Source: https://patents.google.com/patent/US8492162B2/en
Timestamp: 2018-07-16 22:40:50
Document Index: 134711625

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1']

US8492162B2 - Electronic system for tracking and monitoring articles to be sterilized and associated method - Google Patents
US8492162B2
US8492162B2 US12708849 US70884910A US8492162B2 US 8492162 B2 US8492162 B2 US 8492162B2 US 12708849 US12708849 US 12708849 US 70884910 A US70884910 A US 70884910A US 8492162 B2 US8492162 B2 US 8492162B2
US12708849
US20100217620A1 (en )
Roland C. Kippenhan
Philip A. Bolea
This application is a continuation of U.S. application Ser. No. 11/472,671, filed Jun. 22, 2006, now abandoned which is a divisional of U.S. application Ser. No. 10/303,465, filed Nov. 25, 2002, now abandoned which is a continuation of U.S. application Ser. No. 09/369,098, filed Aug. 5, 1999, which issued as U.S. Pat. No. 6,485,979 on Nov. 26, 2002, which are incorporated herein by reference.
Integrating chemical indicators are described in U.S. Pat. No. 3,981,683B1, (Larsson et al.) and U.S. Pat. Reissue No. 34,515 to Foley. Other chemical indicators are described in U.S. Pat. Nos. 3,114,349; 3,313,266; 3,341,238; 3,652,249; 4,138,216; 4,382,063; 4,576,795; 4,692,307; 4,579,715; and 5,451,372 (the entire contents of each of which are herein incorporated by reference).
FIGS. 32 and 33 show an alternative embodiment of the present invention. FIG. 32 is a top view of a sterilization indicator 2 prior to being subjected to a sterilization cycle in sterilizer 20 (FIG. 1). In the sterilization indicator 2, the sterilizing agent sensitive means for responding to a sterilization process comprises a tablet 5 that wicks along a backing 3 using the components of the indicators described in U.S. Pat. No. 3,981,683B1, (Larsson et al.) and U.S. Pat. Reissue No. 34,515 to Foley (the entire contents of the file histories of the patents, the Reexamination and Reissue are herein incorporated by reference).
The optional binder should be compatible with the ink. One example of a preferred binder includes 24% nitrocellulose ethyl alcohol (Hercules Inc., Wilmington, Del.); 3% phenol-formaldehyde resin (BECKClTE™ 24-102, BTL Specialty Resins, Toledo, Ohio); 9% tricresyl phosphate; 14% butyl alcohol; 27% xylene, and 23% butyl acetate.
Optionally, the sterilization indicator 10 may comprise a label with a suitable adhesive. The sterilization indicator 10 shown in FIGS. 1 and 2 is shown as a part of a label applied to a sterilization pack 12. Labels are particularly useful in distinguishing packs 12 stored in a storage means 30, such as a shelf or cart. Suitable adhesives for labels for use in sterilization processes are described in Amhof et al., U.S. Pat. No. 6,238,623 (the entire contents of which are herein incorporated by reference). Alternatively, the sterilization indicator 10 with a bar code can comprise a label placed on a bioligical indicator (e.g. the vial of a biological indicator). While the sterilization indicator 10 is suitable for use as a label or sterilization indicator tape, it is appreciated that the sterilization indicator 10 can also be an indicator without an adhesive as well.
The components of the sterilization indicator 10 may also be selected so that the sterilization indicator 10 satisfies the 134 degree Celsius test defined in Section 6.1 of the Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements, ANSI/AAMI ST 60-(1996) (again referencing the test methods described in ANSI/AAMI ST 45-1992, Bier/Steam vessels) in that:
In this embodiment, the processing means 81 includes means for comparing information generated from the chemical indicator 70 with reference data. The reference data may comprise reference spectral curves for the particular type of chemical indicator. For example, if the scanning means is attempting to read a 3M Comply (SteriGage) Steam Chemical Integrator No. 1243A, it can be programmed to open a reference file containing information taken from reference indicators that were subjected to varying degrees of a sterilization process and/or a lethal sterilization cycle and/or a sterilization process exhibiting a known sterilizer failure mode. For example, to construct the reference file, several 3M Comply (SteriGage) Steam Chemical Integrators may be subjected to partial steam cycles that satisfy only two of the three critical parameters of a steam sterilization cycle (e.g. time, temperature and steam). This reference data can be used to assist the scanning means in identifying 3M Comply (SteriGage) Steam Chemical Integrators that indicate that an inadequate sterilization cycle occurred.
