Advanced Sterilization Products Submits 510(k) Application For 30-minute STERRAD Velocity™ Biological Indicator System

IRVINE, Calif., March 16, 2017 /PRNewswire/ -- Advanced Sterilization Products (ASP), part of Johnson & Johnson Medical Devices Companies, announced today it submitted a 510(k) application to the U.S. 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 U.S. 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.^1,2

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.

About Advanced Sterilization Products (ASP)
Advanced Sterilization Products (ASP) has a long track record of designing and delivering innovative infection prevention solutions that dramatically raise the level of health care and safety for those who matter most. Our pioneering technology, global distribution and established leadership position enable us to simplify the process of buying and operating infection prevention products and services every day for thousands of medical facilities around the world. This enables our customers to focus on what they do best – preventing infection and saving lives. For more information, please visit www.ASPJJ.com or follow us on Twitter at www.twitter.com/ASPJJ.

STERRAD^® is a registered trademark of Advanced Sterilization Products, division of Ethicon US, LLC, a Johnson & Johnson company. STERRAD VELOCITY™, ALLClear™, and ASP ACCESS™ are trademarks of Advanced Sterilization Products, division of Ethicon US, LLC, a Johnson & Johnson company.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding performance expectations for the STERRAD^® VELOCITY™ Biological Indicator (BI) System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon US, LLC and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty as to whether the STERRAD^® VELOCITY™ Biological Indicator (BI) System will be cleared by the FDA and whether it will perform as expected; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under the caption "Cautionary Note Regarding Forward-Looking Statements" and in Item 1A, "Risk Factors", and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.  Neither Ethicon US, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

© Ethicon US, LLC 2017. All rights reserved. 065862-170123

¹ HAI Data and Statistics. U.S. Centers for Disease Control and Prevention. www.cdc.gov/hai/surveillance. October 2016. Accessed December 28, 2016.
² Zimlichman E, Henderson D, Tamir O, Franz C, Song P, Yamin CK, Keohane C, Denham CR, Bates DW. Health Care–Associated Infections: A Meta-analysis of Costs and Financial Impact on the US Health Care System. JAMA Intern Med. 2013;173(22):2039-2046. doi:10.1001/jamainternmed.2013

SOURCE Advanced Sterilization Products

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