Current through Register Vol. 39, No. 6, September 16, 2024
(a) Each office of
each electrologist and laser hair practitioner shall be inspected by the Board
or its agent:
(1) prior to initial
licensure;
(2) each time an office
is relocated;
(3) annually after a
license is issued; and
(4) at any
time the Board deems necessary to ensure safety of the public, including in
response to a complaint or inquiry.
(b) Electrologists shall observe the
following safety precautions for the cleaning and sterilization of instruments:
(1) Coordinate sterilized instruments and
supplies needed for each treatment in a manner whereby adherence to aseptic
technique is maintained;
(2) Wear
gloves when handling soiled instruments; and
(3) Avoid puncture injury from
instruments.
(c) As used
in this Rule, instruments and other items include:
(1) Needles that are:
(A) single-use, pre-sterilized, and
disposable;
(B) stored in a manner
that will maintain sterile conditions of contents;
(C) not recapped, bent, or otherwise
manipulated by hand prior to disposal;
(D) placed in a puncture-resistant sharps
container after use, when opened or found damaged, when contaminated before
use, or when not used before pre-printed expiration date; and
(E) disposed of in accordance with State and
local regulations when the sharps container is no more than three quarters
full;
(2) Forceps,
phoresis rollers, and epilator tips that are:
(A) disinfected before initial use and after
use on the client;
(B) disinfected
after a 24-hour period when packaging is opened and instruments are unused or
when packaging is contaminated before use, for example, dropped or placed on a
surface not protected by barriers;
(C) accumulated after use and before cleaning
and sterilization in a covered holding container by submersion in a solution of
a protein-dissolving enzyme detergent and water, following manufacturer's
instruction for dilution, then rinsed and drained; and
(D) cleaned and sterilized in accordance with
the standards in Paragraphs (d) and (e) of this Rule.
(d) Electrologists shall observe
the following standards for cleaning:
(1)
Place items and other instruments in the basket of a covered ultrasonic
cleaning unit containing a fresh solution of a protein-dissolving enzyme
detergent and water;
(2) Follow
manufacturer's instructions for dilution and ultrasonic running
times;
(3) Remove basket from
ultrasonic unit rinse under running water and drain;
(4) Drain and air dry items on a clean,
disposable, absorbent, non-shedding cloth in an area protected from exposure to
contaminants with a hot-air dryer or by placement into a drying
cabinet;
(5) Package forceps,
rollers, and heat-stable tips individually in woven or non-woven wraps, paper
or film pouches, or rigid container systems for the sterilization
process;
(6) Place packaged
instruments and items in an autoclave or dry-heat sterilizer with a chemical
indicator;
(7) If dry-heat
sterilizers are used, subject the heat-sensitive tips to an intermediate-level
disinfectant, after which the tips are rinsed and dried; and
(8) Store instruments and items in a clean
and dry covered container, drawer or closed cabinet after the cleaning
process.
(e)
Electrologists shall observe the following standards for sterilization:
(1) The required minimum time and temperature
relationship for sterilization methods shall be:
(A) for the dry heat method, the minimum
time-temperature relationship required to be attained is 340° F (170°
C) for one hour or 320° F (160° C) for two hours; and
(B) for the autoclave (steam under pressure)
method, the minimum time-temperature-pressure relationship required to be
attained is 15 to 20 minutes at 121°C (250°F) and 15 psi (pounds per
square inch) for unpackaged instruments and items and 30 minutes at 121° C
(250° F) and 15 psi (pounds per square inch) for packaged instruments and
items.
(C) temperature and exposure
requirements in Parts (A) and (B) of this Subparagraph relate to the time of
exposure after attainment of the required temperature and do not include a
penetration of heat-up lag time, drying time, or cool-down time;
(2) Sterilizers shall have visible
physical indicator gauges, for example, thermometers, timers, on the devices
that shall be monitored during the sterilization cycle;
(3) The interior of the sterilization devices
shall be cleaned according to the manufacturer's instructions;
(4) Packaging for sterilization shall:
(A) accommodate the size, shape, and number
of instruments to be sterilized;
(B) be able to withstand the physical
conditions of the selected sterilization process;
(C) allow enough space between items in each
package for the sterilization of all surfaces to occur; and
(D) chemical indicators shall be visible on
the outside of each package sterilized that indicates the instruments and items
have been exposed to a sterilization process.
(5) Manufacturer's recommendations shall be
followed for aseptic removal of contents in the sterilized packages;
(6) Biological monitors shall be used no less
than once a month for each sterilization device according to manufacturer's
instruction in order to ensure that proper mechanical function of the
sterilizer is maintained; and
(7)
Recorded laboratory reports from the biological monitors shall be filed in a
permanent sterility assurance file.
(f) Safety precautions shall be observed for
other treatment related items as follows:
(1)
Indifferent electrodes, epilator cords, and eye shields shall be cleaned,
dried, and subjected to intermediate-level disinfection before initial use and
after each treatment and replaced when showing signs of wear and
tear;
(2) Ultrasonic cleaning units
and all other containers and their removable parts shall be used during soaking
and cleaning procedures, cleaned, dried daily, and used and maintained
according to manufacturer's instructions; and
(3) Environmental surfaces directly related
to treatment shall be cleaned and subjected to low-level disinfection daily and
whenever visibly contaminated.
Authority
G.S.
88A-6(9);
88A-16;
Eff. December
1, 2010;
Amended Eff. September 1, 2015;
Pursuant to
G.S.
150B-21.3A, rule is necessary without
substantive public interest Eff. May 1, 2018;
Recodified from
21 NCAC
19 .0407 Eff. January 1,
2023.