Patent Publication Number: US-2004041839-A1

Title: Method and apparatus for electronically managing, manufacturing, and testing of a medical device in accordance with a set of regulatory provisions

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
     [0001] The present application is a non-provisional and claims priority of provisional U.S. Ser. No. 60/408,109 filed Sep. 3, 2002. 
    
    
     
       BACKGROUND OF INVENTION  
       [0002] The present invention relates generally to manufacturing and testing of medical equipment and, more particularly, to a method and apparatus for electronically managing the manufacture and testing of a device in accordance with strict regulatory provisions.  
       [0003] During the manufacturing and testing of a device, assemblers, technicians, engineers, and the like typically use a set of instructions on how to assemble and test a product. These work instructions must be revision-controlled and easily accessible to the technicians as well as the support engineers who are responsible for updating the work instructions during the manufacturing and testing of the device. To ensure that the device is assembled and/or tested in accordance with regulatory provisions, there must a strict discipline with regard to maintaining and deploying the work instructions. This is particularly true during the manufacturing and testing of medical equipment that must be manufactured and tested in accordance with strict guidelines set forth by the Food and Drug Administration. Thus, there is a need to develop a platform by which digitized work instructions are maintained through a regulatory compliant tool that can enforce rules regarding the maintenance, updating, and accessing of the work instructions.  
       [0004] During the assembling and/or testing of a device, device history records are corrected and maintained. A number of issues surround the collection and authentication of paper device history records. Specifically, the use of paper based device history records are susceptible to completion of a device history record without proper authorization, falsified signature or outdated information, misplacement or accidental destruction, as well as, issues surrounding maintaining the voluminous device history records often associated with manufacturing and testing a complex device such as an imaging scanner. Therefore, there is need to manage and maintain the collection of data for device history records that helps ensure the authentication of data as well as comply with regulatory provisions.  
       [0005] As indicated previously, maintenance and collection of device history records may be prone to error especially when maintaining and collecting voluminous device history records. These concerns are magnified when considering the extent of data and information often associated with each device history record. For example, when completing a device history record associated with a particular test of the device, test data must be collected from the device and included in the device history record. Not only is the importation of test data from the device to a device history record time-consuming but is also prone to errors considering the extent and complexity of the test data. Moreover, with the manual completion and updating of a device history record associated with a test of the device, it is imperative that a technician or engineer be cognizant that a test has, in fact, been completed. If a test of the device is run and a device history record is not completed or updated as a result of that test, regulatory provisions may have been violated. Thus, there is a need to automatically detect and verify that a test has been run in accordance with regulatory provisions, as well as automatically collect testing data from the device and import that data to a device history record.  
       [0006] Therefore, it would be desirable to design an electronic manufacturing and testing tool that facilitates the maintenance as well as compliance of manufacturing and/or testing instructions associated with the device as well as provide a system whereby data associated with the actual manufacturing and testing of the device is efficiently, systematically, and precisely maintained in accordance with regulatory provisions.  
       SUMMARY OF INVENTION  
       [0007] The present invention is directed to a method and apparatus of managing and maintaining data associated with the manufacturing and/or testing of a device overcoming the aforementioned drawbacks. Specifically, the present invention provides a graphical user interface (GUI) that displays digitized work instructions for service technicians and engineers associated with the manufacturing and/or testing of the device. Moreover, the present invention includes a system whereby historical data associated with the manufacturing and testing of a device is digitally maintained and automatically collected upon the testing of a device or a user input. By incorporating authenticated input associated with changes in the manufacturing and/or testing process as well as data associated with the actual manufacturing and/or testing of the data, the present invention manages the manufacturing and/or testing of a device in accordance with strict regulatory concerns.  
       [0008] Therefore, in accordance with one aspect of the present invention, a method of coordinating the manufacturing and testing of a device is provided. The method includes the step of determining a series of tasks for at least one of manufacturing and testing a device. The method further includes the steps of developing a master device history record and integrating the series of tasks and the master device history record into a GUI that is accessible by one or more persons responsible for manufacturing and/or testing the device. The method also includes automatically updating a task and the master device history record based on an authorized input to the GUI.  
