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Newer Low-Temperature Sterilization Systems

In the late 1950s, hospitals began using ethylene oxide (EtO) as a low-temperature method to sterilize medical and surgical instruments after it was shown not to cause the heat and humidity damage of steam systems. Though effective, EtO is both toxic and a recognized carcinogen, requiring hospitals to install expensive monitoring, abatement, and aeration equipment and to provide protective clothing and safety training for workers. Ethylene oxide also requires a lengthy aeration period to allow any remaining residues to dissipate from instruments, forcing hospitals to maintain large and expensive equipment inventories to accommodate sterilization cycle time. Finally, because it is explosive, EtO is often mixed with flame-retardent carrier gases that are expensive and have been or are scheduled to be banned by the United States Environmental Protection Agency. Despite these drawbacks, until recently there was no available low-temperature sterilization alternative.

In 1993, Advanced Sterilization Products (ASP), a division of Johnson & Johnson Medical, Inc., introduced the patented STERRAD® Sterilization System--the first new low-temperature sterilization technology since EtO. The low-temperature hydrogen peroxide gas plasma STERRAD System effectively sterilizes medical and surgical instruments, overcoming the heat and moisture limitations of steam and the toxicity of EtO. In August 1997, recognizing the broader potential of the STERRAD System, the Food and Drug Administration (FDA) cleared the sterilizer system for expanded use with an even larger number of medical and surgical instruments, effectively enabling it to operate as the sole sterilization system for many healthcare facilities. Highly effective sterilization technology is especially important given growing concerns about the increasing prevalence of previously rare or newly-discovered viruses and bacteria and the challenge they represent to nosocomial (hospital-acquired) infection control. Many hospitals are abandoning EtO-based systems in favor of newer low-temperature sterilization technologies such as the STERRAD System, which is faster, more cost effective, and safer for workers, patients, and the environment than EtO and other low-temperature sterilization technologies. The STERRAD System can sterilize nearly all medical devices, unlike other newer low-temperature sterilization alternatives that can only sterilize selected instruments.

For more information on this subject, you may download the files listed below. If you would like printed copies of this material please e-mail us your request.

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Available Materials

White Paper

The Future of Low Temperature Sterilization Technology: Safety, Economics, and the Environment

Roundtable Proceedings

The Future of Low-Temperature Sterilization Technology in Healthcare: A Roundtable Discussion

If you would like a copy of these proceedings, please
e-mail us your request.

Symposium Proceedings

Frontiers in Sterilization Practice: The Future of Low-Temperature Technology

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Advances in Sterilization Newsletter

Vol. 1, No. 1 (1995)--Table of Contents--Why Hospitals are Adopting New Sterilization Technologies; European Parliament Calls for Ban on HCFCs by 2003; Hydrogen Peroxide Gas Plasma: Defining a New Technology; Case Report: Adapting to a New Sterilization Technology at UCLA Medical Center
Vol. 1, No. 2 (1995)--Table of Contents--Sterilization of Heat- and Moisture-Sensitive Instruments: The Hidden Costs of Maintaining Sterility in the Operating Room; Literature Update: New Publication Highlights Sterilization Technology; Preparing for a Sterilization Emergency: New Technologies Reduce Risks for Patients and Employees
Vol. 2, No. 1 (1996)--Table of Contents--Instrument Sterilization and the FDA: Facts You Should Know; Publications Explore Issues in Sterilization; The Bell Tolls: CFCs Are Gone, But Regulations Linger; News Briefs; Manufacturers' Promotion of "Off-Label" Uses: Are You at Risk?

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