TSO3 Inc., an innovator in sterilization technology for medical devices in health care settings, has received clearance from U.S. regulators for its most recent 510(k) submission for the terminal sterilization of multi-channeled flexible endoscopes using the Company’s STERIZONE VP4 Sterilizer.
The new clearance for the STERIZONE VP4 Sterilizer will allow a hospital to terminally sterilize gastrointestinal endoscopes that have dimensions within the cleared intended use. The technical characteristics of the devices that could fall within this cleared intended use statement include certain colonoscopes, duodenoscopes and gastroscopes which have 4 or less channels and up to 3.5 meters in length with internal diameters of 1.2 mm or greater.
“In 2009, TSO3 set itself on a path to bring about lasting and meaningful change to health care sterilization practices. The recent and highly publicized outbreaks associated with use of flexible endoscopes have highlighted the need for innovative approaches to reprocessing of these complex devices. Today, TSO3 is proud to announce that this clearance enables a significant step forward in achieving this change and our goal to provide a sterile instrument for every procedure. This advancement required significant effort and innovation both in technology and reprocessing practices. I am proud of the TSO3 team who made this possible. This clearance allows TSO3 to partner with health care systems to facilitate the terminal sterilization of these devices,” stated TSO3 President and CEO R.M. “Ric” Rumble.