Systems and methods for detecting potential remanufacturing and generate guidance for a biomedical engineer

Abstract

In a remanufacturing regulatory compliance method, information is received describing maintenance performed or planned to be performed on a medical device. One or more modified device metrics are estimated for the medical device as modified by the maintenance. The modified device metrics are based at least on the received information describing the maintenance. A determination is made as to whether the maintenance constitutes remanufacturing of the medical device based on comparison of the estimated modified device metrics with a corresponding original equipment manufacturer (OEM) specification for the medical device. In response to a determination that the maintenance constitutes remanufacturing, guidance is output on modifying the maintenance to not constitute remanufacturing or on complying with a regulation governing remanufacturing of medical devices which covers the medical device.

Description

SYSTEMS AND METHODS FOR DETECTING POTENTIAL REMANUFACTURING AND GENERATE GUIDANCE FOR A BIOMEDICAL ENGINEERFIELD

[0001] The following relates generally to the medical device maintenance arts, medical imaging device maintenance arts, medical device regulatory compliance arts, and related arts.BACKGROUND

[0002] In the United States, the Food and Drug Administration (FDA) has distinguished between servicing of a medical device and remanufacturing of a medical device. Remanufacturing of a medical device significantly changes the finished device’s performance or safety specifications, or intended use. By contrast, servicing is for purposes of returning a medical device to the safety and performance specifications established by the original equipment manufacturer (OEM), and to meet its original intended use.

[0003] The distinction between servicing and remanufacturing can impact regulatory responsibilities of the owner / operator of the medical device. Assuming the original medical device is an FDA-approved medical device, servicing merely results in restoring the medical device to its original FDA-approved state, and hence servicing may not be subject to FDA regulatory oversight. By contrast, remanufacturing can impart significantly new and / or different performance to the medical device which could in some instances make the remanufactured device subject to additional FDA regulatory oversight. The distinction between servicing and remanufacturing is also relevant to a user of the medical device because it can impact the performance or the functioning of the medical device.

[0004] There is little guidance available to service engineers and biomedical engineers (biomeds) as to whether their work constituted servicing or remanufacturing. For example, during servicing of medical equipment, parts may be replaced with non-OEM parts, which may, or may not, take the activity from servicing into remanufacturing. Similarly, activities that involve installing and / or upgrading software may or may not constitute remanufacturing.

[0005] Other jurisdictions may also have distinctions between servicing and remanufacturing, although different terminology may be used, and the regulatory framework may have different granularity. For example, in the European Union (EU), medical devices are regulated by the member states, sometimes with input from the EU-level. In general, anappropriate governing agency (e.g., the FDA in the United States) approves a medical device as manufactured and sold by the OEM for use with patients. A distinction thus may need to be made between servicing which restores a medical device to its already-approved OEM design and capabilities, versus remanufacturing that substantively modifies the design and / or capabilities of the medical device in a way that takes it outside the scope of the regulatory approval of the OEM medical device, and hence may implicate different regulatory compliance requirements.

[0006] The following discloses certain improvements to overcome these problems and others.SUMMARY

[0007] In one aspect, a non-transitory computer readable medium is disclosed, which stores: a database storing a plurality of specifications for a plurality of medical devices; and instructions executable by at least one electronic processor to perform a remanufacturing regulatory compliance method including: receiving information describing maintenance performed or planned to be performed on a medical device; determining whether the maintenance constitutes remanufacturing of the medical device based on comparison of the received information describing the maintenance with a specification for the medical device that is the subject of the maintenance retrieved from the database; in response to a determination that the maintenance constitutes remanufacturing, outputting guidance on for addressing the determined remanufacturing. In some embodiments, the guidance may comprise guidance on modifying the maintenance to not constitute remanufacturing.

[0008] In another aspect, a remanufacturing regulatory compliance method is disclosed. The method includes: receiving information describing maintenance performed or planned to be performed on a medical device; estimating one or more modified device metrics for the medical device as modified by the maintenance based at least on the received information describing the maintenance; determining whether the maintenance constitutes remanufacturing of the medical device based on comparison of the estimated modified device metrics with a corresponding original equipment manufacturer (OEM) specification for the medical device; and in response to a determination that the maintenance constitutes remanufacturing, outputting guidance on modifying the maintenance to not constitute remanufacturing or on complying with a regulation governing remanufacturing of medical devices which covers the medical device.

[0009] In another aspect, a remanufacturing regulatory compliance apparatus is disclosed, comprising a hardware processor programmed to perform a remanufacturing regulatory compliance method including: receiving information describing a modification or planned modification of a medical device comprising replacement of an original equipment manufacturer (OEM) component of the medical device with a non OEM component or installation of a nonoriginal equipment manufacturer (non OEM) software update or addition; estimating one or more modified device metrics for the medical device with the modification or planned modification described by the received information; determining whether the modification or planned modification constitutes remanufacturing of the medical device based on comparison of the estimated one or more modified device metrics with corresponding OEM specifications for the medical device extracted from testing data used to obtain regulatory approval of the medical device; and, in response to a determination that the modification or planned modification constitutes remanufacturing, outputting guidance on revising the modification or planned modification to not constitute remanufacturing or on complying with a regulation governing remanufacturing of medical devices which covers the medical device.

[0010] One advantage resides in distinguishing between servicing processes and remanufacturing processes for medical devices.

[0011] Another advantage resides in educating service engineers and biomedical engineers on servicing processes and remanufacturing processes for medical devices.

[0012] Another advantage resides in assisting in compliance with regulatory requirements when performing maintenance on medical equipment.

[0013] Another advantage resides in providing individualized guidance on such regulatory compliance for specific maintenance tasks.

[0014] A given embodiment may provide none, one, two, more, or all of the foregoing advantages, and / or may provide other advantages as will become apparent to one of ordinary skill in the art upon reading and understanding the present disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the disclosure.

