WO2012048324A2

WO2012048324A2 - Standard-compliant label, method of providing a standard-compliant label, and standard -compliant label printer

Info

Publication number: WO2012048324A2
Application number: PCT/US2011/055631
Authority: WO
Inventors: Lawrence Srnka; Peter Botten
Original assignee: Codonics Inc
Current assignee: Codonics Inc
Priority date: 2010-10-08
Filing date: 2011-10-10
Publication date: 2012-04-12
Anticipated expiration: 2013-04-08
Also published as: CN203759721U; WO2012048324A3; JP2014500806A

Abstract

Provided is a label generated on-demand for identifying a medicinal substance to be administered to a patient, and a printing apparatus for generating such a label. The label includes a content surface on which label content is printed on-demand by a computer printer. The label content includes information required by a medical labeling standard. An adhesive surface is provided to be applied against a container for storing the medicinal substance and adhering the label to the container. A color code is visible when viewing the content surface. The color code is specified by the medical labeling standard for conveying information about the medicinal substance to be stored in the container, and the label content and color code render the label compliant with the medical labeling standard.

Description

STANDARD-COMPLIANT LABEL, METHOD OF PROVIDING A STANDARD- COMPLIANT LABEL, AND STANDARD-COMPLIANT LABEL PRINTER

BACKGROUND OF THE INVENTION

[0001] This application claims priority from U.S. application serial no.

12/901,110 and U.S. application serial no. 12/901,088, both of which were filed on October 8, 2010, and are incorporated herein by reference in their entirety.

1. Field of the Invention

[0002] This application relates generally to a standard-compliant label and, more specifically, to a method of providing a label on-demand that is compliant with a medical labeling standard.

2. Description of Related Art

[0003] Conventional labeling systems suffer from many drawbacks, and have limited reliability due primarily to human error. Sloppy handwriting can make the label difficult to read, or altogether illegible. Each technician who prepares such a label may also do so in a different manner, or attribute different meanings to the content of a label than another technician. In such situations, the label content is left open to interpretation, and often lacks information essential for proper documentation and record keeping purposes.

[0004] Also, in sterile environments the technicians involved in preparing a syringe and corresponding label may also be wearing sterile medical garments. It is desirable to minimize contact with objects that may not be sterile, but the conventional labeling methods require the technician to physically interact with the labels, pen and their respective packages.

[0005] Sterile environments are common in the medical field for treating patients with minimal risk of infection. To avoid exposing patients in such environments to infectious organisms medical personnel working therein are required to take precautionary measures. All personnel are required to wash thoroughly before entering the environment, and wear items of clothing such as surgical scrubs that have been decontaminated.

[0006] Other objects such as medical equipment can also be contaminated with infectious organisms and such organisms into sterile environments. Bedding, medical devices, and virtually all other objects brought into a sterile environment must undergo sterilization procedures to minimize the risk of infection to patients. Labels for identifying medications, personal possessions, tissue samples, or any other object within a sterile environment are among the other objects that also undergo a sterilization procedure.

[0007] Traditionally, each label has been sterilized by the manufacturer before being sealed within an individual wrapper before the wrapped labels were distributed to users. Likewise, pens used for hand writing label content on sterile labels have also been sterilized by the manufacturers and sealed in individual wrappers to be distributed to users in the medical field. In use, a wrapped label would be retrieved from a bin of such labels along with a wrapped pen. Both the label and the pen were opened by the user within or near the sterile environment, and the label content applied to the sterile label with the sterile pen. However, this traditional method and system for providing sterile labels in the medical field is prone to errors due to illegible handwriting.

BRIEF SUMMARY

[0008] Accordingly, there is a need in the art for a label that is compliant with a medical labeling standard, and a method of providing such a label on demand. There is also a need in the art for an apparatus for generating a machine -printed, substantially- sterile label on demand for use in medical applications.

[0009] According to one aspect, the subject application involves a method of providing a label for a medicinal or other substance in the medical field. The method includes receiving an identification of the medicinal substance entered via a computer- input peripheral. Based on the identification of the medicinal substance received, selecting at least one requirement mandated by a labeling standard such as a color code associated with the medicinal substance, a font to be used for label content, any other requirement of the labeling standard, or any combination thereof. And, with a computer printer, printing label content on demand, the label content optionally comprising at least one of a name of the medicinal substance on a label stock and a color code to produce a color-coded label for the medicinal substance, said label being compliant with a labeling standard governing at least one aspect of a label employed in a medical application.

[0010] According to another aspect, the subject application involves a computer terminal for generating a label for identifying a medicinal substance to be administered to a patient. The computer terminal includes a processor; a computer-input peripheral for entry of an identification of the medicinal substance; a printer for printing label content on the label; and a non-transitory computer-readable medium storing computer-executable instructions that, when executed, control the terminal in performing a method. The method includes receiving the identification of the medicinal substance entered via the computer-input peripheral. Based on the identification of the medicinal substance received, a color code for the medicinal substance is selected in compliance with a medicinal substance labeling standard. With the printer, label content that is required by the medicinal substance labeling standard is printed. The label content includes at least a name of the medicinal substance on label stock to produce a color- coded label for the medicinal substance, said color-coded label being compliant with the medicinal substance labeling standard.

