FDA SHUTS DOWN 3 SIEMENS PLANTS

The Food and Drug Administration says it found problems at 10 Siemens Medical Systems Inc. plants that could affect the safety of such devices as cardiac monitors and ultrasound equipment.

The FDA said Thursday it was shutting down three U.S. plants - in Concord, Calif., Danvers, Mass., and Issaquah, Wash. - with the most serious violations.But the plants will continue to export equipment and to perform maintenance on machinery already in U.S. hospitals, said Siemens President Bob Dumke.

A consent decree filed in U.S. District Court also requires that the Iselin, N.J.-based company suspend imports from two divisions in Sweden and correct problems at five other plants. Siemens also must hire an independent evaluator to certify that its other facilities worldwide comply with FDA regulations.

Siemens makes ultrasound equipment, cardiac monitors, pacemakers and other medical products.

FDA requires that whenever medical device companies receive complaints, as all do, they follow specific procedures to see whether there is a major problem with a product or if an individual machine just needs a tuneup. Siemens violated those procedures, meaning "some needed precautions may be falling through the cracks," said FDA deputy policy director Joe Levitt.

FDA couldn't say whether any patients had been harmed by the violations but said it acted to prevent that from happening.

"We did not believe the safety or effectiveness of our equipment was involved as an issue," Dumke said.

This was the FDA's third injunction in two months against a medical device manufacturer for violating such "good manufacturing practices."