User authorization system and method for a sedation and analgesia system

• US 7,578,802 B2
• Filed: 05/16/2003
• Issued: 08/25/2009
• Est. Priority Date: 05/16/2002
• Status: Expired due to Fees

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US10/439,323
• Publication Number:
  US 20040039257A1
• Time in Patent Office: 2,293 Days
• Field of Search: 600/300, 600/544, 604/131, 604/67, 604/890.1, 604/891.1, 604 65- 66, 463/29
• US Class Current: 604/131
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 2205/609 Biometric patient identification means
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

The present invention comprises a security system integral with a sedation and analgesia system. The invention includes a computer assisted IV drug infusion administration device coupled with a secure user interface, or other security means, that can restrict and monitor user access to prevent unauthorized or improper use of the device. The system can also provide varying levels of access to the device so that different users may have different levels of access to system operations. The variety of access levels may prevent accidental or intentional misuse of the drug delivery system, while still permitting access to the required functionality. Data, such as usage statistics and procedural events associated with drug delivery, may be recorded in association with a user'"'"'s personal identification information to help identify training needs and to identify possible misuse of access information.

Claims

1. A sedation and analgesia system comprising:

a patient health monitor device adapted so as to be coupled to a patient and generate a signal reflecting at least one physiological condition of the patient;

a user interface allowing a user to enter inputs;

a drug delivery controller supplying one or more drugs to the patient;

an electronic controller operably connected to the patient health monitor, and the drug delivery controller, wherein said electronic controller receives said signal and in response manages the application of the drugs in accord with stored parameters of at least one monitored patient physiological condition; and

a security system incorporated into said user interface that requires said user to input authorized personal identification information so as to restrict unauthorized use of said sedation and analgesia system, wherein information related to negative procedural events during the use of said sedation and analgesia system is recorded in association with said authorized personal identification information of said user and said information related to negative procedural events is used to determine future authorization of said user, and wherein administrative access to the sedation and analgesia system is separable from access to features of the sedation and analgesia system related to drug delivery and/or patient care.

2. The sedation and analgesia system according to claim 1, wherein said security system comprises a security prompt that requires said user to input said authorized personal identification information before said sedation and analgesia system is enabled for operation.

3. The sedation and analgesia system according to claim 2, wherein data relating to said authorized personal identification information is stored in a memory device associated with said sedation and analgesia system.

4. The sedation and analgesia system according to claim 3, wherein said authorized personal identification information is at least one of a personal identification number, a retinal scan, a fingerprint, a biometric scan, a voice recognition command, and a magnetic strip identification card.

5. The sedation and analgesia system according to claim 3, wherein said authorized personal identification information is transmitted to said sedation and analgesia system via wireless communications.

6. The sedation and analgesia system according to claim 3, wherein said security system comprises a plurality of security levels that permits access to varying functionalities of said sedation and analgesia system.

7. The sedation and analgesia system according to claim 6, wherein said plurality of security levels includes a maintenance access level, an administration access level, and a clinician access level.

8. The sedation and analgesia system according to claim 3, wherein general data relating to the use of said sedation and analgesia system is recorded in association with said authorized personal identification information of said user.

9. The sedation and analgesia system according to claim 8, wherein said general data comprises at least one of a duration of use by said user, a number of times said user has accessed said sedation and analgesia system, a time of day said user accessed said sedation and analgesia system, and information related to administration of drugs.

10. The sedation and analgesia system according to claim 8, wherein said general data comprises system failures, such that training needs can be identified for said user associated with said data.

11. A method of operating a sedation and analgesia system comprising the steps of:

connecting to a patient a drug delivery device having a drug delivery controller supplying one or more drugs, said drug delivery controller being coupled to an electronic controller which controls the delivery of the drugs to the patient;

attaching at least one patient health monitor device to a patient, which health monitor device generates a value reflecting at least one physiological condition of a patient and is coupled to said electronic controller;

inputting into a security system identification information of an authorized user to enable operation of said sedation and analgesia system;

accessing a safety data set reflecting parameters of at least one patient physiological condition;

delivering the drugs to the patient in accord with the safety data set, and

recording information related to negative procedural events during the use of said sedation and analgesia system in association with said security system identification information wherein said information related to negative procedural events is used to determine future authorization of said user, and wherein administrative access to said information is separable from access to features of the sedation and analgesia system related to drug delivery and/or patient care.

12. The method of operating a sedation and analgesia system according to claim 11, further comprising the step of pre-programming said security system to accept particular authorized identification information.

13. The method of operating a sedation and analgesia system according to claim 12, wherein data relating to said authorized identification information is stored in a memory device associated with said sedation and analgesia system.

14. The method of operating a sedation and analgesia system according to claim 13, wherein said authorized identification information is at least one of a personal identification number, a retinal scan, a fingerprint, a biometric scan, a voice recognition command, and a magnetic strip identification card.

15. The method of operating a sedation and analgesia system according to claim 13, wherein said authorized identification information is transmitted to said sedation and analgesia system via wireless communications.

16. The method of operating a sedation and analgesia system according to claim 13, wherein said security system comprises a plurality of security levels that permits access to varying functionalities of said sedation and analgesia system.

17. The method of operating a sedation and analgesia system according to claim 16, wherein said plurality of security levels includes a maintenance access level, an administration access level, and a clinician access level.

18. The method of operating a sedation and analgesia system according to claim 13, wherein general data relating to the use of said sedation and analgesia system is recorded in association with said authorized identification information of said user.

19. The method of operating a sedation and analgesia system according to claim 18, wherein said general data comprises at least one of a duration of use by said user, a number of times said user has accessed said sedation and analgesia system, a time of day said user accessed said sedation and analgesia system, and information related to administration of drugs.

20. The method of operating a sedation and analgesia system according to claim 18, wherein said general data comprises system failures, such that training needs can be identified for said user associated with said data.