[0011] According to another aspect, the subject application involves a healthcare facility that includes a substantially sterile environment in which a medical procedure is to be performed on a patient. A computer terminal is provided for generating a label for a medicinal substance to be administered to the patient, or for labeling any other object or substance involved in a medical application. The terminal includes a processor, a computer-input peripheral for entry of an identification of the medicinal substance, a printer for printing label content on the label, and a non-transitory computer-readable medium storing computer-executable instructions that, when executed, control the terminal in performing a method. The method includes receiving the identification of the medicinal substance entered via the computer-input peripheral. Based on the identification of the medicinal substance received, a color code for the medicinal substance is selected in compliance with a medicinal substance labeling standard. With the printer, label content that is required by the medicinal substance labeling standard is printed. The label content includes at least a name of the medicinal substance on label stock to produce a color-coded label for the medicinal substance. The color-coded label is compliant with the medicinal substance labeling standard.

[0012] According to another aspect, the subject application involves a label generated on-demand for identifying a medicinal substance to be administered to a patient. The label includes a content surface on which label content is printed on-demand by a computer printer. The label content includes information required by a medical labeling standard. An adhesive surface is provided to be applied against a container for storing the medicinal substance and adhering the label to the container. A color code is visible when viewing the content surface. The color code is specified by the medical labeling standard for conveying information about the medicinal substance to be stored in the container, and the label content and color code render the label compliant with the medical labeling standard.

[0013] According to another aspect, the subject application involves a method of generating a label for use in a medical application. The method includes receiving label content specified by a user that is to be applied to a surface of the label. The label content comprising a machine-generated character is printed, on demand, onto the label, and the label bearing the label content is dispensed in a substantially-sterile condition for use in the medical application.

[0014] According to another aspect, the subject application involves a printer for generating a label for use in a medical application. The printer includes a label feeder that supplies labels on which label content is to be printed, and a print head that applies the label content comprising a machine-generated character to the label on demand. A dispenser that dispenses the label bearing the label content in a substantially-sterile condition for use in the medical application is also provided. [0015] According to another aspect, the subject application involves a printer accessory that is to cooperate with a printer for producing labels for use in a medical application. The printer accessory includes a receiver for receiving the label with label content printed, on demand and at a facility where the label is to be used in the medical application, and dispensed by the printer. The label content includes machine-generated characters. A packager that introduces the label with the label content to a package that is to at least partially enclose the label and dispenses the label in a substantially-sterile condition suitable for use in the medical application is also provided.

[0016] The above summary presents a simplified summary in order to provide a basic understanding of some aspects of the systems and/or methods discussed herein. This summary is not an extensive overview of the systems and/or methods discussed herein. It is not intended to identify key/critical elements or to delineate the scope of such systems and/or methods. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The invention may take physical form in certain parts and arrangement of parts, embodiments of which will be described in detail in this specification and illustrated in the accompanying drawings which form a part hereof and wherein:

[0018] FIG. 1 shows an illustrative embodiment of a computer terminal for producing, on demand, a label that is compliant with a medical labeling standard and in a substantially-sterile condition;

[0019] FIG. 2 shows a block diagram illustrating components of the computer terminal shown in FIG. 1;

[0020] FIG. 3 shows an illustrative embodiment of a label that complies with a medical labeling standard;

[0021] FIG. 4 shows an illustrative embodiment of a syringe provided with a label that is compliant with a medicinal labeling standard; [0022] FIG. 5 shows a flow diagram schematically depicting an embodiment of a method of producing a label that complies with a medicinal labeling standard;

[0023] FIG. 6 shows a block diagram illustrating components of a computer terminal for producing labels in a substantially-sterile condition according to an alternate embodiment;

[0024] FIG. 7 shows an illustrative embodiment of a dispenser provided to a printer for dispensing labels in a substantially-sterile condition; and

[0025] FIG. 8 shows another illustrative embodiment of a dispenser provided to a printer for dispensing labels in a substantially-sterile condition.

DETAILED DESCRIPTION

[0026] Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. Relative language used herein is best understood with reference to the drawings, in which like numerals are used to identify like or similar items. Further, in the drawings, certain features may be shown in somewhat schematic form.

[0027] It is also to be noted that the phrase "at least one of, if used herein, followed by a plurality of members herein means one of the members, or a combination of more than one of the members. For example, the phrase "at least one of a first widget and a second widget" means in the present application: the first widget, the second widget, or the first widget and the second widget. Likewise, "at least one of a first widget, a second widget and a third widget" means in the present application: the first widget, the second widget, the third widget, the first widget and the second widget, the first widget and the third widget, the second widget and the third widget, or the first widget and the second widget and the third widget.

