STERILE MEDICATION IDENTIFICATION AND LABELING SYSTEM
20190125627 ยท 2019-05-02
Inventors
- Matthew S. MacFarlane (Geneva, IL, US)
- Shawn L. Adams (Chicago, IL, US)
- Joseph M. Patton (Westlake, OH, US)
Cpc classification
A61J2205/60
HUMAN NECESSITIES
B32B1/00
PERFORMING OPERATIONS; TRANSPORTING
A61J1/18
HUMAN NECESSITIES
A61L2202/181
HUMAN NECESSITIES
B65D75/545
PERFORMING OPERATIONS; TRANSPORTING
International classification
Abstract
Systems, methods, and apparatus for maintaining association of label information to an original medication container are disclosed herein. As such, transferring medication into a sterile field is facilitated with pre-printed and sterile labels for use once the medication has been dispensed into a sterile container within a sterile field. In one embodiment, a sterile label container includes at least one extension portion which is affixable to the exterior of a medication container. In another embodiment, RFID devices are employed and may be programmed with information relative to the medication.
Claims
1. An apparatus for maintaining association of label information to an original medication container, the apparatus comprising: a medication in a medication container having a sterile interior and a non-sterile exterior; the medication container being received in a second container; at least one sterile printed label containing information specific to the medication provided in a third container having a sterile interior and a non-sterile exterior; the third container being removably affixed to the exterior of the second container, facilitating association of the third container to the first container; whereby the medication in the medication container may be dispensed into another sterile container within a sterile field and one of the at least one sterile printed labels from the third container may be applied to the corresponding sterile container within the sterile field.
2. The apparatus as recited in claim 1 wherein said removable affixation of said third container to said second container is operative to associate the label information to the original medication.
3. The apparatus as recited in claim 1 wherein said second container comprises one of a bag, box, or membrane.
4. The apparatus as recited in claim 1 further comprising a tape member for securing an edge of the third container to the second container.
5. The apparatus as recited in claim 4 wherein said tape member includes perforations arranged in a line for facilitating tearing, said perforations aligned with an edge of the second container.
6. The apparatus as recited in claim 1 further comprising a plurality of sterile labels disposed in said third container.
7. The apparatus as recited in claim 6 wherein at least one of said plurality of sterile labels further comprises an RFID device.
8. The apparatus as recited in claim 1 wherein said second container is not hermetically sealed.
9. A method of maintaining association of label information with a medication or medical solution to be dispensed in a sterile field comprising: providing a medication or medical solution in a first container having a sterile interior and a non-sterile exterior; placing the first container within a second container; providing, in a third container having a sterile interior and a non-sterile exterior, at least one sterile printed label containing information specific to the medication or medical solution in the first container, the third container being adapted to dispense the at least one sterile printed label in a sterile state; and removably associating the third container to the second container.
10. The method of claim 9, further comprising masking a portion of the second container with a masking element; positioning the third container relative to the second container in position to form a product wherein at least some of the information contained on the label is blocked from view when the third container is removably associated to the second container; distributing the product to medical professionals for sterile dispensing of the medication or medical solution and sterile label as part of a medical procedure.
11. The method of claim 10, wherein the placing the first container within a second container includes a placing the first container in a bag, and closing the bag in a manner sufficient to retain the first container during handling.
12. The method of claim 11, wherein closing the bag includes non-hermetically closing the bag with an adhesive closure member across an opening of the bag.
13. The method of claim 11, wherein the closing the bag includes hermetically closing the bag with at least one of an adhesive, heat seal, perforated seal or tear-notch seal.
14. An apparatus for maintaining association of label information to an original medication container, the apparatus comprising: a medication container having a sterile interior and a non-sterile exterior; at least one sterile printed label containing the label information specific to the medication container, said at least one sterile printed label disposed in a sterile label container having a label retaining portion and at least one extension portion; the sterile label container being affixed to the exterior of the medication container via said at least one extension portion, whereby the medication within the medication container may be dispensed into a sterile container in the sterile field and one of the at least one sterile printed labels from the sterile label container may be applied to the sterile container in the sterile field.
