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Quality Digest

FDA Compliance

FDA Clears Pulled Reprocessed Devices

Published: Tuesday, April 26, 2005 - 22:00

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.

“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.

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