[0028] As shown in FIG. 1, the computer terminal 10 includes a touch-screen display 14 pivotally attached to the a cabinet 20 that displays a virtual label 16 to be printed as the label 12, and displays soft keys that can be touched by a technician or any user to input data and commands into the computer terminal 10. The virtual label 16 is a computer-generated rendering of the label 12 that offers the user visual confirmation of the appearance of the physical label 12 to be printed by a printer 26. A computer-input peripheral such as a contactless scanner 18 can be provided at a convenient location such as integrally formed as part of the display 14, adjacent a bottom portion of the display 14 to read a machine -readable code. Integrating the scanner 18 into the monitor 14 allows for efficient use of space. For example, the computer-input peripheral can be a barcode reader or radio-frequency identification ("RFID") tag reader, or any other device that reads a machine -readable code such as a barcode or RFID code, respectively, or any other machine-readable code, with or without requiring contact between the computer terminal and the code, and optionally without requiring additional input from the user during entry of the code. Alternate embodiments can include a scanner 18 that can not only read the machine-readable code, but also transmit data to programmable embodiments of the code such as a RFID tag. According to yet alternate embodiments, the display 14 can be utilized by a user as the computer-input peripheral. For such embodiments, the soft keys displayed by the display 14 can be selected to input information such as a medicinal substance being prepared to be administered to a patient or other information to be utilized in generating the label as described herein.

[0029] FIG. 1 shows an illustrative embodiment of a computer terminal 10 for generating a label 12 for identifying a medicinal substance to be administered to a patient, a tissue sample, a medical device, a solvent, or any other material encountered in a medical application. The medical application can be considered any activity, object or substance relating to, or otherwise involved in the provision of medical treatment, healthcare, and the performance of any activity in the life sciences. However, for the sake of brevity, the labeling of a medicinal substance is described in the examples below. The invention is not limited to the labeling of a medicinal substance according to a medicinal substance labeling standard, but encompasses the labeling of any material encountered in the medical field according to a standard observed in the medical field governing the labeling of that material.

[0030] As shown in FIG. 1, the computer terminal 10 includes a touch-screen display 14 that is pivotally coupled to a cabinet 20 and displays a virtual label 16 to be printed as the label 12, and displays soft keys that can be touched by a technician or any user to input data and commands into the computer terminal 10. The pivotal coupling allows the display 14 to be pivoted between upward and downward orientations relative to the cabinet 20, making the display 14 readable by users of various different heights. Further, the pivotal nature of the display 14 provides great flexibility in the height at which the computer terminal 10 can be positioned for use. The virtual label 16 is a computer-generated rendering of the label 12 that offers the user visual confirmation of the appearance of the physical label 12 to be printed by a printer 26. A computer-input peripheral such as a contactless scanner 18 can be provided at a convenient location such as integrally formed in a bottom portion of the display 14 to read a machine -readable code supported beneath the scanner 18. Integrally forming the scanner 18 as part of the display 14 provides for space savings over an arrangement where the scanner 18 is formed as a separate peripheral, which can be repositioned relative to the display 14. However, other embodiments can allow for a separate and distinct scanner 18 and/or display 14. For example, the computer-input peripheral can be a barcode reader or radio- frequency identification ("RFID") tag reader, or any other device that reads a machine- readable code such as a barcode or RFID code, respectively, or any other machine- readable code without requiring contact between the computer terminal and the code, and optionally the user during entry of the code. According to alternate embodiments, the display 14 can be utilized by a user as the computer-input peripheral. For such embodiments, the soft keys displayed by the display 14 can be selected to input information such as a medicinal substance being prepared to be administered to a patient or other information to be utilized in generating the label as described herein.

[0031] The computer terminal 10 also includes the cabinet 20 housing components that are operable to produce the label 12 in compliance with a medical labeling standard. But again, if what is being labeled is anything other than the medicinal substance, then the label 12 produced is to be compliant with a standard developed by a trade or professional organization, governing body, government agency, a healthcare provider or facility such as a hospital, or any other standards body setting forth policies for labeling such material. The cabinet 20 can also pivotally support the display 14 with the integrated scanner 18 to form a self-contained, stand-alone unit. The internal components housed within the cabinet 20 are schematically illustrated by the block diagram of FIG. 2. A computer processor 22 is provided to execute computer-executable instructions stored in a non-transitory computer readable memory 24 such as a hard disk drive, read-only memory ("ROM"), random access memory ("RAM"), optical disc, or any other suitable memory device. The computer-executed instructions, when executed by the computer processor 22, result in the performance of the method of generating a label for a medicinal substance described in detail below. A bus system 28 facilitates communication between components such as the display 14, scanner 18, processor 22, memory 24 and printer 26.

