U.S. patent application number 09/775152 was filed with the patent office on 2001-07-05 for labels and tracking systems for sterilization procedures.
This patent application is currently assigned to 3M Innovative Properties Company. Invention is credited to Amhof, Anita, Ignacio, Ramon T., Jauslin, Urs, Stoop, Christian, Weinig, Florian.
Application Number | 20010006818 09/775152 |
Document ID | / |
Family ID | 21793264 |
Filed Date | 2001-07-05 |
United States Patent
Application |
20010006818 |
Kind Code |
A1 |
Amhof, Anita ; et
al. |
July 5, 2001 |
Labels and tracking systems for sterilization procedures
Abstract
A novel label may be used in a novel sterilization tracking
system. The label preferably has first and second portions and a
first and second liners. Perforations may preferably attach the
first portion to the second portion. The label is particularly
suitable for use in monitoring and/or tracking hydrogen peroxide
sterilization procedures.
Inventors: |
Amhof, Anita; (Rueschlikon,
CH) ; Jauslin, Urs; (Rueschlikon, CH) ;
Ignacio, Ramon T.; (Flemington, NJ) ; Weinig,
Florian; (Rueschlikon, CH) ; Stoop, Christian;
(Rueschlikon, CH) |
Correspondence
Address: |
Office of Intellectual Property Counsel
3M Innovative Properties Company
PO Box 33427
St. Paul
MN
55133-3427
US
|
Assignee: |
3M Innovative Properties
Company
|
Family ID: |
21793264 |
Appl. No.: |
09/775152 |
Filed: |
February 1, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09775152 |
Feb 1, 2001 |
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09019445 |
Feb 5, 1998 |
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6238623 |
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09019445 |
Feb 5, 1998 |
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08859759 |
May 21, 1997 |
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6063631 |
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Current U.S.
Class: |
436/1 ; 422/28;
422/86; 422/87; 436/135 |
Current CPC
Class: |
A61L 2/208 20130101;
A61L 2202/24 20130101; Y10T 428/1476 20150115; A61L 2/26 20130101;
A61L 2/28 20130101; Y10T 436/206664 20150115; G01N 31/226 20130101;
Y10T 428/1495 20150115; Y10T 428/1486 20150115; G01N 31/223
20130101; A61L 2/186 20130101; A61L 2/14 20130101; A61L 2202/21
20130101; A61L 2202/181 20130101; G01N 31/228 20130101 |
Class at
Publication: |
436/1 ; 422/86;
422/87; 422/28; 436/135 |
International
Class: |
G01N 021/78 |
Claims
What is claimed is:
1. A label for use with objects that are to be subjected to a
hydrogen peroxide sterilization procedure, the label comprising:
(a) a first side constructed to receive printed indicia, the first
side having an indicating composition with a first indicating state
prior to exposure to the hydrogen peroxide sterilization procedure
and a second indicating state after exposure to the hydrogen
peroxide sterilization procedure, (b) a second side including an
adhesive; and (c) a removable liner adhered to the adhesive.
2. A label according to claim 1 wherein label includes first and
second portions, the label being constructed such that the first
portion is separable from the second portion.
3. A label according to claim 2 wherein perforations are situated
between the first and second portions.
4. A label according to claim 2 wherein both the first and second
portions have the indicating composition.
5. A label according to claim 2 wherein the label includes a first
removable liner attached to the first portion and a second
removable liner attached to the second portion.
6. A label according to claim 1 wherein the first indicating state
is a first color and the second indicating states is a second color
which is different than the first color.
7. A label for use in a tracking system for tracking objects to be
subjected to a sterilization procedure, the label comprising: (a)
first and second portions constructed to be manually separable from
each other, each of said first and second portions having a first
side constructed to receive printed indicia, and a second side with
an adhesive, (b) the first side of each of said first and second
portions including an indicating composition with a first
indicating state prior to exposure to the sterilization procedure
and a second indicating state after exposure to the sterilization
procedure, and (c) a removable liner adhered to the adhesive.
8. A label according to claim 7 wherein perforations are situated
between the first and second portions.
9. A label according to claim 7 wherein the label includes a first
removable liner attached to the first portion and a second
removable liner attached to the second portion.
10. A label according to claim 7 wherein the first indicating state
is a first color and the second indicating states is a second color
which is different than the first color.
11. A label for use in a tracking system for tracking objects to be
subjected to a sterilization procedure, the label comprising: (a)
first and second portions with perforations situated between the
first and second portions affording separation of the first and
second portions from each other, each of said first and second
portions having a first side constructed to receive printed
indicia, and a second side with an adhesive, (b) the first side of
at least one of said first and second portions including an
indicating composition with a first indicating state prior to
exposure to the sterilization procedure and a second indicating
state after exposure to the sterilization procedure, and (c) a
liner adhered to the adhesive.
12. A label according to claim 11 wherein both the first and second
portions have the indicating composition.
13. A label according to claim 11 wherein the label includes a
first removable liner attached to the first portion and a second
removable liner attached to the second portion.
14. A label according to claim 11 wherein the first indicating
state is a first color and the second indicating states is a second
color which is different than the first color.
