Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Calorimeter
Reexamination Certificate
1998-02-05
2001-05-29
Jones, Deborah (Department: 1775)
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Calorimeter
C422S051000, C422S051000, C428S042300, C428S041800, C428S042100, C116S206000
Reexamination Certificate
active
06238623
ABSTRACT:
FIELD OF INVENTION
This invention relates to tracking systems for sterilization procedures and the like and components such as labels for use in such tracking systems.
BACKGROUND
There are many different types of sterilization procedures available to those who sterilize products. While steam sterilization remains a popular procedure for sterilizing objects, the sterilization art now has many different procedures that provide options for those interested in sterilizing objects. Hydrogen peroxide sterilization procedures offer one option. As used herein, vapor phase, liquid phase and plasma hydrogen peroxide sterilization procedures are all within the broad aegis of hydrogen peroxide sterilization procedures.
The sterilization art recently witnessed the introduction of plasma sterilizers. U.S. Pat. Nos. 4,643,876 and 4,756,882 are said to cover the Sterrad® Hydrogen Peroxide Plasma Sterilizers available from Advanced Sterilization Products of Irvine, Calif. U.S.A. (a division of Johnson and Johnson). U.S. Pat. No. 5,084,239 describes a peracetic acid plasma sterilizer. Peracetic acid plasma sterilizers are sold by AbTox of Mundelein, Ill. Other patents assigned to AbTox include U.S. Pat. Nos. 5,115,166; 5,376,332; 5,413,759; 5,413,760 and 5,472,664.
There is a problem associated with tracking goods treated by a Sterrad® Hydrogen Peroxide Plasma Sterilizer. While chemical indicators and chemical indicating tape are sold for use with Sterrad® sterilizers, there are believed to be no adhesive labels available for use with the Sterrad® sterilizers that include an indicating composition that is responsive to the sterilization process associated with the Sterrad sterilizer. Of course tracking systems for use with the Sterrad sterilizers would not include such adhesive labels.
Dry heat sterilization, formaldehyde, gamma irradiation, ethylene oxide procedures and the above described hydrogen peroxide sterilization procedures provide a daunting array of options for those who sterilize objects. Often a hospital will utilize several different types of sterilizers to address its needs.
The state of objects to be sterilized should be carefully managed and monitored at all times, especially prior to the use of such objects on patients. This holds true for any sterilization procedure. When a hospital utilizes several different types of sterilizers, it makes this problem even more complex.
There are many tracking systems that include steps taken even before the objects emerge from a sterilizer. U.S. Pat. No. 3,568,627 discloses a combined record card and sterilization indicator. The card and indicator are for use in a steam sterilizer.
European Patent Application No. 630 820 discloses a process and system for monitoring material flow during the preparation of sterile goods. That document describes data carriers that contain two sections with identical data sets. One section may be adhesively attached to a treatment protocol, while the other section may remain at the sterilized unit. Printable adhesive labels are also described that include a carrier layer that possesses a first adhesive coating and a data carrier layer that adheres to the carrier layer by means of a second adhesive coating. The adhesive strength of the second adhesive coating toward the carrier layer is said to be lower than the adhesive strength of the first adhesive coating to an adhesive accepting surface of a sterile goods container.
Vereinigte Papierwarenfabriken GmbH of Munich, Germany sells the Stericlin System Batch Documentation. Stericlin systems are available at least in Germany. A first Stericlin system includes a label for use with certain steam sterilization procedures. A second Stericlin system includes a label for use with certain ethylene oxide sterilization procedures. Codes for the objects to be sterilized are utilized. The Stericlin systems are limited as they do not include any labels for use in any sterilization procedures other than the particular steam and ethylene oxide procedures mentioned above. For example, the Stericlin systems do not include any labels with an indicating ink that is suitable for use in a hydrogen peroxide sterilization procedure. The use of an existing Stericlin label in a tracking system for a hydrogen peroxide sterilizer can be misleading or confusing.
The Stericlin systems include an elongate label that has an adhesive coated major left portion and an adhesive coated minor right portion. The left portion is separate from the right portion by virtue of a cut. The left and right portion are located on a liner that includes a single incision extending perpendicular to the direction of elongation of the labels at the middle of the major left portion. As discussed in greater detail below, the right portion of the liner is associated with the entire right portion of the label and about one half of the left portion of the label.
The Stericlin labels for the steam and ethylene oxide procedures also suffer drawbacks. Only the left portions of the labels include an ink that changes color upon exposure to a sterilization procedure. The left portion of the Stericlin label for use in steam sterilization procedures includes a strip of ink which is brown upon exposure to the sterilization procedure. The right portion is free of any indicating ink. The left portion of the Stericlin label for use in ethylene oxide sterilization procedures includes a strip of ink which is yellow upon exposure to the ethylene oxide sterilization procedure. The right portion is free of any indicating ink.
The left portions of the labels are initially placed on the sterile goods packaging with about one half of its adhesive. This is accomplished by leaving one half of the liner on the adhesive of the left portion. A problem exists when the labels are used with sterile goods packaging made of crepe sheet paper. When the labels are used with goods packaging made of crepe sheet paper, the left portion is placed on an opening flap formed through a fold because, during the vacuum portion of the sterilization procedure, the label can become detached from the surface of the package. The Stericlin system even suggests that additional tape could be used to secure the label in an effort to address this problem. The left portions of the labels are thereafter removed from the sterilized goods packaging, the remaining portion of the liner is removed, and the left portions are thereafter placed on patient's files using the other half of their adhesives. This can lead to several problems such as damage to the goods packaging, and partial separation or “flagging” on the patient's file.
The right portions of the labels are placed on batch cards. Because the right portions do not include indicating ink, the information provided by the indicating ink is not available on the batch card.
German Utility Model (Gebrauchsmuster) No. G 90 04 818.0 (assigned to Vereinigte Papierwarenfabriken GmbH) discloses a label for sterile packaging. The label includes a major left portion and a minor right portion separated by a cut. The left portion may have an indicating ink. Indicating inks for water vapor sterilization, ethylene oxide gas sterilization and formaldehyde sterilization are mentioned. The minor right portion of the label is free of any indicating ink. A two part liner is disclosed. The first part covers about one-half of the major left portion, the second part covers the rest of the major left portion and all of the right portion.
SUMMARY OF THE INVENTION
The present invention provides a label for use in a sterilization tracking system. The label securely adheres to the packaging of the goods to be sterilized even during sterilization procedures which utilize a vacuum. The label affords the user complete freedom to mark, stamp or print on the label. A code for the objects to be sterilized is entirely optional and not necessary.
The present invention includes a label preferably comprising first and second portions. Preferably, the second portion is easily, manually separable from the first portion. The first and second portion
Amhof Anita
Ignacio Ramon T.
Jauslin Urs
Stoop Christian
Weinig Florian
3M Innovative Properties Company
Burtis John A.
Jones Deborah
McNeil Jennifer
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