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Page: << Prev | 1 | 2 | 3 | Next >> The agency said it hopes these measures "will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure."
One expert welcomed the move.
"Studies published within the past several months have demonstrated a dramatic uptick in radiation exposure from diagnostic tests such as CT scans over recent years, with the aggregate exposure large enough to constitute a meaningful cancer risk at the population level," said David Katz, director of the Prevention Research Center at Yale University School of Medicine. "I know from up close and personal, working in clinics, ERs and CCUs over the years, that while much of this testing is warranted, and even essential, a considerable portion is neither."
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"The actual risks of any given scan for an individual are small, and well worth taking for valuable diagnostic information," Katz added. "But even that small risk is far too high a price to pay for a scan that is not truly necessary."
"Standardizing criteria for exposing patients to radiation is a welcome, needed and potentially important advance," Katz noted. "Enforcing such criteria without hindering the application of good clinical judgment will be challenging for the FDA, however. Still, establishing standards is the right first step. In medical care, the only acceptable standard is the very best we can, and we can do better than this."
The FDA also plans to require makers of CT and fluoroscopic devices to build safeguards into their machines and to develop safer technology, and to train users of these devices on their proper use. The agency will hold a meeting in late March to get expert opinion on what needs to be done to improve the safety of these devices.
Some suggestions under consideration include requiring the devices to display and record the radiation dose being administered. The FDA said it may also require that the devices record and transmit the radiation dose used to a patient's electronic medical record as well as to a national radiation doses database.
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