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Journal of Long-Term Effects of Medical Implants
Abstract of "The Ethics of Medical Device Safety"
How safe is safe? The design intent of a medical device is to offer maximum flexibility and low-cost, failsafe features. Easily said, these requirements are difficult to deliver in a litigious society where performance standards are uncommon. Medical device manufacturers face challenges as they strive to offer the ultimate in product safety, keeping the price affordable for the technology deployed, while making the usability of typically complex products common sense for the operator. Since microprocessors are able to assist designers in providing intelligent, multifunctional systems, care must be taken during the design process to balance technological ability with intuitive use. The medical device development process requires rigor that is not often taught to biomedical engineers. Ethical product development requires a process that will be described in this paper using as an example the development of a recent cardiopulmonary perfusion system. However, in the final analysis, the operator of any medical product holds the primary responsibility for understanding how to use the system in normal use as well as emergent situations; the technology is his or her backup.
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