A newer version of the unit improves sterilizer efficacy by using two cycles with a hydrogen peroxide diffusion stage and a plasma stage per sterilization cycle. This revision, which is achieved by a software modification, reduces total processing time from 73 to 52 minutes. The manufacturer believes that the enhanced activity obtained with this system is due in part to the pressure changes that occur during the injection and diffusion phases of the process and to the fact that the process consists of two equal and consecutive half cycles, each with a separate injection of hydrogen peroxide.856, 884, 885 This system and a smaller version 400, 882 have received FDA 510[k] clearance with limited application for sterilization of medical devices (Table 6). The biological indicator used with this system is Bacillus atrophaeus spores.851 The newest version of the unit, which employs a new vaporization system that removes most of the water from the hydrogen peroxide, has a cycle time from 28-38 minutes (see manufacturer’s literature for device dimension restrictions).
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Penetration of hydrogen peroxide vapor into long or narrow lumens has been addressed outside the United States by the use of a diffusion enhancer. This is a small, breakable glass ampoule of concentrated hydrogen peroxide (50%) with an elastic connector that is inserted into the device lumen and crushed immediately before sterilization.470, 885 The diffusion enhancer has been shown to sterilize bronchoscopes contaminated with Mycobacteria tuberculosis.886 At the present time, the diffusion enhancer is not FDA cleared.
Another gas plasma system, which differs from the above in several important ways, including the use of peracetic acid-acetic acid-hydrogen peroxide vapor, was removed from the marketplace because of reports of corneal destruction to patients when ophthalmic surgery instruments had been processed in the sterilizer.887, 888 In this investigation, exposure of potentially wet ophthalmologic surgical instruments with small bores and brass components to the plasma gas led to degradation of the brass to copper and zinc.888, 889 The experimenters showed that when rabbit eyes were exposed to the rinsates of the gas plasma-sterilized instruments, corneal decompensation was documented. This toxicity is highly unlikely with the hydrogen peroxide gas plasma process since a toxic, soluble form of copper would not form (LA Feldman, written communication, April 1998).
The Advantages of Decontaminating with Vapor Hydrogen Peroxide used in processes where traces of toxic substances are unacceptable.
ADVANTAGES
1. Efficacy
Hydrogen peroxide vapor at low concentrations is an effective decontaminant against a wide variety of microorganisms. Not only is it capable of permeating most materials, VHP can kill microorganisms residing in seams and joints. Permeation by a vapor allows effective penetration into these areas. Vapor hydrogen peroxide can also penetrate plastic membranes.
2. Low Temperature Processing
Most polymers & adhesives being used to manufacture devices cannot tolerate high temperatures without suffering deleterious effects. Sterilization with hydrogen peroxide vapor can be accomplished efficiently at temperatures as low as 4°C (39°F). Using these low temperatures during processing lessens the chances of damage to the materials which could comprise the load being sterilized.
3. Short Processing Cycles
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D-values for vapor hydrogen peroxide sterilization are low, thus allowing for short sterilization cycles. Short cycle times, mean increasing the availability of the isolators for additional use.
4. Lower Investment & Operating Costs
A pressure vessel is not required with VHP; therefore, lower investment is required. In addition, because of increased efficacy of peroxide vapor, there is low chemical consumption per cycle.
5. Materials Compatibility
VHP processing extends the service life of enclosures (as compared to other sterilant systems) by virtue of the low temperature, the low concentrations of peroxide vapor used, and minimal pressure differences.
6. Safety
The VHP process poses little danger to the operator when properly controlled. The natural degradation products of hydrogen peroxide are water and oxygen. Because the sterilant is decomposed in the VHP process, there is no concern about disposing of toxic chemicals following processing.
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