This article is from in the April 2008 issue of DOTmed Business News. A list of registered users that provide sales & service can be found at the end.

In a normal business environment, we would start this report by noting that the Millennium Research Group's Global Markets Report for C-Arms 2008 stated that the U.S. market for fixed C-arm systems was estimated over $1.4 billion in 2007, and is expected to grow to over $1.8 billion in 2012.

But 2007 was not a normal year for C-arms.

The Initial Problem: GE/OEC & FDA

It is no secret that GE/OEC took a big hit in its C-arm market share (once estimated at 65 to 70 percent) in 2007, when the FDA revealed that CGMP (current good manufacturing practices) with the OEC C-arm were deficient at OEC facilities in Salt Lake City, Utah and Lawrence, Massachusetts.

That discovery led to a consent decree, signed in January 2007, that effectively shut down shipment of OEC products, including 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 components and accessories.

GE/OEC Now Waits Hopefully in The Wings

GE/OEC has been working diligently for more than a year to correct deficiencies, and the FDA has just finished an on-site review of OEC's remedial actions. Sometime during the first week in April, the FDA is scheduled to deliver its decision as to whether GE can resume production, first at its Salt Lake City facility.

Peter McCabe, President and Chief Executive Officer of GE/OEC Medical Systems and GE Healthcare Surgery states, "I am hopeful that the FDA will report that we are in compliance with CGMP requirements very soon, and we are ready to go." In fact, McCabe notes, the downtime has allowed GE/OEC to not only address and correct FDA's concerns, "it has also allowed us to take the time to improve on our C-arm products so the quality is the best it has ever been."

We'll be back

Since GE/OEC did have the lion's share of the C-arm market, many in the field are wondering if they can get it back. McCabe is confident that customer loyalty will prevail, and when they get the green light, backlogs will be filled within six months (three to four for the 9900 model - the first machines to resume production). The consent decree did allow GE/OEC to continue to provide routine service maintenance, replacement parts and accessories for the GE/OEC systems.




Filling the vacuum

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