Fluoroscopy

 Description

 Benefits/Risks

 Information for Patients

 Information for Health Care Providers

o Information for the referring physician

o Information for the imaging team

o Radiation protection for health care workers

o Regulations and guidelines for imaging facilities and personnel

 Information for Industry

 Reporting Problems to the FDA

Description

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.

 
Image Courtesy of Siemens Healthcare USA
Benefits/Risks

Fluoroscopy is used in a wide variety of examinations and procedures to diagnose or treat patients.
Some examples are:

 Barium X-rays and enemas (to view the gastrointestinal tract)

 Catheter insertion and manipulation (to direct the movement of a catheter through blood
vessels, bile ducts or the urinary system)

 Placement of devices within the body, such as stents (to open narrowed or blocked blood
vessels)

 Angiograms (to visualize blood vessels and organs)

 Orthopedic surgery (to guide joint replacements and treatment of fractures)

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:

 radiation-induced injuries to the skin and underlying tissues (“burns”), which occur shortly after
the exposure, and

 radiation-induced cancers, which may occur some time later in life.

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.

See the Medical X-ray Imaging webpage for more information on benefits and risks of X-ray imaging,
including fluoroscopy.

Information for Patients

Fluoroscopy procedures are performed to help diagnose disease, or to guide physicians during certain
treatment procedures. Some fluoroscopy procedures may be performed as outpatient procedures while
the patient is awake – for example, upper gastrointestinal series to examine the esophagus, stomach
and small intestine, or a barium enema to examine the colon.
Other procedures are performed as same-day hospital procedures or sometimes as inpatient
procedures, typically while the patient is sedated – for example, cardiac catheterization to examine the
heart and the coronary arteries that supply blood to the heart muscle. Still other fluoroscopy procedures
may be performed under general anesthesia during surgery – for example to help align and fix fractured
bones.

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 risks and benefits 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:

 Patient Information  on interventional radiology procedures from the Society of Interventional

Radiology

 Information on heart disease and cardiology procedures, including cardiac catheterization and
coronary artery stenting can be found at the Society for Cardiovascular Angiography and
Interventions 

 The Heart Rhythm Society’s Patient Information  addresses heart disease, abnormal heart

rhythms and treatment of abnormal heart rhythms

 The Society of Vascular Surgery’s Vascular Conditions, Tests, Treatments  contain information on

diagnosis and treatment of abnormalities of blood vessels

Resources for patients on concerns about radiation from fluoroscopy include:

 The Alliance for Radiation Safety in Pediatric Imaging  : The Step Lightly campaign for
interventional radiology  and the Pause and Pulse campaign for fluoroscopy 

 International Atomic Energy Agency (IAEA) Radiation Protection of Patients (RPOP):  

o Information for Patients: Interventional Procedures  

 National Cancer Institute of the National Institutes of Health on Interventional Fluoroscopy:

Reducing Radiation Risks for Patients and Staf f

Information for Health Care Providers

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
developedQuestions 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.

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.

FDA publications relevant to promoting safety and quality in fluoroscopy imaging:

 Important Information for Physicians and Other Healthcare Professionals: Avoidance of Serious
X-ray-Induced Skin Injuries to Patients During Fluoroscopically-Guided Procedures

 Recording Information In The Patient's Medical Record That Identifies The Potential For Serious
X-ray-Induced Skin Injuries

 CDRH Paper on Radiation-Induced Skin Injuries from Fluoroscopy

 CDRH Organ Dose Handbooks. For specific information on fluoroscopy, please go to these
handbooks:

o Handbook of Selected Tissue Doses for the Upper Gastrointestinal Fluoroscopic

Examination

o Handbook of Selected Tissue Doses for Fluoroscopic and Cineangiographic Examination

of the Coronary Arteries

Information for the referring physician

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.

Information for the imaging team

The imaging team, which includes the physician, radiologic technologist, physicist, and other medical
personnel should be 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:

 Assuring that all operators of the system are trained and that they understand the operation of
the fluoroscopic system, including the implications for radiation exposure from each mode of
operation.

 Assuring that physicians performing fluoroscopic procedures are appropriately trained and
credentialed, so they can, on a case-by-case basis, assess risks and benefits for individual
patients, considering variables such as age, pregnancy status, beam location and direction,
tissues in the beam and previous fluoroscopic procedures or radiation therapy.

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:

 International Commission on Radiological Protection (ICRP):

o Publication 85: Avoidance of Radiation Injuries from Medical Interventional Procedures 

o Publication 113: Education and Training in Radiological Protection for Diagnostic and

Interventional Procedures 

o Publication 117:Radiological Protection in Fluoroscopically Guided Procedures outside

the Imaging Department 

o Draft Report: Patient and Staff Radiological Protection in Cardiology 

 National Council on Radiation Protection and Measurements   (NCRP) Report 168: Radiation
Dose Management for Fluoroscopically Guided Interventional Medical Procedures.

