Abstract:
In one embodiment, a quality compliance system for a medical device includes at least one medical device configured to diagnose, monitor, or treat a medical condition, the at least one medical device configured to lockout operation of the at least one medical device, a refurbishment device configured to establish a communication link with the at least one medical device, generate electronic documentation of a maintenance or service procedure on the at least one medical device, provide for associating a digital signature of an operator with the generated electronic documentation, transmit the digital signature and generated electronic documentation, and unlock the medical device with a received key, and a service application configured to receive the transmitted digital signature and generated electronic documentation, verify the transmitted digital signature and generated electronic documentation, and transmit the key to the refurbishment device upon verification of the transmitted digital signature and generated electronic documentation.

Description:
[0001]    This application claims the benefit of U.S. Provisional Application No. 61/675,542 filed Jul. 25, 2012, the entire contents of which is herein incorporated by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This disclosure relates to systems used to ensure quality of refurbished medical devices. 
       BACKGROUND 
       [0003]    Medical devices are used for diagnosis, monitoring, and prevention or treatment of diseases. Some medical devices are designed to be temporarily used at a remote location such as the home of a patient. When the medical device is no longer needed by the initial patient, the medical device is retrieved from the initial patient and re-used by a second patient typically at a second location. By re-using medical devices, an issuer and the patients can realize significant savings. 
         [0004]    Prior to re-use, the medical devices are refurbished. Refurbishment includes extensive testing of the device and excising data related to the previous user. In the event that any of the components of the medical device are not in an acceptable condition, the component is replaced or refurbished. After repair or replacement of components, the medical device is typically retested. 
         [0005]    In some instances, testing and refurbishment of a medical device is most economically achieved by servicing the device in the field. In these instances, a field technician tests/replaces components and performs any needed maintenance procedures. Field technicians may further repair medical devices for continued use by the original patient. In both instances, known systems rely upon the field technician to properly test, repair, and return to service the medical device. 
         [0006]    While the use of field technicians to test/replace components can be very cost effective, known approaches to using field technicians do not include sufficient safeguards against technician error. Consequently, it is possible for a device to be returned to service which is not operating at an optimal level. 
         [0007]    What is needed is a system which provides increased quality assurance of the refurbishment/repair of medical devices. It would be advantageous if such a system was integrated with field repair/refurbishment procedures for medical devices. It would be further advantageous if the system ensured proper refurbishment prior to allowing the medical device to be returned to service. 
       SUMMARY 
       [0008]    The embodiments herein provide a system and method which can be used to ensure that a medical device at a remote location, such as at the home of a patient, is properly refurbished/serviced. 
         [0009]    In one embodiment, a quality compliance system for a medical device includes at least one medical device configured to diagnose, monitor, or treat a medical condition, the at least one medical device configured to lockout operation of the at least one medical device, a refurbishment device configured to (i) establish a communication link with the at least one medical device, (ii) generate electronic documentation of a maintenance or service procedure on the at least one medical device, (iii) provide for associating a digital signature of an operator with the generated electronic documentation, (iv) transmit the digital signature and generated electronic documentation, and (v) unlock the at least one medical device with a received key, and a service application configured to receive the transmitted digital signature and generated electronic documentation, verify the transmitted digital signature and generated electronic documentation, and transmit the key to the refurbishment device upon verification of the transmitted digital signature and generated electronic documentation. 
         [0010]    In another embodiment, a method of ensuring quality compliance for a medical device includes providing a medical device configured to diagnose, monitor, or treat a medical condition, locking out operation of the medical device, providing a refurbishment device, establishing a communication link between the refurbishment device and the medical device, generating electronic documentation of a maintenance or service procedure on the medical device using the refurbishment device, associating a digital signature of an operator with the generated electronic documentation using the refurbishment device, transmitting the digital signature and generated electronic documentation to a service application using the refurbishment device, verifying the transmitted digital signature and generated electronic documentation with the service application, transmitting a key from the service application to the refurbishment device upon verification of the transmitted digital signature and generated electronic documentation, and unlocking the medical device with the key using the refurbishment device. 
         [0011]    Other features of the embodiments herein will be apparent from the drawings, and detailed description that follows below 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  depicts a functional block diagram of a medical device quality compliance system; 
           [0013]      FIG. 2  depicts a functional block diagram of a medical device in the medical device quality compliance system of  FIG. 1 ; 
           [0014]      FIG. 3  depicts a functional block diagram of a refurbishment device in the medical device quality compliance system of  FIG. 1 ; and 
           [0015]      FIG. 4  depicts a method of ensuring quality compliance in refurbishment or servicing of a medical device. 
       
    
    
     DESCRIPTION 
       [0016]    For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and described in the following written specification. It is understood that no limitation to the scope of the invention is thereby intended. It is further understood that the present invention includes any alterations and modifications to the illustrated embodiments and includes further applications of the principles of the invention as would normally occur to one skilled in the art to which this invention pertains. 
