Source-based operational parameter thresholds for medical devices

Abstract

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

Description

SOURCE-BASED OPERATIONAL PARAMETER THRESHOLDS FOR MEDICAL DEVICESBACKGROUNDField

[0001] Aspects of the present disclosure relate to establishing operational parameter thresholds for a medical device, based on the source providing operational parameters.Description of Related Art

[0002] An infusion pump is a type of medical device configured to infuse therapeutic fluid into a patient, such as in a hospital or other medical care site. Generally, an infusion pump is programmed to pump fluid at a specific flow rate and up to a specific volume in order to administer a specific dose of a treatment. In particular, the infusion pump may be configured to receive one or more operational parameters used to control operation of the infusion pump from one or more sources. The one or more operational parameters may include one or more of flow rate, volume, velocity, infusion time, and / or the like. The infusion pump then operates according to the one or more operational parameters.

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

[0004] A clinician may configure one or more operational parameters at an infusion pump to operate the infusion pump subject to any operational limits or thresholds (referred to as “operational parameters thresholds”). For example, a clinician may input a flow rate at the infusion pump, and the infusion pump may compare the inputted flow rate with a flow rate threshold to determine whether the flow rate satisfies the flow rate threshold. If the flow rate satisfies the flow rate threshold, then the infusion pump operates with the flow rate. If the flow rate does not satisfy the flow rate threshold, the infusion pump may alert the clinician to the potential error, e.g., with auditory and / or screen based alerts. The clinician may then resolve the error.

[0005] Conventionally, a single set of operational parameter thresholds are configured for an infusion pump for all sources of operational parameters. A source as referred to herein may be a particular source type and / or a source that uses a particular control modality to provide theoperational parameters. Examples of source types include algorithms, clinicians, electronic medical records, and the like. Examples of control modalities include local control by direct programming (e.g., clinician keying in an input, algorithm providing a local input, etc.), remote control via control messaging (e.g., clinician using a remote device to provide input, an algorithm providing input over a network, etc.), and the like. Accordingly, example sources include an algorithm, a clinician, a clinician using a remote device, a clinician using local input, etc. However, the source of an operational parameter may suggest a different set of operational parameter thresholds based on, for example, different trust levels for different sources. For example, a human controller may merit a wider operational range (higher trust) than an algorithmic controller (lower trust). Conventional medical device (e.g., infusion pump) control architecture cannot accomplish this level of control.

[0006] Similarly, alarm systems, are not equally effective for all sources, such as sources corresponding to different control modalities. For example, an audible alert may be useful for a local control mode in which a clinician can hear and respond to the alert. However, an audible alert is completely ineffective for a remote control mode in which, for example, an algorithm cannot “hear” or otherwise respond to the alert without suitable programming.

[0007] Accordingly, a technical problem exists in the field of medical devices, such as infusion pumps, regarding how to configure operational parameter thresholds and alarm systems to maintain proper and safe operation of a medical device when controlled using different control modalities.SUMMARY

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

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

[0010] Other aspects provide processing systems configured to perform the aforementioned methods as well as those described herein; non-transitory, computer-readable media comprising instructions that, when executed by a processors of a processing system, cause the processing system to perform the aforementioned methods as well as those described herein; a computer program product embodied on a computer readable storage medium comprising code for performing the aforementioned methods as well as those further described herein; and a processing system comprising means for performing the aforementioned methods as well as those further described herein.

[0011] The following description and the related drawings set forth in detail certain illustrative features of one or more aspects.DESCRIPTION OF THE DRAWINGS

[0012] The appended figures depict certain aspects and are therefore not to be considered limiting of the scope of this disclosure.

[0013] FIG. 1 depicts an example medical device system.

[0014] FIG. 2 depicts another example medical device system.

[0015] FIG. 3 depicts an example drug library with various example operational rules for operating a medical device.

[0016] FIG. 4 depicts an example flowchart for implementing operational limits based on the source operating the medical device.

[0017] FIG. 5 depicts an example method for implementing operational limits based on the source operating the medical device.

[0018] FIG. 6 depicts an example computing device for implementing the various aspects described herein.

[0019] To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the drawings. It is contemplated that elements and features of one embodiment may be beneficially incorporated in other embodiments without further recitation.DETAILED DESCRIPTION

[0020] Aspects of the present disclosure provide apparatuses, methods, processing systems, and computer-readable mediums for improving safe operation of medical devices by providing source-specific operational parameter thresholds and / or alarm systems. For example, a medical device, such as an infusion pump, may be configured with different operational parameter thresholds for different sources (e.g., local control by a clinician, remote control by a clinician, remote algorithmic control, remote system control, etc.). Though certain aspects are discussed with respect to an infusion pump system, it should be noted that the techniques discussed herein may similarly be used to control operation of other types of medical devices.

[0021] As discussed above, a technical problem exists in the field of medical device systems in that operational control of such devices is source agnostic and thus cannot account for different levels of trust for operational parameters emanating from different sources. Modern medical devices are capable of receiving operational parameters from a variety of sources, including local (such as through a user interface on the actual device) and remote (e.g., through a communication, such as a message sent over a wired or wireless connection), to control operation of the medical device. Because an erroneous operational parameter may cause improper operation of the medical device, operational parameter thresholds may be used to ensure proper operation of the medical device. However, the wide range of scenarios in which a medical device may be operated makes configuration of any single set of operational parameter thresholds an inherently compromised task.

[0022] Aspects described herein beneficially provide a technical solution to this technical problem by utilizing different operational parameter thresholds based on the source providing the operational parameters for the medical device. Accordingly, different sets of operational parameter thresholds may be configured for different operational parameter sources. Using different operational parameter thresholds based on the source of the operational parameter provides the beneficial technical effect of reducing different types of risk and / or error associatedwith different sources. Thus, patient safety is improved while simultaneously improving the ability to control medical devices by multiple sources, such as corresponding to multiple control modalities, including local, remote, algorithmic, artificial intelligence (Al)-enhanced, etc.

[0023] For example, one source of operational parameters is local control by a clinician. In particular, a clinician may enter operational parameters directly into a medical device (e.g., infusion pump) using, for example, physical inputs (e.g., buttons) and / or touch-sensitive displays on the medical device itself. This may be considered a relative low risk source of operational parameters and thus operational parameter thresholds applied to such operational parameter inputs may be relatively more permissive. For example, an operational parameter threshold may be relatively higher or lower (e.g., allowing a higher infusion rate, or a lower infusion time) compared to other sources. Similarly, a set of operational parameter thresholds may define a range, and the operational parameter range may be larger in this example compared to other, higher-risk sources.

[0024] Another source of operational parameters is remote control by a human using a device in data communication with the medical device. For example, the medical device may be configured to communicate with a smartphone, tablet computer, networked computing device, etc. In this example, a clinician may enter one or more operational parameters on the remote control device that are then sent to the medical device, e.g., over a network data connection. Because in this example the medical device is being controlled remotely, though by a human, this may be considered an intermediate risk source and thus operational parameter thresholds applied to such operational parameter inputs may be relatively less permissive. For example, a set of operational parameter thresholds may define a range, and the operational parameter range may be smaller in this example compared to other, lower-risk modalities.

