CoxHealth of Springfield said that a calibration error following the 2004 installation of a stereotactic radiation therapy system from BrainLab of Munich, Germany, resulted in patients receiving too much dose until the error was discovered in September 2009. The miscalibration resulted in patients receiving an average of about 50% more dose than was medically prescribed, according to the hospital.
CoxHealth attributed the error to a medical physicist working at the hospital at the time of the installation, who used the wrong measurement device, or chamber, to measure the strength of the BrainLab system's radiation beam. The mistake affected 76 patients who had very small areas of irradiation, or small field sizes, out of a total of 152 patients treated with the device over five years.
The hospital added that the error was discovered in September, when a second CoxHealth physicist received training on the BrainLab system and the initial programming calibrations were recalculated. The hospital suspended BrainLab treatments pending a review performed by an outside physics expert. That review was received on February 16, confirming the hospital's initial analysis, and CoxHealth began calling patients to notify them of the errors.
The hospital said that no patients had reported symptoms of radiation exposure during the period in question. It noted that a variation in delivered dose of up to 10% from the prescribed dose is not considered to be medically significant, and it pointed out that many of the patients receiving BrainLab treatments already had serious tumors and poor prognoses.
CoxHealth went on to note that the 152 patients treated with the BrainLab system represent only one-half of 1% of the total number of radiation oncology procedures performed by the hospital. In addition to suspending the BrainLab program, the hospital is reviewing all the technology and equipment used in both its radiation oncology and radiology departments.
Finally, CoxHealth president and CEO Robert Bezanson has written a letter to the U.S. Food and Drug Administration (FDA), urging that the agency's new initiative to regulate medical radiation from medical imaging devices be expanded to include radiation oncology. Hearings are scheduled to be held on February 26 in the U.S. House of Representatives to discuss radiation dose from both radiology and radiation therapy procedures.
By Brian Casey
AuntMinnie.com staff writer
February 25, 2010
FDA meeting to address radiation-reduction initiative, February 25, 2010
FDA staff says agency may need new device powers, February 22, 2010
Congressional hearings on medical radiation rescheduled, February 19, 2010
FDA launches initiative to rein in medical radiation, February 9, 2010
Congress sets hearing to review medical radiation, February 8, 2010
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