[0016] FIGURE 1 diagrammatically illustrates a medical device maintenance guidance apparatus in accordance with the present disclosure.

[0017] FIGURE 2 diagrammatically illustrates an embodiment of a medical device maintenance guidance method using the apparatus of FIGURE 1.

[0018] FIGURE 3 diagrammatically illustrates an embodiment of modules of the medical device guidance apparatus of FIGURE 1.DETAILED DESCRIPTION

[0019] The following relates to maintenance performed on a medical device that, in its originally sold or leased state, has been approved for use with patients by a governing regulatory agency. As used herein, a maintenance operation may constitute repair, update, or upgrade of the medical device. Systems and methods disclosed herein advantageously provide service engineers, biomeds, or other maintenance personnel with guidance as to whether a maintenance operation performed on a medical device constitutes servicing or remanufacturing. To do so, OEM specifications for the medical device that are promulgated by the original equipment manufacturer (OEM) are employed. For example, the OEM specifications may comprise information (or a summary thereof) that was provided to one or more governing regulatory agencies to obtain approval of the medical device for use with medical patients. The OEM specifications may be generated or derived from validation or verification tests performed on prototypes of the medical device, numerical simulations of performance of the medical device design, and / or other types of empirical or other supporting data. By way of some nonlimiting illustrative examples, the OEM specifications may include specifications such as minimum image quality metrics (for a medical imaging device), air flow characteristics of a mechanical ventilator (e.g., maximum deliverable flow rate, maximum deliverable air pressure, et cetera), patient data acquisition characteristics in the case of a patient monitoring device (e.g., vital sign sampling rate, vital sign sample digital resolution, et cetera), and so forth. The OEM specifications may also include operating rules, such as a minimum air gap around the medical device to provide sufficient ventilation for the medical device, or a specification for how the medical device should be electrically connected and / or electrically grounded, or a specification that a certain component of the medical device must not contact the patient (e.g., an electrically insulating barrier must be provided to ensure a high-voltage component cannot come into contact with the patient). The OEM specifications for the medical device as-sold (or as-leased) thus serve as an effective surrogate standard for determining whethera maintenance operation would likely be considered by a governing regulatory agency to be servicing or remanufacturing.

[0020] As used herein, the term “servicing” (and variants thereof) entails maintenance performed on a medical device which does not take the medical device outside of the scope of its OEM specifications (so that the maintenance would likely not impact its regulatory approval). In some illustrative examples, the jurisdiction is the United States, the governing regulatory agency is the Food and Drug Administration (FDA), an approved medical device is an FDA-approved medical device, and the OEM specifications were supplied to the FDA in obtaining FDA approval for the medical device, or the OEM specifications are a summary of or derived from verification or validation data provided to the FDA in obtaining the FDA approval. As an example of the latter, if the verification or validation data provided to the FDA demonstrated that the medical device satisfied a certain performance level (e.g., a certain attainable image resolution and other image quality characteristics in the case of a medical imaging device), then that demonstrated performance level may be a part of the OEM specifications. In other countries or other jurisdictions, the governing regulatory agency may be different (e.g., a member-level governing regulatory agency in the case of a member state of the European Union), and an approved medical device is one that is approved by that governing regulatory agency. In the case of a medical device being utilized in different jurisdictions, the same OEM specifications may be applied across the jurisdictions (e.g., the most rigorous OEM specifications in any jurisdiction may be promulgated by the OEM), or different OEM specifications may be applied in different jurisdictions in assessing servicing or remanufacturing, to reflect the different regulatory standards in different jurisdictions.

[0021] A medical device is considered to have been serviced if it continues to satisfy the OEM specifications. This is because satisfying these OEM specifications makes it likely that the serviced medical device continues to have the regulatory approval of the originally sold or leased medical device, which was obtained on the basis of those OEM specifications. This is a consequence of the servicing maintaining or merely restoring the medical device to its original OEM specifications. Hence, servicing is not expected to require regulatory agency authorization, or the undertaking of regulatory compliance actions to ensure the serviced medical device remains in regulatory compliance for use with patients in performing medical functions.

[0022] In contrast to servicing, a maintenance operation that takes the medical device out of its OEM specifications is likely to constitute remanufacturing. This is because the OEMspecifications are the basis for the regulatory approval (or are derived from verification or validation data used to obtain the regulatory approval) and so a maintenance operation that takes the device outside of those OEM specifications are likely to take the medical device outside of the scope of its regulatory approval. In this case, the regulatory approval that was obtained for the medical device as it was originally sold or leased may not continue to apply to the remanufactured medical device. Consequently, remanufacturing may require regulatory agency authorization, and / or may require undertaking certain regulatory compliance actions to ensure the remanufactured medical device remains in regulatory compliance for use with patients in performing medical functions.

[0023] The distinction between servicing and remanufacturing is also relevant to a user of the medical device because remanufacturing can impact the performance or the functioning of the medical device. For example, remanufacturing of a medical imaging device may degrade the image resolution of medical images acquired by the medical device, or remanufacturing of a mechanical ventilator may remove certain functionality of the mechanical ventilator (e.g., by removing its ability to perform in certain ventilation modes).

[0024] The disclosed apparatuses and devices for providing guidance as to whether a maintenance operation is servicing or remanufacturing thus provide a data-driven and physically realizable approach for making this assessment. The disclosed approach thus addresses a difficult challenge for service engineers, biomeds, or other maintenance personnel - namely that the distinction between servicing and remanufacturing can be difficult to discern, especially for a service engineer who (typically) lacks specialized training in regulatory governance, and / or may not be familiar with the OEM’s expectations for the performance of the medical device. This guidance can be useful for servicing personnel who are under pressure to return a medical device to service but may lack the knowledge of whether the maintenance being performed to do so falls within the testing performed with the regulatory submission.

