ASP Submits 510(k) Application for 30-Minute STERRAD Velocity Biological Indicator System

Advanced Sterilization Products (ASP), part of Johnson & Johnson Medical Devices Companies, announces that it submitted a 510(k) application to the Food and Drug Administration (FDA) for the ultra-fast STERRAD VELOCITY™ Biological Indicator (BI) System. Pending clearance, it will be the fastest hydrogen peroxide (H202) BI on the market, using a new, integrated reader to provide automated confirmation – within 30 minutes – that proper sterilization conditions have been achieved when instruments are reprocessed in STERRAD® Systems.

Ensuring instruments are properly sterilized is one way healthcare workers can help reduce the incidences of healthcare-associated infections (HAI). According to the Centers for Disease Control and Prevention, about one in every 25 hospitalized patients acquires at least one HAI.1 HAIs cause an estimated 75,000 deaths in the United States per year, with total annual costs amounting to almost $10 billion annually.

Given the constant demands placed on hospital operating rooms, speed and efficiency of in-house Central Sterile Services Departments (CSSDs) are critical to supplying properly reprocessed medical devices as needed. In CSSDs, BIs are used to test and confirm sterilization cycle performance and provide sterility assurance. However, with current BIs taking several hours or more to confirm results, many instruments are sent back to operating rooms without sterility assurance.  

"For more than 20 years, the biggest need we have heard from CSSDs and infection control departments is for a BI that provides almost immediate confirmation of sterility assurance," said Suneel Shorey, vice president of ASP Global Marketing. "An ultra-fast system will help staff ensure every instrument has been properly sterilized and can be swiftly delivered back to the operating room to be used with patients."

The STERRAD VELOCITY™ BI Reader will enable synchronization of BI and sterilization cycle records through a barcode scanner and touchscreen. It will also feature a countdown display for each well and on-screen and audible alerts. The reader will be validated for use with the recently FDA-cleared STERRAD® 100NX® and NX® Systems with ALLClear™ Technology, as well as existing STERRAD® NX, 100NX® and 100S® System sterilizers.

Source: Advanced Sterilization Products