interfere with the effectiveness of STERILIZATION. Cleaning is accomplished using water with detergents or enzymatic products (CDC, 2019a). BODY ARTISTS must use enzymatic detergents in accordance with the manufacturer’s instructions, including proper dilution of the detergent and contact with equipment for the amount of time specified on the label (CDC, 2019a). Chemical indicators are control tools used to test and monitor the STERILIZATION capabilities of AUTOCLAVES and steam sterilizers (Dubrey, 2020). ISO standards define six types of chemical indicators: Type 1: Process Indicators; Type 2: Specific-Use Indicators; Type 3: Single-Variable Indicators; Type 4: Multivariable Indicators; Type 5: Integrating Indicators; and Type 6: Emulating Indicators. ISO 11140-1:2014 contains specific STERILIZATION manufacturing and application standards to which each type of chemical indicators must adhere. The use of chemical indicators is not a substitute for biological monitoring or spore testing. 8.7 If the BODY ART ESTABLISHMENT is using only SINGLE-USE, disposable INSTRUMENTS that are not to be reprocessed, an AUTOCLAVE, ULTRASONIC, and STERILIZATION ROOM or STERILIZATION AREA are not required. If a BODY ART ESTABLISHMENT, however, is sterilizing clean, unused INSTRUMENTS and/or JEWELRY, the ESTABLISHMENT shall have an AUTOCLAVE, but a separate STERILIZATION ROOM might not be necessary. 8.8 STERILIZED INSTRUMENTS must be stored in a cabinet, drawer, or tightly covered container that prevents exposure to dust, moisture, and any other source of CONTAMINATION and is dedicated for storing STERILIZED INSTRUMENTS. The CYCLE NUMBER must be recorded on the packaging or indicator/integrator strip and correspond to the sterilization log. Clean INSTRUMENTS to be STERILIZED immediately prior to a PROCEDURE must be stored in an area where they can remain clean to prevent exposure to dust, moisture, and any other source of CONTAMINATION. 8.9 STERILE EQUIPMENT and INSTRUMENT packaging should be inspected prior to use. If packaging is compromised or the expiration date has passed, the INSTRUMENTS are no longer considered STERILE and must go through the cleaning and STERILIZATION processes discussed in Section 8.6 or be disposed of in the appropriate waste receptacle. Pre-sterilized equipment or tools not intended or manufactured for single use with compromised packaging may be reprocessed if the physical properties of an item provides it the ability to withstand the sterilization process without being compromised or degraded. 8.10 In addition to chemical monitoring, biological monitoring must be done to verify STERILITY. According to CDC (2018a), BIOLOGICAL INDICATORS (spore tests) are the most accepted means of monitoring STERILIZATION. Spore tests must be done at least weekly. Spore test records must be retained for 3 years in compliance with Section 6 of this Code. 8.11 A BODY ART ESTABLISHMENT’S procedure for responding to a positive spore test should be included in its Exposure Control Plan. A single positive spore test does not necessarily indicate that the STERILIZATION procedure or sterilizer is defective. Single positive spore tests can
23
Powered by FlippingBook