TSO3 Inc., an innovator in sterilization technology for medical devices in healthcare settings, confirmed that it is pursuing extended claims for its STERIZONE® Sterilizer for the Canadian, U.S. and European markets. These extended claims, when achieved, will allow sterilization of increasingly complex medical devices, which are currently only high-level disinfected. In the U.S, regulatory authorities are currently reviewing recommendations to improve the safe reprocessing of complex medical devices such as colonoscopes, duodenoscopes as well as other complex instruments. Simultaneously, TSO3 continues to perform specific studies and compiles the required data to support regulatory requirements in each of the targeted markets.
Following a two-day meeting held earlier this year in May, the FDA's Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee reviewed recommendations to reclassify certain devices from semi-critical to critical devices. These devices included colonoscopes, duodenoscopes as well as other complex instruments. Such a reclassification would require a shift from the current practice of high-level disinfection to that of a more robust "terminal sterilization" process between patient uses.
"Although we cannot be sure of the regulators future guidance and direction, we believe that the market wants to move toward sterilization of these complex medical devices," says R.M. Rumble, president and CEO. "To date there simply has been no technology available that could quickly and cost effectively, terminally sterilize these long, complex and delicate devices. Based on past and continuing studies with the instruments in question, we strongly believe that our STERIZONE® Sterilizer can offer this increased level of safety to the patient population. Based on our ongoing work, we know that sterilization is achievable (SAL-6); we also believe that in some cases device manufacturers will want to modify selected components of specific instruments in order to increase the longevity of the devices when repeatedly sterilized. It is clear that obtaining such a claim will provide significant clinical importance to our customers while enhancing the commercial opportunity for the company and its shareholders. The company expects documentation to be available this year and we will introduce the new claims in Canada first, and then expand to additional markets as clearances are obtained."
Source: TSO3 Inc.