LAKELAND, Fla. -- The U.S. Food and Drug Administration (FDA) has determined that ultrasonic scalpels 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 the scalpels 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
"The FDA has now thoroughly reviewed our manufacturing procedures -- not once, but twice -- and both times we have passed with flying colors," said Charles Masek, president and CEO of Vanguard. "This should finally establish what we've said all along: that Vanguard-reprocessed devices are as safe and reliable as original equipment, at a fraction of the original cost and that reprocessing is absolutely the right thing to do, for both the patient and the environment."
The ultrasonic scalpel uses sound waves to make incisions at lower temperatures than electrosurgery and laser scalpels. The result is less collateral tissue damage and scarring, as well as reduced recovery time and pain for the patient during recovery.
The average original selling price for these devices is approximately $260. About $175 million of ultrasonic scalpels are sold annually. The savings from reprocessing them is approximately 50 percent the cost of buying a new device.
Vanguard Medical Concepts Inc. provides 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.