Regulations
The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices
Premarket Approval (PMA)
This act established national standards to protect patients' medical records and other personal health information
HIPAA - Health Insurance Portability and Accountability Act
Careful compliance with regulation and standards Patient safety is at its highest level of quality of care
True
Requires anyone who processes single-use devices to obtain and comply with FDA 510k directives to reprocess SUDs
FDA - Food and Drug Administration
These are designed to keep both patients and employees safe
Standards and Regulations
FDA Medical Device Classification is the most stringently regulated device including heart valves, pacemakers and other life sustaining devices
Class III
This regulatory agency is responsible for minimizing greenhouse gasses and toxic emission regulating the reuse of solid wastes, controlling indoor air pollution, and developing and enforcing chemical regulations
EPA - Environmental Protection Agency
EUA is authorized as long as it is needed
False
Only authorized during a designated time period
Primary role and responsibility to protect workers from occupationally caused illnesses and injuries
OSHA - Occupational Safety and Health Administration
A non governmental, international organization that brings together experts to develop voluntary, consensus based standards
ISO - International Organization for Standardization
Rules issued by administrative agencies that have the force of the law
Regulation
A non-profit voluntary consensus organization whose membership is comprised of healthcare technology professionals
AAMI - Association for Advancement of Medical Instrumentation
SP technicians are not affected by regulations and standards
False
Federal government agency dedicated to enduring a fast, sage and efficient transportation system
DOT - Department of Transportation
A method of technique that has consistently shown results superior to those achieved by other means
Best Practice
Means there is a possibility that the product will cause a temporary or medically reversible adverse health problems
Class II: Less Serious Risk
Holds the infection prevention and control department, n conjunction with SP management, responsible for cleaning and sterilization outcomes within the SPD
TJC - The Joint Commission
TJC standards are voluntary but nonetheless carry significant weight
True
Federal agency that works to promote health and quality of life by preventing and controlling disease, injury and disability
CDC - Centers for Disease Control and Prevention
A uniform method of defining basic parameters for processes, products, services and measurements
Standard
Low Risk Devices such as most handles surgical instruments, hospital beds etc.,
Class I Device
A non-profit organization dedicated to the safe and effective practice of gastroenterology and endoscopy nursing.
SGNA - Society of Gastroenterology Nurses and Associates
Other countries follow the U.S. standard organizations for healthcare medical device processing.
False
They have their own standards that they follow
Perioperative nurses and others who are dedicated to providing optimal care to the surgical patient
AORN - Association of perioperative Registered Nurses
This comprehensive OSHA guideline outlines employee safety in all areas of the facility as they relate to potential exposure from bloodborne pathogens
The Occupational Exposure to Bloodborne Pathogens Standard