Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

Through the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging1, FDA is advocating the universal adoption of two principles of radiation protection: appropriate justification for ordering each procedure, and careful optimization of the radiation dose used during each procedure. Each patient should get the right imaging exam, at the right time, with the right radiation dose.
FDA held a public meeting entitled "Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging" on March 30-31, 2010. The main topic was
dose reduction in procedures using computed tomography (CT) and fluoroscopy equipment. The meeting included both presentations from interested members of the public and round table discussions on specific aspects of the dose reduction issue featuring experts in the field. The purpose of the meeting was to get feedback for use in improving safety of CT and fluoroscopy equipment, enhancing operator training and improving facility quality assurance practices. CDRH will accomplish this by developing guidance and requirements for industry and by working with various public and private partners. The meeting agenda is posted here: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm201448.htm Watch these pages for more announcements and future activities.

White Paper: Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
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Table of Contents
Executive Summary
Background
Types of Medical Imaging Procedures
Concerns about Radiation Exposure
Unnecessary Radiation Exposure
Factors Contributing to Unnecessary Radiation Exposure
Issues Related to Device Use
Issues Related to Clinical Decision Making
Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
Promote Safe Use of Medical Imaging Devices
Support Informed Clinical Decision Making
Increase Patient Awareness
Conclusion

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Executive Summary
Like all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams present both benefits and risks. These types of imaging procedures have led to improvements in the diagnosis and treatment of numerous medical conditions. At the same time, these types of exams expose patients to ionizing radiation (hereinafter “radiation”), which may elevate a person’s lifetime risk of developing cancer. A balanced public health approach seeks to support the benefits of these medical imaging exams while minimizing the risks.

Managing the risks of computed tomography (CT), fluoroscopy, and nuclear medicine imaging procedures depends on two principles of radiation protection: appropriate justification for ordering and performing each procedure, and careful optimization of the radiation dose used during each procedure. These types of imaging exams should be conducted only when medically justified. When such exams are conducted, patients should be exposed to an optimal radiation dose – no more or less than what is necessary to produce a high-quality image. In other words, each patient should get the right imaging exam, at the right time, with the right radiation dose.

FDA can advance this goal by using our regulatory authority judiciously while also collaborating with the healthcare professional community.

This document announces the launch of a cooperative Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. Through this initiative, FDA and our partners will take steps to:

Promote safe use of medical imaging devices;
Support informed clinical decision making; and
Increase patient awareness.
By coordinating these efforts, we can optimize patient exposure to radiation from certain types of medical imaging exams, and thereby reduce related risks while maximizing the benefits of these studies.

open here to see the full-text (large):
http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199994.htm