Whole Body Scanning, Do You Really Need One?
Currently some medical imaging facilities are promoting a new use of computed tomography (CT), also called computerized axial tomography (CAT) scanning. This use is referred to as whole-body CT scanning or whole-body CT screening, and it is marketed as a preventive or proactive healthcare measure to healthy individuals who have no symptoms or suspicion of disease. At this time the FDA knows of no data demonstrating that whole-body CT screening is effective in detecting any particular disease early enough for the disease to be managed, treated, or cured and advantageously spare a person at least some of the detriment associated with serious illness or premature death. Any such presumed benefit of whole-body CT screening is currently uncertain, and such benefit may not be great enough to offset the potential harms such screening could cause. Public health agencies and national medical societies-the American College of Radiology, the American College of Cardiology, the American Association of Physicists in Medicine, and the American Heart Association -do not recommend CT screening.
CT is a diagnostic imaging procedure that uses x rays to obtain cross-sectional images of the body. Since its introduction and rapid adoption into medicine in the mid-1970s, CT has become recognized as a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
Important information regarding whole-body CT screening:
No screening indication approved: CT systems were manufactured and marketed for diagnostic use prior to the 1976 Medical Device Amendments and were placed in Class II based on the level of risk they present. These devices continue to be cleared for marketing for general imaging purposes. No data have been presented to the FDA to demonstrate that these devices are effective for screening, i.e., testing individuals without symptoms. Before FDA would allow such a claim or indication for use by the manufacturer, the manufacturer would have to provide valid scientific data for such a new use by submitting a premarket approval application for this new indication. This means that manufacturers of CT imaging systems cannot make claims that the products are intended to be used for screening non symptomatic individuals. Nevertheless, individual physicians may decide that a patient without symptoms can benefit from screening with CT even though data supporting such a use has not been submitted to the agency. Such use of a medical device is referred to as "off-label" use and is a judgment left to physicians. However, statements that say or imply that FDA has approved CT scanning for whole-body screening uses are not correct.
For more, please visit the Computerized Axial Tomography (CAT Scan/CT Scan) Center.
This information has been provided with the kind permission of the FDA (www.fda.gov).
Last Editorial Review: 7/7/2004
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