FDA is working with healthcare regulators and other agencies worldwide to strengthen the regulatory and legislative framework for radiation treatment and diagnosis to offer greater protections for patients from unnecessary radiation exposure.
The agency, along with participants from 77 countries and 16 organizations, met in December 2012 in Bonn, Germany, and developed a list of 10 priorities for radiation protection in medicine for the next decade – called the Bonn Call for Action. The International Atomic Energy Agency (IAEA) sponsored the meeting, in co-sponsorship with the World Health Organization (WHO). The Government of Germany hosted the event through the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety.
Attendees agreed to 10 principle action items, each of which includes sub-items, to strengthen radiation protection over the next decade. The first action item is to enhance the implementation of the principle of justification. This action item calls for introducing and applying the 3A's of awareness, appropriateness, and audit as tools to facilitate and enhance justification for radiation use. Included in this action item is the sub items of developing harmonized evidence-based criteria to ensure appropriate use of clinical imaging and conducting additional clinical audits to ensure that justifications are an effective, transparent, and accountable part of the normal radiological practice. FDA is participating in developing the International Commission on Radiological Protection's (ICRP) guidance on justification in medicine.
The second action item is to enhance the implementation of the principle of optimization of protection and safety. A sub-item calls for establishing, using, and regularly updating diagnostic reference levels for radiological procedures, including interventional procedures, in particular for children. Another sub-item calls for harmonizing the criteria for releasing patients after radionuclide therapy as well as the dose data formats provided by imaging equipment. FDA has worked with the American College of Cardiology (ACC; Washington) to incorporate radiation dose data in procedure data submitted to the ACC's National Cardiovascular Data Registry, and is working with the Society of Interventional Radiology (SIR; Reston, Virginia) to accomplish the same.
Thirdly, attendees agreed to strengthen manufacturers' role in contributing to the overall safety regime. The sub-actions include enhancing the radiation protection features in the design of both physical equipment and software and making these available as default features rather than optional extra features. In this area, the agency is actively engaged with standards development and industry organizations to introduce safety features into the national and international standards for medical devices.
The fourth action item is to strengthen radiation protection education and training of health professionals. This action items calls for prioritizing radiation protection education and training for health professionals globally, targeting professionals using radiation in all medical and dental areas. FDA has provided financial support and subject matter experts for a National Council of Radiation Protection & Measurements (NCRP) report, currently in preparation, on radiation protection in dentistry.
As a fifth item, attendees agreed to shape and promote a strategic research agenda for radiation protection in medicine. For example, a sub-action call for exploring rebalancing radiation research budgets in recognition of the fact that an overwhelming percentage of human exposure to man-made sources is medical and exploring the possibility of identifying biological markers specific to ionizing radiation. Another sub-action calls for promoting research to improve methods for organ dose assessment, including patient dosimetry when using unsealed radioactive sources, as well as external beam small-filed dosimetry. The FDA did not comment as to it work related to this action item.
The sixth item is to increase availability of improved global information on medical exposures and occupational exposures in medicine. The sub actions call for improving the collection of dose data and trends on medical exposures globally, and especially in low- and middle-income countries, by fostering international cooperation. The data would then be made available as a tool for quality management and trending analysis, decision-making, and resource allocation. FDA said it has worked with the ACC to incorporate collecting radiation dose data as part of the National Cardiovascular Data Registry.
The seventh item is to improve prevention of medical radiation incidents and accidents. Sub-actions include implementing and supporting voluntary educational safety reporting systems to learn from the return of experience of safety related events in medical uses of radiation and implementing prospective risk analysis methods to enhance safety in clinical practice. FDA said it is an active participant in the American Association of Physicists in Medicine AAPM, American Society for Radiation Oncology (ASTRO), and American Society of Radiologic Technologists (ASRT) annual meetings.
As an eighth item, attendees agreed to strengthen radiation safety culture in healthcare. This item includes establishing patient safety as a strategic priority in medical uses of ionizing radiation, and recognizing leadership as a critical element of strengthening radiation safety culture. It also includes fostering closer cooperation between radiation regulatory authorities, health authorities, and professional societies. FDA has met with members of the heads of the European Radiological protection Competent Authorities (HERCA) to develop a closer working relationship and promote convergence of regulatory efforts. FDA and HERCA have entered into a memorandum of understanding (MoU) and a Confidential Disclosure Agreement to aid in these efforts.
The ninth action item is to foster an improved radiation benefit-risk-dialogue. This action item includes increasing awareness about radiation benefits and risks among health professionals, patients, and the public. FDA staff have participated in WHO's Global Initiative on Radiation Safety in Health Care Settings since 2008, and serve on the Core Group of Experts. One of the goals of this initiative is to raise awareness of the safe use of radiation in medicine among health authorities, health policy makers, healthcare providers, patients, and public.
The final action is strengthening the implementation of safety requirements globally. One sub-action includes developing practical guidance for implementing the International Basic Safety Standards in healthcare globally and working toward an active decision-making process for patients. Other sub actions include creating a legislative and administrative framework to protect patients, workers, and the public at the national level, enforce requirements for radiation protection education, training of health professionals, and performing on-site inspections. FDA staff members consultant the IAEA in developing radiation safety related reports and publications. The agency also has trained its inspectors on special issues related to X-ray imaging devices and provided inspectors tips on issues to focus on when inspecting an X-ray equipment manufacturer's facility.