Methods and apparatuses for assuring quality and safety of drug administration and medical products and kits

• US 20030074223A1
• Filed: 09/24/2002
• Published: 04/17/2003
• Est. Priority Date: 09/24/2001
• Status: Abandoned Application

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Cobb, Nicholas Edward, Hickle, Randall S.
• Application Number:
  US10/252,818
• Publication Number:
  US 20030074223A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: A61J 1/14 Details; Accessories therefor A61J7/00 takes precedence; openers B65D, B67B7/00
• CPC Class Codes: A61J 2205/10 Bar codes
• CPC Class Codes: A61J 2205/30 Printed labels
• CPC Class Codes: A61J 2205/50 using icons or symbolic figures, e.g. by a graphical representation symbolising the type of pathology or the organ by an image
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

The present invention provides apparatuses and methods for marking components, supplies and kits of drug administration devices and other medical systems with quality assurance information. The invention also provides apparatuses and methods for tracking time of use of such components, supplies and kits and various apparatuses and methods for preventing use or reuse of tainted, recalled or unrecognized components, supplies and kits. Quality assurance markers (QAMs) are described which store information regarding the identity and manufacturer of disposable components, supplies and kits. The invention utilizes several QAM modalities, such as, among others, 1-D and 2-D bar codes, 1-D and 2-D symbologies, holograms, written text, radio frequency identification devices (RFIDs), integrated chip smart cards, and EEPROMs.

Claims

1. A medical product marked with a quality assurance module, wherein said quality assurance module stores information relating to the product, said information comprising an identifier unique to the medical product and/or to the origin of the product.

2. The medical product according to claim 1, wherein said medical product is selected from the group consisting of a drug administration drug container, a drug administration cassette, and a drug administration kit.

3. The medical product according to claim 1, wherein said medical product is a drug container, and wherein said information further comprises information relating to properties of the drug container and the drug provided therein.

4. The medical product according to claim 3, wherein said information further comprises information selected from the group consisting of the concentration of the drug provided in the container, the drug mix, identification of the manufacturer of the drug and/or the container, an expiration date of the drug and/or the container, the dimensions of the container, the nominal drug volume when the container is full of drug, a network address.

5. The medical product according to claim 3, wherein the quality assurance module is printed on or affixed to an existing label on said drug container.

6. The medical product according to claim 3, wherein the quality assurance module is printed on or affixed directly on said drug container.

7. The medical product according to claim 3, wherein the quality assurance module is printed on or affixed to said drug container as part of a series of identical quality assurance modules repeated at regular intervals around the circumference of the container.

8. The medical product according to claim 1, wherein said medical product is a drug cassette, and wherein said information further comprises information relating to properties of the drug cassette.

9. The medical product according to claim 8, wherein said information further comprises information selected from the group consisting of identification of the manufacturer of the cassette, a product ID for the cassette, a lot number for the cassette, an expiration date for the cassette, the internal or dead space volume of drug flow channels associated with the cassette, and a value reflecting the flow resistance of drug flow channels associated with the cassette.

10. The medical product according to claim 8, wherein a drug container having a quality assurance module storing information relating to the container is coupled to the cassette, and wherein the quality assurance module of the cassette is positioned such that quality assurance modules of both the container and the cassette are within a common scan field of a reader device which senses the information stored on the modules.

11. The medical product according to claim 1, wherein the information is encrypted.

12. The medical product according to claim 11, wherein the encrypted information comprises an extra digit or character to the identifier.

13. The medical product according to claim 1, wherein said quality assurance module is a 1-D bar code.

14. The medical product according to claim 1, wherein said quality assurance module is a 2-D bar code.

15. The medical product according to claim 1, wherein said quality assurance module is a hologram.

16. The medical product according to claim 1, wherein said quality assurance module is a selection of written text.

17. The medical product according to claim 1, wherein said quality assurance module is a radio frequency identification device.

