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JOHNSON & JOHNSON MEDICAL ENTERING U.S. STERILIZER MARKET WITH STERRAD

This article was originally published in The Gray Sheet

Executive Summary

JOHNSON & JOHNSON MEDICAL ENTERING U.S. STERILIZER MARKET WITH STERRAD, a system for 11 rapid, safe and effective sterilization of medical instruments and devices by gas plasma," according to an Oct. 7 company release. The company received 510(k) clearance for the device on Oct. 1. J & J will begin shipping the device, which is priced at approximately $100,000 installed, in about a month. The Sterrad system has been marketed in Germany and France since 1992 and was launched in Australia this year. The patented system creates a reactive gas plasma by using radiofrequency energy to break hydrogen peroxide into free radicals that interact with and destroy micro-organisms. The hydrogen peroxide is continuously depleted as free radicals recombine to form oxygen and water vapor. "At the end of the process, no harmful residues remain on sterilized devices," the firm says. The company is billing the system as "a needed alternative to sterilization by steam or ethylene oxide especially for instruments such as fiberoptic devices, endoscopic and respiratory equipment, power tools and microsurgical instruments that are sensitive to heat and moisture." The firm claims the system is faster than ethylene oxide processing and, in contrast to EtO, emits no harmful chemicals. Also, Sterrad will not "degrade medical devices as steam can," the firm says. The Sterrad system completes its sterilization cycle in about one hour and requires no special ventilation or aeration since oxygen and water vapor are the only substances produced, the press release states. On the other hand, EtO requires about two hours for sterilization followed by eight to 12 hours of aeration to reduce toxic residuals. The system will be manufactured and marketed by Advanced Sterilization Products, a J & J Medical division created expressly for that purpose and whose sole product to date is the Sterrad system. The firm expects the system, which is about four cubic feet and is designed to handle several trays of devices at a time, will be used in hospitals, ambulatory surgery centers and clinics.
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