GE lays groundwork for resuming surgical C-arm shipments

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Multimodality vendor GE Healthcare is getting ready to resume shipments of surgical C-arms, more than a year after voluntarily halting deliveries from its GE OEC Medical Systems unit as part of a consent decree with the U.S. Food and Drug Administration (FDA). The Chalfont St. Giles, U.K., company is completing the final steps required by the FDA to meet the agency's concerns over good manufacturing practices (GMPs) at GE OEC facilities.

GE voluntarily halted shipments from plants in Salt Lake City and Lawrence, MA, in August 2006 after an FDA inspection went poorly. The FDA said that the facilities had failed "to establish and maintain adequate procedures for validating the device design and (failed) to establish and maintain adequate procedures for implementing corrective and preventive actions."

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Pete McCabe, president and CEO of GE OEC Medical Systems.
In January 2007, GE and the FDA entered into a consent decree that outlined the steps GE must take to resume surgical C-arm shipments. The company has been working since then to meet the requirements of the decree, according to Pete McCabe, who took over as president and CEO of the division shortly after the FDA inspections. McCabe previously had been the chief quality officer at GE Healthcare.

The improvements involve changes to both GE's surgical C-arm products and its manufacturing processes, in particular the way the division handles feedback and comments -- some of which the FDA believes should be handled under the agency's complaint-handling process for medical devices.

For example, GE might receive a comment from a user on an issue with a surgical C-arm, stating that the product doesn't boot up properly. Prior to the consent decree, such a comment might not necessarily have been handled under a formal complaint process. Now, the incident is registered, evaluated, and investigated under a formal procedure, McCabe said in an interview with

"What is required is that you capture (alleged concerns and issues), and you should treat those as complaints and make formal decisions," McCabe said. "In some cases the decision could be, 'This is not a safety risk, we're not going to do anything about it,' and in some cases a formal decision could be, 'This is happening too frequently, and we want to (fix it).' But nonetheless you have to make that formal decision."

McCabe pointed out that the FDA's concerns were primarily related to GMP processes, and that the division's products were not found to be unsafe or dangerous to patients when used according to operator manuals and any recall notices.

Meeting milestones

The company has already passed several milestones in its effort to implement the terms of the consent decree. In July 2007 the FDA signed off on GE's corrective action plan (CAP) for fixing surgical C-arms installed in the field. The company has also made a number of design improvements to its surgical C-arms, such as using an automated tool for analyzing software code to identify bugs that might have been causing the systems to boot up improperly. McCabe estimates that GE has implemented some 300 new or revamped procedures as part of the consent decree.

Also as part of the consent decree, GE contracted with a third-party consulting firm that was given the task of inspecting the company's facilities and products. The firm in December certified that GE's quality management system is compliant with GMP rules, and that the product improvements are appropriate and effective.

The next step is for the FDA to conduct a final inspection of GE OEC facilities before allowing the company to resume shipments. The inspection should occur this month, and McCabe hopes to receive final word from the FDA by March.

As the company waits on the FDA, McCabe said that the experience has been a learning process for GE that has benefited the rest of the company's business units. For example, the software code analyzer tool is now being used by other divisions at the company. "Every single (quality improvement) process that we learn, in some cases the hard way, is taken back to the rest of GE Healthcare," McCabe said.

GE doesn't have an estimate on the amount of lost revenue caused by the suspension of shipments. But McCabe said the company's backlog has grown significantly -- the company's facilities will have to operate at full tilt for six months to meet the supply of pent-up orders. Prior to the suspension, the company had a few days of backlog.

Some of GE's customers have simply postponed the replacement of older systems while they wait for the company to start shipping again. GE has missed some orders, such as for customers outfitting brand-new facilities, but McCabe believes that most of GE's customers have remained loyal. In fact, data from the National Electrical Manufacturers Association (NEMA) of Rosslyn, VA, show the company gaining market share in the third quarter of 2007 compared to the second quarter of the same year.

While the suspension was a short-term setback for the business, McCabe believes that in the long run the division will prove to be stronger, with better-quality products.

"We're not happy to be under a consent decree, nobody ever would be. But I think if you look at where we are today, we are a better business," McCabe said. "Our product is four times more reliable than it was a year ago, and it's going to be the most reliable product in our 30-year history, based on our lab data. The discipline that we have internally improves our quality, but it also improves our efficiency from a cost perspective."

By Brian Casey staff writer
January 7, 2008

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GE halts surgical C-arm sales due to FDA concerns, January 16, 2007

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