FDA promotes tracking of radiation safety metrics (e.g. dose data and adverse events) by advocating the development of national registries and databases.
The FDA is working with imaging device manufacturers to ensure their equipment is capable of automatically recording dose, protocol data, and patient information in standardized formats.
Dose registries would enable facilities to compare their radiation doses to those delivered in other facilities for the same exam, and such comparisons over time could assist in optimizing patient radiation doses for medical imaging. The goals of tracking imaging exams and the associated radiation exposure include: (1) providing information at the point-of-care for the referring practitioner (i.e. supporting justification); (2) promoting development and use of diagnostic reference levels (DRLs) (i.e. supporting optimization); (3) providing information for assessment of radiation risks; and (4) establishing a tool for use in research and epidemiology.
The FDA continues to collaborate with key stakeholders to identify data sources and develop systems that will advance goals of establishing free public access to dose information on a variety of medical imaging exams. This long-term effort will facilitate the establishment of national diagnostic reference levels where they do not yet exist and allow for broad validation of reference levels that have been developed to date.
The FDA is working with:
- the Conference of Radiation Control Program Directors (CRCPD) to collect dose data through the Nationwide Evaluation of X-ray Trends (NEXT) program. Also, CRCPD's Taskforce on CT Brain Perfusion Exposure Survey developed procedures for collecting protocol and dose information in various states via phone interviews and site visits.
- the National Council on Radiation Protection and Measurements (NCRP) in developing diagnostic reference levels (DRLs), based in part on FDA/CRCPD NEXT data, for the most common medical imaging procedures. The draft report "Diagnostic Reference Levels in Medical and Dental Imaging: Recommendations for Applications in the United States" was released for public comment by NCRP in February 2011.
- the Alliance for Radiation Safety in Pediatric Imaging and the Medical Imaging and Technology Alliance (MITA) on an Image Gently survey for digital radiography. The purpose of the study is to develop technique charts for digital X-ray equipment, categorized by detector type and manufacturer, based on characterization of the state of clinical practice for selected routine pediatric radiographic examinations.
- the Veterans Administration (VA), Department of Defense (DoD), Indian Health Service, and CDC's National Center for Health Statistics about the possibility of creating a federal dose registry.
- the American College of Radiology (ACR) regarding its Dose Index Registry , NCI, the Quality Assurance Review Center (QARC), the American College of Cardiology and the Society of Interventional Radiology to further collect and analyze medical imaging exposure data. Through these discussions, FDA has identified types of information and equipment features that would be useful, and has followed up with manufacturers to address any features that are currently unavailable.
- the Centers for Disease Control and Prevention to co-sponsor the National Academies of Science Beebe Symposium on Tracking Radiation Exposure From Medical Diagnostic Procedures in December 2011. FDA staff gave presentations at the Beebe Symposium and at the ACR Dose Monitoring Forum in November 2011.
- the International Atomic Energy Agency (IAEA) on endorsing a "Joint Position Statement on the IAEA Patient Radiation Exposure Tracking" through efforts such as the IAEA Smart Card/SmartRadTrack Project .
The Centers for Medicare & Medicaid Services (CMS) uses quality measures for various quality initiatives including quality improvement and public reporting. CMS has submitted a list of measures under consideration for 2012 to the National Quality Forum (NQF)-convened Measure Applications Partnership (MAP) for multi-stakeholder group input. A number of the measures under consideration relate to radiation dose optimization for medical imaging (e.g., percentage of CT exams reported to a radiation dose index registry and percentage of pediatric CT imaging studies that use individualized protocols in compliance with widely used guidelines). More information on the CMS quality reporting programs, including currently adopted imaging efficiency measures, can be found on the QualityNet website.
The FDA is currently working with CRCPD to better define medical radiation adverse events and improve reporting of incidents (e.g. through establishment of a national adverse event database ). FDA expects this work will sustain awareness of adverse events related to unnecessary radiation exposure and further clarify, for industry and facilities alike, when medical radiation adverse events are reportable.