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Published: Tuesday, April 26, 2005 - 22:00 “We have always held ourselves to the most stringent cleaning, testing and sterilization standards,” says Charles Masek, president and CEO of Vanguard. “With today’s announcement, we have completed an unprecedented second round of intense regulatory scrutiny and passed with flying colors.” Used to establish the path of entry for minimally invasive endoscopic surgical instruments, the vast majority of trocars are sold as single-use disposables. The average ECRI national selling price ranges from $27 to $64, and approximately $1 billion is spent on endoscopic trocars annually. The savings from reprocessing is approximately 50 percent more than the cost of a new device. “We applaud the FDA’s aggressive stance on patient safety,” says Mac Brown, Vanguard executive vice president. “Given our proven understanding of the enhanced requirements of the FDA, look for us to significantly expand our already industry-leading product offerings in the future.” For more information, visit www.safe-reuse.com. Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.FDA Clears Pulled Reprocessed Devices
The Food and Drug Administration has determined that endoscopic trocars reprocessed by Vanguard Medical Concepts Inc. are substantially equivalent to new instruments and has cleared the company to resume selling them. Vanguard voluntary took its trocars off the market last fall, pending an FDA request for additional documentation of Vanguard’s methods for cleaning, testing and sterilizing the costly devices. At issue was whether the trocars, which are marketed for single use, could be safety reconditioned for a limited number of additional uses and function as new without patient health risks.
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