Source-based operating parameter thresholds for medical devices

Abstract

Certain aspects of the present disclosure provide an apparatus configured to receive an operational parameter configured to control operation of a medical device from a source, and determine a source of the operational parameter. The apparatus selects a set of operating parameter thresholds from a plurality of sets of operating parameter thresholds based on sources of the communication, wherein each set of operating parameter thresholds of the plurality of sets of operating parameter thresholds is associated with a corresponding source. The apparatus determines that the operating parameter satisfies at least one operating parameter threshold of the selected set of operating parameter thresholds, and controls the medical device based on the operating parameter and the determining that the operating parameter satisfies the at least one operating parameter threshold of the selected set of operating parameter thresholds.

Description

Technical Field

[0001] This disclosure relates to establishing threshold values ​​for operating parameters for medical devices based on the source of the operating parameters. Background Technology

[0002] An infusion pump is a type of medical device configured to infuse therapeutic fluids into a patient, such as in a hospital or other healthcare setting. Generally, an infusion pump is programmed to pump fluid at a specific flow rate and to a specific volume in order to administer a specific dose of treatment. Specifically, an infusion pump can be configured to receive one or more operating parameters from one or more sources for controlling its operation. These one or more operating parameters may include flow rate, volume, velocity, infusion time, and / or one or more of others. The infusion pump then operates according to these one or more operating parameters.

[0003] Infusion pumps can be configured with operational limitations to prevent improper or dangerous operation. Such operational limitations can be based on, for example, the mechanical capabilities of the infusion pump or safety restrictions related to drug therapy administered by the infusion pump.

[0004] A clinician can configure one or more operating parameters at the infusion pump to operate the pump under any operating limitations or thresholds (referred to as "operating parameter thresholds"). For example, the clinician can input a flow rate at the infusion pump, and the pump can compare the input flow rate to a flow rate threshold to determine if the flow rate meets the threshold. If the flow rate meets the threshold, the pump operates at that flow rate. If the flow rate does not meet the threshold, the pump can alert the clinician to the potential error, for example, using auditory cues and / or screen-based alerts. The clinician can then address the error.

[0005] Typically, a single set of operating parameter thresholds is configured for all sources of operating parameters for an infusion pump. As referred to herein, a source can be a specific source type and / or a source using a specific control modality to provide the operating parameters. Examples of source types include algorithms, clinicians, and electronic medical records. Examples of control modalities include local control via direct programming (e.g., a clinician typing input, an algorithm providing local input, etc.) and remote control via control messaging (e.g., a clinician using a remote device to provide input, an algorithm providing input over a network, etc.). Therefore, example sources include algorithms, clinicians, clinicians using remote devices, and clinicians using local input. However, the source of operating parameters may suggest a different set of operating parameter thresholds based on, for example, different trust levels for different sources. For example, a human controller may deserve a wider range of operations (higher trust) than an algorithmic controller (lower trust). Conventional medical device (e.g., infusion pump) control architectures cannot achieve this level of control.

[0006] Similarly, alarm systems are not equally effective for all sources (such as those corresponding to different control modalities). For example, auditory alerts may be useful in local control modes where clinicians can hear and respond to them. However, auditory alerts are completely ineffective in remote control modes, where, for example, the algorithm cannot "hear" or otherwise respond to alerts without proper programming.

[0007] Therefore, in the field of medical devices (such as infusion pumps), there are technical problems regarding how to configure operating parameter thresholds and alarm systems to maintain the correct and safe operation of medical devices when controlled using different control modes. Summary of the Invention

[0008] Some aspects described herein include an apparatus comprising: one or more memories including computer-executable instructions; and one or more processors configured to execute the computer-executable instructions and cause the apparatus to: receive from a source operating parameters configured to control operation of a medical device; determine the source of the operating parameters; select a set of operating parameter thresholds from a plurality of sets of operating parameter thresholds based on the source, wherein each set of operating parameter thresholds is associated with a corresponding source; determine that the operating parameters satisfy at least one operating parameter threshold from the selected set of operating parameter thresholds; and control the medical device based on the operating parameters and the determination that the operating parameters satisfy the at least one operating parameter threshold from the selected set of operating parameter thresholds.

[0009] Some aspects described herein include a method comprising: receiving from a source operational parameters configured to control the operation of a medical device; determining the source of the operational parameters; selecting a set of operational parameter thresholds from a plurality of sets of operational parameter thresholds based on the source of the operational parameters, wherein each set of operational parameter thresholds is associated with a corresponding source; determining that the operational parameters satisfy at least one operational parameter threshold from the selected set of operational parameter thresholds; and controlling the medical device based on the operational parameters and the determination that the operational parameters satisfy the at least one operational parameter threshold from the selected set of operational parameter thresholds.

[0010] Other aspects include a processing system configured to perform the methods described above and those described herein; a non-transitory computer-readable medium including instructions that, when executed by a processor of the processing system, cause the processing system to perform the methods described above and those described herein; a computer program product implemented on a computer-readable storage medium including code for performing the methods described above and those further described herein; and a processing system including components for performing the methods described above and those further described herein.

[0011] The following description and related figures illustrate certain illustrative features of one or more aspects. Attached Figure Description

[0012] The accompanying drawings depict certain aspects and should not be construed as limiting the scope of this disclosure.

[0013] Figure 1 An example medical device system is described.

[0014] Figure 2 Another example medical device system is described.

[0015] Figure 3 A sample drug library is described, featuring various example operating rules for operating medical devices.

[0016] Figure 4 An example flowchart is depicted for implementing operational restrictions based on the source of the medical device being operated.

[0017] Figure 5 An example method for implementing operational restrictions based on the source of the medical device being operated is described.

[0018] Figure 6 An example computing device for implementing the various aspects described in this paper is depicted.

[0019] For ease of understanding, the same reference numerals are used where possible to designate common elements in the figures. It is contemplated that elements and features of one embodiment may be advantageously incorporated into other embodiments without further description. Detailed Implementation

[0020] This disclosure provides apparatus, methods, processing systems, and computer-readable media for improving the safe operation of medical devices by providing source-specific operating parameter thresholds and / or alarm systems. For example, medical devices (such as infusion pumps) can be configured with different operating parameter thresholds for different sources (e.g., local control by a clinician, remote control by a clinician, remote algorithm control, remote system control, etc.). While certain aspects have been discussed with regard to infusion pump systems, it should be noted that the techniques discussed herein can be similarly used to control the operation of other types of medical devices.

[0021] As discussed above, there are technical challenges in the field of medical device systems because the operation control of such devices is source-independent and therefore cannot account for different levels of trust in operating parameters originating from different sources. Modern medical devices are capable of receiving operating parameters from a variety of sources, including local (such as through a user interface on the actual device) and remote (e.g., through communications, such as messages sent via wired or wireless connections), to control the operation of the medical device. Since incorrect operating parameters can lead to improper operation of the medical device, operating parameter thresholds can be used to ensure correct operation. However, the wide range of scenarios in which medical devices may operate makes configuring any single set of operating parameter thresholds an inherently compromised task.

[0022] The aspects described herein offer a beneficial technical solution to this technical problem by utilizing different operating parameter thresholds based on the source of the operating parameters provided for the medical device. Therefore, different sets of operating parameter thresholds can be configured for different operating parameter sources. Using different operating parameter thresholds based on the source of the operating parameters provides a beneficial technical effect of reducing different types of risks and / or errors associated with different sources. Thus, patient safety is improved, while simultaneously enhancing the ability to control medical devices through multiple sources, such as those corresponding to multiple control modalities, including local, remote, algorithmic, and artificial intelligence (AI) enhancements.

[0023] For example, one source of operating parameters is local control by a clinician. Specifically, the clinician may type operating parameters directly into the medical device (e.g., an infusion pump) using physical inputs (e.g., buttons) and / or a touch-sensitive display on the device itself. This can be considered a relatively low-risk source of operating parameters, and therefore the operating parameter thresholds applied to such inputs can be relatively more lenient. For example, the operating parameter thresholds may be relatively high or low compared to other sources (e.g., allowing for higher infusion rates or shorter infusion times). Similarly, a set of operating parameter thresholds can define a range, and in this example, the range of operating parameters may be wider compared to other higher-risk sources.

