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.

Reliance Fusion incorporates the best properties of cellulose-based and polypropylene-based materials. This material allows a significant reduction in drying time, reduces the likelihood of wet packs and leads to increased efficiency in the sterilization of trays at hospitals’ Central Sterilization Service Department (CSSD), thanks to higher throughput and savings in energy and labor.

The Reliance Fusion portfolio consists of two sterilization wrap options, which can eliminate the need for multiple types of wraps, contributing to the simplification of the sterilization process and greatly reducing the number of products needed in stock. Reliance Fusion Light is for light-to-medium duty applications, and Reliance Fusion Heavy is for heavy-duty applications. Both options offer superior pre-vacuum steam drying time performance under high tray weight conditions.

“Honoring Ahlstrom’s rich history and decades of experience in nonwoven manufacturing, we are thrilled to announce the launch of Reliance Fusion – a solution to reduce wet packs and gain efficiency within sterile processing. We are confident that Reliance Fusion will have a positive impact within healthcare, improving operational efficiencies and patient outcomes while empowering healthcare professionals to deliver the highest standard of care,” says Kim Anders, vice president for Ahlstrom’s Medical business.