Under the Mammography Quality Standards Act (MQSA), FDA regulates personnel qualifications, quality control and quality assurance programs, and accreditation and certification of mammography facilities. FDA also has regulations covering the safety and effectiveness and radiation control of all x-ray imaging devices. Individual states and other federal agencies regulate the use of imaging devices through recommendations and requirements for personnel qualifications, quality assurance and quality control programs, and facility accreditation.
FDA conducts and supports research, development, and training, and maintains liaisons with other government agencies, industry, and professional organizations to minimize exposure of people to unnecessary radiation from all types of electronic products. FDA has formed partnerships to promote incorporation of aspects of radiation safety into imaging accreditation programs, personnel certification requirements, and relevant federal and state regulations and guidelines. These efforts are intended to encourage facilities to make use of the new equipment features, training information, and radiation-safety-metric tracking methods. Some of these collaborative efforts are described below.
Centers for Medicare & Medicaid Services
In accordance with Section 1834(e) of the Social Security Act as amended by the Medicare Improvements for Patients and Providers Act of 2008, by January 1, 2012 freestanding advanced diagnostic imaging facilities (performing CT, MRI, nuclear medicine) that seek Medicare reimbursement must be accredited by one of three accreditation organizations (the American College of Radiology, the Intersocietal Accreditation Commission, or The Joint Commission) recognized by the Centers for Medicare & Medicaid Services (CMS). CMS has posted further information on Advanced Diagnostic Imaging Accreditation. CMS and FDA have also engaged in ongoing discussions about radiation safety issues for these advanced imaging modalities.
This requirement does not apply to hospitals, which are subject to separate Medicare Conditions of Participation at 42 CFR 482.26 and 42 CFR 482.53, governing the provision of radiologic and nuclear medicine services. Information regarding CMS interpretive guidelines for these hospital regulations can be found in the State Operations Manual Appendix A- Survey Protocol, Regulations, and Interpretive Guidelines for Hospitals. FDA is working with CMS to update this guidance.
For further information about CMS regulations and guidelines, see the full list of CMS Internet-Only Manuals.
The individual states have the authority to regulate users, practitioners, prescribers, and facilities. A number of states are updating their regulations to address radiation safety and patient protection in medical imaging. The Conference of Radiation Control Program Directors (CRCPD) publishes Suggested State Regulations for the Control of Radiation, which may be voluntarily adopted by states. FDA will continue to engage CRCPD to update its Suggested State Regulations to address facility quality assurance and operator qualifications.
An important role of professional organizations is to ensure that facilities and state inspectors have the information they need to follow these new regulations. Examples of such efforts include training for state CT inspectors run jointly by the American Association of Physicists in Medicine (AAPM) and CRCPD in May 2011 (presentations including an inspection checklist are publicly available) and recommendations of the California Clinical and Academic Medical Physicists (C-CAMP) on how to implement the new California dose reporting law (SB 1237).
Federal Guidance Document
FDA worked with the Environmental Protection Agency (EPA) and the Interagency Steering Committee on Radiation Standards (ISCORS) to develop and publicize the Federal Radiation Protection Guidance for Diagnostic and Interventional X-ray Procedures (FGR-14) on medical use of radiation in Federal facilities. While this comprehensive set of voluntary guidelines was written for federal facilities, most of the recommendations are applicable to all X-ray imaging facilities and professionals.