[0025] Yet another source of operational parameters is local or remote control by a nonhuman, such as by a control algorithm or artificial intelligence (Al) system generating operational parameters. For example, a control algorithm or Al system may process various inputs (e.g., sensor data) received to determine and adjust operational parameters. Because in this example the medical device is being controlled remotely by a non-human, this may be considered a relatively higher risk source and thus operational parameter thresholds applied to such operational parameter inputs may be even less permissive. For example, a set of operational parameter thresholds may define a range, and the operational parameter range may be smaller in this example compared to other, lower-risk sources. Note that while algorithmic or Al systems are used as a relatively higher risk source in this discussion that need not always be the case. Indeed, in various cases, algorithmicor Al systems may be the lower (or lowest) risk sources. The examples herein and their associated risks are merely for convenience of the discussion.

[0026] One type of control algorithm or Al system may be implemented in a closed-loop configuration in which one or more operational parameters (e.g., based on sensor data) are determined and provided to the medical device without any input or further confirmation from a user (e.g., clinician). Another type of control algorithm or Al system may be implemented in a semi-closed-loop configuration in which the control algorithm generates suggested values for the one or more operational parameters, which may thereafter be provided to the medical device only after user input confirming the operational parameters. The additional requirement of user input to confirm the operational parameters before they are provided to the medical device as input may indicate that sources using a semi-closed-loop configuration are lower risk that sources using a closed-loop configuration, and therefore such different sources may have different operational parameter thresholds.

[0027] Operational parameter thresholds and alarm systems may further be based on reducing errors associated with particular sources, such as associated with particular control modalities, including local, remote, algorithmic, Al-enhanced, etc. As discussed above, as medical devices, such as infusion pumps, becoming more interconnected and subject to more complex (and often remote) control schemas, a single set of operational parameter thresholds and alarm systems may be insufficient to address different error types for different sources. For example, one control algorithm may be prone to determining an erroneously lower operation parameter, while another control algorithm may be prone to determining an erroneously higher operation parameter. Thus, adapting operational parameter thresholds and alarm systems based on the source of the operational parameter beneficially reduces errors and thereby provides a beneficial technical effect. In particular, aspects described herein increase the reliability and effectiveness of a medical device system by determining operational limits and alarm systems based on a per-source basis.

[0028] In certain aspects, an operational parameter threshold may be considered a maximum threshold, whereby an operational parameter may not be set above (e.g., greater than) the maximum threshold. In certain aspects, an operational parameter threshold may be considered a minimum threshold, whereby an operational parameter may not be set below (e.g., less than) the minimum threshold. In certain aspects, an operational parameter may be associated with one operational parameter threshold, for example, a maximum threshold or a minimum threshold. In certain aspects, an operational parameter may be associated with a set of one or more operational parameter thresholds, for example, a maximum threshold and a minimum threshold.

[0029] In some aspects, a maximum operational parameter threshold and a minimum operation operational parameter threshold may define a range of permissive operational parameter values, whereby an operational parameter may only be set above the minimum threshold and below the maximum threshold. For example, where the source of the operational parameters is less trusted, an operational parameter threshold range may be more restrictive, such as a narrower range between the minimum and maximum thresholds (e.g., fewer values between the minimum and maximum thresholds). Where the source of the operational parameters is more trusted, an operational parameter threshold may 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, operational parameter thresholds and alarms systems may be based on a level of trust associated with a particular source of operational parameters, such as corresponding to a particular control modality including local, remote, algorithmic, Al-enhanced, etc. For example, a first algorithm may be more trusted, such as due to longer historical use, and the set of operation operational parameter thresholds may therefore be less restrictive, by setting the maximum and minimum operational parameter thresholds to a wider range. A second algorithm, meanwhile, may be less trusted, such as due to newness (e.g., only recent use), and maximum and minimum operational parameter thresholds may be set to a narrower range. Therefore, different operational parameter thresholds may be used based on the specific algorithm controlling the medical device.

[0031] In another example, a source type may include a human having a particular role. Accordingly, humans with different roles may correspond to different sources. For example, different clinicians may be assigned different roles, such as to enable role-based operational parameter thresholds. A traveling nurse may be assigned a first role with a first set of operational parameter thresholds, and a nurse practitioner may be assigned a second role with a second set of operational parameter thresholds. A traveling nurse may be less trusted, due to limited experience at the care site, and maximum and minimum operational parameter thresholds may be set to a narrower range. A nurse practitioner may be more trusted, due to credentials and experience, and maximum and minimum operational parameter thresholds may be set to a wider range. Therefore, in certain aspects, different operational parameter thresholds may be used based on the role assigned to the clinician.

[0032] Beneficially, a medical device, such as an infusion pump, may utilize more than one source of operational parameters, such as more than one control modality of a particular type ofsource, by using more restrictive sets of operational parameter thresholds (e.g., a narrow range) for less trusted sources (e.g., less trusted control modalities) and less restrictive sets of operational parameter thresholds (e.g., a wider range) for more trusted sources (e.g., more trusted control modalities). Using different operational parameter thresholds based on the specific source of the operational parameters provides the technical effect of ensuring less trusted sources are more tightly restricted, but not overly restricting trusted sources. Thus, patient safety is maintained, while increasing operational range for more trusted sources, and reducing operational range for less trusted sources.

[0033] In certain aspects, certain sources may be associated with different alarm systems. For example, where the source is a clinician operating locally at the medical device, and the operational parameters do not satisfy the operational parameter thresholds for the source, one alarm system may be utilized. The alarm system may be an alert displayed on the medical device the clinician is operating. Thus, the clinician is alerted and may correct the operational parameters. However, where the source is a control algorithm, another alarm system may be utilized because, displaying an alert on the medical device may be ineffective to alert a clinician of the issue with the algorithmic control. Aspects described herein overcome this issue by enabling source-specific alarm systems. Such alarm systems for an algorithm, for example, may include sending an alert to, for example, a clinician, such as at a clinician device, and limiting the implementation of operational parameters. Therefore, using different alarm systems for different sources provides the beneficial technical effect of maintaining awareness of medical device operation under a variety of different control schemes, which in turn improves patient safety.Example Medical Device System

[0034] FIG. 1 depicts an example medical device system 100, which may implement methods described herein to manage operational parameter thresholds received at the medical device system, based on the source controlling the medical device.

[0035] Medical device system 100 may be used to monitor and treat patient 112. Medical device system 100 includes sensor 102. Though one sensor 102 is shown, there may be additional sensors (e.g., of different types), or no sensors. In certain aspects, sensor 102 is configured to monitor / sense one or more vital signs of the patient. For example, sensor 102 may be one or more of a heart rate monitor, a pulse oximeter, a continuous glucose monitor, a blood pressure monitor, etc. In another example, sensor 102 may monitor / sense operational parameters of medical device system 100, such as a flow rate of infusion pump 104 included in medical device system 100.Sensor 102 transmits communications including sensor data to control module 110 of medical device system 100.

[0036] In some embodiments, control module 110, such as using sensor data from sensor 102, determines one or more operational parameters for infusion pump 104 to implement and treat patient 112. Accordingly, control module 110 sends (e.g., in one or more communications) the one or more operational parameters (e.g., as one or more control inputs) to infusion pump 104 to control operation of infusion pump 104. Control module 110 may include a user interface 108 to display sensor data, operational parameters, and the like. In some embodiments, like a semi-closed loop system, a clinician may confirm operational 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 an insulin pump.

