Regulatory Agencies
Agency that inspects and cites organizations for statue violations of transportation of minimally processed instrumentation
DOT, Department of Transportation
A written law adopted by a legislative body that governs a city, county, state or country
Statute
Low risk subject to general controls
Class I devices
Third party reprocessors are regulated by
The FDA
Agency of the United Nations to further international cooperation in improving health conditions
WHO World Health Organization
Agency that may intervene in a matter of worker protection even if there are no specific regulations covering the situation
Occupational safety and health administration
Rules issued by administrative agencies that have the force of law
Regulation
Most stringently regulated devices, must obtain a premarket approval from the FDA
Class III device
When state and federal regulations differ which one must be followed
The more strigent
Professional organization dedicated to providing optimal care to the surgical patient
AORN Association of Perioperative Nurses
Agency which imposes strict labeling requirements on manufacturers of disinfectants used by central service departments
The environmental protection agency
A uniform method of defining basic parameters for processes, products, services and measurements
Standard
Sterilizers, chemical indicators, Biological indicators
Class II device
This FDA recall class poses low risk and use of this product is not likely to cause adverse health consequences.
Class III recall
A private independent, nonprofit organization that develops standards for healthcare facilities
TJC The Joint Commission
Agency that is organized within the health and human services that works to promote health and quality of life by preventing and controlling disease.
The CDC, Center for Disease Control
A comparison benchmark that is mandated by a governing agency, noncompliance with may result in citations and legal penalties.
Regulatory standards
Most items in this class are exempt from a premarket notification approval
Class I device
FDA requires the manufacturer to provide detailed instructions on how to properly process and use a product which is known as
an IFU Instruction for Use
Nonprofit organization of nurses and associates dedicated to the safe and effective practice of gastroenterology
SGNA Society of Gastroenterology Nurses and Associates
Agency that classifies implantable medical devices
FDA food and drug administration
A method or techniques that has consistently shown results that are superior to those achieved by other means
Best Practice
Heart valves, pacemakers, and other lifesaving devices
Class III device
A program designed for the voluntary reporting of device related problems
Medwatch
Nonprofit organization of healthcare technology professionals whose committees and workgroups research and develop new standards and technical information reports that address the use, care and processing of devices and systems.
AAMI Association for the Advancement of Medical Instrumentation