15. A label for use in a tracking system for tracking objects to be
subjected to a sterilization procedure, the label comprising: (a)
first and second portions constructed to be manually separable from
each other, each of said first and second portions having a first
side constructed to receive printed indicia, and a second side with
an adhesive, (b) the first side of at least one of said first and
second portions including an indicating composition with a first
indicating state prior to exposure to the sterilization procedure
and a second indicating state after exposure to the sterilization
procedure, and (c) a first removable liner adhered to the adhesive
of the first portion and free of attachment to the second portion,
and a second removable liner adhered to the adhesive of the second
portion and free of attachment to the first portion.
16. A label according to claim 15 wherein perforations are situated
between the first and second portions.
17. A label according to claim 15 wherein both the first and second
portions have the indicating composition.
18. A label according to claim 15 wherein the first indicating
state is a first color and the second indicating states is a second
color which is different than the first color.
19. A method of tracking objects to be sterilized comprising the
steps of: (a) providing a label comprising first and second
portions having an adhesive, the first and second portions being
constructed to be separable from one another; both the first and
second portions being suitable for receiving printed information,
and both the first and second portions having a composition that
changes indicating state when exposed to a sterilization procedure;
(b) adhering the label to packaging of objects to be sterilized;
(c) subjecting the packaging and the objects to be sterilized to a
sterilization procedure; (d) then removing the second portion of
the label from the first portion leaving the first portion adhered
to the packaging of the objects to be sterilized; and (e) then
adhering the second portion to a patient's file.
20. A method according to claim 19 wherein the step of adhering the
first portion to the packaging of the objects to be sterilized
comprises adhering the first portion to the packaging of the
objects to be sterilized with substantially all of the adhesive of
the first portion.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part of and claims
priority from U.S. patent application No. 08/859,759 entitled,
"Sterilization Indicator" filed May 21, 1997.
FIELD OF INVENTION
[0002] This invention relates to tracking systems for sterilization
procedures and the like and components such as labels for use in
such tracking systems.
BACKGROUND
[0003] There are many different types of sterilization procedures
available to those who sterilize products. While steam
sterilization remains a popular procedure for sterilizing objects,
the sterilization art now has many different procedures that
provide options for those interested in sterilizing objects.
Hydrogen peroxide sterilization procedures offer one option. As
used herein, vapor phase, liquid phase and plasma hydrogen peroxide
sterilization procedures are all within the broad aegis of hydrogen
peroxide sterilization procedures.
[0004] The sterilization art recently witnessed the introduction of
plasma sterilizers. U.S. Pat. Nos. 4,643,876 and 4,756,882 are said
to cover the Sterrad.RTM. Hydrogen Peroxide Plasma Sterilizers
available from Advanced Sterilization Products of Irvine, Calif.
U.S.A. (a division of Johnson and Johnson). U.S. Pat. No. 5,084,239
describes a peracetic acid plasma sterilizer. Peracetic acid plasma
sterilizers are sold by AbTox of Mundelein, Ill. Other patents
assigned to AbTox include U.S. Pat. Nos. 5,115,166; 5,376,332;
5,413,759; 5,413,760 and 5,472,664.
[0005] There is a problem associated with tracking goods treated by
a Sterrad.RTM. Hydrogen Peroxide Plasma Sterilizer. While chemical
indicators and chemical indicating tape are sold for use with
Sterrad.RTM. sterilizers, there are believed to be no adhesive
labels available for use with the Sterrad.RTM. sterilizers that
include an indicating composition that is responsive to the
sterilization process associated with the Sterrad sterilizer. Of
course tracking systems for use with the Sterrad sterilizers would
not include such adhesive labels.
[0006] Dry heat sterilization, formaldehyde, gamma irradiation,
ethylene oxide procedures and the above described hydrogen peroxide
sterilization procedures provide a daunting array of options for
those who sterilize objects. Often a hospital will utilize several
different types of sterilizers to address its needs.
[0007] The state of objects to be sterilized should be carefully
managed and monitored at all times, especially prior to the use of
such objects on patients. This holds true for any sterilization
procedure. When a hospital utilizes several different types of
sterilizers, it makes this problem even more complex.
[0008] There are many tracking systems that include steps taken
even before the objects emerge from a sterilizer. U.S. Pat. No.
3,568,627 discloses a combined record card and sterilization
indicator. The card and indicator are for use in a steam
sterilizer.
[0009] European Patent Application No. 630 820 discloses a process
and system for monitoring material flow during the preparation of
sterile goods. That document describes data carriers that contain
two sections with identical data sets. One section may be
adhesively attached to a treatment protocol, while the other
section may remain at the sterilized unit. Printable adhesive
labels are also described that include a carrier layer that
possesses a first adhesive coating and a data carrier layer that
adheres to the carrier layer by means of a second adhesive coating.
The adhesive strength of the second adhesive coating toward the
carrier layer is said to be lower than the adhesive strength of the
first adhesive coating to an adhesive accepting surface of a
sterile goods container.
[0010] Vereinigte Papierwarenfabriken GmbH of Munich, Germany sells
the Stericlin System Batch Documentation. Stericlin systems are
available at least in Germany. A first Stericlin system includes a
label for use with certain steam sterilization procedures. A second
Stericlin system includes a label for use with certain ethylene
oxide sterilization procedures. Codes for the objects to be
sterilized are utilized. The Stericlin systems are limited as they
do not include any labels for use in any sterilization procedures
other than the particular steam and ethylene oxide procedures
mentioned above. For example, the Stericlin systems do not include
any labels with an indicating ink that is suitable for use in a
hydrogen peroxide sterilization procedure. The use of an existing
Stericlin label in a tracking system for a hydrogen peroxide
sterilizer can be misleading or confusing.
