Methodology for the Clinical Assessment of Medical Instrumentation

Medical instruments can be used for screening, diagnosis, prognosis, and monitoring natural history or therapeutic intervention. With the developing role of ultrasonometry it is important to assess how these instruments will effectively be used for each of these utilizations. No two types of ultrasonometers are the same: there are differences in anatomical sites, measurement variables and methodology in obtaining those variables. To determine optimal utilization the clinician has to evaluate each instrument. Eight factors have to be considered for each utilization comprising of discrimination, precision, reliability, relevance, acceptance by regulatory authorities, inexpensive, acceptability to the patient, and safety. This paper discusses these factors and presents an overview in relationship to the utilization of instruments using ultrasonometry.