[0024] Another source of operating parameters is remote control by a human using a device that communicates with the medical device via data. For example, the medical device can be configured to communicate with smartphones, tablets, networked computing devices, etc. In this example, a clinician can type one or more operating parameters on a remote control device, which are then sent to the medical device, for example, via a network data connection. Because the medical device is remotely controlled by a human in this example, it may be considered a medium-risk source, and therefore the thresholds applied to such operating parameter inputs can be relatively less lenient. For example, a set of operating parameter thresholds can define a range, and in this example, the range of operating parameters may be smaller compared to other lower-risk modalities.

[0025] Another source of operating parameters is local or remote control performed by non-human entities, such as control algorithms or artificial intelligence (AI) systems that generate the operating parameters. For example, a control algorithm or AI system can process various received inputs (e.g., sensor data) to determine and adjust the operating parameters. Because the medical device is remotely controlled by a non-human entity in this example, this can be considered a relatively high-risk source, and therefore the operating parameter thresholds applied to such inputs may be less lenient. For example, a set of operating parameter thresholds may define a range, and in this example, the range of operating parameters may be smaller compared to other lower-risk sources. Note that while algorithms or AI systems are used as relatively high-risk sources in this discussion, this is not always the case. In fact, in various situations, algorithms or AI systems can be lower (or lowest) risk sources. The examples and associated risks in this article are for discussion purposes only.

[0026] One type of control algorithm or AI system can be implemented in a closed-loop configuration, where (e.g., based on sensor data) one or more operating parameters are determined and provided to a medical device without any input or further confirmation from a user (e.g., a clinician). Another type of control algorithm or AI system can be implemented in a semi-closed-loop configuration, where the control algorithm generates suggested values ​​for one or more operating parameters, which may then be provided to the medical device only after the user has input confirmation of the operating parameters. The additional requirement for user input to confirm the operating parameters before providing them as input to the medical device may indicate that sources using a semi-closed-loop configuration are less risky than those using a closed-loop configuration, and therefore such different sources can have different operating parameter thresholds.

[0027] Operating parameter thresholds and alarm systems can also be based on reducing errors associated with specific sources, such as those related to specific control modes (including local, remote, algorithmic, AI-enhanced, etc.). As discussed above, as medical devices (such as infusion pumps) become more interconnected and subject to more complex (and often remote) control schemes, a single set of operating parameter thresholds and alarm systems may be insufficient to address different error types from different sources. For example, one control algorithm may tend to determine operating parameters with lower error rates, while another may tend to determine operating parameters with higher error rates. Therefore, source-adapted operating parameter thresholds and alarm systems based on operating parameters beneficially reduce errors, thus providing a beneficial technical effect. In particular, the aspects described herein increase the reliability and effectiveness of medical device systems by determining operating limits and alarm systems based on each source.

[0028] In some respects, an operating parameter threshold can be considered a maximum threshold, thus the operating parameter cannot be set higher than (e.g., greater than) the maximum threshold. In some respects, an operating parameter threshold can be considered a minimum threshold, thus the operating parameter cannot be set lower than (e.g., less than) the minimum threshold. In some respects, an operating parameter can be associated with an operating parameter threshold (e.g., a maximum threshold or a minimum threshold). In some respects, an operating parameter can be associated with a set of one or more operating parameter thresholds (e.g., a maximum threshold and a minimum threshold).

[0029] In some respects, the maximum and minimum operating parameter thresholds can define the range of allowed operating parameter values, meaning the operating parameter can only be set above the minimum threshold and below the maximum threshold. For example, when the source of the operating parameter is less reliable, the range of operating parameter thresholds can be more restrictive, such as a narrower range between the minimum and maximum thresholds (e.g., fewer values ​​between the minimum and maximum thresholds). When the source of the operating parameter is more reliable, the operating parameter thresholds can be, for example, less restrictive, such as a wider range between the minimum and maximum thresholds (e.g., more values ​​between the minimum and maximum thresholds).

[0030] Additionally, the operating parameter thresholds and alarm system can be based on the trust level associated with a specific source of the operating parameters, such as corresponding to a specific control modality, including local, remote, algorithmic, AI-enhanced, etc. For example, a first algorithm may be more trustworthy, for example, due to a longer history of use, and the set of operating parameter thresholds can therefore be less restrictive by setting the maximum and minimum operating parameter thresholds to a wider range. Meanwhile, a second algorithm may be less trustworthy, for example, due to freshness (e.g., only recently used), and the maximum and minimum operating parameter thresholds can be set to a narrower range. Thus, different operating parameter thresholds can be used based on the specific algorithm controlling the medical device.

[0031] In another example, the source type can include humans with specific roles. Therefore, humans with different roles can correspond to different sources. For example, different roles can be assigned to different clinicians, such as assigning different roles to enable role-based operational parameter thresholds. A traveling nurse can be assigned a first role with a first set of operational parameter thresholds, and a nurse practitioner can be assigned a second role with a second set of operational parameter thresholds. A traveling nurse may be less trustworthy due to limited experience in the nursing setting, and the maximum and minimum operational parameter thresholds can be set to a narrower range. A nurse practitioner may be more trustworthy due to qualifications and experience, and the maximum and minimum operational parameter thresholds can be set to a wider range. Therefore, in some respects, different operational parameter thresholds can be used based on the role assigned to a clinician.

[0032] Advantageously, medical devices (such as infusion pumps) can utilize more than one operating parameter source, such as more than one control modality for a specific type of source, by using more restrictive multiple sets of operating parameter thresholds (e.g., a narrower range) for less trusted sources (e.g., a less trusted control modality) and less restrictive multiple sets of operating parameter thresholds (e.g., a wider range) for more trusted sources (e.g., a more trusted control modality). Using different operating parameter thresholds based on specific sources of operating parameters provides the technical effect of ensuring that less trusted sources are subject to stricter restrictions without unduly restricting trusted sources. Therefore, patient safety is maintained while increasing the range of operations available for more trusted sources and decreasing the range of operations available for less trusted sources.

[0033] In some respects, certain sources may be associated with different alarm systems. For example, if the source is a clinician operating locally at a medical device and the operating parameters do not meet the thresholds for that source, one alarm system can be used. This alarm system could be an alert displayed on the medical device being operated by the clinician. Thus, the clinician is alerted and can correct the operating parameters. However, if the source is a control algorithm, a different alarm system may be used because displaying an alert on the medical device may not be effective in alerting the clinician to problems with algorithmic control. The aspects described herein overcome this problem by enabling source-specific alarm systems. Such alarm systems for algorithms could, for example, include sending alerts to, for example, a clinician (e.g., at the clinician's device) and restricting the implementation of operating parameters. Therefore, using different alarm systems for different sources provides the beneficial technical effect of maintaining awareness of medical device operation under various control schemes, which in turn improves patient safety.

[0034] Example medical device system

[0035] Figure 1 An example medical device system 100 is depicted, which can implement the methods described herein to manage the threshold values ​​of operating parameters received at the medical device system based on the source of the control medical device.

[0036] Medical device system 100 can be used to monitor and treat patient 112. Medical device system 100 includes sensor 102. Although one sensor 102 is shown, additional sensors (e.g., of different types) may be present, or no sensors may be present. In some aspects, sensor 102 is configured to monitor / sensor one or more vital signs of the patient. For example, sensor 102 may be one or more of a heart rate monitor, pulse oximeter, continuous glucose monitor, blood pressure monitor, etc. In another example, sensor 102 may monitor / sensor operating parameters of medical device system 100, such as the flow rate of infusion pump 104 included in medical device system 100. Sensor 102 transmits communication including sensor data to control module 110 of medical device system 100.

