Cleaning compositions for solid surfaces – auxiliary compositions – Cleaning compositions or processes of preparing – For cleaning a specific substrate or removing a specific...
Reexamination Certificate
2000-03-31
2002-05-14
Boyer, Charles (Department: 1751)
Cleaning compositions for solid surfaces, auxiliary compositions
Cleaning compositions or processes of preparing
For cleaning a specific substrate or removing a specific...
C510S220000, C510S221000, C510S233000, C510S235000, C510S403000
Reexamination Certificate
active
06387858
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to the care of surgical instruments which come into contact with body fluids during use. It finds particular application in conjunction with the treatment of dental, surgical, veterinary and other medical instruments prior to cleaning and sterilization, and will be described with particular reference thereto. It should be appreciated, however, that the invention is applicable to a wide variety of equipment and pre-cleaning operations for removing protein or other contamination that becomes harder to remove with the loss of fluid content.
Medical devices are subjected to thorough cleaning and antimicrobial decontamination between each use. During surgery, the devices become coated with blood and other protein-rich body fluids which, if left to dry on the devices, form a hardened layer of biological residue that becomes difficult to remove in the cleaning process. Not only do such residues present a barrier to sterilant penetration, but in left in place, present a cleaning challenge for the automated washing cycles, and therefore, may require further cleaning by recycling through the automated washer, or may require a laborious manual cleaning step. Additionally, if not sufficiently removed after cleaning and sterilization, they may later break down to form toxic substances which pose hazards to patients when the devices are reused.
Immediately after a surgical procedure, therefore, the devices are often rinsed in a cleaning solution, such as an enzymatic cleaner, to remove the bulk of the blood, other body fluids and proteins from their surfaces. The rinsing process is generally carried out by immersing the devices in a shallow tray of the cleaning solution. Moreover, to minimize handling of contaminated instruments and to maintain the sterile zone around the surgical site and the surgeon and surgical nurses, the tray of cleaning fluid is prepared prior to surgery. The tray is open, posing hazards to personnel and equipment due to spillage. It also takes up valuable space in the operating theater, depending on the quantity and size of the instruments.
Disadvantages associated with soak cleaners include exposing workers to harmful microorganisms. Trays containing the soak cleaning solution and any contaminated instruments, are typically open, thereby exposing patients and workers to any biohazards present in the solution. Additionally, large trays are employed for treating large instruments and/or a significant number of instruments, and typically contain a relatively large volume of cleaning solution. Soaking involves complete immersion of contaminated instruments, entailing relatively large volumes of the soak cleaners. The heavy trays and large volumes make handling cumbersome for health care workers, and thereby increase the likelihood of spillage or sloshing. The additional weight presents challenges in safely relocating and transporting the heavy trays.
Foams are sometimes employed as a substitute to soak cleaners. Foams, such as a thin film of surfactant, are typically applied to instruments by spray methods. A disadvantage of foams is that the foam film collapses, thereby exposing the surface of the treated instrument to the atmosphere. Upon exposure to air, the fluid contained on the treated instrument dries out. Contaminants can also be released as the coated surface is re-exposed. Foams typically collapse in less than a half-hour. In the case of very stable foams, the film may last for about an hour before completely collapsing.
Although foams may be reapplied to a substrate, the short life of the film entails frequent monitoring to check foam stability. Having to reapply a foam at frequent intervals results in the use of larger quantities of a foam product.
There remains a need for a composition that will keep medical instruments moist, specifically keeping the soil or fluids contained thereon moist, to facilitate efficient cleaning in the subsequent cleaning steps. It is also desirable that a composition meeting the above requirement is easily applied to contaminated medical devices and can be used in relatively small quantities.
The present invention provides a new and improved method for post-operative treatment of medical instruments, and the like which overcomes the above-referenced problems and others.
SUMMARY OF THE INVENTION
In accordance with one aspect of the present invention, a method is provided for treating medical instruments after a surgical procedure which leaves blood or other body fluid on the instrument. The method includes applying a gel composition that inhibits the fluid from drying on the instrument.
In accordance with another aspect of the present invention, a method is provided for treating and cleaning a medical instrument contaminated with blood or other body fluid. The method includes applying a gel to surfaces of the medical instrument to form a gel film over the fluid, transporting the medical instrument to a cleaning station and cleaning the medical instrument. Applying sufficient gel film over the fluid inhibits the biological fluid from encrusting the instrument.
In accordance with a further aspect of the present invention, a composition is provided that is adapted to containing and maintaining fluids in a soluble state on contaminated medical instruments. The composition includes from about 0.1% to about 0.3% of a gel forming polymer, from about 0.1% to about 0.3% of neutralizing agent, from about 0.005% to about 0.01% of one or more corrosion inhibitors, from about 0% to about 14% of an antimicrobial agent, and the balance of the composition is water.
One advantage of the present invention is that it contains and keeps protein containing fluids moist for extended periods of time.
Another advantage of the present invention is that it provides for focused treatment of specifically contaminated areas of a medical instrument.
Another advantage of the present invention is that it facilitates ease of handling and treating medical instruments which are contaminated with blood or other body fluids.
A further advantage of the present invention is that it provides a method of treating medical instruments that facilitates relocation and transportation, prior to subsequent cleaning steps, by effectively reducing the weight associated with methods currently used for treating contaminated medical instruments.
Still another advantage of the present invention is that it inhibits blood or other fluids from drying out.
Another advantage of the present invention is that it encapsulates bioburdens and meets Occupational Safety and Health Association (OSHA) requirements.
Still further advantages of the present invention will become apparent on reading and understanding the following detailed description.
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Bernando Mildred R.
Keller Shahin
Shah Sayed S.
Boyer Charles
Fay Sharpe Fagan Minnich & McKee LLP
Steris Inc.
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