REDUCING RADIATION EXPOSURE TO AMERICANS FROM
DIAGNOSTIC IMAGING STUDIES
Steering Committee
William G. Bradley, Jr, MD, PhD
Chair, Dept. of Radiology
University of California San Diego
Chairman
R. Nick Bryan, MD, PhD
Professor and Chairman
Department of Radiology
University of Pennsylvania Health
System
Jim Beckett
Vice President, Clinical Research
Philips Medical Systems, N.A.
N. Reed Dunnick, MD
Chair, Dept. of Radiology
University of Michigan Medical Center
Steven Haberlein
Vice President, Sales
FUJIFILM Medical Systems USA, Inc.
James Jorkasky
Executive Director
National Alliance for
Eye and Vision Research
Michael Kalutkiewicz
Director of Government Affairs
International & American Associations
for Dental Research
Bich Le
General Manager, Academic Segment
GE Healthcare
Richard Mather, PhD
Senior Manager, Clinical Programs
Toshiba Medical Research Institute
Martha Nolan, JD
Vice President, Public Policy
Society for Women's Health Research
Christi M. Pedra
Senior Vice President, Strategic New
Business Development & Marketing
Siemens Healthcare
Lenny Reznik
Director, Enterprise Imaging and
Information
Agfa HealthCare Corporation
Sheila Ross
Special Counsel
Lung Cancer Alliance
President
Renée L. Cruea, MPA
Executive Director
Academy of Radiology Research
Goal:
A need exists to manage and reduce the amount of ionizing radiation that
patients receive from diagnostic imaging studies. The Academy of
Radiology Research believes that this need can be met through initiatives
that focus on improved outcomes and safety for patients while promoting
the appropriate utilization of medical imaging. The Academy seeks to
develop Federal legislation that would provide funding to be administered
through NIH, AHRQ and FDA that would be targeted to finance the
required research, regulation and implementation of practices that will yield
these benefits to patients and the healthcare system.
Background:
A large and important part of diagnostic imaging depends on the use of
ionizing radiation as an underlying technology, including computed
tomography (CT), fluoroscopy, X-ray, mammography and nuclear
medicine procedures such as positron emission tomography (PET).
Advances in these modalities over the past several decades have greatly
enhanced their value for a wide variety of medical conditions and clinical
indications, and these tools are employed widely for the detection,
diagnosis, management, treatment guidance, and planning and monitoring
of diseases.1
While these technologies deliver crucial benefits to individual patients and
to public health, the increasing use of ionizing radiation for diagnostic
imaging warrants greater scrutiny of population-based and cumulative
individual risks. Although the medical community remains divided about
the accuracy of radiation risk models, it is widely accepted that minimizing
risk without compromising diagnostic imaging quality is highly desirable,
particularly in vulnerable populations such as children and women of
reproductive capacity. As an example, the Image Gently campaign,
sponsored by the Alliance for Radiation Safety in Pediatric Imaging,2 was
founded in 2007 as a national (now international) educational campaign to
reduce radiation exposure from medical imaging in children including
“child-sizing” CT protocols and minimizing fluoroscopy exposure (Step
Lightly).
1
This paper focuses only on Diagnostic Imaging. The therapeutic use of ionizing
radiation, such as in the field of Radiation Oncology, is outside of the scope of our
proposals.
2
Founded by the American College of Radiology (ACR), the Society of Pediatric
Radiology (SPR), the American Association of Physicists in Medicine (AAPM), and
the American Society of Radiologic Technologists (ASRT).
1029 Vermont Avenue NW, Suite 505 • Washington, DC 20005
Phone: 202.347.5872 • Fax: 202.347.5876 • www.imagingcoalition.org
Recognizing the public health needs, FDA has announced an Initiative to Reduce Unnecessary
Radiation Exposure from Medical Imaging, focused on CT, fluoroscopy, and nuclear medicine.
Through this initiative, FDA has proposed steps to address important elements of radiation safety.
Other government agencies, including CMS, HHS (through the Office of the National Coordinator
for Health IT), and NIH, have proposed rules or initiatives directed at encouraging the “appropriate”
use of medical imaging while decreasing the volume of unnecessary, inappropriate or suboptimal
imaging, all of which contribute to the goal of reducing radiation exposure to patients.

The Academy of Radiology Research believes that FDA‟s initiative and these other governmental
efforts are important components of a broader solution to reduce and manage ionizing radiation
exposure attendant to diagnostic imaging, and that additional steps are needed to ensure that we do
not diminish the crucial benefits that medical imaging delivers to patients across the disease
spectrum. In particular, the Academy believes that crucial research, development and collaboration
involving government agencies, academic researchers and manufacturers of imaging equipment is
required to ask and answer the key questions that will serve as the underpinning for legislative or
regulatory action. We believe that the needed research, development and collaboration can be
conducted and completed rapidly through a coordinated approach to these complex problems. This
document proposes such a coordinated approach.

