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FDA trial is targeting Utah Medical quality

The U.S. Food and Drug Administration on Monday opened its case in U.S. District Court against Utah Medical Products, a Midvale-based company that the FDA alleges has failed to comply with industry standards in the manufacturing of medical devices.

In opening arguments, Allan Gordus, an attorney for the FDA, said the agency inspected Utah Medical's facilities four different times over a period of four years and found during each inspection significant violations in quality system regulations designed to ensure the safety of medical devices during manufacturing.

Utah Medical's product line includes medical devices used in labor and delivery, neonatal intensive care, gynecology and blood pressure monitoring.

The FDA is seeking an injunction to stop the company from manufacturing and distributing medical devices. Without the injunction, the FDA says, public safety will be put at risk.

Daniel Jarcho, an attorney for Utah Medical Products, called the FDA's actions a "case about speculation" and said the government's claims were based on the assumption that "if you don't do it their way, real-world problems might develop."

Jarcho said Utah Medical, which has been in business since 1978, competes against industry giants like Johnson & Johnson and Tyco.

"It does so by making a superior product," Jarcho said. "The majority of birthing centers in the U.S. rely on products of this company."

Jarcho said Utah Medical makes roughly 30 million component medical devices each year. He described the company's quality controls as robust, well organized and calibrated on a regular schedule.

However, Gordus said Utah Medical failed to meet industry standards in three crucial areas, including process validation, software validation and complaint handling.

In particular, Gordus said, the company failed to validate its extrusion and injection molding processes, two primary methods used to convert plastics to medical devices.

The trial is expected to last seven days.