As shown by lines in FIG. 4, the various components of the system may be placed in communication (e.g. electronic communication) by means such as electronic wiring, wireless connections, interne or intranet connections, and/or ethernet connections.
Information from a device 327 for automatically reading the results of a biological indicator can optionally be connected to the computer 306 as a part of the system. U.S. Pat. Nos. 5,030,832; 5,063,297; 5,334,841; 5,863,790 and 6,025,189 and U.S. patent application Ser. No. 08/856,104, filed May 14, 1997 (the entire contents of which are herein incorporated by reference) describe electronic reading apparatus for objectively reading fluorescence of biological indicators. These devices can be modified to provide information to the system of the present invention.
The load for the particular pack is also identified in FIG. 25. Pack number 9999 is designed to be sterilized within a particular load (#410). If the items within pack 9999 should not be sterilized in the predetermined load, the system may optionally provide a warning signal to the user. As an example, if the article to be sterilized cannot withstand the heat of a steam cycle, the system of the present invention can send a warning to the user if load number 410 is to be a steam sterilizer load. As another example, if the sterilizer for a particular load (e.g. load number 410) is not approved for a particular type of article to be sterilized (e.g. a surgical instrument with a lumen such as a trocar) then appropriate information may be sent to the user.
Referring again to FIG. 25, prompts 74 and 75 can link a chemical indicator readout to articles within a sterilizer pack: Prompt 76 can link a biological indicator readout to those same articles. More specific instructions relating to how to create a challenge pack may also be provided to the user.
Lead Halstab White Lead A/Halstab/Hammond, IN 24.88
Lithium Cyclone Fine #400-A/Lithium Corporation of 02.68
Carbonate America/Gastonia, NC
Nickel 3M Company, St. Paul, MN 04.7
Disodium salt of E. M. Science, Gibbstown, NJ 19.0
Ethyl Cellulose Colonial G-20-90-NL/Colonial Printing 74.3
Binder Ink Co.,/East Rutherford, NJ
Ammonium Akzo Chemical of America, Chicago, IL 02.0
Run Number Number Scanned
Standard Steam Indicator Ink Hue Before
Code B Before After 20/20 After
Name Name/Source/Address (percent)
Rhoplex Rohm & Haas Corp./Philadelphia, PA 36.30
Bleached CT
Ethyl 18.20
The ink formulation was gravure flood coated onto S&S 410 Grade Filter Paper from Schleicher & Schuell Corp., Keene, N. H. Code 39 bar codes B were modified as described in Example 1. Ten Modified Code Bs were sterilized in a Sterrad 100 from Advanced Sterilization Products (ASP) full cycle and scanned as described in Example 1. The results are shown in Table 2b.
1 Commercial Dark Purple Pale Blue 0/10 9/10
“3M™ Comply™ ‘00152’ Ethylene Oxide Sterilometer Strips” from 3M Company, St. Paul, Minn. were used to monitor an ethylene oxide sterilization process. The ninth bar of Code B was replaced with strips cut from the indicator strips before and after processing in a 3M 4XL Ethylene Oxide Sterilizer on a full warm cycle. The Modified Code Bs were scanned as described in Example 1. The results are shown in Table 5a.
FIG. 8 shows spectral scans made at a 90 degree illumination incidence angle for five EO chemical indicator strips. After two EU indicator strips were exposed for a full warm EU cycle, they appeared blue 512, 520 (fully exposed to sterilant). After a third EO indicator strip was exposed for 10 minutes, it appeared yellow/green 514 (partial exposure). After a fourth EU indicator strip was exposed for 30 minutes, it appeared green 518 (more exposure). A fifth EO indicator strip was not exposed to any portion of a sterilization cycle and it appeared yellow 516 (no exposure). These indicator strips also had specular first surfaces due to a plastic lamination to prevent the surface of the ink from coming in contact with items being sterilized. Note the variability for reading of the two blue indicator strips 512, 520 in FIG. 8 which were fully exposed to sterilant; and therefore, should be similar to each other if not the same.