[0011] The Stericlin systems include an elongate label that has an
adhesive coated major left portion and an adhesive coated minor
right portion. The left portion is separate from the right portion
by virtue of a cut. The left and right portion are located on a
liner that includes a single incision extending perpendicular to
the direction of elongation of the labels at the middle of the
major left portion. As discussed in greater detail below, the right
portion of the liner is associated with the entire right portion of
the label and about one half of the left portion of the label.
[0012] The Stericlin labels for the steam and ethylene oxide
procedures also suffer drawbacks. Only the left portions of the
labels include an ink that changes color upon exposure to a
sterilization procedure. The left portion of the Stericlin label
for use in steam sterilization procedures includes a strip of ink
which is brown upon exposure to the sterilization procedure. The
right portion is free of any indicating ink. The left portion of
the Stericlin label for use in ethylene oxide sterilization
procedures includes a strip of ink which is yellow upon exposure to
the ethylene oxide sterilization procedure. The right portion is
free of any indicating ink.
[0013] The left portions of the labels are initially placed on the
sterile goods packaging with about one half of its adhesive. This
is accomplished by leaving one half of the liner on the adhesive of
the left portion. A problem exists when the labels are used with
sterile goods packaging made of crepe sheet paper. When the labels
are used with goods packaging made of crepe sheet paper, the left
portion is placed on an opening flap formed through a fold because,
during the vacuum portion of the sterilization procedure, the label
can become detached from the surface of the package. The Stericlin
system even suggests that additional tape could be used to secure
the label in an effort to address this problem. The left portions
of the labels are thereafter removed from the sterilized goods
packaging, the remaining portion of the liner is removed, and the
left portions are thereafter placed on patient's files using the
other half of their adhesives. This can lead to several problems
such as damage to the goods packaging, and partial separation or
"flagging" on the patient's file.
[0014] The right portions of the labels are placed on batch cards.
Because the right portions do not include indicating ink, the
information provided by the indicating ink is not available on the
batch card.
[0015] German Utility Model (Gebrauchsmuster) No. G 90 04 818.0
(assigned to Vereinigte Papierwarenfabriken GmbH) discloses a label
for sterile packaging. The label includes a major left portion and
a minor right portion separated by a cut. The left portion may have
an indicating ink. Indicating inks for water vapor sterilization,
ethylene oxide gas sterilization and formaldehyde sterilization are
mentioned. The minor right portion of the label is free of any
indicating ink. A two part liner is disclosed. The first part
covers about one-half of the major left portion, the second part
covers the rest of the major left portion and all of the right
portion.
SUMMARY OF THE INVENTION
[0016] The present invention provides a label for use in a
sterilization tracking system. The label securely adheres to the
packaging of the goods to be sterilized even during sterilization
procedures which utilize a vacuum. The label affords the user
complete freedom to mark, stamp or print on the label. A code for
the objects to be sterilized is entirely optional and not
necessary.
[0017] The present invention includes a label preferably comprising
first and second portions. Preferably, the second portion is
easily, manually separable from the first portion. The first and
second portions may be rendered manually separable in a variety of
manners such as by scoring, stamping or perforating the boundary
between the first and second portions. Although in some
embodiments, the present invention may be practiced with a single
liner, the label preferably includes a first removable liner
removably attached to the first portion and a separate and distinct
second liner removably attached to the second portion. The first
removable liner is adhered to the adhesive of the first portion and
free of attachment to the second portion. The second removable
liner is adhered to the adhesive of the second portion and free of
attachment to the first portion.
[0018] The first portion preferably has a composition thereon that
changes indicating state (e.g. color) upon exposure to a
sterilization procedure. The second portion also preferably has a
composition that changes indicating state (e.g. color) when exposed
to a sterilization procedure. Thus, the information provided by the
indicating compositions is available to a user viewing either the
first or the second portion of the label.
[0019] Unlike the Stericlin system which ultimately removes all
portions of the label from the packaging of the sterilized goods,
the first portion of the label of the present invention may remain
with the packaging of the sterilized goods for use in other control
procedures.
[0020] The label is particularly suitable for use with objects that
are to be subjected to a hydrogen peroxide sterilization procedure.
The label comprises a first side constructed to receive indicia and
a second side having an adhesive associated therewith. A removable
liner is adhered to the adhesive. In this embodiment, the label
includes an indicating composition with a first indicating state
(e.g. a first color) prior to exposure to the hydrogen peroxide
sterilization procedure and a second indicating state (e.g. a
second color different than the first color) after exposure to the
hydrogen peroxide sterilization procedure.
