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Monday, February 15, 2010

F.D.A. to Increase Oversight of Medical Radiation

[A few numbers for perspective: 400 chest x-rays is approximately 2-4 rem. The US average amount of radiation dose effect per person is about 0.4 rem per year with some regions having higher average natural doses of about 3 rem per year (e.g., Kerala, India). Higher cancer rates are not statistically detectable in populations with average doses below 10 rem per year.]


Published: February 9, 2010
The federal Food and Drug Administration said Tuesday that it would take steps to more stringently regulate three of the most potent forms of medical radiation, including increasingly popular CT scans, some of which deliver the radiation equivalent of 400 chest X-rays.

With the announcement, the F.D.A. puts its regulatory muscle behind a growing movement to make life-saving medical radiation — both diagnostic and therapeutic — safer.

Last week, the leading radiation oncology association called for enhanced safety measures. And a Congressional committee was set to hear testimony Wednesday on the weak oversight of medical radiation, but the hearing was canceled because of bad weather.

The F.D.A. has for weeks been investigating why more than 300 patients in four hospitals were overradiated by powerful CT scans used to detect strokes. The overdoses were first discovered last year at Cedars-Sinai Medical Center in Los Angeles, where patients received up to eight times as much radiation as intended.

The errors occurred over 18 months and were detected only after patients lost their hair.

In making the announcement, the F.D.A. said it hoped to reduce unnecessary radiation exposure from three medical imaging procedures: CT scans, which provide three-dimensional images; nuclear medicine studies, in which patients are given a radioactive substance and doctors watch it move through the body; and fluoroscopies, in which a radiation-emitting device provides a continuous internal image on a monitor.

“These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk,” the F.D.A. said. “Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts.”

Patients today receive far more radiation than ever before. The average lifetime dose of diagnostic radiation — excluding therapeutic radiation — has increased sevenfold since 1980, prompting widespread concerns that certain procedures are overused and that they needlessly expose patients to an increased risk of cancer. Children and women are particularly vulnerable.

Last month, The New York Times documented the harm that can result when complex machines that generate radiation are programmed incorrectly and when basic safety procedures are not followed. The Times also found that a patchwork of laws and regulations to protect patients are weak or unevenly applied.

The F.D.A. has long had jurisdiction over medical devices, but it has made limited use of its power. Consumer groups, for example, have repeatedly contended that the agency allows manufacturers to sell new devices without first having to prove their safety and efficacy.

In its announcement, the agency said it might require manufacturers of CT scanners and fluoroscopic devices to incorporate new safeguards into the design of their machines and to provide better training to medical personnel. The agency said it plans to hold a public meeting on March 30 and 31, “to solicit input on what requirements to establish.”

Among the proposals under consideration: that devices display, record and report equipment settings and radiation dose; that an alert be issued when the radiation dose exceeds an optimal dose for most patients; and that devices be required to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.

The F.D.A. said it would also work with the Centers for Medicare and Medicaid Services to incorporate new safety practices into the accreditation process of imaging facilities and hospitals.

“I think it is very timely in light of concerns about radiation exposure and the possibility of overexposure,” said Dr. James Thrall, professor of radiology at Harvard Medical School and chairman of the American College of Radiology. “I think it will nudge the industry.”

A major issue, Dr. Thrall said, is that “there is nothing on the machine that tells the technologist that they’ve dialed in a badly incorrect radiation exposure.”

Dr. Jeffrey Shuren, director of the F.D.A.’s Center for Devices and Radiological Health, said manufacturers were generally supportive of the agency’s proposal. “We are using a variety of tools available to us — both regulatory in nature and collaborative in nature — to maximize benefits,” Dr. Shuren said.

The Medical Imaging and Technology Alliance, an association of manufacturers of radiological equipment, issued a statement supporting the F.D.A. initiative, while calling for mandatory accreditation of advanced imaging facilities and for establishing minimum standards for personnel who perform medical imaging exams and deliver radiation therapy treatments.

“There is a patchwork of licensure and registration across the country,” said David N. Fisher, managing director of the manufacturers alliance, “and we believe in setting standards for physicians, physicists, technologists — all sorts of operators, the whole shooting match.”

Just last week, the American Society for Radiation Oncology called for the nation’s first central database for the reporting of errors involving linear accelerators — machines that generate radiation — and CT scanners.

In some states, radiation accidents involving CT scans, fluoroscopy equipment and radiotherapy devices need not be reported to the authorities.

Kristina Rebelo contributed reporting.


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