ACR Statement on FDA Radiation Reduction Program

ACR Statement on FDA Radiation Reduction Program

The American College of Radiology (ACR) supports and is actively pursuing the goals of reducing any unnecessary radiation exposure that patients might receive from medical imaging exams and ensuring that patients receive appropriate imaging care. The ACR thanks the U.S. Food and Drug Administration (FDA) for recognizing the need for such efforts and supporting efforts to make sure that these issues are properly addressed.

The advent and increased use of medical imaging exams and image guided therapies has made it possible to diagnose disease earlier than ever before, improved treatment planning, and enabled more accurate, cost-effective therapies that help save lives every day.

While adverse events, such as those outlined in recent media reports are rare, they do underscore the need for continual steps to help ensure that patients receive the safest, most appropriate care possible. As the FDA stated, there is disagreement over the extent of the risk associated with exposure to radiation from medical imaging. However, there is broad agreement that steps can and should be taken to reduce radiation exposure and the ACR has been a leader in this process.

The American College of Radiology (ACR) advises that no imaging exam should be performed unless there is a clear medical benefit that outweighs any associated risk. The ACR supports the ‘as low as reasonably achievable’ (ALARA) concept which urges providers to use the minimum level of radiation needed in imaging exams to achieve the necessary results. ACR is a founding participant in the Image Gently™ campaign for dose reduction in pediatric imaging and has launched, Image Wisely, an adult radiation dose reduction effort.

While imaging growth is in line with, or below that of other physician services, appropriate use of imaging can be addressed by wider adoption of ACR Appropriateness Criteria®, which help physicians prescribe the most appropriate imaging exam for more than 200 clinical conditions (particularly when an imaging exam that does not use radiation may be more appropriate for a given condition), and point of entry physician ordering systems based on this tool, such as the 2010 Medicare pilot project mandated by the Medicare Improvements for Patients and Providers Act of 2008.

The College has long advocated for mandatory accreditation for providers of advanced medical imaging and was a driving force behind the inclusion of accreditation requirements for nonhospital providers of such imaging included in the MIPPA Act. The ACR would support expansion of the accreditation requirements to hospital and outpatient providers of advanced imaging and to all radiation oncology providers as well and looks forward to working with the FDA to refine the quality assurance practices inherent to these programs.
ACR accreditation ensures that:

1. The physician interpreting scans has met stringent education and training standards

2. The technologists operating the equipment are certified by the appropriate body

3. The imaging equipment is surveyed regularly by a medical physicist who makes sure that it is functioning properly, it is taking optimal images, and assesses radiation dose levels.

As the FDA recognized, the ACR has previously established a CT dose registry and encourages all providers of these exams to take part. We are hopeful that FDA backing of this effort will lead to enhanced participation on the part of CT facilities nationwide. This registry can help gauge the ongoing effectiveness of radiation reduction efforts and the quality assurance baseline provided by nationwide accreditation.

The College has, as part of the Alliance for Radiation Safety in Pediatric Imaging helped create an imaging record card that patients, and particularly parents, can utilize to keep track of their imaging exams and those of their children. We encourage all patients to use this low-tech, but very important tool, while the imaging community, the FDA, and others work toward the ultimate goal of an electronic record of such exams for all patients.

Patients should use the imaging record card to keep a record of their X-ray history and before undergoing a scan, should ask their physician:

Why do I need this exam?

How will having this exam improve my health care?

Are there alternatives that do not use radiation which are equally as good?

Is this facility ACR accredited?

Is my child receiving a “kid-size” radiation dose (for pediatric exams)?

The ACR looks forward to working with the FDA, other government agencies and imaging stakeholders to help ensure that patients get safe, appropriate care. The College urges patients and providers to visit the “Radiology Safety” section of the ACR Web site as well as the “Radiation Safety” section of www.radiologyinfo.org, the patient information site co-managed by the ACR and the Radiological Society of North America (RSNA), and the Image Gently™ site (www.imagegently.org) for more information regarding radiation exposure from medical imaging exams.