18. The medical product according to claim 1, wherein said quality assurance module is a magnetic strip.

19. The medical product according to claim 1, wherein said quality assurance module is a smart card.

20. The medical product according to claim 1, wherein said quality assurance module is an EEPROM.

21. The medical product according to claim 1, wherein said identifier is a serial number.

22. An integrated drug delivery system, said 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 drug delivery controller supplying one or more drugs to the patient;

at least one medical product removably coupled to the system, said product having a quality assurance module for storing information regarding the product, wherein the quality assurance module comprises an identifier unique to the medical product and/or to the origin of the product;

a reader device for reading information stored on the quality assurance module of said medical product;

a memory device storing a safety data set reflecting safe and undesirable parameters of at least one monitored patient physiological condition and reflecting safe and undesirable parameters of the medical product; and

an electronic controller interconnected between the patient health monitor, the drug delivery controller, the reader device, and the memory device storing the safety data set;

wherein said electronic controller receives said signals and in response manages the application of the drugs in accord with the safety data set.

23. The integrated drug delivery system of claim 22, wherein said drug delivery system is used for sedation and analgesia, deep sedation and/or general anesthesia.

24. The integrated drug delivery system of claim 22, wherein the information includes identifying information of the medical product, and wherein the managed delivery of drugs by the electronic controller comprises the acceptance or prevention of the use of the medical product based on the comparison of said identifying information to the information stored in the safety data set.

25. The integrated drug delivery system of claim 22, wherein the system further comprises a mechanism for altering the medical product in a particular way when the product is coupled with the system and a reuse detector which generates a signal based on the existence or absence of the particular alteration in the medical product when it is coupled with the system, and wherein the electronic controller is further interconnected with the reuse detector and receives the signal generated by the detector, wherein the managed delivery of drugs by the electronic controller comprises the acceptance or prevention of the use of the medical product based on the signal generated by the detector.

26. The integrated drug delivery system of claim 22, wherein the system further comprises a second medical product removably coupled to the system, said second product having a second quality assurance module for storing information regarding the second product.

27. The integrated drug delivery system of claim 26, wherein the reader is capable of sensing information stored on both quality assurance modules.

28. The integrated drug delivery system of claim 22, wherein the memory device further stores the identifier of the medical product once the product has been used with the system.

29. A drug delivery apparatus, said apparatus comprising:

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

at least one medical product removably coupled to the apparatus, said product having a quality assurance module for storing information regarding the product, wherein the quality assurance module comprises an identifier unique to the medical product and/or to the origin of the product.

30. A method of assuring quality, safety, and/or certified manufacture of a medical product to be used with a medical system, said method comprising the steps of tagging the medical product with a quality assurance module, wherein said quality assurance module comprises information related to the medical product including an identifier unique to the medical product and/or to the origin of the product;

sensing the information on the quality assurance module;

comparing the information to parameters, wherein the parameters are pre-defined as signifying quality, safety, and/or certified manufacture;

rejecting the use of the medical product with the medical system if said comparison suggests that the product is not of quality, safety, and/or certified manufacture.

31. The method according to claim 30, wherein said medical system is a drug administration system.

32. The method according to claim 31, wherein said drug administration system is used for sedation and analgesia, deep sedation and/or general anesthesia.

33. The method according to claim 30, wherein the information further includes one or more of a product ID for the product, a lot number for the product, an expiration date for the product, and the dimensions and characteristics of the product.

34. The method according to claim 30, said method further comprising the step of checking whether the medical product has been previously used with the medical system or other similar system.

35. The method according to claim 30, said method further comprising the step of checking whether the medical product is subject to a recall.

36. The method according to claim 30, said method further comprising the step of identifying a patient with whom a recalled product had inadvertently been used.

37. The method according to claim 30, said method further comprising the step of tracking the amount of time a medical product has been in use with the medical system and the step of determining the risk of contamination of the product based upon said amount of time.

38. The method according to claim 30, said method further comprising the step of monitoring whether a medical product presented for use with the medical system has been used prior to the presentation.

39. The method according to claim 30, said method further comprising the step of monitoring whether the medical product is presented for use with the medical system after the expiration date of the product.

40. The method according to claim 30, said method further comprising the step of sensing the information on the quality assurance module at the same time as sensing a quality assurance module on a second medical product to be used with the medical system.

41. A cassette for use with an intravenous infusion apparatus, wherein said cassette is removably attachable to the intravenous infusion apparatus, and wherein said cassette comprises a mechanical use indicator which undergoes alteration upon being attached or upon being removed from the infusion apparatus, and wherein the alteration of the use indicator is sensed by a use detector provided with the infusion apparatus.