FIG. 10 shows spectral scans made at a 90 degree illumination incidence angle for four model 1251 EO indicator strips. After a first EU indicator strip was exposed for 60 minutes at 50% relative humidity (RH), it appeared green 530 (exposed to sterilant). After a second EO indicator strip was exposed for 30 minutes at 90% RH, it appeared olive 534 (partial exposure). After a third EU indicator strip was exposed for 21 minutes at 30% RH, it appeared brown 536 (less exposure). A fourth EO indicator strip was not exposed to any portion of a sterilization cycle and it appeared red 532 (no exposure). These indicator strips had specular first surfaces made by covering the exposed ink with clear “Scotch™ Mailing Tape”.
The processor of a reader or scanner for this chemical indicator may be programmed such that the initial (unexposed) indicator's primary absorbtion relative intensity is set to 100%. As the individual molecules of the indicator chemistry react, they will begin to absorb at a different wavelength (λ1). As the sterilization cycle proceeds, there will be a decrease in the relative intensity (from RI0,init to RI0,final) of λ0 and an increase in relative intensity (from RI1,init to RI1,final) of λ1.
In a first embodiment, the processor may be programmed to respond to the remaining relative intensity of λ0. This threshold value (a) (see equation below) should correspond to a suitable decrease in the initial color to represent an “accept” cycle of the sterilizer. That is:
IF ⁢ ⁢ ( RI 0 , initial - RI 0 , final RI 0 , initial ) ≤ a , THEN ⁢ ⁢ “ ACCEPT ” ⁢ ⁢ or ⁢ ⁢ “ ADEQUATE ” IF ⁢ ⁢ ( RI 0 , initial - RI 0 , final RI 0 , initial ) > a , THEN ⁢ ⁢ “ REJECT ” ⁢ ⁢ or ⁢ ⁢ “ INADEQUATE ”
In a second embodiment, the processor may be programmed to respond to the increase of relative intensity of λ1. The threshold value (b) (see equation below) should correspond to a suitable increase in the final color to represent an “accept” cycle of the sterilizer. That is:
IF ⁢ ⁢ ( RI 1 ⁢ finall - RI 1 , initial RI 1 , finall ) ≤ b , THEN ⁢ ⁢ “ ACCEPT ” ⁢ ⁢ or ⁢ ⁢ “ ADEQUATE ” IF ⁢ ⁢ ( RI 1 ⁢ finall - RI 1 , initial RI 1 ⁢ finall ) > b , THEN ⁢ ⁢ “ REJECT ” ⁢ ⁢ or ⁢ ⁢ “ INADEQUATE ”
In yet another embodiment, a combination of the two factors can be implemented:
( IF ⁡ ( RI 0 , initial - RI 0 , final RI 0 , initial ) ≤ a ) ⁢ ⁢ AND ⁢ ⁢ ( IF ⁡ ( RI 1 ⁢ ⁢ finall - RI 1 , initial RI 1 ⁢ finall ) ≤ b ) , THEN ⁢ ⁢ “ ACCEPT ” ⁢ ⁢ or ⁢ ⁢ “ ADEQUATE ” ( IF ⁡ ( RI 0 , initial - RI 0 , final RI 0 , initial ) > a ) ⁢ ⁢ OR ⁢ ⁢ ( IF ⁡ ( RI 1 ⁢ finall - RI 1 , initital RI 1 ⁢ finall ) > b ) , THEN ⁢ ⁢ “ REJECT ” ⁢ ⁢ or ⁢ ⁢ “ INADEQUATE ”
a sterilization indicator information reader that uses a sterilization indicator sensor to read sterilization indicator information from a sterilization indicator associated with an item to be subjected to a sterilization cycle, the sterilization indicator forming at least a portion of a code, the sterilization indicator information indicating efficacy of the sterilization cycle to which the sterilization indicator was subjected;
an inventory data reader that uses a inventory data sensor to read inventory data encoded on an inventory data medium associated with the item; and
a processing unit coupled to the user interface, the sterilization indicator information reader, and the inventory data reader, wherein the processing unit:
receives the sterilization indicator information of the item from the sterilization indicator information reader and the inventory data of the item from the inventory data reader, and
associates the sterilization indicator information of the item with the inventory data of the item.
