A Medical Device Daily

The FDA reported that GE OEC Medical Systems (Salt Lake City), its parent company, General Electric (Little Chalfont, UK), doing business as GE Healthcare (Waukesha, Wisconsin), and two of their top executives have signed a consent decree of permanent injunction related to X-ray surgical imaging systems manufactured by GE OEC Medical Systems.

The consent decree prohibits the manufacturing and distribution of specified GE OEC Medical Systems X-ray surgical imaging systems at facilities in Salt Lake City, and Lawrence, Massachusetts, until the devices and facilities have been shown to be in compliance with FDA’s current good manufacturing practice (CGMP) requirements as set forth in the Quality System (QS) regulation for devices.

The decree was filed in the U.S. District Court for the District of Utah and is subject to court approval.

The X-ray surgical imaging systems subject to the decree are manufactured and designed at GE OEC Medical Systems’ facilities in Salt Lake City, and Lawrence, and include the 9900 Elite C-Arm system, 9900 Elite NAV C-Arm system, 9800 C-Arm system, 2800 UroView system, 6800 MiniView system, Insta-Trak 3500 NAV system, and ENTrak 2500 NAV system, as well as their components and accessories. These are radiological image processing and image-intensified fluoroscopic X-ray systems that are used during diagnostic, surgical, and interventional procedures, such as orthopedic, cardiac, critical-care, emergency room procedures, and other imaging applications.

“These devices are used on thousands of patients, and their dependability and accuracy are critical for the successful outcomes of important medical procedures,” said Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health. “When FDA’s August 2006 inspection found ongoing CGMP deficiencies at the Utah facility, GE voluntarily stopped distributing devices from that facility and is working with the FDA to ensure that necessary corrective actions are fully implemented.”

The FDA said that the most recent inspection of the Utah facility, conducted between July 31 and Aug. 29, 2006, revealed CGMP deficiencies, including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions.

The FDA previously inspected the Utah facility between Nov. 15 and Dec. 1, 2004. Following that inspection, the FDA issued a warning letter on March 31, 2005, citing violations of the CGMP requirements. The government brought this enforcement action when FDA’s 2006 inspections showed inadequate responses to FDA’s requests for corrections in the 2005 Warning Letter.

Under the terms of the consent decree, the companies have agreed to take measures to ensure that the X-ray surgical imaging systems manufactured and designed at the Utah and Massachusetts facilities comply with CGMP requirements, as well as FDA regulations for reporting adverse events and malfunctions and device corrections and removals.

The decree also requires that the companies hire an independent expert to conduct inspections of GE OEC Medical Systems facilities in Utah and Massachusetts and certify to the FDA that corrections have been made. Manufacturing and distribution can resume at the Utah and Massachusetts facilities once FDA is satisfied that those facilities are in compliance with the law.

An outside expert also will conduct yearly audit inspections for four years to assure that the facilities remain in compliance and will submit his findings to the FDA. The FDA may order the companies to stop manufacturing and distributing the X-ray imaging systems if they fail to comply with any provision of the consent decree, the Federal Food, Drug, and Cosmetic Act or FDA regulations.

The consent decree allows the companies to continue to provide routine service maintenance, replacement parts, and accessories for the GE OEC X-ray surgical imaging systems that are already used in U.S. hospitals and other healthcare facilities.