Smart supplies, components and capital equipment

• US 20020188259A1
• Filed: 05/21/2002
• Published: 12/12/2002
• Est. Priority Date: 05/21/2001
• Status: Active Grant

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S., Lampotang, Samsun
• Granted Patent: US 7,299,981 B2
• Time in Patent Office: Days
• US Class Current: 604/189
• CPC Class Codes: A61J 1/14 Details; Accessories therefor A61J7/00 takes precedence; openers B65D, B67B7/00
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61M 16/183 Filling systems
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6027 Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: B65D 2203/10 Transponders
• CPC Class Codes: B65D 23/14 of tags , labels, cards, coupons, decorations or the like B65D23/008 takes precedence
• CPC Class Codes: G06K 19/0723 the record carrier comprising an arrangement for non-contact communication, e.g. wireless communication circuits on transponder cards, non-contact smart cards or RFIDs
• CPC Class Codes: G06K 19/073 Special arrangements for circuits, e.g. for protecting identification code in memory protection against unauthorised use of computer memory G06F12/14
• CPC Class Codes: G06K 19/07749 the record carrier being capable of non-contact communication, e.g. constructional details of the antenna of a non-contact smart card
• CPC Class Codes: G06K 19/07758 arrangements for adhering the record carrier to further objects or living beings, functioning as an identification tag
• CPC Class Codes: G06K 19/0776 the adhering arrangement being a layer of adhesive, so that the record carrier can function as a sticker
• CPC Class Codes: G06K 19/07798 part of the antenna or the integrated circuit being adapted for rupturing or breaking, e.g. record carriers functioning as sealing devices for detecting not-authenticated opening of containers electronic seals G09F3/03
• CPC Class Codes: G06Q 10/087 Inventory or stock management, e.g. order filling, procurement or balancing against orders
• CPC Class Codes: G06Q 20/203 Inventory monitoring

Abstract

The present invention relates to capital equipment units, such as systems for providing medical treatment, that are associated with smart supplies. The smart supplies are tagged with data carriers which may encode such information as a unique ID for the supply or component, the identification of the supply or component, the identification of the source of the supply or component, the status of whether said supply or component has been previously used, the expiration date of the supply or component, and in the case where the supply or component contains drug, the purity levels of the drug and the concentration levels of the drug. The capital equipment units or their users then utilize the information to assure quality of any procedure run with the units, by way of improved pre-use checks, certification of the supplies for use, record keeping, inventory control, and charge capture.

Claims

1. A medical supply or component comprising a generic data carrier tag, said tag being associated with said medical supply or component and providing information regarding said medical supply or component, said information comprising one or more of the following:

a unique ID for the supply or component, identification of the supply or component, identification of the source of the supply or component, purity levels of any drug contained in the supply or component, concentration levels of any drug contained in the supply or component, status of whether said supply or component has been previously used, a batch number of the supply or component, a date of manufacture of the supply or component, an address where updated information on said supply or component can be obtained, number of recorded use cycles and recommended number of use cycles for the supply or component, and an expiration date of the supply or component.

2. The medical supply or component according to claim 1, wherein said medical supply or component is a container containing a drug and wherein said tag provides information identifying said drug.

3. The medical supply or component according to claim 2, wherein said tag comprises a radio-frequency identification circuit incorporated into a label of said container.

4. The medical supply or component according to claim 1, wherein said tag is a radio-frequency identification or electrical circuit that is provided with mechanical means for updating said information provided by said tag.

5. The medical supply or component according to claim 4, wherein said mechanical means for updating said information provided by said tag is a conductive element that is adapted to be severed when said medical supply or component is used or readied for use.

6. The medical supply or component according to claim 1, wherein said medical supply or component is a package containing a second medical supply or component, and wherein said tag further provides information regarding said second medical supply or component, said information comprising one or more of the following:

a unique ID for the supply or component, identification of the supply or component, identification of the source of the supply or component, purity levels of any drug contained in the supply or component, concentration levels of any drug contained in the supply or component, status of whether said supply or component has been previously used, a batch number of the supply or component, a date of manufacture of the supply or component, an address where updated information on said supply or component can be obtained, number of recorded use cycles and recommended number of use cycles for the supply or component, and an expiration date of the supply or component.

