Category: Sterilization / Calibration

Breeden's Robert Fields quietly steps down from Steris board

March 11, 2010 by MedCity News

By Mary Vanac

Robert Fields, a partner and managing director at Breeden Capital Management and Breeden Partners, quietly resigned from the Steris Corp. (NYSE:STE) board for personal reasons March 5.

Normally, the resignation of a director causes few questions. However, Fields and Richard Breeden, the former Securities and Exchange Commission chief who has since become an investment manager and shareholder activist, are a special case.

FDA warns endoscope makers on Steris System 1

February 24, 2010 by MassDevice staff

The Food & Drug Administration is once again making noises about Steris Corp.'s (NYSE:STE) System 1 processor, warning endoscope manufacturers that they must change any labeling indicating that their devices can be reprocessed using the popular sterilizing device.

The Steris System 1 processor is typically used in surgical and endoscope suites for sterilizing and disinfecting medical devices.

In a letter dated Feb. 22, the FDA warned all endoscope makers that they must change the labeling on any devices that state they can be reprocessed using the Steris system and even suggested they add language indicating that "The STERIS System 1 (SS1) is not a legally marketed device."

Steris Corp.'s Q3 sales and earnings rise despite FDA uncertainty

February 2, 2010 by MedCity News

By Mary Vanac

MENTOR, Ohio — Steris Corp. (NYSE:STE) reported higher operating profits and a modest increase in revenue for its fiscal third quarter over the year-ago quarter.

FDA gives hospitals six months to ditch Steris System 1

December 11, 2009 by MassDevice staff

The Food & Drug Administration told hospital administrators across the country to stop using a popular endoscope sterilizer made by Steris Corp. (NYSE:STE) within six months, after the watchdog agency could not verify the safety of the product.

The Steris System 1 processor is typically used in surgical and endoscope suites for sterilizing and disinfecting medical devices.