WO2005027767A1 - Medical procedure kit and method - Google Patents

Medical procedure kit and method Download PDF

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Publication number
WO2005027767A1
WO2005027767A1 PCT/AU2004/001265 AU2004001265W WO2005027767A1 WO 2005027767 A1 WO2005027767 A1 WO 2005027767A1 AU 2004001265 W AU2004001265 W AU 2004001265W WO 2005027767 A1 WO2005027767 A1 WO 2005027767A1
Authority
WO
WIPO (PCT)
Prior art keywords
kit
tab
label
medical procedure
procedure
Prior art date
Application number
PCT/AU2004/001265
Other languages
French (fr)
Inventor
Jagmohanbir Singh Dillon
Andrew John Partington
Original Assignee
Itl Healthcare Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2003905218A external-priority patent/AU2003905218A0/en
Application filed by Itl Healthcare Pty Ltd filed Critical Itl Healthcare Pty Ltd
Publication of WO2005027767A1 publication Critical patent/WO2005027767A1/en

Links

Classifications

    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09F—DISPLAYING; ADVERTISING; SIGNS; LABELS OR NAME-PLATES; SEALS
    • G09F3/00—Labels, tag tickets, or similar identification or indication means; Seals; Postage or like stamps
    • G09F3/08—Fastening or securing by means not forming part of the material of the label itself
    • G09F3/10—Fastening or securing by means not forming part of the material of the label itself by an adhesive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/94—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text
    • A61B90/96—Identification means for patients or instruments, e.g. tags coded with symbols, e.g. text using barcodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0065—Peelable cover

