Feature | Radiology Imaging | July 06, 2015

This article appeared as an introduction to a Comparison Chart on CT Dose Management in the July/August 2015 issue.

The U.S. Food and Drug Administration (FDA) announced its latest efforts in supporting the Bonn Call for Action on radiation protection.

In December 2012, the German government hosted the International Conference on Radiation Protection in Medicine: Setting the Scene for the Next Decade. The meeting - sponsored by the International Atomic Energy Agency and co-sponsored by the World Health Organization - resulted in a list of priorities for radiation protection in medicine for the next decade, called the Bonn Call for Action. The meeting was attended by 536 participants from 77 countries and 16 organizations, including the FDA.

The Bonn Call for Action is divided into 10 principal actions, each of which is considered essential for strengthening radiation protection over the next decade. Each action is further subdivided into several sub-actions. As a regulatory agency, FDA shares in the responsibility for strengthening radiation protection of patients and health workers with other national and international agencies, researchers, educators, medical institutions, professional societies and individual practitioners. 

Some of the actions proposed by the Bonn conference are outside of FDA's role and authority. Many of the actions, however, are areas where FDA has made efforts and contributions. The following list of selected actions and sub-actions highlights areas where FDA is participating actively to implement the Bonn Call for Action.

Enhance the implementation of the principle of justification: FDA staff are participating in drafting the International Commission on Radiological Protection's (ICRP) guidance on justification in medicine. FDA staff have also made substantial contributions to Federal Guidance Report No. 14 (Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures), which discusses justification extensively and recommends the use of clinical decision support technology.

Enhance the implementation of the principle of optimization of protection and safety:

"¢ Ensure establishment, use of and regular update of diagnostic reference levels for radiological procedures.

"¢ Develop and apply technological solutions for patient exposure records, harmonize the dose data formats provided by imaging equipment and increase utilization of electronic health records.

Strengthen manufacturers' role in contributing to the overall safety regimen:

"¢ Ensure improved safety of medical devices by enhancing the radiation protection features in the design of both physical equipment and software and to make these available as default features.

"¢ Support development of technical solutions for reduction of radiation exposure of patients and health workers while maintaining clinical outcome.

"¢ Enhance the provision of tools and support in order to give training for users specific to the particular medical devices, taking into account radiation protection and safety aspects.

"¢ Reinforce the conformance to applicable standards of equipment with regard to performance, safety and dose parameters.

"¢ Strengthen cooperation and communication between manufacturers and other stakeholders.

"¢ Support usage of platforms for interaction between manufacturers and health and radiation regulatory authorities and their representative organizations.

Strengthen radiation protection education and training of health professionals:

"¢ Prioritize radiation protection education and training for health professionals globally, targeting professionals using radiation in all medical and dental areas.

"¢ Pay particular attention to the training of health professionals in situations of implementing new technology.

"¢ Improve collection of dose data and trends on medical exposures globally, especially in low- and middle-income countries, by fostering international cooperation.

"¢ Improve data collection on occupational exposures in medicine globally, also focusing on corresponding radiation protection measures taken in practice.

Improve prevention of medical radiation incidents and accidents: 

"¢ Work toward inclusion of all modalities of medical usage of ionizing radiation involuntary safety reporting, with an emphasis on brachytherapy, interventional radiology and therapeutic nuclear medicine in addition to external beam radiotherapy.  

"¢ Ensure prioritization of independent verification of safety at critical steps, as an essential component of safety measures in medical uses of radiation.

Strengthen radiation safety culture:

"¢ Establish patient safety as a strategic priority in medical uses of ionizing radiation, and recognize leadership as a critical element of strengthening radiation safety culture.

"¢ Foster closer cooperation between radiation regulatory authorities, health authorities and professional societies.

"¢ Foster closer cooperation on radiation protection between different disciplines of medical radiation applications as well as between different areas of radiation protection overall, including professional societies and patient associations.

"¢ Support integration of radiation protection aspects in health technology assessment.

Foster an improved radiation benefit-risk dialogue:

"¢ Increase awareness about radiation benefits and risks among health professionals, patients and the public.

"¢ Support improvement of risk communication skills of healthcare providers and radiation protection professionals, and involve both technical and communication experts, in collaboration with patient associations, in a concerted action to develop clear messages tailored to specific target groups.

Strengthen the implementation of safety requirements globally:

"¢ Develop practical guidance to provide for the implementation of the International Basic Safety Standards in healthcare globally.

"¢ Further the establishment of sufficient legislative and administrative framework for the protection of patients, workers and the public at the national level, including enforcing requirements for radiation protection, education and training of health professionals, and performing on-site inspections to identify deficits in the application of the requirements of this framework.  itn

Editor's note: This information was provided by the FDA. To read the complete initiative, visit www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm2007191.htm


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