FDA Grants Clearance to Langford IC Systems, Inc.
"The motivation for developing the Manzi device was sparked by the factthat no validated, quantifiable standard for clean existed in the medicalcleaner industry. This directly contradicted a universally accepted assumptionthat sterilization cannot be achieved without the instrument first beingdeclared clean. Working under the guidance of the FDA we focused on definingan industry clean standard. Our efforts were realized when the FDA granted us510(k) clearance on the Manzi Mach 1 Instrument Cleaner-Processor," statedTerry Langford, President and CEO. "This quantifiable clean standard alsoaddresses a shift in the current industry climate. New governmental andMedicare regulations are now requiring hospitals to report hospital acquiredinfections and limiting Medicare reimbursement for treatment of thoseinfections."
The Manzi system cleans and reprocesses instruments, at the point of use,using no connectors. The uninterrupted, three-step process takes place in asingle chamber as follows:
Cleaning Cycle: The Manzi system uses a patented "push-pull" actionproducing a powerful mechanical shear that strips contaminants and efficientlyreduces bio-burden from the surfaces of the instrument, to a residual of<6.4micrograms/cm2 of Protein. No brushes are used, that could score orscratch instrument surfaces and possibly create bacterial laden crevices.
Germicide Cycle: The Manzi system does not use connectors, resulting infull exposure of all instrument surfaces to the sterilizing germicide. Thiscycle sanitizes to a resulting Sterility Assurance Level (SAL) of >6 with nosurviving Colony Forming Units (CFU's).
Rinsing Cycle: The Manzi system includes a patented, integrated waterpurification system that provides a final rinse of Sanitized Rinse Water(TM)that will not compromise the integrity of the sterilization process.
Introduction of the Manzi system addresses several organizational andefficiency issues, not addressed by existing technology. The Manzi system isdesigned to be on-site and at point of use. This permits medical facilitycontrol over the operator and operator training, the instrument supply chain,and physical monitoring of the cleaner-processor device. Additionally, theon-site reprocessing time cycle is approximately 45 minutes. This is asignificant reduction of time compared to off-site or central supplyreprocessing.
The advanced capabilities of the Manzi system are a proactive response toimprove the chain of patient care. Between five and 10% of patients admittedto hospitals in the United States develop hospital-acquired infections(nosocomial infections). Governmental agencies are focusing efforts to reducesuch infections by imposing new Medicare regulations and hospital reportinglaws. Hospitals will no longer receive additional payment for costs associatedwith a patient's hospital acquired infection. Fourteen states already requirereporting of these infection rates. The Manzi device will greatly reduce therisk of patient exposure to certain pathogen residue on medical instrumentsand the potential resulting infections.
Langford IC Systems, Inc.'s mission is to utilize advanced technology toprovide the Healthcare Industry with affordable, easy to operate,cleaner-processors that safely and effectively reprocess medical devices,instruments, and implantable(s). Langford IC Systems is a privately heldcorporation h
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