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Questions and Answers about the Radiation Safety Performance Standard for Diagnostic X-Ray Systems

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About Fluoroscopy

Q: What is fluoroscopy?
Q: What are the risks from fluoroscopy?
Q: Do the benefits from fluoroscopy outweigh the risks of the procedure?

Amendments to the Performance Standard for Diagnostic X-Ray Systems

Q: What are the amendments to the performance standard?
Q: What are the new requirements for fluoroscopic x-ray equipment?
Q: How do the new requirements affect a patient’s diagnosis or treatment?
Q: How do the new amendments protect pediatric patients?
Q: Will the new amendments require changes to existing x-ray systems?
Q: When must manufacturers begin to comply with the new requirements?
Q: How will these amendments change the way a physician performs a fluoroscopic procedure?
Q: How do the amendments to the diagnostic x-ray standard fit in to FDA’s overall Radiological Health Program?

About Fluoroscopy

Q: What is fluoroscopy?
A: 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.

Q: What are the risks from fluoroscopy?
A: The two major risks associated with fluoroscopy are radiation-induced injuries to the skin and underlying tissues (“burns”) and the small possibility of developing a radiation-induced cancer some time later in life.

Q: Do the benefits from fluoroscopy outweigh the risks of the procedure?
A: When an individual has a medical need, the benefit of an x-ray procedure far exceeds the small cancer risk associated with the procedure. However, even when medically necessary, it is advisable to use the lowest possible exposure.

Amendments to the Performance Standard for Diagnostic X-Ray Systems

Q: What are the amendments to the performance standard?
A: The FDA is issuing a final rule to change the radiation safety performance standard for diagnostic x-ray systems, particularly fluoroscopic x-ray systems. This standard reflects new developments in technology and product usage, and it better aligns the U.S. standard with international standards (thus relieving manufacturers from having to meet two sets of requirements). The amendments require new equipment features to reduce radiation exposures while maintaining image quality.

Q: What are the new requirements for fluoroscopic x-ray equipment?
A: Equipment manufactured after the effective date of the amendments will need to include:

• displays of the duration, rate, and cumulative amount of radiation exposure patients receive.
• increased x-ray filtration (on certain types of equipment) to reduce the possibility of radiation injuries during long procedures.
• tighter controls on the size of the x-ray field to reduce the amount of radiation that falls outside the image target area.
• a last-image-hold feature so that physicians can view images without continually exposing patients to radiation.

Q: How do the new requirements affect a patient’s diagnosis or treatment?
A: The new requirements will help physicians know the radiation exposure their patients are receiving during fluoroscopic procedures. This will allow them to reduce the exposures when possible.

Q: How do the new amendments protect pediatric patients?
A: There is nothing in the amendments that is specific to pediatric patients. However, all of the new features to help reduce radiation exposures will also apply to pediatric patients. Because pediatric patients are more sensitive to the adverse effects of radiation, it is important to limit exposures only to those absolutely necessary. This is especially true for children who need repeated procedures over the course of their treatments.

Q: Will the new amendments require changes to existing x-ray systems?
A: No, the requirements will apply only to new systems manufactured and sold after the effective date of the amendments. Owners of existing x-ray systems who wish to upgrade their systems to meet the new requirements are encouraged to do so. Not all manufacturers will be able to supply upgrades to all models of x-ray systems.

Q: When must manufacturers begin to comply with the new requirements?
A: All new systems must comply with the new requirements beginning one year from the date the amendments are published (insert date when known).

Q: How will these amendments change the way a physician performs a fluoroscopic procedure?
A: The new displays will give information on the amount of radiation administered to the patient. With this real time information, the physician can limit the exposure time and avoid high exposures to radiation. The last-image-hold feature permits review of an image, when necessary, without continuing the radiation exposure to the patient during the review.

Q: How do the amendments to the diagnostic x-ray standard fit in to FDA’s overall Radiological Health Program?
A: The Radiological Health Program has shifted its focus to encourage better management of patient exposures. This is particularly important in high-exposure procedures such as fluoroscopy or computed tomography (CT). The fluoroscopy amendments are the first example of the new focus.

Updated June 10, 2005

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