In this chapter, the following terms have the meanings indicated. Terms Defined. Critical Items. “Critical items” means the instruments or objects that come in direct contact with the bloodstream or other normally sterile areas of the body. “Critical items” includes tweezers and needles. “Transfer forceps” means a medical tool that is used for grasping or holding things. Each electrologist office and institution teaching the clinical practice of electrology shall maintain and use sterilization equipment adequate in size to accommodate critical items, transfer forceps, and soaking receptacles. Except as provided in §C of this regulation, critical items, transfer forceps, and soaking receptacles that are dropped on the floor or otherwise contaminated may not be used until sterilized. All needles used in an electrologist office and institution teaching the clinical practice of electrology shall be purchased as pre-sterilized and disposable for one-time use only. The sterilization procedure outlined in Regulation .04 of this chapter is not applicable to needles. If a needle is dropped on the floor or otherwise contaminated, the needle shall be properly disposed of and may not be used. Prior to sterilization as required in Regulation .03 of this chapter, tweezers and needle caps shall be: Mechanically precleaned as follows: Cleansed with a clean cotton ball or swab moistened with a low-residue detergent and cool water; Accumulated in a holding container by submersion in a low-residue detergent and cool water; and Then, thoroughly rinsed with warm water and drained; Then, cleaned by soaking in a protein-dissolving detergent enzyme cleaner or in an ultrasound cleaning unit according to manufacturer's instructions; and Rinsed and dried. Except as provided in Regulation .02C of this chapter, critical items, transfer forceps, and soaking receptacles shall be placed on a steel tray or rack in the center of an autoclave or heat sterilizer, separating instruments and keeping them away from the walls of the unit, and shall be sterilized according to manufacturer specifications or by: Autoclave at the temperatures listed for the following minimum time periods after completing a heat-up period: 15—20 minutes at 121°C (250°F), 15 psi (pounds per square inch) for unpackaged instruments; and 30 minutes at 121°C (250°F), 15 psi (pounds per square inch) for packaged instruments; or Dry heat, at the temperatures listed for the following minimum time periods after completing a heat-up period: 170°C (340°F) for 1 hour; and 160°C (320°F) for 2 hours. Sterile critical items, transfer forceps, and soaking receptacles shall be stored in sterile covered containers until used. Transfer forceps and holding containers shall be cleaned and sterilized daily or more frequently if visibly contaminated. Unused instruments in containers and containers that have been opened shall be resterilized after a 24-hour period. Dry heat ovens and autoclaves shall be of a type registered with the federal Food and Drug Administration (FDA) and shall be cleaned, used, and maintained according to manufacturers' instructions. Sterilizers shall have visible temperature and time indicators. Chemical indicators using color change materials shall be used on or in each package to assure that each package or container has been processed through the sterilization cycle. Biological indicators shall be used no less than once a month according to manufacturers’ instructions to assure that the sterilizer is functioning properly. Health Occupations Article, §§8-205 and 8-6B-01—8-6B-29, Annotated Code of Maryland Effective date: January 16, 1984 (11:1 Md. R. 45) Regulation .01 amended effective August 5, 1991 (18:15 Md. R. 1727) Regulation .01, Requirements for Instructor's License, repealed and new Regulations .01—.03 adopted under new chapter, Sterilization Procedures, effective June 20, 2005 (32:12 Md. R. 1047) Chapter revised effective August 5, 2024 (51:15 Md. R. 710) Regulation.04A amended effective September 15, 2025 (52:18 Md. R. 923)