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

• US 8,959,617 B2
• Filed: 03/15/2013
• Issued: 02/17/2015
• 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:
  US13/833,883
• Publication Number:
  US 20130222108A1
• Time in Patent Office: 704 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
• 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 medical instrument with a disposable component, the disposable component to be received in the medical instrument, the method comprising:

accepting input of an authentication key via an interface provided by a computer, the authentication key associated with a number of authorized uses, the authentication key generated from a validation code and a number of disposables for the medical instrument;

verifying the authentication key using the computer; and

authorizing use of the medical instrument upon verification of the authentication key.

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

3. The method of claim 1, wherein the authentication key is rendered invalid after the number of authorized uses has been exceeded, a count of the number of uses to increment after each authorized use of the biological fluid processing instrument.

4. The method of claim 1, 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.

5. The method of claim 1, wherein the interface is an RFID interface and the authentication key is received by the RFID interface.