S.C. Code Regs. § § 61-12.VI.602

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

Section 61-12.VI.602 - Sterilization Procedures

A. Adequate space shall be provided for storage, maintenance and distribution of sterile supplies and equipment.

B. Sterile supplies and equipment shall not be mixed with unsterile supplies, and shall be stored in dust-proof and moisture-free units. They shall be properly labeled.

C. Sterilizing equipment of appropriate type shall be available and of adequate capacity to properly sterilize instruments and materials. The sterilizing equipment shall have approved control and safety features.

1. There must be documentation of each load run daily. A biological test of the autoclave shall be run daily and the results maintained on a log.

2. Each separate package of instruments to be sterilized must have internal and external chemical indicators.

3. The accuracy of instrumentation and equipment shall be provided by periodic calibration and/or preventive maintenance as necessary, but not less than annually, and a log maintained.

D. The policies and procedures shall indicate how the shelf life of a packaged sterile item is determined. Methods approved for use are:

1. Date of expiration being marked on the item; or

2. Event-related, i.e., day-to-day expiration, utilizing such wording as, "sterile unless the integrity of the package is compromised."

S.C. Code Regs. § 61-12.VI.602