FDA Grants Clearance to Langford IC Sys...( First Parametric Release...),Health

First Parametric Release(TM) Instrument Processor

TUCSON, Ariz., Oct. 12 /PRNewswire/ -- Langford IC Systems, Inc. announces the introduction of The Manzi Mach 1 Cleaner-Processor, the only Parametric Release(TM) 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.

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