Needles must be
single use, used on one client, then properly disposed of in an approved sharps
container defined under OAR
(2) All non-sterilized or reusable
instruments that come in direct contact with a client's skin or are exposed to
blood or other potentially infectious materials must be cleaned and sterilized
before use on a client or re-use on another client.
(3) New gloves must be worn during any
cleaning or sterilization procedure.
(4) The cleaning and sterilization process
listed in subsection (5) of this rule is not required if single-use prepackaged
sterilized instruments, obtained from suppliers or manufacturers are used.
Approved cleaning and
sterilization process for non-sterilized or reusable instruments includes the
following ordered method after each use:
Clean instruments by manually brushing or swabbing visible foreign matter and
rinsing the instruments with warm water and an appropriate detergent solution
to remove blood and other potentially infectious materials;
(b) Place instruments in an ultrasonic
cleaner filled with an appropriate ultrasonic solution including but not
limited to an enzymatic cleaner. The ultrasonic unit must be used according to
the manufacturer's instructions. The ultrasonic unit must operate at 40 to 60
kilohertz. The ultrasonic cleaner must remain covered when in use.
Self-contained instrument washers used to decontaminate instruments prior to
sterilization may be used in place of an ultrasonic cleaner and used according
to manufacturer instructions;
Remove instruments from the ultrasonic unit or self-contained instrument
washer. All instruments must be rinsed, air dried, and individually packaged in
sterilization pouches that include use of a color change indicator strip to
assure sufficient temperature during each sterilization cycle. The date the
sterilization was performed must be applied to the sterilization pouch; OR
instruments which are sterilized in an autoclave that do not require packaging
or use of a color change indicator strip must be sterilized after use on a
client, stored in a clean disinfected location and resterilized immediately
before performing a service on a client;
(d) Instruments must be sterilized by using
an autoclave sterilizer, steam, chemical or gas, registered and listed with the
(e) A steam sterilization
integrator must be used to monitor the essential conditions of steam
sterilization for each autoclaved cycle. Results must be recorded in a log book
for each sterilization cycle. Each steam sterilization integrator must indicate
the date the sterilization cycle took place. Steam sterilization integrators
must be kept for a minimum of sixty days; and
(f) After sterilization, the sterilized
instruments must be stored in individually packaged sterilization pouches that
include a color change indicator strip listed under (5)(c) of this rule and in
a dry, disinfected, closed cabinet or other tightly-covered container reserved
for the storage of such instruments.
(6) Use of a biological monitoring system
("spore tests") must be done at least once a month, verified through an
independent laboratory, to assure all microorganisms have been destroyed and
ultrasonic unit listed in subsection (5)(b) of this rule must be used, cleaned,
and maintained in accordance with manufacturer's instructions and a copy of the
manufacturer's recommended procedures for the operation of the ultrasonic unit
must be kept on file at the body art facility.
(8) All sterilization pouches with color
change indicator strips listed in subsection (5)(c) of this rule must contain a
chemical/temperature and/or humidity sensitive tapes, strips or pellets for
monitoring each sterilization cycle.
(9) Sterilization pouches with color change
indicator strips listed in subsection (5)(c) of this rule and steam
sterilization integrators listed in (5)(e) of this rule must be available at
all times for inspection by the Office.
(10) Biological spore test results listed in
subsection (6) of this rule must be immediately available at all times for
inspection by the Office and kept at facility premises for a minimum of two
(11) The autoclave listed in
subsection (5)(d) must be used, cleaned, and maintained in accordance with
manufacturer's instructions and a copy of the manufacturer's recommended
procedures for the operation of the autoclave must be kept on file at the body
(12) The expiration
date for sterilized instruments is one year from the date of sterilization
unless the integrity of the package is compromised.
(13) Sterilized instruments may not be used
if the package integrity has been breached, is wet or stained, or the
expiration date has passed without first meeting the requirements listed in
Subsection (5) of this rule.
All sterilized instruments used in body piercing procedures must remain stored
in sterile packages and in a dry, disinfected, closed cabinet or other
tightly-covered container reserved for the storage of such instruments until
just prior to the performance of a body piercing procedure.
If a biological spore test listed in
subsection (6) of this rule, result is positive, a licensee must discontinue
the use of that sterilizer (autoclave) until it has been serviced and a
negative spore test has been recorded before putting the sterilizer back into
service. Until a negative spore test has been received, the licensee must:
(a) Use an alternative sterilizer
(b) Use only single
a positive spore test has been received, all instruments sterilized prior to
the positive spore test must be repackaged and sterilized pursuant to
subsection (5) of this rule, before use.
(17) Following the receipt of a positive
spore test, the licensee or facility must notify all clients in writing stating
a positive spore test had been received during the time they received their
body piercing procedure. The licensee or facility must provide the client with
the risks of having a body piercing procedure with instruments that may not
have been sterilized pursuant to (5)(c) and (d) of this