Understanding Regulatory and Non-Regulatory Agencies in Dentistry
School
Ross Medical Education Center**We aren't endorsed by this school
Course
DA 101
Subject
Medicine
Date
Dec 11, 2024
Pages
5
Uploaded by ChiefIceSeal90
Regulatory and non-regulatory agencies●It is important for the dental assistant to recognize and understand the roles of thegovernment agencies and professional organizations that have a direct influence on thepractice of dentistry.●This is especially true in the areas of infection control, chemicals, and other occupationalhealth and safety issues.●There are specific agencies that are regulatory and issue laws and regulations withwhich dental offices must comply.●Penalties for not complying with regulations may include fines, imprisonment, orsuspension or revocation of licenses.●Then there are agencies that are advisory and have no authority for enforcement.●These non-regulatory agencies issue recommendations that are based on strongscientific evidence and are the standard of care for dentistry today.●The governmental agencies and organizations described in this chapter are intended toserve as an introduction to them.●As a member of the dental team, these agencies will be an excellent source ofinformation, guidance, and laws to abide by.Food and drug administration●The U.S. Food and Drug Administration (FDA) is a regulatory agency and is part of theDepartment of Health and Human Services (DHHS).●The FDA regulates the manufacturing and labeling of medical devices.●In dentistry, the FDA must approve sterilizers, biologic and chemical indicators,ultrasonic cleaners and cleaning solutions, liquid sterilants, gloves, masks, protectiveeyewear, dental handpieces and instruments, dental chairs, and dental unit lights.●The FDA also regulates antimicrobial handwashing products and mouth rinses.●The FDA requires “good manufacturing practices” and reviews the safety andeffectiveness of drugs and medical devices.●The agency also reviews claims on the labels of products to be certain that those claimsare true.●All medical and dental devices to be sold in the United States must first be cleared bythe FDA before they can be marketed.
Environmental protection agency●The U.S. Environmental Protection Agency (EPA) is a regulatory agency.●The EPA is associated with dentistry in ensuring the safety and effectiveness ofdisinfectants.●Manufacturers of disinfectants must submit information about the safety andeffectiveness of their products.●The EPA reviews the manufacturer’s antimicrobial claims to ensure that they aresupported by scientific evidence.●If the manufacturer’s claims meet the EPA criteria, the product receives an EPAregistration number.●That number must appear on the product label.●The EPA is also involved in regulating waste materials, such as chemicals and medicalwaste after they are sent from the dental office to a final disposal site.National institutes of health●The National Institutes of Health (NIH) is part of the Department of Health and HumanServices (DHHS).●It is the primary federal agency for conducting and supporting medical research.●NIH scientists investigate ways to prevent disease, and they research the causes,treatments, and even cures for common and rare diseases.●This agency provides leadership and financial support to researchers in every state andnation throughout the world.●The NIH supports a wide spectrum of research, ranging from medicine, to science,safety, regulation and guidance.●The agency is at the forefront of new progress in medical research.●Indeed, many important health and medical discoveries of the past century resulted fromresearch supported by the NIH.●The NIH translates research results into practice and communicates research findings topatients and their families, healthcare providers, and the general public.National institute of dental and craniofacial research●The National Institute of Dental and Craniofacial Research (NIDCR) is responsible forcarrying out research work for improving the oral, dental, and craniofacial health of thepublic.●Through research and the training of researchers, the NIDCR promotes health, preventsdiseases and pathologic conditions, and develops new diagnostic and therapeutictechniques.
National institute for occupational safety and health●The National Institute for Occupational Safety and Health (NIOSH) does not haveregulatory authority.●NIOSH is the only federal institute responsible for conducting research and makingrecommendations for the prevention of work-related disease and injury.●NIOSH, which is part of the CDC, conducts research on the full scope of occupationaldisease and injury, ranging from lung diseases in miners to carpal tunnel syndrome andallergic reactions to latex.Centers for disease control and prevention●The Center for Disease Control and Prevention (CDC) is an agency of the U.S. DHHS.●The CDC is not a regulatory agency, and does not have the authority to make laws, butmany local, state, and federal agencies use CDC recommendations to formulate laws.●Its role is to issue specific recommendations that are based on sound scientific evidencefor health-related matters.●It is recognized as the lead federal agency for protecting the health and safety of peopleat home and abroad.●The CDC bases its public health recommendations on scientific data of the highestquality.●The CDC is an excellent resource for health information for the public and for all dentalprofessionals.●In 1986, the CDC issued the first recommendations for the dental profession to preventthe transmission of blood-borne disease and are updated every year.●The infection control procedures practiced in dentistry today are based on theGuidelines for Infection Control in Dental Healthcare Setting issued by the CDC.●The CDC also has an Oral Health Services section that studies oral diseases, fluorideapplication, and infection control in dentistry.●The CDC has published guidelines on preventing the transmission of tuberculosis inhealthcare settings, including dental offices.●The CDC and the Occupational Safety and Health Administration (OSHA) are federalagencies that play a very important role in infection control for dentistry.
Occupational safety and health administration●The U.S. Occupational Safety and Health Administration (OSHA) is a federal regulatoryagency that is a division of the U.S. Department of Labor.●The responsibility of OSHA is to ensure the safety and health of America’s workers.●To do this, OSHA sets and enforces protective standards that employers must follow soas to provide a safe workplace for their employees.●In addition, OSHA provides training and outreach education and encourages continualimprovement in workplace safety and health.●In dentistry, the two most important OSHA standards are the BBP Standard and theHazard Communication Standard (HCS). All states are regulated by the federal OSHA●. In addition, 22 states administer their own state-operated OSHA programs.●In those states that administer their own OSHA programs, the state standards mustmeet or exceed federal OSHA standards.●OSHA monitors compliance with its standards through a process of investigation of theworkplace.●If the workplace fails to meet safety requirements, a citation may be issued for eachviolation.●Citations usually result in a fine.●If a workplace fails to correct the unsafe conditions, OSHA has the legal authority toclose the workplace until the problem is corrected.●OSHA provides hazard information, record-keeping guidelines, and copies of standardsat no cost.Employee training●The BBP Standard requires the dentist/employer to provide training in infection controlprocedures and safety issues to all personnel who may come in contact with blood,saliva, or contaminated instruments or surfaces.●The employer must keep records of all training sessions.●The record of each training session must include the date of the session, the name ofthe presenter, the topic, and the names of all employees who attended.Hepatitis B immunization●The BBP Standard requires the dentist/employer to offer the HBV vaccination series toall employees whose jobs include category I and II tasks.●The vaccine must be offered within 10 days of assignment to a category I or II job.●To document compliance, the dentist/employer must obtain proof from the physicianwho administered the vaccination to the employee.●The employee has the right to refuse the HBV vaccine for any reason.●The employee is then required to sign an informed refusal form that is kept on file in thedental office.●Even if the employee originally signed the refusal form, the employee always has theright to reverse the decision and receive the vaccine at a later date at no charge.