         [0017]      FIG. 1  depicts a functional block diagram of a medical device quality compliance system  100 . The medical device quality compliance system  100  includes a medical device  102 , a patient management database  104 , a care manager application  106 , a service application  108 , a device master record and service database  110 , and a refurbishment device  112 . While only one medical device  102  is depicted, a typical medical device quality compliance system  100  includes multiple medical devices  102  of different types and models. 
         [0018]    As depicted in  FIG. 1 , each of the components of the medical device quality compliance system  100  is in communication with at least one other component in the system through a communication network. The communication network may include one or more wired or wireless communication systems such as a local area network (LAN), a wireless area network (WAN), a virtual private network (VPN), the internet, etc. Moreover, while depicted as separate components, one or more of the components may be realized in a single device. Specifically, one or more of the patient management database  104 , the care manager application  106 , the service application  108 , and the device master record and service database  110  may be co-located. Thus, for example, the patient management database  104  and the care manager application  106  may be stored in a common memory of a single server in some embodiments. 
         [0019]    The medical device  102 , also depicted in  FIG. 2 , may be for example a motorized wheelchair, a location monitoring system, a blood pressure monitoring system, a glucose monitoring system, an aspirator, a defibrillator, a continuous positive airway pressure (CPAP) system, or the like. The medical device  102  includes a functional module  120 , a communication module  122 , and a GPS receiver  124 . The functional module  120  includes components used for the primary function of the medical device  102  such as diagnosing, monitoring, or treating a disease. Thus, in the case of a CPAP device, the functional module  120  includes an air pump (not shown) that operates under the control of a processor (not shown) executing program instructions stored in a memory (not shown). 
         [0020]    The communication module  122  provides a communication link between the medical device  102  and the patient management database  104 . The communication module  122  may be a wireless connection or may be configured to be wired into a communication network. Accordingly, the communication link with the patient management database  104  in some embodiments is established automatically while in other embodiments the communication link is established only on an as-needed basis as discussed more fully below. 
         [0021]    The patient management database  104  is operably connected to and maintained by the care manager application  106 . The patient management database  104  stores individual medical device data which is received from the medical device  102 . Individual medical device data may include software version data, usage data, configuration data, etc. 
         [0022]    The care manager application  106  is operated by the care manager providing the medical device  102  to a user. The care manager application  106  includes various rules governing the use of the medical device including authorization for the device to be used as discussed more fully below. 
         [0023]    The service application  108  is controlled by a service manager who is responsible for field technicians who in turn provide services for the medical device  102 . The service application  108  controls/maintains the device master record and service database  110 . The device master record and service database  110  includes, for example, the various software versions used in the medical device  102  as well as a record of the appropriate software version to be installed on a particular type of medical device  102 . The device master record and service database  110  further includes data related to refurbishment processes and maintenance processes that are appropriate for the medical device  102 . 
         [0024]    The refurbishment device  112  is further depicted in  FIG. 3 . The refurbishment device  112  includes a digital camera  130 , a radio frequency identification (RFID) interrogator  132 , a GPS receiver  134 , a communication module  136 , and a user interface  138 . The communication module  136  is configured to establish communications with both the device master record and service database  110  and the medical device  102  as discussed more fully below. 
         [0025]    Additional details of the medical device quality compliance system  100  are provided along with discussion of a refurbishment/repair process  140  of  FIG. 4 . The process  140  begins at block  142  when the medical device  102  is provided to a patient. When the medical device  102  is initially provided, data related to the medical device  102  is stored in the medical device management database  104  which is maintained by the care manager application  106 . The patient then uses the medical device  102  (block  144 ) 
         [0026]    At block  146 , the medical device  102  is locked-out of service. A medical device  102  may be locked-out of service autonomously in response to a predetermined condition or in response to a lockout command from the care manager application  106 . For example, if a medical device  102  has exceeded a predetermined number of uses without required maintenance, the medical device  102  may autonomously lockout further operation of the device. Likewise, if a significant fault in the functional module  120  is detected, the medical device  102  may autonomously lockout further operation. In other embodiments, the care manager application  106  can control the medical device  102  to a locked-out condition for one or more of the above reasons, upon expiration of a service agreement, when a patient is dis-enrolled, when the patient no longer needs the medical device  102 , etc. 
         [0027]    After the medical device  102  has been locked-out, a notification is sent to the service application  108  that the medical device  102  has been locked-out (block  148 ). In one embodiment, the lockout message is transmitted from the medical device  102  to the patient management database  104 , to the device master record and service database, and then to the service application  108 . In another embodiment, the care manager application  106  initiates the lockout message. Depending upon the particular embodiment, the lockout message may include a request for service. The lockout message may include data indicating the reason that the medical device  102  has been locked-out. Thus, the lockout message may indicate a need for cleaning the previous patient data prior to providing the medical device  102  to a subsequent patient, a need for providing the latest software upgrade, a need to replace a component, or the need for retesting the medical device. 
