Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter V - MINIMUM STANDARDS FOR LICENSURE OF TATTOO AND CERTAIN BODY PIERCING STUDIOS › Section 229.407 - Sterilization

Current through Reg. 49, No. 28; July 12, 2024
(a) A studio or
				  temporary location is required to utilize instruments that have been prepared
				  as described in §
										229.409(a)-(e)
				   of this title (relating to Tattooing and
				  Body Piercing Instruments and Jewelry). The studio or temporary location shall
				  use sterilization equipment that is approved by the United States Food and Drug
				  Administration for the purpose of sterilization, and adequate in size to
				  accommodate necessary utensils and instruments. A copy of the manufacturer's
				  recommended procedures for operation of the sterilization unit(s) must be
				  available for inspection by an authorized agent at the time of
				  inspection.
(b) Each person
				  responsible for the sterilization of instruments and jewelry shall be able to
				  demonstrate to the department's authorized agent the correct sterilization
				  procedures and the proper operation of autoclave and/or dry heat sterilization
				  equipment.
(c) After each use, the
				  reusable instruments and jewelry shall be cleansed to remove blood and tissue
				  residue before sterilization as described in §
										229.409(n)
				  of this title.
(d) Instruments and
				  jewelry requiring sterilization shall be packed in packages approved for the
				  sterilization unit. Instruments and jewelry shall be packed individually, or as
				  a set provided such set is intended to be used for a single procedure. Each
				  package shall be labeled with the date of sterilization and the initials of the
				  person sterilizing the instruments. Packaged sterilized instruments shall be
				  kept in a sterile condition and stored in a clean dust-tight container when not
				  in use. Instruments and jewelry may be sterilized immediately before tattooing
				  or body piercing without the use of sterilization packages as provided by the
				  sterilization unit's manual. The studio must keep records in accordance with
				  subsection (g) of this section.
(e)
				  Each package of instruments and jewelry sterilized shall be monitored for
				  sterilization by the use of chemical/heat sensitive indicators.
(f) Each sterilization unit used by the
				  studio to sterilize instruments and jewelry must have a spore test performed
				  each calendar month by an approved laboratory, and the test results be made
				  available for inspection.
(g) Each
				  studio or temporary location shall maintain sterilization records. The
				  information shall be permanently recorded and made available for examination by
				  an authorized agent in the studio for at least two years from the date of the
				  last entry. These permanent records shall be maintained at the studio and shall
				  include the following:
(1) date of
				  sterilization;
(2) quantity and
				  type of instruments to be sterilized; and
(3) name or initials of the individual
				  sterilizing the instruments.