Definitions

  • This invention relates to medical procedure kits and to methods associated with their use.
  • the procedure kits with which this invention is concerned will usually be sealed and sterile, but can be suited to a great variety of uses; for example: • Packs for use in operating rooms, • Kits for general medical use, • Packs and kits for use in the field by emergency and paramedical services, • First aid kits for hikers, travelers, yachtsmen and adventurers, • Procedure packs for use in intensive care units [ICUs] • Diagnostic kits for a great variety of tests, • Packs or kits designed for use in the home setting for a variety of acute or chronic conditions.
  • Such procedure kits with can also take many different physical forms; for example: • A shaped semi-rigid tray, which may be divided into compartments for housing or locating the kit components, and that has a cover or closure (usually a flexible polymer film) bonded to the rim of the tray. • A tray of the above type packed and sealed within a plastic pouch. • A sealed plastic bag or pouch containing the components of the kit in loose-packed form, wrapped in a drape or wipe cloth.
  • kits may be partially evacuated, and/or filled with a gas mixture other than air, before being sealed.
  • kits include all the disposable materials, such as instruments, syringes, needles, swabs, towels, catheters and the like, needed for a specific procedure in a single sterile package. This is not only a convenience for the medical staff who perform the procedures, and of benefit to patients by ensuring the sterility of the components but, with appropriately designed kits, it can also help in accounting for and disposing of the components after use.
  • An objective of the present invention is to improve the record-keeping within medical practices and hospitals with respect to the use and accounting of procedure kits.
  • the invention comprises a medical procedure kit containing multiple components needed for a specified medical procedure, characterized in that the kit includes a peel-off self-adhesive tab bearing indicia identifying the procedure and/or identifying kit production information (such as the manufacturer, the batch or lot number, a serial number and/or the date of manufacture), the tab being adapted for attachment to a patient's record sheet, a fault report or the like.
  • the indicia on the tab may be in the form of ordinary words, alphanumeric symbols, barcodes, manufacturer's logos and the like in any combination.
  • the tab can be paper or plastic based, or a combination thereof as a blend or laminate. It can be opaque or translucent, or it may be formed as a transparent or semi-transparent plastic film.
  • the exposed surface of the tab is adapted to retain handwriting applied thereto so that medical personnel can record the date and/or time of use and, if desired, other information - such as the person responsible - thereon by hand.
  • the tab can function as a transfer medium for imprinting indicia on a paper form. This may be done, for example, by using pigments or dyes contained in frangible micro-capsules that are crushed when the tab is pressed to the form. Such micro-capsules are widely used in carbonless paper forms in the stationary industry.
  • the tab can be applied to a label that is applied to or included with the kit, the label identifying the kit contents, supplier or manufacturer and other information if desired.
  • the kit may have a transparent closure, and the label, with the tab affixed thereto can be located inside the kit so as to be visible through the closure.
  • the label can be is affixed to the inside surface of the closure of the kit, and the tab can be applied to the back of the label so that it can be only removed therefrom after the kit has been opened.
  • the tab can be applied to the front of the label so that it can be only removed therefrom after the kit has been opened and after the label has been at least partially detached from the closure.
  • the label bearing the peel-off tab may be applied to the outside of the kit. This is less preferable because it is then possible to remove the tab from the label without opening the kit.
  • the invention comprises a peel-off tab of the type indicated above for use with medical procedure kits.
  • the tab may be color- coded to indicate the procedure to which the kit is related, or perhaps the manufacturer of the kit, but the former is preferable.
  • the tab may have provision for a handwritten name and a date for completion by the user and preferably has pre-printed information identifying the kit and manufacturing details (eg, batch number), as already mentioned.
  • the invention comprises a method of accurately recording the manufacturer's identification of a procedure kit on a patient's record, and/or on another hospital or physician's record, the method comprising the steps of applying or including a peel-off tab on or within a procedure kit, which tab carries indicia identifying the kit type and the manufacturer's reference (eg, batch number), removing the tab from the kit at the time the procedure is performed, and applying the tab to the patient's or other record sheet.
  • the method may also include writing on the tab to indicate the person who performed the procedure and/or the date on which it was performed.
  • Figure 1 is a perspective view from above of the procedure kit, label and tab of the first example, the label being applied internally.
  • Figure 2 is a perspective view from above of a first variant of the kit of Figure 1 immediately after it has been opened.
  • Figure 3 is a perspective view from above of a second variant of the kit of Figure 1 immediately after it has been opened.
  • Figure 4 is a perspective view of a procedure kit comprising the second example, in which the label and tab are applied externally.
  • Figure 5 is an enlarged plan view of a label and tab suitable for use in the kits of Figures 1 to 3.
  • the procedure kit 10 of the first example comprises a vacuum-formed tray-like body 12 with out-turned upper flange or rim 14 to which a transparent closure 16 is heat-sealed around its periphery, as indicated at 18.
  • a label 20 is applied to the inside of closure 16 so that it is visible from the outside, the label having indicia identifying the nature and contents of the kit, the identity of the manufacturer and various regulatory standards with which the kit complies.
  • a peel-off tab 22 is applied to the back of the label so that it is only accessible after the kit has been opened and the closure peeled back, as indicated in Figure 2.
  • tab 22 may be applied to the front of label 20, which is only lightly stuck to the inside of closure 16, so that it can be accessed and removed by peeling off label 20 and then removing tab 22.
  • label 20a may simply be laid in the kit 10a on top of the kit materials so that it is visible through closure 16, the appearance of the unopened kit being essentially identical to that shown in Figure 1.
  • label 20a must be first removed before the kit contents can be used.
  • tab 22a can be peeled off the label immediately and applied to the patient's record sheet before the procedure is actually performed.
  • label 20a can be placed to one side and tab 22a removed and applied to the patient's record sheet after the procedure has been performed.
  • the second example comprises a procedure kit 50 shown in Figure 4 that is similar to that of the first example, having a tray-like body 52, a closure 54 sealed thereto and a label 56 securely applied to the exterior of closure 54. Since label 56 is externally applied, there is no need for closure 54 to be transparent, though this will generally be the case so that the contents of the kit are visible. A peel-off tab 58 is adhered to the front of label 56 so that it can be removed and applied to the patient's record sheet even before the kit is opened.
  • tab 58 is not removed before the kit is opened and closure 54 (with label 56) is not completely detached from body 52 so that there is no danger of losing the label and tab and so that tab 58 can be removed and applied to the patient's records once the procedure has been completed.

Abstract

A procedure kit (50) has a tray-like body (52), a cover or closure (54) sealed to the body and a label (56) securely applied to the exterior of closure (54). A peel-off self-adhesive tab (58) is adhered to the front of the label (56) so that it can be manually removed and applied to the patient's record sheet even before the kit is opened. Preferably, the tab (58) bears indicia identifying the procedure and the manufacturers' batch number so that faults with the kit may be accurately reported. The tab (58) may also have provision for medical staff using the kit to sign or initial and for the date of use to be recorded. In one variant, the tab (56) may be applied directly to the inside or outside of the kit (50) rather than being applied to a separate label. Alternatively, the tab (58) and/or label (56) may be included inside the kit (50) so that the tab (58) cannot be removed without the kit being opened and so that there is no danger of losing the tab before the kit is opened.

