This application is the United States national phase of International Application No. PCT/US2017/066507, filed Dec. 14, 2017, the content of which is incorporated by reference herein in its entirety.
The present invention relates to an interchangeable/removable labelling plate for marking/identifying sterile containers and/or instrument trays being removable stored or being storable within the sterile containers.
Today, most sterile containers are marked by a combination of barcode labels containing, for example, production data, and/or instrument data like the name of the set/content of the container, etc. and tags (RFID-tags/pucks) preferably made of an aluminium material. In general, at least the tags but in many cases also the labels (containing the barcode and/or alphanumeric information) are firmly fixed with the container, for example, in a window-like device at both ends or opposing side walls of the container. Furthermore, labels are also fixedly connected with the instrument trays being intended and adapted to be stored within the container having the identical label.
The tags may remain on/at the container during cleaning processes with mild alkaline detergents, wherein, however, cleaning processes with high-alkaline cleaning detergents would be more favourable. In the event of a cleaning process with high-alkaline cleaning detergents, however, the problem arises that current aluminium identification tags for performing identification generally do not allow a cleaning in washer-disinfectors using instrument cleaning programs because of missing compatibility with high-alkaline cleaning detergents. Accordingly, in order to solve this problem sterile containers can also be labelled with at least one barcode label (also containing alphanumeric information) only, which can optionally be removed from the container.
The labels used for marking/identifying sterile containers of this kind are generally printed with the relevant data on the clean section of a so-called “sterile processing department” (SPD) and are then glued on the sterile container. The labels can then be optionally removed, for example, in an operation room (OR) and, preferably glued into a patient's documentation. They also can remain on the container or get disposed later on.
In the event of using a sterile container with a firmly fixed identification tag the user on the clean section of the above-mentioned SPO has to wait for the right container to be processed with mild alkaline detergents until he can merge the corresponding instrument tray(s) being processed with high-alkaline cleaning detergents and containers after cleaning and disinfection. This merging process is quite complicate and error-prone.
In the event of using a sterile container with a removable identification tag both the specific sterile container (optionally having the barcode label fixed thereon) and the tag must be processed separately and be connected with each other again in a correct manner. Detachable barcode labels would allow for an individual identification of any container with the respective content, however, they are not linked with the respective set/tray of instruments during the cleaning process. Accordingly, the assignment of the already removed right label and information tag to the right instrument tray is also error-prone.
Finally, the sterile container must be prepared for holding tags and/or labels in a removable manner. This makes the production of such a sterile container complicate and expensive, especially in case that the sterile container shall be prepared to become individually labelled by different labels and/or tags.
It is an object of the present invention to provide a labelling system and labelling method for sterile containers achieving a higher flexibility especially prior to and after a cleaning process.
Accordingly, one gist of the invention can be seen in the provision of a separate (individual) labelling plate being adapted to be removable connected with a sterile container (and optionally with an instrument tray) wherein the separate labelling plate comprises interfaces (docking/connecting systems) for at least one (barcode) label and at least one (RFID) identification tag. The interfaces are preferably designed for removable holding the at least one tag and/or the at least one label at the separate labelling plate.
In other words, the present invention substantially refers to a labelling system comprising a labelling plate being adapted to be removable connected with a sterile container (using an uniform labelling plate connecting/catch mechanism) wherein the labelling plate comprises (a plurality of individual) interfaces for at least one (barcode) label and at least one (RFID) identification tag, wherein the interfaces on the labelling plate are designed for removable/detachable holding the at least one tag and/or the at least one label at the separate labelling plate.
By the provision of such a labelling plate, the sterile container can be manufactured with exclusively one single/uniform/standard interface for the (one) labelling plate, which contributes to keep the manufacturing costs low, wherein the separate labelling plate is equipped with a plurality of individual interfaces for the tag(s) and the label(s) which contributes to keep the flexibility in handling the sterile container high.
According to an optional aspect of the present invention the at least one interface of the labelling plate is/comprises a (retaining) clip or brace. The clip is advantageously designed like a paper-clip wherein the one clip leg is fixedly connected with the labelling plate and the other clip leg is elastically movable relative to a front side of the labelling plate to clamp, for example, a plate- or card-like label between the movable clip leg and the front side of the labelling plate.
