Advanced Sterilization Products Announces FDA Clearance of Instrument Trays for Expanded Use

IRVINE, Calif. -- Advanced Sterilization Products (ASP), a Johnson & Johnson company and a leading developer of instrument processing technologies, today announced that its APTIMAX Instrument Trays and Accessories received U.S. Food & Drug Administration 510(k) marketing clearance for expanded use. The clearance now includes use of the trays in the company's STERRAD Sterilization System, prevacuum steam sterilizers, and ethylene oxide (EtO) gas systems, providing sterile processing personnel with the flexibility to purchase and utilize one product line with all sterilization technologies.

According to Santi Corsaro, worldwide president for ASP, the clearance for expanded use is the first for any instrument-processing tray available in the United States. "Our proactive pursuit of marketing clearance of the APTIMAX Trays and Accessories for use in hydrogen peroxide gas plasma, prevacuum steam, and EtO is further evidence of our commitment to provide customers and patients worldwide with safe, effective, high-quality instrument processing solutions," Corsaro said. "The result is an advanced, adaptable sterilization product that is truly unique in the marketplace."

APTIMAX Instrument Trays, mats, and holders are specially designed to accommodate all microsurgical and procedure instrument-processing needs, and are manufactured using proprietary, lightweight material that makes them universally compatible with all sterilization technologies. The trays feature innovative snug-fitting lids that ensure ease of handling and allow for stacking during storage for improved space efficiency -- critical in hospital and outpatient settings where storage space often is severely limited.

The STERRAD System has become the market leader in low-temperature sterilization for delicate heat- and moisture-sensitive instruments due to its gentle, patented sterilization process involving hydrogen peroxide and the generation of low-temperature gas plasma. To date, more than 16.8 million STERRAD System cycles have been safely run in healthcare facilities around the world.

Advanced Sterilization Products, a Johnson & Johnson company, Division of Ethicon, Inc., manufactures and markets a full range of innovative sterilization and disinfection technologies that safely, economically, and effectively meet the needs of healthcare providers. Since its formation in 1986, Advanced Sterilization Products has been dedicated to protecting the safety of healthcare workers, patients, and the environment. This lasting commitment is reflected in pioneering products such as the STERRAD Sterilization System and the CIDEX family of products for high-level disinfection. The company is based in Irvine, Calif.

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