(1) To prevent clients from being exposed to diseases through needles or other instruments, licensees must:

(a) Use single-use, presterilized disposable needles on one client and then dispose of the needle immediately in a sharps container. Reusable needles must not be used.

(b) Use single-use sharps on only one client and dispose of the items immediately in a sharps container.

(c) Reuse only cleaned and sterilized instruments that are intended for multiple use between clients. A distinct, separate area must be used for cleaning instruments, wrapping/packaging the items and for handling and storing sterilized instruments. Prior to sterilizing and as soon as practical after use, instruments must be brushed or swabbed to remove foreign material or debris, rinsed, then either:

(i) Submersed and soaked in a protein dissolving detergent or enzyme cleaner; or

(ii) Immersed in detergent and water in an ultrasonic cleaning unit used according to the manufacturer's instructions; and

(iii) Rinsed and dried prior to packaging for sterilization. Ensure that the rinse step is adequate for removing cleaning residues to levels that will not interfere with the subsequent sterilization process.

(iv) Inspect instrument surface for breaks in integrity that would impair either cleaning or sterilization. Ensure that detergents or enzymatic cleaners are compatible with the metals and other materials used in the instruments.

(d) Seal cleaned instruments in bags/packing materials that are compatible with the sterilization process and are sufficiently strong to resist puncture and tears and are cleared by the FDA. Label sterilized instruments with a load number that indicates the sterilizer used, the cycle or load number, and the date of sterilization.

(e) Sterilize instruments using a monitored sterilizer. Follow the sterilization times, temperatures and other parameters recommended by the manufacturers of the instruments, sterilizer and packaging used.

(f) Arrange all items to be sterilized so all surfaces will be directly exposed to the sterilizing agent, which means loading procedures must allow for free circulation of steam (or another sterilant) around each item.

(g) Use mechanical, chemical and biologic monitors to ensure the effectiveness of the sterilization process.

(i) Monitor each load with mechanical (e.g., time, temperature, pressure) and chemical (internal and external) indicators. If the internal chemical indicator is visible, an external indicator is not needed.

(ii) At least monthly use biologic indicators to test effectiveness of sterilizer with an FDA cleared commercial preparation of spores intended specifically for the type and cycle parameters of the sterilizer.

(h) For each sterilization cycle, record the type of sterilizer and cycle used; the load identification number; the load contents; the exposure parameters (e.g., time and temperature); the operator's name or initials, and the results of the mechanical, chemical and biological monitoring. Records must be retained for three years and must be provided to the department upon request.

(i) Perform preventive maintenance of sterilizer as directed by the manufacturer's instructions.

(j) Handle sterilized instruments using aseptic technique to prevent contamination. Store in secure, dry, clean cabinets or other secure covered containers to prevent contamination and packaging being compromised (e.g., wet, punctured, torn).

(2) If a licensee only uses sterile single-use, disposable instruments, sharps and products, and uses sterile supplies, a sterilizer is not required.