November 5, 2020
Sciessent has over twenty years of experience playing a key role in infection control plans, through the development of antimicrobial solutions that are incorporated into a range of medical devices. Rigorously tested and approved by regulatory agencies and monitoring organizations across the globe, Silver Copper Zeolite (SCZ), the heart of our Agion® treatment, is based on naturally occurring elements that have been used broadly for 300 years, including in dental fillings, jewelry, eating utensils, and toys. Silver and copper are approved in several FDA and other nationally (EU and Canada) cleared devices for in dwelling body applications, such as hernia mesh and central venous catheters. The safety of Agion has been proven repeatedly, in even the most vulnerable of patient populations: in one clinical study, the use of Agion-treated catheters reduced catheter-related bloodstream infections in preterm infants by 90%.
In 2020, safety is a paramount concern. The COVID-19 pandemic has broadened the need for infection control planning beyond healthcare facilities, into our everyday lives. Face masks play an important part in stopping the spread of this airborne strain of coronavirus; in schools, on playgrounds, in grocery stores, on factory floors, in office towers…wherever people gather as economies around the world struggle to stay open safely. Sciessent is committed to helping both healthcare device manufacturers and those from other sectors who are retooling to produce face masks, to get up and running with its proven effective, FDA cleared antimicrobial solution.
To that end, in 2020 Sciessent began working with a cooperative consortium of major apparel manufacturers dedicated to meeting the need for masks during the COVID-19 pandemic. The Agion treatment incorporated into masks is modeled after the FDA, EU and Canadian cleared Nexera surgical respirator.
The Nexera SpectraShield surgical respirator, incorporating the Agion SCZ treatment, was cleared by NIOSH and received an updated 510(k) from the Food and Drug Administration in 2015 with approved claims to inactivate viruses by 99.99% in 5 minutes (including seasonal, pandemic, avian, swine and equine influenza viruses) and kill 99.99% of bacteria in one hour (including Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus) and Haemophilus inflenzae). It has also been cleared in Canada and the European Union. Separately and independent from the Nexera mask, efficacy testing of the Agion treatment on Coronavirus 229E via the ISO 18184 textile protocol has demonstrated 99.99% deactivation in five minutes.
Hundreds of millions of the face masks incorporating the Agion treatment, produced by the consortium of major apparel manufacturers and their subsidiaries, have been distributed worldwide to help meet the needs of the pandemic. In the U.S. alone, where the masks received FDA Emergency Use Authorization, more than 350 million masks are in use, with zero reports of any negative impacts. The rigors of the review process, in North America and beyond, are considerable: the studies submitted to support global approvals of face masks incorporating Agion have been reviewed independently by the US EPA, FDA, PMRA (Canada) and the EU Scientific Committee on Foods (now EFSA).
As a supplier of antimicrobial solutions to critical applications across several industries, including medical device manufacturers, Sciessent has always been strongly committed to the quality and safety of its products. We embrace our role as knowledgeable, effective partners to the manufacturers incorporating our solutions in their products in navigating the regulatory process. We recently extended our partnership with the BLUESIGN network, which represents suppliers and manufacturers that are dedicated to producing high-quality textile solutions with minimal environmental impact. Manufacturers that incorporate Agion into their products can be confident they have chosen an effective solution that is safe for the environment.
Being a US-based company, we have a deep understanding of EPA regulations around claims that can be made related to Agion. We have begun an effort, with our partner brands, to secure EPA approval of antiviral claims. We welcome inquiries from current or potential partner brands to join us in this effort, so as to enable more consumers to experience the performance benefits of Agion.
At Sciessent, we believe in the power of science, of human ingenuity, to meet this moment. We are proud to be a part of the global manufacturing community’s extraordinary response to the challenges of the pandemic. We know that every time a mask embedded with Agion is worn, it represents a person’s commitment to keeping not just themselves, but their community, that much safer. We do not take that responsibility lightly. It’s a phrase now used around the world, but it bears repeating: we’re all in this together.