Diagnostic Imaging Scan - March 25, 2008 - (Page 3) “If they came in and found something was not right (during the FDA final inspection), then we would have some bad product in the door,” said Pete McCabe, president and CEO of GE OEC Medical Systems and GE Healthcare Surgery. “But what was important to us was we had new people, new processes, new procedures, and we wanted to test their integration.” More than a year earlier, company execs had shut down manufacturing at OEC Medical Systems as part of a voluntary consent agreement with the FDA. Agency inspectors in summer 2006 had uncovered problems in the company’s quality management system. To fix what had gone wrong, GE Healthcare put together a team of quality assurance experts led by its quality assurance guru, Pete McCabe. His analysis showed how easily a good company can stumble. “We confused customer loyalty and customer success with quality management system compliance,” McCabe said. “What we found—and what the FDA found—was that we weren’t capturing all alleged deficiencies. An alleged deficiency should be reported as a complaint, meaning you document it, evaluate it, and investigate it. We weren’t processing them appropriately and in some cases weren’t reporting them to the FDA, because we didn’t identify the issue in the first place.” As the company neared the spring of 2008, its efforts to remedy QA problems had led its staff to review 50,000 service records and 42,000 equipment tests, identify and fix deficiencies, then write and submit to the FDA a 4000-page corrective action plan. A private, FDA-sanctioned third-party reviewer has certified GE’s QA program. And the FDA has finished its reinspection of the facility. Now the company is waiting for word, due April 7, on whether it can return to the U.S. marketplace. McCabe believes the company’s experience with the FDA over the last year and a half has improved its products and operations. As part of its new QA system, GE reviews and evaluates every service report that comes in. Complaints trigger risk assessments followed by full evaluations and fast, thorough fixes, according to McCabe. As great a challenge as revamping its QA process was holding onto its customer base. The company was not entirely successful. Some customers couldn’t wait for GE to clear its regulatory troubles. They were building new facilities, expanding old ones, or just needed to replace worn out equipment. “In those situations, where they didn’t have an option, we told them to go to a competitor, and we would look forward to earning back their business in the future,” McCabe said. Most of the customers who could wait, did, he said. McCabe attributes customer loyalty partly to the firm’s history of providing dependable, quality equipment and service. More than 60 million procedures have been performed on C-arms made by OEC, he said. GE’s response to the crisis was another reason. Rather than hunkering down and laying off workers to cut costs, the company assigned its assembly workers to desk jobs for the interim and hired another 30 to work in service. The objectives were to retain the skilled workers who would be needed when GE restarted production and to keep the installed base as happy as possible. Training was a big part of that, particularly its “OEC University,” GE’s twist on a users’ group meeting for technologists. Last year, the company held more than 80 such meetings in major U.S. cities, hosting some 2300 technologists. This compares with 15 sessions in 2006 and only a few the year before. GE ramped up “OEC U” to stay connected to its customers in a year when it was not shipping product, according to the company. But even after shipping resumes, the firm plans to keep the number of classes high. It will take months to whittle down the backlog of C-arm orders. If regulators give the go-ahead by early April, as expected, McCabe plans to cut the current six-month backlog in half by early summer. If a problem arises, he’ll apply OEC’s new mantra: Stop, document it, fix it, and move forward. “If you do that, the FDA is going to love it, and you’re going to be a better business,” he said. “It’s all about making safe and efficacious equipment.” revenues were flat at $1.9 million compared with the year-earlier quarter. Improved sales for its gamma cameras were offset by declines in blood flow products, according to the company. Neoprobe markets the neo2000 line of gamma ray detectors used during surgery to locate cancer tumors. It also sells the Quantix line of blood flow measurement products developed by its subsidiary, Cardiosonix. Two urological products from Siemens Healthcare, each capable of treating kidney stones, are poised to enter the U.S. market. Both have been available outside the U.S., but now with FDA 510(k) clearance, the German vendor can begin marketing Lithoskop and Modularis Variostar here. Lithoskop, a multifunctional high-end system, supports lithotripsy, endourology, urodiagnostics, and percutaneous interventions. Its shockwave head, mounted on an isocentric C-arm, simplifies patient positioning, while allowing the system to address the left and right kidneys, as well as the ureter. Siemens’ Modularis can be configured with either of two lithotripsy modules: the comfort version, Modularis Variostar with flexible treatment positions; or the standard version, Lithostar Modularis Vario with a universal coupling mechanism for C-arm systems. QuiCk HiTs Merge Healthcare will be late in filing its Securities and Exchange Commission-mandated annual report for 2007. The restatement of its 2006 annual report and first quarter 2007 report caused the company to be late in filing its second and third quarter 2007 quarterly reports, according to Merge. These late filings caused the delay in filing the year-end statement by the March 17, 2008, deadline. Distributors for American Medical Sales in February tallied PACS orders from 14 sites in February. Customers included hospitals, imaging centers, and provider offices. The Trellis Peripheral Infusion System from Bacchus Vascular March 25, 2008 Copyright © 1991-2008 CMP Healthcare Media Group LLC
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