Validating a technology that exceeds the standards for medical device disinfection...

RESTEC recommends that hospitals validate the disinfection cycle, in accordance with their facility sterile quality assurance program.

The chemical indicator is a laboratory grade product from Sigma-Aldrich(St Louis MO) that indicates proper MEC(mg/L) sterilant is deployed for each cycle.  This indicator meets ANSI/AAMI/ISO 11140 published standards.

The recommended biological indicator challenge is a >Log 6 bacterial endospore with known sterilization resistance properties.  The Geobacillus stearothermophilus (12980) products supplied by MESA Labs (Bozeman MT) meet ANSI/AAMI/ISO 11138 standards for HLD and sterilization cycle validation.

The validation process demonstrates a significantly greater microbial efficacy than the FDA guidelines for general disinfection of non-implantable equipment.