"Working together," said Shuren, "the FDA and other organizations hope to help patients get the right imaging exam, at the right time, with the right radiation dose."

The three-pronged initiative the FDA is announcing will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure.


The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish.

Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient's electronic medical record and to national dose registries.

In addition, the FDA and the Centers for Medicare and Medicaid Services are collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. These quality assurance practices will improve the quality of oversight and promote the safe use of advanced imaging technologies in those facilities.

The FDA recommends that health care professional organizations continue to develop, in collaboration with the agency, diagnostic radiation reference levels for medical imaging procedures, and increase efforts to develop one or more national registries for radiation doses.

A dose registry would pool data from many imaging facilities nationwide, capturing dose information from a variety of imaging studies. This registry will help define diagnostic reference levels where they do not yet exist, validate levels that do exist, and provide benchmarks for health care facilities to use in individual imaging studies.

In a bid to empower patients and increase awareness, the FDA is collaborating with other organizations to develop and disseminate a patient medical imaging history card. This tool, which will be available on the FDA's Web site, will allow patients to track their own medical imaging history and share it with their physicians, especially when it may not be included in their medical records.

More HCB News