Authorization scheme to minimize the use of unauthorized medical device disposables on a medical device instrument

• US 8,539,573 B2
• Filed: 02/19/2010
• Issued: 09/17/2013
• Est. Priority Date: 02/19/2010
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Newlin, Douglas, Krause, Kevin, Crampton, Robert, Foley, John T., Case, Brian, Cork, William
• Primary Examiner(s): MOORTHY, ARAVIND K
• Application Number:
  US12/708,964
• Publication Number:
  US 20110209212A1
• Time in Patent Office: 1,306 Days
• Field of Search: 726/17, 713/182, 600/300, 604/6.01
• US Class Current: 726/17
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: G05B 1/00 Comparing elements, i.e. elements for effecting comparison directly or indirectly between a desired value and existing or anticipated values
• CPC Class Codes: G06F 21/31 User authentication
• CPC Class Codes: G06F 21/44 Program or device authentication
• CPC Class Codes: G06F 21/629 to features or functions of an application
• CPC Class Codes: G06F 2221/2141 Access rights, e.g. capability lists, access control lists, access tables, access matrices
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04L 2209/80 Wireless network architectures or network communication protocols for wireless network security H04W12/00
• CPC Class Codes: H04L 2209/88 Medical equipments
• CPC Class Codes: H04L 63/08 for authentication of entities cryptographic mechanisms or cryptographic arrangements for entity authentication H04L9/32
• CPC Class Codes: H04L 63/083 using passwords cryptographic mechanisms or cryptographic arrangements for entity authentication using a predetermined code H04L9/3226
• CPC Class Codes: H04L 9/3226 using a predetermined code, e.g. password, passphrase or PIN network architectures or network communication protocols for supporting authentication of entities using passwords in a packet data network H04L63/083

Abstract

Systems, methods, apparatus, and computer readable media are provided for disposable component authentication with respect to a biological fluid processing device instrument. An example instrument authentication system includes a computer facilitating configuration and operation of the biological fluid processing instrument using a disposable component. A first interface is provided by the computer and is used by a service technician to configure the biological fluid processing instrument for a number of disposable components and to provide a service technician with a validation code. A key generator is to accept the validation code from the service technician and generate an authentication key in response to the entered validation code. A second interface is provided by the computer, the second interface prompting the service technician to enter an authentication key, wherein the authentication key authorizes use of a certain number of disposable components for the biological fluid processing instrument.

Claims

1. A method for authorizing use of a biological fluid processing instrument with a disposable component, the method comprising:

receiving the disposable component in the biological fluid processing instrument;

acknowledging communication between a controller computer and a validation computer in the biological fluid processing instrument;

accepting user input of an authentication key associated with the disposable component via an interface on the validation computer, the authentication key representing an authorized number of uses, the authentication key generated from a validation code in combination with a number of biological fluid processing disposables for the biological fluid processing instrument;

verifying the authentication key using the validation computer; and

disabling the biological fluid processing instrument upon a failure verifying the authentication key.

2. The method of claim 1, wherein the authentication key is provided with the disposable component.

3. The method of claim 1, wherein the biological fluid processing instrument comprises a controller computer and wherein a second computer acting as the validation computer must be in periodic communication with the controller computer for continued operations of the biological fluid processing instrument.

4. The method of claim 1, wherein disabling results in the biological fluid processing instrument entering a fault state, which requires a cycling of power to clear.

5. The method of claim 1, wherein user input is blocked while the biological fluid processing instrument is disabled.

6. The method of claim 1, further comprising facilitating continued operation of the biological fluid processing instrument upon successful communication between the controller computer and the validation computer and successful verification of the authentication key.

7. The method of claim 1, wherein verifying the authentication key using the validation computer occur after the disposable component has been primed.

8. The method of claim 1, wherein the authentication key verification is implemented completely in the validation computer apart from the controller computer.

9. The method of claim 8, wherein the interface accepting user input of the authentication key at the validation computer temporarily replaces an interface defined by the controller computer.

10. The method of claim 1, further comprising auditing a number of validated versus unvalidated disposable components used with the biological fluid processing instrument.

11. The method of claim 1, wherein the authentication key is provided via a data card.

12. The method of claim 11, wherein the data card stores a single use authentication key.

13. The method of claim 1, wherein the authentication key is provided via a radio frequency identifier.

14. The method of claim 13, wherein the radio frequency identifier provides a single use access to the biological fluid processing instrument.

15. The method of claim 1, wherein the authentication key is provided via a barcode.

16. The method of claim 1, wherein the authentication key is provided via at least one of a personal digital assistant and a mobile phone.