[0021] The present invention may also be described as a method of
tracking objects to be sterilized which utilizes a novel label as
discussed above.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The present invention will be further described with
reference to the accompanying drawing wherein like reference
numerals refer to like parts in the several views, and wherein:
[0023] FIG. 1 is a perspective view of a label according to one
aspect of the present invention;
[0024] FIG. 2 is a sectional view taken approximately along lines
2-2 of FIG. 1 with the scale of certain elements of label
exaggerated in FIG. 2 in order to emphasize details;
[0025] FIG. 3 is a flowchart of one example of the use of the label
of FIG. 1 as a component of a sterilization tracking system;
[0026] FIGS. 4a through 4f schematically illustrate the use of the
label substantially as described in FIG. 3 wherein:
[0027] FIG. 4a illustrates with solid lines a series of labels on
an optional perforated liner, and a label that could be removed
from the liner with dashed lines;
[0028] FIG. 4b illustrates the label that has been removed from the
liner of FIG. 4a;
[0029] FIG. 4c illustrates a package of items to be sterilized and
the label of FIG. 4b adhered to the package by the adhesive exposed
when the label was removed form the liner shown in FIG. 4a;
[0030] FIG. 4d illustrates the step of placing the package of
objects to be sterilized into a sterilizer;
[0031] FIG. 4e shows the second portion of the label that has been
adhered to the package and subjected to the sterilization procedure
being removed by being torn along a perforation between the first
and second portions of the label, FIG. 4e also illustrates that the
first portion of the label remains attached to the package of the
sterilized objects for use in other control procedures; and
[0032] FIG. 4f illustrates the second portion of the label of FIG.
4e being adhered to a patient's file after removal of the liner of
the second portion exposes the adhesive of the second portion.
DETAILED DESCRIPTION
[0033] Referring now to FIGS. 1 and 2, there is shown a preferred
embodiment of label 10 according to the present invention. While
the label 10 is preferably used in accordance with a novel
sterilization tracking system which is described below, the label
10 may simply be used with objects or goods that are to be
subjected to a sterilization procedure. The label 10 has particular
utility when used in conjunction with a sterilization procedure
which utilizes hydrogen peroxide during at least a portion of the
procedure.
[0034] The label 10 preferably comprises first 26 and second 28
portions constructed to be manually separable from each other.
Preferably, perforations 35 are situated between the first 26 and
second 28 portions. While the perforations 35 should afford manual
tearing of the second portion 28 from the first portion 26, this
portion of the label should withstand the rigors of the
sterilization procedure so as not to unduly weaken the attachment
between the first and second portions 26 and 28 in order to avoid
separation of the first and second portions 26 and 28 during the
sterilization procedure.
[0035] While the label preferably includes perforations 35, the
present invention could alternatively utilize any means for
rendering the label tearable between the first and second portions
26 and 28. For example, such a means may comprise a weakened
portion provided by scoring, cutting, drilling, stamping, slitting
or other partial destruction of the material between the first and
second portions 26 and 28, or combinations of such means.
[0036] The first and second portions 26 and 28 are preferably
substantially the same size and shape. In the depicted embodiment,
they form a rectangle.
[0037] The first and second portions 26 and 28 may be provided by a
backing constructed from a material capable of withstanding the
rigors of a sterilization cycle. Examples of suitable materials
include paper, polymers, laminates and combinations thereof. U.S.
Pat. No. 4,898,762 (the entire contents of which are herein
expressly incorporated by reference) discloses an isotactic
polypropylene backing suitable for use in the present invention.
Further non-limiting examples include latex saturated paper
backings, foil backings, woven and nonwoven backings,
polyolefin-based film backings (e.g. polyethylene), and polyester
film backings.
[0038] Each of the first 26 and second 28 portions have a first
side constructed to receive indicia and/or information provided by
an indicating composition or indicating ink. The indicia received
on the first and second portions 26 and 28 may be provided by
printing, stamping, dipping, manual writing or by automated means
such as a computer printer. The printed indicia on the first
portion may optionally comprise sterilization equipment
identification, sterilization conditions, dates, general comments,
validity date, names (e.g. the operator of the sterilizer), or
contents of the packaging. The indicia on the second portion may
comprise information for the patient's file. For example, the first
and second sides may include a surface treatment which assists in
retaining an indicating composition. Such a surface treatment may
also be used to assist the first and second sides in receiving ink
from a permanent ink pen or marker.
[0039] The first 26 and second 28 portions preferably each have an
adhesive 20 that is on a side opposite the side constructed to
receive printed indicia. The adhesive 20 may be any suitable
adhesive capable of withstanding the rigors of a sterilization
procedure and yet retain a suitable degree of adhesive quality. The
adhesive 20 may be a permanent adhesive, a removable adhesive or a
repositionable adhesive. Unlike some conventional tracking systems
however, the adhesive 20 need not be a removable or repositionable
adhesive, but could optionally comprise a permanent adhesive.
[0040] Nonlimiting examples of adhesives suitable for use in the
present invention include normally tacky, pressure sensitive
adhesives known in the art. The adhesives useful herein are
resistant to softening upon exposure to sterilization conditions
(including heat, steam or other chemical methods such as hydrogen
peroxide and ethylene oxide). Typical pressure sensitive adhesives
employed with indicator tapes and labels that are also useful in
the present invention include water insoluble natural rubber-based
adhesives, natural rubber and synthetic rubber blend adhesives,
styrene-isoprene-styrene block copolymers with tackifying resins,
vinyl ethers, high molecular weight acrylate copolymers having
minimal amounts of plasticizing monomers included therein. See
e.g., U.S. Pat. Nos. 2,889,799; 3,067,057; 3,078,182; 3,311,084;
and 4,188,437 (the entire contents of each of which are herein
incorporated by reference).
