FDA Grants Clearance To Langford IC Systems
Langford IC Systems introduced The Manzi Mach 1 Cleaner-Processor, the only Parametric Release liquid chemical instrument processor. The Manzi is a fully integrated cleaning, sterilizing and rinsing system that cleans and reprocesses instruments at the point of use. This system is designed for use by hospitals, medical clinics, and in any medical setting conducting procedures involving medical instruments, including but not limited to lumen devices.
"The motivation for developing the Manzi device was sparked by the fact that no validated, quantifiable standard for clean existed in the medical cleaner industry. This directly contradicted a universally accepted assumption that sterilization cannot be achieved without the instrument first being declared clean. Working under the guidance of the FDA we focused on defining an industry clean standard. Our efforts were realized when the FDA granted us 510(k) clearance on the Manzi Mach 1 Instrument Cleaner-Processor," stated Terry Langford, President and CEO. "This quantifiable clean standard also addresses a shift in the current industry climate. New governmental and Medicare regulations are now requiring hospitals to report hospital acquired infections and limiting Medicare reimbursement for treatment of those infections."
The Manzi system cleans and reprocesses instruments, at the point of use, using no connectors. The uninterrupted, three-step process takes place in a single chamber as follows:
Cleaning Cycle: The Manzi system uses a patented "push-pull" action producing a powerful mechanical shear that strips contaminants and efficiently reduces bio-burden from the surfaces of the instrument, to a residual of <6.4micrograms/cm2 of Protein. No brushes are used, that could score or scratch instrument surfaces and possibly create bacterial laden crevices.
Germicide Cycle: The Manzi system does not use connectors, resulting in full exposure of all instrument surfaces to the sterilizing germicide. This cycle sanitizes to a resulting Sterility Assurance Level (SAL) of >6 with no surviving Colony Forming Units (CFU's).
Rinsing Cycle: The Manzi system includes a patented, integrated water purification system that provides a final rinse of Sanitized Rinse Water that will not compromise the integrity of the sterilization process.
Introduction of the Manzi system addresses several organizational and efficiency issues, not addressed by existing technology. The Manzi system is designed to be on-site and at point of use. This permits medical facility control over the operator and operator training, the instrument supply chain, and physical monitoring of the cleaner-processor device. Additionally, the on-site reprocessing time cycle is approximately 45 minutes. This is a significant reduction of time compared to off-site or central supply reprocessing.
The advanced capabilities of the Manzi system are a proactive response to improve the chain of patient care. Between five and 10% of patients admitted to hospitals in the United States develop hospital-acquired infections (nosocomial infections). Governmental agencies are focusing efforts to reduce such infections by imposing new Medicare regulations and hospital reporting laws. Hospitals will no longer receive additional payment for costs associated with a patient's hospital acquired infection. Fourteen states already require reporting of these infection rates. The Manzi device will greatly reduce the risk of patient exposure to certain pathogen residue on medical instruments and the potential resulting infections.