TSO3, Inc. in partnership with the U.K.’s Health Protection Agency is studying low temperature decontamination methods for reusable medical devices. Their ongoing research on the use of ozone sterilization to eliminate prion contamination has now reached another milestone. The HPA uses the TSO3 Sterizone 125L to perform its research. The current method for prion inactivation is via high temperature autoclaving. This means the new equipment’s performance must meet a high standard to be considered effective. So far, the results are hopeful.
TSO3’s CSO Simon Robitaille presented findings on this current series of studies to the French Health Products Safety Agency (AFFSAPS) in January. The data from this ongoing research continues to show promise as an effective method of prion decontamination for surgical instruments. Confirmation studies are ongoing to prove that these results are repeatable. If ozone is eventually approved for this type of application, healthcare facilities will have the option of eliminating prions from materials that cannot be autoclaved.
What Is A Prion?
Proteinaceous infectious particles (prions) call into question current scientific theory regarding what constitutes a living organism. These protein based pathogens have no DNA or RNA and are apparently even simpler than viruses. The means by which this infectious agent replicates is poorly understood. Prions cause fatal diseases such as scrapie and bovine spongiform encephalopathy (BSE) in livestock. These debilitating infections destroy healthy brain tissue and cause horrific symptoms before the host finally dies.
Transmission of BSE to humans in the form of vCJD has rarely occurred. However, since cross species infection is a proven possibility, the specter of a serious outbreak still hangs over the international medical community. Prions are notoriously hard to kill (possibly because they are not alive in any recognizable way to begin with). This is one reason for the interest in developing more effective sterilization methods to address the problem.
More About The Company And The Sterizone Product
TSO3 is fairly unique in the sterilizer industry in that it only offers one device at this time. The Sterizone 125L delivers a cost effective, safe, and environmentally friendly solution to hospitals, clinics, and research facilities. The 125L unit has been approved by the both FDA and Health Canada for these markets. The product has only been commercially available since 2005, so it may be some time before additional models are added to the TSO3 product line.
The use of O3 as a sterilizing agent makes it possible to effectively process medical instruments that are sensitive to moisture and heat. Problems with maintaining a consistent level of exposure to the gas delayed the initial development of this technology. The last 15 years have seen this issue resolved. This method is now advertised as being less espensive than hydrogen peroxide plasma, ethylene oxide, and liquid peracetic acid. As with pure steam autoclaving, the byproducts of this sterilization process are harmless. Safety concerns are always important for the end user of any sterilizer or autoclave. To find out what type of equipment is right for your application, ask for our free report.