Omnia Medical’s PEEK VBR system receives FDA clearance
Nonwovens/Converting
US clearance for next-generation sterilization wrap
Incorporating the best properties of cellulose and polypropylene-based nonwovens.
5th February 2024
Innovation in Textiles
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Finland
Ahlstrom has received FDA 510(k) clearance from the US Food and Drug Administration for its Reliance Fusion, a next-generation sterilization wrap that helps increase efficiency in the sterilization of surgical equipment trays at hospitals. The clearance is required to market and sell medical devices in the USA.
Sterilization wraps are extensively used in healthcare facilities worldwide to help maintain the sterility of surgical instruments. The Ahlstrom single-use wraps help to prevent microorganisms – bacteria, viruses, spores – from easily gaining access to the tray contents, allow sterilization, provide physical protection and maintain the sterility of surgical instruments up to the point of use.
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 wrap to ensure all moisture has been eliminated.
Reliance Fusion incorporates the best properties of cellulose and polypropylene-based materials.
The absorbent wetlaid nonwoven inner layer is made with cellulose, synthetic binder and PET fibres, resulting in a softer and stronger fabric for superior moisture pass-through performance. The outer layer is a spunmelt nonwoven which is strong and durable, with low lint and high barrier. It is is made of 100% polypropylene and treated to resist static charge.
This combination 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.
The Reliance Fusion portfolio consists of two wrap options – light and heavy. Both offer superior pre-vacuum steam drying time performance under high tray weight conditions.
“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,” said Kim Anders, vice president of Ahlstrom’s Medical business.
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