Abstract:
A tracking code is adhered to a syringe label cradle for tracking each activity regarding the syringe label cradle, e.g., drug preparation, drug inventory, drug dispensing, drug administration, drug return, drug charges, etc. The tracking code may be in the form of bar or other machine readable code, as well as human readable indicia. The unique tracking code enables tracking of events pertaining to a specific syringe from the time of being prepared with a prescribed drug to its disposal or return to a hospital pharmacy. A log is created relating the patient to the specific drug used and all information inputted with respect to the tracking code.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]    The present application claims the benefit of U.S. Provisional Application No. 60/253,911, filed Nov. 29, 2000, the disclosure of which is hereby incorporated by reference herein. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    The present invention relates in general to a drug delivery system, and more particularly, to a unique tracking code associated with a medical device for use in drug delivery to a patient which enables the creation and retrieval of a data log relating the patient to the specific drug associated with the medical device and all patient and drug information/data stored in the system in association with the tracking code by the physician or other health care professional.  
           [0003]    Manual dispensing of drugs from a hospital pharmacy for administration to a patient is a common practice in hospitals and other surgical facilities. Pharmacy departments generally fill syringes with drugs, the drugs being administered to the patient with the documenting of the drug handling process being performed in a retrospective manner using handwritten entries by the physician or other health care professional. The likelihood of human imperfection makes drug diversion, medication errors, errors of admission, medication contamination and inadvertent needle sticks a constant companion to drug administration. Additionally, the process is exacerbated by emergency situations which demand hurried setup and administration of drugs, with concurrently less time to pay attention to timely and accurate record keeping. In the end, there is generally no complete record regarding the history of the syringe from the time of being filled to the time of its disposal or return to the pharmacy.  
           [0004]    Walker, et al., U.S. Pat. No. 5,651,775, assigned to the same assignee of the present application, which is incorporated herein by reference, discloses a drug delivery and monitoring system whereby drugs are safely delivered to a patient, monitored in real time during delivery and crucial events are recorded during delivery to provide on-line information and details for an audit trail. The basic components of the drug delivery and monitoring system include a scanning module, a syringe label cradle, a cassette tray and a drug injection port. The syringe label cradle is designed as a holder and positioner for a drug containing syringe. The syringe label cradle is constructed in a plurality of sizes to accommodate varying sizes of syringes to provide a constant needle height of the combined unit independent of the syringe volume, i.e., syringe barrel diameter. The syringe is positioned within the cradle and preferably securely affixed thereto by a self adhesive, preprinted label. The label provides drug identification indicia and drug preparation information such as drug dosage and concentration which can be in the form of human and/or machine readable indicia such as bar code and the like. The information on the label is automatically read into the system from the label using, for example, an optical bar code scanning module.  
           [0005]    A plurality of syringe label cradle units, i.e., combination syringe label cradle and syringe, are placed within a cassette tray for transport and storage prior to, during and after use. Generally, the cassette tray is organized to hold the syringe label cradles and drug loaded syringe in a logically progressive array. In use, the cassette tray is aligned with the injection port which is most commonly connected to a patient-connected needleless IV injection set. The scanning module incorporates bar code or other digital indicia scanners to read the labels affixed to the syringe label cradle. Information contained on the label is in the nature of a code identifying, for example, the drug contained in an associated syringe, size of the syringe, syringe type, preparer of the drug and any expiration date associated with the drug. The scanning module also is used to monitor the syringe plunger movement as the drug is administered, thus acquiring drug administration dynamics in real-time, i.e., determining delivery rate and volume of administered drugs.  
           [0006]    There is the desirability for further improvements in a drug administration system which provides a variety of medical devices, e.g., preloaded syringes and IV ports, with machine readable and/or human readable coded information enabling the tracking and accurate recording of the event history of the medical device, e.g., in the case of a syringe from the time of being filled to the time of its disposal or return to the pharmacy.  
         SUMMARY OF THE INVENTION  
         [0007]    The tracking code system of the present invention may be used for a variety of medical applications and devices including, but not limited to injected drugs as noted herein. Broadly, the term “medical device” as used herein means any syringe application, IV ports, pill containers, drug vials, drug ampules, non-injectable drugs and fluids, whether intravenously or otherwise, all of which can be monitored using the tracking code system of the present invention. Specifically, the present invention uses a tracking code associated with a syringe cradle label unit and/or a port cradle label unit as to be more fully described hereinafter.  
