Regulatory and Advisory Agencies Chapter 22 Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 1

Chapter 22 Lesson 22.1 Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 2

Learning Objectives Pronounce, define, and spell the Key Terms. Explain the difference between regulations and recommendations. Identify four professional sources of dental information. Name the premiere infection-control educational organization in dentistry. (Cont’d) Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 3

Learning Objectives (Cont’d) Describe the role of the Centers for Disease Control and Prevention (CDC). Describe the role of the Food and Drug Administration (FDA) in relation to dentistry. Describe the role of the Environmental Protection Agency (EPA) in relation to dentistry. Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 4

Learning Objectives (Cont’d) Explain a primary difference between the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH). Describe the role of the National Institutes of Health (NIH). Describe the role of the National Institute of Dental and Craniofacial Research (NIDCR). Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 5

Introduction Several government agencies and professional organizations have direct influence on dentistry, infection control, and other healthcare-safety issues. In addition to issuing recommendations and regulations, some have regulatory roles and others are advisory. These agencies can serve as an excellent resource for information and educational materials. Ask students to name the agencies and organizations they believe are involved with dentistry. Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 6

Recommendations and Regulations Recommendations are made by individuals, groups, or agencies that are advisory and have no authority with regard to enforcement. Regulations are made by groups or agencies that do have the authority to enforce compliance with the regulations. Enforcement penalties may include fines, imprisonment, or suspension or revocation of licenses. Recommendations may be made by anyone, but regulations are made by governmental groups or licensing boards in towns, cities, counties, and states. Of the agencies and organizations named by the students, ask which provide regulations versus recommendations. Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 7

Associations and Organizations The ADA is the professional organization for dentists. The ADA periodically updates its infection control recommendations as new scientific information becomes available. The Organization for Safety and Asepsis Procedures (OSAP) is a not-for-profit organization composed of dentists, hygienists, dental assistants, government representatives, dental manufacturers, university professors, researchers, and dental consultants. This organization is an excellent resource for information on infection control, injury prevention, and occupational-health issues. (Cont’d) Fig. 22-1 Logo of the ADA. (Courtesy of the ADA.) Seven of 10 dentists are members of the ADA. Not only does the ADA provide information for dental professionals, it also provides information for the public on oral health. OSAP is currently focusing on the issue of SARS—severe acute respiratory syndrome—and the dental office. Through December 2003, according to the OSAP, 161 confirmed or suspected cases of SARS were investigated in the United States and more than 8000 probable cases were reported worldwide. Fig. 22-4 Logo of OSAP. (Courtesy Organization for Safety and Asepsis Procedures.) Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 8

Associations and Organizations (Cont’d) State and local dental societies can help you comply with regulatory issues in your specific area. National, state, and local dental-assisting societies can often answer questions and provide opportunities for continuing dental education. In the state of Washington, the dental association is composed of 17 local component societies that play an important role in implementing projects and programs at the state and local levels. Why is it important to be involved with the local dental society? (It can answer questions and work with the dental professional or act as a liaison with regulatory agencies.) Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 9

Government Agencies CDC FDA OSHA NIOSH Ask each student to name a dental product that is regulated by the FDA. Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 10

Centers for Disease Control and Prevention The CDC is recognized as the lead federal agency for protecting the health and safety of people at home and abroad. The CDC bases its public-health recommendations on the highest-quality scientific data. Infection-control procedures practiced in dentistry today are based on the Guidelines for Infection Control in Dental Health-Care Settings, issued by the CDC. The guidelines contain an Oral Health Services section that concerns oral diseases, fluoride application, and infection control in dentistry. The CDC does not have the authority to make laws, but many local, state, and federal agencies use CDC recommendations to formulate laws. Recently the CDC published statistics on how many people in the United States visited the dentist within a 1-year timeframe. What do you believe the statistics were? (67.9% yes, 32.1% no.) Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 11

Food and Drug Administration The FDA, a regulatory agency, is part of the U.S. Department of Health and Human Services. The FDA regulates the manufacture and labeling of medical devices (e.g., sterilizers, biologic and chemical indicators, ultrasonic cleaners and cleaning solutions, liquid sterilants, gloves, masks, protective eyewear, dental handpieces and instruments, dental chairs, and dental-unit lights). It also regulates antimicrobial handwashing products and mouth rinses. Inform the students what should occur if a medical device regulated by the FDA malfunctions. Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 12

Fig. 22-6 Overview of a dental operatory showing items (arrows) regulated by the FDA. Discuss other examples of medical products regulated by the FDA. Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 13

Environmental Protection Agency (EPA) The EPA is a regulatory agency. It ensures the safety and effectiveness of disinfectants. Manufacturers of disinfectants must submit information about the safety and effectiveness of the product. If the claims meet the EPA criteria, the product receives an EPA registration number that must appear on the product label. The EPA regulates discharge and final treatment of waste materials (e.g., chemicals), as well as medical waste after it leaves the dental office. Discuss different disinfectants and the information provided on the labeling. Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 14

Occupational Safety and Health Administration OSHA is a regulatory agency. It protects workers against physical, chemical, and infectious hazards in the workplace. It establishes protective standards, enforces those standards, and offers technical assistance and consultation programs. OSHA is a federal agency, but 22 states administer their own state-operated OSHA programs. In states that administer their own OSHA programs, the state standards must be equivalent to or more stringent than those of the federal agency. What OSHA standards apply to dentistry? (bloodborne pathogens, hazard communication, occupational exposure to hazardous chemicals in laboratories, medical services and first aid, respiratory protection, personal protective equipment, formaldehyde, portable fire extinguishers, nitrous oxide, ethylene oxide.) Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 15

National Institute for Occupational Safety and Health NIOSH does not have regulatory authority. It is responsible for conducting research and making recommendations for the prevention of work-related disease and injury. NIOSH makes recommendations and disseminates information on preventing workplace disease, injury, and disability. It provides training to professionals in the field of occupational safety and health. The research branch is known as the National Occupational Research Agency, or NORA. What projects or areas might NORA research that benefit dental professionals? (Allergic and irritant dermatitis, infectious diseases, lower-back disorders, emerging technologies, mixed exposures, control technology and personal protective equipment, exposure-assessment methods, and risk-assessment methods.) Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 16