par Lauren Dubinsky
, Senior Reporter | April 20, 2020
From the April 2020 issue of HealthCare Business News magazine
In September 2018, ICUS submitted a petition to the FDA to remove the boxed warnings from ultrasound contrast agent labels. The petition states that this would “bring the labeling into line with the current body of scientific research, which now clearly demonstrates the favorable safety profile and clinical benefits of these radiation-free diagnostic imaging products.”
Many individual physicians have submitted letters in support of the petition, as well as other medical societies including the American Institute of Ultrasound in Medicine (AIUM), the World Federation of Ultrasound in Medicine and Biology (WFUMB), the Society of Radiologists in Ultrasound (SRU), the Society of Diagnostic Medical Sonography (SDMS), the Society for Pediatric Radiology (SPR), the American Society of Echocardiography (ASE) and the Liver Imaging Reporting and Data System (LI-RADS) CEUS working group.
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According to Dr. Steven Feinstein, co-president of ICUS and professor of medicine at Rush University Medical Center in Chicago, and Dr. Brian Fowlkes, professor of radiology and biomedical engineering at University of Michigan Health System, the black box harms patient care because it misrepresents the risks and inappropriately deters the use of ultrasound contrast agents when they are medically indicated. They argue that the black box creates unfounded fears around using these agents and as a result, many patients are exposed to potentially more harmful investigative procedures or have been misdiagnosed or not diagnosed at all.
Dr. Brian Coley, president of AIUM and professor of medicine and radiologist-in-chief at Cincinnati Children’s Hospital, believes that the black box warning should be done away with, but doesn’t think it affects the use of ultrasound contrast agents.
“Personally, the black box warning does not dissuade me or others that I know from using these agents,” he said. “Most of our pediatric patients do not have serious cardiopulmonary disease.”
The factors that he believes do influence the use of these contrast agents in pediatrics are lack of familiarity and training in administration, the need for sonographer and physician training, changes in workflow, the need to start an IV on a child and concerns over reimbursement.