[0037] In some embodiments, a clinician may determine one or more operational parameters for infusion pump 104 to implement and treat patient 112, for example, based on sensor data from sensor 102. The clinician may enter the one or operational parameters into infusion pump 104, such as through user interface 106 on infusion pump 104, or user interface 108 on control module 110. The one or more operational parameters control operation of infusion pump 104.

[0038] Generally, sensor 102, control module 110, and infusion pump 104 may be connected through a wired connection, or a wireless connection, such as a Bluetooth connection, a Wi-Fi connection, an RFID connection, a near-field communication connection, etc.

[0039] Although depicted here as separate devices, in some cases, control module 110 may be integral to or form part of sensor 102 or infusion pump 104.

[0040] In an example, the operational controls, including operational parameter thresholds and / or alarm systems, discussed herein may be used to manage devices of medical device system 100. For example, infusion pump 104 may 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.Example Medical Device System

[0041] FIG. 2 depicts another example medical device system 200, which may implement methods described herein to manage operational parameter thresholds received at the medical device system, based on the source controlling the medical device, such as infusion pump 104 inFIG. 1, connected to patient 112. A patient care system may include one or more pumps, for example, pump 202, pump 204, pump 206, and pump 208. Although a large volume pump is illustrated, other types of pumps may be implemented, such as a peristaltic pump, a small volume pump, a syringe pump, an anesthesia delivery pump, or a patient-controlled analgesic. A pump may be an infusion device configured to deliver a substance, (e.g., fluid, nutrients, drug, etc.) to a patient’s circulatory system, or epidural space, for example, via an intravenous infusion, subcutaneous infusion, arterial infusion, epidural infusion, etc., or to a patient’s digestive system, for example, via a nasogastric tube (NG), a percutaneous endoscopic gastrostomy tube (PEG), nasojejunal tube (NJ), etc.

[0042] Each of the pumps 202, 204, 206, or 208, may be fluidly connected with an upstream fluid line 212, fluid line 214, fluid line 216, and fluid line 218, respectively. Further, each of pump 202, pump 204, pump 206, and pump 208, may be fluidly connected with a downstream fluid line 222, fluid line 224, fluid line 226, and fluid line 228, respectively. The fluid lines may be any type of fluid conduit, such as tubing, through which fluid can flow.

[0043] Each of fluid supply 232, fluid supply 234, fluid supply 236, and fluid supply 238, may be a reservoir, for example, as bottles shown, are inverted and suspended above the pumps. Fluid supplies may also take the form of bags, syringes, or other types of contains. The medical device system 200 may be mounted on a roller stand or intravenous pole 240.

[0044] Medical decide system 200 may further comprise check valves, drip chambers, valved ports, connectors, and other devices configured to administer a substance.Example Operational Parameter Thresholds

[0045] FIG. 3 depicts an example drug library 300 with various example rules 302, 310, and 320 for operational parameter thresholds associated with various sources, which may be used by a medical device, such as infusion pump 104, to manage operational parameter thresholds for various sources.

[0046] In some embodiments, operational parameter thresholds may be set by a manufacturer, such as a manufacturer of infusion pump 104. In some embodiments, operational parameter thresholds may be set by a care site, such as the hospital in which the medical device is used. In some embodiments, operational parameter thresholds may be set by medical treatment guidelines. In certain embodiments, operational parameter thresholds may be updated from time to time.

[0047] Generally, each rule may contain one or more operational parameter thresholds and context data associated with the one or more operational parameter thresholds of the rule. The context data associated with the rules may include, for example, a care area, a drug type, a source, a patient type, a patient weight, a room temperature, etc. Example operational parameter thresholds may include, for example, dosing thresholds, concentration thresholds, trend thresholds, bolus thresholds, or thresholds associated with other operational parameters. In certain cases, an operational parameter threshold may be associated with a single operational parameter. For example, a dosing value may be received as an operational parameter, and the dosing value may be compared to a maximum dosing threshold. In certain 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 that outputs a value that is compared to an operational parameter threshold.

[0048] In certain embodiments, the rule, and accordingly the one or more operational parameter thresholds associated with the rule, to be applied to a particular operational parameter is determined based on context data associated with the particular operational parameter. In particular, the operational parameter is associated with context data, such as an indication of a source that provided the operational parameter, a drug type to which the operational parameter applies, and a care area where the drug being controlled by the operational parameter is being infused. In certain embodiments, the rule containing context data that matches the context data of the operational parameter is applied to the operational parameter, such that the one or more operational parameter thresholds associated with the rule are applied to the operational parameter. In particular, the rule including a source that matches the source of the operational parameter may be applied to the operational parameter.

[0049] A care area field may be populated by a care area for which the medical device may be used. For example, a care area may be a treatment location, such as a neonatal intensive care unit (NICU), an intensive care unit (ICU), pediatrics, oncology, medical-surgical, operating room, etc. Rules 302, 310, and 320, for example, are associated with an infusion pump used in a NICU.

[0050] A drug type field may be populated by a drug name or treatment name which the medical device may infuse as part of a medical treatment. Rules 302, 310, and 320, for example, are associated with an infusion pump infusing Drug A.

[0051] A source field may be populated by a source controlling operation of the medical device. As discussed above, various sources may provide operational parameters for controllingoperation of the medical device. For example, a source may be a clinician using physical inputs on the medical device or a clinician using a control module (e.g., control module 110 in FIG. 1). Rule 302, for example, is associated with a clinician entering operational parameters.

[0052] In another example, a source may be a clinician remotely entering operational parameters, such as through a remote control device. In some cases, a 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 a clinician. The operational parameters may then be transmitted to the medical device to control operations. Further, a clinician may be identified based on an assigned role, such as a travel nurse, a nurse practitioner, a physician assistant, a physician, a pharmacist, etc., for the clinician entering the information. Rule 310, for example, is associated with an order entered into an EMR.

[0053] Another example source may be an algorithm that determines operational parameters for a medical device. Rule 320, for example, is associated with operational parameters provided by algorithm 1, such as an algorithm using sensor data from sensor 102 in FIG. 1. In some embodiments, an algorithm may be identified by the type of sensor data used to determine operational parameters. For example, an algorithm may be identified as a heart rate algorithm because the algorithm utilizes heart rate data provided by a heart rate monitor.

[0054] In some embodiments, an algorithm may be additionally or alternatively identified based on one or more drug therapies determined by the algorithm. For example, an algorithm may be identified as a heparin dosing algorithm because the algorithm determines heparin dosing treatment.

[0055] In some embodiments, an algorithm may be additionally or alternatively identified based on one or more medical devices used to implement the operational parameters. In some embodiments, an algorithm may be identified as an infusion pump algorithm because the algorithm determines operational parameters for a medical device.

