News | July 09, 2007

Hand Sanitation Device May Surpass FDA Requirements

July 10, 2007 — A new hand sanitation device for use by hospital healthcare workers and doctors has been demonstrated by Germgard Lighting LLC.

"It is a unique device," said Dr. Eugene Gordon, Germgard's acting CEO and CTO. "In a field in which effective hand sanitation technology has been absent for so long, and viable solutions are desperately needed, the new hand sanitizer is a timely and important contribution. Our patented device, based on ultraviolet (UV-C) exposure of the gloved hand within a small, closed volume, has been designed to allow a system of frequent, fast, and immediately available hand sanitation during patient care, interrupting the infection pathway in a way that infrequent bare hand sanitation cannot. The UV-C is blocked by the exam gloves and no UV-C leaves the device, hence the process is totally safe for the healthcare worker, doctor, and patient."

The ongoing testing study, carried out by MaryPaul Laboratories of Sparta, NJ has demonstrated, in preliminary studies, that Pseudomonas aeruginosa, the first of a series of test pathogens, was inactivated to better than 99.999% in 3 seconds over all glove surfaces including the space between fingers.

The demonstrated sanitation capability significantly exceeds current infection control guidelines published by CDC, and requirements set by FDA.

Ongoing studies will challenge a variety of organisms, including Bacillus spores.

Additionally, it is anticipated that this technology will demonstrate that it can inactivate all pathogens including virus, and rugged C. difficile and anthrax spores.

Current bare hand hygiene practice based on lengthy hand washing and/or alcohol rubs takes about 30 seconds, typically achieves only 99.5% inactivation, and is unable to sanitize spores.

For more information: www.fda.gov/ohrms/dockets/dockets/06n0065/06N-0065-EC3.htm

Overlay Init