Elements of a coordinated approach to reducing radiation exposure from diagnostic imaging:

A multifaceted national initiative is needed to ensure that ionizing radiation is used only when
medically necessary and appropriate, and that the radiation dose delivered meets the ALARA (“as
low as reasonably achievable”) standard. The elements of this initiative include:

 Encouraging or requiring improvements to diagnostic imaging equipment and software,

particularly enhancements that permit or require:
o Lower doses for each exam, taking into account patient-specific and exam-specific
information;
o Transparency (for the ordering physician and ultimately the patient) of the expected
dose the patient will receive per the ordered scan protocol and the actual dose received
by the patient;
o Failsafe mechanisms to minimize or prevent machine or human error;
o Auditable tracking of doses per type of exam and per patient; the latter requiring
connectivity to health systems‟ electronic health records.
 Creating informatics tools that harvest radiation exposure data from healthcare providers and
export this data to local, regional and national EMR and data registries;
 Enabling patient access to and awareness of personal medical imaging and radiation exposure
history;
 Encouraging or mandating the use of computerized physician order entry (CPOE) equipped
with decision support tools that incorporate evidence-based practice guidelines for appropriate
use, such as those developed by the American College of Radiology;
 Limiting or eliminating self-referral opportunities that may result in overutilization of
advanced imaging;
 Funding research to answer key radiation safety questions in diagnostic imaging, including
research to:

2
 o Optimize image quality (e.g., improving signal to noise characteristics while
decreasing effective radiation doses) through acquisition technology changes and post-
processing improvements (e.g., reconstruction algorithms that find more information
without higher radiation doses);
o Compare effectiveness studies to ensure optimal balance between low-radiation
techniques and current state-of-art for diagnostic capability;
o Estimate patient exposure from phantom-based dose estimates using practical, easy to
use tools.
 Funding the training of medical professionals in ways to manage/reduce dose and adopt best
practices, including life-long learning approaches for radiologists and nuclear medicine
physicians in image/dose optimization and other radiation related issues.
 Requiring a standardized approach to benchmarking radiation doses associated with standard
medical imaging examinations, including the standardization of measuring, recording and
reporting of radiation exposure.
 Requiring sites that utilize diagnostic imaging equipment to be regularly accredited in
radiation safety (including compliance with the measures described above).

Current Research to Answer Key Questions

To achieve the goals described above and deliver the maximum benefit to the American public, there
are many questions that must be asked and answered, as well as technical, practical and
economic/political problems that must be addressed with the best information available. The
Academy believes that there are near-term, mid-term and long-term initiatives that could advance this
process, and recommends that the following research initiatives be funded through the NIH, AHRQ,
CMS or other appropriate agencies:

 ABR Foundation and CMS-endorsed initiatives to curb „overutilization‟ via decision support
and improve physician-to-physician communications. These efforts involve developing,
validating and comparing the effectiveness of evidence-based content on appropriate imaging
and delivering this content as decision support as part of computerized physician order entry
(CPOE) systems.
 AAPM Technology Assessment Initiative. This initiative was created to evaluate and
optimize emerging imaging technologies and to address dose and quality concerns in
diagnostic imaging.
 Creating a regional and/or national repository of patient exposure data. This repository will
help physicians, payors and policy makers better understand and manage radiation exposure
issues on a regional and national basis, and will inform and assist many of the other research
and policy initiatives described below.
 Developing better models to estimate the cancer risks from imaging procedures using existing
CMS, payor and other databases (perhaps including international databases).
 Creating a public repository of optimal imaging protocols. This project involves developing,
evaluating and storing in a publicly available repository a set of imaging protocols for
common indications that minimize radiation dose while preserving the clinical value of the
requested exam. These protocols would be available to hospitals, imaging centers and other
providers, all of whom will be encouraged to implement the protocols.

3
 Selecting an optimal and standardized method to translate „machine-based‟ exposure
parameters (e.g., CTDI and DLP) into accurate estimates of patient exposure; harmonization
of exposure estimate methods from CT, X-ray and Nuclear Medicine. Effectively, we need a
practical and easy way to determine and express radiation dose to the organs of a specific
patient.
 Developing and testing of methods to provide „fail safe‟ procedures. This initiative involves
evaluating and disseminating standards, approaches, equipment features and other
interventions (across all vendor products) to minimize the likelihood of patient injury due to
equipment malfunction or misuse.
 Developing and testing of post-processing methods, such as iterative reconstruction to create
high fidelity images at lower radiation doses. This project involves research into computer
science techniques that deliver more clinical information from lower radiation doses.
 Funding „human performance‟ studies to determine how radiologists‟ ability to perform
common imaging interpretations is affected by image noise. This research will help
physicians answer critical questions about how much lower dose studies, which have lower
“signal to noise” value, impact the clinical outcome of the study.
 Development and optimization of standardized methods to „export‟ radiation exposure data
from acquisition devices to EMR and other registries. This project will develop the standards
and means required to incorporate cumulative radiation exposure data into individual patient
health records and decision support systems so that patients and physicians can better
understand the patient‟s specific risk/benefit calculus when considering a given exam.
 Research on methods to reduce duplicative imaging, including ways to share radiology
information across health care institutions and vendor systems. This research recognizes that
if an imaging study can be avoided (because a similar study is already available for the
patient), the patient has immediate benefits (avoiding additional radiation exposure) and the
healthcare system avoids the cost and waste of a repeated study.