Cenorin receives updated 510k for pasteurization and disinfection systems
Cenorin received an updated FDA 510(k) clearance for the Cenorin 610 and 610HT Washer-Pasteurizer/High Level Disinfectors. These systems are designed to provide safe and effective automated cleaning and high-level disinfection using a full immersion pasteurization process.
The systems are intended for reprocessing semi-critical and non-critical reusable medical devices such as those used in respiratory therapy, sleep labs (including CPAP accessories), anesthesia, intensive care departments, diagnostic labs, emergency departments and patient clinics.
Independent worst-case and in-use testing has shown that the Cenorin 610 wash/pasteurization cycle achieves the 6-log reduction of all representative organisms that is required by the U.S. Food and Drug Administration (FDA) for high-level disinfection. “When using chemical disinfection methods for high-level disinfection, users must deal with toxicity risks for patients and workers in addition to the added costs,” said Drew Radford, President of Cenorin. “The Cenorin 610 and 610HT systems provide a cleaning and high-level disinfection option for heat-sensitive medical devices that is sustainable, safe and economical.”
The full immersion pasteurization cycle provides a sustainable high-level disinfection process without the need for HLD chemistries that may produce chemical waste effluent. In addition, reprocessing reusable devices can reduce the hospital waste stream by replacing many single-use devices.
The process controls assure proper cycle completion. Specific safeguards are included in the design of the hardware and software to assist the user in safe use of these systems. The process record meets Joint Commission, AORN, IAHCSMM and APIC recommendations. The user interface notifies staff when system maintenance is required. In addition, staff safety and ergonomics are incorporated into design elements in these units.
