US company submits 510(k) application for new biological indicator

Advanced Sterilization Products says it will be the fastest hydrogen peroxide BI on the market, ensuring that proper sterilisation conditions have been achieved when instruments are reprocessed in Sterrad Systems

BIs are used to test and confirm sterilisation cycle performance in hospital CSSDs

Advanced Sterilization Products (ASP), part of Johnson & Johnson Medical Devices Companies, has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its fast Biological Indicator (BI) System, called Sterrad Velocity.

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 sterilisation conditions have been achieved when instruments are reprocessed in Sterrad Systems.

Ensuring instruments are properly sterilised is one way that healthcare workers can help reduce the incidences of healthcare-associated infections.

Given the constant demands placed on hospital operating rooms, speed and efficiency in 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 sterilisation 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 sterilised and can be swiftly delivered back to the operating room to be used with patients."

The Sterrad Velocity BI Reader will enable synchronisation of BI and sterilisation 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 sterilisers.

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