       [0009] In accordance with another aspect of the present invention, a system for a manufacturing device in accordance with a set of regulatory provisions includes at least one assembly station and at least one testing station. The system also includes at least one user station positioned proximate to the at least one assembly station and the at least one testing station wherein the at least one user station includes a monitor configured to display a GUI. A main station is also provided remotely from the at least one assembly station and the at least one testing station wherein the main station is networked with the at least one user station. The main station includes a processor configured to display a GUI on each user station user monitor as well as populate the GUI with a number of markers identifying a status of assembling a device. The processor is further configured to detect a user input identifying completion of a task associated with assembling of the device and authenticate the user based on the set of regulatory provisions. If the user is authenticated, the processor updates the number of markers to reflect on the GUI process toward completion of the assembling of the device.  
       [0010] In accordance with yet another aspect of the present invention, a computer data signal embodied in a carrier wave and representing a sequence of instructions is provided that when executed by a processor causes the processor to display a number of markers wherein each marker indicates the status of a task associated with at least one of manufacturing and testing a device. The sequence of instructions then causes the processor to display a master history record for the device and update the marker and the device history record upon completion of a task only if data indicating completion of the task is certified in accordance with a set of regulatory provisions.  
       [0011] Various other features, objects and advantages of the present invention will be made apparent from the following detailed description and the drawings. 
     
    
    
     BRIEF DESCRIPTION OF DRAWINGS  
     [0012] The drawings illustrate one preferred embodiment presently contemplated for carrying out the invention.  
     [0013] In the drawings:  
     [0014]FIG. 1 is a schematic block diagram of an integrated manufacturing and/or testing system for use with the present invention.  
     [0015]FIG. 2 is a schematic block diagram setting forth several communication paths communication in accordance with the present invention. 
    
    
     DETAILED DESCRIPTION  
     [0016] Referring to FIG. 1, an overview block diagram of an integrated networked manufacturing and/or testing system  10  is shown which includes a plurality of manufacturing and/or testing sites, such as Testing Site  12 , and Manufacturing Site  14 . It is understood, that the number of sites can be limitless located in separate, remote facilities, or housed within a single facility. Each site is sufficiently constructed to facilitate production and/or testing of a device. The sites  12 ,  14  are connected to a centralized facility or main station  16  through a communications link, such as a network of interconnected server nodes  18  or a remote link  20 . The centralized facility may be located in the same facility as either site or remotely located from each. Although a single centralized facility is shown and described, it is understood that the present invention contemplates the use of multiple centralized facilities, each capable of communication with each site.  
     [0017] The various sites disclosed are configured to be selectively linked to the centralized facility  16  by either the remote link  20 , or in the example of site  12 , a user station  22  such as a laptop computer connected to an internal network of user stations  24 . Such selective linking is desirable for managing and monitoring the testing and/or assembling of devices or components thereof, which includes accessing data regarding completion of a task associated with manufacturing and/or testing device such as a user input or the auto-detecting of a test and the subsequent transference of test data.  
     [0018] In general, a site may have a number of stations for manufacturing and/or testing devices such as medical diagnostic systems of various modalities. User station  22  may be connected to a number of networked stations  26  via an internal network  24  served by a server. Alternately, as shown with regard to site  14 , each site can include a number of non-networked stations  30 ,  32 , and  34  each having a computer or workstation  36 ,  38 ,  40  associated therewith and having an internal modem to connect the station to a communications link, such as the Internet  18  through links  37 ,  39 , and  41 , respectively, to communicate with the centralized facility  16 . Internet  18  is shown in phantom to indicate that an external communications network can include Internet  18 , together with communication links  29 ,  37 ,  39 , and  41 , or alternatively, can include direct dial-up links through dedicated lines, an intranet, or public communications systems.  
     [0019] It is understood that each of the network stations may include its own workstation for individual operation and are linked together by the internal network  24  so that an operator such as a technician or engineer can centrally manage each of the stations. Further, such a system is provided with communications components allowing it to send and receive data over a communications link  29 . Similarly, for the non-networked stations at site  14 , each of the user stations  30 ,  32 , and  34  communicate with the centralized facility via communications links  37 ,  39 , and  41 , respectively. Although FIG. 1 shows each of these links connected through an open network  18 , these links can permit data to be transferred to and from the systems over a dedicated network as well.  
     [0020] The embodiment shown in FIG. 1 contemplates a facility for manufacturing and testing systems as magnetic resonance imaging (MRI) systems, ultrasound systems, x-ray systems, computed tomography (CT) systems, as well as positron emission tomography (PET) systems, or any other type of medical imaging system or component thereof, however, the present invention is not so limited and may be implemented with the manufacturing and testing of a device that must be assembled and tested in accordance with stringent regulations. In the embodiment shown in FIG. 1, each site station  12 ,  14  can include any combination of the aforementioned stations, or a site may have all of a single type of station. A site can also include a single manufacturing or testing station.  