[0041] Nonlimiting examples of adhesives include the water
dispersible pressure sensitive adhesives disclosed in U.S. Pat.
Nos. 2,838,421; 3,441,430; 3,865,770; 4,413,080 and 4,569,960 (the
entire contents of each of which is herein incorporated by
reference). Further examples of water-soluble or water-dispersible
pressure sensitive adhesive compositions can be found in U.S. Pat.
Nos. 3,096,202; 3,152,940; 3,763,117; 3,890,292; 4,341,680;
4,388,432; 4,413,082 and 5,125,995 (the entire contents of each of
which is herein incorporated by reference). The adhesive may
optionally comprise water dispersible adhesives such as those
disclosed in U.S. Pat. Nos. 5,460,880; 5,518,763 and 5,622,764 (the
entire contents of which are herein incorporated by reference),
especially when the present invention is utilized in a steam
sterilization procedure.
[0042] Preferably, the adhesive 20 is associated with substantially
all of one side of the first and second portions 26 and 28.
Alternatively, only parts of the first and second portions 26 and
28 may have an adhesive associated therewith. The adhesive 20 may
be applied in various manners such as, for example, coating (e.g.
stripe, knife, pattern or flood coating) or printing such as
gravure printing.
[0043] Preferably the adhesive 20 is a unitary adhesive in that the
adhesive associated with the first portion 26 is substantially the
same as the adhesive associated with the second portion 28.
Optionally the adhesive 20 associated with the first portion 26 may
be substantially different than the adhesive associated with the
second portion 28. For example, the adhesive associated with the
first portion 26 may comprise a repositionable adhesive and the
adhesive associated with the second portion 28 may comprise a
permanent adhesive. The converse of this example could also be
employed.
[0044] At least one and preferably both of the first and second
portions 26 and 28 have an indicating composition 32 on the same
side as the side that is constructed to receive printed indicia.
Providing an indicating composition 32 on both the first and second
portions 26 and 28 affords the use of the information associated
with the indicating composition 32 to both a viewer of the first
portion 26 and a viewer of the second portion 28. This is
particularly helpful when the first and second portions 26 and 28
are separated.
[0045] Indicating compositions suitable for use in the present
invention have a first indicating state prior to exposure to a
sterilization procedure and a second indicating state after
exposure to the sterilization procedure. Suitable indicator
compositions are described in U.S. Pat. Nos. 2,118,144; 2,937,279;
3,098,751; 3,258,312; 3,311,084; 3,360,337; 3,360,338; 3,360,339;
3,386,807; 3,523,011; 3,627,469; 3,667,916; 3,684,737; 3,852,034;
3,862,824, 4,138,216; 4,015,937; 4,094,642; 4,168,779; 4,240,926,
4,382,063, 5,064,576; and 5,451,372 (the entire contents of each of
which are herein incorporated by reference). UK Patent Nos. 1458533
and 1370470 and EPO Publication No. 0282178 also disclose suitable
compositions (the entire contents of each of which are herein
incorporated by reference). The literature also describes suitable
compositions. See Royce and Bower, "An Indicator Control Device for
Ethylene Oxide Sterilization." J. Pharm. and Pharm. 11, Suppl.
294T-298T, and Brewer et al, Journal of Pharmaceutical Sciences,
pages 57-59, January 1966.
[0046] The present invention is associated with a plurality of
sterilization procedures including those procedures which utilize
hydrogen peroxide, peracetic acid, oxygen (including singlet
oxygen), steam, dry heat, ethylene oxide, formaldehyde, and gamma
irradiation as a steriliant or as an element in a step in the
procedure, and those sterilization procedures which utilize
combinations of such sterilants. The present invention may be
utilized with procedures which utilize matter in a variety of
states such as liquids, gases, fluids, plasmas and sterilization
procedures which utilize combinations of those states.
[0047] The present invention is particularly suitable for use in a
procedure which utilizes hydrogen peroxide. As used herein, vapor
phase, liquid phase and plasma hydrogen peroxide sterilization
procedures are all within the broad definition of hydrogen peroxide
sterilization procedures. Sterilization procedures which utilize
hydrogen peroxide as merely a component during a substantial
portion of the procedure are also included within the meaning of a
hydrogen peroxide sterilization procedure. U.S. Pat. Nos.
4,169,123; 4,169,124; 4,642,165; 4,643,876, 4,744,951; 4,756,882;
4,943,414; and 5,667,753 all describe hydrogen peroxide
sterilization procedures and the entire contents of each of which
are herein incorporated by reference.
[0048] When the present invention is utilized in a steam
sterilization procedure, the preferred indicating composition
comprises an ink including a lead carbonate sulfur system in a
binder system, gravure printed in lines onto a Kraft paper backing.
More preferably, the ink comprises 38% binder, 23%sulfur, 15%
lacquer thinner, 23% lead carbonate, and 1% clay (available as
BENTONE.TM. 38 from NL Chemicals of Hightstown, N.J.), which ink is
constructed in accordance with the teachings of U.S. Pat. No.