[0025] The following discloses a system for assessing a maintenance action to determine whether it may actually constitute remanufacturing. In doing so, the OEM specifications (e.g., those provided for regulatory approval, or OEM specifications derived from the testing data supplied to the regulator in obtaining that approval) are used to enable this assessment. If the action is determined to be remanufacturing, then the system provides guidance as to appropriate regulatory compliance actions that should be taken. These compliance actions could, for example,include filing appropriate FDA and / or other regulatory documents, checking whether the service engineer is working on behalf of a certified remanufacturer, or not proceeding with the action (e.g., ordering an OEM part rather than using an available non-OEM part whose installation would constitute remanufacturing).

[0026] To this end, the disclosed system includes a translation / quantifi cation module that generates measurable metrics of the OEM specification. For hardware, this may include metrics such as whether the part contacts the human body, various performance metrics of the medical device, various safety metrics, and so forth. The measurable metrics may also consider the interrelationship of the parts or components of the medical device. Parts or components may seem equivalent in isolation, but may create issues upon system integration. This is particularly true with software, which is why software modifications, including loading any third party software on the medical device, is likely to constitute remanufacturing.

[0027] As an example of operation of the disclosed system, an OEM magnetic field gradient coil used in a medical device which is (in this example) a magnetic resonance imaging (MRI) scanner has a peak gradient strength specification. A suspicious activities detector monitors maintenance actions performed on the MRI scanner (for example, by monitoring the parts ordering system or monitoring the service log) to detect actions that may in fact cross over from servicing to remanufacturing. When a suspicious action is detected, the relevant measurable metrics quantifying the OEM specifications are determined for the action (e.g., for the non-OEM replacement part), and if the determined metric is a significant change from the OEM specification, then this is identified as possible remanufacturing. The metrics quantifying the OEM specifications may be computed by way of a simulation, or determined by natural language processing (NLP) or other analysis of documentation of the non-OEM part (e.g., a non-OEM gradient coil should have listed specifications including its peak gradient strength). If the action is determined likely to be remanufacturing, a guidance generation module then generates appropriate recommendations to the service engineer or biomed for ensuring regulatory compliance.

[0028] In some nonlimiting illustrative examples, the outputting of the guidance may, for example, include outputting an indication of a change in a metric related to the OEM specification of the medical device. The output guidance may also include recommending one or more possible ways to avoid the maintenance causing this change in the metric, or one or more possible ways to minimize the change so that the maintenance is deemed servicing rather than remanufacturing.

[0029] In the case of new software or a software upgrade, calculation of measurable metrics for assessing servicing versus remanufacturing may be difficult or impossible. In some embodiments, the identification of possible remanufacturing may be class-based, e.g. certain classes of software that impact image acquisition speed, image resolution, or other medically relevant output of a medical device, or that constitute control software that impacts the mechanics of the medical device, are likely to qualify as remanufacturing; whereas, antivirus software and other types of software that do not impact the medical operation are unlikely to qualify as remanufacturing. However, in other embodiments the assessment may have a stronger tendency to classify software upgrades or revisions as remanufacturing. For example, the assessment may differentiate between modifications / third party software and tested and approved patches. An introduction of new security software can have significant performance issues on the system. Modifications of security software can create an issue in the system and cause it to fail. Hence, in some embodiments, the assessment may classify such security upgrades or additions as possible re-manufacturing.

[0030] In a disclosed optional aspect, a database is maintained of prior maintenance actions that were determined to be remanufacturing. Anytime one of these actions is performed it is automatically identified as suspicious. However, since the assessment of servicing versus remanufacturing can depend on numerous factors such as the system into which the non-OEM part is installed as one example, the relevant measurable metrics are computed for each case to determine whether a given action is likely to be remanufacturing. To provide a case-based assessment, in some embodiments log files of the medical device and fault finding trees from service manuals are analyzed to determine the most likely root cause of a problem, and the corresponding likely repair action can be analyzed to determine if the repair action is likely to take the medical device outside of the OEM specifications.

[0031] In another disclosed optional aspect, the performance of the medical device may be monitored after the maintenance action is performed, for example by monitoring machine logs of the medical device. If this monitoring determines that the action has resulted in the medical device having performance that is outside of the OEM specification then the action may be identified as remanufacturing, and suitable guidance is given for ensuring regulatory compliance retroactively.

[0032] With reference to FIGURE 1, an illustrative apparatus 10 for guidance of maintenance of a medical device 12 is shown. The medical device 12, for example, can comprisean illustrative medical imaging device 12 (also referred to as a medical device, an imaging device, imaging scanner, and variants thereof) which can be a magnetic resonance imaging (MRI) scanner, a computed tomography (CT) scanner, a positron emission tomography (PET) scanner, a gamma camera for performing single-photon emission computed tomography (SPECT), an interventional radiology (IR) device, an X-ray device, an image-guided therapy (IGT) device, an ultrasound (US) device, or so forth. Although described herein as an imaging device, the medical device 12 can also be any other suitable medical device that is used with patients to perform medical functions such as diagnosis and / or treatment, such as a patient monitor, a radiation therapy device, a mechanical ventilator, and so forth.

[0033] An electronic processing device 18, such as a workstation computer, or more generally a computer, a smart device (e.g., a cellular telephone (“cell phone”), a smart tablet, and so forth), is operable by a service engineer (SE). The electronic processing device 18 may also include a server computer or a plurality of server computers, e.g., interconnected to form a server cluster, cloud computing resource, or so forth, to perform more complex computational tasks. The electronic processing device 18 includes typical components, such as an electronic processor 20 (e.g., a microprocessor), at least one user input device (e.g., a mouse, a keyboard, a trackball, and / or the like) 22, and a display device 24 (e.g., an LCD display, plasma display, cathode ray tube display, and / or so forth). In some embodiments, the display device 24 can be a separate component from the electronic processing device 18, or may include two or more display devices.

