331-915-0080 Approved Sterilization Standards for Tattooing (1) Needles must be single use, used on one client, then properly disposed of in an approved sharps container defined under OAR 331-915-0000. (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 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. (5) Approved cleaning and sterilization process for nonsterilized or reusable instruments includes the following ordered method after each use: (a) 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. A 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. (b) Remove instruments from the ultrasonic unit or a self-contained instrument washer. 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; (c) 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 that 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 FDA; (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. The date the sterilization was performed must be applied to the sterilization pouch while being stored. (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 sterilization achieved. (7) The ultrasonic unit listed in subsection (5)(a) 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 years. (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 art facility. (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 exceeded without first meeting the requirements listed in subsection (5) of this rule. (14) All sterilized instruments used in tattooing 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 tattooing procedure. (15) 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 (autoclave); or (b) Use only single-use instruments. (16) If 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 tattoo procedure. The licensee or facility must provide the client with the risks of having a tattoo procedure done with instruments that may not have been sterilized pursuant to (5)(c) and (d) of this rule. Statutory/Other Authority: 690.390 & 690.405 Statutes/Other Implemented: 676.615, 690.390 & 690.405 History: HLO 1-2018, amend filed 01/04/2018, effective 01/04/2018 HLO 1-2017, f. & cert. ef. 1-6-17 HLA 1-2013, f. & cert. ef. 1-16-13 HLA 10-2012, f. & cert. ef. 6-25-12