Intro
Rules issued by administrative agencies that have the force of law?
Regulations
The US FDA safety information and adverse event reporting system that serves healthcare professionals and the public?
Med Watch
A federal medical insurance program that serves older people?
Medicare
What is ISO?
International Standardization Organization
A uniform method of defining basic parameters for processes products services and measurements?
Standard
Class II medical device means there is a possibility that the product will cause a temporary or medically reversible adverse Problem?
Yes
A federal program state assisted that pays covered medical expenses?
Medicaid
what does SGNA mean?
Society of Gastro- Nurses and Associates
The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices?
Pre-Market Approval
What does DOT mean?
Department Of Transportation
What is HIPPA?
Health Insurance Portability and Accountability Act
A method or technique that has consistently shown results superior to those achieved?
Best Practice
What does CDC mean?
Center for Disease Control
Voluntary guidelines representing a consensus of AAMI
Standards of AAMI
An injury or illness that is life threatening resulting in permanent impairment or permanent damage?
Serious injury
What does EUA mean?
Emergency Use of Authority
Reports developed by by experts in the field that contain valuable information?
TIR Technical Information Report
What Does USPNF stand for
United States Pharmacopeia National Formulary