Congressional hearing: More oversight needed for medical radiation procedures
During testimony before a committee of the House of Representatives Friday, stakeholders from the medical imaging and radiation oncology communities extolled the life-saving virtues and safety of medical imaging procedures, but also agreed that more needs to be done to regulate the profession and protect patient safety.

“Image-guided medical procedures have replaced more invasive surgical options for many patients, while improving outcomes and reducing hospitalization and recovery times,” E. Stephen Amis, Jr., MD, told the House Energy and Commerce Health Subcommittee. “Furthermore, clinical trials and experience have demonstrated the benefits of radiation therapy in curing cancer, extending life, and alleviating pain and suffering for over one million patients each year.”

Amis, former chair of the Board of Chancellors of the American College of Radiology (ACR), also told the subcommittee that a recent series of articles in the New York Times laying out several tragic cases of medical imaging radiation errors, was a reminder that the use of medical radiation has risks as well.

“As a profession, we can and must do a better job of preventing such errors – not only to ensure all patients get the best quality of care we can provide, but also to maintain the confidence of the public who rely on our care,” Amis said.

Medical radiation errors involving the use of CT scanners have dominated the headlines recently and several panelists focused on CT.

Cynthia McCollough, PhD, professor of Radiological Physics at the Mayo Clinic in Rochester, Minn., said that while technological innovations have helped to drive CT radiation doses lower than in years past, “as with any medical device or procedure, both human and electrical/mechanical systems can fail.” McCollough said that more and better training of physicists, radiologists and technologists is still needed to keep up with the rapid developments in CT technology.

"The single most important contribution we can make to patient safety is to ensure that all personnel involved in the operation of CT systems meet nationally-prescribed, minimum levels of training and competency,” said McCollough. “The needed accreditation and certification programs exist, but without mandatory requirements for a consistent level of advanced education, we are allowing, in some cases, minimally-trained personnel to operate extremely advanced medical equipment.”

Rebecca Smith-Bindman, the author of a well-publicized study in the December 14/28 issue of the Archives of internal Medicine on CT scans and radiation dose, told the committee that oversight for CT radiation dosing is “currently very fragmented.

“Radiologists determine how the CT tests are performed. However, there are few national guidelines on how these studies should be conducted and, therefore, there is great potential for practice variation that could introduce unnecessary harm from excessive radiation dosing,” said Smith-Bindman. “Furthermore, since information on radiation is reported differently across the different types of CT machines, it is difficult for radiologists to standardize their practice.”

She also told the committee that she has found that radiation doses received from CT scans can vary substantially between facilities and even within the same facility for the same clinical problem.

“Consensus is growing that efforts are needed to minimize radiation exposure from CT and to ensure patients receive the minimum dose necessary to produce a medical benefit,” she said. “These efforts must include reducing unnecessary studies, reducing the dose per study and reducing the variation in dose across patients and facilities.”

Speaking for the ACR, Amis called for mandatory accreditation of all advanced imaging and radiation oncology providers. And David Fisher, executive director of the Medical Imaging and Technology Alliance, announced that CT manufacturers will begin installing new radiation dose safeguards on scanners starting this year.

In his opening statement, Subcommittee Chairman Frank Pallone, D-N.J., said that while the purpose of the hearing is not to send the message that medical radiation is unsafe and shouldn’t be used, he does have concerns about the apparent lack of regulatory oversight of medical radiation.

"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,” said Pallone. “Even in states where there are licensing requirements, the requirements to report errors and the penalties for making errors are basically non-existent or not enforced.”

Procedures that have “such a small margin of error should be stringently overseen and monitored, but these critical steps appear to be sorely lacking,” Pallone said. He added  that further hearings may be needed to determine what kind of legislative steps need to be taken to further regulate medical radiation procedures.