Sterizone VP4 steriliser is FDA-cleared for expanded uses

Getinge Group's Sterizone VP4 steriliser has been cleared for expanded uses by the US Food and Drug Administration (FDA).

The Sterizone VP4 steriliser, manufactured by Canadian firm TSO3, can now be used to sterilise colonoscopes, gastroscopes and other multi-channel flexible endoscopes of up to four channels and 3.5m in length. Getinge Group's Surgical Workplaces business category unit has exclusive global rights to distribute this new low-temperature (41°C) steriliser, which uses the dual-sterilants of vaporised hydrogen peroxide (H₂O₂) and ozone (O₃) to achieve terminal sterilisation of heat and moisture-sensitive medical devices.

'With the new FDA-cleared Indications for Use, the Sterizone VP4 steriliser is the only validated and cleared low-temperature steriliser available in the US, Europe and Canada that can sterilise long and complex endoscopes,' said Joacim Lindoff, President, Surgical Workflows, Getinge Group.

'With these expanded indications, in addition to our current global efforts to commercialise in acute care facilities, we plan to introduce low-temperature sterilisation into GI and endoscopy clinics, which are currently using only high-level disinfection.'

Regulatory authorities are increasingly scrutinising 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 sterilisation because it does not necessarily kill all harmful micro-organisms, especially bacterial spores, the firm says.

According to Getinge, the Sterizone VP4 steriliser offers a more effective solution, because it involves a proprietary physical and chemical process that thoroughly destroys all types of microbiological organisms.

The Sterizone VP4 steriliser can sterilise multi-channelled flexible endoscopes (with a maximum of four channels) that have internal lumens of >=1.45mm in inner diameter and <=3,500mm in overall length, and >=1.2mm in inner diameter and <=1,955mm in overall length, which are commonly found in video colonoscopes and gastroscopes.