What is the major source of radiation exposure to staff during fluoroscopy?
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 IntroductionConcerns over radiation safety are valid. Understanding and maintaining safe administration helps patients understand the potential risks during endovascular procedures. MethodsX-ray production, units of radiation exposure, and forms of direct and indirect exposures are discussed. ResultsPositioning of the image intensifier as close to the patient as practical, moving the x-ray tube as far from the patient as possible, and using pulse fluoroscopy are all ways to help decrease the radiation dose. Collimation, achievable without the use of fluoroscopy, improves image quality while decreasing the radiation dose. Time, distance, and shielding are the three most productive means of reducing radiation exposure. ConclusionThe best defense against radiation injury to both patient and staff is to minimize the total fluoroscopy time, keep the image intensifier close to the patient, collimate to the region of interest, and use appropriate radiation shielding and monitoring. Cited by (0)Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved. Image Wisely, a joint initiative of ACR, RSNA, ASRT and AAPM, provides information to the medical community to promote radiation safety in medical imaging.
ChecklistsThis section provides a list of tasks promoting radiation-safety items during fluoroscopy. The checklist is divided into pre-procedure, intra-procedure and post-procedure items. Continue reading
Technical Principles for Cardiac ProceduresEstablishing a radiation safety-conscious environment in the cardiac catheterization laboratory for all procedures, diagnostic and therapeutic/interventional, should be a collaborative effort involving physicians, staff, medical physicists, quality assurance personnel and hospital administration. Continue reading
Fluoroscopy ProtocolsPhysicians and ancillary professionals should be familiar with current recommendations on protocols and radiation management from professional organizations. Continue reading
Image Quality Versus UtilityAs image quality improves, it begins providing more and more information that leads to increases in the probability of success. However, these increases eventually reach a point where further increases in image quality have little or no impact on the result. Continue reading
DescriptionFluoroscopy 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/RisksFluoroscopy is used in a wide variety of examinations and procedures to diagnose or treat patients. Some examples are:
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. See the Medical X-ray Imaging webpage for more information on benefits and risks of X-ray imaging, including fluoroscopy. Information for PatientsFluoroscopy 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:
Resources for patients on concerns about radiation from fluoroscopy include:
Information for Health Care ProvidersConcerns 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. 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:
Information for the referring physicianThe 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 teamThe 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:
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:
Radiation protection for health care workersHealth 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:
Regulations and guidelines for imaging facilities and personnelThe 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 IndustryThe 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.” Recent 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 Variance Application Process. Reporting Problems to the FDAPrompt 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:
Required Reports for Industry
Where does most of the scatter radiation come from in the fluoroscopy suite?Highest scatter radiation levels are often where the operator stands. Radiation levels are highest beneath the table (when X-ray tube is below the table) because the patient provides an effective beam stop. Highest levels are directed at the operator's waist.
What type of radiation is used in fluoroscopy?As in many areas of medicine, there are risks associated with the use of fluoroscopy, which uses ionizing radiation to generate images of the body. Risks from exposure to ionizing radiation include: A small increase in the likelihood that a person exposed to radiation will develop cancer later in life.
Which is the major component in fluoroscopy?The key components include an X-ray tube, spectral shaping filters, a field restriction device (aka collimator), an anti-scatter grid, an image receptor, an image processing computer and a display device.
Does fluoroscopy use a lot of radiation?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.
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