Advanced Sterilization Products (ASP) announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a 15-minute time to result on the STERRAD VELOCITY Biological Indicator (BI)/Process Challenge Device (PCD) for use in STERRAD Systems. The 15-minute time to result is up to 38% faster than competition and offers the fastest way to provide instrument sterility assurance for healthcare professionals.
STERRAD VELOCITY BI/PCD is used to monitor loads and assess process performance for vaporized hydrogen peroxide (H2O2) sterilization. This is a crucial step to verify load sterility for critical and semi-critical surgical instruments prior to releasing them to the operating room. AAMI ST58:2013/(R) 2018 states frequent monitoring may mitigate the many factors that could affect cycle variation and reduce risk to patients. It is for this reason AAMI ST58 recommends using a PCD with the appropriate BI daily, but preferably in every sterilization cycle. STERRAD VELOCITY® BI/PCD is the only rapid-read PCD validated for STERRAD Systems that meets AAMI guidelines.
STERRAD VELOCITY BI/PCD is commercially available in the U.S. Existing STERRAD VELOCITY System customers should contact ASP to get the 15-minute result with a software upgrade to their reader.