7. The medical supply or component according to claim 6, wherein said tag comprises a radio-frequency identification circuit that is provided with mechanical means for updating said information provided by the tag wherein said mechanical means is a conductive element that is adapted to be severed when said second medical supply or component is removed from said package.

8. The medical supply or component according to claim 1, wherein said tag comprises a radio-frequency identification circuit that allows said information to be updated electronically.

9. The medical supply or component according to claim 8, wherein said medical supply or component is contained in a package that is constructed in a manner and from a material that shields the tag so as to prevent information from being updated.

10. The medical supply or component according to claim 1, wherein said tag comprises an electronic data transmitter of a type selected from the group consisting of a radio frequency identification circuit, an EEPROM, and a readable magnetic strip.

11. An electronically tagged medical supply or component, said supply or component comprising at least one of a mechanical use indicator and a generic electronic data carrier tag, said tag having a first data set that represents information regarding said medical supply or component, and said tag further having a second data set having values dependent upon the physical status of said mechanical use indicator, wherein said first data set and said second data are readable by an electronic data reader or reader/writer.

12. The medical supply or component according to claim 11, wherein said tag is attached to packaging of said medical supply or component and utilizes a data carrier mechanism selected from the group consisting of a radio frequency identification, EEPROM, and magnetic strips.

13. The medical supply or component according to claim 11, wherein said electronic data reader utilizes said first and second data sets to determine according to a predetermined set of rules how a system connected to said reader or reader/writer utilizes said medical supply or component.

14. The medical supply or component according to claim 11, wherein said first data set is read-only.

15. The medical supply or component according to claim 14, wherein said read-only data set represents information regarding at least an identification of said disposable medical supply or component to a medical care system connected to said electronic data reader.

16. The medical supply or component according to claim 11, wherein said tag is a radio frequency identification tag and is inductively coupled to said electronic data reader.

17. The medical supply or component according to claim 11, wherein said tag is a radio frequency identification tag and is capacitively coupled to said electronic data reader.

18. The medical supply or component according to claim 11, wherein said first data set can be electronically written to by said electronic data reader/writer to record a change in a status of said medical supply or component.

19. The medical supply or component according to claim 18, wherein said change in status relates to the status of said medical supply or component as used or unused.

20. The medical supply or component according to claim 18, wherein said change in status relates to the use status of said medical supply or component as the number of uses of the supply or component.

21. The medical supply or component according to claim 18, wherein said change in status relates to the use status of said medical supply or component as the expiration date of the supply or component.

22. The medical supply or component according to claim 11, wherein said mechanical use indicator comprises a breakable conductive loop connected to said tag wherein said loop assigns said second data set a first value when intact and a second value when broken.

23. The medical supply or component according to claim 22, wherein said breakable conductive loop comprises conductive material applied on a breakable seal wherein said breaking of said seal to use said medical supply or component causes said conductive loop to be broken.

24. The medical supply or component according to claim 22, wherein said first data set is read-only.

26. The medical treatment system according to claim 25, wherein said information provided by said tag can be altered electronically via a signal generated by said electronic data reader.

27. The medical treatment system according to claim 26, wherein said system further comprises a shielded region that prevents said tag from being altered electronically via a signal generated by said electronic data reader when said medical supply or component is placed within the shielded region.

28. The medical treatment system according to claim 27, wherein said shielded region is a metallic drawer.

29. The medical treatment system according to claim 25, wherein said tag is inductively coupled to said electronic data reader during use of said medical supply or component with said medical treatment system.

30. The medical treatment system according to claim 25, wherein said tag is capacitively coupled to said electronic data reader during use of said medical supply or component with said medical treatment system.

31. The medical treatment system according to claim 25, wherein said information provided by said tag has multiple values dependent upon the physical status of a mechanical use indicator.

