Biomedical Engineering Principles, Spring 2019
Due: Tuesday, Feb 12th (5 pm)
Instructions: This assignment should be completed individually . Read the provided article (Defects and Deceptions: The Bjork-Shiley Heart Valve), and answer the following questions. Submit electronically via Blackboard or submit a hard-copy to the instructor’s mailbox.
- What evidence was there that the strut fractures that occurred in Bjork-Shiley’s C/C valves were not random component failures?
- Why did Shiley, Inc. claim that their C/C valves should be marketed despite the known strut failures?
- How did Shiley, Inc. mislead patients, surgeons, and the FDA?
- Considering Utilitarian ethical theory, were Shiley’s actions ethical? Explain.
- Considering Kant’s ethical theory, were Shiley’s actions ethical? Explain.
- The Safe Medical Devices Act was enacted following the Bjork-Shiley incident. How do the provisions of the Act prevent similar incidences from occurring?
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Biomedical Engineering Principles, Spring 2019 was first posted on February 8, 2019 at 7:19 pm.
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