General Information

CDC Dental Sterilization Guidelines
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Amend Section 1005 of Division 10 Title 16 of the California Code of Regulations to read as
§ 1005. Minimum Standards for Infection Control

(a) Definitions of terms used in this section:
(1)“Standard precautions” is a set of combined precautions that include the major components of
universal precautions (designed to reduce the risk of transmission of blood borne pathogens) and
body substance isolation (designed to reduce the risk of transmission of pathogens from moist
body substances). Similar to universal precautions, standard precautions are used for care of all
patients regardless of their diagnoses or personal infectious status.
(2) “Critical instruments” are surgical and other instruments used to penetrate soft tissue or bone.
(3) “Semi-critical instruments” are surgical and other instruments that are not used to penetrate
soft tissue or bone, but contact oral tissue.
(4) “Non-critical instruments and devices” are instruments and devices that contact intact skin.
(5) “Low-level disinfection” is the least effective disinfection process., kills some bacteria,
viruses and fungi, but does not kill bacterial spores or mycobacterium tuberculosis var bovis, a
laboratory test organism used to classify the strength of disinfectant chemicals.
(6) “Intermediate-level disinfection” kills mycobacterium tuberculosis var bovis indicating that
many human pathogens are also killed, but does not necessarily kill spores.
(7) “High-level disinfection” kills some, but not necessarily all bacterial spores. This process
kills mycobacterium tuberculosis var bovis, bacteria, fungi, and viruses.
(8) All germicides must be used in accordance with intended use and label instructions.
(9) “Sterilization” kills all forms of microbial life.
(10) “Personal Protective Equipment” includes items such as gloves, masks, protective eyewear
and protective attire (gowns/labcoats) which are intended to prevent exposure to blood and body
(11) “Other Potentially Infectious Materials” (OPIM) means any one of the following: (A)
human body fluids such as saliva in dental procedures and any body fluid that is visibly
contaminated with blood, and all body fluids in situations where it is difficult or impossible to
differentiate between body fluids; (B) any unfixed tissue or organ (other than intact skin) from a
human (living or dead); (C) HIV-containing cell or tissue cultures, organ culture and blood, or
other tissues from experimental animals.
(b) Licensees shall comply with infection control precautions mandated by the California
Division of Occupational Safety and Health (Cal-DOSH)
(c) All licensees shall comply with and enforce the following minimum precautions to minimize
the transmission of pathogens in health care settings:
(1) Standard precautions shall be practiced in the care of all patients.
(2) A written protocol shall be developed by the licensee for proper instrument processing,
operatory cleanliness, and management of injuries.
(3) A copy of this regulation shall be conspicuously posted in each dental office.
Personal Protective Equipment:
(4) Health care workers shall wear surgical facemasks in combination with either chin length
plastic face shields or protective eyewear when treating patients whenever there is potential for
splashing or spattering of blood or OPIM. After each patient, and during patient treatment if
applicable, masks shall be changed if moist or contaminated. After each patient, face shields and
protective eyewear shall be cleaned and disinfected, if contaminated.
(5) Health care workers shall wear reusable or disposable protective attire when their clothing or
skin is likely to be soiled with blood or OPIM. Gowns must be changed daily or between patients
if it should become moist or visibly soiled. Protective attire must be removed when leaving
laboratories or areas of patient care activities. Reusable gowns shall be laundered in accordance
with Cal-DOSH Bloodborne Pathogens Standards, (Title 8, Cal. Code of Regs., section 5193).
Hand Hygiene:
(6) Health care workers shall wash contaminated or visibly soiled hands with soap and water
and put on new gloves before treating each patient. If hands are not visibly soiled or
contaminated an alcohol based hand rub may be used as an alternative to soap and water.
