An industry group representing the top five manufacturers of CT equipment said on Thursday the companies will add new safeguards to their machines to help prevent patients from being exposed to too much radiation.
The Medical Imaging & Technology Alliance said manufacturers will add a color-coded warning system to give health care providers clear warning when they are doing scans that give patients potentially dangerous doses of radiation.
A CT or computed tomography scan gives doctors a view inside the body, often eliminating the need for exploratory surgery.
But CT scans deliver a much higher radiation dose than conventional X-rays. A chest CT scan exposes the patient to more than 100 times the radiation dose of a typical chest X-ray. High doses of radiation can cause skin burns, cataracts and other injuries.
The new safeguards would apply to machines made by General Electric, Toshiba Corp, Hitachi Ltd, Siemens and Philips.
The changes, which would be phased in starting this year, would provide a yellow alert screen when the dose is higher than expected. It would also offer 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 being done.
“Some of our companies will be able to provide features before the end of this year based on when new releases become available,” Dave Fisher, executive director of the alliance, told reporters in a telephone briefing.
The group also promised that it will standardize the way radiation doses are recorded.
“The dose information would be saved in a standard format, making it easier to integrate the information into a national dose registry, identical to what the president identified as one of the goals in his budget,” Fisher said.
The changes follow the U.S. Food and Drug Administration’s call earlier this month for makers of CT machines and other medical imaging equipment to add new safety features to their machines.
Fisher said the alert system “will definitely be included in new equipment. It also is going to be included in some versions of older equipment.”
On Friday the group will testify before the Committee on Energy and Commerce’s Health subcommittee hearing on radiation exposure.
The FDA said in December it was investigating several cases of patients who received up to eight times the normal level of radiation from brain scans performed with equipment from GE and Toshiba.
CT scan use in the United States has grown sharply. About 70 million CT scans were done on Americans in 2007, up from 3 million in 1980.
(Editing by Eric Walsh)