32. The medical treatment system according to claim 31, wherein said mechanical use indicator comprises a breakable conductive loop connected to said tag wherein said information comprises a first value when said loop is intact and a second value when said loop is broken.

33. The medical treatment system according to claim 31, wherein said breakable conductive loop comprises conductive material applied on a breakable seal wherein said breaking of said seal to use said medical supply or component or ready said medical supply or component for use causes said conductive loop to be broken.

34. The medical treatment system according to claim 25, wherein said tag is attached to packaging of said medical supply or component and utilizes a data carrying mechanism selected from the group consisting of radio frequency identification tags, EEPROM devices, and magnetic strips.

35. The medical treatment system according to claim 25, wherein said medical supply or component is a container containing a drug and wherein said tag comprises information identifying said drug.

36. The medical treatment system according to claim 35, wherein said patient treatment apparatus performs a pre-use check of said medical supply or component using said information provided by said tag.

37. The medical treatment system according to claim 35, wherein said tag is a radio-frequency identification circuit incorporated into a label of said drug container.

38. The medical treatment system according to claim 25, wherein said electronic data transmitter comprises an EEPROM having read-write memory wherein said information provided by said tag can be altered electronically via a signal generated by said electronic data reader/writer.

39. The medical treatment system according to claim 25, wherein said electronic data reader stores said information representing said change in status of said medical supply or component in a database.

40. The medical treatment system according to claim 39, wherein said database is located on an external computer network that is electronically connected to said electronic data reader.

41. The medical treatment system according to claim 40, wherein said information representing said change in status of said medical supply or component that is stored in said database is used for inventory tracking of said medical supply or component.

42. The medical treatment system according to claim 25, wherein said medical treatment system is a sedation and analgesia delivery system.

43. The medical treatment system according to claim 26, wherein said medical treatment system is a sedation and analgesia delivery system.

44. The medical treatment system according to claim 27, wherein said medical treatment system is a sedation and analgesia delivery system.

45. The medical treatment system according to claim 28, wherein said medical treatment system is a sedation and analgesia delivery system.

46. The medical treatment system according to claim 29, wherein said medical treatment system is a sedation and analgesia delivery system.

47. The medical treatment system according to claim 30, wherein said medical treatment system is a sedation and analgesia delivery system.

48. The medical treatment system according to claim 31, wherein said medical treatment system is a sedation and analgesia delivery system.

49. The medical treatment system according to claim 32, wherein said medical treatment system is a sedation and analgesia delivery system.

50. The medical treatment system according to claim 33, wherein said medical treatment system is a sedation and analgesia delivery system.

51. The medical treatment system according to claim 34, wherein said medical treatment system is a sedation and analgesia delivery system.

52. The medical treatment system according to claim 35, wherein said medical treatment system is a sedation and analgesia delivery system.

53. The medical treatment system according to claim 36, wherein said medical treatment system is a sedation and analgesia delivery system.

54. The medical treatment system according to claim 37, wherein said medical treatment system is a sedation and analgesia delivery system.

55. The medical treatment system according to claim 38, wherein said medical treatment system is a sedation and analgesia delivery system.

56. The medical treatment system according to claim 39, wherein said medical treatment system is a sedation and analgesia delivery system.

57. The medical treatment system according to claim 40, wherein said medical treatment system is a sedation and analgesia delivery system.

58. The medical treatment system according to claim 41, wherein said medical treatment system is a sedation and analgesia delivery system.

60. The electronic tag according to claim 59, wherein said breakable conductive element is formed from conductive material on a breakable seal.

61. The electronic tag according to claim 60, wherein said first signal represents that said tagged object is unused and said second signal represents that said tagged object has been used.

62. The electronic tag according to claim 60, wherein said first signal represents that a package of said tagged object is sealed and said second signal represents that a package of said tagged object has been opened.

63. The electronic tag according to claim 59, wherein said electronically readable data transmitter comprises a radio frequency identification tag.

64. The electronic tag according to claim 59, wherein said electronically readable data transmitter comprises an EEPROM.

65. The electronic tag according to claim 59, wherein said electronically readable data transmitter comprises a readable magnetic strip.