         [0028]    Once the medical device  102  is locked-out, the medical device  102  cannot be further operated until a key is provided by the service application  108 . In order to accomplish unlocking of the medical device  102 , an operator or field technician with the refurbishment device  112  is deployed to the location of the medical device  102  (block  150 ). At block  152 , the refurbishment device  112  establishes communication with the medical device  102 . Establishment of communication in some embodiments is accomplished by a hardwire connection between the refurbishment device  112  and the medical device  102 . In other embodiments, the communication is wireless. 
         [0029]    The refurbishment device  112  then uses the RFID interrogator  132  to interrogate the medical device  102  to obtain identification of the medical device  102 . In some embodiments, the identification data is used to verify the correct medical device  102  is being refurbished by confirming the identity of the medical device  102  with identification data received from the care manager application  106 . In some embodiments, the identification data is stored in a memory and transmitted to the refurbishment device  112  through the communication module  122 . 
         [0030]    Once the medical device  102  has been identified at block  154 , the refurbishment device  112  establishes communication with the device master record and service database  110 . The device master record and service database  110  provides the most recent refurbishment/repair data for the particular type or model of medical device  102  to the refurbishment device  112  (block  156 ). In some embodiments, this data is provided prior to block  150 . 
         [0031]    The data provided to the refurbishment device  112  from the device master record and service database  110  includes a check list of processes involved in a refurbishment operation. The checklist may include steps related to upgrading software, replacing components, testing components, performing required regulatory checks, or performing maintenance on components. Consequently, as refurbishment/service is performed (block  158 ), the field technician confirms the refurbishment/service is conducted using the user interface  138  and the checklist(s) (block  160 ). Other refurbishment/service steps are verified electronically by the refurbishment device  112 . For example, proper installation of software upgrades may be verified electronically. 
         [0032]    In order to provide additional quality assurance, the RFID data obtained by the RFID interrogator is electronically affixed to the checklist. Thus, there is an electronic record of the precise medical device  102  which has been refurbished/serviced. 
         [0033]    One step in the checklists may require the use of the digital camera  130  to obtain images of the medical device  102 . The physical condition/status of the medical device  102  may thus be documented. Additionally, images may be acquired at various steps in component disassembly/repair. 
         [0034]    The documentation of the refurbishment/service may further be appended using the GPS receivers  124  and  134 . Data from the GPS receivers  124  and  134  can be used to confirm the amount of time that the medical device  102  and the refurbishment device  112  were in proximity. Additionally, data associated with the communication link between the two devices can be used for the same purpose. 
         [0035]    Once all of the necessary repairs/testing/maintenance has been properly documented using the refurbishment device  112 , the field technician digitally signs a field service record including all of the documentation of the refurbishment/service. The signed documentation is communicated to the device master record and service database  110  (block  162 ). Data indicating the present state of the medical device  102  is further communicated to the patient management database  104 . This data may be transmitted from the device master record and service database  110  or from the medical device  102 . 
         [0036]    Along with the electronic documentation, the refurbishment device  112  transmits an “unlock” request to the service application  108 . If the documentation satisfies all of the requirements, the service application  108  transmits a key to the refurbishment device  112  which can unlock the medical device  102  block  164 . Transmission of an unlock key may further be dependent upon acquiring a new service agreement, a new prescription, etc. At block  166 , the refurbishment device  112  uses the key to unlock the medical device  102 . 
         [0037]    Once the medical device  102  has been unlocked, the medical device  102  is returned to service, either at the original user location or at a different location. 
         [0038]    The above described embodiment thus provides a quality compliance system and method for the refurbishment process on a medical device which ensures that a refurbishment/service/maintenance process is properly performed on a medical device before the medical device is reused or redeployed to another patient. In different embodiments, the various steps may be performed in different orders. Moreover, depending upon the particular embodiment, some of the steps may be modified, combined, or omitted. 
         [0039]    The processes which can be documented by the above described embodiments include data cleaning process, device cleaning process, identity confirmation operations, device testing processed, and software updating process. 
         [0040]    In one embodiment, a locked medical device triggers a message to a field server (service application) indicating that the medical device is locked and also sends data explaining the basis for locking the medical device. The basis may be a need for cleaning patient data, a need for providing a software upgrade, or a need for retesting the medical device. A refurbishment device documents the refurbishing process electronically or manually. The refurbishment device checks the identity of the medical device and the status of the process steps taken after coupling with the medical device. The refurbishment device has a digital camera to confirm the appearance and the cleaning operation of the medical device. The location of the operator during the refurbishment operation is confirmed with a GPS receiver attached to the refurbishment device. 
         [0041]    While the invention has been illustrated and described in detail in the drawings and foregoing description, the same should be considered as illustrative and not restrictive in character. It is understood that only the preferred embodiments have been presented and that all changes, modifications and further applications that come within the spirit of the invention are desired to be protected.