Regulatory Agencies
What regulatory agency creates and enforces laws relating to cleaner water, air and land?
Environmental Protection Agency
What voluntary agency promotes health by preventing and controlling disease?
Centers for Disease Control
What federal agency regulates the manufacture of all medical devices, requires premarket clearance of new devices, sterilants, and high level disinfectants?
U.S. Drug Administration
Which state agency monitors chemicals poured into the main sewer lines?
Environmental Protection Agency
What regulatory agency is responsible for pre- and post-market medical device requirements, MedWatch, medical device classification and medical device recall?
U.S. Food and Drug Administration
What voluntary international agency is dedicated to the prevention and control of infections and related outcomes.
Association for Professionals in Infection Control and Epidemiology
Which medical device class includes heart valves and pacemakers?
Class III medical devices
Which state agency regulates the transportation of healthcare waste from facilities to landfills or other final disposal sites?
Department of Transportation
What regulatory agency protects workers from occupationally-caused illnesses and injuries?
Occupational Safety and Health Administration
What voluntary agency provides standards and evaluations (onsite and every 3 years) for healthcare facilities?
The Joint Commission
Which medical device class includes most hand-held surgical instruments and ultrasonic cleaners?
Class I medical devices
Which state agency typically follows the same penalty criteria as those at the federal level?
Occupational Safety and Health Administration
What regulatory agency enforces laws relating to the transportation of medical waste?
Department of Transportation
What voluntary agency develops nationally recognized guidelines for the perioperative setting?
Association of Perioperative Registered Nurses
Which medical device class includes most types of sterilization equipment and biological and chemical indicatiors?
Class II medical device
Which state agency establishes local health safety standards?
Department of Health Services
Which two regulatory agencies are responsible for regulating ethylene oxide?
Occupational Safety and Health Administration and Environmental Protection Agency
What voluntary agency is considered one of the major resources for healthcare guidelines?
Association for the Advancement of Medical Instrumentation
Who is required to report suspected medical device related deaths to the U.S. Food and Drug Administration?
Hospitals and device manufacturers
Which agencies standards and regulations would take precedence, State or Federal?
The requirements of the most restrictive agency always applies.