Class III - answer Which class of devices requires premarket approval from the
FDA?
Does it work; is it valuable; is it safe. - answer Capitalism and lack of government
intervention play a major role in the desire to have the state-of-the-art technology. What
three qualities are necessary to determine effectiveness of technology regarding patient
care?
The approval before a new drug can be marketed. - answer The Food and Drug
Administration (FDA) is responsible for:
Health care providers are required to report all injuries and deaths attributed to the use
of medical devices. - answer What is required under the Safe Medical Devices Act of
1990?
National Institutes of Health; Agency for Healthcare Research and Quality - answer
Which two federal agencies support research associated with medical technology?
The patient's overall satisfaction with life. - answer Quality of life is measured by:
clinical trials - answer Efficacy and safety of medical technology are evaluated
through:
Efficacy - answer What is the term for the benefits derived from a health care service
or product?
Benefits must outweigh any negative consequences. - answer What is the primary
benchmark for safety?
cost effective - answer When the benefits of a technology exceed the cost, it is
referred to as what?
Increasing quality, reducing cost, or doing both. - answer Value in health care is
enhanced by what?
They are guidelines to assist practitioners in delivering appropriate health care for
specific clinical issues. - answer Standardized practice protocols are what?
Incorporation of cost-effectiveness into clinical practice. - answer which of the
following has not taken central stage in U.S. health care delivery?
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