5,460,880 (the entire contents of which are incorporated by
reference).
[0049] An indicating composition for use in a hydrogen peroxide
sterilization procedure (e.g. the procedure provided by the
Sterrad.RTM. Hydrogen Peroxide Plasma Sterilizers available from
Advanced Sterilization Products of Irvine, Calif. U.S.A.) is
described in U.S. patent application No. 08/859,759, filed May 21,
1997, Attorney Reference No 53404USA5A entitled, "STERILIZATION
INDICATOR" by Ignacio (the entire contents of which are herein
incorporated by reference). For example, such an indicating ink may
comprise acid fuchsin.
[0050] U.S. Pat. Nos. 5,084,239; 5,115,166; 5,288,460; 5,376,332;
5,413,759; 5,413,760 and 5,472,664 (the entire contents of each of
which are herein incorporated by reference) describe plasma
peracetic acid sterilization procedures for which the present
invention may be employed.
[0051] An indicating composition for use in a sterilization process
including the use of a peracid vapor such as a plasma sterilization
procedure (e.g. the procedure provided by the AbTox.RTM. Peracetic
Acid Plasma Sterilizers available from AbTox of Mundelein, Ill.
U.S.A.) is described in U.S. patent application No. ______ filed
Feb. 5, 1998, 3M Attorney Reference No 53407USA7B, entitled,
"STERILIZATION MONITORS" by R. Ignacio and A. Piechowski (the
entire contents of which are herein incorporated by reference). For
example, such an indicating composition may comprise a colorant
susceptible to halogenation. Such an indicating ink may comprise
fluorescein and/or phenol red.
[0052] Preferably, the first indicating state of the composition is
a first color (e.g. purple for a hydrogen peroxide cycle) and the
second indicating state of the composition is a second color (e.g.
green for the hydrogen peroxide cycle) which is different than the
first color. The first state could be a substantially clear or
transparent or translucent state, and the second state could be a
substantially opaque or colored state. The converse of these states
could also be employed.
[0053] The indicating composition 32 may be provided in the form of
printed stripes as shown in FIG. 1. Alternatively, the indicating
composition could be provided in the form of printing or symbols or
characters. For example, the indicating composition may be provided
in the form of characters, such as, "Steam Sterilized" or "Ethylene
Oxide Sterilized", or "Hydrogen Peroxide Sterilized if Green". In
the first state, such characters may be substantially transparent
or difficult to see for a user. In the second state, such letters
could be readily apparent to a user. For example, the characters
may change from a light color to a dark, opaque color upon exposure
to the particular sterilant.
[0054] Optionally, one or both of the first and second portions 26
and 28 may include a first indicating composition having a first
indicating state prior to exposure to a first sterilization
procedure and a second indicating state after exposure to the first
sterilization procedure; and a second indicating composition having
a first indicating state prior to exposure to a second
sterilization procedure (which is of a different type than said
first sterilization procedure), and a second indicating state after
exposure to the second sterilization procedure. Preferably, the
first indicating composition remains in the first indicating state
if exposed to the second sterilization procedure, and the second
indicating composition remains in the first indicating state if
exposed to the first sterilization procedure. For example, the
first sterilization procedure may comprise a hydrogen peroxide
sterilization procedure and the second sterilization procedure may
comprise a steam sterilization procedure. Such a label could help
avoid confusion at a location (e.g. a hospital) where both steam
and hydrogen peroxide sterilization procedures exist. It also
provides a benefit in that only one label needs to be manufactured
for both sterilization procedures.
[0055] The label 10 preferably includes a first removable liner 12
adhesively attached to the first portion 26 and a second removable
liner 24 adhesively attached to the second portion 28. To
contribute to ease of use, the first removable liner 12 is
preferably adhered to the adhesive of the first portion 26 and is
free of attachment to the second portion. Also preferably, the
second removable liner 24 is adhered to the adhesive of the second
portion 28 and is free of attachment to the first portion 26.
[0056] The first removable liner 12 may optionally be the type
which includes holes 15 which afford use of the label 10 with word
processing equipment such as computers and printers. Alternatively,
the first removable liner 12 may be smaller. For example, the first
removable liner 12 could merely just cover the adhesive associated
with the first portion 26 leaving just enough area for a grasping
tab for removal of the liner. In such an instance, the first
adhesive liner 12 could simply be separated from the second
adhesive liner 24 by a small cut or slit in the material
constructing the liners 12 and 24.
[0057] The liners 12 and 24 may be constructed from any suitable
material. The second liner 24 should be capable of withstanding the
rigors of the particular sterilization procedure. Examples of
suitable materials include papers, plastics, polymers, laminates
and combinations thereof For example, the liner could comprise a
paper coated with a release substance such as wax or a low adhesion
backsize.
EXAMPLE 1
[0058] A sample label 10 for use in a steam sterilization procedure
according to the present invention may be constructed using the
following steps.