[0032] The printer 26, like the scanner 18, can be integrally formed as part of the stand-alone configuration of the computer terminal 10, meaning all components necessary for operation are packaged together as part of a common enclosure. The printer 26 includes a print head 30 enclosed within the cabinet 20 for applying label content onto label stock delivered from a supply 32 of labels, which can be blank, or at least in partial compliance with a medical labeling standard. The print head 30 can fall within any category of printing technology suitable to apply label content onto label stock. For example, the print head 30 can be an inkjet print head that deposits droplets of ink in a pattern to create the label content, a laser print head that directs a laser across a photoreceptor to create the pattern for the label content to be printed, a solid-ink print head, a dot matrix print head, and the like.

[0033] The label supply 32 can include a roll of label stock that has blank labels supported on a release tape, a tray of individual blank labels, or any other source of labels on which label content is to be printed. The label supply 32 can be internally disposed within the printer 26 or fed into the printer from an external location.

[0034] The computer terminal 10 can optionally be deployed at a healthcare facility such as a hospital or surgical center, for example, where medicinal substances are prepared and administered to patients. An operating room, treatment room, or other facility including a sterile field that is a substantially-sterile environment can optionally be provided within the healthcare facility, and the computer terminal 10 disposed within, or immediately adjacent to such a sterile environment. According to such embodiments, the label can be generated as described in detail below within, or at least within a close proximity to the sterile environment, and applied to the syringe, vial or other container in which the medicinal substance is to be contained with minimal exposure to other environments that are not sterile.

[0035] FIG. 3 shows an illustrative embodiment of a label 12 to be generated by the computer terminal 10. The label 12, as shown, includes label content that is compliant with, and renders the label 12 compliant with a medical substance labeling standard. For example, the medicinal substance labeling standard can be the guidelines promulgated by the National Safety Patient Goals of the Joint Commission, the American Society of Anesthesiologists, any other medicinal labeling standard established by a professional governing or trade organization or a governmental organization, or any combination thereof. Such guidelines can be based on other medicinal substance labeling standards such as those created by ASTM International, for example. The medicinal substance labeling standards can also require specific sizes, colors and patterns, type faces and other label content used on labels applied to unlabeled syringes that are filled by the users (i.e., those who will administer the medicinal substance to the patient) or their agents to identify the medicinal substance. Such standards are typically not intended to govern the requirements of labels applied by the drug manufacturer.

[0036] The label content required to render the label 12 compliant with a labeling standard created to govern the labeling of any material in the medical field can be specific to the particular standard against which compliance is to be measured. For instance, depending on the medicinal substance labeling standard, the label content can include one, a plurality, or all of the following:

[0037] a concentration of a medicinal substance to be identified by the label

12,

[0038] a dilution of a medicinal substance and a diluent used to dilute the medicinal substance;

[0039] a date and/or time on which the medicinal or other substance in the medical field to be labeled was prepared [0040] an expiration date and/or time of the medicinal or other substance to be labeled;

[0041] an identification of an individual who prepared the medical substance to be labeled;

[0042] a warning about a risk associated with the medicinal substance; and

[0043] a color to be applied to the label 12 as required by the medicinal substance labeling standard for the particular medicinal substance to be labeled.

[0044] For the illustrative embodiment of the label 12 shown in FIG. 3, the label content 36 is applied by the printer 26 to a content surface 34 of the label 12 that is exposed and viewable when the label 12 is applied to the syringe or other container. An adhesive surface (opposite the content surface 34) can also be provided to be applied against a syringe or other container for storing the medicinal substance and adhere the label 12 to such syringe or other container. The label content is printed on-demand by the computer printer 26 under the control of the users who are involved in preparing the syringe or other container with the medical substance, administering the medicinal substance to the patient, or their agents. By "on demand" it is meant that the label is caused to be generated by the aforementioned users, as opposed to a drug manufacturer, at a time when the syringe or other container is being prepared with the medicinal substance to be labeled, or shortly before or after preparation of the syringe or other container with the medicinal substance to be labeled.

[0045] The illustrative embodiment of the label 12 in FIG. 3 is compliant with a medicinal substance labeling standard requiring the name 38 of the medicinal substance, which is Propofol in the present embodiment, along with a concentration 40 of the medicinal substance, which is 10 mg/mL. The name of the medicinal substance can be printed using so-called "tall man lettering" to help emphasize the difference between different medicinal substances with similar spellings. Tall man lettering requires printing a distinguishing portion of the name in all caps, and the remainder of the name in common with the distinguished medicinal substance in lower case letters. The label content 36 on the label 12 also includes the identity 42 of the person who prepared the label 12 and/or the syringe of the medicinal substance, along with the date and time 44 the syringe of the medicinal substance was prepared, and the expiration date and time 46 of that syringe of the medicinal substance.

