If you go in for a computed tomography scan of your abdomen, you’ll be exposed to the equivalent of 400 chest X-rays. As the number of CT scans and other imaging procedures has risen over the past 20 years or so, Americans’ exposure to potentially damaging radiation has escalated as well.
With that in mind, the Food & Drug Administration is proposing a series of moves to help limit unnecessary exposure to radiation from CT scans, nuclear medicine studies and fluoroscopy. Although the exact medical risks are unclear, it’s believed that these types of exams, which expose patients to ionizing radiation, increase the risk of developing cancer. Exposure to high levels of radiation, as happened late last year at medical facilities in Los Angeles, can also cause skin burns, hair loss and cataracts.
In November, Cedars-Sinai Medical Center in Los Angeles revealed that it had accidentally exposed more than 260 patients to eight times the normal dose of radiation for CT brain scans over a period of 18 months, according to the Los Angeles Times. Two other LA facilities, Providence St. Joseph Hospital in Burbank and Glendale Adventist Medical Center, and a hospital in Alabama also reported possible radiation over-exposure from imaging procedures in about 104 patients, according to the Times.
For CT and fluoroscopic imaging equipment makers, the new FDA push means they will have to build safeguards into their devices. The federal watchdog agency said it will likely require the devices to display, record and report settings and radiation doses for each procedure and issue alerts when the doses exceed optimal doses. The devices may also be required to capture and transmit that data to patients’ electronic medical records and to proposed national dose registries. The FDA is slated to hold public comment sessions March 30-31 to solicit input on the proposed requirements.
The agency and the Centers for Medicare and Medicaid Services are also cooperating to beef up the quality assurance requirements for hospitals and medical imaging facilities and is pushing professional healthcare organizations to create diagnostic radiation reference levels and develop a national radiation dose registry.
The final prong of the initiative, a patient medical imaging history card stored on the FDA’s website, is aimed at enabling patients and doctors to track medical imaging histories that might not be included in medical records.