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Software problem played a role in cancer patients' radiation overdoses

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Rainforest Alliance revamps its Eco-Index


Software problem played a role in
cancer patients’ radiation ODs

by Eric Jackson

Criminal proceedings are still underway against several technicians from the Instituto Oncologico Nacional (ION), the nation’s public cancer hospital that’s now located in the old Gorgas complex. A Theratron radiation treatment machine for which the ION had no operating guidebook was used without its dosage levels being manually checked, and at least 28 patients received radiation overdoses, some of them fatal.

Some doctors were disciplined in the case, but of course a dangerous machine being used without an instruction manual is a serious administrative failure. However, the hospital’s director, Juan Carlos Barés, is the brother of National Police Chief Carlos Barés and the brother-in-law of Immigration director Ilka de Barés, so under the rules of the Moscoso administration’s nepotism there would be no question of him having to answer for any administrative shortcoming.

Journalists from Baseline magazine, a US business and technology publication, have been pursuing another story that led them to the ION problem, and what they have found adds a whole new dimension to this case.

It seems that the fatal flaw was not a faulty machine, but faulty software from Multidata Systems International, a St. Louis-based computer programming company that specializes in cancer treatment software. Or more properly, used to.

The US Food and Drug Administration (FDA) regulates medical devices, and after a decade of problems with the company ordered Multidata out of the business. According to a May 7, 2003 FDA press statement:

“The Food and Drug Administration (FDA) today announced that it has entered into a consent decree of injunction with Multidata Systems International Corporation to stop them from manufacturing and distributing radiation therapy medical devices.

“Multidata Systems International, headquartered in St. Louis, [Missouri], primarily manufactures devices used to treat cancer. The company's radiation treatment planning software reportedly contributed to 28 patients receiving excessive amounts of radiation at a medical facility in Panama City, Panama, in 2001. Several patients died.

“Multidata failed to conform to current good manufacturing practice and design standards and also failed to file prompt reports with the FDA after it became aware that its products may have caused or contributed to death or serious injury.

"’Multidata Systems has a nine year history of violations and failure to correct them,’ said FDA Commissioner Mark B. McClellan, M.D., Ph.D. ‘Despite repeated warnings, the company continued to manufacture its medical devices in a way which put the public health at risk. This cannot be tolerated.’”

It does seem, however, that Panamanian authorities are more tolerant.

The same software problems apparently did not cause deaths in the United States because malpractice suits are a way of life there, and thus operators of radiation therapy machines take much more care to check radiation settings manually. The discrepancies were noticed and reported to the FDA.





Also in this section:
Software problem played a role in cancer patients' radiation overdoses
New resources in the global battle against tuberculosis resurgence
Rainforest Alliance revamps its Eco-Index



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