[0046] The label 12 also includes a color code that is visible when viewing the content surface 34 of the label 12. For the illustrative embodiment in FIG. 3, the color code appears as a solid colored background 48 to printed text such as the name 38, concentration 40, identity 42 of the preparer, and preparation and expiration dates and times 44, 46. The color code is specified in this example by the medicinal substance labeling standard. For example, induction agents such as thiopental and ketamine are identified by a solid yellow color code. Tranquilizers such as diazepam and midazolam are identified by a solid orange color background. Narcotics such as morphine and fentanyl are identified by a solid blue color background. Antagonist medicinal substances are denoted by diagonal stripes of the agonist color alternating with white stripes.

[0047] The color code can optionally be printed onto the content surface 34 as label content 36 by the printer 26. According to alternate embodiments, the color code is pre-applied to the label 12 to be visible when viewing the content surface 34 by a manufacturer of the label stock before the label 12 is introduced to the printer 26. For such alternate embodiments, the appropriate pre-color-coded label stock is selected from among available label stock that is pre-color coded with a plurality of different colors. Each of the different colors corresponds to a different medicinal substance in accordance with the medicinal substance labeling standard. Thus, several rolls of different colored label stock may be available, and the appropriate roll having the color code

corresponding to the medicinal substance to be labeled can be selected.

[0048] A machine -readable code 50 can also optionally be printed by the printer 26 as label content 36 on the label 12. The machine-readable code can be a barcode, RFID code, or other suitable code that is indicative of the medicinal substance being labeled. For instance, the machine-readable code 50 can represent the other label content 36, and optionally the color code, for integrating the labeling of the syringe or other container with an Anesthesiology Information Management System ("AIMS") or other hospital information system. [0049] FIG. 4 shows an illustrative embodiment of a syringe 52 storing a medicinal substance that is labeled with a label 12 generated according to the method described herein. As shown, the label 12 bearing the machine -readable code 50 can be applied to the syringe 52 and, before administration of the medicinal substance, the machine-readable code 50 can be scanned by scanner 18 (FIG. 1) provided to the computer terminal 10. The computer terminal 10 can optionally display the virtual label 16, and optionally audibly announce the medicinal substance identified by the label 12 for confirmation purposes.

[0050] A method of providing a label for a medicinal substance is illustrated schematically in FIG. 5. The method includes receiving, at step 100, an identification of the medicinal substance entered via a computer-input peripheral such as the display 14, scanner 18, or a combination thereof. According to one embodiment, a vial from which the medicinal substance is to be extracted into a syringe 52 is also labeled with a barcode or other machine -readable code identifying the medicinal substance. That barcode can be scanned by the scanner 18 to automatically input into the computer terminal 10 information such as the name of the medicinal substance, concentration and preparation and expiration dates to be included in the label content 36. A machine-readable code on a badge worn by the user preparing the label and/or syringe can also be scanned by scanner 18 to input the identity of the person who is to appear as the preparer on the label 12.

[0051] Based on at least one of the identification of the medicinal substance received, a medical field in which the material is to be used, and an application of the material in the medical field, a color code for the medicinal substance is selected in compliance with a medicinal substance labeling standard and the label content, optionally including the color code, is printed in compliance with the medicinal substance labeling standard at step 110. For instance, Propofol is an induction agent, so the yellow color code can be selected according to one labeling standard. A lookup table storing relationships between the color code, text font, label size, and the various medicinal substances can be stored in the non-transitory computer-readable memory provided to the computer terminal 10. [0052] In response to selection of the color code and/or receiving the identification of the material to be labeled, the printing on demand at step 110 can optionally occur automatically without operator intervention, with a computer printer. The label content can optionally comprise at least the name 38 (FIG. 3) of the medicinal substance on the content surface 34 of label stock to produce a color-coded label 12 for the medicinal substance that is compliant with the medicinal substance labeling standard.

[0053] Another embodiment of the computer terminal 10 provided with a printer 26 for printing sterile labels suitable for use in sterile conditions is illustrated in FIGs. 6-8. The printer 26 includes a print head 30 for applying label content comprising at least one machine-generated character to the label 12, on demand, delivered to the print head 30 by a feeder 32 of label stock. The print head 30 can fall within any category of printing technology suitable to apply label content onto label stock. For example, the print head 30 can be an inkjet print head that deposits droplets of ink in a pattern to create the label content, a thermal print head that applies label content through application of a thermal printing process, a laser print head that directs a laser across a photoreceptor to create the pattern for the label content to be printed, a solid-ink print head, a dot matrix print head, and the like.

[0054] The feeder 32 can be adapted to support a roll of label stock that has base labels supported on a release tape, can include a tray for storing a supply of individual base labels, or any other source of labels on which label content is to be printed. The feeder 32 can be internally disposed within the printer 26 or located at an external location relative to the printer 26 from where it can feed base labels into the printer 26.