[0034] The electronic processor 20 is operatively connected with one or more non- transitory storage media 26. The non-transitory storage media 26 may, by way of non-limiting illustrative example, include one or more of a magnetic disk, RAID, or other magnetic storage medium; a solid-state drive, flash drive, electronically erasable read-only memory (EEROM) or other electronic memory; an optical disk or other optical storage; various combinations thereof; or so forth; and may be for example a network storage, an internal hard drive of the workstation 18, various combinations thereof, or so forth. It is to be understood that any reference to a non- transitory medium or media 26 herein is to be broadly construed as encompassing a single medium or multiple media of the same or different types. Likewise, the electronic processor 20 may be embodied as a single electronic processor or as two or more electronic processors. The non- transitory storage media 26 stores instructions executable by the at least one electronic processor20. The instructions include instructions to generate a visualization of a graphical user interface (GUI) 28 for display on the display device 24.

[0035] The electronic processing device 18 is also in communication with a database 30 (shown in FIGURE 1 as a server computer) that stores a plurality of OEM specifications 32 for a plurality of medical devices 12. For example, the OEM specifications 32 can include OEM specifications such as maximum slew rate of a gradient coil, physical dimensions, whether a component may contact a patient, and so forth. It will be appreciated that the number of specifications 32 in the database 30 may be large, e.g., tens of thousands of cases, hundreds of thousands of cases, or more, and a search can in many cases return a few tens of thousands of specifications 32 (or more). For example, different OEM specifications may be stored for different models or configurations of the same medical device, different OEM specifications may be stored for different regulatory jurisdictions, and / or so forth. It will be appreciated that the OEM specifications 32 may be stored in a variety of representations, such as an OEM specification being stored as a set of quantitative metrics for assessing whether a given medical device satisfies the OEM specification. In some embodiments, the database 30 further stores information on previously performed maintenance of medical devices annotated with whether the maintenance was determined to be servicing or remanufacturing. The database 30 also has includes or has access to medical device maintenance information 34 about the maintenance performed on the medical device 12 (and, typically, about maintenance performed on other medical devices in the hospital, radiology laboratory, or so forth). The medical device maintenance information 34 may, for example, include or be derived from a purchase record of components purchased for installation in the medical device 12 (for example, the purchase record may constitute or be extracted from a parts ordering system, parts inventory, or the like), a service record of the medical device 12, and / or the like. In the case of replacement of a component of the medical device 12 with a non-OEM component, the medical device maintenance information 34 may include a specification for the non-OEM replacement part obtained for example from the Internet (e.g., by accessing a manual for the non-OEM replacement part available at the supplier’s website). In some cases, the non-OEM replacement part may include a QR code or bar code or the like which can be scanned using a cellphone or the like to automate retrieval of the specification information for the non-OEM part.

[0036] The apparatus 10 is configured as described above to perform a remanufacturing regulatory compliance method or process 100. The non-transitory storage medium 26 stores instructions which are readable and executable by the at least one electronic processor 20 to perform disclosed operations including performing the maintenance assessment method or process 100. In some examples, the method 100 may be performed at least in part by cloud processing.

[0037] With reference to FIGURE 2, and with continuing reference to FIGURE 1, an illustrative embodiment of an instance of the method 100 is diagrammatically shown as a flowchart. At an operation 102, the information 34 describing the subject medical device 12 is received from the database 30, and in an operation 103 the maintenance operation to be performed on the medical device 12 is determined from this information. In a retrospective case in which the maintenance operation has already been performed, the information obtained in the operation 102 may include a service log for the medical device which directly states the maintenance operation that was performed. In a prospective case, the maintenance planned to be performed on the medical device 12 (or information sufficient to determine the planned maintenance) is retrieved from the database 30 and received at the electronic processing device 18. In one example, the service engineer enters the planned maintenance operation into the service log before it is performed, and this is retrieved in operation 103. In other embodiments, as the service engineer enters observed symptoms or other problem description information into the service log this information is extracted (possibly along with automatically generated log information from the medical device 12) and this information is analyzed to determine the likely maintenance operation, e.g., using a fault-finding tree. In some examples, the maintenance operation determined at operation 103 can include a replacement of an original equipment manufacturer (OEM) component of the medical device 12 with a non-OEM component or installation of a non-OEM software update or addition. In this example, the information received at the operation 102 may include specification information for the replacement non-OEM component. Such information may be retrieved from the Internet for example, e.g., using a search query automatically generated based on non-OEM component manufacturer and part number information, or obtained semi-automatically by scanning a QR code or bar code disposed on the non-OEM component. If the requisite information is not available in such an automated or semi-automated fashion, then the user may be asked to manually input relevant information on the non-OEM component to complete operation 102. The relevant information generally corresponds to analogous information for the medical device 12 setforth in the medical device specification 32, insofar as that information relates to the regulatory approval of the medical device. As one illustrative example, in the case of a medical imaging device the relevant information may include information such as attainable image resolution and other image quality characteristics, imaging field of view, maximum magnetic field applied to the patient (in the case of an MRI), whether a component may come into contact with the patient, and / or so forth.

