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

• US 6,485,979 B1
• Filed: 08/05/1999
• Issued: 11/26/2002
• Est. Priority Date: 08/05/1999
• Status: Expired due to Term

• Current Assignee: 3M Innovative Properties Company (3M Company)
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Kirckof, Steven S., Bolea, Phillip A., Rumble, Richard M., Kippenhan, Roland C.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US09/369,098
• Time in Patent Office: 1,209 Days
• Field of Search: 422/58, 422/61, 422/82.08, 422/82.91, 422/55, 422/11, 422/28, 436/1, 436/164, 436/166, 436/169
• US Class Current: 436/1
• 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

A 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 method of monitoring articles to be subjected to a sterilization process comprising the steps of:

a) providing a sterilization indicator capable of providing information relating to the efficacy of a sterilization process, an article to be subjected to said sterilization process, a reading device capable of obtaining information from said sterilization indicator, and processing means for processing information associated with said sterilization indicator and said article;

b) subjecting said sterilization indicator and said article to said sterilization process;

c) reading information from the sterilization indicator with said reading device; and

d) associating information from said sterilization indicator with said article by said processing means.

2. A method according to claim 1, further including processing the information, and

then determining the effectiveness of the sterilization cycle.

3. A method according to claim 1, wherein the step of reading information from the sterilization indicator with said reading device includes the step of:

reading the magnetic property of the sterilization indicator.

4. A method according to claim 1, wherein the step of reading information from the sterilization indicator with said reading device includes the step of:

optically reading the color of a chemical indicator.

5. A method according to claim 1, wherein the step of reading information from the sterilization indicator with said reading device includes the step of:

reading fluorescence from the sterilization indicator.

6. A method according to claim 1, wherein the step of reading information from the sterilization indicator with said reading device includes the step of:

receiving radio frequency signals from the sterilization indicator.

7. A method according to claim 1, wherein the sterilization indicator is a biological indicator and the reading device is capable of reading fluorescence of the biological indicator.

8. A method according to claim 1, wherein the sterilization indicator is a chemical indicator forming at least a portion of a bar code and the reading device is a bar code reader.

9. A method according to claim 1, wherein the processing means is a computer capable of receiving, transmitting, and printing data relating to said article and said sterilization indicator.

10. A method according to claim 1, wherein the processing means is a hand held computer.

11. A method according to claim 1 wherein the step of reading information from the sterilization indicator includes the step of electronically communicating the information to said processing means.

12. A method according to claim 1 wherein the step of providing a sterilization indicator comprises the step of providing a chemical indicator within a substantially opaque, closed sterilization pack, and the step of reading information from the sterilization indicator includes the step of reading the chemical indicator through the opaque sterilization pack without opening the sterilization pack.

13. A method according to claim 1 wherein the step of associating information from said sterilization indicator with said article includes the step of determining whether the sterilization process has failed;

and

controlling the use of said article based upon the determination of whether the sterilization process has failed.

14. A method according to claim 1 wherein the step of associating information from said sterilization indicator with said article by said processing means comprises the steps of:

machine reading a code on said article and transferring the information to an inventory database in said processing means, and

machine reading a code on said sterilization indicator and transferring the information to a sterilization indicator database in said processing means.

15. A method according to claim 14 wherein the step of associating information from said sterilization indicator with said article by said processing means further includes the step of:

establishing a relationship between said sterilization indicator database and said inventory database.

16. A method according to claim 15 wherein the step of establishing a relationship between said sterilization indicator database and said inventory database includes the step of electronically linking said sterilization indicator and said inventory database.

17. A method according to claim 1 wherein the step of associating information from said sterilization indicator with said article by said processing means comprises the steps of:

manually keying in information concerning said article to an inventory database in said processing means, and

reading a bar code on said sterilization indicator and transferring the information to a sterilization indicator database in said processing means.

18. A method according to claim 17 wherein the step of associating information from said sterilization indicator with said article by said processing means further includes the step of:

communicating information between said inventory database and said sterilization indicator database.

19. A method according to claim 1 wherein the step of providing a sterilization indicator comprises the step of:

providing a readable code comprising a sterilizing agent sensitive means on said article, and said step of associating information from said sterilization indicator with said article by said processing means comprises the step of machine reading said code.

20. A method according to claim 1 wherein the step of providing a sterilization indicator and an article to be subjected to a sterilization cycle comprises the steps of:

providing a pack including a plurality of articles, and

providing a label on said pack that includes a readable code comprising a

sterilizing agent sensitive means; and

said step of associating information from said sterilization indicator with said article by said processing means comprises the step of machine reading said code.

21. A method of monitoring articles to be subjected to a sterilization process at a healthcare facility comprising the steps of:

a) providing a chemical indicator forming at least a portion of a code on a label, the chemical indicator being capable of providing information relating to the efficacy of a sterilization process, an article to be subjected to a sterilization process, a reading device capable of reading said chemical indicator, and computer means for managing information associated with said chemical indicator and said article;

b) subjecting said chemical indicator and said article to a sterilization process;

c) reading the code on the label to obtain information relating to the efficacy of the sterilization process with said reading device;

d) communicating information from said reading device to said computer means.

22. A method of tracking articles to be subjected to a sterilization process comprising the steps of:

providing a sterilization indicator capable of indicating whether a sterilization process has failed;

providing a computer;

storing information relating to the articles within memory of the computer;

placing the articles and the sterilization indicator within a substantially opaque sterilization pack and closing the pack;

subjecting the sterilization pack to a sterilization procedure;

reading the results of the sterilization indicator with a reading device;

determining whether the sterilization procedure has failed; and

controlling the use of said article based upon the determination of whether the sterilization process has failed.

23. A method according to claim 22 further including the step of outputting the determination of whether the sterilization cycle has failed to one or more of the group consisting of a display, recording device or other computer peripheral.

24. A system for monitoring an article to be subjected to a sterilization process comprising:

a) storage means for storing data on a storage medium;

b) first means for reading sterilization indicator data from a sterilization indicator under scrutiny and storing the sterilization indicator data in said storage medium;

c) second means for receiving inventory data associated with an article to be subjected to a sterilization cycle and storing the inventory data in said storage medium;

d) third means for establishing a relationship between said sterilization indicator data and said inventory data, and

e) processing means for determining whether the article to be subjected to a sterilization cycle may be used.

25. A system according to claim 24 further including a means for determining whether the sterilization cycle was an adequate sterilization cycle.

26. A system according to claim 24 wherein said first and second means are bar code readers.

27. A system according to claim 24 wherein said first means comprises a reader capable of detecting the fluorescence of a biological indicator and said second means is a bar code reader.

28. A system according to claim 24 wherein the processing means comprises means for preventing the use of said article in the event that the sterilization indicator indicates that the sterilization cycle was an inadequate sterilization cycle.

29. A system according to claim 24 wherein the first means and said processing means comprise an electronic circuit configured to retrieve information from a reference file in said storage means and calculate the closest match between the sterilization indicator data and said reference information.

30. A system according to claim 29 wherein the processing means comprise an electronic circuit configured to receive information from said match and store those results in a separate file in said storage means.

31. A system according to claim 24 wherein the electronic circuit is programmed to search files.