July 20, 2010
By: David Gutierrez
New concern over lack of regulation in medical radiation has been spurred by a case in which more than 300 patients received excessive levels of radiation, but doctors only uncovered the problem when patients’ hair began to fall out.
The radiation errors occurred at three hospitals in Los Angeles and one in Alabama, during heart tests performed with a special form of computed tomography (CT) scan. Some patients received more than eight times the intended radiation dose.
Since the case became public, there has been a growing call for tighter regulation of diagnostic and therapeutic radiation techniques. The American Society for Radiation Oncology, the country’s foremost radiation oncology association, recently called for new safety measures, including a central database where technicians can report any errors in CT scanners or the linear accelerators that produce medical radiation. The New York Times has printed features documenting the severe health problems that can result from the improper use of medical radiation, especially in women and children.
This concern is made all the more urgent by the ever-growing popularity of diagnostic radiation. Largely because of a vast increase in the use CT scans and similar tests, the average U.S. resident’s lifetime radiation dose has increased to seven times above 1980 levels. Even if no errors occur in any of these tests, harm may still result simply from the overuse of inherently risky procedures.
Congress is investigating why oversight into medical radiation remains so weak in the United States. Many observers have attributed the problem to the lack of a clear regulatory framework, with the New York Times noting that laws and rules designed to protect patients from excessive radiation exposure are weak, unevenly applied, and inconsistent across states and institutions. For example, some states do not even require the reporting of radiation accidents involving medical scanning devices.
“There is a patchwork of licensure and registration across the country,” said David N. Fisher, managing director of the Medical Imaging and Technology Alliance, a manufacturers’ group, “and we believe in setting standards for physicians, physicists, technologists — all sorts of operators, the whole shooting match.”
Although the FDA technically has jurisdiction over all medical devices, it has rarely made use of its authority. Consumer groups have criticized the agency for failing to make manufacturers even perform safety tests before putting radiation scanners or other medical devices on the market.
Spurred in part by the recent scandal, however, the FDA is moving to impose some measure of federal regulation on the use of radioactive imaging machines.
“These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk,” the FDA said in a press release. “Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts.”
The agency has introduced a three-pronged plan to regulate the use of three radiation scanning devices: CT scans, nuclear medicine studies and fluoroscopies. It is currently considering several options for ways to make devices safer, allow doctors and patients to make informed decisions about their use, and increase patient awareness about the devices’ risks.
The FDA’s effort has been well received by workers in the field.
“I think it is very timely in light of concerns about radiation exposure and the possibility of overexposure,” said James Thrall, chair of the American College of Radiology. “I think it will nudge the industry.”
The Medical Imaging and Technology Alliance has said it supports the FDA’s plan. It is asking the agency to impose mandatory accreditation for all facilities that carry out advanced imaging, and minimum standards for all health workers who use devices that deliver radiation.
July 20, 2009
by S. L. Baker
No matter what your health complaint is, if you go see your doctor you might end up undergoing some kind of high tech imaging procedure such as cardiac angiography, CT (computed tomography) or MRI (magnetic resonance imaging). According to a study published last fall in the journal Health Affairs, medical imaging has soared over the last few years across all types of these tests, doubling the annual medical cost per patient. In fact, the study confirmed previous reports that patients are far-too-often being subjected to unnecessary imaging.
At least, most of these tests are minimally invasive and thoroughly studied to make sure they carry few risks so they are safe, right? Unfortunately, the answer is no. New reports of lasting, health-harming effects from some imaging tests are accumulating. A case in point: a new study just published in the Clinical Journal of the American Society Nephrology (CJASN) warns that seemingly minor and reversible kidney damage injury which can arise after undergoing certain common medical imaging procedures is a serious health threat. The reason? It is linked to a greatly increased risk of stroke, heart attack and death.
University of Vermont physician Richard Solomon,MD, and his colleagues investigated 294 patients with kidney disease who were exposed to contrast agents during cardiac angiography. Patients in this study, dubbed the CARE (Cardiac Angiography in REnally Impaired Patients) trial, were randomly divided with half receiving the contrast agent iopamidol and the other receiving the contrast agent iodixanol.
Many medical imaging techniques, including cardiac angiography and CT scans, often involve the use of contrast agents, substances that contain iodine (like iopamidol and iodixanol) and barium, because they enhance the contrast between body structures or fluids within the body. This allows blood vessels and changes in tissues to be more clearly visualized.
When Dr. Solomon and his colleagues followed the CARE patients for one year or longer, they found that 92 (31 percent) of the research subjects experienced negative health effects after their imaging test. Their risk of having a stroke or heart attack over the next year or two after the test was elevated. Overall, 38 (13 percent) of the patients experienced a major event, such as death, stroke, heart attack, or end-stage renal disease. Those who developed contrast-induced kidney injuries had twice as many long-term negative health effects compared with patients who didn’t suffer kidney damage.
It isn’t only people who already have problems with their kidneys who can be at risk from the imaging testing, either. Doctors have long known exposure to contrast agents can cause damage in seemingly healthy kidneys, but patients are usually assured this is just a temporary side effect that will resolve on its own. However, recent studies have suggested that contrast-induced kidney damage might actually be lasting and serious. In a statement to the media, the University of Vermont researchers said “the CARE trial findings should prompt investigators to design additional studies on the long-term negative health effects of contrast-induced kidney damage”.
In addition to kidney damage, the contrast agent iopamidol has also been known to sometimes cause seizures in people with a history of epilepsy. In rare case reports, including one published earlier this year in the Internet Journal of Neurology, iopamidol has been found to cause severe seizures and respiratory arrest in non-epileptic patients undergoing imaging tests.
As reported in Natural News last April, the use of contrast agents isn’t the only potentially dangerous downside to some common imaging procedures. A study in the medical journal Radiology found that people who had numerous CT scans over their lifetime had a significantly increased risk of cancer. In fact, CT scans increased the risk of cancer by 2.7 to 12 percent.