FDA Issues Amendments to the Federal Radiation Safety Performance Standard for Diagnostic X-Ray Systems

FDA recently issued amendments to the performance standard for diagnostic x-ray systems. The new amendments update safety requirements to address new technology and new uses for diagnostic x-ray systems. Within one year, manufacturers will have to produce systems that comply with the amendments. One new aspect of the standard will require fluoroscopic x-ray systems to display information on the amount of radiation exposure a patient receives during an imaging procedure. This will allow physicians to reduce the exposure when possible.

Fluoroscopy is a technique for generating x-ray images and presenting them continuously as visible images during a diagnostic or interventional procedure. It is usually used to track the movement of a dye (contrast agent) or an object through the body. Some examples of fluoroscopy include viewing contrast agents moving through the upper GI tract, examining blood flow to organs, or directing the placement of a catheter during angioplasty.

• Federal Register: Electronic Products; Performance Standard for Diagnostic X-ray Systems and Their Major Components [PDF]
• Questions and Answers about the Radiation Safety Performance Standard for Diagnostic X-Ray Systems
• CDRH Radiological Health Program - New Directions
• Changes to the Performance Standard for Diagnostic X-Ray Systems (Published June 10, 2005) [PDF]