According to another optional aspect of the present invention the at least one other interface of the labelling plate comprises at least one retaining hole or recess being adapted to (removable) receive an elastically deformable tag connection/catch mechanism, for example, in the form of a hook-like cone, engaging pawl or notch, which mechanism is formed/provided at the tag. Therefore, the tag can be pressed or clicked onto the front side of the labelling plate (parallel to the label) wherein the cone or cones are inserted into the hole(s) on the front side of the labelling plate thereby generating preferably a form fit.
According to another optional aspect of the present invention the labelling plate has an uniform plate connection/catch mechanism, for example in the form of elastically movable/deformable hooks, cones or borders which are adapted to get removable engaged with the single/uniform/standard plate interface, especially recesses or grooves, (uniformly) formed/provided at the sterile container to be marked. Alternatively thereto, an adapter element can be provided which is (individually) adapted to get fixed at a sterile container of known design, wherein the adapter element comprises the (uniform) plate interface (recesses/grooves) for the labelling plate.
Another gist of the invention can be seen in the provision of a sterile container comprising a basis pan/trough (lower shell) and a lid/cover (upper shell) which are connectable with each other to form a closed container compartment for accommodating instrument tray(s) therein.
According to the invention the sterile container, especially its basis pan/trough has an uniform plate interface, especially at least one or a plurality of recesses or grooves being adapted to removable receive the plate connection/catch mechanism, especially the hooks or borders of the labelling plate as defined above (such that the labelling plate can be temporarily connected to the tray by form fit).
Another gist of the invention can be seen in the provision of a sterile container set comprising the labelling plate and the sterile container as defined above.
According to an optional aspect of the present invention the sterile container set further comprises at least one instrument tray adapted to be accommodated within the container compartment, wherein the tray has an uniform plate interface, especially at least one or a plurality of recesses or grooves, wherein the plate interface of the tray is adapted to removable receive the plate connection/catch mechanism, especially the hooks or borders of the labelling plate as defined above such that the labelling plate can be temporarily connected to the tray (for example during a disinfection process).
Another gist of the invention can be seen in the provision of a labelling method for sterile containers especially in the event of disinfection processing cycles comprising the following method steps:
The present invention will be described in more detail below on the basis of a preferred embodiment by reference to the enclosed figures, according to which:
According to
In the preferred embodiment the lower shell 1a comprises a plate receiving interface 6 preferably in the form of two parallel distanced groove-like recesses 6a being pressed into a side wall of the lower shell 1a. Alternatively, instead of grooves also hole-like recesses could be formed. Besides, instead of or in addition to the lower shell 1a also the upper shell 1b could be formed with a plate receiving interface 6 of this kind.
In general, the plate receiving interface 6 is intended to have a standard or uniform shape at each sterile container 1 being manufactured in future. In case of already existing sterile containers an adapter element (not shown) could be provided which is connectable to the (existing) sterile container, for example by gluing or welding, and which has the (standard) receiving interface 6 on its free side.
As can be seen in
The labelling plate 8 comprises at least two interfaces 12, 14 at its (free) front side which are adapted to detachably hold at least one information tag 16 and at least one card-like label 18. As can be seen especially in
According to
It shall be pointed out here, that the labelling plate 8 may have more interfaces for additional information tags and/or labels which are just indicated in the front side of the labelling plate 8 by through holes as shown especially in
With the labelling system comprising the labelling plate 8 the information tag 16 and the label 18 as described above the interchangeable (front) labelling plate 8 for tags and (barcode) labels is used made from materials which are compatible with reprocessing methods in sterile processing like stainless steel, plastic like PEEK or PPSU, etc. (irrespective to the materials of the tag and/or the label). Accordingly the use of such a labelling system in processing cycles for disinfection is as follows (starting in the clean section of the SPD):
The above-described procedure allows at any time during the sterile processing cycle to identify the content of an instrument set inside and outside the container. At the clean section of the sterile processing department (SPD) any container of the right size can be used for merging with an instrument tray regardless its former content.
Different from using single use barcode labels the identification of the instrument tray during cleaning and disinfection is possible because the labelling plate holding the label can be connected at the instrument tray for the cleaning process.
The use of different additional tags on the labelling plate allows also the break-up of the content of the sterile container into different instrument trays for cleaning and disinfection.
Filing Document | Filing Date | Country | Kind |
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PCT/US2017/066507 | 12/14/2017 | WO |
Publishing Document | Publishing Date | Country | Kind |
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WO2019/117928 | 6/20/2019 | WO | A |
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Number | Date | Country | |
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20210077222 A1 | Mar 2021 | US |