Principle Of Fluoroscopy
Tarja Hempton
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Fluoroscopy is a type of medical imaging that shows a continuous X-ray image on a monitor, much like an X-ray movie. During a fluoroscopy procedure, an X-ray beam is passed through the body. The image is transmitted to a monitor so the movement of a body part or of an instrument or contrast agent ("X-ray dye") through the body can be seen in detail.
Fluoroscopy carries some risks, as do other X-ray procedures. The radiation dose the patient receives varies depending on the individual procedure. Fluoroscopy can result in relatively high radiation doses, especially for complex interventional procedures (such as placing stents or other devices inside the body) which require fluoroscopy be administered for a long period of time. Radiation-related risks associated with fluoroscopy include:
The probability that a person will experience these effects from a fluoroscopic procedure is statistically very small. Therefore, if the procedure is medically needed, the radiation risks are outweighed by the benefit to the patient. In fact, the radiation risk is usually far less than other risks not associated with radiation, such as anesthesia or sedation, or risks from the treatment itself. To minimize the radiation risk, fluoroscopy should always be performed with the lowest acceptable exposure for the shortest time necessary.
The clinical benefit of a medically appropriate X-ray imaging exam outweighs the small radiation risk. The FDA encourages patients and parents of pediatric patients to engage in a discussion with their health care provider about the benefits and risks of fluoroscopy procedures (see the Medical X-ray Imaging webpage for advice on questions to ask your health care provider).
Extensive information is available on fluoroscopy, diseases and conditions where fluoroscopy is used for diagnosis or treatment, and on the benefits and risks of fluoroscopy. In addition to the patient information links on the Medical X-ray Imaging webpage, more specific information on procedures conducted using fluoroscopy is provided below:
Concerns about radiation-related injuries to patients have increased since the mid-1990s due to the increasing complexity and radiation dose of some fluoroscopically-guided interventions. In 2005, the FDA revised the radiation safety performance standard for diagnostic X-ray systems, including fluoroscopy to improve the display of dose information to the physicians (21 CFR 1020.32). The FDA developed Questions and Answers about the Radiation Safety Performance Standard for Diagnostic X-ray Systems.
The increase in medical radiation exposure was highlighted by the National Council on Radiation Protection and Measurements (NCRP) Report 160 (2009). In 2010 the FDA Center for Devices and Radiological Health (CDRH) launched an Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. As part of this initiative, the FDA held a public meeting on ways to improve devices to reduce unnecessary radiation exposure to help the agency decide on any new targeted requirements for manufacturers of CT and fluoroscopic devices. The new requirements that could be built into fluoroscopy equipment could facilitate implementation of the principles of justification and optimization in the protection of patients undergoing radiological examinations. These principles, implemented through a clinical facility's quality assurance program, are fundamental to radiation protection. FDA's activities to improve radiation dose management in medical x-ray imaging devices, including fluoroscopes, are summarized in a 2021 CDRH paper.
More information about the principles of justification and optimization can be found on the Medical X-ray Imaging webpage. The sections below include supplemental information that can be used to reduce radiation exposure for fluoroscopy equipment currently available on the market.
The referring physician should be prepared to discuss the rationale for the examination with the patient and/or parent. As discussed in the Medical X-ray Imaging webpage, the referring physician should make use of available medical specialty guidelines to help assess the need for a particular exam and order only those exams that are appropriate for the patient's condition.
The imaging team, which includes the physician, radiologic technologist, physicist, and other medical personnel are typically responsible for developing optimized protocols, implementing regular equipment quality control tests, and monitoring radiation doses to patients as part of quality assurance program emphasizing radiation management.