[0056] A dosing limit field may be a set of one or more thresholds for a dosing operational parameter. For example, a dosing operational parameter may be a quantity of a drug to be infused by the infusion pump. A dosing operational parameter threshold may be a limit at which the infusion pump dosing operational parameter may be set, or be associated with a further action in order to set the dosing operational parameter. For example, a first threshold may be a “hard” threshold, such as a hard maximum (or minimum) threshold, whereby an operational parameter may not be set beyond (e.g., above the maximum or below the minimum) the threshold. In anotherexample, a second threshold may be a “soft” threshold, such as a soft maximum (or minimum) threshold, whereby an operational parameter set beyond (e.g., above the maximum or below the minimum) the threshold is associated with an additional action in order to set the operational parameter. In certain embodiments, additional actions associated with a threshold may include activating an alarm system, such as through an alarm, a warning, a message, a request for confirmation, and the like. For example, rule 302 has a set of dosing limit thresholds, including a hard maximum, soft maximum, soft minimum and hard minimum.

[0057] A concentration limit field may be a set of one or more thresholds for a concentration operational parameter. For example, a concentration operational parameter may be a concentration of the drug to be infused by the infusion pump. A concentration operational parameter threshold may be a limit at which the infusion pump concentration operational parameter may be set, or be associated with a further action in order to set the concentration operational parameter. For example, a first threshold may be a “hard” threshold, such as a hard maximum (or minimum) threshold, whereby an operational parameter may not be set beyond (e.g., above or below) the threshold. In another example, a second threshold may be a “soft” threshold, such as a soft maximum (or minimum) threshold, whereby an operational parameter set beyond (e.g., above or below) the threshold is associated with an additional action in order to set the operational parameter. In certain embodiments, additional actions associated with a threshold may include activating an alarm system, such as through an alarm, a warning, a message, a request for confirmation, and the like. For example, rule 302 has a set of dosing limit thresholds, including a hard maximum, soft maximum, soft minimum and hard minimum.

[0058] A trend limit field may be a set of one or more thresholds for a trend of one or more operational parameters. For example, a trend may be a percent change of an operational parameter over time, for example, between a new operational parameter received from a source, and the current and / or past operational parameter value(s) being used at the infusion pump. For example, as depicted at rule 302, a 100% trend may be a 100% change in value of the new operational parameter over the current operational parameter, such as where the new operational parameter is 30 and the current operational parameter is 15.

[0059] A trend may also include one or more previous operational parameter values, such as one or more prior operational parameter values during the treatment. A trend may be determined for one or more operational parameters, such as a dosing operational parameter trend, or a concentration operational parameter trend.

[0060] Where an operational parameter trend does not satisfy the trend threshold(s), the operational parameter may not be set, even where the operational parameter satisfies other operational parameter thresholds. For example, given a prior dosing operational parameter value of 6 and a new dosing operational parameter of 15, the dosing trend (e.g., percent change over time), is 150% change. The new dosing operational parameter satisfies (e.g., is less than) the hard and soft max thresholds for dosing limit, however, the hard and soft max thresholds for the trend limit are not satisfied (e.g., exceeded). Thus, the new dosing operational parameter may not be set. Beneficially, a trend limit may restrict implementation of rapid and significant changes to an operational parameter, for example, where the operational parameter is determined by an algorithm.

[0061] A trend limit may include, for example, a first threshold, which may be a “hard” threshold, such as a hard maximum threshold, whereby if an operational parameter trend is beyond (e.g., above) the threshold, the operational parameter may not be set. In another example, a second threshold may be a “soft” threshold, such as a soft maximum threshold, whereby if an operational parameter trend is beyond (e.g., above) the threshold, additional action may be required before the operational parameter may be set. In certain embodiments, additional actions associated with a threshold may include activating an alarm system, such as through an alarm, a warning, a message, a request for confirmation, and the like.

[0062] Although example drug library 300 depicts rules 302, 310 and 320, additional or alternative rules are contemplated. Further, the rules for operational limits may include additional or alternative fields and thresholds.Example Flowchart for Operating a Medical Device based on Appropriate Operational Parameters

[0063] FIG. 4 depicts an example flow 400 for operating a medical device based on the appropriate operational parameters, such as operating infusion pump 104 in FIG. 1. In some embodiments, a medical device operating based on flow 400 may include or be coupled to a control module, such as control module 110 in FIG. 1. Flow 400 may be performed by a medical device and / or a control module.

[0064] Initially, flow 400 begins at step 402 with receiving, from a source, one or more operational parameter for controlling operation of a medical device. In particular, values for the one or more operational parameters are received. For example, one or more operational parameters for operating an infusion pump may include a drug type, a dose regime, and / or a concentration.

[0065] In certain embodiments, context data associated with the one or more operational parameters is determined, as discussed. In some embodiments, the context data is received from the source such as in a message along with the one or more operational parameters. In some embodiments, the context data is inferred, such as based on how the one or more operational parameters are received (e.g., over a particular wireless or wired connection). In some embodiments, the context data is inferred based on an identifier received from the source such as in a message along with the one or more operational parameters. In some embodiments, the context data is received separately from the one or more operational parameters, such as via a separate input (e.g., from a prior communication, such as a communication received during a setup phase of a medical device).

[0066] Flow 400 proceeds to step 404 with determining the source of the one or more operational parameters. In certain embodiments, the source is determined based on the control modality by which the operational parameters are received. For example, a physical input over which the operational parameters are received (e.g., internally at the device such as from a button press, on a port of the device from a wired interface, over a wireless interface of the device, etc.). In certain embodiments, the source is additionally or alternatively determined based on an identifier included with the operational parameters indicating the source, such as in a message or other communication. In some embodiments, the identifier may be a token or some other verifiable information. In certain embodiments, the source is additionally or alternative determined based on an additional input received at the control module or medical device indicating the source. 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 certain embodiments, the source is additionally or alternative determined based on a characteristic of the operational parameters. For example, different sources may be associated with different encryption schemes or keys used to encrypt the operational parameters. The encryption type used to encrypt the operational parameters may indicate the source. For example, the device may 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 discussed above with respect to FIG. 3, sources may include clinicians, EMRs, and algorithms. Determining the source at 404 may include determining a type for the source (e.g., human, machine) based on, for example, information received from the source or a message therefrom.

[0067] Flow 400 then proceeds to step 406 with determining one or more operational parameter thresholds associated with the source, such as based on one or more rules described with respect to FIG. 3. For each operational parameter provided, a set of one or more thresholds associated with the operational parameter may be determined.

[0068] For example, where the source is a clinician, such as a clinician manually entering operational parameters on a medical device, a set of operational parameter thresholds (a set including one or more operational parameter thresholds) is determined for each operational parameter provided, such as dose regime, concentration, and trend. Thus, a set of operational parameter thresholds associated with a clinician is determined for dose regime associated with a clinician, a set of operational parameter thresholds associated with a clinician is determined for concentration, and a set of operational parameter thresholds associated with a clinician is determined for trend, based on the drug type and care area, such as depicted at rule 302 in FIG. 3.

[0069] 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 operational parameter of provided, such as dose regime, concentration, and trend. Thus, a set of operational parameter thresholds is associated with an EMR determined for dose regime, a set of operational parameter thresholds associated with an EMR is determined for concentration, and a set of operational parameter thresholds associated with an EMR is determined for trend, based on the drug type and care area, such as depicted at rule 310 in FIG. 3.

[0070] In yet another example, where the source is an algorithm, such as an algorithm determining operational parameters based on sensor data, a set of operational parameter thresholds is determined for each operational parameter provided, such as dose regime, concentration and trend. Thus, a set of operational parameter thresholds associated with an algorithm is determined for dose regime, a set of operational parameter thresholds associated with an algorithm is determined for concentration, and a set of operational parameter thresholds associated with an algorithm is determined for trend, based on the drug type and care area, such as depicted at rule 320 in FIG. 3.