15. The apparatus as recited in claim 14 wherein affixation of said sterile label container to the exterior of the medication container is operative to associated the label information with the medication container.
16. The apparatus as recited in claim 14 wherein said sterile label container comprises a first sheet with a peripheral edge and a second sheet with a peripheral edge, said first sheet peripheral edge being releasably bonded to said second peripheral edge.
17. The apparatus as recited in claim 14 wherein said sterile label container further includes a plurality of extension portions.
18. The apparatus as recited in claim 17 wherein each of said plurality of extension portions are independently affixed to the exterior of the medication container.
19. The apparatus as recited in claim 14 wherein said at least one extension portion is dimensioned and configured to be affixed to the exterior of the medication container without obscuring information disposed on the medication container.
20. The apparatus as recited in claim 14 wherein said at least one sterile printed label includes an RFID device.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] For a fuller understanding of the nature of the present invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which:
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[0055] Like reference numerals refer to like parts throughout the several views of the drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0056] Referring now to the drawings wherein the showings are for purposes of illustrating the disclosed embodiments only and not for purposes of limiting the same.
[0057] With initial reference to
[0058] The labeling system 10 includes a first and second sheet of flexible plastic material 14, 16 (or other materials) and in one or more embodiments, may include other packaging materials known in the pouch trade. Each sheet has peripheral edges. In this embodiment the first and second sheet are similar sizes, however, this need not be the case. The first and second sheet 14, 16 may encompass a variety of different shapes and sizes, and may comprise other packaging materials, whether now known in the pouch trade or yet to be developed. Sterile peel packs of this type are well known, and a wide variety of peel packs can be used in conjunction with aspects of the present disclosure.
[0059] The first and second sheet 14, 16 include peripheral edges 18, which may be in communication with one another. In this form the peripheral edges 18 of each sheet are joined together by a band of adhesive, or a heat seal, to form a joint J. It should be noted that the joint J at peripheral edges 18 need not be at the extreme far edges of the sheet. The joint J and peripheral edges 18 serve the purpose of forming an isolated internal cavity between the two sheets 14, 16 in which at least one sterile label 20 is received. Whereas, the internal cavity is generally completely enclosed for sterility to be maintained after the package is subjected to a sterilization process. The two sheets may also have separation flaps F between the two of them. Generally, these separation flaps F are not joined with the adhesive or heat seal, and allow a medical professional to separate the two sheets in an aseptic manner to expose the label 20. It will be appreciated that a wide variety of sterile peel pack designs having various features can be used in connection with aspects of the present disclosure.
[0060] The first and second sheet 14, 16 may also be transparent. In this form, the label 20 may show through the sheets 14, 16 so that the user will know which label 20 is inside without opening the peel pack 12. This may also aid in reducing human errors resulting from application of the wrong label to an accessory medical container.
[0061] After sterilization, the cavity remains sterile as a result of the fact that it does not come in contact with any non-sterile environment outside of the first and second sheet 14, 16. The outside of the first and second sheet 14, 16 may be handled by a licensed medical professional, whereas the label 20 on the inside will remain sterile to be handled within the sterile field.
[0062] The peel pack may also include a sterilization indicator. The sterilization indicator may be placed in the cavity, or on the face of the outer flexible sheets 14, 16. In this form, the sterilizing indicator can be seen through the clear sheets, 14, 16 without opening the pack. The sterilization indicator is generally used to indicate that an item has been subjected to a sterilization process. In some embodiments it appears as stripe, however, it may appear as a dot or other object. In the illustrated embodiment, the word sterile is included on at least one side of the label 20 indicating that the label is sterile. As will be described below in more detail, because the word sterile may be visible through the clear sheets, 14, 16 without opening the peel pack 12, a mask element 40 can be included to mask the word sterile while the peel pack 12 is affixed to an associated container.
