CHICAGO (Reuters) - The U.S. government needs to establish national guidelines for controlling the amount of radiation a patient gets from diagnostic exams and treatments and the level of training required by a medical technician who delivers it, experts told a congressional panel on Friday.
Radiation exposure from medical scans and treatments became a major concern for patients and lawmakers last fall after patients at hospitals in Los Angeles and Philadelphia were exposed to toxic levels of radiation.
High doses of radiation can cause skin burns, cataracts and other injuries, and in extreme cases, cancer and death.
With diagnostic exams, the concern has largely been excess radiation from CT or computed tomography -- an advanced type of X-ray that delivers a much higher radiation dose than conventional X-rays.
“Oversight for CT radiation dosing is currently very fragmented,” Dr. Rebecca Smith-Bindman, a professor of radiology at the University of California, San Francisco, told the House Committee on Energy and Commerce subcommittee on health in Washington.
“The Food and Drug Administration oversees the approval of the CT scanners as medical devices, but does not regulate how the test is used in clinical practice,” she told lawmakers.
Earlier this month, the FDA said it would seek manufacturing changes to add safety measures to imaging devices including more prominent displays of the radiation dosages or alarms that sound when the dose is too high. The agency has also called for a public meeting on the issue March 30-31.
Earlier this week, Medical Imaging & Technology Alliance, an industry group, said they would voluntarily begin phasing in such safeguards -- including the addition of a color-coded system to give health care providers clear warning when scans could harm patients.
FEW NATIONAL GUIDELINES
The new safeguards would affect machines made by General Electric, Toshiba Corp, Hitachi Ltd, Siemens and Philips.
Smith-Bindman said part of the problem is there are few national guidelines that govern how studies using CT scanners are done, leaving open the potential for wide variation in the radiation dose delivered.
“It’s imperative that we make CT scanning as safe as possible,” Smith-Bindman said.
To do that, she said doctors should lower the radiation dose on routine CT scans and only conduct them when necessary.
“There is evidence that for many types of CTs the radiation dose can be reduced 50 percent or more without reducing quality,” she said.
But many experts said adding safeguards to the technology would not be enough to protect patients.
“The technology is not ... our fundamental problem,” Cynthia McCollough of the Mayo Clinic in Rochester, Minnesota, told the panel, citing poor education and training programs for radiologists who order the tests, radiation technologists who perform them and medical physicists who test the equipment.
“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,” McCollough said.
The American College of Radiology has called for an accreditation program for facilities that deliver radiation therapy to cancer patients, something the medical equipment industry group AdvaMed supports as a way to enhance patient safety.
Committee Chairman Representative Frank Pallone said in a statement the point of the hearing was not to scare patients, but to look for ways to keep them safe. He said more hearings may be needed.
Editing by Todd Eastham
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