[0071] Additionally or as an alternative to the determinations at step 404 and 406, rather than determining the source or source type, the flow 400 may generate a trust level for the source and determine a threshold corresponding to the trust level. Generating a trust level may include considering the source, the source type, the parameter sought to be configured, the amount of change between a current parameter value and the proposed new value, or the frequency ofchanges. Trust level may also be based on patient or drug to be administered. A trust level may be an aggregation of assessments such as for each parameter to be adjusted. For example, if a device is currently programmed using ten variables and a message is received to change one value by 3%, the command may be associated with a higher trust level than a message seeking to change nine values or a message seeking to change the one value by 30%. A trust level may have a corresponding value in the drug library to identify which safety thresholds should apply.

[0072] Flow 400 then proceeds to step 408 with comparing the one or more operational parameters with the one or more sets of operational parameter thresholds to determine whether the one or more operational parameters satisfy the corresponding operational parameter threshold(s). An operational parameter satisfies an operational parameter threshold where the value of the operational parameter satisfies the threshold. For example, where the operational parameter threshold is a maximum threshold, the operational parameter satisfies the threshold when the operational parameter is less than the maximum. In another example, where the operational parameter threshold is a minimum threshold, the operational parameter satisfies the threshold when the operational parameter is more than the minimum.

[0073] In certain embodiments, the set of operational parameter thresholds includes one or more thresholds, such as a hard maximum threshold, a soft maximum threshold, a soft minimum, and / or a hard minimum. The operational parameter may be compared to each threshold and determined whether the value satisfies each threshold.

[0074] In certain embodiments, more than one operational parameter is provided. The value for each operational parameter may be compared with the corresponding set of operational parameter thresholds to determine whether the operational parameter values satisfy the corresponding operational parameter thresholds.

[0075] For example, where the source of is a clinician, the device may compare the operational parameters with the set of operational parameter thresholds associated with a clinician for each operational parameter. Where a first operational parameter is dose regimen, the dose operational parameter is compared to a set of operational parameter thresholds associated with a clinician for a dose limit, such as described for rule 302 in FIG. 3. For example, at rule 302, the dose hard maximum threshold is 50 and the dose soft maximum threshold is 20. If the dose operational parameter value is 55, then the dose operational parameter does not satisfy the soft maximum threshold nor hard maximum threshold.

[0076] Where a second operational parameter is concentration limit, the concentration operational parameter is compared to a set of operational parameter thresholds associated with a clinician for concentration limit, such as described for rule 302 in FIG. 3. For example, at rule 302, the concentration soft maximum threshold is 100 and the concentration soft minimum threshold is 75. If the concentration operational parameter value is 85, the concentration operational parameter satisfies the soft maximum threshold and the soft minimum threshold.

[0077] Where a third operational parameter is trend limit, the trend operational parameter is compared to a set of operational parameter thresholds associated with a clinician for a trend limit, as described for rule 302 in FIG. 3. For example, at rule 302, the trend soft maximum for a dose operational parameter is 75% change, and the hard maximum is 100% change. If the current dose operational parameter value is 10 and the new dose operational parameter value is 18, then the trend is 80% change. An 80% change exceeds the 75% soft maximum, but is below the 100% hard maximum.

[0078] In another example, where the source is an EMR, the device may compare the operational parameters provided with the set of operational parameter thresholds associated with an EMR for each operational parameter. Where a first operational parameter is dose regimen, the dose operational parameter is compared to a set of operational parameter thresholds associated with an EMR for a dose limit, such as described for rule 310 in FIG. 3. For example, at rule 310, the dose hard maximum threshold is 50 and the dose soft maximum threshold is 25. If the dose operational parameter value is 35, then the dose operational parameter does not satisfy the soft maximum threshold but does satisfy the hard maximum threshold.

[0079] Where a second operational parameter is concentration limit, the concentration operational parameter is compared to a set of operational parameter thresholds associated with an EMR for concentration limit, such as described for rule 310 in FIG. 3. For example, at rule 310, the concentration soft maximum threshold is 100 and the concentration soft minimum threshold is 75. If the concentration operational parameter value is 65, the concentration operational parameter satisfies the soft maximum threshold but not the soft minimum threshold.

[0080] Where a third operational parameter is trend limit, the trend operational parameter is compared to a set of operational parameter thresholds associated with an EMR for a trend limit, as described for rule 310 in FIG. 3. For example, at rule 310, the trend soft maximum for a dose operational parameter is 75% change, and the hard maximum is 100% change. If the current dose operational parameter value is 35 and the new dose operational parameter value is 30, then thetrend is 17% change. A 17% change is below both the soft maximum and hard maximum, and thus satisfies the trend thresholds.

[0081] In yet another example, where the source is an algorithm, the device may compare the operational parameters provided with the set of operational parameter thresholds associated with an algorithm for each operational parameter. Where a first operational parameter is dose regimen, the dose operational parameter is compared to a set of thresholds associated with an algorithm for a dose limit, such as described for rule 320 in FIG. 3. For example, at rule 320, the dose soft minimum threshold is 10 and the dose soft maximum is 15. If the dose operational parameter value is 12, then the dose operational parameter satisfies both the soft minimum and the soft maximum thresholds.

[0082] Where a second operational parameter is concentration limit, the concentration operational parameter is compared to a set of thresholds associated with an algorithm for concentration limit, such as described for rule 320 in FIG. 3. For example, at rule 320, the concentration soft maximum threshold is 100 and the concentration soft minimum threshold is 85. If the concentration operational parameter value is 90, the concentration operational parameter satisfies the soft maximum threshold and the soft minimum threshold.

[0083] Where a third operational parameter is trend limit, the trend operational parameter is compared to a set of thresholds associated with an algorithm for a trend limit, as described for rule 320 in FIG. 3. For example, at rule 320, the trend soft maximum for a dose operational parameter is 50% change, and the hard maximum is 75% change. If the current dose operational parameter value is 12 and the communicated dose operational parameter value is 10, then the trend is 20% change. A 20% change is below both the soft maximum and hard maximum.

[0084] Accordingly, by comparing the provided one or more operational parameters with the corresponding operational parameter threshold(s) associated with the source, the device may determine whether the one or more operational parameters satisfy the threshold(s). Beneficially, then, different thresholds allow the restrictions to be tailored to each source.

[0085] In some embodiments, each operational parameter provided is compared to the corresponding threshold(s) before flow 400 proceeds to step 420 (or step 410). In some embodiments, each operational parameter provided is compared to the corresponding threshold(s) and flow 400 proceeds to step 420 (or step 410), before returning to step 408 for each additional operational parameter.

[0086] If the one or more operational parameters do not satisfy the set of operational parameter thresholds associated with the source, then flow 400 proceeds to step 410 with generating an alert. The alert may indicate, for example, the operational parameter does not satisfy one or more operational parameter thresholds. For example, an alert may be displayed as an icon, a warning message, etc. The alert may be (or include) an audible alarm, such as a tone, ringer, etc. Various aspects of an alert may change in intensity, volume, color, message, etc., relative to the message or type of alert.