     [0021] An input regarding completion of a task associated with manufacturing or testing of the device or an altering of the assembling/testing process in accordance with the present invention can be initiated by authorized personnel, such as an on-line engineer or technician from a computer or workstation  42  in the remote link  20 , which can be a part of the centralized facility  16 , or be separately connected to the centralized facility  16  by a dialup link  44  to a web server  46  in the centralized facility  16 . Alternatively, it is contemplated that the system could be initialized by a laptop computer  22  connected to internal network  24 , or individually connected to each of the stations  30 ,  32 , or  34 . The remote link  20  can also serve to connect the centralized facility  16  to a site by a telephone and telephone connection  48  through a conventional telephone network  50  and to an interactive voice recognition system (IVR)  52  in the centralized facility  16 . The centralized facility  16  includes a number of processing systems including computers for the IVR system  52 , an automated support center  54 , the web server  46 , and an auto checkout server  56 , for processing station and device data and creating an appropriate configuration file. Other processor systems include computers to maintain a voicemail system  58 , a pager system  60 , an email system  62 , and a main frame  64 , and more generally, an output report generator and notifier. Each is connectable and can transmit data through a network, such as an Ethernet  66  with one another, and/or with at least one database  68 . However, it is understood that the single representation of a database in FIG. 1 is for demonstrative purposes only, and it is assumed that there is a need for multiple databases in such a system. It is also understood that the IVR system is not only a voice recognition system, but can also process interactive keypad entry from a touchtone telephone  48 . A bank of modems  70  is connected to the Ethernet  66  to relay data from the centralized facility  16  to the sites  12 ,  14  through a plurality of modem links  72 .  
     [0022] As previously described, each of the sites and stations described herein and referenced in FIG. 1 may be linked selectively to the centralized facility  16  via a network  18 . According to the present invention, any acceptable network may be employed whether public, open, dedicated, private, or so forth provided the network is capable of displaying a GUI on a user station monitor. The communications links to the network may be of any acceptable type, including conventional telephone lines, fiber optics, cable modem links, digital subscriber lines, wireless data transfer systems, or the like. Each of the stations is provided with communications interface hardware and software of generally known design, permitting them to establish network links and exchange data with the centralized facility  16 . The systems are provided with interactive software so as to configure the systems and exchange data between the sites and the centralized facility  16 . In some cases, during periods when no data is exchanged between the sites and the centralized facility, the network connection can be terminated. Preferably, however, the network connection is maintained continuously.  
     [0023] The present invention is directed to an integrated, digitized platform for disseminating work instructions and historical data regarding the manufacturing and/or testing of a device or a component thereof. Specifically, the platform allows for the display of work instructions or operational method sheets (OMSs) and historical data or device history records (DHRs) on a graphical user interface (GUI) that may be accessed from a computer over an Internet or other electronic communication. As will be described with respect to FIG. 2, the present invention includes several data communication lines such that up-to-date and compliant data is readily accessible and provideable through a GUI.  
     [0024] Referring to FIG. 2, the interrelationship and several communication lines to effectuate the providing, viewing, and certifying data associated with the manufacture and/or testing of a device or component thereof is shown. Once a design and/or process for the manufacturing and/or testing of a device is established, that information is provided to mainframe  64  or central processor from a design station  74 . The design station  74 , which may be located remotely located from the mainframe  64  housed in the centralized facility  16 , may be connected to mainframe directly using a dedicated connection via a GUI that is displayed on the design station monitor. As such, when the design engineer begins to input initial or set-up data regarding the manufacturing and/or testing of a device, the mainframe may display a template designed to assist the engineer with the “setting-up” the manufacturing and/or testing platform.  
     [0025] Further, during the setup, mainframe  64  may access information from a personnel database  76  based on the team members identified during the set up. The personnel database  76  includes contact information as well as rights and privilege information regarding the manufacturing and/or testing of the device. That is, to be compliant with a set of regulatory provisions, regulations regarding the accessing and updating of data regarding the manufacturing and/or testing of a device must be followed and maintained. As such, personnel information setting forth the rights and privileges regarding access to data is maintained in a personnel database.  
     [0026] During the set up process mainframe  64  also accesses a DHR database  78  that maintains templates as well as actual historical data associated with a device, as will be described below. In setting up the manufacturing and/or platform, mainframe  64 , based on a series of inputs by the platform initiator, will determine a DHR template appropriate to the device being assembled and/or tested. The DHR template will set forth that which is needed for initializing the manufacturing and/or testing of the device. Moreover, the DHR template is constructed to automatically comply with any regulatory provisions that must be taken into consideration during the manufacturing and/or testing process.  
