c) After autoclaving, the package must be dated and initialed by the artist. If the autoclaved instrument or jewelry is not used within six months of the sterilization date, or if the packaging is no longer intact, the article must be rewrapped and resterilized before use.

(d) Monthly biological monitoring must be conducted on the autoclave using standard spore units that are analyzed by a certified laboratory. The results of the monthly spore test must be posted in a conspicuous place.

(e) The department or its designee may require that an operator submit the results of a monthly spore test directly to its office if the establishment fails to perform a monthly spore text or has one or more failed spore tests.

(f) In the event of a failed spore test, the operator must immediately cease use of the autoclave and contact the health authority within one business day.

(g) Following sterilization, equipment, and jewelry must remain in the autoclave packaging.

(4) Sterile packages must be opened in full view of the client.

History: 50-48-103, MCA; IMP, 50-48-103, MCA; NEW, 2007 MAR p. 351, Eff. 3/23/07; AMD, 2013 MAR p. 156, Eff. 2/1/13.