FDA cracking down on excess radiation from medical imaging devices

(NaturalNews) The FDA has announced a plan to reduce patients' unnecessary exposure to radiation from three different medical imaging tests. The three-pronged strategy will focus on increasing the safety of the devices, increasing patient awareness of risks, and improving the ability of patients and doctors to make informed decisions.

The tests in question are computed tomography (CT) scans, nuclear medicine studies and fluoroscopy. CT scans produce three-dimensional images of different areas of the body, nuclear medicine studies involve consumption of a radioactive substance to observe its motion through the body, and fluoroscopy uses a continuous beam of radiation to produce a real-time, moving image.

"The FDA continues to support a strong dialogue between patients and physicians over the medical necessity and risk associated with these types of imaging studies," the agency said. "However, like all medical procedures, CT, nuclear medicine, and fluoroscopy pose risks."

The FDA chose to focus on the three procedures because together they provide the single greatest source of radiation exposure for the U.S. population. CT scans, nuclear medicine studies and fluoroscopy all deliver much higher doses than other radioactive imaging procedures, such as mammography or X-rays. For example, a single CT abdomen scan uses as much radiation as 400 chest X-rays or 800 dental X-rays.

Yet in spite of the risks, which according to the FDA include cancer, cataracts and burns, the use of radioactive imaging tests has become much more common in the United States in recent years.

"The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

The FDA plans to reduce unnecessary exposure by encouraging "appropriate justification" of all radiation tests, as well as "optimization of the radiation dose."

"Working together," said Shuren, "the FDA and other organizations hope to help patients get the right imaging exam, at the right time, with the right radiation dose."

Under the first prong of its three-prong strategy, the FDA seeks to encourage safer use of the three techniques. Toward this goal, it plans to require manufacturers of radiation imaging devices to implement specific safeguards in the machines and implement standardized training for all device operators. The specific requirements to be established have yet to be determined, but might include making all devices display, record and report radiation doses and other relevant settings; having devices issue alerts when a higher-than-normal dose is entered; and making devices immediately add information about each test to a patient's permanent medical record and a national dose registry.

The FDA is also working with the Centers for Medicare and Medicaid Services to impose new accreditation requirements on all facilities that perform radioactive imaging, with the goal of improving oversight and safe device use.

In order to improve patient awareness, the FDA is working with a number of other organizations to design a patient medical imaging history card, which would record every radiation test undergone by a specific patient in a fashion similar to an immunization card. This card (which will also be available via the FDA web site) could then be presented to physicians to inform them about the patient's prior lifetime radiation exposure.

In service of the final goal, informed consent, the FDA is encouraging the development of a national radiation dose registry so that researchers can monitor nationwide radiation exposure and help produce more targeted recommendations on when the risk of a procedure outweighs its benefits.

"Health care decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure," the agency said.

Sources for this story include: www.fda.gov/NewsEvents/Newsroom/Pre... www.nytimes.com/2010/02/10/health/p....

FINALLY: NIH takes a step to track radiation exposure from medical tests

(NaturalNews) Many Americans are exposed to atomic bomb levels of radiation (http://www.naturalnews.com/025767_R...) over their lifetimes, thanks to the medical industry's determination to push radiation imaging techniques like mammography and CT scans on the healthy as well as the ill. In fact, over the past three decades, Americans' exposure to radiation through common medical tests has soared six-fold. But although it is a well-known scientific fact that radiation exposure, which is cumulative, increases the risk of cancer, government scientists have failed to warn the public about the dangers of repeated tests involving radiation, claiming the specific risk level is unknown.

Now, finally, researchers at the National Institutes of Health (NIH) Clinical Center have decided radiation dose exposure reports should be included in patients' electronic medical records. According to an article in the February issue of theJournal of the American College of Radiology (JACR), the NIH researchers hope this effort will result in an eventual accurate assessment of cancer associated with low-dose radiation exposure from medical imaging tests.

"The cancer risk from low-dose medical radiation tests is largely unknown. Yet it is clear that the U.S. population is increasingly being exposed to more diagnostic-test-derived ionizing radiation than in the past," David A. Bluemke, MD, lead author of the article and director of Radiology and Imaging Sciences at the NIH Clinical Center, said in a statement to the press. "One widely publicized appraisal of medical radiation exposure suggested that about 1.5 to 2 percent of all cancers in the USA might be caused by the clinical use of CT alone."

