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Ethical and Legal Issues in Clinical Practice: Medical Devices

Please select the best response for each question.

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1: Conformance with ________ determines the ethicity and legality of a clinical decision.: current local practices
professional standards of care
economics
supervisors� instructions
2: Which of the following are legitimate sources for standards of care?: AARC Clinical Practice Guidelines
The Joint Commission for Accrediting Healthcare Organizations (JCAHO)
State professional credentialing boards
All of the above
3: Most respiratory care devices are classified by the Federal Drug Administration in which category?: Class I
Class II
Class III
Class IV
4: The Federal Drug Administration would classify a new type of ventilator, that is not equivalent to those currently on the market, in which category?: Class I
Class II
Class III
Class IV
5: Deaths that occur due to medical devices must be reported to the Federal Drug Administration within what time interval?: 24 hours
10 days
30 days
No report is required
6: Which of the following is an organization that provides means for voluntary reporting of problems wit medical devices?: The Emergency Care Research Institute (ECRI)
The Commission for Accreditation of Respiratory Care (CoARC)
The Joint Commission for Accrediting Healthcare Organizations (JCAHO)
The National Board for Respiratory Care (NBRC)
7: When a medical device functions according to manufacturer�s specifications; but, fails under specific clinical circumstances, this is an example of _________.: Product defect
Device misuse
Design defect
All of the above
8: All of the following are elements of negligence guilt, EXCEPT:: injury to the patient
duty to care for the patient
slander
proximate cause
9: Measuring a patient�s oxygen saturation by applying a finger sensor to the ear is an example of:: device misuse
product defect
design defect
appropriate clinical practice
10: Which of the following are responsibilities of respiratory care managers in promoting device safety?: Final device adoption decisions
Directing evaluation trials
Ensuring staff competency
All of the above