Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Reexamination Certificate
2000-08-08
2002-02-12
Thornton, Krisanne (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
Reexamination Certificate
active
06346218
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to methods and apparatus for treatment of medical waste and, more specifically, to methods and apparatus for treatment of medical waste that are not dependent upon incineration.
2. Description of the Related Art
The present invention is useful for the effective treatment of a relatively wide variety of medical wastes, but its applicability and effectiveness are particularly noteworthy as to certain classes of medical wastes. There is a lack of uniformity and convention as to the use of certain terms involved in discussions of medical wastes, and for that reason some discussion of nomenclature would facilitate an understanding of the invention.
The term medical waste is defined by the U.S. Environmental Protection Agency (the “U.S. EPA”) as any solid waste which is generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining to these, or in the production or testing of a biological. 40 C.F.R. Ch.1, § 259.10(a);
U.S. Environmental Protection Agency
, Mar. 24, 1989, pp. 12,373-12,374. Biological as used herein refers to preparations made from living organisms and their products, including vaccines, cultures, etc., intended for use in diagnosing, immunizing or treating humans or animals in research pertaining thereto. Such medical waste may derive from a variety of sources, including hospitals, clinics, health maintenance organizations, and the like. Specific examples of medical wastes are provided below.
The term infectious medical waste is defined as waste containing any organism (such as a virus or bacteria) that is capable of being communicated by invasion of or multiplication in body tissues and is capable of causing disease or adverse health impacts in humans. The closely-related term regulated medical waste, used by some synonymously with the term infectious medical waste, is defined by the U.S. EPA as any solid waste [defined in 40 C.F.R. § 259.10(a)], generated in the diagnosis, treatment, (e.g., provision of medical services), or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of a biological, that is not excluded or exempted under 40 C.F.R. § 259.30(b), and that is listed in the table of regulated medical waste provided at 40 C.F.R. § 259.30(a). 40 C.F.R. § 259.30 (1992).
Technically, medical waste qualifies as infectious or regulated medical waste only if it contains pathogens (microorganisms capable of causing disease) of sufficient quantity and virulence so that human exposure to the medical waste could result in infectious disease. Thus, this class of medical waste is defined in terms of its effect on humans, i.e., the effect of the waste on humans must be known or predicted to classify waste as infectious or regulated medical waste. In view of this definition, the manner in which one determines whether a particular batch of medical waste qualifies as infectious or regulated medical waste has not been reduced to a single, universally-recognized test.
Infection Control and Hospital Epidemiology
, January 1992, page 40.
One common approach to classification of such wastes involves using a subjective standard in which the waste is deemed to be infectious or regulated medical waste if it is suspected to contain pathogens in sufficient quantity and virulence to cause disease.
Infection Control and Hospital Epidemiology
, January 1992, page 39.
For purposes of the present invention, the term infectious medical waste as used hereinbelow is interpreted in a broad sense to include the U.S. EPA definition of regulated medical waste at 40 C.F.R. § 259.10(a) as referred to above, including wastes that meet the subjective standard referred to above. Moreover, the term as used in connection with the invention includes any medical waste that is handled or treated as infectious or regulated medical waste as defined by any of the above definitions.
Infectious or regulated medical waste is commonly divided into seven groups or subcategories. These subcategories, which are summarized, e.g., in the table of regulated medical waste at 40 C.F.R. § 259.30(a), include the following:
1. Cultures and Stocks. This group includes cultures from medical and pathological laboratories, cultures and stocks of infectious agents from research and industrial laboratories, wastes from the production of biologicals, discarded live and attenuated vaccines, and culture dishes and devices used to transfer, inoculate and mix cultures.
2. Pathological Wastes. This group includes tissues, organs, and body parts and body fluids that are removed during surgery or autopsy, or other medical procedures, and specimens of body fluids and their containers.
3. Human Blood and Blood Products. This group includes liquid waste human blood, products of blood, items saturated and/or dripping with human blood, or items that were saturated and/or dripping with human blood that are now caked with dried human blood, including serum, plasma, and other blood components, and their containers, which were used or intended for use in either patient care, testing and lavatory analysis, or the development of pharmaceutical. Intravenous bags are also included in this category.
4. Sharps. This group includes sharp items that have been used in animals or human patient care or treatment or in medical research, or industrial laboratories, including hypodermic needles, syringes (with or without the attached needles), pasteur pipettes, scalpel blades, blood vials, needles with attached tubing, and culture dishes (regardless of presence of infectious agents). Also included within this group are other types of broken or unbroken glassware that were in contact with infectious agents, such as used slides and cover slips.
5. Animal Waste. This group includes contaminated animal carcasses, body parts, and bedding of animals that were known to have been exposed to infectious agents during research (including research in veterinary hospitals), production of biologicals, or testing of pharmaceutical.
6. Isolation Wastes. This group includes biological waste and discarded materials contaminated with blood, excretion, exudates or secretions from humans who are isolated to protect others from certain highly-communicable diseases, or isolated animals known to be infected with highly-communicable diseases.
7. Unused Sharps. This category includes unused discarded hypodermic needles, suture needles, syringes, and scalpel blades.
The present invention is well suited for the effective treatment of a wide variety of medical wastes. It is particularly well suited, however, and finds greatest practical advantage, in the treatment of solid or semi-solid infectious medical wastes falling within subcategories 3 and 6 above, i.e., blood and blood products, and isolation wastes. These materials typically comprise synthetic or man-made materials that contain microorganisms, biologicals, or pathogens. Medical waste falling within either of these two subcategories is referred to in this document as treatable medical waste.
Although most infectious medical wastes are generated in hospitals and other health care facilities, relatively little data are available on their specific composition. It is believed that infectious medical wastes typically include a heterogeneous mixture of materials such as plastics, dry cellulosic solids, wet cellulosic solids, and noncombustible materials such as metals. A typical mix of such materials within a batch of medical waste might include, for example, approximately 14% by weight of plastics, about 45% by weight of dry cellulosic material, approximately 18% by weight of wet cellulosic material, and approximately 20% by weight of noncombustibles.
Infection Control and Hospital Epidemiology
, January 1992, page 40. These wastes often comprise the disposable contents and packaging of single-use products, such as incontinency products, surgeon's instruments, woven towels, non-woven towels, non-woven surgical barrier drapes, non-woven surg
Milum Craig
Sherrill Joseph C.
Craig Milum
Sullivan Law Group
Thornton Krisanne
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