Authority: IC 16-19-3-4

Affected: IC 16-19-3

Sec. 34. (a) Heating procedures capable of sterilization must be used when heat stable, nondisposable equipment is sterilized.

(b) Equipment that is to be sterilized shall be put in single-use packaging.

(c) Records must be maintained to document the following:

1. (1) Duration of sterilization technique.
2. (2) Determination of effective sterility, such as use of a biological indicator, is performed monthly.
3. (3) Equipment is maintained as recommended by the owner's manual, and proof is available that the owner's manual recommendations are reviewed monthly.

(d) Reusable contaminated equipment shall not be stored or processed in a manner that requires any person to reach by hand into the containers where these sharp items have been placed.

(e) Reusable contaminated equipment shall be:

1. (1) placed in puncture-resistant containers;
2. (2) labeled with the biohazard symbol;
3. (3) leakproof on both sides and bottom; and
4. (4) stored in a manner that does not require reaching by hand into the container where the equipment is stored until cleaning prior to sterilization.

(f) Reusable contaminated equipment shall be effectively cleaned prior to sterilization or disinfection.

(g) Any reusable contaminated equipment that comes into direct contact, or is likely to come into direct contact, with an instrument that penetrates the skin other than a piercing gun shall be effectively cleaned and sterilized prior to use.

(h) All sterilized equipment shall not be removed from wrappers or sterilizer packaging until immediately prior to use.

(i) Any reusable equipment that comes into contact with mucus [sic., mucous] membranes shall be effectively cleaned and sterilized prior to use.

(j) Piercing guns shall be cleaned and undergo, at a minimum, high level disinfection after each use and whenever visibly contaminated.

(k) All reusable equipment that has contact with intact skin shall undergo, at a minimum, intermediate level disinfection.

(l) All other equipment used during the tattooing or body piercing procedure shall be single use, including corks.

(m) All body piercers and tattoo artists shall comply with all other equipment manufacturer's recommendations.

(Indiana Department of Health; 410 IAC 1-5-34; filed May 12, 1998, 10:00 a.m.: 21 IR 3819; filed Jun 30, 2000, 4:10 p.m.: 23 IR 2713; readopted filed Jul 21, 2004, 5:00 p.m.: 27 IR 4140; readopted filed Jul 15, 2010, 12:12 p.m.: 20100728-IR-410100261RFA; readopted filed Nov 10, 2016, 8:45 a.m.: 20161207-IR-410160371RFA; readopted filed Sep 15, 2022, 10:01 a.m.: 20221012-IR- 410220206RFA)