17. A biological fluid processing instrument disposable component authentication system, the system comprising:

a computer facilitating configuration and operation of the biological fluid processing instrument using a disposable component;

a first interface provided by the computer, the first interface used by a service technician to configure the biological fluid processing instrument for a number of disposable components and to provide a service technician with a validation code;

a key generator to accept the validation code from the service technician and generate an authentication key in response to the entered validation code;

a second interface provided by the computer, the second interface prompting the service technician to enter an authentication key, wherein the authentication key authorizes use of a certain number of disposable components for the biological fluid processing instrument.

18. The system of claim 17, wherein the biological fluid processing instrument comprises a controller and wherein the computer must be in periodic communication with the controller for continued operation of the biological fluid processing instrument.

19. The system of claim 17, wherein the validation code and authentication key are unique to the biological fluid processing instrument.

20. The system of claim 17, wherein the computer facilitates operation by a user of the biological fluid processing instrument using the disposable component upon successful verification of a number of authorized components remaining.

21. The system of claim 17, wherein the biological fluid processing instrument is disabled when the number of authorized components reaches zero.

22. The system of claim 17, wherein the validation code is provided using an authorization computer accessed by the service technician.

23. The system of claim 22, wherein the validation code includes a number of disposable components used on the biological fluid processing instrument.

24. The system of claim 17, wherein the number of disposable components is one.

25. The system of claim 17, wherein the validation code is to be provided via a single use data card.

26. The system of claim 17, wherein the validation code is to be provided via a single use radio frequency identifier.

27. The system of claim 17, wherein the validation code is to be provided via a single use barcode.

28. The system of claim 17, wherein the validation code is to be provided via at least one of a personal digital assistant and a mobile phone.

29. A non-transitory computer readable storage medium having set of instructions for execution on a computing device, the set of instructions, when executed, configure the computing device to implement a method for authorizing a biological fluid processing instrument procedure using a disposable component, the method comprising:

receiving a disposable component in a biological fluid processing instrument;

acknowledging communication between a controller computer and a validation computer in the biological fluid processing instrument;

accepting user input of an authentication key associated with the disposable component via an interface on the validation computer, the authentication key representing an authorized number of uses, the authentication key generated from a validation code in combination with a number of biological fluid processing disposables for the biological fluid processing instrument;

verifying the authentication key using the validation computer; and

disabling the biological fluid processing instrument upon a failure verifying the authentication key.

30. The computer readable medium of claim 29, wherein verifying the authentication key using the validation computer occurs after the disposable component has been primed.

31. The computer readable medium of claim 29, wherein the authentication key verification is implemented completely in the validation computer apart from the controller computer.

32. The computer readable medium of claim 29, wherein the authentication key is provided via at least one of a data card, a radio frequency identifier, a barcode, a personal digital assistant, a mobile phone and a disk-based medium.

33. The computer readable medium of claim 32, wherein the authentication key comprises a single use authentication key.

34. A method for authorizing use of a biological fluid processing instrument with a disposable component, the method comprising:

receiving the disposable component in the biological fluid processing instrument;

acknowledging communication between a controller computer and a validation computer in the biological fluid processing instrument;

accepting input of an authentication key via an interface on the validation computer, the authentication key associated with a number of authorized uses, the authentication key generated from a validation code in combination with a number of biological fluid processing disposables for the biological fluid processing instrument;

verifying the authentication key using the validation computer; and

authorizing use of the biological fluid processing instrument upon verification of the authentication key and the number of authorized uses.

35. The method of claim 34, wherein the authentication key is provided with the disposable component as a single use authentication key.

36. The method of claim 34, wherein the authentication key is rendered invalid after the number of uses has been exceeded, a count of the number of uses to increment after each authorized use of the biological fluid processing instrument.

37. The method of claim 34, wherein the authentication key is provided via at least one of a data card, a radio frequency identifier, a barcode, a personal digital assistant, a mobile phone and a disk-based medium.

38. A non-transitory computer readable storage medium including at least one of instructions and an identifier which, when acted upon by a processor, provide a biological fluid processing instrument authorization device comprising:

an authorization code associated with a disposable component to be used in a biological fluid processing instrument to processing biological fluid using the biological fluid processing instrument, the authorization code to be input via the computer readable medium and validated using a processor to authorize use of the biological fluid processing instrument with the disposable component for a defined number of uses, the authentication authorization code to be generated from a validation code in combination with a number of disposable units for the biological fluid processing instrument.

39. The computer readable medium of claim 38, wherein the defined number of uses is one.

40. The computer readable medium of claim 38, wherein the authorization code is rendered invalid after the defined number of uses has been exceeded.

41. The computer readable medium of claim 38, wherein the authorization code is provided via at least one of a data card, a radio frequency identifier, a barcode, a personal digital assistant, a mobile phone and a disk-based medium.