ACR balks at FDA control of CT; promotes its model

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A New England Journal of Medicine ( NEJM) article suggesting FDA jurisdiction over CT use has sparked an uproar in the radiology community. The American College of Radiology (ACR) and Society of Computed Body Tomography and Magnetic Resonance (SCBTMR) offered an alternative solution in a joint statement issued on June 29.

The organizations instead recommend that the government adopt existing ACR guidelines as requirements for imaging providers.

“Direct FDA jurisdiction over how CT scanners are used—including radiation dose requirements—as suggested recently by an article published online in the NEJM, is likely a logistical impossibility given number of scanner types, scanner generations, and the variety of indications for which medical imaging serves an appropriate role,” wrote the ACR and SCBTMR. Narrowly defined regulations could inhibit the flexibility physicians need to access and enable informed patient care, the organizations continued.

Instead, the government should require all imaging providers adhere to existing, previously voluntary, programs that have proven effective, offered the ACR and SCBTMR. The ACR/SCBTMR model allows for more immediate adoption than the FDA option and could provide a more effective way to address radiation dose and appropriate utilization of imaging exams, according to the statement.

Existing ACR programs shown to be effective include:

  • Computerized exam ordering systems based on ACR Appropriateness Criteria help doctors prescribe the best exam for a patient’s given condition, inform them when an exam that does not use radiation may be more appropriate or when no scan may be warranted at all. This could reduce unnecessary exams and radiation exposure to patients.
  • ACR facility accreditation requires facilities to maintain image quality, checks radiation dose used and minimizes the likelihood of adverse events such as those highlighted in recent news reports, by requiring physicians to meet certain education/training standards, scanners to be surveyed regularly by a medical physicist to ensure proper function, and technologists operating scanners to be certified.
  • The ACR CT dose index registry will allow providers to submit radiation dose data so facilities can compare their CT dose indices against realistic national benchmarks and re-examine their imaging protocols if necessary. It also will alert facilities if a dose threshold has been exceeded.

 
The ACR and SCBTMR also voiced support for the National Council of Radiation Protection and Measurements’ effort to develop more detailed CT reference levels that include more exam types and body areas. The ACR CT dose index registry will aid in the development of DRLs and provide scientific feedback regarding the effectiveness of radiation dose reduction efforts over time.