The overdoses, which began to emerge late last summer, set off an investigation by the Food and Drug Administration into why patients tested with this complex yet lightly regulated technology were bombarded with excessive radiation. After 10 months, the agency has yet to provide a final report on what it found.
But an examination by The New York Times has found that radiation overdoses were larger and more widespread than previously known, that patients have reported symptoms considerably more serious than losing their hair, and that experts say they may face long-term risks of cancer and brain damage.…
While in some cases technicians did not know how to properly administer the test, interviews with hospital officials and a review of public records raise new questions about the role of manufacturers, including how well they design their software and equipment and train those who use them.
Apparently, the higher the dose, the clearer the image. The Times found that “Most of the known
overdoses, including the biggest, occurred on scanners made by GE Healthcare.
At two hospitals that use Toshiba scanners — Los Angeles County-U.S.C. and
South Lake in Florida — officials said the manufacturer suggested machine
settings that ultimately produced too much radiation. Representatives of
Toshiba agreed to be interviewed in their California office but abruptly
canceled.”
Moreover, “[A]mong the victims: a member of Cedars-Sinai’s own board
of governors, Ruthe Feldman. Mrs. Feldman says she left the board after
learning about the mistake.”
Woopsy daisy.
Another patient told the Times that it was “unconscionable
that equipment able to deliver such high radiation doses lacks stronger safety
features. ‘When you are in a car and it backs up, it goes beep, beep,
beep. If you fill the washing
machine up too much, it won’t work. There is no red light that says you are
overradiating.”
GE defends itself by saying that “the way scanners were
programmed was ‘determined by the user and not the manufacturer.’” Except that, with certain kinds of
tests, “when used with certain machine settings that govern image clarity, the
[machine’s] automatic feature [to regulate radiation] did not reduce the dose —
it raised it.”
Said Kathleen Kaufman, head of radiation management for the
Los Angeles County Department of Public Health, “I cannot believe that this is
not occurring in the rest of the country.
That’s why we are so keen on the rest of the states to go look at this.”
Why so many of these dangerous tests? The Times called it “a result of rapid
technological advancements that improve diagnosis but can also do harm when
safeguards and oversight fail to keep pace.” (We caution to note here that whatever is causing
over-testing in California, with its “gold standard” medical malpractice cap on compensation of
patients, it sure isn’t so-called “fear of lawsuits.”)
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