[0037] In some embodiments, control module 110 (e.g., using sensor data from sensor 102) determines one or more operating parameters for infusion pump 104 to implement and treat patient 112. Therefore, control module 110 (e.g., in one or more communications) sends one or more operating parameters (e.g., as one or more control inputs) to infusion pump 104 to control the operation of infusion pump 104. Control module 110 may include user interface 108 to display sensor data, operating parameters, etc. In some embodiments (such as semi-closed-loop systems), clinicians can confirm the operating parameters on user interface 108. In some embodiments, control module 110 may be connected to more than one sensor 102 or more than one infusion pump 104. In some embodiments, control module 110 may be connected to one or more other medical devices, such as insulin pumps.

[0038] In some embodiments, a clinician may determine one or more operating parameters for implementing and treating patient 112 using infusion pump 104, for example, based on sensor data from sensor 102. The clinician may input these one or more operating parameters into infusion pump 104, such as through user interface 106 on infusion pump 104 or user interface 108 on control module 110. These one or more operating parameters control the operation of infusion pump 104.

[0039] Generally, the sensor 102, control module 110 and infusion pump 104 can be connected via wired or wireless connections (such as Bluetooth, Wi-Fi, RFID, near-field communication, etc.).

[0040] Although described herein as a separate device, in some cases, the control module 110 may be integral to or part of the sensor 102 or the infusion pump 104.

[0041] In the example, the operational controls discussed herein (including operational parameter thresholds and / or alarm systems) can be used to manage the devices of medical device system 100. For example, infusion pump 104 can evaluate operational parameters from sensor 102, control module 110, user interface 106, user interface 108, other control modules, other devices, etc., based on the operational parameter thresholds described herein.

[0042] Example medical device system

[0043] Figure 2 Another example medical device system 200 is depicted, which can implement the methods described herein to control the source of the medical device (such as...) Figure 1 An infusion pump 104 connected to the patient 112 manages the threshold values ​​of operating parameters received at the medical device system. The patient care system may include one or more pumps, such as pumps 202, 204, 206, and 208. While a large-capacity pump is illustrated, other types of pumps, such as peristaltic pumps, small-capacity pumps, infusion pumps, anesthesia delivery pumps, or patient-controlled analgesia pumps, can be implemented. The pump may be an infusion device configured to deliver substances (e.g., fluids, nutrients, medications, etc.) to the patient's circulatory system or epidural space, for example, via intravenous infusion, subcutaneous infusion, arterial infusion, epidural infusion, etc., or to the patient's digestive system, for example, via a nasogastric tube (NG), percutaneous endoscopic gastrostomy tube (PEG), nasojejunal tube (NJ), etc.

[0044] Each of pumps 202, 204, 206, or 208 can be fluidly connected to upstream fluid lines 212, 214, 216, and 218, respectively. Furthermore, each of pumps 202, 204, 206, and 208 can be fluidly connected to downstream fluid lines 222, 224, 226, and 228, respectively. The fluid lines can be any type of fluid conduit (such as tubing) through which fluid can flow.

[0045] Each of fluid supplies 232, 234, 236, and 238 can be a reservoir, such as a bottle as shown, inverted and suspended above the pump. Fluid supplies can also take the form of bags, syringes, or other types of containers. The medical device system 200 can be mounted on a roller holder or intravenous infusion pole 240.

[0046] The medical device system 200 may also include a check valve, a drip chamber, a valved port, a connector, and other devices configured to administer a substance.

[0047] Example operation parameter threshold

[0048] Figure 3 An example drug library 300 is described, having various example rules 302, 310 and 320 for operating parameter thresholds associated with various sources. This drug library can be used by medical devices such as infusion pump 104 to manage operating parameter thresholds from various sources.

[0049] In some embodiments, the operating parameter thresholds may be set by the manufacturer (such as the manufacturer of the infusion pump 104). In some embodiments, the operating parameter thresholds may be set by the care facility (such as a hospital where medical devices are used). In some embodiments, the operating parameter thresholds may be set by medical treatment guidelines. In some embodiments, the operating parameter thresholds may be updated from time to time.

[0050] Generally, each rule may contain one or more operational parameter thresholds and contextual data associated with those thresholds. Contextual data associated with a rule may include, for example, the care area, drug type, source, patient type, patient weight, room temperature, etc. Example operational parameter thresholds may include, for example, dose thresholds, concentration thresholds, trend thresholds, bolus thresholds, or thresholds associated with other operational parameters. In some cases, an operational parameter threshold may be associated with a single operational parameter. For example, a dose value may be received as an operational parameter, and this dose value may be compared to a maximum dose threshold. In some cases, an operational parameter threshold may be associated with a combination of multiple operational parameters and / or other data. For example, a function may be applied to a first operational parameter and a second operational parameter, and this function outputs a value compared to the operational parameter threshold.

[0051] In some embodiments, a rule to be applied to a particular operating parameter and one or more operating parameter thresholds associated with that rule are determined based on contextual data associated with that particular operating parameter. Specifically, the operating parameter is associated with contextual data such as an indication of the source providing the operating parameter, the type of medication to which the operating parameter applies, and the care area where the medication controlled by the operating parameter is being infused. In some embodiments, a rule containing contextual data matching the contextual data of the operating parameter is applied to the operating parameter such that the one or more operating parameter thresholds associated with the rule are applied to the operating parameter. Specifically, a rule including a source matching the source of the operating parameter may be applied to the operating parameter.

[0052] The nursing area field can be populated with nursing areas for which medical devices can be used. For example, a nursing area can be a treatment location such as a neonatal intensive care unit (NICU), an intensive care unit (ICU), pediatrics, oncology, internal medicine / surgery, operating room, etc. Rules 302, 310, and 320 are associated, for example, with infusion pumps used in a NICU.

[0053] The drug type field can be filled with the drug name or treatment name, which a medical device can infuse as part of a medical treatment. Rules 302, 310, and 320 are, for example, associated with an infusion pump infusing drug A.

[0054] The source field can be populated by the source controlling the operation of the medical device. As discussed above, various sources can provide operational parameters for controlling the operation of the medical device. For example, the source could be a clinician using physical inputs from the medical device or using a control module (e.g., Figure 1 The clinician in the control module 110. For example, rule 302 is associated with the clinician who enters the operating parameters.

[0055] In another example, the source could be a clinician who remotely enters operational parameters via a remote control device. In some cases, the remote control device may connect to an electronic medical record (EMR) system or other physician order system configured to receive and store one or more operational parameters entered by the clinician. These operational parameters can then be transmitted to the medical device to control the operation. Furthermore, the clinician entering the information can be identified based on their assigned role (such as a travel nurse, nurse practitioner, physician assistant, physician, pharmacist, etc.). For example, Rule 310 is associated with orders entered into the EMR.

[0056] Another example source could be algorithms that determine operating parameters for medical devices. For instance, Rule 320 and algorithms derived from Algorithm 1 (such as those using data from...) Figure 1 The operating parameters are associated with the sensor data (algorithm) of sensor 102 in the sensor. In some embodiments, the algorithm can be identified by the type of sensor data used to determine the operating parameters. For example, the algorithm can be identified as a heart rate algorithm because it utilizes heart rate data provided by a heart rate monitor.

[0057] In some embodiments, the algorithm may be identified additionally or alternatively based on one or more drug therapies determined by the algorithm. For example, the algorithm may be identified as a heparin dosing algorithm because it determines heparin dosage treatment.

[0058] In some embodiments, the algorithm may be identified additionally or alternatively based on one or more medical devices used to implement the operating parameters. In some embodiments, the algorithm may be identified as an infusion pump algorithm because it determines the operating parameters for the medical device.

