Tom Shope, PhD, a physicist and special assistant to the director in the FDA’s science and technology center for devices and radiological health, said the new guidelines have been proposed for fluoroscopy machines and are currently in the agency’s 120-day public comment period. Following that, they will be published in the Federal Register and become effective one year later — by mid-2002.

Shope says patients should not shy away from considering and then receiving appropriate diagnostic and interventional procedures (such as draining an infection or having a major blood vessel opened up by a catheter and balloon) because of sporadic reports of x-ray injuries. And, he emphasizes, with respect to cancer treatments involving radiation therapy, patients should continue on the course of treatment recommended by their physicians. "These are not diagnostic treatments — they are serious treatments," he says.

The proposed guidelines, which were sculpted in the mid-1990s, will be discussed at an FDA-sponsored meeting on May 17. They are necessary because the fluoroscopy machines that are used in these diagnostic and interventional procedures have advanced over the past decade, Shope says. With those advancements, the machines have become more powerful and, in turn, there have been infrequent and "informal" reports of skin injuries and overexposure to x-rays during the treatments, he adds. The proposed guidelines will set up a system on the new machines to alert technicians when the patient is nearing a radiation danger zone while receiving a treatment.

"Currently, physicians don’t have a way to know what radiation exposure patients are getting as they receive it," Shope says. "Now, with the computerization of equipment, the technology is available to give a display of information related to the patient’s radiation exposure. These guidelines are not going to drastically change the performance of the equipment, but they will provide some additional tools."

Treatment with high-energy rays like x-rays or gamma rays is frequently used in cancer therapy to kill or shrink cancer cells, according to the American Cancer Society (ACS). In some cases, the radiation therapy is used prior to surgery to shrink a tumor — and sometimes after surgery to kill remaining cancer cells. Radiation is also used in a new procedure to help keep open heart arteries clogged after angioplasty.

However, the most common use of x-rays is in the various diagnostic procedures that most people are familiar with, such as a chest x-ray, computerized tomography or CT scan, and the fluoroscopy used during cardiac catheterization and balloon angioplasty. Over the past several years, there has been a substantial increase in the number of interventional procedures, where catheters (long, thin tubes inserted into the body or a blood vessel) and needles are used to either diagnose or treat various conditions. These procedures are done under fluoroscopic guidance, where x-rays and ultrasound are used to monitor the placement of the catheters, needles or other devices. Many of these conditions used to require a trip to the operating room and many days of post-operative recovery. Now, these new types of procedures allow doctors to treat these conditions either without staying in the hospital, or at most during a short hospital stay.

Shope cautions patients from shying away from appropriate radiology tests or procedures. "I would strongly urge patients not to become alarmed about reports (about skin injuries and overexposure to radiation) and avoid any diagnostic procedures. In many cases, the procedures are the only option."

Jim Borgstede, MD, the chair of the American College of Radiology patient safety task force, agrees. Borgstede says patients need to ask questions regarding the training of their physician. "This is a safety issue which can be avoided and should not occur," Borgstede says.

"Radiologists in general tend to be very attentive to this sort of problem. During our training, we take a yearlong physics course," he says. "We are tested and are well aware of issues."