[0038] At an operation 104, the electronic processing device 18 determines whether the determined maintenance operation constitutes remanufacturing of the medical device 12 based on comparison of the information describing the maintenance operation and its impact on performance of the medical device 12 received in the operation 102 with the OEM specification 32 for the medical device 12 that is the subject of the maintenance retrieved from the database 30. For example, if the maintenance is a replacement of an original equipment manufacturer (OEM) component of the medical device 12 with a non-OEM component, then the determining operation 104 includes determining, based on the OEM specification 32 for the medical device 12 that is the subject of the maintenance, that the OEM component never directly contacts a patient during clinical use of the medical device 12 on the patient, and determining that the maintenance constitutes remanufacturing of the medical device 12 if it is determined that the non-OEM component may directly contact a patient during clinical use of the medical device 12 as modified by the replacement of the OEM component with the non-OEM component. (For example, this could be the case if the OEM component is a high voltage component with an insulating housing to ensure the patient cannot contact the high voltage; whereas, the non-OEM component lacks such a housing). In another example, if the maintenance is installation of a non-OEM software update or addition, then the determining operation 104 includes assigning a class to the software update based on functionality of the non-OEM software update or addition, and determining whether the maintenance constitutes remanufacturing of the medical device 12 based on the assigned class. In a further example, the information on previously performed maintenance of medical devices annotated with whether the maintenance was determined to be remanufacturing is retrieved from the database 30, and the determining operation 104 includes whether the maintenance matches one of the stored previously performed remanufacturing maintenance actions.

[0039] To perform the determining operation 104, the electronic processing device 18 is configured to generate one or more OEM specification metrics from the OEM specification 32 for the medical device 12 that is the subject of the maintenance. As previously discussed, the OEM specification 32 comprises or is derived from testing data that was used to obtain regulatory approval of the medical device 12, and so serves as a data driven quantitative mechanism for assessing whether the maintenance operation constitutes servicing or remanufacturing. For example, the metrics can satisfy a predetermined criteria of a regulatory body (i.e., the FDA), and can include one or more of whether a replacement part for the medical device 12 contacts the human body, performance metrics of the medical device, and safety metrics.

[0040] One or more modified device metrics for the medical device 12 as modified by the maintenance are estimated based at least on the received information describing the maintenance from the receiving operation 102. To estimate the modified device metrics, a simulation process for the medical device 12 as modified by the maintenance is performed. A deviation of one or more modified device metrics from the one or more OEM specification metrics is then determined. The electronic processing device 18 is configured to determine that the maintenance constitutes remanufacturing if the deviation exceeds a predetermined remanufacturing threshold.

[0041] At an operation 106, in response to a determination that the maintenance constitutes remanufacturing, guidance 38 on for addressing the determined remanufacturing is output on the display device 24. In one example, the guidance 38 is guidance on complying with a regulation governing remanufacturing of medical devices which covers the medical device 12. In another example, the guidance 38 comprises guidance on modifying the servicing to not constitute remanufacturing. Optionally, the guidance can be recorded in the service log of the medical device 12 for use in tracing future failures, and / or can be reported to desired recipients such as a designated regulatory compliance officer. Thereafter the process ends at termination 108.

[0042] On the other hand, in response to a determination that the maintenance constitutes servicing, the process flows directly to the termination 108. Alternatively, although not shown it is contemplated that in response to a determination that the maintenance constitutes servicing, an indication to this effect may be output.EXAMPLE

[0043] The following describes the apparatus 10 and the method 100 in more detail. The apparatus 10 is configured to translate regulatory or quality management documents into measurable assessments, detects suspicious maintenance activities (that is, maintenance activities that are suspected to constitute remanufacturing because they would take the medical device outside of the OEM specifications), estimates the scale of change and generates guidance and / or questions requiring further inputs to the user.

[0044] FIGURE 3 shows another example of the apparatus 10. As shown in FIGURE 3, the apparatus 10 includes a first module 40 implemented in the electronic processing device 18. The first module 40 is configured to translate relevant guideline items into assessments. To do so, the first module 40 is configured to retrieve textual information regarding remanufacturing in the online resources or local knowledgebase and then translate them into measurable assessments, e.g., from new guidelines on how to determine a performance change to performance metrics, or from hospital quality regulations to quality metrics. The baseline performance can be from the specifications 32 and / or performance tests, as well as manual input. The first module 40 retrieves the relevant regulatory requirements depending on the legal location of the customer. The resources of such regulatory requirements can be from either the authoritative parties such as FDA or the hospital’s own quality management systems. The requirements include the criteria for meeting remanufacturing, repairing, refurbishing, remarketing etc., as well as the requirements of other processes.

[0045] As described herein, the FDA is described as the main external regulatory body for. The FDA issues guidelines, whitepapers, and workshop notes regarding remanufacturing of medical devices over time. These documents introduce the definition of remanufacturing and repair (i.e., servicing), which contains lists of heuristic guidelines, examples, and flow charts to help distinguish between service actions and remanufacturing. One can use various technologies to extract the assessment of determining remanufacturing actions from the documents. An example of the assessment could be, for example, direct contact with a human body, performance, safety, dimensional, operational failure, and so forth.

[0046] In addition, the first module 40 retrieves documents (e.g., specifications, manuals, training materials) from the OEM of the medical device 12, where it extracts the relevant OEM specifications from test data that was used to obtain regulatory approval of the medical device.Further, the first module 40 finds a baseline performance or a process to test performance from documents such as training materials.

[0047] The output of the first module 40 could be, for each part, metrics of the OEM specifications for the medical device as a list of assessments with measurable indicators and baseline measurements (or indications). In one example, for a gradient coil, the performance assessment metrics may include slew rate, slice thickness, spatial resolution etc., and a binary metric indicating whether the gradient coil can come into direct contact with the patient. For each metric, it defines the threshold of change (if it is numeric) that would be considered significant; or, in the case of a binary metric, defines the answer which complies with the OEM specification (e.g., the OEM performance metric specifies the gradient coil should not be able to come into contact with the patient). The baseline dimension is retrieved from the OEM specification 32. Table 1 shows an example of assessment and indicators of gradient coil.Table 1

[0048] Additionally, the first module 40 also takes local market and hospital regulations requirements into account, translating them into assessments and indicators. The threshold would be defined by the corresponding authority body, if not, they can be measured by pilot tests or by analyzing usage data.