[0059] A dose limitation field can be a set of one or more thresholds for a dose operation parameter. For example, a dose operation parameter can be the amount of medication to be infused by an infusion pump. A dose operation parameter threshold can be a limit that the infusion pump dose operation parameter can be set to, or it can be associated with further actions to set the dose operation parameter. For example, a first threshold can be a “hard” threshold, such as a hard maximum (or minimum) threshold, whereby the operation parameter cannot be set beyond that threshold (e.g., above the maximum or below the minimum). In another example, a second threshold can be a “soft” threshold, such as a soft maximum (or minimum) threshold, whereby setting an operation parameter beyond that threshold (e.g., above the maximum or below the minimum) is associated with additional actions to set that operation parameter. In some embodiments, the additional actions associated with the threshold can include, for example, activating an alarm system via an alarm, warning, message, confirmation request, etc. For example, Rule 302 has a set of dose limitation thresholds including a hard maximum, a soft maximum, a soft minimum, and a hard minimum.

[0060] A concentration limit field can be a set of one or more thresholds for a concentration operating parameter. For example, a concentration operating parameter can be the concentration of a drug to be infused by an infusion pump. A concentration operating parameter threshold can be a limit that the infusion pump concentration operating parameter can be set to, or it can be associated with further actions to set the concentration operating parameter. For example, a first threshold can be a “hard” threshold, such as a hard maximum (or minimum) threshold, whereby the operating parameter cannot be set above (e.g., above or below) this threshold. In another example, a second threshold can be a “soft” threshold, such as a soft maximum (or minimum) threshold, whereby setting an operating parameter above (e.g., above or below) this threshold is associated with additional actions to set that operating parameter. In some embodiments, the additional actions associated with the threshold can include, for example, activating an alarm system via an alarm, warning, message, confirmation request, etc. For example, Rule 302 has a set of dose limit thresholds including a hard maximum, a soft maximum, a soft minimum, and a hard minimum.

[0061] A trend limit field can be a set of one or more thresholds for a trend of one or more operating parameters. For example, a trend can be a percentage change of an operating parameter over time (e.g., between a new operating parameter received from a source and one or more current and / or past operating parameter values ​​being used at the infusion pump). For example, as depicted in Rule 302, a 100% trend can be a 100% change of the new operating parameter relative to the current operating parameter value, such as a case where the new operating parameter is 30 and the current operating parameter is 15.

[0062] Trends may also include one or more previous operating parameter values, such as one or more previous operating parameter values ​​during treatment. Trends can be determined for one or more operating parameters, such as dose operating parameter trends or concentration operating parameter trends.

[0063] If an operating parameter trend does not meet one or more trend thresholds, the operating parameter cannot be set even if it meets other operating parameter thresholds. For example, given a previous dose operating parameter value of 6 and a new dose operating parameter of 15, the dose trend (e.g., percentage change over time) is a 150% change. The new dose operating parameter meets (e.g., is less than) the hard and soft maximum thresholds for dose limits, but does not meet (e.g., exceeds) the hard and soft maximum thresholds for trend limits. Therefore, the new dose operating parameter cannot be set. Advantageously, trend limits can restrict the application of rapid and significant changes in operating parameters, for example, when the operating parameter is determined by an algorithm.

[0064] Trend restrictions may include, for example, a first threshold, which may be a "hard" threshold, such as a hard maximum threshold, whereby if the trend of an operating parameter exceeds (e.g., is higher than) this threshold, then the operating parameter cannot be set. In another example, a second threshold may be a "soft" threshold, such as a soft maximum threshold, whereby if the trend of an operating parameter exceeds (e.g., is higher than) this threshold, then additional action may be required before the operating parameter can be set. In some embodiments, the additional action associated with the threshold may include, for example, activating an alarm system via an alert, warning, message, confirmation request, etc.

[0065] While example drug library 300 depicts rules 302, 310, and 320, additional or alternative rules are also envisioned. Furthermore, rules for operational restrictions may include additional or alternative fields and thresholds.

[0066] Example flowchart for operating medical devices based on appropriate operating parameters

[0067] Figure 4 Describes the use of appropriate operating parameters to operate medical devices (such as...) Figure 1 Example process 400 (infusion pump 104 in the example). In some embodiments, a medical device operating based on process 400 may include a control module or coupled to a control module, such as Figure 1 The control module 110 is included. Process 400 can be executed by the medical device and / or the control module.

[0068] Initially, process 400 begins at step 402, where one or more operating parameters for controlling the operation of a medical device are received from a source. Specifically, the values ​​of these one or more operating parameters are received. For example, the one or more operating parameters for operating an infusion pump may include drug type, dosage regimen, and / or concentration.

[0069] In some embodiments, as discussed, context data associated with one or more operating parameters is determined. In some embodiments, context data is received from a source, such as in a message accompanying one or more operating parameters. In some embodiments, context data is inferred based on how the one or more operating parameters are received (e.g., via a specific wireless or wired connection). In some embodiments, context data is inferred based on an identifier received from a source, such as in a message accompanying one or more operating parameters. In some embodiments, context data is received separately from the one or more operating parameters, such as via a separate input (e.g., from previous communications, such as communications received during the setup phase of a medical device).

[0070] Process 400 proceeds to step 404, where the source of the one or more operating parameters is determined. In some embodiments, the source is determined based on the control mode through which the operating parameters are received. For example, through which physical input to the operating parameters is received (e.g., from a button press, from a device port of a wired interface, through a wireless interface of the device, etc.). In some embodiments, the source is additionally or alternatively determined based on an identifier indicating the source, such as one included with the operating parameters in a message or other communication. In some embodiments, the identifier may be a token or some other verifiable information. In some embodiments, the source is additionally or alternatively determined based on additional input indicating the source received at a control module or medical device. For example, a radio frequency identification (RFID) tag may be attached to the source and scanned at the device. The RFID tag may include identifier information of the source. As another example, a barcode or QR code may be attached to the source and scanned at the device. The barcode or QR code may include identifier information of the source. In some embodiments, the source is additionally or alternatively determined based on the characteristics of the operating parameters. For example, different sources may be associated with different encryption schemes or keys used to encrypt the operating parameters. The encryption type used to encrypt operational parameters can indicate the source. For example, a device can try different decryption schemes to decrypt the operational parameters, and the scheme or key that successfully decrypts the operational parameters is used to identify the source. For example, as mentioned above... Figure 3 The sources discussed may include clinicians, EMRs, and algorithms. Identifying the source at 404 may include, for example, determining the type of source (e.g., human, machine) based on information received from or messages derived from the source.

[0071] Process 400 then proceeds to step 406, where, for example, based on... Figure 3 One or more rules are described to determine one or more operational parameter thresholds associated with a source. For each operational parameter provided, a set of one or more thresholds associated with that operational parameter can be determined.

[0072] For example, in cases where the source is a clinician (such as a clinician manually typing operating parameters into a medical device), a set of operating parameter thresholds (including a set of one or more operating parameter thresholds) is determined for each provided operating parameter (such as dosage regimen, concentration, and trend). Therefore, based on, for example, in Figure 3 The drug type and care area described in Rule 302 of the document define a set of clinically relevant threshold parameters for dosage regimens, a set of clinically relevant threshold parameters for concentrations, and a set of clinically relevant threshold parameters for trends.

[0073] In another example, where the source is an EMR (such as a medication order in an EMR), a set of operational parameter thresholds is determined for each provided operational parameter (such as dosage regimen, concentration, and trend). Therefore, based on, for example, in Figure 3 The drug type and care area described in Rule 310 of the document determine a set of operational parameter thresholds associated with EMR for dosing regimens, a set of operational parameter thresholds associated with EMR for concentrations, and a set of operational parameter thresholds associated with EMR for trends.

[0074] In yet another example, where the source is an algorithm (such as one that determines operating parameters based on sensor data), a set of operating parameter thresholds is determined for each provided operating parameter (such as dosage regimen, concentration, and trend). Therefore, based on, for example, in Figure 3 The drug type and care area described in rule 320 determine a set of operational parameter thresholds associated with the algorithm for the dosage regimen, a set of operational parameter thresholds associated with the algorithm for the concentration, and a set of operational parameter thresholds associated with the algorithm for the trend.

