Biomedical Engineering Reference
In-Depth Information
kept for a certain period of time, and an SOP for quality records would govern this
aspect. If there are raw materials used in the manufacture of medical devices, which
have been tested for certain applications and have been found to have acceptable
properties, they should be disclosed. This could speed up the validation process,
prevent unnecessary animal tests from being conducted, and save time and money.
The FDA, and in some cases parallel organizations in certain states, routinely
audit a firm's quality system. These audits determine whether the quality system
is consistent with the regulations and whether it describes actual operations. The
quality system is the yardstick against which regulatory authorities measure com-
pliance. Although the primary definition of the content of a quality system is found
in 21 CFR 820, other FDA regulations that must be taken into account include
those governing labeling, medical device reporting, and reports of corrections and
removals (or recalls). If the FDA finds a manufacturer to be in violation of FDA
rules, the consequences can be serious: warning letters, mandatory product recalls,
inability to ship products, and criminal penalties for individual managers may
occur.
Problems
11.1 Recently, the use of embryonic stem cells has been controversial. Write five
bulleted points from the perspective of a person who ethically thinks it is: (a)
right to use them and (b) wrong to use them in biomedicine.
11.2 The face of a French citizen was mauled by a dog, which led to a few portions
being completely lost. Physicians had to reconstruct the entire face using the
face of another deceased person. Since the face has many meanings to different
people, it raised a number of ethical issues. Summarize the risks and benefits
of facial transplant research.
11.3 In your organization, one of the basic steps of bioethical training is to take a
multiple choice test through the Internet. Identify if your company has such
a test. If you can take the test, provide a printout of your score on various
modules.
11.4 You are interested in demonstrating some biomedical applications to high
school students visiting your campus. You want to know the effectiveness of
the demonstration for which you have to survey the students (the majority of
them minors) before and after the demonstration. Write the steps involved in
taking this action.
11.5
A bioengineer has developed a novel porous structure. She is interested in test-
ing it in mice. However, she is not sure of the process involved. Please explore
the IACUC in your institution and write the steps involved in obtaining an
approved protocol.
11.6
Determine how many nontechnical members are present in your institution's
IRB. How many of them do not work in the institution?
11.7
Your company is interested in selling their new pacemakers in Italy. Write
the initial approach you would pursue in terms of whom you contact or