[0049] The first module 40 is configured to translate textual guidelines into assessments, for example using natural language processing (NLP). The NLP can extract a list of constraints the remanufactured component should compare against. Constraints would consist of a set of performance indicators, some of them associated with values reported in the guidelines. For others, specification values may be evaluated from historical or third-party data as per main embodiment. The NLP would be configured as a specialized Named Entity Recognition (NER) (see, e.g., Puccetti, G., Chiarello, F., & Fantoni, G. (2021). A simple and fast method for Named Entity context extraction from patents. Expert Systems with Applications, 184(0957-4174) and Relation Extraction (RE) processor (see, e.g., Korger, A., & Baumeister, J. (2021). Rule-based Semantic Relation Extraction in Regulatory Documents. LWDA 2021. Munich), which recognizes a portion of text representing specific entities, associates them with an entity type froma pre-defined set and put them into relations, e.g., associating performance indicators with related values.

[0050] With the extracted and structured information, it is possible to create a set of constraints to be automatically checked. A similar approach can be designed to extract the same information from documents containing indicators in textual tables. Dedicated Image Processing and OCR (Optical Character Recognition) can be applied to convert the table the corresponding textual representation, and an NLP engine trained for the purpose would extract the entities and their relationship.

[0051] As shown in FIGURE 3, the apparatus 10 includes a second module 42 implemented in the electronic processing device 18. The second module 42 is configured to detect suspicious maintenance activities that may become remanufacturing based on the medical device servicing information 34. This information 34 may be obtained, for example, by a self-report (when a biomedical engineer (“biomed”) is using a third-party component), a QR scan, software detection, or using sensors (sensed that the part is not from the OEM).

[0052] The suspicious hardware maintenance activity that may become remanufacturing can be detected by QR scan on the part, and use of sensors on the device (e.g., sensing that the part is not from the OEM). It can use part information recorded in parts database, purchase records, quotations or even CAD / 3D model of the part. Once a non-OEM hardware part is detected, it is seen as a potential remanufacturing activity.

[0053] For software, the second module 42 would remove the assessments that are not applicable to software, e.g., direct contact with a human body. Further, one can detect the type of software activity the user is performing. FDA has guidelines that certain types of software activities are likely not considered as remanufacturing. Some examples can include implementing OEM-provided updates and upgrades, running software-based hardware diagnostics, assessing for viruses, malware, and other cybersecurity-related issues, reinstalling OEM software to restore original performance and safety specifications, collecting system logs, and so forth.

[0054] To understand whether the software is likely to constitute remanufacturing (that is, expected to take the medical device outside of the OEM specifications), one can retrieve relevant documents about the software release / update, such as software specifications, release notes, manuals etc. For example, a software specification may in a nonlimiting illustrative example state that a new feature to detect a new virus abc is added. The second module 42 will try to match thisstatement with one of the software activities in the guidelines extracted from the regulatory document and finds out that it satisfies one guideline (that likely not considered as remanufacturing), that is, assessing for viruses, malware, and other cybersecurity-related issues. In another nonlimiting illustrative example, the software specification document indicates that a bug fix on the image post-processing was added to the update. This statement could not be matched with any known guidelines in the above list that are usually not considered as remanufacturing, and so may be considered suspicious (i.e., likely to be remanufacturing). The second module 42 then applies a pre-defined rule (e.g., the rule states that image post-processing is mapped with image quality) or uses NLP to determine that the bug fix is related to image quality and is therefore suspicious of a quality change defined by the hospital. In other embodiments, the analysis for software may be designed to have a stronger tendency to classify software upgrades or revisions as remanufacturing. For example, any third-party software that is not on a list of tested and approved software patches may be considered to be suspicious (i.e., likely remanufacturing).

[0055] The output of the second module 42 is a binary option (e.g., “YES “(it is a suspicious remanufacturing activity) or “NO” (it is not a suspicious remanufacturing activity)). In some examples, it has one more output, which is ‘to be monitored’ in case the magnitude of the change introduced by software cannot be determined before the actual usage.

[0056] As shown in FIGURE 3, the apparatus 10 includes a third module 44 implemented in the electronic processing device 18. The third module 44 is configured to estimate the scale of change of the maintenance. This can include using machine logs, parts manuals, software release notes and evaluation results to estimate whether it is a significant change in the assessment metrics; In a case using third party parts, the OEM can offer an API feature to run a simulation with a 3rd party component to test the chang e / deviati on. Alternatively, a performance change can be compared with the previous repair action on the same part. For each factor, namely performance, safety and others, there is a list of corresponding metrics. A performance change can be compared with the previous repair action on the same part or provided by the OEM. Safety indicators can be based on risk assessment or historic records.

[0057] As shown in FIGURE 3, the apparatus 10 includes a fourth module 46 implemented in the electronic processing device 18. The fourth module 46 is configured to generate the guidance 38 to users. In some examples, when a change can be estimated, the guidance 38 can guide the user to follow FDA or other regulatory processes (i.e., FDA, local government, andhospital QM (quality management) processes), or to adopt alternative options for a repair (not remanufacturing). In case of a lack of data, the fourth module 46 can generate questions to guide the user to perform risk assessment or other risk evaluations (e.g., After reinstalling, the performance indicator Pl values between x and y - no significant change or After installing the part, the image quality test shows 50% less compared to before the replacement. ). When answers cannot be automatically acquired, the fourth module 46 generates questions to guide the user to provide input, such as risk assessment. Another possibility is when a remanufacturing is deemed likely, one can provide a recommendation on possible remedial actions. This could be placing a service call to the OEM or authorized remanufacturer, undoing certain or all steps, or taking some corrective action.

