FDA Takes Multidata to

By John McCormick  |  Posted 2004-03-08 Print this article Print

Task"> In 2003, Multidata signed a consent decree with the FDA that precludes the company from making or selling software for radiation-therapy devices in the U.S., although it can still export its products. According to the FDAs injunction announcement, Multidata failed to meet the FDAs manufacturing practices and design standards.

Of all the criticism the firm received, perhaps the harshest was a statement made by FDA Commissioner Mark McClellan when the injunction was made public on May 7, 2003.

"Multidata Systems has a nine-year history of violations and failure to correct them," he said. "Despite repeated warnings, the company continued to manufacture its medical devices in a way which put the public health at risk."

Indeed, the FDA has taken Multidata to task several times over the last 10 years for its software-development practices.

The FDAs policy is to inspect any company that makes medical devices about every two or three years. Each time its examiners visited Multidata they found problems. The FDA would not say how common it is to find problems on each company visit, but Gladys Rodriguez, head of the FDA enforcement unit that deals with medical devices and radiological health products, says an injunction is a "rare" action.

According to documents obtained by Baseline under the Freedom of Information Act, the FDA inspected Multidatas products and manufacturing operations four times in the past dozen years.

In 1993, 1995 and 1998, FDA inspectors found the same deficiencies in Multidatas software-development process coming up time and again: a lack of good software specification and documentation procedures to guide and control the software-development and change process; insufficient documentation to show that the software had been properly tested to see if it worked; and inadequate investigation into customer complaints.

The FDA inspectors report from the 1993 investigation noted: "[C]omplaint review found a number of reports of software errors or bugs which indicate Multidatas software testing is incomplete. Several of these complaints reported incorrect dose calculation described as off by about 20 percent, and bizarre and dramatic. Follow-up investigation of these and other complaints found many software errors present in software shipped to customers that could have been found with structured, thorough, and rigorous testing throughout the software development process using basic software analysis and testing techniques."

Conley says the company looked into the complaints and corrected any problems. "We fixed what we found," he says, adding that some of the complaints the company looked into were not software-related, but resulted from users being unfamiliar with its product. And, he says, theres no link between the 1993 report and the accidents in Panama.

Next Page: FDA sends warning to Multidata in 1998.


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