Chemistry: analytical and immunological testing – Optical result – With fluorescence or luminescence
Reexamination Certificate
2000-11-15
2003-11-25
Wallenhorst, Maureen M. (Department: 1743)
Chemistry: analytical and immunological testing
Optical result
With fluorescence or luminescence
C436S063000, C436S164000, C422S082080, C356S051000, C250S461100, C250S461200
Reexamination Certificate
active
06653146
ABSTRACT:
BACKGROUND OF THE INVENTION
Field of the Invention
The present invention relates to a bio-burden visualization system, and more in particular, to a system and method for visualizing organic bio-burden residues on medical instruments.
It is of the utmost importance in the medical field that medical instruments, particularly surgical instruments, be carefully and completely cleaned prior to sterilization. After use, such instruments typically contain bio-burden residues of blood, fat, mucous, lipids, carbohydrates, protein or food residues which must be removed before sterilization. If such matter is not removed before sterilization they can harden and entrap bacteria protecting them from sterilization, therefore promoting cross contamination during subsequent procedures. That process does not remove such residue which remains on the instrument. The entrapped bacteria can contaminate a surgical site when the instrument is used again.
Normally, unaided visual inspection of a medical, “cleaned” device will usually not be able to detect bio-burden residue. Therefore, simple visual inspection does not ensure that proper cleaning has occurred and does not ensure that successful sterilization will take place.
In addition, despite the most careful cleaning, many surgical instruments, including orthopaedic and laproscopic instruments, as well as endoscopes and the like, are very difficult to clean. Therefore, it has been found desirable to visually ensure that such instruments are completely cleaned and all of the above-described bio-burden removed before sterilization. Alternatively, a sterilized instrument can be checked for bio-burden with the system of the present invention after sterilization and, if necessary, the instrument can then be re-cleaned and re-sterilized.
It is an object of the present invention to provide a bio-burden visualization system which is relatively simple to use and highly effective in allowing visualization of bio-burden remaining on surgical instruments.
Yet another object of the present invention is to provide a bio-burden visualization system which is reliable in use.
A further object of the present invention is to provide a bio-burden visualization system which is economical and yet has a high degree of accuracy.
In accordance with an aspect of the present invention, a bio-burden visualization system and method is provided which utilizes visualizing compounds or dyes that will affix to specific bio-burden residues and fluoresce or phosphoresce under appropriate conditions. These visualization compounds are generally in a liquid form which can be easily applied to an instrument by dipping or swabbing. However, solid or gas visualizing compounds may also be used.
The method of the present invention can be utilized to visualize bio-burden residues left on surfaces of surgical instruments, medical equipment and the like after cleaning or after sterilization. The system can also be used in a training program to test the quality of cleaning supplies and techniques used in the cleaning process. It could also be used for inspection, training and certification of cleanliness on food preparation surfaces.
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Esquenet Bernard
Esquenet Marc
Ruvinsky Lee
Chemclean Corporation
Wallenhorst Maureen M.
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