A new radiation reporting policy

To attempt to document the amount of radiation exposure patients receive from medical tests, the radiology and nuclear medicine experts at the NIH Clinical Center have come up with a radiation reporting policy that involves the major radiation equipment vendors, starting with keeping track of exposures from CT and PET/CT scans. "All vendors who sell imaging equipment to Radiology and Imaging Sciences at the NIH Clinical Center will be required to provide a routine means for radiation dose exposure to be recorded in the electronic medical record. This requirement will allow cataloging of radiation exposures from these medical tests," said Dr. Bluemke. In addition, the NIH will now require that vendors make sure that radiation exposure can be tracked by patients in their own personal health records.

Dr. Bluemke added that this approach is consistent with the American College of Radiology's and Radiological Society of North America's official stance that "patients should keep a record of their X-ray history". You read that correctly.Patients themselves are currently supposed to keep up with how much radiation they've been bombarded with, according to the radiology industry.

What's more, the NIH's new pronouncement that requires radiation testing vendors to keep track of how much radiation they expose patients to only applies to people receiving screening or testing through the NIH. "We encourage all medical imaging facilities to include similar requirements for radiation-dose-reporting outputs from the manufacturers of radiation-producing medical equipment," Dr. Bluemke said.

So the new NIH policy does not mean other medical centers and hospitals that use medical imaging are now required to keep records of how much radiation they are zapping patients with -- the government is only encouraging these facilities to follow through on this recommendation. Bottom line: the only real protection from excessive medical radiation is for people to take control of their own health, to ask questions of any doctor who wants to order these tests, and to avoid any and all unnecessary radiation imaging testing.

For more information:
http://www.naturalnews.com/radiatio...
http://www.jacr.org/article/S1546-1...)00362-7/ tests

One heart attack results in medical imaging scans equivalent to 725 chest X-rays

(NaturalNews) Researchers from Duke University Medical Center in North Carolina have discovered that the tests administered to a person undergoing a heart attack emit radioactive elements at levels equivalent to 725 chest X-rays. The aggregate average of radiation administered is about a third of what nuclear power plant workers are allowed to be exposed to annually.

Dr. Prashant Kaul, author of the research study, indicated that doctors typically fail to identify any other tests a heart attack victim may have already received when administering their own. As a result, patients are being exposed to high levels of radiation that far exceed safe maximum levels.

The research team accumulated and analyzed data from over 64,000 patients who had undergone treatment for heart attacks between 2006 and 2009. The team discovered that patients underwent an average of seven tests utilizing ionizing radiation, the kind that is capable of penetrating tissue and damaging DNA cells. The vast majority of the tests were chest X-rays, followed by catheter procedures and computed tomography, also known as CT scans.

According to the American Heart Association, the aggregate number of medical tests given each year that involve some sort of radioactive exposure has skyrocketed, increasing 700 percent between 1980 and 2006. Most of these tests deal in some way with heart disease as it is one of the fastest growing disease epidemics in America.

Improvements in scanning technology have resulted in a sevenfold increase in radiation exposure compared to diagnostic scans performed in 1980. The New England Journal of Medicine reported in August that roughly 4 million Americans are exposed to dangerously high levels of radiation each year due to such medical testing procedures.

The obvious threat from radioactive testing procedures is the potential for increased rates of cancer. The U.S. Food and Drug Administration (FDA) has indicated that a person subjected to a CT scan may develop cancer at some point in his or her life due to the amount of radiation emitted from the test. For this reason, doctors should be cautious in advising patients to undergo such tests unless absolutely necessary.

Magnetic resonance imaging (MRI) is an alternative technology that involves no ionizing radiation. MRIs utilize magnetic fields to generate images that are typically clearer than those produced by a CT scan. Ultrasound is another option that uses sound waves to form images. Heart ultrasounds work especially well at assessing the heart for possible risk factors before a heart attack occurs.

Sources for this story include

http://www.reuters.com/article/heal...

http://www.fda.gov/Radiation-Emitti...