[0059] A backing for the label may comprise 29 pound basis weight
Kraft paper ("M-2383 Smooth Crepe Semi-Bleached Kraft Saturating
Paper"; available from Mosinee Paper Corp., Mosinee, Wis.). The
Kraft paper could be gravure printed in lines with a sulfur-lead
ink system in a binder system. The ink can contain a 38% binder,
23% sulfur, 15% lacquer thinner, 23% lead carbonate and 1% clay
("Bertone-38", NL Chemicals, Highstown, N.J.). The binder system
may contain 24% nitrocellulose ethyl alcohol; 3%
phenol-formaldehyde resin ("Beckcite.TM. 24102"; BTL Specialty
Resins, Toledo, Ohio); 9% tricresyl phosphate; 14% butyl alcohol;
27% xylene and 23% butyl acetate.
[0060] An adhesive may be uniformly coated on the side of the
backing opposite the ink side. The adhesive may comprise a natural
rubber based adhesive.
[0061] The ink printed Kraft paper could be strengthened using a
vulcanized natural rubber-wood rosin system coated onto the paper.
The rubber system may comprise 23% natural rubber (Goodyear Tire
and Rubber Co., Akron, Ohio); 6% zinc dioxide ("Type A-140"; New
Jersey Zinc. Co., Palmerton, Pa.); 29% wood rosin ("Tenex 36-710";
Reichold Chemicals Inc. Oakbrook, Ill.); 2% calcium lithol pigment
(Hercules Inc.); and 37% mineral spirits. The vulcanizer used to
crosslink the rubber system could be 40% white mineral oil (Type
#31 USP; AMOCO Chemical Corp., Chicago, Ill.); 15%
tetramethylthirum disulfide accelerator (RT Vanderbilt Co.,
Norwalk, Conn.); and 45% ortho-pentamethylenethiuram sulfads (RT
Vanderbilt Co.).
[0062] The printed, saturated paper backing could then be treated
to decrease moisture penetration with a solution containing 19%
butyl alcohol, 0.2% phosphoric acid, 9% urea, 0.8% aqueous ammonia,
31% formaldehyde, 6% isopropyl alcohol, 10% acrylic polymer
("Elvacite 2044"; E. I. dupont Nemours, Wilmington, Del.); 9%
butanol and 15% xylene.
[0063] A low adhesion backsize may be used on the side of the
backing opposite the adhesive side. Depending on the nature of the
adhesive, a urethane based low adhesion backsize may be used. The
urethane backsize as described in U.S. Pat. No. 2,532,011
(incorporated by reference) may be used.
[0064] The backing may optionally be coated with an adhesive
priming agent to increase the bond of the adhesive to the backing.
A priming agent such as NEOPRENE.TM. N 115 (E. I. dupont Nemours,
Wilmington, Del.) may be used.
[0065] The natural rubber-based pressure sensitive adhesive in a
solvent system could be coated on the Kraft paper at 0.68 grams per
154.8 cm.sup.2 (24 in.sup.2) using a standard laboratory knife
coater, with drying for about 15 minutes in a forced air oven at
100.degree.C.
[0066] The above described assembly may be cut to a dimension of
109 mm.times.300 m. Paper or other liner material may be cut or
slit to dimensions of 45 mm.times.500 m and 125 mm.times.500 m. On
a rotation machine, the 45 mm slitted liner may be laminated onto
the adhesive side of the 109 mm assembly. Next, the 125 mm liner is
then laminated on (the now 1/2adhesive side of) the previously
described 109 mm/45 mm liner assembly. Finally, in the same step,
die cut the previously described assembly to dimensions of 102
mm.times.34 mm including perforations in the middle of the label as
a "kiss cut", and at the same time, die-cut the edge holes (e.g. 15
in the drawings) in the liner. In this example, the same tool is
die cutting the shape of 102 mm.times.34 mm, the perforations and
the edge holes 15.
EXAMPLE 2
[0067] A sample label for use in a hydrogen peroxide sterilization
procedure according to the present invention may be constructed
using the following steps.
[0068] A backing may be constructed using a premium CIS white litho
stock with high internal strength and uniform flat finish. The
caliper may be 0.0036 inches plus or minus 10% with a basis weight
of 60 pounds per ream plus or minus 10 percent. The adhesive may
comprise a uniformly coated general purpose ultra permanent type
pressure sensitive adhesive with high initial tack. The caliper may
be about 0.0006 inches plus or minus 10%. The release liner may
comprise a forty pound Fastrip, bleached sulfate stock with a basis
weight of 42 pounds per ream plus or minus 10%. The caliper can be
about 0.0025 inches thick plus or minus 10%. The liner may have a
width of about {fraction (13/16)}inches.
[0069] Unlike example 1, the indicating ink may comprise an
indicating composition as described in U.S. patent application No.
08/859,759, filed May 21, 1997. The particular indicating ink
applied to the backing may comprise acid fuchsin. That ink may be
used to indicate whether a label has undergone the procedure
provided by a Sterrad.RTM. Hydrogen Peroxide Plasma Sterilizer. The
Sterrad sterilizer is a hydrogen peroxide procedure that utilizes a
plasma step.
[0070] The thickness of the label may be about 0.0067 inches plus
or minus 10%. The width may be about 4 inches plus or minus
{fraction (1/16)}inches. The labels may be placed on the liner at
intervals of about 0.118 inches inset about {fraction (1/16)}inch
from the edge of the liner. The bleached sulfate stock of the
release liner may have a weight of about 37-47 pounds per ream. The
tensile yield strength of the assembly in the machine direction may
be 32 pounds per inch width minimum.