           [0008]    As discussed in Walker, et al., the syringe label cradle (SLC) is a single use product constructed to hold a syringe that is specific by size and manufacturer. A family of SLCs has been developed for use with common syringes of standard sizes. The SLC and attached syringe which form a syringe cradle label unit are encoded with a patient-specific tracking code. By way of one example, the tracking code is in the form of a machine readable bar code. The bar coded SLC incorporates a unique numeric field of, for example, 22 characters. The encoding takes place in the pharmacy or other designated preparation area, and a bar code label is mounted on the SLC flange. The SLC is then matched with the appropriate standard syringe and placed in administration sequence in a cassette tray. The encoded SLC provides accurate drug delivery data and digital tracking.  
           [0009]    The tracking code in the form of a bar code is computer generated utilizing a time stamp and drug identification information. Each activity in which the SLC participates, e.g., drug preparation, drug inventory, drug dispensing, drug administration, drug return, drug charge or credit, etc., will be recorded and related to the unique tracking code. The tracking code enables tracking of events pertaining to a specific syringe or other medical device such as an IV port attached to a patient. Each time an SLC is utilized to deliver a drug to a patient, a log is created relating the patient to the specific drug used and all information contained in the respective patient and drug data bases. Relating the data bases via the tracking code enables specific drug use to be tracked. This can prove useful in FDA drug recalls as well as in narcotic control and drug research, both of which are important areas of pharmacy practice. Federal and state law requires narcotic control. The host data base server retrieves the detailed stored information regarding the medication about to be administered, e.g., name, concentration, expiration date/time, technician preparer, etc. This information can reside on either the server itself or on a remote network server, i.e., Ethernet/network implementation.  
           [0010]    In accordance with one embodiment of the present invention there is described a medical device for the administration of a drug, the device comprising a source of a drug to be administered to a patient, a holder for the source, and a tracking code operatively associated with the source.  
           [0011]    In accordance with another embodiment of the present invention there is described a syringe label cradle unit comprising a syringe label cradle, a syringe attached to the cradle, and a tracking code affixed to at least one of the cradle and the syringe.  
           [0012]    In accordance with another embodiment of the present invention there is described a port label cradle unit comprising a port label cradle, an IV port attached to the cradle, and a tracking code affixed to at least one of the cradle and the IV port.  
           [0013]    In accordance with another embodiment of the present invention there is described a method for tracking data associated with a medical device adapted for the administration of a drug to a patient, the method comprising providing a source of a drug to be administered to a patient, associating a tracking code with the source, providing date associated with the drug to be administered, and storing the data in association with the tracking code.  
           [0014]    In accordance with another embodiment of the present invention there is described a method for tracking data associated with a medical device adapted for the administration of a drug to a patient, the method comprising providing a source of a drug to be administered to a patient, affixing the source in a cradle, providing a label having a bar code corresponding to a tracking code affixed to at least one of the source and the cradle, identifying data associated with the drug and the patient, storing the data in association with the tracking code on a storage device, and retrieving the data from the storage device in response to the tracking code.  
           [0015]    In accordance with another embodiment of the present invention there is described a system for tracking data associated with a medical device adapted for the administration of a drug to a patient, the device comprising a cradle, a source of a drug to be administered to a patient attached to the cradle, a tracking code associated with at least one of the cradle and the source, and a storage and retrieval device for storing and retrieving data related to the drug in association with the tracking code.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]    The above description, as well as further objects, features and advantages of the present invention will be more fully understood with reference to the following detailed description of a drug delivery device incorporating a tracking code, when taken in conjunction with the accompanying drawings, wherein:  
         [0017]    [0017]FIG. 1 is a perspective diagrammatic illustration of a drug administration and monitoring device using a syringe cradle label unit and a port cradle label unit associated with a tracking code in accordance with the present invention;  
         [0018]    [0018]FIG. 2 is a front elevational view of a syringe cradle label unit having a label printed with a tracking code affixed to a flange of the cradle in accordance with one embodiment of the present invention;  
         [0019]    [0019]FIG. 3 is a front elevational view of a port cradle label unit having a label printed with a tracking code affixed to a flange of the cradle in accordance with one embodiment of the present invention; and  
         [0020]    [0020]FIG. 4 is a diagrammatic illustration of a medical data and information storage and retrieval system embodying a medical device incorporating a medical device having a tracking code in accordance with one embodiment of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0021]    In describing the preferred embodiments of the subject matter illustrated and to be described with respect to the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected and is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.  
