Medical Device Link.

Originally Published PMPN January 2004

NEWS

FDA has approved the first new medical device sterilization technology, ozone sterilization, in about 10 years. The system’s manufacturer is trying to position it as a competitor to one of the most common sterilization methods, ethylene oxide (EtO).
TSO3 Inc. (Quebec City, Canada) claims the technology is safer, faster, and more cost-effective than other methods. These methods serve 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. Cote is TSO3’s director of corporate communications and investor relations. 
The ozone sterilization process, she says, only requires medical-grade oxygen and water. When it is completed, only oxygen and water are released into the air. 

“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.

Skytron (Grand Rapids, MI) will handle U.S. distribution.

How quickly ozone sterilization might be adopted is unknown. Some suppliers offer EtO. Gas plasma, another ‘cold’ sterilization technology competing with EtO, is the domain of Advanced Sterilization Products (Irvine, CA), a Johnson & Johnson company. Device manufacturers are very familiar with EtO. They know what materials will work with it. Gas plasma is known for its short cycle times (55–75 minutes). It has been on the market for 10 years. 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 touting its potential cost savings. It says the cost of the sterilizing agent for one cycle is 6 cents. This compares 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. They should also consider compatibility with commonly used materials, throughput, and additional services the vendor might provide.

TSO3’s first product has a 125-L chamber. It 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 that current and future products are compatible with the technology. We are already getting great feedback from 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, BScN. Vandoremalen is director of the central sterilization unit at Sunnybrook and Women’s College Health Sciences Centre (Toronto).

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