BIOMEDICAL ENGINEERING

Name

Institute of Affiliation

Date

Question 1

According to the reports compiled from those who complained of the failed, it recorded that the struts used to fail at similar points after they were implanted. Though only a very small percentage of the people who had implants reported this, the fact that failures occurred at similar points indicates that failures were not random at all. Design manufacturing was responsible for the failure of the component. Changes on how welding was done in later ensured that the failures did not occur at the same point. In the event that there fractures on both legs, the ring would fall, and the heart would have unrestricted blood flow.

Question 2

Statistics showed that about 1% of all the implant failure because of the manufacturing problem. After the voluntary recall, the problem was identified as the fractures of the strut at the outlet. Such a small number of failures is small compared to 99% of the patients who were doing well. Therefore, according to the Shiley/Pfizer, that small percentage did not warrant them to withdraw from the market. Further, if they were to remove them from the market, designing and testing a new model would take unrealistically long period while the patients would be suffering. Withdrawing from the market meant the 99% would suffer also.

Question 3

Shiley used to come up with a theory every time a valve failed. For instance, one theory was that the cause of failure was how the valve was bent before it was welded. Though Shiley knew that those were just theories, they made new models based on new techniques in the market hoping that they would not fail. Failed never stopped regardless of the number of changes that were on each valve. It was after the doctors and FDA become alarmingly concerned that the company agreed to withdraw the valve form the market fully. It is unfortunate because the last design was never reported to have failed.

Question 4

According to the utilitarian theory, an action is considered good if the motive is to promote happiness to those performing it and those around. An action is qualified to be wrong if the intentions are to bring the reverse of happiness. According to the Shiley, their invention was meant to save the lives of several people who had heart defects. Statistically, their device was doing alright since only 1% failure occurred. Therefore, according to this ethical theory, the Shiley was correct by whatever they did. Their invention was meant for the joy of the patient and not their death. They were ethically right.

Question 5

According to Kant, the only intrinsically good thing a will that is good. The theory goes further to say that action qualifies to be good only if it has a duty to the moral law as the principle behind. The moral law is categorically imperative and acts on all people irrespective of what their desires are or interests. Shiley found out that they will be not only to make money but also to save the majority of the people with heart diseases. According to this ethical theory, they were right. They never considered what other people felt or thought, they only saw the 99% chance of saving a life.

Question 6

Safe medical device act protects people as follows;

All incidents are required to be reported if a medical device failure or user error occurs causing serious injuries or even death to the patient. The physician is exempted from this. All the reports that have been compiled are made available for the public through the FDA. If the device is of unknown manufacturer, it should be reported to FDA facility available.

Earlier before the amendment, the hospital or the ambulatory would report to the manufacturers. However, this is left to the facilities discretion. The medical device was redefined such that other things were included such as the lasers.

Reference

White, M. D. (2011). Kantian ethics and economics: Autonomy, dignity, and character. Stanford, Calif: Stanford University Press.

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