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Product Testing and Labeling

Nov. 1, 2006
The practice of dentistry and dental hygiene requires the use of many infection control products.
Click here to enlarge image

The practice of dentistry and dental hygiene requires the use of many infection control products. These include personal protective equipment such as masks, gloves and eyewear, as well as protective barriers, surface disinfectants and chemical sterilants. Choosing the right products can be challenging, because the selection of products varies widely.

Many resources are available to help dental professionals select products that meet the needs of the practice and have been evaluated for efficacy. Selecting disinfectants and chemical sterilants seems to cause the most confusion. While it’s reasonable to assume that products sold through dental suppliers are effective, it’s helpful to know what type of testing and approval processes these products have undergone.

Two government agencies, the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA), oversee the testing and approval of disinfectants and chemical sterilants, respectively. Several other organizations are involved in product testing and evaluation, such as the American Dental Association (ADA), Clinical Research Associates (CRA®), and the U.S. Air Force Dental Evaluation and Consultation Service (DECS).

Environmental Protection Agency The EPA registers low to intermediate level surface disinfectants. These solutions are classified as pesticides, and they must be effective against the microorganisms that they claim to kill, which are listed on the product labels. It is important for dental practices to review product labels to be sure that the product is EPA registered, is an intermediate-level hospital grade disinfectant, is tuberculocidal, and has cleaning properties (usually labeled as a cleaner/disinfectant). A cleaner/disinfectant is a good choice for dental practices, since it can remove debris and bioburden from surfaces as well as disinfect the surfaces.

Food and Drug Administration The FDA reviews the efficacy testing of high-level disinfectants, referred to as chemical sterilants or “cold sterile” solutions. The FDA grants “clearance” to these products after they have been tested for efficacy. The FDA also oversees the labeling of these products and recalls products that fail to meet their label claims for efficacy.Information regarding the clearance of a disinfectant or sterilant can be obtained from the FDA Web site at

American Dental Association The ADA Acceptance Program does not grant its seal of acceptance to disinfectants and sterilants, but does evaluate other infection control products such as sterilization pouches. Product manufacturers voluntarily submit their products for testing and evaluation in order to receive the ADA’s seal of acceptance. In addition, the ADA’s Professional Product Review evaluates various products through its Council on Scientific Affairs and a panel of clinical evaluators. More information on the ADA Seal of Acceptance Program and Professional Product Review can be found at

Clinical Research Associates Clinical Research Associates is a well-known research foundation that evaluates products in its laboratory and in clinical field trials conducted by a network of volunteer clinical evaluators. CRA publishes a widely read newsletter, in which the results of the product testing and evaluation are made available to subscribers. Unlike the ADA, CRA does test disinfectants for efficacy. Information about CRA is available at

Dental Evaluation and Consultation Service The USAF Dental Evaluation and Consultation Service (DECS) is probably better known by its former name, the Dental Investigation Service (DIS). This agency’s primary charge is to provide materials and equipment evaluation and resource information for the federal dental services. DECS performs clinical and laboratory testing of equipment and materials, including infection control and safety products, and the results of these evaluations are available to non-military dental professionals via the DECS Web site at

These agencies and organizations are excellent resources to help dental practices in product selection. Additional resources for information on disinfectants and chemical sterilants are the Centers for Disease Control and Prevention’s (CDC) Guidelines for Infection Control in Dental Health-Care Settings -2003 and the Organization for Safety and Asepsis Procedures (OSAP).

Centers for Disease Control and Prevention The CDC guidelines are widely accepted as the standard of care for patient safety and include specific recommendations on the use of surface disinfectants. A copy of the CDC guidelines can be accessed at

Organization for Safety and Asepsis Procedures OSAP is an organization dedicated to promoting infection control and occupational safety in dentistry. Among the many resources that OSAP has available is the Surface Disinfectant Reference Chart. Information on OSAP membership and the reference chart is available at

Researching products is very helpful in making the right product selection. Another component of product selection is a good understanding of the product label. The image at the beginning of this article is an example of a product label for a surface disinfectant that highlights important information for dental professionals, such as the active agents present, hazards associated with use, what microorganisms the product is active against, whether it is a cleaner and disinfectant, if it is tuberculocidal (and how quickly it kills), the EPA registration number, and special instructions and contact time.

When selecting products for infection control, research them through these agencies to determine whether the products meet the criteria in CDC guidelines and meet the needs in the practice. Make a habit of reading product labels to ensure proper use of the product. If there are questions regarding product use, call the manufacturer for additional information.

Implementation of effective infection prevention protocols should be based on knowledge of standards and guidelines, as well as product research. When you know where to look, researching products is easier than you think. OSAP

Mary Govoni, CDA, RDH, MBA, is the owner of Clinical Dynamics, a consulting company based in Michigan. She is a member of the Organization for Safety and Asepsis Procedures and is a featured speaker on the ADA Seminar Series. She also writes a column for Dental Equipment & Materials magazine. She can be contacted at [email protected].