Fluoroscopy

By Effective Medicine  On  In Medical Devices Tagged  

  • 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 FDA

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

 

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 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.

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 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 disclaimer icon(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:

 

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:

 

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.

 

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).

 


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