The U.S. Food and Drug Administration last week halted a General Electric subsidiary, GE OEC Medical Systems, from selling certain imaging systems for surgical procedures. The company and regulators have come to an agreement that stops the production and distribution of the x-ray surgical imaging systems — while the company works out problems.
Specifically, 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, Utah, and Lawrence, Mass., until the devices and facilities have been shown to be in compliance with the FDA's current good manufacturing practice (CGMP) requirements as set forth in the Quality System (QS) regulation for devices, according to an FDA release.
The x-ray surgical imaging systems subject to the decree 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, FDA said.
“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 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 FDA to ensure that necessary corrective actions are fully implemented."
FDA's most recent audit of the manufacturing of the systems between July 31 and August 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 initial inspection took place in March 2005, and violations were cited relating to CGMP requirements.
Under the terms of the consent decree, GE has agreed to take necessary measures to ensure that the x-ray surgical imaging systems manufactured and designed at the facilities comply with CGMP requirements, as well as FDA regulations for reporting adverse events and malfunctions and device corrections and removals, FDA said.
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 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, FDA said.
The agreement 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 employed in U.S. hospitals and other health care facilities.