[0075] Alternatively, or as an alternative to the determinations made at steps 404 and 406, process 400 may generate a trust level for a source and determine a threshold corresponding to that trust level, rather than determining the source or source type. Generating a trust level may include considering the source, source type, parameters being attempted to be configured, the amount of change between the current parameter value and the proposed new value, or the frequency of change. Trust levels may also be based on the patient or the medication to be administered. Trust levels may be an aggregation of assessments for each parameter to be adjusted. For example, if the device is currently programmed with ten variables and receives a message to change one value by 3%, then that command may be associated with a higher trust level compared to a message seeking to change nine values ​​or a message seeking to change one value by 30%. Trust levels may have corresponding values ​​in a drug library to identify which safety thresholds should be applied.

[0076] Process 400 then proceeds to step 408, where the one or more operation parameters are compared with one or more sets of operation parameter thresholds to determine whether the one or more operation parameters meet the corresponding operation parameter threshold(s). An operation parameter meets an operation parameter threshold if its value meets that threshold. For example, if the operation parameter threshold is a maximum threshold, the operation parameter meets the threshold when it is less than the maximum value. In another example, if the operation parameter threshold is a minimum threshold, the operation parameter meets the threshold when it is greater than the minimum value.

[0077] In some embodiments, the set of operating parameter thresholds includes one or more thresholds, such as a hard maximum threshold, a soft maximum threshold, a soft minimum value, and / or a hard minimum value. The operating parameter can be compared to each threshold to determine whether the value satisfies each threshold.

[0078] In some embodiments, more than one operation parameter is provided. The value of each operation parameter can be compared with a corresponding set of operation parameter thresholds to determine whether the operation parameter value meets the corresponding operation parameter threshold.

[0079] For example, when the source is a clinician, the device can compare each operating parameter with a set of operating parameter thresholds associated with the clinician. In the case where the first operating parameter is a dosage regimen, for parameters such as... Figure 3 For the dose restrictions described in Rule 302, the dose operation parameter is compared to a set of operation parameter thresholds associated with the clinician. For example, in Rule 302, the hard maximum dose threshold is 50, and the soft maximum dose threshold is 20. If the dose operation parameter value is 55, then the dose operation parameter does not meet either the soft maximum threshold or the hard maximum threshold.

[0080] When the second operating parameter is a concentration limit, for example, Figure 3 For the concentration limits described in Rule 302, the concentration operating parameter is compared to a set of operating parameter thresholds associated with the clinician. For example, in Rule 302, the soft maximum threshold for concentration is 100, and the soft minimum threshold for concentration is 75. If the concentration operating parameter value is 85, then the concentration operating parameter satisfies both the soft maximum and soft minimum thresholds.

[0081] When the third operating parameter is a trend limit, for example... Figure 3 The trend constraint described in Rule 302 compares the trend operating parameter to a set of operating parameter thresholds associated with the clinician. For example, at Rule 302, the soft maximum trend for the operating parameter used for dosing is 75%, and the hard maximum is 100%. If the current dosing operating parameter value is 10 and the new dosing operating parameter value is 18, then the trend is 80%. An 80% change exceeds the 75% soft maximum but is below the 100% hard maximum.

[0082] In another example, where the source is an EMR, the device can compare the provided operating parameter with a set of operating parameter thresholds associated with the EMR for each operating parameter. In the case where the first operating parameter is a dosing regimen, for parameters such as... Figure 3 For the dose restrictions described in Rule 310, the dose operating parameters are compared to a set of operating parameter thresholds associated with the EMR. For example, in Rule 310, the hard maximum dose threshold is 50, and the soft maximum dose threshold is 25. If the dose operating parameter value is 35, then the dose operating parameter does not meet the soft maximum threshold but meets the hard maximum threshold.

[0083] When the second operating parameter is a concentration limit, for example, Figure 3 For the concentration limits described in Rule 310, the concentration operating parameter is compared to a set of operating parameter thresholds associated with EMR. For example, in Rule 310, the soft maximum threshold for concentration is 100, and the soft minimum threshold for concentration is 75. If the concentration operating parameter value is 65, then the concentration operating parameter meets the soft maximum threshold but does not meet the soft minimum threshold.

[0084] When the third operating parameter is a trend limit, for example... Figure 3 Regarding the trend constraint described in Rule 310, the trend operating parameter is compared to a set of operating parameter thresholds associated with EMR. For example, at Rule 310, the soft maximum trend for the dose operating parameter is a 75% change, and the hard maximum is a 100% change. If the current dose operating parameter value is 35 and the new dose operating parameter value is 30, then the trend is a 17% change. A 17% change is less than both the soft and hard maximum values, and therefore meets the trend threshold.

[0085] In yet another example, where the source is an algorithm, the device can compare the provided operating parameter with a set of operating parameter thresholds associated with the algorithm for each operating parameter. In the case where the first operating parameter is a dosage regimen, for parameters such as... Figure 3 For the dose constraints described in Rule 320, the dose operation parameters are compared to a set of thresholds associated with the algorithm. For example, in Rule 320, the soft minimum dose threshold is 10, and the soft maximum dose threshold is 15. If the dose operation parameter value is 12, then the dose operation parameter satisfies both the soft minimum and soft maximum thresholds.

[0086] When the second operating parameter is a concentration limit, for example, Figure 3 For the concentration restrictions described in Rule 320, the concentration operating parameter is compared with a set of thresholds associated with the algorithm. For example, in Rule 320, the soft maximum threshold for concentration is 100, and the soft minimum threshold for concentration is 85. If the concentration operating parameter value is 90, then the concentration operating parameter satisfies both the soft maximum and soft minimum thresholds.

[0087] When the third operating parameter is a trend limit, for example... Figure 3 The trend constraint described in Rule 320 compares the trend operation parameter to a set of thresholds associated with the algorithm. For example, at Rule 320, the soft maximum trend for the dose operation parameter is 50% change, and the hard maximum is 75% change. If the current dose operation parameter value is 12, and the transmitted dose operation parameter value is 10, then the trend change is 20%. A 20% change is lower than both the soft maximum and the hard maximum.

[0088] Therefore, by comparing one or more provided operating parameters with corresponding operating parameter(s) thresholds associated with the source, the device can determine whether one or more operating parameters meet the threshold(s). Advantageously, different thresholds then allow for customized restrictions for each source.

[0089] In some embodiments, before process 400 proceeds to step 420 (or step 410), each provided operation parameter is compared with a corresponding threshold(s). In some embodiments, each provided operation parameter is compared with a corresponding threshold(s), and process 400 proceeds to step 420 (or step 410), and then returns to step 408 for each additional operation parameter.

[0090] If one or more operation parameters do not meet the threshold values ​​associated with the source for that set of operation parameters, then process 400 proceeds to step 410, where an alert is generated. The alert may indicate, for example, that an operation parameter does not meet one or more operation parameter thresholds. For example, the alert may be displayed as an icon, warning message, etc. The alert may be (or include) an auditory alarm, such as tone, ringtone, etc. Various aspects of the alert may vary relative to the type or message of the alert in terms of intensity, volume, color, message, etc.

[0091] In some embodiments, the alert can be displayed on a device (such as a medical device, e.g., Figure 1 The user interface on the infusion pump 104 or the user interface on the control module (e.g., Figure 1 The message is displayed on the user interface 108 of the control module 110. In some embodiments, such as a closed-loop system, the reminder may be displayed on a remote device. For example, if the source of one or more operating parameters is an EMR, the reminder may be transmitted to a device associated with the EMR for display. In some aspects, the control module may be a remote device in which the reminder is displayed, such as a clinician device.

[0092] Process 400 then proceeds to step 412, whereby the clinician can respond to the alert. In some embodiments, the clinician can override the alert, for example, by manually typing one or more operation parameters. If the clinician types one or more operation parameters, then process 400 returns to step 402.

[0093] If the clinician does not overwrite the reminder, then process 400 proceeds to step 414, where the operation parameter(s)(s) is rejected.

[0094] Process 400 then proceeds to step 424, where the log records the one or more operation parameters and associated data. Such data may include contextual data, such as the source, the threshold and comparison of the operation(s), alerts(s), and rejections of the operation(s).