Health care providers who use fluoroscopy should be properly trained in its use. In a report issued in 2010, the National Council on Radiation Protection and Measurements (NCRP) made specific recommendations for facilities that perform fluoroscopic procedures. These recommendations can be applied to all fluoroscopy procedures. They include:
In addition to the information in the Medical X-ray Imaging webpage about radiation management, quality assurance (including diagnostic reference levels), and training, the following resources provide information specific to radiation management, facility quality assurance, and training in fluoroscopy:
Health care providers are exposed to scattered radiation from patients during fluoroscopically guided procedures and need to protect themselves appropriately. Information on occupational radiation protection during fluoroscopy is available from:
The FDA regulates the manufacturers of all X-ray imaging devices, including fluoroscopic X-ray systems to assure that these medical devices are safe and effective when used as indicated (see the section "Information for Industry"). Individual states and other federal agencies regulate the use of fluoroscopy systems through recommendations and requirements for personnel qualifications, quality assurance and quality control programs, and facility accreditation.
The FDA regulates manufacturers of fluoroscopic X-ray systems through the Electronic Product Radiation Control (EPRC) and the medical device provisions of the Federal Food, Drug, and Cosmetic Act. The FDA specifies mandatory requirements as well as related recommendations through the issuance of "guidance." Guidance documents related to EPRC and fluoroscopy devices are Policy Clarification for Certain Fluoroscopic Equipment Requirements and Medical X-Ray Imaging Devices Conformance with IEC Standards.
For more information on EPRC and medical device regulations and guidance for fluoroscopy and other X-ray equipment, please see the Medical X-ray Imaging webpage and Getting to Market with a Medical Device.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with the product. We encourage health care providers and patients who suspect a problem with a medical imaging device to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
Medical device manufacturers, distributors, importers, and device user facilities (which include many health care facilities) must comply with the Medical Device Reporting (MDR) Regulations of 21 CFR Part 803.
In addition to following the general recommendations (for manufacturers, facilities, and any member of the public) for reporting problems for adverse events associated with fluoroscopy overexposure, the following information should be included in reports, if available:
Fluoroscopy is a study of moving body structures--similar to an X-ray"movie." A continuousX-raybeam is passed through the body part being examined. The beam istransmitted to a TV-like monitor so that the body part and its motion canbe seen in detail. Fluoroscopy, as an imaging tool, enables physicians tolook at many body systems, including the skeletal, digestive, urinary,respiratory, and reproductive systems.
Other related procedures that may be used to diagnose problems of thebones, muscles, or joints include X-rays, myelography (myelogram), computed tomography (CT scan), magnetic resonance imaging (MRI), and arthrography.
Fluoroscopy is used in many types of examinations and procedures, such asbarium X-rays,cardiac catheterization,arthrography(visualization of a joint or joints),lumbar puncture, placement of intravenous (IV) catheters (hollow tubes inserted into veinsor arteries),intravenous pyelogram, hysterosalpingogram, and biopsies.
Inbarium X-rays, fluoroscopy used alone allows the doctor to see the movement of theintestines as the barium moves through them and allows the doctor toposition the patient for spot imaging. Incardiac catheterization, fluoroscopy is used as an adjunct to enable the doctor to see the flow ofblood through the coronary arteries in order to evaluate the presence ofarterial blockages. For intravenous catheter insertion, fluoroscopy assiststhe doctor in guiding the catheter into a specific location inside thebody.
You may want to ask your doctor about the amount of radiation used duringthe procedure and the risks related to your particular situation. It is agood idea to keep a record of your past history of radiation exposure, suchas previous scans and other types of X-rays, so that you can inform yourdoctor. Risks associated with radiation exposure may be related to thecumulative number of X-ray examinations and/or treatments over a longperiod of time.
If contrast dye is used, there is a risk for allergic reaction to the dye.Patients who are allergic to or sensitive to medications, contrast media,iodine, or latex should notify their doctor. Also, patients with kidneyfailure or other kidney problems should notify their doctor.
Medically appropriate fluoroscopy examinations provide clinical benefitsthat outweigh the risk from the radiation received during the examination.When used by highly trained, board certified radiologists and radiologictechnologists, fluoroscopic examinations provide substantial diagnosticbenefit to patients and is instrumental in guiding treatment plans.Patients and parents of pediatric patients should talk with their personalphysician and their radiologist about the examination.
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