Getinge Group Announces STERIZONE VP4 Sterilizer Now FDA-Cleared for Expanded Uses

Getinge Group announces that the STERIZONE® VP4 Sterilizer has been cleared for expanded indications for use by the Food and Drug Administration (FDA). The STERIZONE VP4 Sterilizer can now be used to sterilize colonoscopes, gastroscopes and other multi-channel flexible endoscopes of up to four channels and 3.5 meters in length. Getinge Group's Surgical Workplaces business category unit has exclusive global rights to distribute this next-generation, low-temperature sterilizer, which is manufactured by TSO3.

"With the new FDA-cleared Indications for Use, the STERIZONE VP4 Sterilizer is the only validated and cleared low-temperature sterilizer available in the United States, Europe and Canada that can sterilize long and complex endoscopes," said Joacim Lindoff, president of surgical workflows for Getinge Group. "The STERIZONE VP4 Sterilizer offers a practical and cost-effective way to safely sterilize devices previously processed with the less robust high-level disinfection process. The STERIZONE VP4 Sterilizer raises the standards for infection control and patient safety. With these expanded indications, in addition to our current global efforts to commercialize in acute care facilities, we plan to introduce low-temperature sterilization into GI and endoscopy clinics, which are currently using only high-level disinfection."
Regulatory authorities are increasingly scrutinizing medical device reprocessing, particularly for colonoscopes and other complex medical devices used during minimally invasive surgical procedures, because of the risk of patient-to-patient transfer of multidrug resistant bacteria that are not inactivated by high-level disinfection. Published reports confirm the significant health risk of device-related transfer of antibiotic-resistant microbes, including patient injury or death. Disinfection is significantly less effective than sterilization because it does not necessarily kill all harmful microorganisms, especially bacterial spores.

Low temperature terminal sterilization with the STERIZONE VP4 Sterilizer offers a more effective solution, because it involves a proprietary physical and chemical process that thoroughly destroys all types of microbiological organisms with a sterility assurance level of 10-6 (SAL-6). Also, the STERIZONE VP4 Sterilizer can sterilize multi-channeled flexible endoscopes (with a maximum of four channels) that have internal lumens of =1.45 mm in inner diameter and =3,500 mm in overall length, and =1.2 mm in inner diameter and =1,955 mm in overall length, which are commonly found in video colonoscopes and gastroscopes.

The STERIZONE VP4 Sterilizer is a low-temperature (41°C or 105.8°F) sterilization system that utilizes the dual-sterilants of vaporized hydrogen peroxide (H2O2) and ozone (O3) to achieve terminal sterilization of heat and moisture-sensitive medical devices. With its single pre-programmed cycle, it can sterilize a large number and wide range of compatible devices. Its unique Dynamic Sterilant Delivery System™ automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. This capability removes the potential for human error, as there is no need to sort instruments and choose the appropriate cycles.

The STERIZONE VP4 Sterilizer can process a mixed load consisting of general instruments, single and multi-channel flexible endoscopes, and single or double channel rigid endoscopes in the same cycle with load weights of up to 75 lbs. The ability to run mixed loads significantly reduces labor costs by minimizing the amount of instrument sorting required, while maximizing the device turns (more productivity from increased throughput capacity). Other H2O2 sterilizers are limited to load weights of up to only 25 pounds and require dedicated fixed cycles for different types of instruments (reducing overall throughput).

Source: Getinge Group