The Food and Drug Administration released a followup report yesterday on 385 patients who had received radiation in excess of 8 times the normal treatment. 206 of these patients were from the same hospital, Cedars-Mt. Sinai Medical Center. The patients were all being screened for possible stroke.
While there have been no reported deaths associated with the excess radiation, prolonged exposure to these doses could result in “long-term radiation effects, such as cancer. ”
The FDA’s report indicated the manufacturers’ equipment were all within the FDA’s rules and regulations. However, it appeared that the operators were confused by the indicators on the computer screens error as to the strength of the dose of radiation as well as the length of time for the treatment.
As a result, the FDA has recommended warning screens that alert the operator the equipment has been set to a level of radiation which may be outside the norm. It does not mean the level is not appropriate for the patient at hand, but is above the norm. At the time it would be up to the operator to double check the physicians orders.
The FDA was cautious, however, in warning patients to continue to have CT scans as prescribed by their physicians:
“Patients should follow their doctors’ recommendations for receiving CT scans. A medically-needed CT scan that does not expose the patient to unnecessary radiation has benefits that far outweigh the radiation risks.”