[0087] In some embodiments, the alert may be a message, such as displayed on the device, such as a user interface on the medical device (e.g., infusion pump 104 in FIG. 1) or a control module (e.g., user interface 108 on control module 110 in FIG. 1). In some embodiments, such as a closed-loop system, the alert may be displayed on a remote device. For example, where the source of the one or more operational parameters is an EMR, the alert may be transmitted to a device associated with the EMR for display. In some aspects, a control module may be a remote device, such as a clinician device, where the alert is displayed.

[0088] Flow 400 then proceeds to step 412 whereby a clinician may respond to the alert. In certain embodiments, a clinician may override the alert, for example, by manually entering one or more operational parameters. If a clinician enters operational parameter(s), flow 400 returns to step 402.

[0089] If the clinician does not override the alert, then flow 400 proceeds to step 414 with denying the operational parameter(s).

[0090] Flow 400 then proceeds to step 424 with logging the one or more operational parameters and associated data. Such data may include context data, such as the source, the operational parameter threshold(s) and comparison, alert(s) and the denial of the operational parameters.

[0091] If the one or more operational parameters satisfy the set of operational parameter thresholds associated with the source, then flow 400 optionally proceeds to step 420 with displaying the one or more operational parameters, such as for a clinician to confirm the operational parameter(s) in a manual or semi-closed loop system.

[0092] In some embodiments, operational parameter(s) are displayed where one or more operational parameters satisfy some, but not all of the operational parameter thresholds, such as where an operational parameter satisfies a hard threshold, but not a soft threshold. For example, if the operational parameter(s) are provided by an EMR, such as at rule 310 in FIG. 3, the dosehard maximum threshold is 50 and the dose soft maximum threshold is 25. If the dose operational parameter value is 35, then the dose operational parameter does not satisfy the soft maximum threshold but does satisfy the hard maximum threshold. At step 420, the dose operational parameter value of 35 may be displayed. The display at step 420 may include an alert or message indicating the operational parameter(s) do not satisfy one or more soft thresholds, but do satisfy one or more hard thresholds.

[0093] In some embodiments, a clinician may confirm the displayed operational parameter(s) before flow 400 proceeds to step 422. The confirmation may be received via a user interface, such as user interface 106 or user interface 108 in FIG. 1. In some embodiments, one or more operational parameters are displayed with a confirmation, such as a “YES” or a “NO” to be selected.

[0094] In some embodiments, if the one or more operational parameters satisfy the set of operational parameter thresholds associated with the source, then flow 400 proceeds directly to step 422.

[0095] At step 422, the device implements the one or more operational parameters provided by the source. For example, where the operational param eter(s) are for an infusion pump, the infusion pump may implement the operational param eters(s).

[0096] Flow 400 then proceeds to step 424 with logging the one or more operational parameters and data associated with the implementation. Such data may include additional data, the source of the, the set of operational parameter thresholds and comparison to the operational parameter thresholds, any alerts, and any clinician confirmation or override.

[0097] Note that flow 400 is just one example, and other flows including fewer, additional, or alternative steps, consistent with this disclosure, are possible.Example Method for Operating a Medical Device based on Appropriate Operational Parameters

[0098] FIG. 5 depicts an example method 500 for determining appropriate operational parameters for operation of a medical device based on a source of the operational parameters.

[0099] Initially, method 500 begins at step 502 with receiving, from a source, an operational parameter configured to control operation of a medical device, such as infusion pump 104 in FIG. 1

[0100] Method 500 proceeds to step 504 with determining the source of the operational parameter, such as described with respect to step 404 of FIG. 4. In some embodiments, the source is one of: an electronic medical record; an algorithm configured to determine the operational parameter; or a clinician.

[0101] In some embodiments, determining the source of the operational parameter comprises determining the source based on an identifier of the source received with the operational parameter.

[0102] Method 500 then proceeds to step 506 with selecting a set of operational parameter thresholds from a plurality of sets of operational parameter thresholds based on the source, wherein each of the plurality of sets of operational parameter thresholds is associated with a corresponding source, such as described with respect to step 406 in FIG. 4.

[0103] In some embodiments, selecting the set of operational parameter thresholds comprises selecting the set of operational parameter thresholds further based on a care center location of the medical device and a treatment type associated with operation of the medical device, wherein each of the plurality of sets of operational parameter thresholds is further associated with a corresponding care center location and a corresponding treatment type.

[0104] Method 500 then proceeds to step 508 with determining the operational parameter satisfies at least one operational parameter threshold of the selected set of operational parameter thresholds, such as described with respect to step 408 in FIG. 4.

[0105] Method 500 then proceeds to step 510 with controlling the medical device based on the operational parameter and the determination the operational parameter satisfies the at least one operational parameter threshold of the selected set of operational parameter thresholds, such as described with respect to step 422 in FIG. 4.

[0106] In some embodiments, method 500 further comprises displaying the operational parameter; and receiving a user input confirming the operational parameter, wherein the medical device is further controlled based on receiving the user input, such as described with respect to step 420 of FIG. 4.

[0107] In some embodiments, the selected set of operational parameter thresholds comprises one or more soft thresholds and one or more hard thresholds, and determining the operational parameter satisfies the at least one operational parameter threshold of the selected set of operational parameter thresholds, comprises determining the operational parameter satisfies theone or more hard thresholds and does not satisfy the one or more soft thresholds, and generating an alert based on the determination the operational parameter satisfies the one or more hard thresholds and does not satisfy the one or more soft thresholds.

[0108] In some embodiments, method 500 further comprises receiving a user input with respect to the alert, the user input confirming the operational parameter, wherein the medical device is further controlled based on receiving the user input.

[0109] In some embodiments, the medical device comprises an infusion pump system; and the operational parameter comprises an infusion flow rate setting.

[0110] Note that method 500 is just one example, and other methods including fewer, additional, or alternative steps, consistent with this disclosure, are possible.Example Processing System for a Medical Device

[0111] FIG. 6 depicts an example computing device 600 for a medical device that implements various features and processes described herein. For example, the computing device 600 may perform one or more steps of any of flow 400 or method 500. The 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 by a bus 602.

[0112] Computing device 600 may perform these processes based on processor 604 executing software instructions stored by 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 inside of a single physical storage device or memory space spread across multiple physical storage devices. Software instructions may be read into memory 606 from another computer-readable medium or from another device via communication interface 608. When executed, software instructions stored in memory 606 may cause processor(s) 604 to perform one or more processes described herein.

[0113] Memory 606 may include data storage or one or more data structures (e.g., a database, etc.). Computing device 600 may be capable of receiving information from, storing information in, communicating information to, or searching information stored in the data storage or one or more data structures in memory 606.

[0114] 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 memory, optical memory, etc.), that stores 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.

[0115] Memory 606 may include a determination component 614, operation component 616, operational parameter thresholds data store 618 and log data store 620.

[0116] Determination component 614 is configured to determine a source of an operational parameter, select a set of operational parameter thresholds, determine an operational parameter satisfies at least one of the selected set of operational parameter thresholds, or generate an alert, according to aspects described herein.

[0117] Operation component 616 is configured to operate a medical device according the operational parameters.

[0118] Operational parameter thresholds data store 618 is configured to store a plurality of operational parameter thresholds and associated data, such as in drug library 300 with rules 302, 310, and 320, described with respect to FIG. 3.

