Smart sterilization tracker tag

• US 10,117,959 B2
• Filed: 06/07/2016
• Issued: 11/06/2018
• Est. Priority Date: 06/07/2016
• Status: Active Grant

• Current Assignee: General Electric Company
• Original Assignee: General Electric Company
• Inventors: Kuzelka, Russell James
• Primary Examiner(s): Nguyen, Phung
• Application Number:
  US15/175,561
• Publication Number:
  US 20170348452A1
• Time in Patent Office: 882 Days
• Field of Search: 3405721-5729, 34053912, 3405731, 340 1251
• CPC Class Codes: A61B 90/70 Cleaning devices specially adapted for surgical instruments
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• 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: G06K 7/10366 the interrogation device being adapted for miscellaneous applications

Abstract

In the present invention, a device, system and associated method is provided, as a compact, automated and self-contained data logger with capability of withstanding conditions used in sterilizing reusable medical device equipment/components. The device includes one or more sensors to automatically sense and store information on the parameters of various autoclave cycle(s) for the component associated with the tracking device and their respective timestamps of each autoclave cycle(s). This information is stored in a data record on the tracking device for the individual component. The data record can be used as evidence of valid sterilization cycles for the component and can also provide information for the host system and/or the user of the status for the component, including the last time the component was sterilized, the time between sterilization cycles, the time for replacement of the component, and too warn if the device was returned to service without proper sterilization.

Claims

1. A system for sensing and recording information concerning a sterilization status of a component of a medical device, the system comprising:

a sterilizable component;

a tracking tag secured to the component, the tag including a sterilization-resistant housing containing a microprocessor, a sensor connected to the microprocessor and configured to sense a sterilization parameter regarding the sterilization of the component, and an electronic storage unit connected to the microprocessor and configured to record data from the sensor on the sterilization status of the component, wherein the electronic storage unit is configured to record start point, end point and intervening point data for the sterilization parameter during a sterilization event; and

a medical device connectable to the component, the device including a central processing unit able to receive data stored on the tag regarding the sterilization status of the component.

2. The system of claim 1 wherein the tracking tag comprises a wireless network interface.

3. The system of claim 1 wherein the data on the sterilization status of the component comprises a time the component was last sterilized.

4. The system of claim 1 wherein the data on the sterilization status of the component comprises a time between sterilization cycles for the component.

5. The system of claim 1 wherein the data on the sterilization status of the component comprises an identifier of whether the component has not been subjected to proper sterilization.

6. The system of claim 1. wherein the data on the sterilization status of the component comprises a time for replacement of the component.

7. The system of claim 6 wherein the data on the time for replacement of the component includes a defined maximum number of autoclave cycles for the component and a number of actual autoclave cycles for the component recorded by the tag.

8. The system of claim 1 wherein the microprocessor is configured to receive data from the medical device for storage in the data record.

9. The system of claim 1 wherein the tag is adhesively secured to the component.

10. The system of claim 1 wherein the tag is directly formed as part of the component.

11. A tracking tag for a sterilizable medical device component, the tag comprising:

a sterilization-resistant housing;

a microprocessor;

at least one sensor connected to the microprocessor and configured to sense a sterilization parameter regarding the sterilization of the component;

an electronic storage unit connected to the microprocessor and configured to record data from the sensor on the sterilization status of the component, wherein the electronic storage unit is configured to record start point, end point and intervening point data for the sterilization parameter during a sterilization event, wherein the electronic storage unit also retains qualified sterilization parameter values for comparison by the microprocessor with the intervening point data for determining a sterilization status of the component; and

a wireless network interface operably connected to the microprocessor.

12. The tag of claim 11 further comprising a battery operably connected to the microprocessor.

13. The tag of claim 11 further comprising a wireless charging mechanism operably connected to the microprocessor.

14. A method of tracking the sterilization of a sterilizable component for a medical device, the method comprising the steps of:

providing a tracking tag including a sterilization-resistant housing containing a microprocessor, a sensor connected to the microprocessor and configured to sense a sterilization parameter regarding the sterilization of the component, and an electronic storage unit connected to the microprocessor and configured to record data from the sensor on the sterilization status of the component;

securing the tag to the component;

sterilizing the component and the tag; and

recording data concerning the sterilization event and status of the component within the tag

wherein the step of recording the data comprises;

sensing a sterilization event trigger;

recording start point, end point and intervening point data for the parameter during the sterilization event;

comparing the recorded intervening point sterilization event data to qualified parameter values for a validated sterilization event; and

storing the sterilization event data in a data record in the electronic storage unit.

15. The method of claim 14 further comprising the step of transmitting the data to a medical device utilized with the component for storage on the medical device.

16. The method of claim 14 further comprising the step of conducting and end of life determination on the component employing the sterilization event data.

17. The method of claim 14 further comprising the step of comparing the recorded sterilization event data to qualified entry and exit parameter values for a validated sterilization event.

18. The method of claim 17 further comprising the step of initiating an alarm on the medical device When the recorded sterilization event parameters do not meet the qualified entry and exit parameter values for a validated sterilization event.

19. The method of claim 14 further comprising the steps of:

connecting the sterilized component including the stored sterilization event data to the medical device for use with the device;

disconnecting the component from the medical device;

re-sterilizing the component and the tag; and

recording data concerning the re-sterilization event and status of the component within the tag.