[0063] The label 20 may contain various elements from the original product label. In one embodiment, the label contains manufacture information. In another embodiment the label 20 has a bar code(s) specific to a corresponding medical product. In another embodiment the label 20 includes space for additional variable information to be added. This additional information may include the time and date in which the original packaging for the corresponding medication was opened. The label 20 may also include expiration information, the name of the medication(s), solutions and/or supplies, dosage, concentration, etc.
[0064] The label 20 may also be constructed out of synthetic stock. It may also be useful for the label to be waterproof. The label 20 may also contain its own adhesive to aid a medical professional in applying the label to another medical accessory such as a syringe, a basin, a cup, a tub, etc. The sterile label 20 may also be part of a set in which many labels can be applied through a plurality of associated medical accessories. The sterile label 20 may be produced at the time of manufacturing its corresponding medication, or at some time other time that allows association of the sterile label 20 to the contents of the original medication container. In this sense the sterile label 20 will contain all of the information that is pertinent according to accrediting requirements and/or manufacturer's specification and specifically matched to the original medication container. Furthermore, this information may be printed with phosphorescent ink that may be visible in the dark or low light conditions. The package containing the label may also, in some embodiments, be secured with a tamper resistant or tamper evident attachment. This may assist in securing the peel pack from being removed at an inappropriate time or indicating such untimely removal.
[0065] With additional reference to
[0066] The peel pack 12 can be secured to the plastic bag 24 in a variety of manners. In the illustrated embodiment, the peel pack 12 is secured or removably attached with an adhesive 34 (see
[0067] It will be appreciated that the plastic bag 24 in the exemplary embodiment provides a larger area for the attachment of peel pack 12 as compared to the vial 26. However, the vial 26 and the information printed thereon are readily visible through the plastic bag 24 for comparing to the information printed on the label 20. This is because the size of the plastic bag 24 has been selected to allow the vial 26 and the peel pack 12 to be spaced apart longitudinally such that the vial 26 is adjacent to the peel pack 12. In other embodiments, the vial or other container may be partially hidden by the peel pack 12 and/or label 20. However, it should be appreciated that the information on the vial or other container, and the label information, can still be compared upon removal of the vial or other container from the plastic bag by the circulating nurse, while still maintaining a sterile protocol. For example, the peel pack 12 can be removed from the outside of the plastic bag 24, the vial 26 can be removed from the inside of the plastic bag 24, and the two can be held in the respective left and right hands of a circulating nurse for comparison.
[0068] Although not shown, the peel pack 12 can also include a tamper resistant or tamper evident attachment. Tamper resistant or evident attachment features are commercially available. They are used extensively on over-the counter drug packages and on other consumer and professional packaging. The attachment may assist in showing that the apparatus has not been detached from the original medication container. When the peel pack is removed from the plastic bag, the tamper resistant attachment may change color or other outward appearance, to alert the user to such a condition. As noted, the apparatus may also include a sterilization indicator and/or the word sterile.
[0069] The presence of the sterilization indicator of the peel pack in conjunction with the plastic bag 24 presents the possibility for a medical professional to interpret the sterilization indicator to mean that the interior of the plastic bag 24 is sterile. While in some embodiments, the interior of the plastic bag 24 can be sterile; in the embodiment of
[0070] By providing the masking element 40 in the manner described above, the word sterile and/or any other sterile indicator(s) associated with the label 20 can be blocked from view until such time as the peel pack 12 is removed from the plastic bag 24. After separation of the peel pack 12 from the plastic bag 24, the sterile indicator is exposed and properly indicates the interior contents of the peel pack 12 are sterile. As such, there is no ambiguity as to what container or package is sterile. In addition, the non-hermetic closure of the plastic bag will generally be recognized by medical personnel as a non-sterile closure and, thus, the contents of the bag as non-sterile.
