In 2013, Dr. Marilyn Goske, a pediatric radiologist within the Department of Radiology at Cincinnati Children’s and the chairperson of the Image Gently Alliance, negotiated a contract between the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) and Image Gently. The overall purpose of the Image Gently Alliance is to improve safe and effective imaging care of children worldwide. This occurs when the radiation dose to children is carefully managed (and reduced if possible) while maintaining the required quality of images the radiologist needs to evaluate and diagnose the health of a child. The purpose of this specific project was the encouragement of the manufacturers of x-ray equipment to develop improvements in their future models of fluoroscopic x-ray equipment specifically targeted to the improvement of patient care during imaging of children.
Fluoroscopic x-ray equipment is specifically designed to provide a movie of the patient’s anatomy as opposed to only still images produced by less complicated x-ray machines. This feature enables the diagnosis of certain diseases and also allows interventional radiologists or cardiologists to insert catheters and devices into the patient’s blood vessels and heart to repair anatomical problems in lieu of surgery.
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Keith Strauss, the vice-chairman of Image Gently and the section head of Clinical Medical Physics within the Radiology Department at Cincinnati Children’s, wrote a technical document that detailed the unique fluoroscopic imaging requirements of children to initiate the project. Using the basic information in this document as a guideline, Keith, on behalf of Image Gently, worked with the Interventional Fluoroscopic Committee (members come from each major manufacturer of fluoroscopic imaging equipment worldwide) of the Medical Imaging and Technology Alliance (MITA) of the United States to develop a guideline for the equipment manufacturer’s design engineers to use during the development of new fluoroscopic x-ray machines. This guideline, Essential Questions for Consideration in the Design of Interventional X-ray Equipment Intended for Pediatric Use, was published on the MITA website in January 2015.
Photo: Dr. Donald Miller (center), Chief, Diagnostic Devices Branch Division of Mammography Quality and Radiation Programs of the CDRH. Markus Lendl (right) is one of the equipment manufacturer representatives from the MITA committee. Radiology Department’s Keith Strauss (left) led the contributions of Image Gently to the project.
For this joint effort between Image Gently and MITA in the preparation of the above document, the CDRH of the FDA elected in 2016 to give a Director’s Special Citation Award to the members of MITA and Image Gently who contributed to the project. The majority of the recommendations in this joint guideline are currently incorporated in the fluoroscopic x-ray units at Cincinnati Children’s.
Contributed by Keith Strauss. PhD., and edited by Glenn Miñano, BFA.