Ahlstrom receives FDA 510(k) clearance for Reliance® Fusion, the next-generation sterilization wrap
Ahlstrom recently received the FDA 510(k) clearance from the U.S. Food and Drug Administration for Reliance® Fusion, a next-generation sterilization wrap that helps increase efficiency in the sterilization of surgical equipment trays at hospitals. FDA 510(k) clearance is needed to market and sell medical devices in the U.S. Sterilization wraps are extensively used in healthcare facilities worldwide to help maintain the sterility of surgical instruments. Ahlstrom single-use sterilization wraps help to prevent microorganisms (bacteria, viruses, spores) from easily gaining access to the tray contents, allow sterilization, provide physical protection, and maintain sterility of surgical instruments up to the point of use. They thus play a crucial role in infection prevention and patients’ safety. The sterilization process is often time-consuming, requires the use of expensive processing aids such as tray liners, and involves longer drying cycles and stocking multiple weights of sterilization wrap to ensure all moisture has been eliminated.