Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Reexamination Certificate
2000-09-08
2002-10-01
Gitomer, Ralph (Department: 1623)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
C422S001000, C435S029000, C435S287100, C435S288100, C424S093100
Reexamination Certificate
active
06458322
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method for the simplified shipping of clinical specimens, especially specimens that may contain an etiologic agent. The present invention further relates to the laboratory analysis of the shipped specimen, preferably directly upon receipt and without further substantial sample preparation.
2. Background of the Invention
The laboratory analysis of human or animal material, including, but not limited, to excreta, secreta, blood and its components, tissue, and tissue fluids is a necessity of modern medicine for the purposes of diagnosis. Most if not all Americans are familiar with “blood tests” used to determine their cholesterol level, the presence or absence of various microorganisms, and, depending upon level of sophistication, phenotyping, genotyping, etc. Such analysis is also used in therapeutic drug monitoring (TDM), which determines the quantity of a drug in the blood. TDM is now routine for approximately 20 different drugs for which dosing level is an issue and for which immnunochemical assays have been commercialized. TDM is extremely important for individualized therapy, and it is a tool used to avoid both toxic and sub-therapeutic blood concentrations (and the drug resistance that sub-therapeutic levels can induce in, for example, the treatment of infectious diseases).
One problem encountered in the laboratory analysis of clinical specimens is that oftentimes the laboratory where analysis is conducted is located apart from where samples are collected. Thus, the clinical specimen must somehow be transported to the site of the laboratory. The transportation of a clinical and, especially, an infectious specimen is highly regulated, complicated and expensive because of safety issues, health concerns, Department of Transportation regulations, and various other laws, rules, and regulations of the States and the United States, and foreign countries. In fact, the packaging and shipping standards for infectious substances in the United States are higher than those for any other class of dangerous goods except high-activity radioactive materials.
For example, Title 49 of the Code of Federal Regulations (CFR) governs the shipping of hazardous materials, and essentially encompasses the International Air Transport Association regulations regarding dangerous materials shipping, including the shipment of infectious substances that can affect a human. 49 CFR 171.8, 172.101, and 173.134, as well as 42 CFR, particularly sections 72.1-72.5, all incorporated herein by reference (current as of the filing date of this application), govern the shipment of etiologic agents (a viable microorganism or its toxin that causes, or may cause, human disease). As noted in 42 CFR 72.2, it is unlawful to knowingly transport or cause to be transported specimens and products that one reasonably believes may contain an etiologic agent unless certain packaging standards and requirements are met. Under 42 CFR 72.3, an extensive, non-comprehensive list of such etiologic agents is provided (incorporated herein by reference), and strict packing requirements, etc. are specified, as is a particular label that must be placed on the outer shipping containers of all materials containing etiologic agents. Of course, any package that possesses special labeling commands a significant surcharge that is payable to the shipping company. What is more, the special packaging that is required has become an industry in and of itself, and it is now common to spend at least $39 to purchase a box for a single sample (see, for example, part numbers STP100, STP300, and STP370, all found at www.cargopak.com/saftpak.htm and at www.saftpak.com). Even when a shipper does not reasonably believe that a clinical specimen contains an etiologic agent, readying such a sample for transport remains burdensome, expensive, and requires staffing by individuals who are fully apprised of all shipping regulations and who possess documentation of ongoing participation in training programs.
Another problem caused by the transport or shipping of clinical specimens to a laboratory for analysis is the integrity of the sample being shipped. If the sample is not maintained at a proper temperature during transport it is possible that the sample when analyzed is different from that when it was obtained, and that the results provided by the laboratory do not reflect the true state of the patient's condition. The incorporation of dry ice or cold packs in a package increases the weight and, hence the shipping cost. The convenience and timeliness of shipping temperature-controlled packages is low as well, since most receiving laboratories state that shipments should be made from Mondays to Thursdays only. What's more, because carbon dioxide is toxic, the transport of dry ice by aircraft adds significant regulatory burden.
The inventor knows of three organizations that openly promote the fee-for-service measurement of antiviral drug concentrations in body fluids of HIV-infected individuals. Specifically, these organizations are University of Liverpool, National Jewish Medical and Research Center, and Specialty Laboratories. In each case, the support literature from these organizations ask that untreated, known infectious plasma or serum be shipped, in a legally proper manner, to the analysis facility. Hence, the burden of precise compliance to all shipping regulations regarding etiologic agents, dry ice, etc. rests squarely on the shipper. Further, the real cost of sample analysis is inflated because of the packaging material costs, shipping surcharges, staffing by highly-trained shipping specialists, etc.
The practical result of the difficulties encountered in shipping a clinical specimen to a laboratory for analysis (i.e., shipping requirements, increased cost, maintenance of sample integrity, etc.) is illustrated by the website for Specialty Laboratories (www.specialtylabs.com), a research-based clinical reference laboratory that provides diagnostic, prognostic, and monitoring services. On this website under “Domestic & International Shipping Procedures” it is explained that the shipper of medical specimens is required to comply with the rules and guidelines for transport of such materials, and the shipper is ultimately responsible for all decisions that are made regarding packaging. Information is provided that outlines, with an intermediate level of detail, the various steps the shipper must go through in preparing a clinical specimen for shipment. Investigation into the shipment of such samples through overnight courier services, such as FedEx, has revealed that, beyond the normal fees based on weight and destination, substantially higher charges are incurred for samples labeled in accordance with the laws, rules and regulations that govern the shipping of clinical specimens that may contain etiologic agents.
OBJECTS OF THE INVENTION
It is one object of the invention to provide a method for the lawful shipment of clinical specimens that does not require compliance with U.S. laws, rules and regulations (including those of the States) regarding the shipment of samples or material that may contain an etiologic agent. (For applications in countries other than the U.S. the laws, rules and regulation are those of the examining country. All countries of the world are included such as Japan, the countries of Europe, South America, etc.)
It is a further object of the invention to provide a sample container useful for shipment of samples or material without the necessity of following the various laws, rules, and regulations regarding the shipment of etiologic materials.
It is a further object of the invention to provide method instructions and/or equipment to allow for the inactivation of clinical and etiologic specimens and their conversion from etiologic to non-etiologic or from biohazardous to non-biohazardous, the method equipment including a sample container for the shipment of the inactivated, non-etiologic sample in accordance with the invention method for ship
Bioavailability Systems, LLC
Chaudhry Mahreen
Gitomer Ralph
LandOfFree
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