Method for monitoring the use of a consumable in a disposable design in one or more analyzers

• US 9,377,452 B2
• Filed: 11/13/2008
• Issued: 06/28/2016
• Est. Priority Date: 11/13/2007
• Status: Active Grant

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Bartel, Arnold, Felsberger, Robert, Ruether, Horst, Steinboeck, Wolf-Dietrich
• Primary Examiner(s): PARK, HYUN D
• Application Number:
  US12/270,126
• Publication Number:
  US 20090151479A1
• Time in Patent Office: 2,784 Days
• Field of Search: 702/84
• US Class Current: 1/1
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

A method for monitoring the use of a consumable in a disposable design in multiple analyzers is disclosed. The method provides a disposable consumable; uses the consumable as intended during operation of the first analyzer; and collects usage-relevant information for the consumable concerning the intended use of the consumable during operation of the first analyzer. Usage-relevant data derived from the usage-relevant information is stored in a memory unit assigned to the consumable. The consumable may be removed and again provided in the first or second analyzer. The first or second analyzer partially reads the usage-relevant data from the memory unit, evaluates the usage-relevant data, and derives control signals concerning the permissibility and/or type of a further intended use of the consumable during operation of the analyzer as a reaction to the evaluation of the read usage-relevant data.

Claims

1. A method for monitoring the use of a consumable in a disposable design in multiple analyzers which are each configured to analyze one or more liquids, wherein the consumable is a liquid container or a reagent pack containing one or more functional fluids comprising reference materials having characteristic data and which have target concentrations of substances contained therein which degrade based on usage due to at least one of temperature and time, wherein the method comprises:

providing a disposable consumable in a first analyzer,

using the disposable consumable as intended during operation of the first analyzer,

collecting usage-relevant information for the disposable consumable which concern the intended use of the disposable consumable during operation of the first analyzer, wherein the collected usage-relevant information comprises information about one or more conditions of use for the intended use or further intended use of the disposable consumable which are chemical usage parameters and/or physical usage parameters,

storing usage-relevant data which are derived from the usage-relevant information in a memory unit assigned to the disposable consumable,

removing the disposable consumable from the first analyzer,

providing the disposable consumable in a second analyzer,

at least partially reading the usage-relevant data from the memory unit in the second analyzer,

evaluating the usage-relevant data that have been read out by a control device, and

deriving control signals concerning the permissibility or type of a further intended use of the disposable consumable during operation of the second analyzer as a reaction to the evaluation of the usage-relevant data that have been read out, and

re-adjusting in the second analyzer the characteristic data of the reference materials on the basis of the stored usage-relevant data that have been read out to account for degradation of the target concentrations of substances contained in the reference materials based on the usage in the first analyzer.

2. The method according to claim 1, further comprises, when the control signals indicate the permissibility of the continued intended use of the disposable consumable,

continuing the intended use of the disposable consumable during the operation of the second analyzer,

collecting further usage-relevant information which concern the further intended use of the disposable consumable during the operation of the second analyzer, and

storing of the further usage-relevant data which are derived from the further consumable-relevant information in the memory unit assigned to the disposable consumable.

3. The method according to claim 1, wherein data are derived from the usage-relevant data that are read out which influence the manner in which the disposable consumable is subsequently used as intended.

4. The method according to claim 1, wherein a user information indicating the inadmissibility of the further intended use of the disposable consumable is generated when the control signals indicate the inadmissibility of the further intended use of the disposable consumable.

5. The method according to claim 1, wherein further intended use of the disposable consumable in the second analyzer is prevented when the control signals indicate the inadmissibility of the further intended use of the disposable consumable.

6. The method according to claim 1, wherein the collected usage-relevant information and the collected further usage-relevant information comprises one or more information aspects selected from the following group of information aspects:

one or more conditions of use for the intended use or further intended use of the disposable consumable such as chemical usage parameters and/or physical usage parameters,

a period of use for the intended use or for the further intended use of the disposable consumable,

a period of non-use of the disposable consumable after it has been removed from the first analyzer,

a time at which the disposable consumable is inserted into the first or the second analyzer,

the actions carried out with the aid of the disposable consumable such as measuring cycles, calibration cycles, quality control cycles, cleaning cycles and/or standby phases, and

the amount consumed and/or extent of consumption of the disposable consumable during its intended use and/or during its further intended use.

7. The method according to claim 1, wherein when collecting usage-relevant information or when collecting further usage-relevant information, partial information is collected at time intervals.

8. The method according to claim 1, wherein the collection of usage-relevant information or the collection of further usage-relevant information takes place in each case before, during or after the intended use or the further intended use of the disposable consumable.

9. The method according to claim 1, wherein partial data are stored at intervals when storing usage-relevant data or storing further usage-relevant data.

10. The method according to claim 1, wherein the usage-relevant data are stored in the assigned memory unit before the disposable consumable is removed from the first analyzer or the further usage-relevant data are stored in the assigned memory unit before the disposable consumable is removed from the second analyzer.

11. The method according to claim 1, wherein after the disposable consumable has been provided in the first or the second analyzer, data that are independent of the usage or consumption of the disposable consumable continue to be read out.

12. The method according to claim 1, wherein the usage-relevant information or further usage-relevant information for the disposable consumable is collected with the aid of a monitoring device.

13. The method according to claim 12, wherein the monitoring device is in the form of a temperature sensor, a clock or a counting unit.

14. The method according to claim 1, wherein the storage of usage-relevant data or storage of further usage-relevant data in the memory unit assigned to the disposable consumable is stored with the aid of a writing device.

15. The method according to claim 1, wherein the usage-relevant data are at least partially read from the memory unit with the aid of a reading device.

16. The method according to claim 1, wherein the liquid is a body fluid.

17. The method according to claim 1, wherein the one or more functional fluids selected from the following group of fluids:

calibration solution, washing solution, reference liquid and reagent solution.

18. The method according to claim 1, wherein the physical usage parameter include information about at least one of:

a temperature to which the disposable consumable has been ex-posed during operation of the analyzer, an air humidity of the disposable consumable, a temperature-dependent substance concentration, and a time-dependent concentration change.

19. The method according to claim 1, wherein the chemical usage parameter includes information about a usage-specific analyte content of the disposable consumable.

20. The method according to claim 1, wherein the characteristic data of the reference materials is target concentrations of substances contained in the reference materials.

21. The method according to claim 1, wherein the reference materials are organic reference substances such as glucose or urea which are degraded at an accelerated rate at elevated temperatures.