[0095] If the one or more operating parameters meet the threshold values ​​of the set of operating parameters associated with the source, then process 400 optionally proceeds to step 420, where the one or more operating parameters are displayed, such as for clinicians to confirm the one or more operating parameters in a manual or semi-closed-loop system.

[0096] In some embodiments, if one or more operating parameters satisfy all operating parameter thresholds (such as when an operating parameter satisfies a hard threshold but not a soft threshold), one or more operating parameters are displayed. For example, if the one or more operating parameters are provided by an EMR, such as in... Figure 3 In rule 310, the hard maximum dose threshold is 50, and the soft maximum dose threshold is 25. If the dose operation parameter value is 35, then the dose operation parameter does not meet the soft maximum threshold but meets the hard maximum threshold. At step 420, the dose operation parameter value 35 can be displayed. The display at step 420 may include an alert or message indicating that the operation parameter(s) does not meet one or more soft thresholds but meets one or more hard thresholds.

[0097] In some embodiments, clinicians may confirm the displayed operation parameters(s) before proceeding from step 400 to step 422. Confirmation may be made via a user interface (such as...) Figure 1 The user interface 106 or user interface 108 in the system receives the information. In some embodiments, one or more operation parameters are displayed along with confirmation, such as "yes" or "no" to be selected.

[0098] In some embodiments, if the one or more operating parameters meet the threshold values ​​of the set of operating parameters associated with the source, then process 400 proceeds directly to step 422.

[0099] At step 422, the device implements the one or more operating parameters provided by the source. For example, if the one or more operating parameters are for an infusion pump, the infusion pump may implement the one or more operating parameters.

[0100] Process 400 then proceeds to step 424, where the log records one or more operational parameters and data associated with the implementation. Such data may include additional data, sources, thresholds for the set of operational parameters and comparisons with those thresholds, any alerts, and any clinician confirmations or overwrites.

[0101] It should be noted that process 400 is just an example, and other processes consistent with this disclosure, including fewer, additional, or alternative steps, are also possible.

[0102] Example methods for operating medical devices based on appropriate operating parameters

[0103] Figure 5 An example method 500 is described for determining appropriate operating parameters for the operation of a medical device based on the source of the operating parameters.

[0104] Initially, method 500 begins at step 502, wherein a device configured to control a medical device (such as...) is received from a source. Figure 1 Operating parameters for the infusion pump 104 in the middle.

[0105] Method 500 proceeds to step 504, where the source of the operation parameters is determined, such as regarding... Figure 4 The step 404 described herein. In some embodiments, the source is one of the following: an electronic medical record; an algorithm configured to determine operating parameters; or a clinician.

[0106] In some embodiments, determining the source of an operating parameter includes determining the source based on a source identifier received along with the operating parameter.

[0107] Method 500 then proceeds to step 506, where a set of operational parameter thresholds is selected from a plurality of sets of operational parameter thresholds based on the source, wherein each set of operational parameter thresholds is associated with a corresponding source, such as regarding Figure 4 As described in step 406.

[0108] In some embodiments, selecting the set of operational parameter thresholds includes further selecting the set of operational parameter thresholds based on the nursing center location of the medical device and the treatment type associated with the operation of the medical device, wherein each of the multiple sets of operational parameter thresholds is further associated with the corresponding nursing center location and the corresponding treatment type.

[0109] Method 500 then proceeds to step 508, wherein it is determined that the operating parameters satisfy at least one operating parameter threshold from a selected set of operating parameter thresholds, such as regarding Figure 4 As described in step 408.

[0110] Method 500 then proceeds to step 510, wherein the medical device is controlled based on operating parameters and determining that the operating parameters satisfy at least one operating parameter threshold from a selected set of operating parameter thresholds, such as regarding Figure 4 As described in step 422.

[0111] In some embodiments, method 500 further includes displaying operating parameters; and receiving user input confirming the operating parameters, wherein the medical device is further controlled based on the received user input, such as regarding... Figure 4 As described in step 420.

[0112] In some embodiments, the selected set of operating parameter thresholds includes one or more soft thresholds and one or more hard thresholds, and determining that an operating parameter meets at least one of the selected set of operating parameter thresholds includes determining that the operating parameter meets one or more hard thresholds and does not meet one or more soft thresholds, and generating an alert based on determining that the operating parameter meets one or more hard thresholds and does not meet one or more soft thresholds.

[0113] In some embodiments, method 500 further includes receiving user input regarding the reminder, the user input confirming operating parameters, wherein the medical device is further controlled based on the received user input.

[0114] In some embodiments, the medical device includes an infusion pump system; and the operating parameters include infusion flow rate settings.

[0115] It should be noted that method 500 is just an example, and other methods consistent with this disclosure, including fewer, additional, or alternative steps, are also possible.

[0116] Example processing system for medical devices

[0117] Figure 6 An example computing device 600 for implementing the various features and processes described herein is depicted. For example, computing device 600 may execute one or more steps of either process 400 or method 500. Computing device 600 may include one or more processors 604, memory 606, one or more input components 610, one or more output components 612, and one or more communication interfaces 608. Each of these components may be coupled via bus 602.

[0118] Computing device 600 can perform these processes based on processor 604 executing software instructions stored in a computer-readable medium, such as memory 606. A computer-readable medium (e.g., a non-transitory computer-readable medium) is defined herein as a non-transitory memory device. A memory device includes memory space located within a single physical storage device or memory space distributed across multiple physical storage devices. Software instructions can be read into memory 606 from another computer-readable medium or from another device via communication interface 608. When executed, the software instructions stored in memory 606 can cause processor(s) 604(s) to perform one or more of the processes described herein.

[0119] The memory 606 may include a data storage device or one or more data structures (e.g., a database). The computing device 600 may be able to receive information from, store information therein, transmit information to, or search for information stored therein in the data storage device or one or more data structures in the memory 606.

[0120] Memory 606 may include random access memory (RAM), read-only memory (ROM), and / or other types of dynamic or static storage devices (e.g., flash memory, magnetic storage, optical storage, etc.) that store information and / or instructions for use by one or more processors 604. For example, memory 606 may include one or more forms of non-volatile memory, including, by way of example, semiconductor memory devices (such as EPROM, EEPROM, and flash memory devices); magnetic disks (such as internal hard disks and removable disks); magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0121] The memory 606 may include a determination component 614, an operation component 616, an operation parameter threshold data storage repository 618, and a log data storage repository 620.

[0122] The determination component 614 is configured to determine the source of the operating parameters according to the aspects described herein, select a set of operating parameter thresholds, determine that the operating parameters satisfy at least one of the selected set of operating parameter thresholds, or generate a reminder.

[0123] The operating component 616 is configured to operate the medical device according to operating parameters.

[0124] Operational parameter threshold data repository 618 is configured to store data such as about Figure 3 The drug library 300, which is described as having rules 302, 310, and 320, stores multiple operational parameter thresholds and associated data.

[0125] Log data repository 620 is configured to store operating parameters and data related to the operation of medical devices, in accordance with the aspects described herein.

[0126] One or more processors 604 may include processors (e.g., central processing unit (CPU), graphics processing unit (GPU), accelerated processing unit (APU), etc.), microprocessors, digital signal processors (DSPs), and / or any processing components (e.g., field-programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), etc.) that can be programmed to perform functions such as those described herein.

[0127] One or more input components 610 may include components that allow computing device 600 to receive information, such as via user input (e.g., touchscreen display, keyboard, keypad, mouse, button, switch, microphone, etc.). Additionally, one or more input components 610 may include sensors for sensing information (e.g., Global Positioning System (GPS) components, accelerometers, gyroscopes, actuators, etc.).

[0128] One or more output components 612 may include components that provide output information from computing device 600 (e.g., display, speaker, one or more light-emitting diodes (LEDs), etc.).