66. The electronic tag according to claim 59, wherein said electronic data transmitter and said breakable conductive element are integrated into a tearable label such that tearing of said label causes said breakable conductive element to be broken.

67. The electronic tag according to claim 66, wherein said tearable conductive element is adapted to be affixed to the packaging of a medical supply or component kit so as to provide information regarding contents of said kit as well as provide an indicator as to whether said kit has been opened.

68. The electronic tag according to claim 65, wherein said medical supply or component kit is for use with a sedation and analgesia system.

69. The electronic tag according to claim 66, wherein said electronic data transmitter comprises a read/write memory such that said previously stored data can be altered and said tearable label is adapted to serve as a tamper-evident seal and electronic inventory of an item selected from the group consisting of a medical apparatus, medical equipment storage device, resuscitation kit, medical kit, sedation and analgesia kit, sedation and analgesia resuscitation kit, drug or equipment container, and a drug or equipment package.

70. The electronic tag according to claim 59, wherein said electronic data transmitter comprises a read/write memory such that said previously stored data can be altered by a user of a product attached to said tag or by a reader/writer device.

71. The electronic tag according to claim 59, wherein said electronic data transmitter comprises a read-only memory such that said previously stored data cannot be altered by a user of said tag or by a reader/writer device.

25. A medical treatment system, comprising a patient treatment apparatus, at least one electronic data reader or reader/writer, and at least one medical supply or component, said medical supply or component having a writable generic electronic data carrier tag, said tag adapted to provide information through said electronic data reader for use by said patient treatment apparatus, and said tag being further adapted to store information representing a change in status of said medical supply or component.

59. An electronic tag for storing and providing information regarding a tagged object, comprising an electronically readable data transmitter coupled to a breakable conductive element, said data transmitter being adapted to transmit previously stored data regarding said tagged object, and said breakable conductive loop causes a first signal to be transmitted with said previously stored data when said breakable conductive material is intact and a second signal to be transmitted with said previously stored data after said breakable conductive material is broken.

72. A method for electronically monitoring the status of tagged items, comprising affixing to each of said tagged items an electronically readable identification tag, said identification tag being adapted to transmit information regarding a particular tagged item, said information including the use status of said tagged item, and transmitting said information and said use status to a tag reader.

73. The method for electronically monitoring the status of tagged items according to claim 72, wherein said identification tag comprises a mechanical means for detecting whether said tagged item has been used.

74. The method for electronically monitoring the status of tagged items according to claim 72, further comprising cataloguing said transmitted information and said transmitted use status for purposes of monitoring the inventory of said tagged items.

75. The method for electronically monitoring the status of tagged items according to claim 72, wherein said information related to an information type selected from the group consisting of product authentication, inventory control numbers, content information, expiration dates, and purity levels.

76. A method for automating the performance of pre-use checks on a plurality of medical treatment supplies for use with a medical treatment apparatus, said method comprising:

affixing to each of said items an electronically readable identification tag, said identification tag being adapted to store information regarding each particular tagged item, said information at least including the use status of said tagged item;

attaching to said medical treatment apparatus means for reading said information stored on each electronically readable identification tag, said means for reading said information being adapted to read any tagged medical treatment supply or component being attached to said medical treatment apparatus for use by said medical treatment apparatus;

installing one or more of said tagged medical treatment supplies on said medical treatment apparatus such that said installed supplies may be used by said medical treatment apparatus;

reading said information stored on each electronically readable identification tag associated with each tagged medical supply or component with said means for reading; and

providing an indication representative of the current status of each medical treatment supply or component to an operator of said medical treatment apparatus.

77. The method according to claim 76, wherein said reading is prior to each use of said medical treatment apparatus.

78. The method according to claim 76, wherein said reading is after powering on said medical treatment apparatus.

79. The method according to claim 76, wherein said reading is after any tagged medical treatment supply or component is installed for use with said medical treatment apparatus.

80. The method according to claim 76, wherein said electronically readable identification tags are affixed to the packaging of said medical treatment supplies.

