3701-9-08 [Effective 9/1/2014] Sterilization and disinfection procedures for body art services.

The operator shall ensure that the business and all body artists comply with the following:

(A) All non-disposable instruments or equipment used for body art procedures shall be thoroughly cleaned and sterilized after each use on any patron in the following manner:

(1) Soaked in an enzymatic pre-cleaner to remove all gross debris;

(2) Rinsed and patted dry;

(3) Disassembled or placed in the open position, if hinged;

(4) Visually inspected to verify that they are clean and to identify any damage including, but not limited to, bends, cracks or pits, that would impair the sterilization process;

(5) Thoroughly cleaned in tepid water and an appropriate detergent capable of breaking down blood, ink, dyes, pigments and other contaminants;

(6) Fully submerged in a disinfectant to ensure contact with all surfaces for the amount of time specified in the manufacturer's instructions;

(7) Rinsed and patted dry;

(8) Placed in an ultrasonic cleaning unit filled with an appropriate solution specified in the manufacturer's instructions.

(9) Rinsed and air dried;

(10) Individually packed in sterilization pouches. Each pouch or its indicator shall be labeled with the date of processing;

(11) Sterilized in a steam sterilizer.

All ultrasonic cleaning units, and steam sterilizers shall be used, cleaned and maintained in accordance with the manufacturer's current instructions. The sterilizer shall be maintained in proper working condition and records of any maintenance performed shall be kept for at least two years.

Alternate sterilizing procedures may be used when specifically approved by the board of health.

(B) Monitoring the function of all sterilizers in accordance with the following:

(1) Sterilization pouches that have a process indicator which changes color upon proper steam sterilization;

(2) A sterilization integrator placed in each load or a digital printout from the sterilizer of each load in accordance with the manufacturer's recommendations, indicating that minimum conditions existed; and

(3) A biological indicator test that is taken and submitted to a lab for analysis on a weekly basis.

(C) Documentation that the sterilization indicators, integrators and biological indicator tests were performed shall be maintained and shall include, but is not limited to:

(1) Date and time the sterilizer load was run or the biological test was performed;

(2) The name of the person who ran the sterilization load or performed the test;

(3) Results of the sterilization integrator or digital printout; and

(4) A copy of the report that a biological indicator test was conducted by an independent laboratory.

All documentation records shall be maintained and readily available for each test performed for at least two years. This documentation may also be kept in each patron's file for all needles and instruments used on that patron.

(D) As of the effective date of this rule, all steam sterilizers in new body art establishments or replacement steam sterilizers in existing body art establishments, shall be designed to sterilize hollow instruments and shall be equipped with a mechanical drying cycle.

(E) When any wetness or moisture remains on or within the sterilization pouch, or if the sterilizer has malfunctioned, the instruments or equipment shall be considered contaminated and shall be re-packaged and re-sterilized in a functioning sterilizer prior to use.

(F) When the process indicator in the pouches and sterilization integrators or digital printout demonstrate that sterilization has been achieved, the sterilized instruments and equipment shall remain in the pouches and be placed into inventory until use.

(G) When the process indicator in the pouches and/or the sterilization integrator or digital printout demonstrate that sterilization has not been achieved, the sterilizer shall not be used until it is examined to determine the malfunction and repaired or replaced.

(H) After sterilization, all equipment and instruments used for body art shall remain in the sterilization pouch, handled with newly gloved hands and stored in a clean, dry, closed cabinet, drawer, or other container reserved for such instruments or equipment. Sterilized instruments or equipment shall not be used until reprocessed if the integrity of the pouch has been compromised, is wet or stained, or is otherwise contaminated.

(I) The expiration date for sterilized equipment or instruments is one year from the date of sterilization unless the integrity of the sterilization pouch is compromised.

Replaces: 3701-9-08

Effective: 09/01/2014
R.C. 119.032 review dates: 09/01/2019
Promulgated Under: 119.03
Statutory Authority: 3730.10
Rule Amplifies: 3730.09
Prior Effective Dates: 4/30/1998