[0055] The computer terminal 10 can be deployed at a healthcare facility such as a hospital or surgical center, or anywhere a substantially- sterile label 12 is desired to minimize the risk of infection to a living organism, for example. An operating room, treatment room, or other substantially-sterile environment such can optionally be provided within the healthcare facility, and the printer 26 disposed within, or immediately adjacent to such a substantially- sterile environment. According to such embodiments, the label 12 can optionally be generated as described in detail below within, or at least within a close proximity to the substantially-sterile environment, or elsewhere the same facility where the label 12 is to be used.

[0056] For the illustrative embodiment of the label 12 shown in FIG. 1, the label content is applied by the printer 26 on a content surface 34 of the label 12 that is exposed and viewable by observers when the label 12 is applied to a syringe or other container storing the medicinal substance. An adhesive surface (opposite the content surface 34) can also be provided to be applied against a syringe, other container or any other object to adhere the label 12 to such objects.

[0057] The label content can include any identifying or other desired information about the object to be labeled, and is printed on-demand by the computer printer 26 under the control of one or more users who are involved in labeling the medicinal substance or other object in the medical field, or their agents. By "on demand" it is meant that the label is caused to be generated by the aforementioned users at a moment when the label 12 is desired. That moment can be when the label 12 is to be used for labeling purposes, such as when the label 12 is desired to be placed on a syringe storing a medicinal substance or while the syringe is being prepared, for example, or as needed at any other time prior to use of the label in the sterile environment. According to an alternate embodiment, the label 12 can be printed at a time when the syringe or other container is being prepared with the medicinal substance to be labeled, or shortly before or after preparation of the syringe or other container with the medicinal substance to be labeled.

[0058] The embodiment of the printer 26 in FIG. 6 also includes a dispenser 136 that dispenses the label 12 bearing label content in a substantially-sterile condition for use in the medical application. For a label 12 to be in a substantially-sterile condition, at least one of the following mush occur: a portion, and optionally the entire label 12 must have undergone a sterilization procedure; a portion, or optionally all of a package 138 (FIGs. 3 and 4) that is to least partially enclose the label 12 must have undergone a sterilization procedure; or a combination thereof. For example, the content surface 34 or other portion of the label 12 can be exposed to a sterilizing agent that can kill a substantial portion of any living organisms on the content surface 34. Examples of suitable sterilizing agents include, but are not limited to UV light, liquid or dry chemical disinfectants, steam, radiation, etc... The sterilization procedure can optionally be performed by the dispenser 136 provided to the printer 26, or by another party such as a manufacturer of label stock before the label stock is provided to the feeder 32 of the printer.

[0059] An embodiment of a dispenser 136 is shown schematically in FIG. 7. As shown, the dispenser is provided to a printer 26 as an after-market peripheral, connected to receive labels 12 bearing label content printed by an inkjet print head 30. The labels 12 are received by the dispenser 136 through a receiver 40, which in the embodiment shown in FIG. 7 is an aperture through which the labels 12 enter the dispenser 136. Other embodiments can optionally include a dispenser 136 integrally formed as a portion of the printer 26, within the cabinet 20.

[0060] Once the labels 12 have had the label content printed thereon and have been received by the dispenser 136, those labels 12 are introduced to a sterilizer 142, which exposes at least the content surface 34 of the labels 12 to a sterilizing agent. In the embodiment shown in FIG. 7, the sterilizing agent is UV light 144 emitted from an UV illumination source 146. Further, according to the present embodiment a plurality of UV illumination sources 146 are provided on opposite sides of the labels 12 being subjected to the sterilization procedure. Such an arrangement allows for substantial sterilization of opposite sides of the label 12.

[0061] From the sterilizer 142 the labels 12 are subsequently introduced to a packager 148, identified by broken lines. The packager 148 introduces the labels 12 to a package material that at least partially encloses the labels 12. According to the embodiment illustrated in FIG. 7, the packager 148 includes two rolls 150 of a non-sterile plastic film 152. Of course materials other than plastic can be used for the film 152, which can also be supplied in forms other than rolls 150. A segment of the film 152 is placed over the content surface 34 of the labels 12 and another segment of film from the other roll 150 under the opposite planar surface of the label 12 relative to the segment passing over the label 12. The film 152 can be subjected to the sterilizing procedure, or can be formed from a material that is not subjected to a sterilizing procedure and, thus, is in a substantially-sterilized condition. For example, the inward-facing surface of each film 152 that is to face the label 12 when formed into the package 138 is exposed to the UV light 144 from the UV illumination source 146. For embodiments where the films 152 are substantially (or at least partially) transparent, this UV light 144 can optionally be transmitted through the films 152 to also substantially sterilize the other outward-facing major surface of one or both films 152. Yet other embodiments of the dispenser 136 can include one or a plurality of additional UV illumination sources (instead of, or in addition to the UV illumination sources 146) disposed adjacent to the outward-facing surface of one or both films 152 to expose those outward-facing surfaces to the UV light 144 to substantially sterilize those outward facing surfaces. The outward-facing surface of each film 152 faces away from the label 12 when formed into the package 138.

