Biomedical Engineering Reference
In-Depth Information
CHAPTER 11
Ethical, Legal, and Societal Aspects
11.1 Overview
The intention of biomedical engineers is to develop tools and methodologies that
help in the diagnosis, treatment, or monitoring of human disease or injury. In
previous chapters, various design considerations were discussed. To maintain ho-
meostasis for which one has to measure, investigate, replace, or support human
physiological functions, requires consideration of various human factors. For ex-
ample, to evaluate a developed prosthetic device, one has to test the efficacy of the
device in a human subject. While performing these tests, a biomedical engineer has
to consider the safety of the test patient, history (both the health and the cultural)
of the test patient, and the potential harm to the test patient if the device fails. How-
ever, if the device is not tested before, many times it is difficult to predict the success
in the clinical settings. During these interactions, it is paramount to perform the
studies legally and ethically so that patient is not abused for the benefit of develop-
ing the device. Historical evidence shows that many times monetary benefits invoke
the abuse of other human beings while developing and utilizing a device. This has
warranted development of many regulatory policies and procedures to be followed
during research, and clinical operations that help in safe implementation. These is-
sues can be grouped into five categories as shown in Figure 11.1.
A number of agencies and policy boards have been developed at the local,
national, and international levels. Understanding these procedures and policies is
critical to the successful development of a biomedical device. For example, if a re-
searcher is interested in testing the developed device on human subjects or animal
models, then understanding the procedure to conduct research within the bioethi-
cal framework is necessary. The Federal Drug Administration is responsible for
the regulation of drugs and medical devices within the United States, and does not
regulate the practice of medicine. Thus, many procedures have to be approved
by the internal oversight committees within a clinical setting. While developing
devices for the international community, different countries have different cultural
influences and different ethical reasoning. World population is also very diverse in-
cluding altered anthrophometry composition and socioeconomic conditions. With
the globalization of manufacturing, one has to understand and comply with the
minimum standards. Understanding the minimum safety requirements for a differ-
ent country during the development of a biomedical device is also important. In
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