Chemistry: molecular biology and microbiology – Process of utilizing an enzyme or micro-organism to destroy... – Cleaning using a micro-organism or enzyme
Reexamination Certificate
1999-10-29
2002-09-10
Redding, David A. (Department: 1744)
Chemistry: molecular biology and microbiology
Process of utilizing an enzyme or micro-organism to destroy...
Cleaning using a micro-organism or enzyme
C510S109000, C510S114000, C510S161000, C510S162000, C510S374000, C510S375000, C510S382000, C510S392000
Reexamination Certificate
active
06448062
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to chemical compositions and methods for using the compositions for simultaneously cleaning and decontaminating devices.
2. Description of Related Art
A variety of industries require that devices used within the industry be cleaned and decontaminated. Examples of two such sectors are the brewing industry and the medical arena. Such sectors require efficient and effective device cleaning and decontaminating foremost for health and safety reasons, but also for economic reasons.
Within the medical field, a variety of devices exist to serve important medical functions. Medical devices may be single-use or may be reusable. Cleaning and decontaminating products for medical devices may also be single-use or reusable and their associated methods or processes of application may be applied once or repeated. As used herein, decontamination is the removal of hazardous or unwanted materials such as bacteria, mold spores or other pathogenic life forms and the like, wherein high- and intermediate-level disinfection and sterilization represent different levels of decontamination. The time interval for achieving decontamination herein for medical devices other than kidney dialyzers is 30 minutes or less. No limitation is placed on the decontamination time useful for kidney dialyzers. These time intervals pertain to the time required to decontaminate a single medical device and do not apply to solution reuse time periods. Sterilization is a level of decontamination representing the complete elimination or destruction of all forms of microbial life, including fungal and bacterial spores. High-level disinfection is a level of decontamination representing a process that eliminates many or all pathogenic microorganisms, with the exception of bacterial spores, from inanimate objects.
Regulatory agencies and other groups have classified medical devices, processes, and cleaning and decontaminating products according to basic principles related to infection control. Medical devices are classified as critical, semicritical or noncritical. Critical devices, for example, scalpels, needles and other surgical instruments, enter sterile tissues or the vascular system. Such devices require sterilization with a process or with prolonged contact with a sporicidal chemical prior to reuse.
Semicritical devices, for example, flexible endoscopes, bronchoscopes, laryngoscopes, endotracheal tubes and other similar instruments, touch all mucous membranes except dental mucous membranes. Such devices require high-level disinfection with a process or short contact with a sporicidal chemical prior to reuse. High-level disinfection can be expected to destroy all microorganisms with the exception of high numbers of bacterial spores. An FDA regulatory requirement for high- and intermediate-level disinfectants is 100% kill of 1,000,000 organisms of
Mycobacterium tuberculosis
(
M. tuberculosis
) in the presence of 2% horse serum in a quantitative tuberculocidal test. This is a suspension test following the EPA Guidelines for the Quantitative Tuberculocidal Procedure. An additional FDA regulatory requirement for high-level disinfectants is that they must also achieve sterilization over a longer exposure time than the disinfection regimen time, as long as sterilization is achieved with 20 hours. The ability to achieve sterilization is measured by sporicidal activity as determined by the AOAC Sporicidal Test, AOAC Official Methods of Analysis, 15
th
edition, 1995. This test measures the ability of a solution to sterilize surfaces contaminated with dried bacterial spores. Spores of
Bacillus subtilis
ATCC #19659 and/or
Clostridium sporogenes
ATCC #3584 are used for this test. Common commercially available high-level disinfectants include glutaraldehyde solutions between 2.4-3.4%
w/v
which also typically require activation with an alkaline buffer just prior to use. Also available are an acidic (pH 1.60-2.00) hydrogen peroxide (H
2
O
2
) formulation comprising 7.5%
w/v
hydrogen peroxide and another antimicrobial agent (for example, Sporox®, Reckitt and Colman, Inc.), and an acidic mixture of 1.0%
w/v
H
2
O
2
and 0.08%
w/v
peracetic acid (PAA) (Peract™ 20, Minntech Corp. or Cidex PA®, Johnson & Johnson). The minimum effective PAA concentration for high-level disinfection at 25 minutes (min) and 20° C. is 0.05%
w/v
(500 ppm) in the presence of 1.0%
w/v
H
2
O
2
(Peract™ 20).
Medical devices such as thermometers and hydrotherapy tanks are also classified as semicritical, but they require intermediate-level rather than high-level disinfection prior to reuse. Intermediate-level disinfection inactivates
M. tuberculosis,
vegetative bacteria, most viruses and most fungi, but does not necessarily kill bacterial spores. A common intermediate-level disinfectant is Cavicide® (Metrex Research Corp.), which contains 0.28%
w/v
diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride, (a so-called super quat) and 17.2%
w/v
isopropyl alcohol.
Noncritical medical devices, for example, stethoscopes, tabletops, bedpans, etc., touch intact skin and require low-level disinfection prior to reuse. Low-level disinfection can kill most bacteria, some viruses, and some fungi, but it cannot be relied upon to kill resistant microorganisms such as tubercle bacilli or bacterial spores. Contact lenses are included in the class of devices which require low-level disinfection prior to reuse. Common low-level disinfectants for contact lens disinfection include acidic 3.0%
w/v
H
2
O
2
and 1-10 ppm solutions of polymeric antimicrobial biguanides or quaternary ammonium compounds (e.g., 1 ppm polyhexamethylene biguanide in Complete® (Allergan Pharmaceuticals, Inc.) or 10 ppm Polyquad™ polyquaternary ammonium compound in Optifree® (Alcon, Inc.).
Standards for sterilization and low, intermediate and high-level disinfection have been concurrently established. These standards are based upon the known or possible risk of contamination of a particular medical device by a particular microorganism, the pathogenic nature of the organism and other principles in infection control. They typically require demonstration of sterilization and/or disinfection efficacy against a particular panel of test organisms, which collectively represent the known or possible contamination and infection risks. The test panels and criteria are different for low, intermediate or high-level disinfection. It is also generally accepted that a high-level disinfectant will meet the disinfection efficacy standards of intermediate- and low-level disinfection as well. It is universally accepted that low-level disinfection performance cannot predict intermediate- or high-level disinfection performance. In fact, it is assumed prior to testing that a low-level disinfectant cannot achieve a higher level disinfection standard. Additionally, other factors such as device compatibility with the disinfection system must also be considered. For example, no high-level disinfecting agent can be used for contact lens low-level disinfection because of the inherent incompatibility of the chemistry of the high-level disinfectants with either the contact lens, contact lens case or eyes with respect to neutralization requirements prior to wearing the lenses. Complicating this issue further is the introduction of cleaning agents into the overall disinfection care system.
Cleaning is the removal of all foreign material, including organic soil such as blood, feces, respiratory secretions, etc., from objects. It has been reported that failure to remove foreign material from a medical device such as an endoscope before a disinfection or sterilization process is likely to render the process ineffective. (Rutala, W A, APIC Guideline for Selection and Use of Disinfectants,
Am J Infect Control,
August 1996; Vol. 24,4:313-342). The presence of organic material or soil may contribute to the failure of disinfection by harboring embedded microbes and preventing the penetration of the germicide. Additionally, some disinfectants are
Huth Stanley William
Yu Zhi-Jian
Metrex Research Corporation
Redding David A.
Wood Herron & Evans L.L.P.
LandOfFree
Simultaneous cleaning and decontaminating compositions and... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Simultaneous cleaning and decontaminating compositions and..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Simultaneous cleaning and decontaminating compositions and... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2913607