The FDA is partnering with a number of organizations to promote awareness of radiation safety among patients and medical professionals. These efforts seek to develop practical tools to limit medical radiation exposure through improved communication of risk and benefit, facility quality assurance, and personnel training. Many of FDA's efforts focus on working with professional organizations and manufacturers to improve educational material, which was identified as an important issue during FDA's March 30-31, 2010 public meeting.
- Radiation Risk Communication
- Patient Medical Imaging Record Card
- CT Imaging
- Pediatric Imaging
- Radiation Protection
- Radiation Safety in Cardiology
As highlighted in the National Council on Radiation Protection and Measurement's 2010 annual meeting on Communication of Radiation Benefits and Risks in Decision Making [proceedings published in Health Physics, 101(5), 497–629 (2011)], communicating about risks of radiation exposure with patients and especially parents of young children undergoing imaging exams poses special challenges. The Image Wisely and Image Gently campaigns, International Atomic Energy Agency’s (IAEA) Radiation Protection of Patients site, and other efforts seek to create awareness and provide tools that patients, parents, and healthcare providers can use to become better informed about the risks and benefits of medical imaging that uses ionizing radiation. Also, FDA is in the process of updating its medical imaging webpages to catalog up-to-date resources for patients, health care providers, and industry.
The FDA collaborated with Image Wisely, a consortium of medical imaging professional groups dedicated to raising awareness of radiation safety in adult medical imaging, to develop a Patient Medical Imaging Record card. This card may be used to track the date, type, and location of radiology exams and foster discussion among patients and health care professionals. A goal is to help reduce repeat exams performed due to insufficient knowledge of the patient medical imaging history.
Over time, advances in technology, integration of medical information systems, and adoption of electronic medical records may permit electronic transmittal, storage and review of patient records and images. An important aspect of automated tracking systems is universal adoption of a uniform Electronic Health Record (EHR), particularly to track individual patient exams so that imaging studies are not repeated unnecessarily. The Centers for Medicare & Medicaid Services (CMS) has an Electronic Health Record Incentive Program designed to encourage adoption of EHR technology.
The FDA is:
- working with Image Wisely to help identify suggested improvements in CT online dose reduction information (e.g., available on the Image Wisely My Equipment page). The FDA considers such efforts from industry to improve their publicly available educational information an important priority.
- serving on an American Association of Physicists in Medicine (AAPM) Working Group on Standardization of CT Nomenclature and Protocols, which also includes the American College of Radiology (ACR), the American Society of Radiologic Technologists (ASRT), the Medical Imaging and Technology Alliance (MITA), and representatives from all major U.S. CT manufacturers. This workgroup has also provided important technical advice to industry on how to best fulfill the recommendations in FDA's November 2010 letter to MITA following the CT brain perfusion safety investigation. The following information is publicly available on the AAPM website:
- protocols for some commonly performed CT exams;
- a lexicon that provides a map between different vendors' CT terminology; and
- "Recommendations Regarding Notification and Alert Values for CT Scanners: Guidelines for Use of the NEMA XR 25 CT Dose Check Standard."
The FDA awarded two contracts in August 2010 and August 2011 to the Alliance for Radiation Safety in Pediatric Imaging (ARSPI) to:
- develop a safety checklist, instructional pamphlet, and quality improvement program for digital radiography (available on the ARSPI website); and
- improve instructions for pediatric fluoroscopy (ongoing project).
Manufacturer involvement through MITA is also important to the success of such pediatric dose reduction projects, particularly in addressing vendor-specific issues.
For more information on radiation protection of pediatric patients, please see FDA’s Pediatric X-ray Imaging web page.
FDA staff have participated in drafting documents with:
- the National Council on Radiation Protection and Measurements (NCRP);
- the International Atomic Energy Agency (IAEA); and
- the International Commission on Radiological Protection (ICRP).
These organizations have developed a wealth of publicly available information devoted to radiation protection issues in medical imaging. The IAEA and ICRP documents form the bases for many countries' radiological protection guidelines and regulations. These documents deal with both patient radiation protection and occupational radiation protection. FDA staff have participated in working groups to develop:
- an ICRP publication on radiological protection outside the imaging department in fluoroscopically guided procedures;
- new guidelines on occupational radiation protection issues in interventional procedures; and
- new guidelines on use of diagnostic reference levels for diagnostic and interventional imaging.
Because of the relatively high doses involved in many cardiovascular imaging procedures, radiation safety awareness by cardiologists is crucial. FDA staff have helped develop a comprehensive ICRP publication on radiation safety in cardiology.
The FDA also participated in a meeting "Developing an Action Plan for Radiation Safety in Cardiovascular Medicine" (Feb. 27-28, 2011) sponsored by The American College of Cardiology (ACC), the American Heart Association (AHA), and the Duke University Clinical Research Institute. Follow-up efforts by the ACC and AHA include forming working groups to address equipment, training and quality assurance, and scientific issues and publishing a report, to which the FDA contributed technical comments.