Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Reexamination Certificate
2001-02-07
2004-11-09
McKane, Elizabeth (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
C422S300000, C134S032000, C134S148000, C134S201000
Reexamination Certificate
active
06814932
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to the decontamination arts. It finds particular application in connection with an automated system for leak testing cleaning, sterilizing, and drying devices for medical, dental, mortuary, and pharmaceutical applications, and the like, and will be described with particular reference thereto. It should be appreciated, however, that the invention is also applicable to the decontamination of other devices in an automated processing system.
Medical devices, such as endoscopes, and other lumened instruments, are subjected to thorough cleaning and antimicrobial decontamination between each use. During medical procedures, the devices become coated with blood and other protein-rich body fluids. If the instruments are sterilized while they are coated with these materials, the high temperatures and/or chemicals used in the sterilization process tend to cause the materials to set as a hardened layer of biological residue that becomes difficult to remove. Not only do such residues present a barrier to sterilant penetration, but even when sterilized, they may later break down to form toxic substances which pose hazards to patients when the devices are reused.
Traditionally, such devices are often rinsed in a cleaning solution, such as an enzymatic cleaner, to remove the bulk of the blood and other body fluids from their surfaces. The rinsing process is generally carried out manually by immersing the devices in a shallow tray of the cleaning solution. However, for devices such as endoscopes, the cleaning fluid may not penetrate the length of the internal lumen, leaving a portion of the endoscope to become coated with dried body fluids. Additionally, the biological materials and strong cleaners may pose hazards to personnel coming into contact with them.
High temperature sterilization processes, such as steam sterilization in an autoclave, are generally unsuited to the sterilization of endoscopes because of the delicate components and materials from which they are manufactured. The high temperature and pressure tend to curtail the useful life of endoscopes, rubber and plastic devices, lenses, and portions of devices made of polymeric materials and the like. High temperature sterilization alone does not clean. Any body fluids that are not removed prior to thermal sterilization are typically baked on to the instrumentation.
Instruments which cannot withstand the pressure or temperature of the oven autoclave are often microbially decontaminated with gas, such as ethylene oxide gas or hydrogen peroxide vapor. Like steam, gases do not clean, requiring a separate cleaning operation. The ethylene oxide sterilization technique also has several drawbacks. First, the ethylene oxide sterilization cycle tends to be longer than the steam autoclave cycle. Second, some medical equipment can not be sterilized with ethylene oxide gas. Third, ethylene oxide is highly toxic and can present health risks to workers if not handled properly.
Liquid microbial decontamination systems are now utilized for equipment which can not withstand the high temperatures of steam sterilization. Peroxyacetic acid, or peracetic acid, is a useful sterilant and/or disinfectant for a variety of applications, including disinfection of waste and sterilization or disinfection of medical equipment, packaging containers, food processing equipment, and the like. It has a broad spectrum of activity against microorganisms, and is effective even at low temperatures. It poses few disposal problems because it decomposes to compounds which are readily degraded in sewage treatment plants.
In some situations, a technician mixes a disinfectant or sterilant composition with water and then manually immerses the items to be microbially decontaminated in the liquid composition. The high degree of manual labor introduces numerous uncontrolled and unreported variables into the process. There are quality assurance problems with technician errors in the mixing of sterilants, control of immersion times, rinsing of residue, exposure to the ambient atmosphere after the rinsing step, and the like. For sterilizing large, instruments, such as endoscopes with narrow lumens, however, a large receiving tray and a considerable quantity of decontaminant solution are used to accommodate and fully immerse the instruments.
Integrated decontamination systems, such as peracetic acid decontamination systems, have now been developed which provide a premeasured dose of a decontaminant in solution. Items to be sterilized are loaded into a receiving tray of a sterilization system and a cartridge of concentrated decontaminant inserted into a well. As water flows through the system, the decontaminant, which may be accompanied by surfactants and corrosion inhibitors, is diluted and carried to the receiving tray.
The items to be decontaminated are typically loaded into a treatment chamber through an opening closed by a door. It is desirable to maintain a seal between the door and the chamber, to prevent leakage of potentially hazardous sterilization chemicals from the chamber, and also to prevent ingress of potentially contaminated outside air into the chamber once the items are sterile.
Spraying the exterior of the instruments, while flowing decontaminant solution through the lumens, would have advantages over full immersion of the devices in reducing the quantity of decontaminant solution used. However, because of the complex shape of endoscopes, the spray jets may not reach all of the surfaces of the device. Additionally, interior surfaces of the lumened devices are not reached by the spray.
The present invention provides for a new and improved system and method for reprocessing endoscopes 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 system for microbially decontaminating a device is provided. The system includes a cabinet which defines an interior chamber for receiving the device. Spray nozzles, disposed within the chamber, spray a decontaminant fluid over an external surface of the device. A support supports the device within the chamber. An activation system displaces at least a portion of the support for changing points of contact between the device and the support.
In accordance with another aspect of the present invention, a system for cleaning and microbially decontaminating endoscopes is provided. The system includes a cabinet defining a vertically elongated chamber having rear and side walls and a front door. Spray nozzles are mounted on at least the rear and side walls of the chamber for spraying liquid cleaning and microbially decontaminating solutions. A hanger is on the chamber rear wall. A rack is configured to support a coiled endoscope. The rack is pivotally and removably hung on the hanger. A reciprocating drive having a drive member extends from the chamber rear wall adjacent the rack such that as the drive member reciprocates it engages and pushes the rack to pivot on the hanger and disengages from the rack to permit the liquid cleaning and decontaminating solutions to contact engaging surfaces of the rack and the drive member.
In accordance with another aspect of the present invention, a method of microbially decontaminating a device is provided. The method includes mounting the device on a support, spraying a microbial decontaminant solution over the device to microbially decontaminate the exterior surfaces of the device, and agitating the support to change points of contact between the device and the support.
One advantage of one embodiment of the present invention is that an endoscope or other lumened device is cleaned and microbially decontaminated in a single automated process.
Another advantage of one embodiment of the present invention is that hazards posed to personnel by handling contaminated devices are minimized.
A yet further advantage of one embodiment of the present invention is that a decontaminant delivery system ensures decontamination of all exterior and interior surfaces
Greszler Alan J.
Hlebovy James C.
Robinson Nancy A.
Fay Sharpe Fagan Minnich & McKee LLP
McKane Elizabeth
Steris Inc.
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