Description

TITLE: MEDICAL PROCEDURE KIT AND METHOD
TECHNICAL FIELD
This invention relates to medical procedure kits and to methods associated with their use.
The procedure kits with which this invention is concerned will usually be sealed and sterile, but can be suited to a great variety of uses; for example: • Packs for use in operating rooms, • Kits for general medical use, • Packs and kits for use in the field by emergency and paramedical services, • First aid kits for hikers, travelers, yachtsmen and adventurers, • Procedure packs for use in intensive care units [ICUs] • Diagnostic kits for a great variety of tests, • Packs or kits designed for use in the home setting for a variety of acute or chronic conditions.
Such procedure kits with can also take many different physical forms; for example: • A shaped semi-rigid tray, which may be divided into compartments for housing or locating the kit components, and that has a cover or closure (usually a flexible polymer film) bonded to the rim of the tray. • A tray of the above type packed and sealed within a plastic pouch. • A sealed plastic bag or pouch containing the components of the kit in loose-packed form, wrapped in a drape or wipe cloth.
The kits may be partially evacuated, and/or filled with a gas mixture other than air, before being sealed. BACKGROUND
The use of disposable medical procedure kits is becoming common and, in many hospitals and doctor's surgeries, the norm. Such kits include all the disposable materials, such as instruments, syringes, needles, swabs, towels, catheters and the like, needed for a specific procedure in a single sterile package. This is not only a convenience for the medical staff who perform the procedures, and of benefit to patients by ensuring the sterility of the components but, with appropriately designed kits, it can also help in accounting for and disposing of the components after use.
However, since procedure kits are being used increasingly widely and are obtained from a wide variety of manufacturers and suppliers, problems do occur from time to time because of missing or inferior components and lack of sterility.
OUTLINE OF THE INVENTION
An objective of the present invention is to improve the record-keeping within medical practices and hospitals with respect to the use and accounting of procedure kits. We have discerned a need for simple means for noting on patient's records what and when procedures are carried out and for identifying the manufacturer, batch number or other identifiers associated with the kit after it has been used and disposed of. If, for example, materials such as sutures are judged to be inferior, or if there is reason to suspect lack of sterility, it would be desirable for the user to be able to report these matters to the supplier even if the kit and its packaging has been disposed of.
From one aspect, therefore, the invention comprises a medical procedure kit containing multiple components needed for a specified medical procedure, characterized in that the kit includes a peel-off self-adhesive tab bearing indicia identifying the procedure and/or identifying kit production information (such as the manufacturer, the batch or lot number, a serial number and/or the date of manufacture), the tab being adapted for attachment to a patient's record sheet, a fault report or the like. The indicia on the tab may be in the form of ordinary words, alphanumeric symbols, barcodes, manufacturer's logos and the like in any combination.
The tab can be paper or plastic based, or a combination thereof as a blend or laminate. It can be opaque or translucent, or it may be formed as a transparent or semi-transparent plastic film.
Preferably, the exposed surface of the tab is adapted to retain handwriting applied thereto so that medical personnel can record the date and/or time of use and, if desired, other information - such as the person responsible - thereon by hand. It is also envisaged that the tab can function as a transfer medium for imprinting indicia on a paper form. This may be done, for example, by using pigments or dyes contained in frangible micro-capsules that are crushed when the tab is pressed to the form. Such micro-capsules are widely used in carbonless paper forms in the stationary industry.
The tab can be applied to a label that is applied to or included with the kit, the label identifying the kit contents, supplier or manufacturer and other information if desired. The kit may have a transparent closure, and the label, with the tab affixed thereto can be located inside the kit so as to be visible through the closure. The label can be is affixed to the inside surface of the closure of the kit, and the tab can be applied to the back of the label so that it can be only removed therefrom after the kit has been opened. Alternatively, the tab can be applied to the front of the label so that it can be only removed therefrom after the kit has been opened and after the label has been at least partially detached from the closure.
Though deemed to be less preferable, the label bearing the peel-off tab may be applied to the outside of the kit. This is less preferable because it is then possible to remove the tab from the label without opening the kit. From yet another aspect, the invention comprises a peel-off tab of the type indicated above for use with medical procedure kits. The tab may be color- coded to indicate the procedure to which the kit is related, or perhaps the manufacturer of the kit, but the former is preferable. The tab may have provision for a handwritten name and a date for completion by the user and preferably has pre-printed information identifying the kit and manufacturing details (eg, batch number), as already mentioned.