         [0022]    Referring to the drawings, wherein like reference numerals represent like elements, there is shown in FIG. 1 a drug administration and monitoring device generally designated by reference numeral  10 . The device  10 , as illustrated by way of one example, is a peripheral device for intravenous medication delivery that combines digital imaging and bar code scanning technologies. The device  10  automatically records drug delivery in real time and allows instant interaction with patient and drug data bases. This alerts the clinician before an impending adverse drug reaction or medication error can occur. A device  10  of the foregoing type is available from MedDoc, Inc. of Mobile, Ala. sold under the mark DocuJect.  
         [0023]    The device  100  includes a housing  102  which contains the electronic components and other microelectronic modules, for example, a microprocessor, memory devices, input/output devices, etc. The housing  102  supports a display  104 , for example, a liquid crystal display. The display  104  is functional to provide the physician or health care professional with the display of information and data during operation of the device  100 . The device  100  includes a scanning module  106  containing an optical or other scanning device which removably supports in operative relationship a syringe label cradle (SLC)  108  to which there is attached a syringe  110  and a port label cradle (PLC)  112  to which there is attached a patient IV port  114 . A detailed description of the basic construction, functions and operation of the device  100  in administering a drug from a syringe is more fully described in the aforementioned Walker, et al. patent.  
         [0024]    As shown in FIG. 2, the SLC  108  is a single-use product designed to hold varying sizes of syringes  110 . The syringe  110  is removably attached to the SLC  108  by means of a configured cradle  116 . The combined SLC  108  and syringe  110  will be referred to hereinafter as the syringe label cradle unit (SLCU)  117 . The SLC  108  includes a generally planar flange  118  supporting one or more slide engagement members  120 . The slide engagement members  120  are received within a corresponding portion of the scanning module  106  permitting longitudinal movement of the SLC  108  within the scanning module, as well as positioning the needle of the syringe  110  into operative association with the patient&#39;s IV port  114 . A more detailed description of the SLC  108  and SLCU  117  is described in the Walker, et al. patent, as well as in co-pending U.S. application Ser. No. 09/454,184 entitled, “Syringe For Use in a Drug Delivery System”, filed on Dec. 3, 1999 in the name of Evans, et al. and assigned to the same assignee of the present application, the disclosures of which are incorporated herein by reference.  
         [0025]    Referring to FIG. 3, the PLC  112  includes a configured cradle  122  and IV tubing holder  123  which allows for the removable attachment of a patient IV port  114 . The combined PLC  112  and IV port  114 , and optionally the tubing holder  123  will referred to hereinafter as the port label cradle unit (PLCU)  125 . The cradle  122  and tubing holder  123  are supported at one end of a planar flange  124  which is of similar construction to flange  118 . One or more slide engagement members  126 , similar to slide engagement members  120 , are attached to the free end of flange  124 . The slide engagement members  126  enable the PLC  112  to be longitudinally and slidingly received within the scanning module  106  in juxtaposition to the SLCU  117 , see FIG. 1. The PLC  112  is a single-use product that secures the patient IV port  114  of the IV line in position to accept selected SLCUs  117  for drug injection. The PLC  112  also stabilizes the syringe  110  to provide an accurate and reliable reading of syringe plunger movement by the device  100 . In a like manner, the SLC  108  stabilizes the syringe  110  in the appropriate position for accurate scanning of the syringe plunger movement for determining drug administration.  
         [0026]    The PLC  112  assists in greatly reducing needle stick accidents by eliminating the need for clinicians to handle the injection port  114  of the IV line each time they inject a medication. The PLC  112  also affords protected IV access, thereby reducing contamination that may lead to nosocomial infections. A more detailed description of the construction and application of the PLC  112  with respect to the device  100  is described in co-pending U.S. application Ser. No. 09/813,547 entitled “Drug Delivery and Monitoring System” filed on Mar. 21, 2001 in the name of Evans and assigned to the same assignee of the present application, the disclosure of which is incorporated herein by reference.  