2. The system of claim 1, wherein the processing unit is configured to:
subsequently retrieve the sterilization indicator information of the item based on the associated inventory data of the item, and
indicate efficacy of sterilization of the item via the user interface based on the retrieved sterilization indicator information.
further comprising a plurality of inventory data readers coupled to the processing unit, each of the plurality of inventory data readers located at a respective one of a plurality of different inventory data reader locations and configured to read the inventory data from the inventory data medium associated with the item,
associates a location of the item with the inventory data based on the inventory data reader location of one of the plurality of inventory data readers that most recently read the inventory data from the inventory data medium associated with the item,
subsequently retrieves the location of the item based on the associated inventory data, and
indicates the retrieved location of the item via the user interface.
wherein the item comprises a pack that contains a plurality of medical articles to be subjected to the sterilization cycle, the medical articles comprising at least one of medical supplies, medical instruments, surgical instruments, or medical devices.
6. The system of claim 5, wherein the processing unit is configured to:
associate information identifying the medical articles contained by the pack with the inventory data for the item and the sterilization indicator information,
receive a request regarding one of the medical articles contained by the pack via the user interface,
in response to the request, retrieve the sterilization indicator information based on the inventory data for the item, and
indicate efficacy of sterilization of the one of the medical articles via the user interface based on the retrieved sterilization indicator information.
7. The system of claim 5, wherein the processing unit is configured to receive the information identifying the medical articles contained by the pack via the user interface.
8. The system of claim 5, further comprising a database that stores information identifying standard pack contents, wherein the processing unit is configured to receive the information identifying the medical articles contained by the pack from the database.
9. The system of claim 5, wherein the sterilization indicator comprises a second sterilization indicator located within the pack, and the sterilization indicator information reader uses a second sterilization indicator sensor to read the sterilization indicator information from the second sterilization indicator through the pack.
10. The system of claim 9, wherein the pack is opaque and closed.
11. The system of claim 9, wherein the sterilization indicator information reader reads at least one of a magnetic property of the second sterilization indicator as sterilization indicator information or a radio-frequency signal from the second sterilization indicator as sterilization indicator information.
further comprising a plurality of sterilization indicator information readers, each of the sterilization indicator information readers configured to read sterilization indictor information from a respective one of a plurality of different types of sterilization indicators,
receives respective sterilization indicator information from each of the sterilization indicator information readers,
associates the sterilization indicator information from each of the sterilization indicator information readers with the inventory data for the item,
subsequently retrieves the sterilization indicator information from each of the sterilization indicator information readers based on the associated inventory data, and
indicates efficacy of sterilization of the item via the user interface based on the retrieved sterilization indicator information.
21. The system of claim 20, wherein the plurality of different sterilization indicators are selected from:
an equipment control indicator;
an exposure control indicator;
a pack control indicator; and
a load control indicator.
22. The system of claim 1, wherein the processing unit is configured to prompt one or more users via the user interface to perform a multistep sterilization process that includes operating the sterilization indicator information reader to read sterilization indicator information from the sterilization indicator, and operating the inventory data reader to read the inventory data encoded on the inventory data medium associated with the item to be subjected to the sterilization cycle.
23. The system of claim 22, wherein the processing unit is further configured to receive user input configuring the multistep sterilization process.
24. The system of claim 22, wherein the processing unit is further configured to prompt the one or more users regarding at least one of:
incompatibility of the item or a medical article within the item with one or more sterilizers;
sterilization indicator placement;
pack contents; and
25. The system of claim 1, further comprising at least one database coupled to the processing unit, wherein the at least one database is configured to associate the sterilization indicator information and inventory data with at least one of patient names, surgeon names, surgical procedure numbers, surgical procedure types, or date of item use.
US12708849 1999-08-05 2010-02-19 Electronic system for tracking and monitoring articles to be sterilized and associated method Active 2020-05-02 US8492162B2 (en)
US11472671 Continuation US20060240563A1 (en) 1999-08-05 2006-06-22 Electronic system for tracking and monitoring articles to be sterilized and associated method
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