81. The method according to claim 80, wherein said identification tags comprise radio frequency identification circuit incorporated into a label of said medical treatment supplies.

82. The method according to claim 76, wherein said information comprises data types selected from the group consisting of a unique ID for the tagged item, identification of the tagged item, identification of the source of the tagged item, purity levels of any drug contained in the tagged item, concentration levels of any drug contained in the tagged item, status of whether said tagged item has been previously used, a batch number of the tagged item, a date of manufacture of the tagged item, an address where updated information on said tagged item can be obtained, number of recorded use cycles and recommended number of use cycles for the tagged item, and an expiration date of the tagged item.

83. The method according to claim 76 further comprising after each use of said medical treatment supply or component updating the information stored on each electronically readable identification tag.

84. The method according to claim 76, wherein said medical treatment apparatus is a sedation and analgesia delivery apparatus.

85. The method according to claim 77, wherein said medical treatment apparatus is a sedation and analgesia delivery apparatus.

86. The method according to claim 78, wherein said medical treatment apparatus is a sedation and analgesia delivery apparatus.

87. The method according to claim 79, wherein said medical treatment apparatus is a sedation and analgesia delivery apparatus.

88. The method according to claim 80, wherein said medical treatment apparatus is a sedation and analgesia delivery apparatus.

89. The method according to claim 81, wherein said medical treatment apparatus is a sedation and analgesia delivery apparatus.

90. The method according to claim 82, wherein said medical treatment apparatus is a sedation and analgesia delivery apparatus.

91. A care system for alleviating patient pain, anxiety and discomfort associated with medical or surgical procedures 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 single-use supply or component removably connected to said system, wherein said supply or component includes a data carrier tag;

a recognition device that reads information carried on said data carrier tag and that generates a signal reflecting the information, wherein said information comprises one or more of the following;

a unique ID for the supply or component, identification of the supply or component, identification of the source of the supply or component, purity levels of any drug contained in the supply or component, concentration levels of any drug contained in the supply or component, status of whether said supply or component has been previously used, a batch number of the supply or component, a date of manufacture of the supply or component, an address where updated information on said supply or component can be obtained, number of recorded use cycles and recommended number of use cycles for the supply or component, and an expiration date of the supply or component;

a memory device storing a safety data set reflecting safe and undesirable parameters of at least one monitored patient physiological condition and reflecting certification parameters for said supply or component; and

an electronic controller interconnected between the patient health monitor, the drug delivery controller, the recognition 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.

92. The care system according to claim 91, wherein said supply or component is a propofol vial.

93. The care system according to claim 91, wherein said supply or component is an infusion pump drug cassette.

94. The care system according to claim 91, wherein said supply or component is a set of infusion tubing.

95. The care system according to claim 91, wherein said supply or component is an O2 cannula.

96. The care system according to claim 91, wherein said supply or component is a resuscitation kit.

97. The care system according to claim 91, wherein said supply or component is a set of ECG pads.

98. The care system according to claim 91, wherein said supply or component is an earpiece adapted for use by a patient.

99. A capital equipment unit, said unit comprising:

at least one supply or component removably connected to said unit, wherein said supply or component includes a data carrier tag; and

an electronic data reader or reader/writer that reads information carried on said data carrier tag and that generates a signal reflecting the information, wherein said information comprises one or more of the following;

a unique ID for the supply or component, identification of the supply or component, identification of the source of the supply or component, purity levels of any drug contained in the supply or component, concentration levels of any drug contained in the supply or component, status of whether said supply or component has been previously used, a batch number of the supply or component, a date of manufacture of the supply or component, an address where updated information on said supply or component can be obtained, number of recorded use cycles and recommended number of use cycles for the supply or component, and an expiration date of the supply or component.

100. The capital equipment unit according to claim 99, wherein said information provided by said tag can be altered electronically via a signal generated by said electronic data reader/writer.

101. The capital equipment unit according to claim 100, wherein said unit further comprises a shielded region that prevents said tag from being altered electronically via a signal generated by said electronic data reader/writer when said component is placed within the shielded region.