         [0027]    The tracking code system of the present invention will now be described for illustrative purposes with reference to an SLCU  117  having an SLC  108  and syringe  110  for illustrative purposes. It is to be understood that the tracking code system can be adapted to other medical devices, such as the PLCU  125 . In accordance with the present invention, the syringe  110  and the contained drug is associated with a tracking code which may be presented in machine and/or human readable form. By way of example, the tracking code may be in the nature of a bar code  128  which is readily readable by an optical scanner such as the scanning module  106 . The tracking code may also be represented by human and machine readable alpha and numeric numbers and characters, as well as combinations thereof. The tracking code can be used for tracking all activities relating to a specific drug loaded syringe  110 , for example, drug preparation, patient data, physician and pharmacist identification, diagnosis, date, drug inventory, drug dispensing, drug administration, drug return, drug credit or charge, etc. The tracking code can be associated with an electronic information and data log that relates the patient to the specific medication and drug data bases. The tracking code provides a useful tool in FDA drug recalls, as well as in narcotic control and drug research, as well as facilitating compliance with federal and state law requiring narcotic control.  
         [0028]    The encoding of the SLCU  117  typically takes place in the pharmacy where a printed label containing the tracking code is applied to the flange  118  of the SLC  108 . However, it is contemplated that the tracking code label can, in addition or in the alternative, be applied to the cradle  116  or directly to the syringe  110  if so desired. In lieu of a label, it is also contemplated that the tracking code can be printed directly on the flange  118 , cradle  116  and/or syringe  110  using any suitable printing ink which will print and adhere to the polymer material of these components. By way of one embodiment, the tracking code is in the nature of a unique numeric field of 22 characters presented as a machine readable bar code. In addition to the tracking code, other bar coded information may be provided on the label which can be read by the scanning module  106 . For example, the additional information can provide direct identification of drug name, drug concentration, patient name, hospital billing information, pharmacist&#39;s name, date of filling the syringe, drug administration information, etc. This additional bar coded information is further described in the Walker, et al. patent. In a similar manner, a tracking code and other bar code or other form of machine readable information may be applied to the PLC  112  for a similar purpose.  
         [0029]    Referring to FIG. 4, there is diagrammatically illustrated an integrated network system as one example of one application of the use of a tracking code in accordance with one embodiment of the present invention. The network system is centered around a data base network server  130  such as those commercially known in the industry for the storage and retrieval of large amounts of information and data received and accessed from multiple locations. A physician or other health care professional, after ascertaining the need for one or more drugs, places an order for same by any suitable means with a pharmacy. The prescription is filled at a pharmacy work station  132  which includes a printer  134 , a bar code label printer  136 , a bar code scanner  138  and a drug administration device  100 , all of which are connected to a desktop computer  140  including a touch screen monitor  142 . The pharmacy workstation  132  also includes a supply of SLCs  108 , syringes  110  of various sizes, vial/ampule kits and standardized drug trays. The drug tray is used for transport and secure storage of the prefilled, labeled SLCU  117 , and drug vial/ampule kits.  
         [0030]    The pharmacy workstation  132  facilitates preparation, e.g., loading, labeling and documentation of the prefilled syringes  110  and bar coded SLCs  108  and drug vial/ampule kits in a controlled, clean environment. The bar coded label may be scanned using the bar code scanner  138  to associate the tracking code with specific patient information stored on the data base server  130  which was entered by the pharmacists using the computer  140 . Similarly, drug information such as drug name, concentration, time of preparation, etc. can also be associated with the tracking code by entering same into the data base server  130  under the tracking code. This is the first step in the creation of a medication administration record during the peri-operative process using the tracking code.  
         [0031]    For each drug to be administered, the pharmacist prepares a kit containing the drug and an SLC  108  with a label printed with the unique tracking code. The kit may also include a syringe  110  of the appropriate size. A storage cart, for example an anesthesia cart, is filled with drug kits that have been prepared by the pharmacist. The anesthesia cart can be delivered to the particular location of drug administration, for example, operating rooms, patient anesthesia care units and the like. The physician will remove a drug kit from the anesthesia cart and prepare the medication by drawing up the drug into the appropriately sized syringe  110 . The syringe  110  will be placed into the SLC  108  which has been previously labeled with the appropriate tracking code. The SLCU  117  can now be inserted into the drug administration device  100  for reading the tracking code and for administering the drug to the patient through, for example, an IV port  114  in the manner described in Walker, et al. and the &#39;547 Application.  
