News | October 11, 2007

FDA Grants Clearance for Parametric Instrument Sterilizer

October 12, 2007 - Langford IC Systems Inc. today introduced the Manzi Mach 1 Cleaner-Processor, a parametric release liquid chemical instrument processor that cleans, sterilizes and rinses instruments at the point of use.

The system is designed for use by hospitals, medical clinics, and in any medical setting conducting procedures involving medical instruments.

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:

In the cleaning cycle the company says it uses a patented “push-pull” action producing a powerful mechanical shear that strips contaminants and reduces bio-burden from the surfaces of the instrument, to a residual of

In the 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).

In the rinsing cycle the Manzi system includes a patented, integrated water purification system that provides a final rinse of the company’s Sanitized Rinse Water.

The maker says the introduction of the Manzi system addresses several organizational and efficiency issues, not addressed by existing technology. The on-site reprocessing time cycle is approximately 45 minutes.

The company says the capabilities of the Manzi system are a proactive response to improve the chain of patient care. Between 5 and 10 percent of patients admitted to hospitals in the United States develop hospital-acquired 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.

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