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Decree Blocks Firm on Radiation Devices

May 7, 2003

WASHINGTON (AP) _ A manufacturer of radiation therapy equipment will be blocked from making and distributing the devices under a consent decree announced Wednesday by the Food and Drug Administration.

The FDA said it had found persistent deficiencies at Multidata Systems International Corp. of St. Louis and acted after the company’s software apparently contributed to 28 patients receiving excessive amounts of radiation at a medical facility in Panama. Several patients died.

Reporters placed several telephone calls to the company seeking comment, but no statement was immediately available.

The agency said Multidata failed to conform to current good manufacturing practice and design standards and failed to file prompt reports with the FDA after it became aware that its products, which are primarily used to treat cancer, may have caused or contributed to death or serious injury.

``Multidata Systems has a nine-year history of violations and failure to correct them,″ FDA Commissioner Mark B. McClellan said in a statement. ``Despite repeated warnings, the company continued to manufacture its medical devices in a way which put the public health at risk.″

Multidata announced a recall of its radiation treatment planning software on Sept. 7, 2001, but the recall wasn’t completed until earlier this year, the FDA said.

The FDA said it had inspected Multidata several times between April 1993 and September 2001 and found extensive and persistent deficiencies in the firm’s manufacturing practices during each inspection.

The firm did not respond to warnings, and FDA said it observed the same violations recurring from one inspection to the next.

Dr. David Feigal, head of FDA’s center for medical devices, said the problem is with software in a planning system that sets up a specific type of radiation for each patient depending on the location and shape of the tumor.

If programmed in a certain way the system can direct an excessive amount of radiation to the patient, Feigal said.

In the United States general practice is to use a dosimeter to check the radiation to prevent overexposure, but he said this may not have been done at the busy clinic in Panama where the problems occurred.

Feigal said the FDA had been working with the company to apply software design principles to prevent such problems from happening and to anticipate problems, as well as to respond to complaints from customers. While there have been problems in the past, they weren’t of this severity, he said.

But, Feigal said, the agency turned to the consent agreement because it was having difficulty getting corrections done in a timely fashion.

The agreement was accompanied by an injunction applying to all products of the company, said Tim Ulatowski, head of FDA’s office of compliance for medical devices.


On the Net: http://www.fda.gov

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