     [0027] An updatable regulatory provisions database  80  is also provided and accessible by mainframe  64 . Database  80  includes data associated with compliance with regulatory concerns regarding the manufacturing and/or testing of the device. Notwithstanding the DHR template which governs the initial input of data being compliant, mainframe  64  will actively compare the input data with the set of regulatory provisions stored on database  80  to ensure that the platform is being established is, in fact, compliant.  
     [0028] Once the platform for the manufacturing and/or testing of the device is established in accordance with any regulatory concerns, mainframe  64  compiles the data input by the user and generates a set of digital documents which are viewable electronically and remotely. For example, the mainframe is designed to display digitized OMSs on a GUI  84  such that authorized technicians and engineers involved in the manufacturing and/or testing process may readily access work instructions regarding the device from a user station  86 . That is, the OMS may display an assembled image of the device, images illustrating each step of the assembly and/or testing process, a list of materials needed for the manufacturing and assembling process, as well as, historical data associated with that particular OMS.  
     [0029] The present invention allows for the updating of data relating to the manufacturing and/or testing process by any authorized user, provided the updated data complies with any regulatory concerns. As such, when a user such a technician or design engineer seeks to update an OMS, mainframe  64  will access databases  76  and  80  to determine if the user is authorized to make such a change and, if so, if the input complies with any regulatory concerns. As a result, an OMS that is regulatory compliant is consistently maintained.  
     [0030] In a further embodiment, a fully integrated manufacturing and/or testing platform is maintained. That is, mainframe  64  based on initial set up of the manufacturing and/or testing platform develops a master DHR  88 . Master DHR  88  includes historical data associated with the particular device being manufactured and/or tested. For example, DHR  88  may include information regarding when a component or a particular test was completed, data regarding the person responsible for certifying completion, a set of status markers, and the like.  
     [0031] A plurality of feeder DHRs  90  may be developed by mainframe  64  during the set up process and selectively linked to the master DHR. The feeder DHRs  90  relate to a particular component to be manufactured and/or tested rather than the system as whole. As such, each feeder DHR operates similarly to the master DHR but is limited to the particular component. Like the master DHR, each feeder DHR includes data associated with completion of a particular task(s), those responsible for completing and/or certifying completion of the task(s), and the like. Moreover, each feeder DHR may have a plurality of feeder DHRs associated therewith. For example, in the context of a CT apparatus, a master DHR for the entire system is created and maintained having a number of feeder DHRs associated therewith for each system or component of the CT apparatus. One feeder DHR could be directed to the manufacturing and testing of the gantry. That feeder DHR could include a series of feeder DHRs associated with completion and/or testing of the components that comprise the gantry. This tree of DHRs could be extended as far as necessary to outline and efficiently manage the manufacturing and/or testing of the CT apparatus.  
     [0032] Moreover, each DHR regardless of level is viewable as GUI on a user station monitor and may be updated by an authorized user. An authorized user, for example, may input data indicating completion of the assembling of a particular component of the system directly to a feeder DHR. Once that input is certified in accordance with the set of regulatory provisions set forth in database  80 , mainframe  64  will automatically update the feeder DHR which is stored on database  78  to reflect the change in data so that subsequent accessing of that DHR will indicate that the task has been completed. Further, mainframe  64  will automatically update any other DHRs associated with the feeder DHR that was updated. Those additional DHRs may include one or more parent feeder DHRs and the master DHR.  
     [0033] As previously described, the present invention includes a platform by which mainframe  64  detects that a device  92  has been tested in accordance with any regulatory concerns and, if the test was properly executed, automatically updates the device history database to include the test data. This linking to the tested device avoids an operator from having to manually enter the test data, which can be voluminous, directly to a DHR. Moreover, the present invention verifies that a test was compliantly executed so that unverified and/or uncertified data does not taint the DHR. Alternately, rather than the mainframe automatically detecting that a test has been executed, an operator could signal that a test was just executed as an input to GUI  84  by which the mainframe would then access the tested device, determine the compliance of the test, and upload the test data automatically. The mainframe would then automatically update database  78  to include the test data as well as automatically populate the master DHR and any related feeder DHR to indicate that the test has been compliantly executed and test data has been attained.  