         [0032]    The tracking code is now attached to a specific SLCU  117  and is associated with a specific patient and syringe  110 , which information is entered into the data base server  130  as if the SLCU had been originally prepared by the pharmacist at the pharmacy workstation  132 . It is also contemplated that the SLCU  117  may be prepared by the pharmacist at the pharmacy workstation  132  and provided to the physician for drug administration to the patient using the drug administration device  100 . In either event, the SLCU  117  will be identified by a unique tracking code. In preparing the SLC  108  or SLCU  117 , the pharmacist or other health care professional enters into the data base server  130  relevant data which is associated with the tracking code. For example as previously noted, patient information, drug name, concentration, volume, date, pharmacist&#39;s name, hospital name, time, physician name, and any other desired information may be entered into the data base, e.g., into the data base network server  130 . This information may be entered by means of the computer  140  or any other suitable data input device.  
         [0033]    The SLCU  117  is adapted for administration of a drug to a patient through the patient IV port  114 . Drug administration may occur, for example, in an operating room  144 , a post anesthesia care unit  146  (PACU), or other location intended for drug administration. The operating room  144  or PACU  146  are equipped with a drug administration system  148  each including a drug administration device  100 , a bar code scanner  138 , a printer  134 , a computer  140  and monitor  142 . As shown, the pharmacy workstation  132 , operating room  144  and PACU  148  are connected to the data base server  130  by any suitable means, such as an internal network system. However, it is also contemplated that communication with the data base server  130  may be accomplished by any suitable means, for example, a wireless preop workstation  149 , such as using infrared, microradio communications and the like. It is further contemplated that the drug administration system  148  can be made portable such as on a self-contained utility cart which can be moved about, for example, from patient room to patient room or other locations as noted above where the drug administration system  148  is intended to be used.  
         [0034]    The SLCU  117  and PLCU  125  are inserted into the drug administration device  100  which allows the bar code corresponding to the tracking code or other bar coded information to be read. The tracking code queries the data base server  130  to identify the syringe  110  and IV port  114 , which may also include, for example, drug name, patient name, concentration, volume, date, pharmacist, etc. as well as information about possible adverse drug events. This information can be returned and generally displayed on the monitor  142  or display  104 . At this time, the physician can dispense the drug from the syringe  110  whose needle has been inserted into the IV port  114 . As the syringe plunger is depressed, the drug administration device  100  will monitor drug administration in real time as described in the Walker, et al. patent. The drug delivery information, i.e., quantity and time of delivery, can be automatically uploaded to the data base server  130  and stored along with the information which is associated with the tracking code for the SLCU  117  and/or PLCU  125 . When completed, the SLCU  117  can be returned to the pharmacy workstation  132  for disposal of the returned drug. At this point, it is possible to verify the returned volume remaining in the syringe  110  against the automatically recorded dose given by the physician which is identified under the tracking code for the SLCU  117 .  
         [0035]    The physician or other health care professional can access data from the data base network server  130  from any one of a number of remote locations, for example, the pharmacy workstation  132 , operating room  144 , PACU  148 , etc. By entering the unique tracking code, all information entered and associated with the tracking code can be displayed on the monitor  142  and printed to obtain a permanent record. The data base network server  130  may be accessed by other than through use of the drug administration system  148 . For example, a physician in his office  149  either at the hospital or off-site may access the data base network server  130  through a hospital firewall  150  which is connected to the data base server through a router  152 . The physician may access the data base network server  130  via the Internet, telephone modem or other suitable communications links.  
         [0036]    In a similar way, other hospital computer management systems  154 , for example, a surgical scheduling system, hospital lab system, hospital pharmacy system, hospital patient management and accounting system, etc. can be connected to the data base server  130  through a network switch  156  which is connected to a hospital interface engine  158 . Accordingly, data to and from the data base server  130  may be accessed from a variety of remote locations by entering the unique tracking code. By inputting the tracking code, all information entered into the data base network server  130  relating to the tracking code which corresponds to an SLCU  117  or PLCU  125  can be retrieved. Thus, the history of the SLCU  117  from its birth in the pharmacy workstation  132  to its return to the pharmacy workstation can be monitored at any time during the life cycle of the SLCU. The physician or other health care provider need only enter the unique tracking code to obtain a real time report as to all events that have taken place with respect to the SLCU  117  or PLCU  125  and all data and information which have been related to the tracking code.  
         [0037]    Although the invention herein has been described with reference to particular embodiments, it is to be understood that the embodiments are merely illustrative of the principles and application of the present invention. It is therefore to be understood that numerous modifications may be made to the embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the claims.