(7) Healthcare workers who have exudative lesions or weeping dermatitis of the hand shall
refrain from all direct patient care and from handling patient care equipment until the condition
(8) Medical exam gloves shall be worn whenever there is a potential for contact with mucous
membranes, blood or OPIM. Gloves must be discarded upon completion of treatment and before
leaving laboratories or areas of patient care activities. Healthcare workers shall perform hand
hygiene procedures after removing and discarding gloves. Gloves shall not be washed before or
after use.
Sterilization and Disinfection:
(9) Heat stable critical and semi-critical instruments shall be cleaned and sterilized before use by
using steam under pressure (autoclaving), dry heat, or chemical vapor. FDA cleared chemical
sterilants/disinfectants shall be used for sterilization of heat-sensitive critical items and for highlevel
disinfection of heat-sensitive semi-critical items.
(10) Critical and semi-critical instruments or containers of critical and semi-critical instruments
sterilized by a heat or vapor method shall be packaged or wrapped before sterilization if they are
not to be used immediately after being sterilized. These packages or containers shall remain
sealed unless the instruments within them are placed onto a setup tray and covered with a
moisture impervious barrier on the day the instruments will be used and shall be stored in a
manner so as to prevent contamination.
(11) All high-speed dental hand pieces, low-speed hand piece components used intraorally, and
other dental unit attachments such as reusable air/water syringe tips and ultrasonic scaler tips,
shall be heat-sterilized between patients.
(12) Single use disposable instruments (e.g. prophylaxis angles, prophylaxis cups and brushes,
tips for high-speed evacuators, saliva ejectors, air/water syringe tips) shall be used for one patient
only and discarded.
(13) Needles shall be recapped only by using the scoop technique or a protective device. Needles
shall not be bent or broken for the purpose of disposal. Disposable needles, syringes, scalpel
blades or other sharp items and instruments shall be placed into sharps containers for disposal
according to all applicable regulations.
(14) Proper functioning of the sterilization cycle shall be verified at least weekly through the
use of a biological indicator (such as a spore test). Test results must be maintained for 12
(15) Sterile coolants/irrigants shall be used for surgical procedures involving soft tissue
or bone. Sterile coolants/irrigants must be delivered using a sterile delivery system.
(16) If items or surfaces likely to be contaminated are difficult to clean and disinfect they
shall be protected with disposable impervious barriers.
(17) Clean and disinfect all clinical contact surfaces that are not protected by impervious
barriers using a Cal-EPA registered, hospital grade low- to intermediate-level disinfectant after
each patient. The low-level disinfectants used shall be labeled effective against HBV and HIV.
Use disinfectants in accordance with the manufacturer’s instructions. Clean all housekeeping
surfaces (e.g. floors, walls, sinks) with a detergent and water or a Cal-EPA registered, hospital
grade disinfectant.
(18) Dental unit water lines shall be anti-retractive. At the beginning of each workday, dental
unit lines shall be purged with air, or flushed with water for at least two (2) minutes prior to
attaching handpieces, scalers and other devices. The dental unit line shall be flushed between
each patient for a minimum of twenty (20) seconds.
(19) Contaminated solid waste shall be disposed of according to applicable local, state, and
federal environmental standards.
Lab Areas:
(20) Splash shields and equipment guards shall be used on dental laboratory lathes. Fresh
pumice and a disinfected, sterilized, or new ragwheel shall be used for each patient. Devices used
to polish, trim or adjust contaminated intraoral devices shall be disinfected or sterilized.
(21) Intraoral items such as impressions, bite registrations, prosthetic and orthodontic
appliances shall be cleaned and disinfected with an intermediate-level disinfectant before
manipulation in the laboratory and before placement in the patient’s mouth. Such items shall be
thoroughly rinsed prior to placement in the patient’s mouth.
(d) The Board shall review this regulation annually.
NOTE: Authority cited: Section 1614, Business and Professions Code. Reference: Section
1680, Business and Professions Code.
DATED: July 21, 2004
Assistant Executive Officer
Dental Board of California