Ozone Sterilization System Approved; Could Compete with EtO, Gas Plasma

Originally Published MDDI January 2004

NEWSTRENDS

Erik Swain

FDA has approved the first new medical device sterilization technology in about 10 years. The ozone sterilization system's manufacturer is trying to position it as a competitor to one of the most common sterilization methods, ethylene oxide (EtO).
The manufacturer, TSO3 Inc. (Quebec City, QC, Canada), claims the technology is safer, faster, and more cost-effective than those that currently serve medical products that can't withstand high temperatures or radiation when sterilized. 

“EtO is still the most commonly used ‘cold' sterilization, even though it is very toxic and requires such a long aeration time that you need a big inventory to justify it,” says Caroline Cote, TSO3's director of corporate communications and investor relations. 

The ozone sterilization process, she says, requires only medical-grade oxygen, and only oxygen and water are released into the air when it is 
completed. 

“What makes it work is its ability to generate humidity at low temperatures,” she says. “This had been talked about for 30 years, but it seemed that nobody could find a way to make it work until we did.” Barriers to success included ozone's instability and difficulties in generating ozone in its pure form. Several years ago, the Cyclops Co. received FDA approval for an ozone sterilization system, but never marketed it. U.S. distribution of TSO3's system will be handled by Skytron (Grand Rapids, MI).

How quickly ozone sterilization might be adopted is unknown. A number of suppliers offer EtO sterilizers, while gas plasma, another “cold” sterilization technology that competes with EtO, is the domain of Advanced Sterilization Products (Irvine, CA), a Johnson & Johnson company. EtO is a process device manufacturers are very familiar with, and it is well known what materials will work with it. Gas plasma systems, known for short cycle times (55 to 75 minutes), have been on the market for 10 years, and in that time about 6000 units have been placed in 40 countries.
In addition to claiming the ozone technology is safer and more environmentally friendly than EtO, TSO3 is also touting its potential cost savings. It says the cost of the sterilizing agent for one cycle is 6 cents, compared with $7.35 for EtO and $8 for gas plasma.

Sterilization vendors point out, however, that when considering financial benefits, device companies and hospitals also need to consider installation costs, cycle times and their effect on inventory, compatibility with commonly used materials, throughput, and additional services the vendor might provide.

TSO3's first product has a 125-L chamber and is intended for hospital sterilization applications. But, Cote says, there are plans for larger units that device companies could use to sterilize large amounts of product. “We are getting into a manufacturer testing program with 20 companies,” she says. “It will be an ongoing endeavor to ensure current and future products are compatible with the technology. We are already getting great feedback from system users.” 

The hospitals that tested the 125-L system also gave positive feedback. “The FDA approval for us validates a technology that we already thought had great potential,” says Helen Vandoremalen, director of the central sterilization unit at Sunnybrook and Women's College Health Sciences Centre (Toronto). 

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