Abstract

In this document, we look at how the study of devices and instruments fits into the undergraduate biomedical engineering (BME) curriculum. Our goal is to review the current state of BME curricula in this area and to delineate the core topics that all biomedical engineering students should understand. These include how modern biology and clinical medicine can be integrated in this aspect of biomedical engineering; how biomedical engineering science topics underpin this area of specialization, and what critical skills in this area should be gained by all undergraduate biomedical engineering students. To fully understand this area we must begin with a definition of what is included when we consider devices and instrumentation. Medical devices refer to hardware, and in the broadest sense refer to that hardware that is used in understanding, assessing, manipulating, and treating living things. Medical devices can cover a very broad range such as from tongue depressors and cotton tipped applicators through heart valves and complex machinery such as cardiopulmonary bypass systems or MRI imagers. Needless to say this is a very expansive definition and could cover most of the BME field. For the purpose of this document we will limit our definition of devices to be those components that are covered by the FDA Medical Devices Act of 1976 and are applied in some direct way to living organisms. The biomedical instrument is a special subclass of device that is used to make measurements of biologic or medical quantities and give quantitative (or sometimes qualitative) results of this measurement. In considering the devices and instruments aspects of the BME curriculum, we will not cover those areas that are major subcategories of biomedical engineering themselves such as medical imaging devices, artificial organs, and signal processors since these are covered elsewhere.

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