Regulations And Standards Flashcards
Regulation
Mandatory law or rule that is issued by a governing body
Standard
Uniform method of defining basic parameters for processes, products, services, and measurements.
Standards (regulatory)
Comparison benchmark that is Mandated by a governing agent and, if not complied with, may cause a facility to be in violation and liable for legal penalty.
Standards (voluntary)
A comparison benchmark that is strongly recommended by a governing agency of professional organization that provides recommendations and guidelines to provide better patient care.
Statute
A written and enforceable law enacted by a governing body.
MedWatch program
A safety information and adverse event reporting system that serves healthcare professionals and the public by reporting serious problems suspected to be associated with the drugs and medical devices they prescribe, dispense, or use.
Hemodialyzers
Equipment used to remove impurities and waste products from blood before turning it to the patients body.
Prions
Virus-like infectious agents that cause a variety of neurodegenerative diseases of humans and animals, including scrapie in sheep and goats, bovine spongiform encephalopathy (BSE) in cattle, and Cruetzfeldt-Jakob disease (CJD) in humans.
Prions are thought to differ from viruses b containing neither DNA nor RNA, only protein. They are extremely resistant to inactivation by heat and disinfecting agents.
Greenhouse gases
Any gas such as carbon dioxide (CO2), methane (CH4), halogenated fluorocarbons (HCFCs), and ozone (O3) which contributes to potential climate change.
Recommended Practices and Standards (AAMI)
Voluntary guidelines representing a consensus of AAMI membersthat are intended for use by healthcare Facilities to help ensure that medical instrumentation is safe for patient use.
Standards (AAMI)
Recommendations representing a consensus of AAMI members that provide guidance to device manufacturers that address design, performance, labeling, and other factors applicable to the instruments they manufacture.
Medicare
Federal medical insurance program that primarily serves those over 65, and younger disabled persons and dialysis patients;
Medical bills are paid from trust funds into which covered persons have paid.
Medicaid
Federal and state assistance program that pays covered medical expenses for low-income persons.,it is run by state and local governments within federal guidelines.
FDA
Food and Drug Administration
CDC
Centers for Disease Control
