SYSTEM AND METHOD FOR REDUCING PATIENT RISK OF ALLERGIC REACTION TO CONTRAST AGENTS OR MEDICAL MATERIAL

• US 20100331673A1
• Filed: 06/26/2009
• Published: 12/30/2010
• Est. Priority Date: 06/26/2009
• Status: Abandoned Application

• Current Assignee: Siemens AG
• Original Assignee: Siemens AG
• Inventors: Hahn, Martin, Pringle, Michael, Maschke, Michael, Zahlmann, Gudrun
• Application Number:
  US12/492,299
• Publication Number:
  US 20100331673A1
• Time in Patent Office: Days
• US Class Current: 600/431
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 6/00 Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment instruments measuring radiation intensity for application in the field of nuclear medicine, e.g. in vivo counting, G01T1/161; apparatus for taking X-ray photographs G03B42/02
• CPC Class Codes: A61B 6/463 characterised by displaying multiple images or images and diagnostic data on one display
• CPC Class Codes: A61B 90/03 Automatic limiting or abutting means, e.g. for safety
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: A61M 2205/6009 for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 30/20 for handling medical images, e.g. DICOM, HL7 or PACS

Abstract

A system and method for improving safety in medical procedures where a substance is introduced into a patient is described. An in-vitro diagnostic (IVD) device may be used to measure the concentration of an analyte representing a marker and compare the measured concentration with a predetermined set point so as to determine whether an adverse reaction to the substance may be anticipated. The test data may be obtained at the point-of-service or retrieved from a patient data base. The device for administering the substance is enabled when the comparison of the test data with the predetermined set point indicates that the procedure is expected to be performed with an acceptable risk of an adverse reaction.

Claims

1. A system for improving patient safety, comprising:

a treatment device having at least two operating states; and

an interface for accepting an operating state switching command, wherein a first operating state inhibits the function of the device, and the second operating state enables the function of the device, and an operating state switching command is provided based on a comparison of an in-vitro diagnostic test data value with a pre-established set-point value.

2. The system of claim 1, wherein when the device is in the second operating state the device is caused to dispense a substance into the patient by a dispense command received through the interface.

3. The system of claim 1, wherein when the device is in the second operating state the device is caused to dispense a substance into the patient by activation of a switch.

4. The system of claim 1, further comprising an in-vitro diagnostic device (IVD).

5. The system of claim 4, wherein the IVD is a microfluidic device.

6. The system of claim 4, wherein the IVD performs an immunoassay.

7. The method of claim 4, wherein the IVD uses a lab-on-a-chip.

8. The method of claim 4, wherein the IVD uses a DNA micro-array.

9. The system of claim 1, wherein the interface includes a card reader for reading data from an in-vitro-diagnostic data card, and generating the operating state switching command based on a patient-specific set point value.

10. The system of claim 1, further comprising a computer communicating with a data base of patient data, the patient data including in-vitro diagnostic data.

11. The system of claim 10, wherein the set-point value is determined by a substance type to be dispensed into the patient.

12. The system of claim 11, wherein the set-point value is determined by a volume of the substance type to be dispensed into the patient.

13. A method of increasing patient safety, comprising the acts of:

determining a patient identity;

selecting a procedure to be performed on the patient, the procedure including the dispensing of a substance into the patient;

determining whether the patient has been tested for a sensitivity to the substance; and

where the patient has been tested for the sensitivity, determining whether a test data value is below a safety set-point value;

or,

where the patient has not been tested for the sensitivity, performing an in-vitro diagnostic test for the sensitivity and determining whether a test data value is below a safety set-point value; and

enabling a device for performing the procedure if the test data value is below the safety set-point value.

14. The method of claim 13, further comprising storing patient test data on a computer data base.

15. The method of claim 13, further comprises the step of:

retrieving patient test data from the computer data base.

16. The method of claim 15, wherein the step of retrieving patient test data further comprises:

obtaining the test data value from the computer data base over a local area network.

17. The method of claim 13, wherein in-vitro diagnostic test includes:

selecting a substance-specific diagnostic analyte type;

obtaining a sample of a bodily fluid; and

determining a value of the analyte type in the bodily fluid.

18. The method of claim 17, wherein the safety set-point value is selected based on the substance to be dispensed and the diagnostic analyte type

20. The computer program product of claim 18, wherein the set-point value is selected such that an in vitro test data value lower than the set point value is represents a safe situation.

19. A computer program product, stored on a machine readable medium, comprising:

instructions for configuring a computer to;

determine an identity of a patient;

accept a user input selecting a procedure to be performed on the patient, the procedure including dispensing of a substance by a device into the patient;

retrieve a procedure and substance specific safety set-point value from a memory;

determine whether the patient has been tested for a sensitivity to the substance using patient data retrieved from a data base; and

where the patent has been tested for the sensitivity, determine whether the test data value is below the safety set point value;

or,

where the patient has not been tested for the sensitivity, request an appropriate in-vitro diagnostic test, wait for results from the requested-vitro diagnostic test, and determine whether the test data value is below the safety set point value; and

transmit an enable command to the device if the test data value is below the safety set point value.