[0129] Communication interface 608 may include transceiver components (e.g., transceivers, separate receivers, and transmitters) that enable computing device 600 to communicate with other devices, such as via wired connections, wireless connections, or a combination of wired and wireless connections. Communication interface 608 may allow computing device 600 to receive information from and / or provide information to another device. For example, communication interface 608 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi interface, a cellular network interface, etc.

[0130] Example Terms

[0131] Examples of implementation methods are described in the following numbered clauses:

[0132] Clause 1: An apparatus comprising: one or more memories including computer-executable instructions; and one or more processors configured to execute the computer-executable instructions and cause the apparatus to: receive from a source operating parameters configured to control operation of a medical device; determine the source of the operating parameters; select a set of operating parameter thresholds from a plurality of sets of operating parameter thresholds based on the source, wherein each set of operating parameter thresholds is associated with a corresponding source; determine that the operating parameters satisfy at least one operating parameter threshold from the selected set of operating parameter thresholds; and control the medical device based on the operating parameters and the determination that the operating parameters satisfy the at least one operating parameter threshold from the selected set of operating parameter thresholds.

[0133] Clause 2: The apparatus of Clause 1, wherein the one or more processors are further configured to execute the computer-executable instructions and cause the apparatus to: display operating parameters; and receive user input confirming the operating parameters, wherein the medical device is further controlled based on the received user input.

[0134] Clause 3: An apparatus of any one of Clauses 1-2, wherein: the selected set of operating parameter thresholds includes one or more soft thresholds and one or more hard thresholds, and in order to determine that the operating parameters satisfy the at least one operating parameter threshold in the selected set of operating parameter thresholds, the one or more processors are further configured to execute the computer-executable instructions and cause the apparatus to determine that the operating parameters satisfy the one or more hard thresholds and do not satisfy the one or more soft thresholds, the one or more processors are further configured to execute the computer-executable instructions and cause the apparatus to generate an alert based on the determination that the operating parameters satisfy the one or more hard thresholds and do not satisfy the one or more soft thresholds.

[0135] Clause 4: The apparatus of Clause 3, wherein the one or more processors are further configured to execute the computer-executable instructions and cause the apparatus to receive user input regarding a reminder, the user input confirming operating parameters, wherein the medical device is further controlled based on the received user input.

[0136] Clause 5: An apparatus of any of Clauses 1-4, wherein the source of the operating parameters is at least one of: an electronic medical record; an algorithm configured to determine the operating parameters; or a clinician.

[0137] Clause 6: Any of Clauses 1-5, wherein the device is a control module separate from the medical device.

[0138] Clause 7: Any device of any of Clauses 1-5, wherein the device is the medical device.

[0139] Clause 8: An apparatus of any one of Clauses 1-7, wherein: the medical device includes an infusion pump system; and the operating parameters include an infusion flow rate setting.

[0140] Clause 9: An apparatus of any one of Clauses 1-8, wherein, in order to determine the source of the operating parameters, the one or more processors are further configured to execute the computer-executable instructions and cause the apparatus to determine the source based on an identifier of the source received along with the operating parameters.

[0141] Clause 10: An apparatus of any one of Clauses 1-9, wherein, in order to select the set of operating parameter thresholds, the one or more processors are further configured to execute the computer-executable instructions and cause the apparatus to further select the set of operating parameter thresholds based on the nursing center location of the medical device and the treatment type associated with the operation of the medical device, wherein each of the plurality of sets of operating parameter thresholds is further associated with a corresponding nursing center location and a corresponding treatment type.

[0142] Clause 11: An apparatus of any one of Clauses 1-10, wherein the one or more processors are further configured to execute the computer-executable instructions and cause the apparatus to: receive from a second source a second operating parameter configured to control operation of the medical device; determine a second source of the second operating parameter; select a second set of operating parameter thresholds from the plurality of sets of operating parameter thresholds, wherein the second set of operating parameter thresholds is associated with the second source; determine that the second operating parameter does not satisfy at least one of the selected second set of operating parameter thresholds; and reject the second operating parameter based on the determination that the second operating parameter does not satisfy at least one of the selected second set of operating parameter thresholds.

[0143] Clause 12: A method comprising: receiving from a source operating parameters configured to control the operation of a medical device; determining the source of the operating parameters; selecting a set of operating parameter thresholds from a plurality of sets of operating parameter thresholds based on the source of the operating parameters, wherein each set of operating parameter thresholds is associated with a corresponding source; determining that the operating parameters satisfy at least one operating parameter threshold from the selected set of operating parameter thresholds; and controlling the medical device based on the operating parameters and the determination that the operating parameters satisfy the at least one operating parameter threshold from the selected set of operating parameter thresholds.

[0144] Clause 13: The method of Clause 12 further includes: displaying operating parameters; and receiving user input confirming the operating parameters, wherein the medical device is further controlled based on the received user input.

[0145] Clause 14: The method of any one of Clauses 12-14, wherein: the selected set of operating parameter thresholds includes one or more soft thresholds and one or more hard thresholds, and determining that the operating parameter satisfies at least one of the selected set of operating parameter thresholds includes determining that the operating parameter satisfies the one or more hard thresholds and does not satisfy the one or more soft thresholds, and generating an alert based on determining that the operating parameter satisfies the one or more hard thresholds and does not satisfy the one or more soft thresholds.

[0146] Clause 15: The method of Clause 14 further includes: receiving user input regarding the reminder, the user input confirming operating parameters, wherein the medical device is further controlled based on the received user input.

[0147] Clause 16: The method of any one of Clauses 12-15, wherein the source of the operating parameters is at least one of: an electronic medical record; an algorithm configured to determine the operating parameters; or a clinician.

[0148] Clause 17: The method of any one of Clauses 12-16, wherein: the medical device includes an infusion pump system; and the operating parameters include an infusion flow rate setting.

[0149] Clause 18: The method of any one of Clauses 12-17, wherein determining the source of the operating parameter includes determining the source based on an identifier of the source received together with the operating parameter.

[0150] Clause 19: The method of any one of Clauses 12-18, wherein selecting the set of operational parameter thresholds includes further selecting the set of operational parameter thresholds based on the nursing center location of the medical device and the treatment type associated with the operation of the medical device, wherein each of the multiple sets of operational parameter thresholds is further associated with the corresponding nursing center location and the corresponding treatment type.

[0151] Clause 20: A processing system comprising: a memory including computer-executable instructions; and a processor configured to execute the computer-executable instructions and cause the processing system to perform a method pursuant to any one of Clauses 12-19.

[0152] Clause 21: A processing system comprising components for performing a method pursuant to any one of Clauses 12-19.

[0153] Clause 22: A nontransitory computer-readable medium storing program code for causing a processing system to perform any of the steps in Clauses 12-19.

[0154] Clause 23: A computer program product implemented on a computer-readable storage medium, comprising code for performing a method pursuant to any one of Clauses 12-19.

[0155] Additional considerations

[0156] The foregoing description is provided to enable any person skilled in the art to practice the various embodiments described herein. The examples discussed herein do not limit the scope, applicability, or embodiments set forth in the claims. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be applied to other embodiments. For example, the function and arrangement of the elements discussed may be changed without departing from the scope of this disclosure. Various processes or components may be appropriately omitted, substituted, or added to the various examples. For example, the described methods may be performed in a different order than described, and various steps may be added, omitted, or combined. Furthermore, features described with respect to some examples may be combined in some other examples. For example, any number of aspects set forth herein may be used to implement an apparatus or practice a method. Additionally, the scope of this disclosure is intended to cover such apparatus or methods practiced using structures, functions, or structures and functions other than or different from the aspects of this disclosure set forth herein. It should be understood that any aspect of this disclosure disclosed herein may be implemented by one or more elements of the claims.

[0157] As used herein, the word “exemplary” means “serving as an example, instance, or illustration.” Any aspect described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects.

[0158] As used in this article, the phrase “at least one of” in a list of items refers to any combination of those items, including a single member. As an example, “at least one of a, b, or c” is intended to cover a, b, c, ab, ac, bc, and abc, as well as any combination with multiples of the same element (e.g., aa, aaa, aab, aac, abb, acc, bb, bbb, bbb, cc, and ccc, or any other ordering of a, b, and c).