[0119] Log data store 620 is configured to store operational parameters and data related to the operation of the medical device, according to aspects described herein.

[0120] One or more processors 604 may include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component (e.g., a field- programmable gate array (FPGA), an application-specific integrated circuit (ASIC), etc.), that may be programmed to perform a function, such as described herein.

[0121] One or more input components 610 may include a component that permits computing device 600 to receive information, such as via user input (e.g., a touch screen display, a keyboard, a keypad, a mouse, a button, a switch, a microphone, etc.). Further, one or more input components 610 may include a sensor for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, etc.).

[0122] One or more output components 612 may include a component that provides output information from computing device 600 (e.g., a display, a speaker, one or more light-emitting diodes (LEDs), etc.).

[0123] Communication interface 608 may include a transceiver-like component (e.g., a transceiver, a separate receiver and transmitter, etc.) that enables computing device 600 to communicate with other devices, such as via a wired connection, a wireless connection, or a combination of wired and wireless connections. Communication interface 608 may permit computing device 600 to receive information from another device 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, and / or the like.Example Clauses

[0124] Implementation examples are described in the following numbered clauses:

[0125] Clause 1 : An apparatus, comprising: one or more memories comprising computerexecutable instructions; and one or more processors configured to execute the computerexecutable instructions, and cause the apparatus to: receive, from a source, an operational parameter configured to control operation of a medical device; determine the source of the operational parameter; select a set of operational parameter thresholds from a plurality of sets of operational parameter thresholds based on the source, wherein each of the plurality of sets of operational parameter thresholds is associated with a corresponding source; determine the operational parameter satisfies at least one operational parameter threshold of the selected set of operational parameter thresholds; and control the medical device based on the operational parameter and the determination the operational parameter satisfies the at least one operational parameter threshold of the selected set of operational parameter thresholds .

[0126] 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 the operational parameter; and receive a user input confirming the operational parameter, wherein the medical device is further controlled based on receiving the user input.

[0127] Clause 3: The apparatus of any one of clauses 1-2, wherein: the selected set of operational parameter thresholds comprises one or more soft thresholds and one or more hardthresholds, to determine the operational parameter satisfies the at least one operational parameter threshold of the selected set of operational parameter thresholds , the one or more processors are further configured to execute the computer-executable instructions, and cause the apparatus to determine the operational parameter satisfies the one or more hard thresholds and does 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 the operational parameter satisfies the one or more hard thresholds and does not satisfy the one or more soft thresholds.

[0128] 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 a user input with respect to the alert, the user input confirming the operational parameter, wherein the medical device is further controlled based on receiving the user input.

[0129] Clause 5: The apparatus of any one of clauses 1-4, wherein the source of the operational parameter is at least one of an electronic medical record; an algorithm configured to determine the operational parameter; or a clinician.

[0130] Clause 6: The apparatus of any one of clauses 1-5, wherein the apparatus is a control module separate from the medical device.

[0131] Clause 7: The apparatus of any one of clauses 1-5, wherein the apparatus is the medical device.

[0132] Clause 8: The apparatus of any one of clauses 1-7, wherein: the medical device comprises an infusion pump system; and the operational parameter comprises an infusion flow rate setting.

[0133] Clause 9: The apparatus of any one of clauses 1-8, wherein to determine the source of the operational parameter 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 with the operational parameter.

[0134] Clause 10: The apparatus of any one of clauses 1-9, wherein to select the set of operational parameter thresholds, the one or more processors are further configured to execute the computer-executable instructions, and cause the apparatus to select the set of operational parameter thresholds further based on a care center location of the medical device and a treatment type associated with operation of the medical device, wherein each of the plurality of sets ofoperational parameter thresholds is further associated with a corresponding care center location and a corresponding treatment type.

[0135] Clause 11 : The 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 operational parameter configured to control operation of the medical device; determine the second source of the second operational parameter; select a second set of operational parameter thresholds from the plurality of sets of operational parameter thresholds, wherein the second set of operational parameter thresholds are associated with the second source; determine the second operational parameter does not satisfy at least one of the selected second set of operational parameter thresholds; and reject the second operational parameter based on the determination the second operational parameter does not satisfy the at least one of the selected second set of operational parameter thresholds.

[0136] Clause 12: A method, comprising; receiving, from a source, an operational parameter configured to control operation of a medical device; determining the source of the operational parameter; selecting a set of operational parameter thresholds from a plurality of sets of operational parameter thresholds based on the source of the operational parameter, wherein each of the plurality of sets of operational parameter thresholds is associated with a corresponding source; determining the operational parameter satisfies at least one operational parameter threshold of the selected set of operational parameter thresholds; and controlling the medical device based on the operational parameter and the determination the operational parameter satisfies the at least one operational parameter threshold of the selected set of operational parameter thresholds.

[0137] Clause 13: The method of clause 12, further comprising: displaying the operational parameter; and receiving a user input confirming the operational parameter, wherein the medical device is further controlled based on receiving the user input.

[0138] Clause 14: The method of any one of clauses 12-14, wherein: the selected set of operational parameter thresholds comprises one or more soft thresholds and one or more hard thresholds, and determining the operational parameter satisfies the at least one operational parameter threshold of the selected set of operational parameter thresholds, comprises determining the operational parameter satisfies the one or more hard thresholds and does not satisfy the one or more soft thresholds, and generating an alert based on the determination the operational parameter satisfies the one or more hard thresholds and does not satisfy the one or more soft thresholds.

[0139] Clause 15: The method of clause 14, further comprising: receiving a user input with respect to the alert, the user input confirming the operational parameter, wherein the medical device is further controlled based on receiving the user input.

[0140] Clause 16: The method of any one of clauses 12-15, wherein the source of the operational parameter is at least one of: an electronic medical record; an algorithm configured to determine the operational parameter; or a clinician.

[0141] Clause 17: The method of any one of clauses 12-16, wherein: the medical device comprises an infusion pump system; and the operational parameter comprises an infusion flow rate setting.

[0142] Clause 18: The method of any one of clauses 12-17, wherein determining the source of the operational parameter, comprises determining the source based on an identifier of the source received with the operational parameter.

[0143] Clause 19: The method of any one of clauses 12-18, wherein selecting the set of operational parameter thresholds, comprises selecting the set of operational parameter thresholds further based on a care center location of the medical device and a treatment type associated with operation of the medical device, wherein each of the plurality of sets of operational parameter thresholds is further associated with a corresponding care center location and a corresponding treatment type.

[0144] Clause 20: A processing system, comprising: a memory comprising computerexecutable instructions; and a processor configured to execute the computer-executable instructions and cause the processing system to perform a method in accordance with any one of Clauses 12-19.

[0145] Clause 21 : A processing system, comprising means for performing a method in accordance with any one of Clauses 12-19.

[0146] Clause 22: A non-transitory computer-readable medium storing program code for causing a processing system to perform the steps of any one of Clauses 12-19.

