Equipment Safety Features
The FDA seeks to improve equipment design and pre-market evaluation for safety and effectiveness through guidance, national and international standards, research, and outreach. Goals include equipment that incorporates:
- default protocols or suggested exposure charts in labeling to support delivery of optimized dose and image quality;
- dose reduction features that are appropriately designed and evaluated;
- automatic notification before delivery of a high dose; and
- controls to assure that access to exam protocol and equipment settings is limited to authorized staff.
Specific activities include:
Guidance to Industry and FDA Staff
The FDA is currently drafting guidance on:
- CT equipment to assure safety and effectiveness and to provide improved instructions for use; and
- pediatric information for X-ray imaging device (CT, fluoroscopy, radiography) premarket notifications.
FDA has announced a public meeting for July 16, 2012 to solicit comments on the draft guidance entitled “Pediatric Information for X-ray Imaging Device Premarket Notifications” and broader radiation safety issues for use of X-ray imaging devices on pediatric populations.
Standardized Dose Reporting
- The FDA is working with the Medical Imaging and Technology Alliance (MITA) to ensure that necessary dose and patient information (e.g. size and age data) for X-ray imaging procedures are recorded in the Digital Imaging and Communications in Medicine (DICOM) radiation dose structured reports, so they can be easily transferred to a dose registry.
- Manufacturers are also working to ensure that their devices support the Integrating the Healthcare Enterprise (IHE) Radiation Exposure Monitoring profile.
- The FDA contributed to an industry standard, Computed Tomography Dose Check , published Oct. 1, 2010 by the National Electrical Manufacturers Association (NEMA). This standard defines safeguards to help prevent CT scanners from delivering excessive radiation. The CT Dose Check notifications and alerts call the user’s attention to what might be high-dose settings and they offer a “time-out” opportunity for the user to confirm or change scan settings before proceeding.
- The FDA continues to engage in discussions with the NEMA Medical Imaging and Technology Alliance (MITA) CT group about development of an access-control standard, which will establish user privileges, require verification of changes, and track modifications.
- MITA is also developing user information guidelines to identify key components of instructions for use recommended in FDA's November 2010 letter to MITA.
- The FDA has made detailed proposals to the International Electrotechnical Commission (IEC) CT standards maintenance team regarding new safe-use features, automatic dose recording, and image quality evaluation.
- The FDA has signed a Memorandum of Understanding with the Heads of the European Radiological Protection Competent Authorities to share information on promoting radiation protection in CT imaging.
The FDA is engaged in discussions with the MITA Cardiovascular and Interventional group about their new Task Force on Dose Exposure in Fluoroscopy. Activities include:
- harmonization of FDA regulations and IEC standards; and
- working with the American Association of Physicists in Medicine (AAPM) to define improved features for physics testing modes.