OVERCOMING PPE SHORTAGES WITH SUPERIOR SUPPLIER SUPPORT

Rapid innovation requires an experienced supplier partner willing to provide hands-on support with R&D, product development and regulatory approval.

- Dr. Trogolo

Supply shortages associated with COVID-19, most notably the need for personal protective equipment (PPE), have been driving innovation among manufacturers in the healthcare industry and beyond. Sciessent is partnering with customers to meet the demand by providing antimicrobial solutions coupled with guidance and support to quickly and effectively navigate the U.S. Food and Drug Administration’s (FDA) regulatory approval process.

Setting the stage with SARS

The work behind proving our Agion Antimicrobial’s effectiveness against viruses started in the early 2000s during the SARS outbreak. At the time, we worked with Foss Performance Materials (FPM) to develop an Agion treated polyester fiber. We then worked with Nexera Medical and FPM to develop Nexera’s SpectraShield 9500 N95 respirator mask. The FDA’s initial clearance of the Nexera mask included antimicrobial claims, but could the embedded antimicrobial combat viruses, such as SARS?

To answer this question, the Sciessent team engaged with university researchers, industry partners and government agencies to investigate the effectiveness of our antimicrobial against viruses. In 2015, based on this data, Nexera secured an updated 510(k) for its mask with approved claims to inactivate viruses by 99.99 percent in five minutes.