[0062] A pair of adjustable heat stakes 154, or any other suitable device for coupling the film 152 from the different rolls 150 together, is used to seal the package 138 formed by the films 152 at opposite ends of the label 12. For the example shown in FIG. 7, the heat stakes 154 are brought together to pinch the films together at the pinch point 158. At least the pinching ends of one or both of the stakes that contact the films 152 is heated to a suitable elevated temperature to melt the films 152 together at the pinch point 158. The location where the films 152 are being joined together by the heat stakes 154 in FIG. 7 seals the package 138 enclosing the substantially-sterile label 12a being dispensed from the dispenser 136 and establishes the first seal of the package that is to at least partially enclose the next substantially-sterile label 12b. The heat and pressure from the heat stakes 154 can also optionally separate the substantially-sterile label 12a from the next substantially-sterile label 12b.

[0063] To apply the substantially-sterile label 12a to an object to be labeled, the user can retrieve the substantially-sterile label 12a being dispensed and peel the segments of films 152 that collectively form the package 138 away from each other. A release liner against which the adhesive surface of the substantially-sterile label 12a is applied can be removed and the substantially-sterile label 12a adhered to the object to be labeled. [0064] In use, the printer 26 receives label content specified by a user. The user can specify the label content by keying the label content into the computer 10 using a keyboard or soft keys presented on the display 14, scanning a machine -readable code using the scanner 18, or in any other manner. Upon receiving the label content, the printer 26 can, on demand, and optionally automatically without user intervention in response to receiving the label content, print the label content on the label 12.

[0065] Between packaging the label 12 and printing the label content, the label 12, or at least a portion thereof, is exposed to the UV light 144 to place the label 12 in a substantially-sterile condition. Following exposure to the UV light 144 the label 12 is packaged between the plastic films 152, one from each roller 150. The heat stakes 154 come together and are heated, thereby completing the enclosure of the label 12 and separating the label 12 from others being dispensed.

[0066] Another illustrative embodiment of a dispenser 66 is schematically illustrated in FIG. 8. Like the embodiment shown in FIG. 7, the present embodiment includes a receiver 62 in the form of an aperture through which labels 12 with label content already printed thereon by the print head 30 can enter the dispenser 66.

[0067] Also similar to the embodiment shown in FIG. 7, the present embodiment also includes a packager 64 comprising two rolls 56a, 56b of material that collectively form a package 68 around the labels 12 to be dispensed from the dispenser 66. Unlike the previous embodiment shown in FIG. 8, however, at least one of the rolls 56a, 56b of material is in a substantially-sterile condition, having been previously subjected to a sterilization procedure. Further, the dispenser 66 lacks a sterilizer such as that described with reference to FIG. 7. Instead, the labels 12 are laminated between laminating material 70 from roll 56a and a release layer 72 from roll 56b. The laminating material 70 can be adhesively coupled to the label 12 and or release layer 72, can be heat activated to bond with the release layer and/or label 12 when subjected to heat and pressure, or can be coupled to the release layer in any desired manner to enclose and seal substantially the entire label 12 between the laminating material 70 and release layer 72. Laminating nip rollers 74 can be provided to apply heat and/or pressure against the laminating material 70 and release layer 72 as necessary to seal the package 68 collectively formed thereby.

[0068] Labels 12 enclosed within the package are in the substantially-sterile condition because the unsterilized label 12 is substantially entirely, and optionally entirely enclosed by the package 68, which has been subjected to a sterilizing procedure by a manufacturer before being coupled to the printer 26. An optional cutting device 76 can be provided between the laminating nip rollers and the location where the labels 12 in the substantially- sterilized condition are dispensed from the dispenser 66. The cutter 76 is operable to separate the labels 12 from one another to be individually dispensed, each in their own individual package 68. Alternately, an optional cutter 78 can be provided between the print head 30 and the dispenser 66 such that individual labels 12 are received by the dispenser 66 rather than a continuous tape supporting a plurality of labels 12.

[0069] According to yet another embodiment, the label 12 on which the label content is to be printed has already been subjected to a sterilization procedure and enclosed within an individual package prior to the printing of the label content.

According to such embodiments, the label within the package is introduced to the print head 30, which can be a thermal print head, already packaged and in a substantially- sterile condition. A thermal printing operation is performed with the thermal print head to apply label content onto the label 12 while the label 12 is enclosed within the package. The resulting label bearing the thermally-printed label content and packaged in a substantially-sterile condition is then dispensed for use in the medical field.

[0070] Illustrative embodiments have been described, hereinabove. It will be apparent to those skilled in the art that the above devices and methods may incorporate changes and modifications without departing from the general scope of this invention. It is intended to include all such modifications and alterations within the scope of the present invention. Furthermore, to the extent that the term "includes" is used in either the detailed description or the claims, such term is intended to be inclusive in a manner similar to the term "comprising" as "comprising" is interpreted when employed as a transitional word in a claim.

