The Associated Press in Paris is reporting that hundreds of brain cancer patients in France, the U.S., and Spain may be contacted about their radiation treatments from malfunctioning machines.
The French government ordered the treatments halted after a warning the equipment manufacturer, BrainLab of Munich, Germany.
The company said the issue involved a small targeting error that was unlikely to cause problems for patients. However, according to the AP report, a company notification sent to a U.S. clinic earlier this month warned the problem could cause "injury or death."
BrainLab said they believe the malfunction occurred in seven models in use worldwide. Four facilities in France, two in the U.S., and one in Spain have the equipment. The company would not name the U.S. hospitals, but did disclose that they are in Ohio and Washington state.
The Cleveland Clinic confirmed that it uses the BrainLab machine. The hospital discontinued use of the machine after being notified of the problems last week.
Martin Weinhouse, a physicist at Cleveland Clinic, told the AP that the problem involves a small aiming error that can occur when BrainLab's Novalis system is used with another manufacturer's head frame to deliver radiation to the patient.
He said the error involves a deviation of about 1.25 mm, which is similar to variations inherent in the delivery system anyway and he did not believe it would lead to serious problems.
A copy of the June 4 notification was obtained by the AP. It said the malfunction meant the "patient is set to an unintended position" when receiving radiation treatment and added: "This may cause serious injury or death to the patient."
Valley Medical Center in Renton, WA, was notified by BrainLab on June 5 and has discontinued its use of the machine. About 70 patients were treated with the machine in the past two years. Doctors are reviewing patients' records and notifying them of the defect. The hospital has not seen any problems with patients.
By AuntMinnie.com staff writers
June 15, 2007
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