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                Medical X-ray Imaging

Medical X-ray Imaging

                        Radiography
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          FluoroscopyMedical X-ray Imaging Fluoroscopy
  
  	
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Description
	Benefits/Risks
	Information for Patients
	Information for Health Care Providers
	Information for the referring physician
		Information for the imaging team
		Radiation protection for health care workers
		Regulations and guidelines for imaging facilities and personnel
	Information for Industry
	Reporting Problems to the FDADescription

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 of a man undergoing a fluoroscopy image.
*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 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:

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 & Interventions webpage SecondsCount - SCAI
	The Heart Rhythm Society's webpage upbeat.org addresses electrophysiology, abnormal heart rhythms and the treatment of abnormal heart rhythms
	The Society of Vascular Surgery's webpage Patients and Referring Physicians contains information on diagnosis and treatment of abnormalities of blood vesselsResources for patients on concerns about radiation from fluoroscopy include:

The Alliance for Radiation Safety in Pediatric Imaging (Image Gently): 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):
	Information for Patients: Interventional Procedures
	National Cancer Institute of the National Institutes of Health on Interventional Fluoroscopy: Reducing Radiation Risks for Patients and Staff
	World Health Organization: Communicating Radiation Risks in Paediatric Imaging: Information to Support Health Care Discussions About Benefit and Risk. Geneva: World Health OrganizationInformation 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 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.

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:
	Handbook of Selected Tissue Doses for the Upper Gastrointestinal Fluoroscopic Examination
		Handbook of Selected Tissue Doses for Fluoroscopic and Cineangiographic Examination of the Coronary ArteriesInformation 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 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:

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 benefits and risks 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):
	Publication 85: Avoidance of Radiation Injuries from Medical Interventional Procedures
		Publication 113: Education and Training in Radiological Protection for Diagnostic and Interventional Procedures
		Publication 117: Radiological Protection in Fluoroscopically Guided Procedures outside the Imaging Department
		Publication 120: Patient and Staff Radiological Protection in Cardiology
		Publication 139: Occupational radiological protection in interventional procedures
	National Council on Radiation Protection and Measurements (NCRP)
	Report 168: Radiation Dose Management for Fluoroscopically Guided Interventional Medical Procedures.
		Statement 11: Outline of administrative policies for quality assurance and peer review of tissue reactions associated with fluoroscopically-guided interventions.
	Society of Interventional Radiology (SIR):
	Stecker MS, et al., for the SIR Safety and Health Committee and the CIRSE Standards of Practice committee.  Guidelines for patient radiation dose management.  J Vasc Interv Radiol 2009, 20:S263-S273.  doi: 10.1016/j.jvir.2009.04.03
		Miller DL, et al.  Occupational radiation protection in interventional radiology:  A joint guideline of the Cardiovascular and Interventional Radiology Society of Europe and the Society of Interventional Radiology. J Vasc Interv Radiol 2010; 21:607-615.  doi: 10.1016/j.jvir.2010.01.007
		Miller DL, et al., for the Society of Interventional Radiology Standards of Practice Committee. Quality Improvement Guidelines for recording patient radiation dose in the medical record for fluoroscopically guided procedures.  J Vasc Interv Radiol 2012; 23:11-18.  doi: 10.1016/j.jvir.2011.09.004
		Dauer LT, et al., for the SIR Safety and Health Committee and the Cardiovascular and Interventional Radiology Society of Europe Standards of Practice Committee. Radiation management for interventions using fluoroscopic or computed tomographic guidance during pregnancy: a joint Guideline of the Society of Interventional Radiology and the Cardiovascular and Interventional Radiology Society of Europe with endorsement by the Canadian Interventional Radiology Association.  J Vasc Interv Radiol 2012; 23:19-32.  doi: 10.1016/j.jvir.2011.09.007
		Dauer L, et al. Occupational radiation protection of pregnant or potentially pregnant workers in IR: a joint guideline of the Society of Interventional Radiology and the Cardiovascular and Interventional Radiological Society of Europe. J Vasc Interv Radiol 2015; 26:171-181.  doi: 10.1016/j.jvir.2014.11.026
	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):
	Clinical Guidelines & Resources
		Radiation Safety Program for the Cardiac Catheterization Laboratory
	Alliance for Radiation Safety in Pediatric Imaging (Image Gently):
	Interventional Radiology – Step Lightly Resources
		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.)
		Mahmood U, et al. Survey of pediatric fluoroscopic air kerma rate values and recommended application of results. AAPM Report No. 251. Alexandria, VA: American Association of Physicists in Medicine, 2022
		Fisher RF, et al. AAPM Medical Physics Practice Guideline 12.a: Fluoroscopy Dose Management. J Appl Clin Med Phys 2022; 23:e13526.  doi: 10.1002/acm2.13526
	Conference of Radiation Control Program Directors:
	Technical White Paper: Monitoring and Tracking of Fluoroscopic Dose
	World Health Organization: Communicating Radiation Risks in Paediatric Imaging: Information to Support Health Care Discussions About Benefit and Risk. Geneva: World Health Organization. 2016
	American College of Cardiology Foundation/Heart Rhythm Society/ North American Society for Cardiovascular Imaging/Society for Cardiac Angiography and Interventions/Society for Cardiovascular Computed Tomography:  2018 ACC/HRS/NASCI/SCAI/SCCT Expert Consensus Document on Optimal Use of Ionizing Radiation in Cardiovascular Imaging: Best Practices for Safety and EffectivenessRadiation 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
	Publication 139: Occupational radiological protection in interventional procedures
	National Council on Radiation Protection and Measurements (NCRP) Report 168: Radiation Dose Management for Fluoroscopically Guided Interventional Medical Procedures.
	Society of Interventional Radiology
	Occupational Radiation Protection in Interventional Radiology: A Joint Guideline of the Cardiovascular and Interventional Radiology Society of Europe and the Society of Interventional Radiology
	Occupational radiation protection of pregnant or potentially pregnant workers in IR: a joint guideline of the Society of Interventional Radiology and the Cardiovascular and Interventional Radiological Society of Europe.
	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." 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.

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 and Getting to Market with a Medical Device.

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 requirements should 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:
	mode
		pulse rate (if pulsed fluoroscopy was used)
		field of view
		dose rate
	the dose-index values displayed (reference air kerma, kerma area product).

                                                                                  Content current as of:
      02/21/2023
              
              
Regulated Product(s)
		 Radiation-Emitting ProductsMedical X-ray Imaging

          
                        Radiography
          Computed Tomography (CT)
          Dental Cone-beam Computed Tomography
          Fluoroscopy
          Mammography
 
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