TSO3 Sterizone appoved to sterilize endoscopes by US FDA

TSO3 Sterizone, a low temperature sterilization device for metal and heat sensitive instruments by TSO3, has approved to expand its use for endoscopes as well, by US FDA.

TSO3 Inc has received clearance from the US Food and Drug Administration to expand the intended use claims for its TSO3 Sterizone 125L Sterilizer, the company announced in a press release.

TSO3 Sterizone’s new uses include the sterilization of packaged, multi-channel flexible endoscopes, such as colonoscopes, gastroscopes, bronchoscopes, ureteroscopes and choledochoscopes.

The TSO3 Sterizone 125L Sterilizer is approved for commercialization by the US and Canadian regulatory agencies for sterilization of metal and heat sensitive instruments, as well as for devices with diffusion-restricted spaces, such as rigid endoscopes having a single stainless steel channel.

However, TSO3 Inc received clearance from Health Canada in 2009 for sterilization of additional complex medical instruments, including multi channel flexible endoscopes.

“Having successfully completed this review, it gives us increased confidence in seeing a successful and prompt review for our new cycles, which we expect to submit in the coming weeks,” stated R.M. (Ric) Rumble TSO3’s President and CEO.

US FDA clearance was important for TSO3 that these same procedures have been followed throughout the course of the recent development of the company’s new cycles. These new cycles are intended to maintain the same sterile efficacy, while taking less time and being gentler on many medical devices, Mr. Rumble said.

Earlier in 2009, TSO3 outlined its plans to increase the utility of its sterilizer though the creation of new cycles. TSO3 was also looking at developing relationships leading to a channel partner and increase market opportunities via expansion outside of North America.

TSO3 had entered into an exclusive negotiation period with 3M, for the distribution of the Sterizone 125L Sterilizer including these new cycles through 3M’s Global Infection Prevention operation on September 2, 2009.

Based in Québec City, TSO3 specializes in the research and development of medical instrument sterilization technology with high commercial potential.

TSO3′s first product, the TSO3 Sterizone 125L Sterilizer, is designed for sterile processing centers in the hospital environment. Its technology represents a replacement solution to other low temperature sterilization processes currently used in hospitals.

The ozone sterilization process developed and patented by TSO3 has efficacy, costs savings, increased safety for patients and hospital staff, and a “green” environmentally safe process.