[0147] Clause 23: A computer program product embodied on a computer-readable storage medium comprising code for performing a method in accordance with any one of Clauses 12-19.Additional Considerations

[0148] The preceding description is provided to enable any person skilled in the art to practice the various embodiments described herein. The examples discussed herein are not limiting of the scope, applicability, or embodiments set forth in the claims. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments. For example, changes may be made in the function and arrangement of elements discussed without departing from the scope of the disclosure. Various examples may omit, substitute, or add various procedures or components as appropriate. For instance, the methods described may be performed in an order different from that described, and various steps may be added, omitted, or combined. Also, features described with respect to some examples may be combined in some other examples. For example, an apparatus may be implemented or a method may be practiced using any number of the aspects set forth herein. In addition, the scope of the disclosure is intended to cover such an apparatus or method that is practiced using other structure, functionality, or structure and functionality in addition to, or other than, the various aspects of the disclosure set forth herein. It should be understood that any aspect of the disclosure disclosed herein may be embodied by one or more elements of a claim.

[0149] 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.

[0150] As used herein, a phrase referring to “at least one of’ a list of items refers to any combination of those items, including single members. As an example, “at least one of: a, b, or c” is intended to cover a, b, c, a-b, a-c, b-c, and a-b-c, as well as any combination with multiples of the same element (e.g., a-a, a-a-a, a-a-b, a-a-c, a-b-b, a-c-c, b-b, b-b-b, b-b-c, c-c, and c-c-c or any other ordering of a, b, and c).

[0151] As used herein, the term “determining” encompasses a wide variety of actions. For example, “determining” may include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Also, “determining” may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory) and the like. Also, “determining” may include resolving, selecting, choosing, establishing and the like.

[0152] The methods disclosed herein comprise one or more steps or actions for achieving the methods. The method steps and / or actions may be interchanged with one another withoutdeparting 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 specific steps and / or actions may be modified without departing from the scope of the claims. Further, the various operations of methods described above may be performed by any suitable means capable of performing the corresponding functions. The means may include various hardware and / or software component(s) and / or module(s), including, but not limited to a circuit, an application specific integrated circuit (ASIC), or processor. Generally, where there are operations illustrated in figures, those operations may have corresponding counterpart means-plus-function components with similar numbering.

[0153] The following claims are not intended to be limited to the embodiments shown herein, but are to be accorded the full scope consistent with the language of the claims. Within a claim, reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. No claim element is to be construed under the provisions of 35 U.S.C. §112(f) unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for.” All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

Claims

CLAIMS:

1. An apparatus comprising: one or more memories comprising computer-executable instructions; and one or more processors configured to execute the computer-executable instructions, and cause the apparatus to: receive, from a source, an operational parameter configured to control operation of a medical device; determine the source of the operational parameter; select a set of operational parameter thresholds from a plurality of sets of operational parameter thresholds based on the source, wherein each of the plurality of sets of operational parameter thresholds is associated with a corresponding source; determine the operational parameter satisfies at least one operational parameter threshold of the selected set of operational parameter thresholds; and control the medical device based on the operational parameter and the determination the operational parameter satisfies the at least one operational parameter threshold of the selected set of operational 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 the operational parameter; and receive a user input confirming the operational parameter, wherein the medical device is further controlled based on receiving the user input.

3. The apparatus of claim 1, wherein: the selected set of operational parameter thresholds comprises one or more soft thresholds and one or more hard thresholds, to determine the operational parameter satisfies the at least one operational parameter threshold of the selected set of operational parameter thresholds, the one or more processors are further configured to execute the computer-executable instructions, and cause the apparatus to determine the operational parameter satisfies the one or more hard thresholds and does not satisfy the one or more soft thresholds, the one or more processors are further configured to execute the computerexecutable instructions, and cause the apparatus to generate an alert based on thedetermination the operational parameter satisfies the one or more hard thresholds and does 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 receive a user input with respect to the alert, the user input confirming the operational parameter, wherein the medical device is further controlled based on receiving the user input.

5. The apparatus of claim 1, wherein the source is at least one of an electronic medical record; an algorithm configured to determine the operational parameter; a remote control device; or a 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 comprises an infusion pump system; and the operational parameter comprises an infusion flow rate setting.

9. The apparatus of claim 1, wherein 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 with the operational parameter.

10. The apparatus of claim 1, wherein to select the set of operational parameter thresholds, the one or more processors are further configured to execute the computer-executable instructions, and cause the apparatus to select the set of operational parameter thresholds further based on a care center location of the medical device and a treatment type associated with operation of the medical device, wherein each of the plurality of sets of operational 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, from a second source, a second operational parameter configured to control operation of the medical device; determine the second source of the second operational parameter; select a second set of operational parameter thresholds from the plurality of sets of operational parameter thresholds, wherein the second set of operational parameter thresholds are associated with the second source; determine the second operational parameter does not satisfy at least one of the selected second set of operational parameter thresholds; and reject the second operational parameter based on the determination the second operational parameter does not satisfy the at least one of the selected second set of operational parameter thresholds.

12. A processing system, comprising: a memory comprising computer-executable instructions; and a processor configured to execute the computer-executable instructions and cause the processing system to: receive, from a source, an operational parameter configured to control operation of a medical device; determine the source of the operational parameter; select a set of operational parameter thresholds from a plurality of sets of operational parameter thresholds based on the source, wherein each of the plurality of sets of operational parameter thresholds is associated with a corresponding source; determine the operational parameter satisfies at least one operational parameter threshold of the selected set of operational parameter thresholds; and control the medical device based on the operational parameter and the determination the operational parameter satisfies the at least one operational parameter threshold of the selected set of operational parameter thresholds.

13. The processing system of claim 12, wherein the processor is further configured to cause the processing system to: display the operational parameter; andreceive a user input confirming the operational parameter, wherein the medical device is further controlled based on receiving the user input.

14. The processing system of claim 12, wherein: the selected set of operational parameter thresholds comprises one or more soft thresholds and one or more hard thresholds, and in order to determine the operational parameter satisfies the at least one operational parameter threshold of the selected set of operational parameter thresholds, the processor is further configured to cause the processing system to determine the operational parameter satisfies the one or more hard thresholds and does not satisfy the one or more soft thresholds, and generate an alert based on the determination the operational parameter satisfies the one or more hard thresholds and does not satisfy the one or more soft thresholds.

15. The processing system of claim 14, wherein the processor is further configured to cause the processing system to: receive a user input with respect to the alert, the user input confirming the operational parameter, wherein the medical device is further controlled based on receiving the user input.

16. The processing system of claim 12, wherein the source is at least one of: an electronic medical record; an algorithm configured to determine the operational parameter; or a clinician.

17. The processing system of claim 12, wherein: the medical device comprises an infusion pump system; and the operational parameter comprises an infusion flow rate setting.

18. The processing system of claim 12, wherein in order to determine the source of the operational parameter, the processor is further configured to cause the processing system to determine the source based on an identifier of the source received with the operational parameter.

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

20. A non-transitory computer-readable medium comprising instructions, which when executed by one or more processors of a medical device, cause the medical device to perform operations comprising: receiving, from a source, an operational parameter configured to control operation of a medical device; determining the source of the operational parameter; selecting a set of operational parameter thresholds from a plurality of sets of operational parameter thresholds based on the source, wherein each of the plurality of sets of operational parameter thresholds is associated with a corresponding source; determining the operational parameter satisfies at least one operational parameter threshold of the selected set of operational parameter thresholds; and controlling the medical device based on the operational parameter and the determination the operational parameter satisfies the at least one operational parameter threshold of the selected set of operational parameter thresholds.

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