FDA Clears 15-Minute Hydrogen Peroxide Sterilization System

Advanced Sterilization Products (ASP) 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 percent faster than competition and offers the fastest way to provide instrument sterility assurance for healthcare professionals.†
 
“Every minute matters in sterile processing,” notes Amy Smith, vice president of Global Marketing for ASP. “ASP Innovation to cut the BI read time in half allows customers to assure sterility for every instrument per AAMI guidelines while keeping up with the pace of a busy SPD. This is just another way ASP continues to partner with the healthcare community to elevate the standard of care by protecting patients at their most critical moments.”
 
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 United States. Existing STERRAD VELOCITY System customers should contact ASP to get the 15-minute result with a software upgrade to their reader.
 
Last spring, ASP received 510(k) clearance from the FDA for the ASP AERO FLEX Automatic Endoscope Reprocessor (AER). The high-level disinfection system, which is designed to be used to clean and disinfect flexible endoscopes from a wide range of manufacturers, offers the fastest complete cycle time (22 minutes) of any AER currently sold in the United States.
 
* Fastest BI/PCD currently marketed for STERRAD Systems. Fifteen or 30 minutes to result dependent on the software version on the STERRAD VELOCITY Reader. Fifteen minutes to result for SW version 1139260410 or greater; 30 minutes to result for SW version 139260317 or below.
 
† Compared to STERIS Celerity 20 HP Biological Indicator and 3M Attest Rapid Readout Biological Indicator 1295 for Vaporized Hydrogen Peroxide Sterilization.