[0071] It should be appreciated that, in some embodiments, a plastic bag can be provided wherein the side of the plastic bag to which the peel pack 12 is secured, or a portion thereof, is opaque such that any sterile indicator of the peel pack 12 is concealed when the peel pack 12 is secured to the plastic bag. Likewise, in other embodiments where, for example, the peel pack is applied to a box, a portion of the box itself can be the masking member 40.
[0072] It should also be appreciated that the plastic bag 24 is exemplary, and that other bag types, as well as other containers, enclosures, membranes, etc., can be used in accordance with the present disclosure. For example, the plastic bag 24 could be replaced by a paper bag having a transparent window for viewing the medication or other medical supplies contained inside, with the peel pack 12 being secured to the paper portion of the bag. Other materials can be used for the bag, such as foils or the like. As mentioned, aspects of the present disclosure are applicable to virtual any type of packaging that allows or maintains association of the peel pack with sterile label to the original medication container.
[0073] For example, and turning to
[0074] In
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[0077] Turning to
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[0082] It should be appreciated that various features of the embodiments of
[0083] It will be appreciated that in any of the above-described embodiments, a user (e.g., a circulating nurse) will generally remove the peel pack from the bag or other container to which it is attached. The user may aseptically open the peel pack without touching the sterile label. This will aid in maintaining the sterility of the label so that it may be aseptically dispensed to a sterile field. The action allows for the user to only come in contact with the outside of the peel pack. The outside of these sheets generally are not sterile because of their exposure to a non-sterile environment. They do, however, protect the cavity portion on the inside of the first and second sheet from becoming contaminated and, in turn, the label contained therein also remains sterile and is not contaminated. If the label comes in contact with a non-sterile surface, the label may be flash sterilized to return it to a sterile state.
[0084] Once the label is aseptically removed from the peel pack a user may apply it to an associated medical accessory, such as a cup. However, the associated accessory may be a variety of different objects, including a medical syringe, a tub, a basin, a towel, etc.
[0085] The medical accessory into or onto which a medication will be dispensed may be sterile. In order to maintain sterility, the user (who may not be sterile) may not be able to come in contact with the label or the medical accessory. Therefore, the non-sterile user may not be able to apply the label. However, that user may touch the outside of one of the first or second flexible plastic sheets of the peel pack to aseptically flip the label to the sterile field. In this form, both the inside and the outside of the container in the sterile field, and the label, can remain sterile and be used in a sterile field. Furthermore, the medication dispensed into the new container within the sterile field will be accurately labeled with the information contained on the label. The label may also have information added to it through use of a sterile writing utensil (not shown). This information may include the amount of medication and time such medication was dispensed to the field. A sterile user may apply the label by attaching the label to the accessory in the sterile field.
[0086] It will be appreciated that the sterile label, and the peel packs of the present disclosure, may come in a wide variety of sizes.
[0087] Now turning to
[0088] In the depicted embodiment, the extension portion 210 is dimensioned and configured as an elongated tail member 2000, and may be comprised of one or both of the first and second sheets 14, 16. As can be seen with respect to
[0089] It will be appreciated that a variety of suitable adhesives and bonding methods may be employed to affix the extension portion 220 to the medication container 26, particularly as the exterior of the medication container 26 need not remain sterile.
[0090] Now with reference to
[0091] The above description merely provides a disclosure of particular embodiments of the claimed invention and is not intended for the purposes of limiting the same thereto. As such, this disclosure is not limited to only the above described embodiments, rather it is recognized that one skilled in the art could conceive alternative embodiments that fall within the scope of the invention.
[0092] The exemplary embodiment has been described with reference to the preferred embodiments. Obviously, modifications and alterations will occur to others upon reading and understanding the preceding detailed description. It is intended that the exemplary embodiment be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.
[0093] Since many modifications, variations and changes in detail can be made to the described preferred embodiment of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents.
[0094] Now that the invention has been described,