From yet another aspect, the invention comprises a method of accurately recording the manufacturer's identification of a procedure kit on a patient's record, and/or on another hospital or physician's record, the method comprising the steps of applying or including a peel-off tab on or within a procedure kit, which tab carries indicia identifying the kit type and the manufacturer's reference (eg, batch number), removing the tab from the kit at the time the procedure is performed, and applying the tab to the patient's or other record sheet. The method may also include writing on the tab to indicate the person who performed the procedure and/or the date on which it was performed.
DESCRIPTION OF EXAMPLES
Having broadly portrayed the nature of the present invention, examples will now be described with reference to the accompanying drawings, in which:
Figure 1 is a perspective view from above of the procedure kit, label and tab of the first example, the label being applied internally. Figure 2 is a perspective view from above of a first variant of the kit of Figure 1 immediately after it has been opened.
Figure 3 is a perspective view from above of a second variant of the kit of Figure 1 immediately after it has been opened. Figure 4 is a perspective view of a procedure kit comprising the second example, in which the label and tab are applied externally.
Figure 5 is an enlarged plan view of a label and tab suitable for use in the kits of Figures 1 to 3.
The procedure kit 10 of the first example comprises a vacuum-formed tray-like body 12 with out-turned upper flange or rim 14 to which a transparent closure 16 is heat-sealed around its periphery, as indicated at 18. In the first variant of the kit of the first example, a label 20 is applied to the inside of closure 16 so that it is visible from the outside, the label having indicia identifying the nature and contents of the kit, the identity of the manufacturer and various regulatory standards with which the kit complies. In this variant of the first example, a peel-off tab 22 is applied to the back of the label so that it is only accessible after the kit has been opened and the closure peeled back, as indicated in Figure 2. [Alternatively, but less preferably, tab 22 may be applied to the front of label 20, which is only lightly stuck to the inside of closure 16, so that it can be accessed and removed by peeling off label 20 and then removing tab 22.]
In the second variant of the first example, illustrated in Figure 3, label 20a may simply be laid in the kit 10a on top of the kit materials so that it is visible through closure 16, the appearance of the unopened kit being essentially identical to that shown in Figure 1. Thus, label 20a must be first removed before the kit contents can be used. If desired, tab 22a can be peeled off the label immediately and applied to the patient's record sheet before the procedure is actually performed. Alternatively, label 20a can be placed to one side and tab 22a removed and applied to the patient's record sheet after the procedure has been performed. However, in the latter case, there is some danger that the label will become misplaced.
The second example comprises a procedure kit 50 shown in Figure 4 that is similar to that of the first example, having a tray-like body 52, a closure 54 sealed thereto and a label 56 securely applied to the exterior of closure 54. Since label 56 is externally applied, there is no need for closure 54 to be transparent, though this will generally be the case so that the contents of the kit are visible. A peel-off tab 58 is adhered to the front of label 56 so that it can be removed and applied to the patient's record sheet even before the kit is opened. Alternatively, and perhaps preferably, tab 58 is not removed before the kit is opened and closure 54 (with label 56) is not completely detached from body 52 so that there is no danger of losing the label and tab and so that tab 58 can be removed and applied to the patient's records once the procedure has been completed.
Turning now to Figure 5, one form that a label 100 and tab 102 can take is illustrated. The referenced areas of the label are as follows:
• 102: the peel-off adhesive tab that is color-coded to signify the procedure type and has the following areas:
• 102a: space for the user to write the date of use
• 102b: space for the name of the person who performed the procedure to be written
• 102c: printed identification of the manufacturer,
• 102d: the manufacturer's (printed) batch number that uniquely identifies the production batch of which the kit is a member,
• 102e: the name of the medical procedure for which the kit is intended, printed on the tab.
• 104: the manufacturer's brand or logo,
• 106: the name of the medical procedure for which the kit is intended, printed on the label,
• 108: a list of contents, • 1 10: symbols indicating the relevant regulatory and/or quality standards with which the kit complies, • 112: full and proper identification of the manufacturer.
While two examples have been described and illustrated, together with a specific example of a label and peel-off tab, it will be appreciated that many changes and modifications can be made thereto without departing from the scope of the present invention as outlined above

