Experts Call for Better Oversight of Radiological Procedures

While diagnostic and therapeutic medical radiation have many important benefits, a House subcommittee on Friday took a closer look at recent reports in which radiation reportedly caused injuries in a variety of settings—and how to avoid these risks and hazards.

Rep. Frank Pallone (D-NJ), chair of the Energy and Commerce Health Subcommittee, said the hearing was not because Congress thinks that medical radiation is bad. "I would like to assure you, this is not the case," he said. "We are not here today to make the statement that medical radiation should not be used."

However, with all the advancements the industry has made, "these technologies have become more complex and complicated to operate," Pallone said. "It is shocking to me that in many states individuals who operate these devices do not need to be licensed and are therefore not regulated at all in terms of education and expertise."

"Part of the problem could be the fact that no single agency has authority over the entire spectrum of issues related to medical radiation and because of this, things are more likely to fall through the cracks," he said.

One of the individuals testifying was the father of Scott Jerome Parks, who received treatments seven times more powerful than required for his tongue cancer. The accident allegedly occurred when a technician did not detect malfunctioning computer software. The story was featured in a series of articles from the New York Times.

James Parks told the subcommittee that because of the error, his son had become deaf and blind before dying in 2007.

"Medical accidents happen. We know that hospitals have a vested interest in making serious accident go away as quickly and quietly as possible," he said. "Hospitals in general cannot be relied upon to report or make public, serious medical accidents without strong external sanctions."

Parks called for the U.S. to develop "a strong, mandatory data base, and force all medical institutions to report all serious medical accidents." It would be a repository for "evaluating trends and identifying medical problems throughout the nation," he added.

While approximately a million patients per year are "safely and accurately treated" with radiation therapy, further steps are needed to ensure patient safety, Eric Klein, PhD, a professor of radiation oncology at Washington University, St. Louis, testified.

First, a national depository for anonymous error reporting should be created in order for communities to learn from such errors or "near misses," he said. Although the anecdotal reported rate of errors in radiation oncology is quoted as less than one in 10,000, this rate likely may be inaccurate because there is no depository or even statewide mandates for reporting such errors.

"In most states, hospitals are not obligated to report errors occurring with their linear accelerator," he said.

Hospitals also need to encourage scheduling patterns to allow for time outs before "each treatment begins to allow for cross checking of all parameters by the therapists," Klein said. In relation to this, the time leading up to the patient’s first treatment should allow for careful review "of all parameters to be used," he added.

The oversight for computed tomography (CT) radiation dosing is currently "very fragmented," said Rebecca Smith Bindman, MD, a professor of radiology, epidemiology, and biostatistics, obstetrics, gynecology ,and reproductive sciences at the University of California, San Francisco. "The Food and Drug Administration (FDA) oversees the approval of the CT scanners—as medical devices—"but does not regulate how the test is used in clinical practice."

While radiologists determine how the CT tests are performed, few national guidelines are available on how these studies should be conducted, Smith-Bindman said. "Therefore, there is great potential for practice variation that could introduce unnecessary harm from excessive radiation dosing."

Since information on radiation is reported differently across the various types of CT machines, radiologists may find it difficult to standardize their practice, she said. The American College of Radiology has established a voluntary accreditation process to standardize practice, Smith-Bindman said.

However, while the approach is promising, data collection is "extremely limited, making it difficult if not impossible for [ACR] to monitor if facilities comply with their recommendations."

In the current environment, medical technology and decision making "are increasingly complex, and rapid changes in diagnosis and care delivery compound the situation," said Tim Williams, MD, chairman of the board of Directors On behalf of the American Society for Radiation Oncology (ASTRAY).

ASTRAY recently launched a new quality- and safety-focused self assessment module based on best practices to improve clinical care in radiation oncology. "This online education tool provides best practice guidelines for dosimetrists, physicists, therapists, physicians, and nurses," Williams said.

The new module emphasizes the use of peer review, including an analysis of treatment steps that may be prone to human error, documentation of near misses, development of departmental checklists to catch errors, and engaging the entire radiation oncology treatment team to openly discuss patient safety, Williams added.