[0071] The labels may be wound on a three inch core with
approximately 2500 feet per roll.
EXAMPLE 3
[0072] A sample label for use in a peracid sterilization procedure
according to the present invention may be constructed using the
following steps.
[0073] A label utilizing the same backing, liner and adhesive as
Example 2 may be provided. Unlike Example 2, the indicating ink may
comprise an indicating composition described in U.S. patent
application No ______, filed Feb. 5, 1998, 3M Attorney Reference No
53407USA7B, entitled, "STERILIZATION MONITORS" by R. Ignacio and A.
Piechowski. The indicating composition comprises a colorant
susceptible to halogenation. Such an indicating ink may comprise
fluorescein or phenol red.
[0074] Referring now to FIGS. 3 and 4a through 4f, there is shown a
preferred sterilization tracking system which may utilize a novel
label 10. The novel method of tracking objects to be sterilized
comprises the steps of:
[0075] (a) providing a label 10 comprising first 26 and second 28
portions having an adhesive 20, the first 26 and second 28 portions
being constructed to be separable from one another; both the first
and second portions being suitable for receiving printed
information (see step 51, FIG. 3) and both the first and second
portions having a composition 32 that changes indicating state when
exposed to a sterilization procedure;
[0076] (b) adhering the label to packaging of the objects to be
sterilized (see steps 52 and 53, FIG. 3; FIGS. 4a, 4b and 4c);
[0077] (c) subjecting the objects to be sterilized and the
packaging to a sterilization procedure (see step 54, FIG. 3; FIG.
4d);
[0078] (d) then removing the second portion of the label from the
first portion leaving the first portion adhered to the packaging of
the objects (see FIG. 4e); and
[0079] (e) then adhering the second portion to a patient's file
(see step 56 in FIG. 3 and FIG. 4f).
[0080] The indicator composition 32 may be checked for a change in
color (e.g. step 55) at any point, but it is particularly
interesting to check after the objects (and label 10) emerge from
the sterilizer.
[0081] Preferably, the step of adhering the first portion 26 to the
packaging of the objects to be sterilized comprises adhering the
first portion 26 to the packaging of the objects to be sterilized
with substantially all of the adhesive of the first portion This
step contributes to a secure attachment of the label 10 to the
packaging of the objects to be sterilized, as opposed to an
attachment which may require additional tape to secure the label to
the packaging of the objects to be sterilized. The label 10 is
preferably free of any attachment means to the packaging 40 except
the attachment provided by the adhesive(s) of the label 10 itself.
This feature eliminates the need for an additional step during the
use of the label 10. In particular, a user need not use separate
and distinct tape to attach the label to the packaging 40.
[0082] Referring to FIGS. 4a through 4f, a preferred use of the
label 10 is shown. The label is particularly suitable for use in
the central sterilization supply departments of hospitals. The
label 10 can help provide a link between objects that have
undergone sterilization and the patient's file. Objects used on a
particular patient during a surgical procedure may be traced back
from the patient to a sterilizer or load number. The label provides
a link between a patient and the various files kept on
sterilization parameters in the central sterilization supply
department of the hospital.
[0083] Preferably, the label 10 is provided with a major liner 12
in the form of a sheet with computer compatible holes 15. In that
manner, the various steps of providing indicia to the label 10 may
be optionally automated.
[0084] The label 10 is removed from the liner 12 (see FIG. 4b), and
then subsequently adhered to the package 40 of the objects to be
sterilized 41 (See FIG. 4c). When the label 10 is removed from the
liner 12, only the adhesive associated with the first portion 26 is
exposed as the liner 24 protects the adhesive associated with the
second portion 28. When the first portion 26 is adhered to the
package 40, preferably substantially all of the adhesive associated
with the first portion 26 adheres the label 10 to the package 40 in
order to contribute to a secure attachment suitable for
withstanding the rigors of a sterilization procedure, even a
sterilization procedure which utilizes a vacuum.
[0085] The objects to be sterilized 41 may comprise any object that
may be subjected to a sterilization procedure such as, but not
limited to, disposable or reusable surgical instruments, or goods
used in the hospital or laundry.
[0086] FIG. 4d illustrates the package 40 (with the label adhered
thereto) being placed within a sterilizer 102. Once the
sterilization procedure is complete, the label 10 and package 40
are removed from the sterilizer 102. If the sterilizer functions
properly, the indicating composition 32 changes state (e.g. color)
from its first state to its second state during the sterilization
procedure.
[0087] The second portion 28 may next be separated from the first
portion 26. The first portion 26 remains attached to the packaging
40 and thus may be used in other control procedures (e.g. further
documentation) or it may be discarded with the packaging.
[0088] The liner 24 remains attached to the second portion 28
during the sterilization procedure thereby affording the adhesive
associated with the second portion 28 a degree of protection from
the sterilization procedure. After the liner 24 is removed, the
second portion 28 may be adhered to the patient's file 100.
[0089] The present invention has now been described with reference
to several embodiments and examples thereof It will be apparent to
those skilled in the art that many changes or additions can be made
in the embodiments described without departing from the scope of
the present invention. Thus, the scope of the present invention
should not be limited to the structures described in this
application, but only by structures described by the language of
the claims and the equivalents of those structures.
* * * * *