Claims

1 A medical procedure kit containing multiple components needed for a specified medical procedure, characterized in that the kit includes a peel-off self-adhesive tab bearing indicia identifying the procedure and/or identifying kit production information (such as the manufacturer, the batch or lot number, a serial number and/or the date of manufacture), the tab being adapted for manual removal from the kit and self-adhesive attachment to a patient's record sheet, a fault report or the like.
2 A medical procedure kit according to claim 1 wherein the indicia on the tab is in the form of ordinary words, alphanumeric symbols, barcodes, manufacturer's logos and the like in any combination.
3 A medical procedure kit according to claim 1 or 2 wherein the tab is paper or plastic based, or a combination thereof as a blend or laminate, whether opaque or translucent, or whether in the form of a transparent or semi- transparent plastic film.
4 A medical procedure kit according to any preceding claim wherein the tab is adapted to retain handwriting applied thereto so that medical personnel can record the date and/or time of use and, if desired, other information - such as the person responsible - thereon by hand.
5 A medical procedure kit according to any preceding claim wherein the tab can function as a transfer medium for imprinting indicia on a paper form.
6 A medical procedure kit according to claim 5 wherein the tab functions as a transfer medium by using pigments or dyes contained in frangible micro- capsules that are crushed when the tab is pressed to the form.
7 A medical procedure kit according to any preceding claim wherein the label has a front face printed or marked to identify the kit contents, supplier or manufacturer and other information if desired and the tab is applied to the front face of the label for ready removal therefrom.
8 A medical procedure kit according to claim 7 wherein the kit has a transparent closure, and the label, with the tab affixed thereto, is located inside the kit so that the front face of the label and the tab are visible through the closure when the kit is unopened and so that the label is only accessible after the kit has been opened.
9 A medical procedure kit according to claim 8 wherein the label is detachably affixed to the inside surface of the transparent closure of the kit so that said front face of the label is adjacent said closure and visible through the closure, so that the tab can be only removed from the label after the kit has been opened and after the label has been at least partially detached from the closure of the kit.
10 A medical procedure kit according to any one of claims 1 - 6 wherein the tab is applied to the outside of the kit.
11 A medical procedure kit according to claim 7 wherein the label is applied to the outside of the kit with the tab and front face of the label exposed.
12 A peel-off tab for use in a medical procedure kit as claimed in any preceding claim wherein the tab is color-coded to indicate the class of procedure to which the kit is related, wherein the tab has provision for a handwritten name and a date for completion by the user and wherein the tab bears pre-printed information identifying the kit and manufacturing details such as batch number.
13 A method of accurately recording the manufacturer's identification of a procedure kit on a patient's record, and/or on another hospital or physician's record, the method comprising the steps of applying or including a peel-off tab on or within a procedure kit, which tab carries indicia identifying the kit type and the manufacturer's reference such as batch number, removing the tab from the kit at the time the procedure is performed, and applying the tab to the patient's or other record sheet.
14 A method according to claim 12 including the step of writing on the tab to indicate the person who performed the procedure and/or the date on which it was performed.
PCT/AU2004/001265 2003-09-25 2004-09-17 Medical procedure kit and method WO2005027767A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2003905218 2003-09-25
AU2003905218A AU2003905218A0 (en) 2003-09-25 Medical Procedure Kit and Method

Publications (1)

Publication Number Publication Date
WO2005027767A1 true WO2005027767A1 (en) 2005-03-31

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US7823727B2 (en) 2005-06-29 2010-11-02 Sage Products, Inc. Patient check system
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WO2012166506A1 (en) 2011-06-03 2012-12-06 Medline Industries, Inc. Medical kit, packaging system, instruction insert, and associated methods
WO2012164201A1 (en) 2011-06-01 2012-12-06 Safe Orthopaedics System and method for traceability of an instrumentation system
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JP2021506412A (en) * 2017-12-19 2021-02-22 ベクトン・ディキンソン・アンド・カンパニーＢｅｃｔｏｎ， Ｄｉｃｋｉｎｓｏｎ Ａｎｄ Ｃｏｍｐａｎｙ Packaging of medical equipment
US11116937B2 (en) 2018-05-11 2021-09-14 Medline Industries, Inc. Foley catheter and corresponding single-layer tray packaging system
USD932649S1 (en) 2010-12-06 2021-10-05 Medline Industries, Inc. Medical tray
US11490983B2 (en) 2018-04-24 2022-11-08 C. R. Bard, Inc. Catheterization packages and methods thereof
US11612715B2 (en) 2018-06-20 2023-03-28 C. R. Bard, Inc. Urinary catheter-insertion kits with integrated instructions for use and methods thereof
US11896778B2 (en) 2017-03-31 2024-02-13 C. R. Bard, Inc. Catheter insertion-tray systems and methods thereof

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