(A) The operator shall keep all tubes, needle bars and other sterilized pieces of equipment in the wrappers or sterilizer bags used during sterilization. The operator shall store these wrapped articles in a clean, closed case or storage cabinet while not in use. The operator shall maintain such case or cabinet in a sanitary manner at all times. The operator shall keep all instruments, tubes, needles, and other items used in tattooing or body piercing procedures free of all contamination and shall not remove the wrappers or sterilizer bags until immediately prior to use.
(B) The individual performing the service shall use all tattoo needles or instruments intended to penetrate the skin only once and dispose of them, or thoroughly clean and sterilize them, after each use. The individual performing the service shall use instruments not intended to penetrate the skin, but which may become contaminated, only once and dispose of them, or thoroughly clean and sterilize them, after each use.
(C) The operator shall place all used, nondisposable instruments in an ultrasonic-type machine to remove excess dye or other matter from the instruments; or the operator shall immerse nondisposable instruments for at least twenty minutes in a disinfectant solution registered with the united states environmental protection agency as a hospital disinfectant before the operator proceeds to scrub the instruments. When this process is completed, the operator shall place the instruments into either a covered container or into a wrapper designed or suitable for steam sterilization. The operator shall daily sanitize the ultrasonic-type unit with a germicidal solution.
(D) The operator shall provide a steam sterilizer (autoclave) for sterilizing all needles and similar instruments before use on any patron. Alternate sterilizing procedures may be used when specifically approved by the board of health. Sterilization of instruments will be accomplished in the autoclave by exposure to steam for at least fifteen minutes at a minimum pressure of fifteen pounds per square inch, temperature of two hundred fifty degrees fahrenheit or one hundred twenty-one degrees celsius.
(E) The operator shall monitor and document the sterilizing function of all sterilizers as follows:
(1) The operator shall use autoclave sterilization bags, with a process indicator which changes color upon proper steam sterilization, during the autoclave sterilization process.
(2) The operator shall monitor each sterilizer load by the use of a sterilization indicator that ensures that minimum conditions exist to achieve sterilization through appropriate levels of:
(a) Pressure of saturated steam;
(b) Temperature of exposure;
(c) Exposure time.
(3) The operator of the sterilizer shall follow the manufacturer's use instructions for the sterilizer and the sterilization indicator being used. Further, the operator shall maintain the sterilizer in serviceable condition and keep a record of any maintenance performed for at least two years.
(4) If the sterilization indicator demonstrates that sterilization has been achieved, the operator may place the contents of the packaged unit in inventory.
(5) If the sterilization indicator demonstrates that sterilization has not been achieved, the operator shall not use the sterilizer further. The operator shall have the sterilizer examined to determine the malfunction and shall have the sterilizer repaired or replaced.
(6) The operator shall maintain a log, for a period of at least two years, of date, time, the name of the person or independent testing entity performing the test and sterilization indicator results for all needles and instruments used. The operator may also keep this record in each client file for all needles and instruments used on that client.
R.C. 119.032 review dates: 03/14/2008 and 03/01/2013
Promulgated Under: 119.03
Statutory Authority: 3730.10
Rule Amplifies: 3730.09
Prior Effective Dates: 4/30/1998