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Decembber 22, 2009 | dentalproductsreport.com The take-aways The set-up Killing microbes in the office environment is an important part of infection control involving sterilization and disinfection. We can monitor this killing during heat sterilization with spore testing, but we cannot determine if a surface disinfection procedure has been successful as used in the office. We must read the label on the disinfectant and must follow the label directions to help ensure success and be able to handle the product safely. Also as we will address below, it is a violation of federal law to use an EPA-registered product in a manner inconsistent with its labeling. The importance of the EPA The EPA regulates disinfectants as “antimicrobial pesticides” used to control, prevent or destroy harmful microbes (but not necessarily bacterial spores) on inanimate surfaces and objects. Sanitizers are less lethal than disinfectants and are used to reduce, but not necessarily eliminate, microorganisms from inanimate surfaces. EPA categorizes disinfectants into two major types: hospital and general use. Hospital type disinfectants are used in medical and dental healthcare environments, and general use products are used in households, swimming pools and water purifiers. A hospital type disinfectant is an EPA-registered disinfectant that has been shown to kill at least three test bacteria (Staphylococcus aureus, Salmonella choleraesuis and Pseudomonas aeruginosa). More than 5000 antimicrobial products are currently registered within the EPA and sold in the marketplace. About 60% of these are registered to control microbes in hospitals and other healthcare environments. In the U.S. all disinfectant labeling (all written, printed or graphic matter attached to, accompanying or referenced on a disinfectant product) must be approved by the EPA. EPA-registration requires disinfectant manufacturers to include certain information on the product’s label. The EPA tries to make the label as specific as possible. For example it must identify the level of antimicrobial activity (disinfectant, sanitizer, etc). Also if the term “antimicrobial” is used, it must appear in close proximity to a qualifying statement giving details of the antimicrobial activity. Phrases like “prevents infection” or controls infection” are not allowed on disinfectant labels because they relate to drug claims regulated by FDA. Disinfectant labels include a variety of information as described below. Additional details are available from the EPA.1, 2 General information At first glance, it may seem like information you can scan and move on from, but once you get past the identifying factors—product name, brand, trademark, name and address of registrant or person for whom the product is produced, and the amount of product in the cointainer—the following general information is important.
Directions for use It may seem obvious to call out the importance of directions, but you’d be surprised how many dental professionals dismiss directions altogether—both for infection control products as well as materials and even technology. This is a quick guide to what you should look for in the directions.
Hazard and precautionary statements The label must have the statement “Keep out of the reach of children” unless otherwise approved by the EPA. The label also must bear a single word on the front panel reflecting the highest toxicity category to which the product has been assigned by any of the five routes of exposure. These routes are Oral, Dermal, Inhalation, Eye Irritation and Skin Irritation, and the toxicity categories for each route range from I (most toxic) to IV (least toxic). If a product is assigned to toxicity category I, then the word that must appear on the label is “DANGER”. In addition the word “POISON” also must appear in red, and a skull and crossbones symbol must appear in close proximity to the word poison. If it is a category II, the word “WARNING” must appear. For category III the word is “CAUTION.” If it is category IV for all routes, no word is required. Each product must bear a “First Aid” statement if it has systemic effects in Category I, II or III, or skin or eye irritation in Category I or II. This statement is to provide the actions to take in the event of accidental swallowing, inhalation or contact with the product. Physical or chemical hazards such as flammability and the precautions to take also must be identified on the label. Storage and disposal information Specific information must be provided on the storage and disposal of the disinfectant and its container. Besides a shelf-life (time the product may be stored before use or activation without losing its effectiveness), there also may be a use-life (time a product remains active after it has been opened, activated or prepared for use). Material safety data sheets The Occupational Safety and Health Administration (OSHA) requires that the manufacturers of hazardous materials provide users with a Material Safety Data Sheet (MSDS) on each chemical. Like the disinfectant labeling, the accompanying MSDS also should be read, for it identifies the hazards associated with the product and provides information on how to safety handle the product and what to do if an exposure occurs.
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