(A) Heat sterilization:
(1) 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 between patients. Sterilization must be accomplished by an FDA-approved device or method.
(3) All instruments and all items that are able to withstand repeated exposure to heat must be heat sterilized between patients. 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 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) Biological monitoring documentation:
(a) In-office testing documentation - Documentation must be maintained in the form of a log reflecting dates, person(s) conducting the testing, and the results of the test capsule and control capsule.
(b) Independent testing documentation - Reports from the independent testing entity shall be used.
(c) Documentation of testing and repairs 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 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, or have come in contact with blood or saliva, 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.
(E) Dental laboratory items:
(1) All items that have been placed in the mouth, or are otherwise 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.
R.C. 119.032 review dates: 03/04/2009 and 03/01/2014
Promulgated Under: 119.03
Statutory Authority: 4715.03
Rule Amplifies: 4715.03
Prior Effective Dates: 11-1-87, 7-25-93, 3-3-95, 4-7-00, 5-15-03