Anti-fomitic devices

Stock material or miscellaneous articles – Hollow or container type article – Nonself-supporting tubular film or bag

Reexamination Certificate

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C206S049000, C206S200000, C206S438000, C206S455000, C383S042000, C383S063000, C383S064000, C383S093000, C383S094000, C383S095000, C383S097000, C383S098000, C383S211000, C428S035400, C428S035700, C428S121000, C428S124000

Reexamination Certificate

active

06468611

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to a cover or barrier to prevent cross-infection. In particular, the present invention relates to a range of anti-fomitic covers to prevent cross-infection, including such covers for pillows, mattresses, X-ray cassettes, surgical and diagnostic equipment, toilet seats, table and chair seat surfaces, wash basin faucet handles and other handles, etc., as well as covers such as diapers or other similar sorts of “clothing,” for example, surgical robes, shoe covers for the surgical room, etc.
BACKGROUND OF THE INVENTION
The problems of cross-infection and the production of antibiotic-resistant mutations have been subjects for concern in hospital settings, as well as in household and other settings, such as the hospitality industry (hotels, motels, bed and breakfast businesses, hostels, etc.). These problems are particularly problematic for those with compromised immune systems or with special bacterial, viral, fungal, parasitic, or other susceptibilities. The latter category of special susceptibilities may also include persons with allergies, and persons who develop one or more of a range of contact dermatitises, to name but a few non-limiting examples.
One means of transmitting bacteria, viruses, fungi, and other pathogens is by fomites, which are inanimate agents of such transmissions, including, for example, bedding, toilet seats, clothes, table tops and other fixed surfaces, surgical and X-ray equipment, etc. Thus, a fomite (also called a fomes) may absorb or otherwise harbor one or more strains of pathogenic bacteria, fungi, viruses, etc., and later transmit those pathogens, by contact, to a human.
A common fomite found in hospitals is metallic X-ray cassettes. Both patients and hospital staff may handle or otherwise touch an X-ray cassette, depending on the X-ray system used and the particular application. For example, in some applications, an undraped patient may hold an X-ray cassette in position against a portion of his body during X-ray filming. Subsequent to the filming, one or more hospital staff members may also touch the X-ray cassette during the progression culminating in photographic development of the X-ray film.
Another common fomite is bedding, where commonly employed materials, such as cotton, act as wicks to carry pathogens far from the initial contact point with human skin, particularly when moisture is present (sweat, semen, saliva, vaginal secretions, secretions from wounds and open pimples, spilled drinks, etc.). Thus, when sheets and pillow cases are changed, the deeper lying material (mattress, mattress cover, pillow) still harbors potential pathogens of the previous user(s). Furthermore, the next user—particularly when moisture is introduced onto the “scene”—can become infected by reverse wicking; i.e., moisture can draw deep lying pathogens back toward the surface of the bedding that is in contact with the user.
Similar to bedding, clothing and related items (such as diapers, surgical robes and covers) also are subject to the problem of passing pathogens from the person wearing the item to another person or surface into which the item comes into contact. Again, as with bedding, the problem of cross-contamination is exacerbated by wicking in the presence of moisture.
Another common fomite is the surfaces encountered in bathrooms. As has been well documented for decades, toilet seats, the faucet handles of wash basins, door handles, etc., and other surfaces in bathrooms are commonly contaminated with
E. coli
and other pathogens. As but one illustration of the problem, one need only recognize that a user of a toilet often will leave the toilet with substantial
E. coli
contamination of at least one hand. That individual may then, in turn, contaminate the knob/handle of the toilet stall, and then one or more faucet handles at a wash basin. Said individual then washes his hands, but touches the one or more faucet handles that he had just contaminated in the process of turning off the water flow, thereby re-contaminating his hand(s). Thus, whatever is subsequently touched by the
E. coli
-contaminated hand(s) of that individual will also become so contaminated.
As another example of cross-contamination in the bathroom setting, pathogens on toilet seats may be transmittable to the next user. One such example is the herpes viruses, which may be transmitted to a subsequent contactor, particularly if that individual has an open wound. Other pathogens may similarly be so transmitted, though some will require relatively immediate contact by the next person when the pathogen is not hardy outside a “biological” setting (i.e., a setting having the requisite moisture and/or temperature close to human interior body temperature).
Yet another setting that is ripe for cross-contamination is the kitchen. Not only is there the well documented potential problems with contamination sources such as chicken skin (Salmonella, etc.), raw beef (
E. coli,
etc.), and insects and other bugs and parts thereof (keeping in mind that the FDA allows such contamination to prescribed levels), but also
E. coli
contamination due to the use of toilets by the kitchen worker (or from contamination by a previous user of the toilet). In the same manner noted above in the context of bathrooms, cross-contamination of faucet handles of wash basins/sinks in kitchens is wide spread. The kitchen cross-contamination problem may also be extended to include problems from the use of cutting boards (problematic particularly with porous material like wood) and from inadequate cooking of contaminated food. In addition, inadequate cleaning of virtually all kitchen surfaces into which human skin comes into contact, directly or indirectly, further compounds the problem of cross-contamination; and this would include not only faucet handles, but also table, counter and other surfaces, as well as handles to ovens, refrigerators, microwave units, etc.
One study of hospitals (
Surgical Clinics of North America
50 [No. 4]: pages 945-952, August 1970) included analysis of portions of X-ray rooms and X-ray equipment, including cassettes used in portable X-ray machines. Organisms cultured from these cassettes included staphylococcus aureus (coagulase negative), staphylococcus aureus (coagulase positive), streptococcus viridans, aspergillus, fungus, and diptheroids. The cassettes cultured in this study included ones placed in direct contact with undraped patients.
U.S. Pat. No. 3,092,252 to Brause, et al. discloses packages with folds at one end for use in protecting humans from pathogens that otherwise might be present on thermometers, tongue depressors, surgical instruments, fingers/hands, etc. The inner surface of the packages of this invention initially are sterile, though the objects placed within the packaging are not sterile. Multiple folds are utilized in the practice of this invention. Complicated folding is utilized in the packaging of this invention.
U.S. Pat. No. 3,215,265 to Welin-Berger discloses the use of a plurality of sheaths to protect patients from cross-contamination from thermometers. An inner package covers a thermometer, and may remain about the thermometer during insertion into a body orifice for temperature measurement. An outer package contains the inner package along with its contents.
U.S. Pat. No. 3,847,280 to Poncy discloses a sterile package for clinical thermometers and similar diagnostic equipment elements, where packaging may be stripped from sheathing surrounding the thermometer or other diagnostic equipment elements. Multiple layers and coatings are used, including ones for lubricants. One embodiment utilizes a plurality of packages that are attached in succession and separated by perforated sections for convenient separation.
U.S. Pat. Nos. 3,941,245 and 3,988,873 to Oliveriuis disclose the use of flexible, multi-layered containers, including a first container that slides within a second container, for containing and securing contaminated articles.
U.S. Pat. No. 4,057,731 to Loseff discloses a sterile conta

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