Claims

CLAIMS What is claimed is:

1. A method of providing a label to be utilized in a medical application, the method comprising:

receiving an identification of a material to be labeled for use in the medical application;

based on the identification of the material to be labeled in the medical application received, printing label content to create the label in compliance with a labeling standard for use in the medical application;

2. The method of claim 1 , wherein the label content is printed by a computer printer and further comprises a color corresponding to a color code mandated by the labeling standard, the color to be printed on label stock approximately at a time when the label content is printed.

3. The method of claim 1, wherein the label content is to be printed on label stock that is pre-color-coded with a color mandated by the labeling standard before the label content is printed, and the label content is printed on the label stock that is pre- color-coded.

4. The method of claim 3, wherein the color code is selected for the material by selecting the pre-color-coded label stock from among available label stock that is pre- color coded with a plurality of different colors, wherein each of the different colors corresponds to a different medicinal substance in accordance with the labeling standard.

5. The method according to claim 1, wherein said receiving the identification of the material to be labeled comprises: reading, with a scanner, a computer-readable code associated with a supply of the material, wherein the computer-readable code comprises one or more of: an optical code, and a radio-frequency code.

6. The method of claim 1, wherein the material to be labeled is a medicinal substance, and the label content further comprises at least one of:

a concentration of the medicinal substance,

a dilution of the medicinal substance and a diluent used to dilute the medicinal substance;

a date on which the medicinal substance to be labeled was prepared

an expiration date of the medicinal substance to be labeled;

an identification of an individual who prepared the medical substance to be labeled; and

a warning about a risk associated with the medicinal substance.

7. The method of claim 1, wherein the material is a medicinal substance and the label content further comprises all of:

a concentration of the medicinal substance,

a date on which the medicinal substance to be labeled was prepared

an expiration date of the medicinal substance to be labeled; and

an identification of an individual who prepared the medical substance to be labeled.

8. The method of claim 1, wherein the labeling standard is a standard developed by at least one of a trade or professional organization, a healthcare provider, a governing body of the medical field, and a government agency.

9. The method of claim 1 further comprising:

applying a machine-readable code representing the material to be labeled on the label stock for entry of the material to be labeled into a database maintained for a healthcare provider when the machine-readable code is read.

10. The method of claim 1, wherein the label content is printed by a computer printer and occurs automatically at a time when said medicinal substance is being prepared for administration to a patient in response to receiving the identification.

11. A computer terminal for generating a label for identifying a material to be used in a medical application, the computer terminal comprising:

a processor;

a computer-input peripheral for entry of an identification of the material to be labeled;

a printer for printing label content on the label; and

a non-transitory computer-readable medium storing computer-executable instructions that, when executed, control the terminal in performing a method

comprising:

receiving an identification of the material to be labeled for use in the medical application;

based on the identification of the material to be labeled in the medical application that is received, printing label content to create the label in compliance with a labeling standard for use in the medical application.

12. The computer terminal of claim 11 , wherein the computer-input peripheral comprises a scanner for reading a machine-readable code in a contactless manner, said receiving the identification of the material comprising reading the machine-readable code associated with the material with the scanner.

13. The method of claim 11, wherein the label content further comprises a color corresponding to a color code mandated by the labeling standard, the color to be printed by the printer on label stock when label content is printed.

14. The method of claim 11, wherein the label content is to be printed on label stock that is pre-color-coded with a color mandated by the labeling standard before the label content is printed, and the label content is printed on the label stock that is pre- color-coded.

15. A healthcare facility comprising :

a substantially sterile environment in which a medical procedure is to be performed on a patient;

a computer terminal for generating a label for a material to be labeled for use in a medical application, the computer terminal comprising: a processor, a computer-input peripheral for entry of an identification of the material, a printer for printing label content on the label, and a non-transitory computer-readable medium storing computer- executable instructions that, when executed, control the computer terminal in performing a method comprising:

receiving an identification of the material to be labeled for use in the medical application; based on the identification of the material to be labeled in the medical application that is received, printing label content to create the label in compliance with a labeling standard for use in the medical application.

16. The healthcare facility of claim 15, wherein the computer terminal is disposed adjacent to, or within the sterile environment.

17. A label generated on-demand for identifying a material for use in a medical application, the label comprising:

a content surface on which label content is printed on-demand, wherein the label content comprises information required by a labeling standard;

an adhesive surface to be applied against the material or a container for storing the material and adhering the label to the material or the container; and

a color code visible when viewing the content surface, said color code being associated with the material to be labeled by the labeling standard for conveying information about the material, wherein the label content and color code render the label compliant with the labeling standard.

18. The label of claim 17, wherein the color code is a computer printed color that is printed onto the content surface by a printer during a process for printing the label content.

19. The label of claim 17, wherein the color code is applied to the label to be visible when viewing the content surface before the label content is printed.