<p> Name (Printed):______</p><p>Final Exam, BME 272, Fall 2006</p><p>October 19, 2006</p><p>This examination is given under the Vanderbilt Honor Code system, no notes or other means of assistance are allowed.</p><p>Pledge: ______</p><p>20 questions, 5 points each 1. Define reliability, give an example. Define failure, give several causes. Define MTBF. </p><p>2. What is MAUDE? What is the Freedom of Information Law? How are the two related?</p><p>3. What is the Joint Commission on Accreditation of Healthcare Organizations? What are its powers? </p><p>4. What is the purpose of the group calling itself “Closing the gap”?</p><p>5. What is an “Investigational Device Exemption”, how is it used, and who regulates the granting of an exemption? 6. What is standby redundancy? What is active redundancy? Why are they used? How do they relate to mean time between failures?</p><p>7. Briefly list the steps involved in drug development, detail the number of subjects used in each phase when doing human testing.</p><p>8. In the discussion of team dynamics, your instructor described a stage called “storming”. What does this entail?</p><p>9. There are 6 basic characteristics of successful teams, name 3.</p><p>10. Define liability. Name three grounds for a lawsuit involving liability.</p><p>11. What is the job of an “Institutional Review Board”? Why do we have such a group? 12. Define HALT in the context of this course.</p><p>13. Define verification and validation in the context of this course.</p><p>14. How is medical device software regulated in the US? How is it classified?</p><p>15. What is the field of “design for failure”? Give three examples.</p><p>16. Generate a brief objectives tree for the process of giving an examination.</p><p>17. We briefly discussed the rules of professional conduct for practicing engineers. List 3 of these, and relate how these are related to “codes of ethics”. 18. Generate a brief (at least 3 qualities & 3 functions) QFD diagram for your design of a new portable pulse oximeter to be used by athletes during competition.</p><p>19. Briefly define method 635 and its drawbacks.</p><p>20. What useful data may be obtained from a process chart?</p>