Balancing Radiation Risks, Benefits, and Quality

Over the years, medical imaging equipment such as X-rays, computed tomography (CT), and magnetic resonance imaging (MRI) have played important roles in providing quality health—by quickly and quietly detecting problems ranging from brain tumors to aneurysms. And, radiation therapy has become important in providing high-quality cancer care.

But recent studies and reports linking radiation overexposure for various reasons to cancer risks, illness, and even death may be the start of a new era in the diagnostic and therapeutic uses of radiation. How can we best reap the benefits while avoiding the risks?

Late last year, in a study published in the Archives of Internal Medicine, researchers estimated that radiation from CT scans done in 2007 could cause 29,000 cancers and kill nearly 15,000 Americans. Currently, more than 70 million CT scans (which can have 50- to 500-times the radiation dose of X-rays) are given in the U.S. today annually—up from 3 million 30 years ago.

In some instances, these scans may be related to overuse or unnecessary use. For instance, a study from this month's Journal of the American College of Radiology that found that one in four MRI and CT scans were "inappropriately recommended" by doctors. The researchers found that of 459 scans at Harborview Medical Center in Seattle, 26% were considered "inappropriate."

On the therapeutic side, emerging stories—such as those presented last week at a congressional hearing on radiation benefits and risks—indicate a need for more safeguards and more staff training as well.

One of the stories presented at the Feb. 25 House hearing was that of the late Scott Jerome Parks. His father testified that Jerome-Parks accidentally had received treatments seven times more powerful than required for his tongue cancer—causing him to go blind and deaf. He eventually died. The cause: malfunctioning computer software that had not been detected by a technician.

So can more be done to address these issues? The answer is yes, of course. But, it is going to require multiple and overlapping efforts on many fronts from both the private and public sectors.

Federal assistance: The issue of overexposure received high-profile attention last month when the federal Food and Drug Administration (FDA) issued a new initiative to reduce unnecessary radiation exposure from three types of medical imaging procedure—CT, nuclear medicine studies, and fluoroscopy.

These combined procedures are considered the leading contributors to total radiation exposure in the U.S., because they use higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography, according to the FDA. Of concern was exposing patients to ionizing radiation a type of radiation that can increase an individual's lifetime cancer risk.

As the first prong of the initiative, FDA said it intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices. These requirements address safeguards in the design of their machines and provide appropriate training to support safe use by practitioners.

For the second part of the initiative, FDA and the Centers for Medicare and Medicaid Services will work together to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals.

One size does not fit all. In an ongoing campaign, the Alliance for Radiation Safety in Pediatric Imaging has reached out on behalf of especially vulnerable populations: Young children. Prior to 2001 the majority of CT imaging for children was conducted using the same techniques—and radiation levels—used for adult imaging.

Imaging teams and members of the community are encouraged to play different roles in using the "image gently" philosophy—to ensure that CT scans for children are performed at levels that are most appropriate for them.

Professional organization assistance. Last month, one professional organization dedicated to radiation oncology called for enhancing safety measures in administering medical radiation-including establishing the nation's first central database for the reporting of errors involving linear accelerators and CT scanners.

The group, the American Society for Radiation Oncology, or ASTRO, issued a six point plan designed to improve safety and quality and reduce the chances of medical errors. The group also said it is pressing for federal legislation to require national standards for radiation therapy treatment teams.

Better record keeping. Earlier this year, the National Institutes of Health announced that all of its physicians should begin recording radiation doses for patients in their medical records.

All vendors that sell imaging equipment to the clinical center will be required to "provide a routine means for radiation dose exposure to be recorded in the electronic medical record," said David A. Bluemke, MD, the study's lead author and director of Radiology and Imaging Sciences at the Clinical Center.

In addition, radiology at NIH also will require that vendors ensure radiation exposure can be tracked by patients in their own personal health records. This approach is consistent with the American College of Radiology's and Radiological Society of North America's stated recommendation that "patients should keep a record of their X-ray history."

Provider assistance. As Massachusetts General Hospital in Boston has found, electronic medical records can be used to help providers when ordering scans. Here, when a provider orders a test, he or she will get an answer back: If the test is questionable or another test might be more appropriate, physicians or other providers will get a yellow cautionary light. If a scan isn't recommended, it comes up red.

Industry alerts. The Medical Imaging & Technology Alliance (MITA) said last week that manufacturers will begin adding a color coded warning system to give healthcare providers clear warning when they are doing scans that give patients potentially dangerous doses of radiation.

The changes, which would be phased in starting this year, would require the machines to provide a yellow alert screen when the dose is higher than anticipated. The scanning devices would display a red alert warning when a patient is about to be given a dangerous dose of radiation. The system would also allow hospitals and imaging centers to set their machines to prevent these scans from happening.

Radiation and radiology have been around for so many years that we rarely give a second thought to issues such as safety and appropriateness. But for our health's sake, perhaps we should.