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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, Mo., 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."
Dr. McClellan has made the reduction of preventable medical errors one of the highest priorities of the FDA.
FDA 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 observed the same violations recurring from one inspection to the next.
During the most recent inspection, FDA found that Multidata failed to establish, maintain and follow procedures to control the design of the radiation treatment planning software to ensure the specifications were met; failed to establish and follow procedures for taking preventive and corrective action; failed to establish and follow procedures for investigating all complaints; and failed to adhere to other standard good manufacturing practices. In addition, the firm failed to identify the root cause of software code problems when brought to its attention.
Multidata initiated a recall of its radiation treatment planning software on Sept. 7, 2001, but did not complete the recall until earlier this year.
The consent decree was filed in the United States District Court for the Eastern District of Missouri. It enjoins Multidata from marketing its radiation therapy medical devices until it satisfies FDA that it has corrected its problems. The consent decree will not take effect until signed by the judge and entered by the court.
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