[0058] In a first example, for a hardware maintenance, a gradient coil of a magnetic resonance (MR) system needs to be replaced. The Biomed finds a non-OEM replacement gradient coil and decided to use this non-OEM component because of timing. According to the second module 42, when the third party service company installs its gradient coil into the MR system, the apparatus 10 detects that the gradient coil is non-OEM. The method 100 requires the new dimension data from the replaced gradient coil, and the Biomed enters it. It concludes that it is not a significant dimensional change compared with the OEM specifications. After a test run, the system collects performance data (see Table 2) and compares it with the performance from OEM, and concludes that the peak gradient strength is significantly different, as well as the image performance (e.g., spatial resolution). While this example analyzes the non-OEM gradient coil in isolation, the analysis may also consider whether the non-OEM gradient coil in combination with other components of the MRI scanner may take the MRI scanner outside the OEM specification and hence constitute likely remanufacturing. For example, the magnetic fields applied to the patient are a combination of the gradient field applied by the gradient coil and the static (Bo) magnetic field applied by the superconducting main magnet. Hence, the gradient coil might be deemed servicing when installed in an MRI scanner with a lower-strength superconducting magnet but might be deemed remanufacturing when installed in an MRI scanner with a higher-strength superconducting magnet.Table 2. An output from a test run after installing a third-party gradient coil.

[0059] The fourth module 46 indicates to the Biomed as the guidance 38: “The replaced Gradient Coil is probably considered as remanufacturing as defined by FDA because the peak gradient strength is 20% higher than the OEM specification.” Further, the guidance 38 guides the Biomed on what to do to be FDA compliant and to document after this replacement. In a prospective embodiment, the foregoing analysis is performed before the gradient coil is installed, for example being triggered by entry of the planned gradient coil replacement in the service log, or by detecting ordering of the non-OEM gradient coil via a linked parts ordering system. The determination of likely remanufacturing could also automatically trigger an inventory check on the OEM parts ordering system to determine if a suitable OEM gradient coil is available, and this could be suggested to the Biomed as a way to ensure the maintenance does not constitute remanufacturing. If no suitable OEM gradient coil is available, then the system could recommend to the Biomed that a certification of regulatory compliance be requested from the seller of the non-OEM gradient coil prior to its purchase or installation.

[0060] In a second example, for a software maintenance, the OEM can provide a machine learning model for more advanced image analysis. Machine learning models are tailored to run on customized hardware. The hospital has the same imaging device; thus, the hardware has not yet been changed. When upgrading the software, it is detected that a new machine learning model is in the package, and it requires a different hardware configuration. The method 100 guides the Biomed to perform a test using the new machine learning model. The output is listed in Table 3.Table 3. An output from a test run after installing a third-party machine learning model.

[0061] In this case, it did not make a significant performance change relative to the OEM specifications. However, the reduction in scanning speed relative to the OEM specifications is significant, so that the addition of the machine learning model would slow down the image throughput (i.e., scanning speed in the table). The system could therefore recommend to the Biomed that the new machine learning model should not be installed, or that some other action be taken such as reconfiguring the machine learning module to operate offline or on a cloud server to reduce its impact on scanning speed. The method 100 retrieves the relevant quality management documents in the hospital and guides the Biomed to complete the hospital process.

[0062] In a third example, over time, the decision-making path and the devices are captured in a learning database 30. It records all the indicators and results so that they can be used for the query later on. An engineer can query by providing information on a part and the device, then the database can match it with similar cases. If the engineer has used a third-party part A before on the same device which was determined as remanufacturing, this could be suspicious as remanufacturing, if no new guidelines from the regulatory body were found. However, if one of the indicators (X) changes, say the size of the part is different from before, the method 100 will re-evaluate the scale of the change and make a new decision and guidance accordingly.

[0063] In a fourth example, after corrective action is completed, the method 100 will keep on estimating the scale of change regardless of whether it was a remanufacturing or repair. If the estimation of change becomes significant, feedback should be given to the engineer on the step he / she should not have done (or should have done differently), along with the reasons (measured indicators); further, it performs root-cause analysis and pinpoints the step that may have led to this change. Because the service record database records the person’s role who performed the corrective action, it knows whether the engineer is a certified remanufacturer or not, it can help determine liability, and educate on potential future issues.

[0064] In a fifth example, the type of repair can generate a series of questions or images to help determine if the maintenance steps taken were proper. This can be provided to the hospital risk department to ensure quality control. If for example, the maintenance operation includes electrical wiring, the risk manager can be presented with a series of photos on the correct and incorrect way the system should look after the repair. If, for example, wiring is exposed or there are connections, ties, or tears in the wiring insulation or protective casing, then this should alert the risk manager that there is an issue in how the repair was completed which may take the systemout of OEM specification and / or create risks. In another example, if the maintenance operation includes replacement of radiation shielding, the questions to the risk compliance manager could include asking whether there are any holes, rips, tears, or taped pieces, as such damage can create increased risk of radiation not accounted for in the specification. In such cases, the concern might not be remanufacturing, but rather that the quality of the part used may take the system out of the OEM specifications.

[0065] In other contemplated scenarios, the system can request a picture of the part that was replaced and compare it using image matching algorithms to a library of reference images showing how the part properly assembled. This is helpful to risk compliance managers who are not trained on the systems and / or cannot see the part that was replaced. The risk manager can then use the outputs of the comparison to review with the biomed to determine why the proper steps were not taken.

[0066] The disclosure has been described with reference to the preferred embodiments. Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the exemplary embodiment be constructed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

CLAIMS:

1. A non-transitory computer readable medium (26) storing: a database (30) storing a plurality of specifications (32) for a plurality of medical devices (12); and instructions executable by at least one electronic processor (20) to perform a remanufacturing regulatory compliance method (100) including: receiving information (34) describing maintenance performed or planned to be performed on a medical device (12); determining whether the maintenance constitutes remanufacturing of the medical device based on comparison of the received information describing the maintenance with a specification for the medical device (12) that is the subject of the maintenance retrieved from the database; and in response to a determination that the maintenance constitutes remanufacturing, outputting guidance (38) on for addressing the determined remanufacturing.