[0159] As used herein, the term "determine" encompasses a wide variety of actions. For example, "determine" can include operations, calculations, processing, derivation, investigation, searching (e.g., looking in a table, database, or another data structure), ascertaining, etc. Moreover, "determine" can include receiving (e.g., receiving information), accessing (e.g., accessing data in memory), etc. Furthermore, "determine" can include parsing, selecting, choosing, building, etc.

[0160] The methods disclosed herein include one or more steps or actions for implementing the methods. The method steps and / or actions may be interchanged without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and / or use of a particular step and / or action may be modified without departing from the scope of the claims. Furthermore, the various operations of the above methods can be performed by any suitable means capable of performing the corresponding functions. These means may include one or more various hardware and / or software components and / or modules, including but not limited to circuits, application-specific integrated circuits (ASICs), or processors. Generally, where operations are illustrated in the drawings, those operations may have corresponding means plus functional components with similar numbering.

[0161] The following claims are not intended to be limited to the embodiments shown herein, but are intended to be given the full scope consistent with the language of the claims. Within the claims, unless specifically stated otherwise, reference to an element in the singular is not intended to mean “one and only one,” but rather “one or more.” Unless specifically stated otherwise, the term “some” means one or more. An element shall not be interpreted in accordance with 35 USC §112(f) unless it is explicitly stated using the phrase “component for…” or, in the case of a method claim, using the phrase “step for…”. All structural and functional equivalents of elements throughout the various aspects described herein that are known to or will be learned by one of ordinary skill in the art are expressly incorporated herein by reference and are intended to be covered by the claims. Moreover, nothing disclosed herein is intended specifically for public disclosure, whether or not such disclosure is expressly stated in the claims.

Claims

1. An apparatus comprising: One or more memories, the one or more memories including computer-executable instructions; as well as One or more processors, the one or more processors being configured to execute the computer-executable instructions, and causing the device to: Receive operating parameters from the source that are configured to control the operation of the medical device; Determine the source of the operating parameters; Based on the source, a set of operational parameter thresholds is selected from multiple sets of operational parameter thresholds, wherein each set of operational parameter thresholds is associated with a corresponding source; Determine that the operating parameters satisfy at least one operating parameter threshold from a selected set of operating parameter thresholds; as well as The medical device is controlled based on operating parameters and determining that the operating parameters satisfy at least one of a selected set of operating parameter thresholds.

2. The apparatus of claim 1, wherein the one or more processors are further configured to execute the computer-executable instructions, and cause the apparatus to: Display operation parameters; and The system receives user input confirming operation parameters, and further controls the medical device based on the received user input.

3. The apparatus of claim 1, wherein: The selected set of operating parameter thresholds includes one or more soft thresholds and one or more hard thresholds. To determine that the operating parameters satisfy at least one operating parameter threshold from a selected set of operating parameter thresholds, the one or more processors are further configured to execute the computer-executable instructions, and cause the apparatus to determine that the operating parameters satisfy the one or more hard thresholds and do not satisfy the one or more soft thresholds. The one or more processors are also configured to execute the computer-executable instructions and cause the device to generate an alert based on determining that operating parameters satisfy the one or more hard thresholds and do not satisfy the one or more soft thresholds.

4. The apparatus of claim 3, wherein the one or more processors are further configured to execute the computer-executable instructions and cause the apparatus to... The system receives user input regarding the reminder, the user input confirming operation parameters, and further controls the medical device based on the received user input.

5. The apparatus of claim 1, wherein the source is at least one of the following: Electronic medical records; The algorithm configured to determine the operation parameters; Remote control equipment; or Clinician.

6. The apparatus of claim 1, wherein the apparatus is a control module separate from the medical device.

7. The apparatus of claim 1, wherein the apparatus is the medical device.

8. The apparatus of claim 1, wherein: The medical device includes an infusion pump system; and The operating parameters include the infusion flow rate setting.

9. The apparatus of claim 1, wherein, in order to determine the source, the one or more processors are further configured to execute the computer-executable instructions, and cause the apparatus to determine the source based on an identifier of the source received along with operating parameters.

10. The apparatus of claim 1, wherein, in order to select the set of operating parameter thresholds, the one or more processors are further configured to execute the computer-executable instructions, and cause the apparatus to further select the set of operating parameter thresholds based on the care center location of the medical device and the treatment type associated with the operation of the medical device, wherein each of the plurality of sets of operating parameter thresholds is further associated with a corresponding care center location and a corresponding treatment type.

11. The apparatus of claim 1, wherein the one or more processors are further configured to execute the computer-executable instructions, and cause the apparatus to: Receive second operating parameters from a second source, configured to control the operation of the medical device; Determine the second source of the second operating parameter; A second set of operating parameter thresholds is selected from the plurality of sets of operating parameter thresholds, wherein the second set of operating parameter thresholds is associated with a second source; Determine that the second operating parameter does not meet at least one operating parameter threshold in the selected second set of operating parameter thresholds; as well as The second operating parameter is rejected based on the determination that it does not meet at least one operating parameter threshold in the selected second set of operating parameter thresholds.

12. A processing system, comprising: Memory, the memory including computer-executable instructions; and Processor, the processor being configured to execute the computer-executable instructions and cause the processing system to: Receive operating parameters from the source that are configured to control the operation of the medical device; Determine the source of the operating parameters; Based on the source, a set of operational parameter thresholds is selected from multiple sets of operational parameter thresholds, wherein each set of operational parameter thresholds is associated with a corresponding source; Determine that the operating parameters satisfy at least one operating parameter threshold from a selected set of operating parameter thresholds; as well as The medical device is controlled based on operating parameters and determining that the operating parameters satisfy at least one of a selected set of operating parameter thresholds.

13. The processing system of claim 12, wherein the processor is further configured such that the processing system: Display operation parameters; and The system receives user input confirming operation parameters, and further controls the medical device based on the received user input.

14. The processing system of claim 12, wherein: The selected set of operating parameter thresholds includes one or more soft thresholds and one or more hard thresholds, and To determine that the operating parameters satisfy at least one operating parameter threshold from a selected set of operating parameter thresholds, the processor is further configured such that the processing system determines that the operating parameters satisfy the one or more hard thresholds and do not satisfy the one or more soft thresholds. An alert is generated based on the determination that the operating parameters meet one or more hard thresholds but do not meet one or more soft thresholds.

15. The processing system of claim 14, wherein the processor is further configured such that the processing system: The system receives user input regarding the reminder, the user input confirming operation parameters, and further controls the medical device based on the received user input.

16. The processing system of claim 12, wherein the source is at least one of the following: Electronic medical records; Algorithms configured to determine operating parameters; or Clinician.

17. The processing system of claim 12, wherein: The medical device includes an infusion pump system; and The operating parameters include the infusion flow rate setting.

18. The processing system of claim 12, wherein, in order to determine the source of the operating parameters, the processor is further configured such that the processing system determines the source based on an identifier of the source received along with the operating parameters.

19. The processing system of claim 12, wherein, in order to select the set of operating parameter thresholds, the processor is further configured such that the processing system further selects the set of operating parameter thresholds based on the nursing center location of the medical device and the treatment type associated with the operation of the medical device, wherein each of the plurality of sets of operating parameter thresholds is further associated with a corresponding nursing center location and a corresponding treatment type.

20. A non-transitory computer-readable medium comprising instructions that, when executed by one or more processors of a medical device, cause the medical device to perform operations, including: Receive operating parameters from the source that are configured to control the operation of the medical device; Determine the source of the operating parameters; Based on the source, a set of operational parameter thresholds is selected from multiple sets of operational parameter thresholds, wherein each set of operational parameter thresholds is associated with a corresponding source; Determine that the operating parameters satisfy at least one operating parameter threshold from a selected set of operating parameter thresholds; as well as The medical device is controlled based on operating parameters and determining that the operating parameters satisfy at least one of a selected set of operating parameter thresholds.

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