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LAKELAND, Fla. -- The U.S. Food and Drug Administration (FDA) has determined that endoscopic trocars reprocessed by Vanguard Medical Concepts Inc. are "substantially equivalent" to new and has cleared the company to resume sales of the product.
Vanguard voluntarily removed its trocars from the market last fall pending an FDA request for additional documentation of the company's methodology for cleaning, testing and sterilizing the costly devices. At issue was whether the complex device, which is marketed for a single use, could be safely reconditioned for a limited number of additional uses and function "as new" without any health risk to patients
"We have always held ourselves to the most stringent cleaning, testing and sterilization standards," said 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. Now, with 100 percent of our product line back on the market, we look forward to getting back to what we do best, which is offering our customers an environmentally friendly, patient-safe, and economical alternative to the wasteful practice of throwing away perfectly good devices after a single use."
Used to establish the path of entry for minimally invasive endoscopic surgical instruments, the vast majority of these trocars are sold as single-use disposables by US Surgical and Ethicon. The average ECRI national selling price ranges from $27 to $64. Approximately $1 billion is spent on endoscopic trocars annually. The savings from reprocessing is approximately 50 percent over the cost of a new device.
"We applaud the FDA's aggressive stance on patient safety," said Mac Brown, 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 near future."
Vanguard Medical Concepts Inc. is a leading medical device reprocessor, providing a broad range of reprocessing services for more than 1,000 healthcare facilities nationwide. Since 1991, it has reprocessed more than 16 million devices, from EP catheters and orthopedic burrs, bits and blades to suture packs and DVT sleeves. Vanguard leads the industry in the science and technology of reprocessing, carrying a certification of ISO 13485: 1996 with specific design controls for medical device reprocessing.
Source: Vanguard Medical Concepts Inc.