2. The non-transitory computer readable medium (26) of claim 1, wherein the specification for the medical device (12) comprises specification of performance of the medical device.

3. The non-transitory computer readable medium (26) of claim 1, wherein the guidance (38) comprises guidance on complying with a regulation governing remanufacturing of medical devices which covers the medical device (12) that is the subject of the maintenance.

4. The non-transitory computer readable medium (26) of claim 1, wherein the guidance (38) comprises guidance on modifying the maintenance to not constitute remanufacturing.

5. The non-transitory computer readable medium (26) of any one of claims 1-4, wherein the specification of the medical device (12) is an original equipment manufacturer (OEM)specification of the medical device, and the determining comprises: generating one or more original OEM specification metrics from the specification (32) for the medical device (12) that is the subject of the maintenance; estimating one or more modified device metrics for the medical device as modified by the maintenance based at least on the received information (34) describing the maintenance; determining a deviation of the one or more modified device metrics from the one or more OEM specification metrics; and determining that the maintenance constitutes remanufacturing if the deviation exceeds a predetermined remanufacturing threshold.

6. The non-transitory computer readable medium (26) of claim 5, wherein estimating the one or more modified device metrics includes: performing a simulation process for the medical device (12) as modified by the maintenance.

7. The non-transitory computer readable medium (26) of claim 5, wherein generating the one or more OEM specification metrics includes: extracting the one or more OEM specification metrics from the specification (32) for the medical device (12) that is the subject of the maintenance by performing natural language processing (NLP) on the specification (32) for the medical device (12) that is the subject of the maintenance.

8. The non-transitory computer readable medium (26) of any one of claims 5-7, wherein the OEM specification for the medical device (12) is derived from testing data on the basis of which a medical device regulatory approval was obtained.

9. The non-transitory computer readable medium (26) of any one of claims 1-8 wherein the maintenance comprises replacing an original equipment manufacturer (OEM) component of the medical device (12) with a non-OEM component.

10. The non-transitory computer readable medium (26) of claim 9, wherein determiningwhether the maintenance constitutes remanufacturing of the medical device (12) comprises: determining, based on the specification (32) for the medical device (12) that is the subject of the maintenance, that the OEM component never directly contacts a patient during clinical use of the medical device on the patient; and determining that the maintenance constitutes remanufacturing of the medical device if it is determined that the non-OEM component may directly contact a patient during clinical use of the medical device as modified by the replacement of the OEM component with the non-OEM component.

11. The non-transitory computer readable medium (26) of any one of claims 1-8, wherein the maintenance comprises installation of a non-original equipment manufacturer (non-OEM) software update or addition.

12. The non-transitory computer readable medium (26) of claim 11 , wherein determining whether the maintenance constitutes remanufacturing of the medical device (12) comprises one of: assigning a class to the software update based on functionality of the non-OEM software update or addition and determining whether the maintenance constitutes remanufacturing of the medical device based on the assigned class; or determining whether the maintenance constitutes remanufacturing of the medical device based on whether the non-OEM software update or addition is an OEM-approved software update or addition.

13. The non-transitory computer readable medium (26) of any one of claims 1-12, wherein the database (30) further stores information on previously performed maintenance of medical devices annotated with whether the maintenance was determined to be remanufacturing, and the method (100) further includes: determining whether the maintenance matches one of the stored previously performed maintenance determined to be remanufacturing.

14. A remanufacturing regulatory compliance method (100), comprising:receiving information (34) describing maintenance performed or planned to be performed on a medical device (12); estimating one or more modified device metrics for the medical device as modified by the maintenance based at least on the received information describing the maintenance; determining whether the maintenance constitutes remanufacturing of the medical device based on comparison of the estimated modified device metrics with a corresponding original equipment manufacturer (OEM) specification for the medical device; and in response to a determination that the maintenance constitutes remanufacturing, outputting guidance (38) on modifying the maintenance to not constitute remanufacturing or on complying with a regulation governing remanufacturing of medical devices which covers the medical device (12).

15. The method (100) of claim 14, wherein the guidance (38) comprises guidance on complying with a regulation governing remanufacturing of medical devices which covers the medical device (12) that is the subject of the maintenance.

16. The method (100) of claim 14, wherein the guidance (38) comprises guidance on modifying the maintenance to not constitute remanufacturing.

17. The method (100) of any one of claims 14-16, wherein the OEM specification for the medical device (12) is derived from testing data used to obtain regulatory approval for the medical device.

18. The method (100) of any one of claims 14-17, wherein estimating the one or more modified device metrics includes: performing a simulation process for the medical device (12) as modified by the maintenance.

19. The method (100) of any one of claims 14-17, wherein receiving information (34) describing maintenance performed or planned to be performed on a medical device (12) includes receiving a fault-finding tree and predicting the maintenance using the fault-finding tree.

20. A remanufacturing regulatory compliance apparatus (10), comprising: a hardware processor (20) programmed to perform a remanufacturing regulatory compliance method (100) including: receiving information (34) describing a modification or planned modification of a medical device (12) comprising replacement of an original equipment manufacturer (OEM) component of the medical device with a non-OEM component or installation of a non-original equipment manufacturer (non-OEM) software update or addition; estimating one or more modified device metrics for the medical device with the modification or planned modification described by the received information; determining whether the modification or planned modification constitutes remanufacturing of the medical device based on comparison of the estimated one or more modified device metrics with corresponding OEM specifications for the medical device extracted from testing data used to obtain regulatory approval of the medical device; and in response to a determination that the modification or planned modification constitutes remanufacturing, outputting guidance (38) on revising the modification or planned modification to not constitute remanufacturing or on complying with a regulation governing remanufacturing of medical devices which covers the medical device (12).

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