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4.1 Public areas

The entire premises of the establishment must be kept clean, sanitary and in good physical condition at all times.

4.2 Cleaning and sanitizing

4.2.1 All tattooing areas, body art work stations, rooms, and articles used on a patron, other than those items requiring full sterilization, must be sanitized before use by a disinfectant or other method approved by the Health Authority.

4.2.2 The tattoo machine parts, excluding the electrical components and interior motor casing, used in administering the tattoo shall be cleaned thoroughly after each use by scrubbing with a soap solution containing a biocide and hot water.

4.3 Sterilization

4.3.1 Sterilizers must be kept clean, in good working order and must be operated in a clean area.

4.3.2 After cleaning, all instruments used in the tattoo procedure shall be packaged individually in paper peel-packs, heat-sealed plastic, or other autoclave packaging approved by the Health Authority, then sterilized by a steam, chemical, or dry heat sterilizer registered and listed with the FDA or equivalent foreign governmental agency that is used, cleaned, and maintained according to the manufacturer’s instructions. Such packages must contain a temperature strip or sterilizer indicator listed with the FDA.

4.3.3 All packs must be marked with the date of sterilization. A colorimetric sterilizer indicator or internal temperature indicator must be used. Equipment packed in peel-packs or heat-sealed plastic and sterilized in house will be considered sterile for a maximum of six (6) months. Commercially available single use ethylene oxide or gamma radiation sterilized equipment may be used as long as all of the manufacturer’s recommendations and expiration dates are followed.

4.3.4 All equipment used in the tattoo procedure must remain stored in sterile packages until just prior to performing a procedure. When equipment is assembled, the tattoo operator shall wear gloves and use great care to ensure that equipment is not contaminated.

4.3.5 Sterilizers are not required in tattoo establishments that exclusively use prepackaged, single-use, sterilized equipment and supplies. The owner or responsible person must submit a signed disclaimer to the Health Authority for review stating that only presterilized equipment will be used in tattoo procedures.

4.3.6 Single-use, prepackaged, sterilized equipment and supplies must obtained from reputable suppliers or manufacturers.

4.3.7 Single-use items shall not be reused for any reason.

4.3.8 If the tattoo establishment operator brings any reusable items or equipment into the tattoo establishment, the Health Authority shall be notified of this action immediately.

4.3.8.1 A properly spore tested sterilizer will need to be provided immediately.

4.3.8.2 The sterilizer shall not be used until approved by the Health Authority, following review of the spore test laboratory report described in Section 4.4.3.4. Until the Health Authority approves the sterilizer, the tattoo establishment must continue to use prepackaged, single-use, sterilized equipment and supplies.

4.4 Sterilizer testing

This Section shall not apply to tattoo establishments that exclusively use prepackaged, single-use, sterilized equipment and supplies.

4.4.1 Each responsible person shall demonstrate that the sterilizer(s) used at the tattoo establishment are capable of attaining proper heat and pressure and are operating correctly through testing, by the means specified below:

4.4.2 Thermal and/or chemical indicator strips consistent with the type of sterilization process used, to ensure sufficient temperature and proper functioning of equipment during the sterilization cycle, are required on all packaged instruments during each sterilization; and

4.4.3 A spore destruction test every 12 months or more often if recommended by the manufacturer. This spore destruction test must consist of the following criteria:

4.4.3.1 A biological monitoring system (commercial preparation of spores consisting of a known quantity of Geobacillus [Bacillus] stearothermophilius spores produced without contamination and provided by an approved supplier) to ensure all microorganisms have been destroyed and sterilization has been achieved.

4.4.3.2 This test shall be verified through an independent approved laboratory which is capable of accurately analyzing the spore test.

4.4.3.3 Approved independent clinical laboratories will concurrently run quality control samples to ensure an accurate assessment of the spore sample. Therefore, an unsterilized sample from the same lot must be submitted with the processed sample to perform the quality control tests.

4.4.3.4 Records of the spore destruction test results shall be maintained at all times on site at the tattoo establishment. These records shall be made readily available for inspection during normal operating hours. Records shall contain at least the following information:

4.4.3.4.1 Name, address, and phone number of the tattoo establishment submitting the spore sample for testing.

4.4.3.4.2 Name, address, phone number, and certification number(s) for the approved independent clinical laboratory performing the spore test and quality control test.

4.4.3.4.3 Name, address, and phone number of the manufacturer of the spore preparation used in the spore test.

4.4.3.4.4 The brand name of the spore preparation and its lot number and expiration date.

4.4.3.4.5 The date and time the spore test was conducted at the tattoo establishment. Include both start and stop times of the spore test.

4.4.3.4.6 The date and start and stop times the spore sample and quality control sample were processed by the laboratory.

4.4.3.4.7 The date the information from the spore test was reported back to the tattoo establishment.

4.4.3.4.8 The results of the spore test and quality control test if requested by SNHD.

4.4.4 The Health Permit shall not be issued or renewed until documentation of the sterilizer’s ability to destroy spores is reviewed on-site at the time of inspection by the Health Authority.

4.4.5 The following actions may result in suspension or revocation of the tattoo establishment’s Health Permit:

4.4.5.1 Laboratory results that indicate the sterilizer failed the spore test.

4.4.5.2 Continuing to operate with the knowledge that the sterilizer failed the spore test.

4.4.5.3 Failure to comply with the requirements for spore testing specifically outlined in this section of these Regulations.

4.5 Dyes and pigments

All dyes and pigments used in tattoo procedures must be obtained from a reputable manufacturer. The pigments and dyes must be designated specifically for use in tattooing and must be used without adulteration or dilution (except when using sterile, distilled water) of the original formula. Repackaging quantities of dyes and pigments is prohibited.

4.6 Materials used in tattoo preparation and application

4.6.1 Materials such as mimeograph paper, markers, alcohol, lubricants, razors, etc. used in preparation for the application of a tattoo must be kept clean and in good condition.

4.6.2 All materials which are designed for multiple use (e.g., markers) shall only be applied directly to clean, unbroken skin. If such materials come into contact with blood or bodily fluids, they cannot be reused and must be immediately discarded.