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
Notes
Ohio Admin. Code
3701-9-08
Effective:
9/1/2014
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
