Health Prostheses

Even with this somewhat stricter definition, there is room for discretion. A sportsman who takes an occasional puff of a bronchodilator for exercise-induced asthma but is otherwise asymptomatic may be considered eligible by some. Individuals who have undergone surgery for a congenital condition and are in excellent health may or may not be suitable. Thus, an asymptomatic patient with a hip prosthesis who is taking no medication may be acceptable whereas an equally healthy individual with a prosthetic heart valve should be excluded from a study involving a cannula because of the risk, however remote, of endocarditis. Clearly, whatever definition of a healthy volunteer is used, sensible clinical judgement is still required. 

FIGURE 44.1 A caged-ball heart valve prosthesis. (Courtesy of Baxter Health Care, Irvine, CA.)... 

The research described in this article was supported in large part by the National Institutes of Health, the National Institute of Neurological Disease and Stroke Neural Prosthesis Program, and the Department of Veterans Affairs Rehabilitation Research and Development Service. Support was also received from the Food and Drug Administration Orphan Products Division, the Paralyzed Veterans of America Spinal Cord Research Foundation, the Movement Disorder Foundation, and the Shapiro Foundation. 

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