331-910-0075 Sterilization Standards for Electrology (1) Needles (filaments) must be single use, used on one client, then properly disposed of in an approved sharps container defined under OAR 331-910-0000. (2) All non-sterilized instruments or reusable instruments that come in blood or potentially infectious materials must be cleaned, disinfected 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, disinfection 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, disinfection and sterilization process for non-sterilized instruments or reusable instruments includes the following ordered method after each use: (a) Clean non-sterilized instruments or reusable instruments by manually brushing or swabbing visible foreign matter and rinsing the instruments with warm water and an appropriate detergent solution to remove blood or potentially infectious materials. (b) Clean non-sterilized instruments or reusable instruments must be rinsed and placed in either: (A) An ultrasonic unit that operates at 40 to 60 hertz which is filled with an appropriate ultrasonic solution including but not limited to an enzymatic cleaner. The ultrasonic cleaner must remain covered when in use; Self-contained equipment used to decontaminate instruments prior to sterilization may be used in place of an ultrasonic cleaner and used according to manufacturer instructions. OR (B) Rinsed, patted dry and submerged and soaked in a protein dissolving detergent or enzyme cleaner, followed by a thorough rinse. (c) Disinfect non-sterilized instruments or reusable instruments by immersing instruments in a high level disinfectant. Instruments must be fully submerged to ensure contact with all surfaces for an amount of time specified in the manufacturer’s instructions. If the electrologist is using an autoclave listed in subsection (e) of this rule the electrologist is not required to immerse instruments in a high level disinfectant. (d) Remove non-sterilized instruments or reusable instruments from the ultrasonic unit or self-contained instrument washer or high level disinfectant. All instruments must be rinsed, air dried, and individually packaged in sterilization pouches that include use of a chemical indicator strip to assure sufficient temperature during each sterilization cycle or other method is used to determine sterilization has been reached. The date the sterilization was performed must be applied to the sterilization pouch; (e) Individually packaged non-sterilized instruments or reusable instruments must be sterilized by using autoclave sterilizer (steam or chemical), or dry heat sterilizer registered and listed with the FDA; (f) After sterilization, the sterilized instruments must be stored 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 sterilization achieved. (7) All sterilization pouches listed in Subsection (5)(d) of this rule must contain a color indicator strip which measures temperature control and general functioning of the equipment. (8) The ultrasonic unit or other self-contained equipment listed in subsection (5)(c) 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. (9) The autoclave sterilizer (steam or chemical), or dry heat sterilizer listed in Subsection (5)(e) 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 autoclave sterilizer (steam or chemical), or dry heat sterilizer must be kept on file at the facility. (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. Biological spore test results must be on laboratory letterhead and must contain the test date, and the name, model and serial number (if applicable) of the sterilizer tested. (11) The expiration date for sterilized instruments is one year from the date of sterilization unless the integrity of the package is compromised. (12) 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. (13) All sterilized instruments used during electrology services 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 an electrology procedure. (14) If a biological spore test listed in subsection (6) of this rule, result is positive, a licensee must discontinue the use of that autoclave sterilizer (steam or chemical), or dry heat sterilizer until it has been serviced and a negative spore test has been recorded before putting that sterilizer back into service. Until a negative spore test has been received, the licensee must: (a) Use an alternative autoclave sterilizer (steam or chemical), or dry heat sterilizer; (b) Use only sterilized instruments that have a sterilization date before the date the last negative spore test was recorded; or (c) Use only single use instruments. (15) Following a positive biological spore test reusable instruments which were sterilized following the receipt of the positive spore test must be repackaged and sterilized pursuant to Subsection (5) of this rule, before use. (16) Following a positive spore test the licensee or facility must contact all clients in writing who may have received services prior to receiving the negative spore test results. Statutory/Other Authority: 676.615, 690.350, 690.390, 690.405, 676.618 & 676.568 Statutes/Other Implemented: 690.350, 690.390 & 690.405 History: HLO 1-2023, amend filed 04/06/2023, effective 04/15/2023 HLO 1-2017, f. & cert. ef. 1-6-17 HLA 10-2012, f. & cert. ef. 6-25-12 HLA 2-2012(Temp), f. & cert. ef. 3-1-12 thru 6-25-12