The FDA Takes on Radiation Exposure

Everyone knows that radiation is harmful.  Now, with more imaging procedures being performed, the FDA has published an initiative to reduce unnecessary radiation exposure.  The primary focus of the initiative is to promote awareness but it also provides guidelines and measures to reduce high levels of patient exposure.

First, let’s define which technologies are most affected.  One study stated that CT, interventional fluoroscopy, and nuclear medicine studies make up approximately 26% of the imaging procedures using radiation but contributed 89% of the total yearly exposure to radiation from medical imaging.  To be more specific, the New England Journal of Medicine listed CT angiography of the chest and spine, myocardial perfusion (nuclear medicine), and cath lab imaging as delivering the highest effective dose per study.  But when considering cumulative effects, mammography is also an area of concern.

Radiologists have been aware of the problem for years.  I asked Vincent Campanella, MD, medical imaging and breast imaging technology consultant at White Plains Hospital Center in White Plains, NY, and a leading expert in breast imaging about the issue.  He said, “Digital X-ray offers a very good image but you have exposure to the radiation.  Ultrasound applications are rapidly expanding and don’t subject the patient to radiation.  Ultrasound applications will also tell you if it is solid, hollow, or fluid-filled tissue; however, it will not tell you if it is cancerous.”

Dr. Campanella also discussed emerging options stating, “We are already looking for ways to reduce a patient’s exposure.  Although optical imaging is a physiological parameter not an image, optical imaging does not expose the patient to an X-ray.”

A unique solution by the American College of Radiology, the Radiological Society of North America, the American Association of Physicists in Medicine, and the American Society of Radiologic Technologists, called the Image Wisely™ program, is to track a patient’s radiation exposure on their medical records.

Manufacturers have also developed new technologies, such as Adaptive Iterative Dose Reduction and Dual-source spiral CT, to accommodate lower doses.  Trials indicate that these technologies have the ability to reduce CT exposure by 25% and 60%.

Along with optical and advanced ultrasound, image guidance has moved from cranial and orthopedic applications to soft tissues and is now being used to help reduce radiation exposure in the cath lab, surgery, and lung cancer studies.  Now is the time to start adopting these new options before a mandate drives the cost up.

James Laskaris, EE, BME
ABOUT THIS EXPERT
James Laskaris, EE, BME, Emerging Technology Analyst — Mr. James Laskaris is a senior emerging technology analyst at MD Buyline and has been with the company since 1994. With over 30 years of experience in the healthcare field, Mr. Laskaris is the primary analyst of high-end OR technology. He also covers issues related to the legislative and reimbursement effect on healthcare and authors a bimonthly “Issues that Matter” publication. Mr. Laskaris received his biomedical engineering degree from Southern Illinois University. His work has been published in hfm Magazine, Radiology Manager and Healthcare Purchasing News.