Vestagen Protective Technologies, Inc., which develops and markets healthcare worker uniforms, scrubs, lab coats and other garments utilizing its proprietary VESTEX® Active Barrier fabric, announced in May that VESTEX apparel has received 510(k) clearance as a Class II medical device from the U.S. Food and Drug Administration (FDA).
VESTEX healthcare uniforms are the first daily-wear scrubs to receive a Class II medical device designation from the FDA. This makes VESTEX the defining product of a new FDA product category created to address the unique performance properties demonstrated by VESTEX Active Barrier garments.
“We are thrilled that VESTEX apparel has received a Class II medical device designation from the FDA,” said Bill Bold, chief executive officer of Vestagen. “Our mission is to protect healthcare workers and patients by providing technologically-advanced, Active Barrier scrubs that are comfortable, affordable, durable and attractive for everyday use. This groundbreaking FDA medical device designation sets a new standard in the healthcare apparel market.”
To obtain 510(k) clearance, VESTEX was subjected to studies that simulated a worst-case clinical use environment. These studies were conducted by specialty research laboratories. The results were further supported by a rigorous, crossover clinical trial conducted within a medical ICU at Virginia Commonwealth University, where VESTEX apparel demonstrated effectiveness in reducing accumulation of Methicillin-resistant Staphylococcus aureus (MRSA) on healthcare workers’ clothing compared to non-protective conventional scrubs.
The clinical testing demonstrated fluid repellency to blood, urine, sputum, gastric fluid and bleach, as well as reduction of MRSA retention on the outer surface of the VESTEX apparel within 15 minutes of first exposure and lasting for up to 12 hours compared to conventional, non-VESTEX treated garments.
Mr. Bold added, “This FDA medical device designation for VESTEX further validates the decisions of our early adopters. The National Science Foundation’s Center for Healthcare Organizational Transformation recently called for healthcare administrators to promote the use of Active Barrier apparel. We are proud that prominent systems such as Baptist Health in Jacksonville, Northwell Health in New York and Mercy Health in Cincinnati were out in front on this important issue, joining us as pioneers on this journey.”
VESTEX is one layer of fabric incorporating a unique combination of technologies to produce comfortable, continuous-wear healthcare worker apparel with a dual mechanism of action that includes fluid-repellent properties and an antimicrobial agent. A proprietary application method during the VESTEX manufacturing
process bonds the fluid repellent and antimicrobial agent to the outer surface of the fabric, while retaining its moisture-wicking properties on the skin-touching side of the interior surface.
As referenced in the 510(k) medical device clearance, the fluid-repellent fabric surface acts to resist bacteria acquisition by repelling fluids and thereby significantly reducing the number of microorganisms that remain on the fabric. The antimicrobial agent then further reduces the MRSA that remains on the surface (outer layer) of the apparel.
VESTEX earned an exclusive endorsement from the American Hospital Association (AHA) in 2015 following the proprietary AHA Signature Due Diligence Process™. VESTEX apparel was selected for AHA endorsement because it can play a vital role in hospitals’ strategic initiatives to improve healthcare worker and patient safety.
Ben Favret, Vestagen’s founder and president, stated: “The FDA’s designation of VESTEX as a cleared medical device is a landmark achievement that has implications beyond healthcare. We see VESTEX as a platform technology with applications in many markets where workers are at risk for unanticipated exposures to dangerous fluids and germs. Non-hospital healthcare professionals, technicians and support workers can benefit from VESTEX garments, as can workers in many other occupations such as hospitality, housekeeping, laundry services, plumbing, maintenance, waste disposal, veterinary services and mortuary services.”
Vestagen is an Associate Member of the DFW Hospital Council. For more information, please visit vestagen.com and VESTEX.com.