S.C. Code Regs. § § 61-108.1400.1403

Current through Register Vol. 48, 12, December 27, 2024

Section 61-108.1400.1403 - Sterilization (If applicable) (I)

A. If applicable, sterilizing equipment of the appropriate type shall be available and of adequate capacity to properly sterilize instruments and treatment/procedure room materials as well as laboratory equipment and supplies. The sterilizing equipment shall have approved control and safety features. The accuracy of instrumentation and equipment shall be tested at least quarterly; periodic calibration and/or preventive maintenance shall be provided as necessary and a history of testing and service maintained.

B. The dates of sterilization and expiration shall be marked on all supplies sterilized or licensees may utilize "event-related" methodologies for determining sterile integrity in lieu of "time-related" methods provided there is an established policy and procedure.

C. Provisions shall be made for appropriate storage and distribution of sterile supplies and equipment pursuant to policies and procedures.

D. Cleaning and disinfection, as needed, of equipment used and/or maintained in each area, appropriate to the area and the equipment's purpose or use, shall be accomplished. A method of monitoring disinfectant performance shall be employed. Disinfectants, e.g., glutraldehyde, Cidex, Sporox, hydrogen peroxide, shall be tested and maintained according to manufacturer's instructions and shall include, at a minimum, a record of readings/testings and change dates of the disinfectant solution. Disinfectants must bear the U.S. Environmental Protection Agency (EPA) registration number and be approved by EPA or FDA for the particular use.

S.C. Code Regs. § 61-108.1400.1403

Added by State Register Volume 28, Issue No. 5, eff May 28, 2004.