Feature | May 15, 2012

FDA Proposal Aims to Reduce Radiation Exposure for Children

May 14, 2012 — On May 9, the U.S. Food and Drug Administration announced that it is seeking public comment on a proposal encouraging manufacturers to consider the safety of children in the design of new X-ray imaging devices. In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.

It also proposes that manufacturers who do not adequately demonstrate that their new X-ray imaging devices are safe and effective in pediatric patients should include a label on their device that cautions against use in pediatric populations.

To help healthcare providers more safely use their current equipment on pediatric patients, the FDA is collaborating with the Alliance for Radiation Safety in Pediatric Imaging (ARSPI) and manufacturers, through the Medical Imaging and Technology Alliance (MITA), to develop pediatric imaging radiation safety training materials.

The FDA has also launched a pediatric X-ray imaging website that provides information on the benefits and risks of imaging using ionizing radiation, recommendations for parents and health care providers to help reduce unnecessary radiation exposure, and information for manufacturers of X-ray imaging devices.

The guidance, website, and ongoing collaborations with ARSPI and MITA are part of FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, launched in February 2010.

When used appropriately, X-ray imaging, such as computed tomography (CT), fluoroscopy and conventional X-ray, can provide valuable information to help with diagnosis, treatment planning and surgical intervention in adults and children. At the same time, these types of exams expose patients to ionizing radiation, which can be of particular concern in pediatric patients.

The cancer risk per unit dose of ionizing radiation is generally higher for younger patients than adults, and younger patients have a longer lifetime for the effects of radiation exposure to manifest. Also, the use of X-ray equipment settings designed for adults can result in a larger radiation dose than necessary to produce a useful image for a smaller pediatric patient.

“The risk from a medically necessary imaging exam is quite small when compared to the benefit of accurate diagnosis or intervention. There is no reason for patients who need these exams to avoid them,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Parents should engage in a discussion with their child's physician about benefits and risks of X-ray, computed tomography (CT) and fluoroscopy exams.”

A workshop scheduled for July 16, 2012, will bring together industry, X-ray imaging equipment users (e.g., physicians, radiologic technologists and physicists), and patient advocates to discuss FDA’s draft guidance.

For more information: www.fda.gov

Related Content

Imaging volumes in hospitals and practices previously slowed by the coronavirus pandemic continue to hold steady, according to new QuickPoLL survey results that gauge how radiologists feel about current business and the impact of COVID-19.
Feature | Coronavirus (COVID-19) | August 03, 2020 | By Melinda Taschetta-Millane
Imaging volumes in hospitals and practices previously slowed by the coronavirus pandemic continue to hold steady, acc
According to the new market research report "Radiation Dose Management Market by Products & Services (Standalone Solutions, Integrated Solutions, Services), Modality (Computed Tomography, Nuclear Medicine), Application (Oncology, Cardiology, Orthopedic), End User (Hospitals) - Global Forecast to 2025", published by MarketsandMarkets, the radiation dose management market is projected to reach USD 422.65 million by 2025 from USD 220.22 million in 2020, at a CAGR of 13.9%.

Courtesy of MarketsandMarkets Research

News | Radiation Dose Management | August 03, 2020
August 3, 2020 — According to the new market research report "...
Franco Fontana, CEO of the Esaote Group, and Xie Yufeng, Chairman of WDM.

Franco Fontana, CEO of the Esaote Group, and Xie Yufeng, Chairman of WDM.

News | Digital Radiography (DR) | July 31, 2020
July 31, 2020 — In the thick of the COVID-19 eme
Older Americans may be receiving cancer screenings not recommended by the U.S. Preventive Services Task Force, according to Penn State College of Medicine researchers.

Getty Images

News | Radiology Imaging | July 31, 2020
July 31, 2020 — Older Americans may be receiving cancer screenings not recommended by the...
A World Health Organization (WHO) rapid advice guide on the use of chest imaging in the diagnosis and management of COVID-19 was published in the journal Radiology.

Getty Images

News | Coronavirus (COVID-19) | July 30, 2020
July 30, 2020 — A World Health Organization (WHO) rapid advice gui
It covers every major modality, including breast imaging/mammography, fixed and portable C-arms (cath, IR/angio, hybrid, OR), CT, MRI, nuclear medicine, radiographic fluoroscopy, ultrasound and X-ray
News | Radiology Imaging | July 29, 2020
July 29, 2020 — IMV Medical Information, part of Scien...
Left, a 3-D rendering of a heart from a cardiac CT exam. Right, a lung-CT exam showing the heart and ground glass lesions in the lungs of a COVID-19 patient. CT has become a front-line imaging modality in the COVID era because it offers both cardiac and lung information to help determine a patients disposition with chest pain, COVID-19 and COVID-caused myocarditis and pulmonary embolism. #COVID19 #CCTfirst #YesCCT

Left, a 3-D rendering of a heart from a cardiac CT exam. Right, a lung-CT exam showing the heart and ground glass lesions in the lungs of a COVID-19 patient. CT has become a front-line imaging modality in the COVID era because it offers both cardiac and lung information to help determine a patients disposition with chest pain, COVID-19 and COVID-caused myocarditis and pulmonary embolism.

Feature | Computed Tomography (CT) | July 28, 2020
July 28, 2020 — The use of cardiova...
 The Radiological Society of North America (RSNA) has been awarded a $750,000 grant by the Department of Energy’s National Nuclear Security Administration (NNSA) to develop a Global Learning Center (GLC) in Sub-Saharan Africa. The grant will help address the growing need in Sub-Saharan Africa for training in radiology.
News | Radiology Education | July 28, 2020
July 28, 2020 — The Radiological Society of North America (RSNA)