     [0034] The present invention contemplates a number of mechanisms by which an operator and subsequent input is authenticated and verified including a dedicated username and password. However, many regulatory agencies require additional authentication measures such as an electronic signature. As such, each OMS and DHR may not be updated or amended unless the input effectuating the change is electronically signed in accordance with mandated regulations. By having each OMS and DHR template from which an actual OMS or DHR is developed audited to satisfy any regulatory concerns together with the electronic signature requirements, the present invention provides a fully compliant regulatory tool for manufacturing and/or testing a device. Furthermore, by addressing any regulatory concerns at the outset, resources required for ensuring regulatory compliance during the manufacturing and/or testing process may be directed elsewhere.  
     [0035] Additionally, by limiting access to the an OMSs and a DHRs so that only those individuals involved in the manufacturing and/or testing of the device, managing the manufacturing and/or testing in a regulatory compliant manner may be better achieved. That is, an individual trained to design, assemble, or test one type of device would be prevented from authorizing a change to the OMS or input data to the DHR of another device for which that individual is not trained. As such, the integrity of the manufacturing and/or testing process is maintained.  
     [0036] As was described with respect to FIG. 1, the present invention contemplates an environment by which a manufacturing site may be remotely located from a testing site and vice-versa. Furthermore, the present invention contemplates multiple manufacturing and/or testing sites that are remote from each other. For example, one manufacturing site may be located in one country and another manufacturing site would be located in another country. The present invention maintains the integrity of the complete manufacturing and/or testing process by digitizing the OMSs and DHRs to be electronically accessible using a GUI and connecting each site through an integrated and secure network. As such, any authorized changes to the process or executed tests and the corresponding test data may be readily accessed and viewed from any user station accessible to the mainframe.  
     [0037] The present invention also includes real-time status indicators that provide a current, up-to-date, real-time indication of progress toward completion of the manufacturing and/or testing process or any step thereof. That is, each GUI includes representative markers indicating a status of the process. For example, the master DHR GUI may include markers indicating a completion status of the tasks of the project as a whole. Each feeder DHR GUI may include markers indicating a completion status of the tasks associated with that feeder DHR. As a result, a stage of the manufacturing and/or testing process may be readily identified.  
     [0038] Preferably, each GUI also includes various hyperlinks to additional information regarding the device. For example, links to personnel information, team organization, team leader, device design history, test history, and regulatory provisions would be included. A link to a help menu is also provided to provide assistance with the input and certification of data or other concerns related to the information displayed on the GUI.  
     [0039] The present invention also provides for the generation of auditing and other reports directly though a GUI thereby eliminating the need to compile the necessary data and generate the report separately. That is, a report template database may be maintained such that mainframe  64  based on an identifying input by a user generates and populates the appropriate report template for generation of the requested report. As such, a report may be generated remotely and without direct access to the data.  
     [0040] Therefore, in accordance with one embodiment of the present invention, a method of coordinating the manufacturing and testing of a device is provided. The method includes the step of determining a series of tasks for at least one of manufacturing and testing a device. The method further includes the steps of developing a master device history record and integrating the series of tasks and the master device history record into a GUI that is accessible by one or more persons responsible for manufacturing and/or testing the device. The method also includes automatically updating a task and the master device history record based on an authorized input to the GUI.  
     [0041] In accordance with another embodiment of the present invention, a system for a manufacturing device in accordance with a set of regulatory provisions includes at least one assembly station and at least one testing station. The system also includes at least one user station positioned proximate to the at least one assembly station and the at least one testing station wherein the at least one user station includes a monitor configured to display a GUI. A main station is also provided remotely from the at least one assembly station and the at least one testing station wherein the main station is networked with the at least one user station. The main station includes a processor configured to display a GUI on each user station user monitor as well as populate the GUI with a number of markers identifying a status of assembling a device. The processor is further configured to detect a user input identifying completion of a task associated with assembling of the device and authenticate the user based on the set of regulatory provisions. If the user is authenticated, the processor updates the number of markers to reflect on the GUI process toward completion of the assembling of the device.  
     [0042] In accordance with yet another embodiment of the present invention, a computer data signal embodied in a carrier wave and representing a sequence of instructions is provided that when executed by a processor causes the processor to display a number of markers wherein each marker indicates the status of a task associated with at least one of manufacturing and testing a device. The sequence of instructions then causes the processor to display a master history record for the device and update the marker and the device history record upon completion of a task only if data indicating completion of the task is certified in accordance with a set of regulatory provisions.  
     [0043] The present invention has been described in terms of the preferred embodiment, and it is recognized that equivalents, alternatives, and modifications, aside from those expressly stated, are possible and within the scope of the appending claims.