 Society of Interventional Radiology (SIR):

 o Safety Guidelines 

o Society of Interventional Radiology Technology Assessment Committee

 C-arm Cone-beam CT: General Principles and Technical Considerations for Use in
Interventional Radiology  (Robert C. Orth, Michael J. Wallace, and Michael D.
Kuo,  J. Vasc. Interv. Radiol. Vol. 19, No. 6, pp. 814-821, 2008)

 Three-Dimensional C-arm Cone-beam CT: Applications in the Interventional

Suite  (Michael J. Wallace et al., J. Vasc. Interv. Radiol. Vol. 19, No. 6, pp. 799-
813, 2008).

 National Cancer Institute and SIR Interventional Fluoroscopy: Reducing Radiation Risks for
Patients and Staff  

 Department of Veterans Affairs:Fluoroscopy Safety 

 Society for Cardiovascular Angiography and Interventions (SCAI):

o Clinical Guidelines & Resources  

o Radiation Safety Program for the Cardiac Catheterization Laboratory   

 Alliance for Radiation Safety in Pediatric Imaging (Image Gently):

o Interventional Radiology – Step Lightly Resources   

o Fluoroscopic Imaging - Pause and Pulse Resources  

 American Association of Physicists in Medicine: Patient radiation dose audits for fluoroscopically

guided interventional procedures  (S. Balter et al., Med Phys. Vol. 38, No. 3, pp. 1611-1618,
2011.)

 International Atomic Energy Agency (IAEA) Safety Report No. 59: Establishing Guidance Levels in
X ray Guided Medical Interventional Procedures: A Pilot Study .

 Reference levels for patient radiation doses in interventional radiology: proposed initial values
for U.S. practice  (D.L. Miller et al.,  Radiology  Vol. 253, No. 6, pp. 753-764, 2009.)

 Conference of Radiation Control Program Directors:

o Technical White Paper: Monitoring and Tracking of Fluoroscopic Dose  

o Monitoring and Tracking of Fluoroscopic Dose Handout (2010)   

 World Health Organization: Efficacy and Radiation Safety in Interventional Radiology   

  American College of Cardiology Foundation/American Heart Association/Heart Rhythm
Society/Society for Cardiac Angiography and Interventions: Clinical Competence Statement on
Physician Knowledge to Optimize Patient Safety and Image Quality in Fluoroscopically Guided
Invasive Cardiovascular Procedures 

Radiation protection for health care workers

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:

 International Commission on Radiological Protection (ICRP) Publication 85: Avoidance of

Radiation Injuries from Medical Interventional Procedures   

 National Council on Radiation Protection and Measurements (NCRP) Report 168  : Radiation
Dose Management for Fluoroscopically Guided Interventional Medical Procedures.

 Occupational Radiation Protection in Interventional Radiology: A Joint Guideline of the

Cardiovascular and Interventional Radiology Society of Europe and the Society of Interventional
Radiology 

 Society for Cardiac Angiography and Interventions (SCAI): Radiation Safety Program for the
Cardiac Catheterization Laboratory  

 SCAI consensus document on occupational radiation exposure to the pregnant cardiologist and
technical personnel  (P.J. Best et al., 2011, Catheter Cardiovasc Interv., 77(2): 232-41.)

 ICRP Statement on Tissue Reactions   (2011) [Includes recommendations for dose limits for
tissues and organs, such as the lens of the eye.]

Regulations and guidelines for imaging facilities and personnel

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.

Information for Industry

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.”

Fluoroscopy devices are classified under 21 CFR 892.1650 . The EPRC performance standard specific to
fluoroscopic equipment is 21 CFR 1020.32 .

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.

Reporting Problems to the FDA

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.

Health care personnel employed by facilities that are subject to FDA's user facility reporting
requirementsshould follow the reporting procedures established by their facilities.

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:

 the protocol being followed during the event;

 the conditions of operation, including technical parameters such as:

o mode

o pulse rate (if pulsed fluoroscopy was used)

o field of view

o dose rate

 the dose-index values displayed (reference air kerma, kerma area product).

 
Fluoroscopy Procedure

Procedure overview

Fluoroscopy is a study of moving body structures--similar to an X-ray "movie." A continuous X-ray beam
is passed through the body part being examined. The beam is transmitted to a TV-like monitor so that
the body part and its motion can be seen in detail. Fluoroscopy, as an imaging tool, enables physicians to
look at many body systems, including the skeletal, digestive, urinary, respiratory, and reproductive
systems.

Fluoroscopy may be performed to evaluate specific areas of the body, including the bones, muscles, and
joints, as well as solid organs, such as the heart, lung, or kidneys.

Other related procedures that may be used to diagnose problems of the bones, muscles, or joints
include X-rays, myelography (myelogram), computed tomography (CT scan), magnetic resonance
imaging (MRI), and arthrography. Please see these procedures for additional information.

Reasons for the procedure

Fluoroscopy is used in many types of examinations and procedures, such as barium X-rays, cardiac
catheterization, arthrography (visualization of a joint or joints), lumbar puncture, placement of
intravenous (IV) catheters (hollow tubes inserted into veins or arteries), intravenous pyelogram,
hysterosalpingogram, and biopsies.

