ABSTRACT
Manufacturers develop products that fit the corporate vision and maximize their return on investment. The expense and time required by the FDA regulatory approval process have a negative impact on product innovation. I propose the following approach: Reduce the amount of documentation required for a PMA or 510(k). Reduce approval times through cooperative interaction among manufacturers, clinicians, and the FDA throughout the product-development process. Allow independent agencies to provide product approvals. Efficacy assessment guidelines should be a function of the level of risk and the claims made for the marked device.
Subject(s)
Consumer Product Safety , Industry , Technology Assessment, Biomedical , Ventilators, Mechanical/trends , Cost-Benefit Analysis , Diffusion of Innovation , Efficiency, Organizational , Organizational Objectives , Respiration, Artificial/trends , United States , United States Food and Drug AdministrationABSTRACT
The reverse redistribution phenomenon (RR) with the apparent worsening of a stress-induced defect or appearance of a new area of relative hypoperfusion does not always indicate coronary artery disease as previously suggested. RR does not correlate closely with the degree of coronary artery disease, nor with the location of the stenosis. Multiple mechanisms are hypothesized wherein the "defect" may be located in the best or worst perfused area.
Subject(s)
Coronary Disease/diagnostic imaging , Radioisotopes , Thallium , Coronary Angiography , Coronary Circulation , Exercise Test , Female , Humans , Male , Physical Exertion , Radionuclide Imaging , Rest , Time FactorsABSTRACT
Bone scintigraphy is of diagnostic value in stress fractures where radiography may not be helpful. Obtaining early blood pool images during scintigraphy for suspected stress fractures may help to identify soft tissue inflammation (plantar fascitis) when delayed images are normal.
