Electronic system for tracking and monitoring articles to be sterilized and associated method

• US 8,492,162 B2
• Filed: 02/19/2010
• Issued: 07/23/2013
• Est. Priority Date: 08/05/1999
• Status: Expired due to Fees

• Current Assignee: 3M Innovative Properties Company (3M Company)
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Kippenhan, Roland C., Kirckof, Steven S., Bolea, Philip A., Rumble, Richard M., Hehenberger, Rodney K., Ignacio, Ramon T.
• Primary Examiner(s): Xu, Robert
• Application Number:
  US12/708,849
• Publication Number:
  US 20100217620A1
• Time in Patent Office: 1,250 Days
• Field of Search: None
• US Class Current: 436/164
• CPC Class Codes: A61L 2/24 Apparatus using programmed or automatic operation
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: A61L 2202/14 Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: Y10T 436/102499 Blood gas standard or control
• CPC Class Codes: Y10T 436/15 Inorganic acid or base [e.g. , hcl, sulfuric acid, etc. ]

Abstract

An electronic system for tracking and monitoring articles to be subjected to a sterilization cycle is disclosed. The method uses a sterilization indicator and electronically links sterilization information with the articles subjected to the sterilization process. The indicator allows a sterilization cycle to be monitored without the need for a user to subjectively distinguish between color, quality or intensity of display patterns.

Claims

1. A system comprising:

a user interface;

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.

3. The system of claim 2, wherein the user interface is located remotely from the sterilization indicator information reader.

4. The system of claim 1,

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,

wherein the processing unit:

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.

5. The system of claim 1,

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.

12. The system of claim 1, wherein the item comprises at least one of a medical supply, medical instrument, surgical instrument, or medical device.

13. The system of claim 1, wherein the inventory data medium is attached to the item.

14. The system of claim 1, wherein the processing unit comprises a plurality of networked processing units.

15. The system of claim 14, wherein one of the processing units determines that the efficacy of the sterilization of the item was inadequate, and at least one other of the processing units provide a recall warning for the item in response to the determination.

16. The system of claim 1, wherein the inventory data comprises a bar code and the inventory data reader comprises a bar code reader.

17. The system of claim 1, wherein the sterilization indicator comprises at least one of a biological indicator or a chemical indicator.

18. The system of claim 17, wherein the sterilization indicator information reader detects fluorescence of the biological indicator as the sterilization indicator information.

19. The system of claim 17, wherein the sterilization indicator information reader optically reads a color of a chemical indicator as the sterilization indicator information.

20. The system of claim 17,

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,

wherein the processing unit:

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

pack assembly.

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.