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Autoclave Sterilizer - Make The Right Decision.


General-Information

Ohio Dental - Sterilization Guidelines

4715-20-02 Sterilization and disinfection.

(A) Heat sterilization:

(1) All instruments and all items that are able to withstand repeated exposure to heat must be heat sterilized between patients. Sterilization must be accomplished by an FDA-approved device or method, For example, autoclave, dry heat, or unsaturated chemical vapor.

(2) All high speed and surgical handpieces, low speed contra angles, prophy angles, and nose cones must be subjected to heat sterilization. Sterilization must be accomplished by an FDA-approved device or method.

(3) The following instruments and items (but not limited to) must be heat sterilized between patients:

(a) All hand and orthodontic instruments;

(b) All burs and bur changers, including contaminated laboratory burs and diamond abrasives;

(c) All endodontic instruments;

(d) Air-water syringe tips;

(e) High-volume evacuator tips;

(f) Surgical instruments;

(g) Ultrasonic periodontal scalers and tips; and

(h) Electro-surgery tips:

(i) Metal impression trays; and

(j) Intra-oral radiographic equipment that can withstand heat sterilization.

(4) All heat sterilizing devices must be tested for proper function on a weekly basis by means of a biological monitoring system that indicates microorganism kill. The biological monitoring system used must include a control to verify proper microbial incubation. In the event of a positive biological spore test, the dentist must take immediate remedial action to ensure that heat sterilization is being accomplished. Immediate remedial action is defined as following manufacturer guidelines and performing a second biological spore test. In the event a second positive biological spore test occurs, the device must be removed from service until repaired. Proof of such repair must be maintained with the testing documentation.

(5) Documentation must be maintained either in the form of a log reflecting dates and person(s) conducting the testing, or copies of reports from an independent testing entity may be used. The documentation shall be maintained for a period of at least two years, and shall be maintained in the dental facility and be made immediately available upon request by an authorized agent of the state dental board.

(B) Chemical sterilization:

(1) Instruments and items that cannot withstand heat sterilization must be subjected to a chemical sterilization process between patients, which is defined as use of a sterilant cleared by the FDA in a 510(k) in accordance with the manufacturer's instructions.

(C) Surface disinfection:

(1) Environmental surfaces that are contaminated by blood or saliva must be properly cleaned prior to disinfection. Disinfection must be accomplished with a an appropriate disinfectant that is registered with the environmental protection agency and used in accordance with the manufacturer's instructions. The disinfection process must be followed between each patient.

(2) Impervious backed paper, aluminum foil or plastic wrap must be used to cover surfaces or items that may be contaminated by blood or saliva and that are difficult or impossible to disinfect. The cover must be removed, discarded and then replaced between patients.

(D) Single use items:

(1) All single use or disposable items, labeled as such, used in patient treatment must be discarded and not reused. Single use items include but are not limited to:

(a) Disposable needles and syringes;

(b) Local anesthetic carpules;

(c) Saliva ejectors, high volume evacuator tips, and air water syringe tips;

(d) Prophy angles, cups, and brushes;

(e) Polishing discs, cups, points;

(f) Fluoride trays; and

(g) Disposable impression trays.

(2) Items such as impressions contaminated with blood or saliva must be thoroughly rinsed, placed in, and transported to the dental laboratory in, an appropriate case containment device that is properly sealed and labeled.

HISTORY: Eff 11-1-87; 7-25-93; 3-3-95; 4-7-00
Rule promulgated under: RC Chapter 119.
Rule authorized by: RC 4715.03
Rule amplifies: RC 4715.30

119.032 review date: 12-16-99, 04-07-05


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