Fluoroscopy may be used alone as a diagnostic procedure, or may be used in conjunction with other
diagnostic or therapeutic media or procedures.

In barium X-rays, fluoroscopy used alone allows the doctor to see the movement of the intestines as the
barium moves through them. In cardiac catheterization, fluoroscopy is used as an adjunct to enable
the doctor to see the flow of blood through the coronary arteries in order to evaluate the presence of
arterial blockages. For intravenous catheter insertion, fluoroscopy assists the doctor in guiding the
catheter into a specific location inside the body.

Other uses of fluoroscopy include, but are not limited to, the following:

 Locating foreign bodies

 Image-guided anesthetic injections into joints or the spine

 Percutaneous vertebroplasty. A minimally invasive procedure used to treat compression

fractures of the vertebrae of the spine
There may be other reasons for your doctor to recommend fluoroscopy.

Risks of the procedure

You may want to ask your doctor about the amount of radiation used during the procedure and the risks
related to your particular situation. It is a good idea to keep a record of your past history of radiation
exposure, such as previous scans and other types of X-rays, so that you can inform your doctor. Risks
associated with radiation exposure may be related to the cumulative number of X-ray examinations
and/or treatments over a long period of time.

If you are pregnant or suspect that you may be pregnant, you should notify your doctor. Radiation
exposure during pregnancy may lead to birth defects.

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
kidney failure or other kidney problems should notify their doctor.

There may be other risks depending on your specific medical condition. Be sure to discuss any concerns
with your doctor prior to the procedure.

Certain factors or conditions may interfere with the accuracy of a fluoroscopy procedure. A recent
barium X-ray procedure may interfere with exposure of the abdominal or lower back area.

Before the procedure

 Your doctor will explain the procedure to you and offer you the opportunity to ask any questions
that you might have about the procedure.

 You will be asked to sign a consent form that gives your permission to do the procedure. Read
the form carefully and ask questions if something is not clear.

 The specific type of procedure or examination being done will determine whether any
preparation prior to the procedure is required. Your doctor will notify you of any preprocedure
instructions.

 Notify your doctor if you have ever had a reaction to any contrast dye, or if you are allergic to
iodine.

 If you are pregnant or suspect that you may be pregnant, you should notify your doctor.

 Based on your medical condition, your doctor may request other specific preparation.

During the procedure

Fluoroscopy may be performed on an outpatient basis or as part of your stay in a hospital. Procedures
may vary depending on your condition and your doctor's practices.
Generally, fluoroscopy follows this process:

 You will be asked to remove any clothing or jewelry that may interfere with the exposure of the
body area to be examined.

 If you are asked to remove clothing, you will be given a gown to wear.

 A contrast substance may be given, depending on the type of procedure that is being
performed, via swallowing, enema, or an intravenous (IV) line in your hand or arm.

 You will be positioned on the X-ray table. Depending on the type of procedure, you may be
asked to assume different positions, move a specific body part, or hold your breath at intervals
while the fluoroscopy is being performed.

 For procedures that require catheter insertion, such as cardiac catheterization or catheter
placement into a joint or other body part, an additional line insertion site may be used in the
groin, elbow, or other site.

 A special X-ray scanner will be used to produce the fluoroscopic images of the body structure
being examined or treated.

 A dye or contrast substance may be injected into the IV line in order to better visualize the
organs or structures being studied.

 In the case of arthrography (visualization of a joint), any fluid in the joint may be aspirated
(withdrawn with a needle) prior to the injection of the contrast substance. After the contrast is
injected, you may be asked to move the joint for a few minutes in order to evenly distribute the
contrast substance throughout the joint.

 The type of procedure being performed and the body part being examined and/or treated will
determine the length of the procedure.

 After the procedure has been completed, the IV line will be removed.

While fluoroscopy itself is not painful, the particular procedure being performed may be painful, such as
the injection into a joint or accessing of an artery or vein for angiography. In these cases, the radiologist
will take all comfort measures possible, which could include local anesthesia, conscious sedation, or
general anesthesia, depending on the particular procedure. 

After the procedure

The type of care required after the procedure will depend on the type of fluoroscopy that is performed.
Certain procedures, such as cardiac catheterization, will require a recovery period of several hours with
immobilization of the leg or arm where the cardiac catheter was inserted. Other procedures may require
less time for recovery.
If you notice any pain, redness, and/or swelling at the IV site after you return home following your
procedure, you should notify your doctor as this could indicate an infection or other type of reaction.

Your doctor will give more specific instructions related to your care after the examination or procedure.

Online resources

The content provided here is for informational purposes only, and was not designed to diagnose or treat
a health problem or disease, or replace the professional medical advice you receive from your doctor.
Please consult your doctor with any questions or concerns you may have regarding your condition.

This page contains links to other websites with information about this procedure and related health
conditions. We hope you find these sites helpful, but please remember we do not control or endorse the
information presented on these websites, nor do these sites endorse the information contained here.

American Academy of Orthopaedic Surgeons 

National Institute of Child Health and Human Development 

National Institutes of Health (NIH) 

National Library of Medicine