AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床課件

1、Rohit NampelliAndrew King, Sam Procter, Dan Andersen, John Hatcliff, Steve Warren (Kansas State Univerty)William Spees, Raoul Jetley, Paul Jones, Sandy Weininger (US FDA)AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床Lack of Medical Device Integration V & V Techniques for Single Sys

2、temsDevelopers More Focused on Firmware DevNot “formal” QA TechniquesMost Devices Have Connectivity, But Not Well IntegratedMany Commercial Companies Are Producing Integrated ProductsSomewhat DangerousAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床2Choosing Middleware & Integration

3、Architectures to Support IntegrationChoosing Programming Models for V&V, Certification, RAD, etc.Appropriate V & V TechniquesCan Existing Regulatory Guidelines be ExtendedInnovation of New TechnologySafe/EffectiveInteroperability & Security AnOpenTestBedforMedicalDeviceIntegrationand一種用于

4、醫(yī)療設(shè)備集成的開放式測(cè)試床3Three ContextsClinical (Room-Oriented)Alarm Integration and ForwardingCritical CareFlexible Pub/Sub middleware architecture using JMSModel-Based ProgrammingAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床4Intensive Care WardSeveral Stand Alone Devices, Each Having its Own L

5、ogging/Monitoring Tools (EHR, Billing, etc.)Inefficiencies: different interfaces (confusion) physically separated different roles/views separate logsAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床5Context 1: Room Oriented Device Information PresentationEHR DB is Single Consumer aggregat

6、es device data into one placeHeads Up Displayinfo from multiple devices displayed on Monitor(s) near patient bedEg: CareAware uses IBMs Eclipse FrameworkDefine “view(s)” based on deviceAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床6Context 1: Room Oriented Device Information Presentati

7、onAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床7Context 1: Room Oriented Device Information PresentationRequirementsSupport different data amounts/rates Pulse oximeterupdated every 10 seconds Electronic stethoscope8 kilosamples/secondIntegration of “Data Transformations” Filters, aggr

8、egations, etc.Allow definition of producers, consumers, transformersProvide facilities for validation and auditingSingle Server or Server/Room?AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床8Context 1: Room Oriented Device Information PresentationPerformanceUnacceptable Latencies and Ji

9、tter?Impact of Heightened Activity in Another RoomSecurityPrivate data, unobservable, unalterableSafetyRedisplay must be faithful to the precision & presentation of originalAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床9Context 1: Room Oriented Device Information PresentationDevice

10、s Produce Alarms IEC 60601-1-8 Standarddistributed alarm systemProblem of False Positives“Smart Alarms” Fuzzy Logic (reasoning)Consider: patient body type, weight, historyEg: pulse oximeter and respiratory monitorSolution:Priority/source of alarm Information signals from monitoring devicesProgrammab

11、le support to correlate data from many sourcesAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床10Alarm integration and forwardingNot just unidirectional flowAutomated Agent Control to Communicate Between DevicesEg: X-ray/VentilatorAcquiring chest x-rays from patients on ventilatorsDoctors

12、 must turn off Ventilator Human ErrorAutomatically Coordinate Ventilator can identify full inhalation/exhalation Capture x-ray at optimal pointEg: “Smart Pumps” (fluid infusion)AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床11Alarm integration and forwardingIntegration SolutionNetwork c

13、apable devices (MAC based ID)DB for scripts written by expertsAllow clinician to choose appropriate scriptScript “selects” necessary devices Script may run uninterrupted or stop for inputIssuesCoordination components as simple automataSupport rigorous validation for regulatory oversightServer per Ro

14、om (too critical)AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床12Alarm integration and forwardingAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床13Alarm integration and forwardingProvide middleware to enable integration of devices from different vendors with minimal effortS

15、upport for common data formatsEnable transformation of data streamsSupport “realistic” device integration contextsPerformance/programmability scalesOptions for guaranteed delivery, logs/audits, message persistenceScript programming from building blocksInfra should be freely available and open source

16、 AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床14Standards-based Framework for enterprise-levelSupport real and simulated devicesAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床15Messaging-Oriented-MiddlewareBased on JMSMeets the Goals of MDCFFlexible messaging, open source

17、, enterprise-level, etc.AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床16Client uses JNDI to get Connection FactoryCreate “Active” Connection Exception Listener monitors problemsIf Conn is good, client creates a JMS SessionSession is Single Threaded (serial delivery)AnOpenTestBedforMedi

18、calDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床17AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床18Dest is “abstract” entity (to/from, pub/sub)Session creates MessageProducers/ConsumersClient requests a Message, updates it, and sends it using MessageProducerClients can add filter expressionsSup

19、ports diff message formats: text (eg. HL7) and objects (eg. DICOM images)AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床19AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床20AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床21Key-value pairsDevice Connection ManagerL

20、istens on JMS channel for desired connectionsAssumes every device has JVMJVM-capable adapter available for non-JVM deviceHHSQL (stores device, driver info)ConsolesMaintenance (allow installation/updates)Monitoring (flow of events)Clinician (data visuals, invocation of scripts)Scenario Manager (manag

21、es life-cycle of objects within a script, teardown of objects)AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床22Component-Based ProgrammingAbstract details of lower-level systemRapid assembly of integration scenariosSupports “typed” input/output event portsSupports multiple categories of

22、 compsData producers, data transformers, data consumersAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床23IDEComponent-based meta-modelingCadena generatesComponent interface editor define comp typesSystem scenario editor allocate/connect compsBuilds executable system“Active Typing”: check

23、s for type correctnessAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床24AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床25AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床26Generates Java Skeleton/ContainerHas all logic required for frameworkCode “Business Logic” O

24、nlyAnalyzes scenario model; gen xml spec filedetails of the scenario modellocation of class filesReduces Programming errorsAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床27BaselineSimple producer/consumer; measure raw perfClinicalAsses ability to support typical usage modesCategories of

25、 DataDevice dataAlarm eventsMedial informatics (patient, images, drug, etc.)Parameter settings (rates set to worst-case)AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床28Simple Event NotificationsNo payload (10 bytes)HL7313-byte (vaccine)2227-byte (adverse reactions to vaccine)4312-byte

26、(additional vaccine events)DICOMChest (379 kb), knee (130 kb), shoulder (70 kb)Connection TopologiesLikely “real world setupAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床29AnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床30Throughput (messages)Producers to ConsumersMessage S

27、ize + Topology Affect TPLarger Message reduces TP rate (marshalling)Greatly affected by TopologyIncreasing Producers; limited impact Increasing Consumers; high impactPossibly due to Queue sharing MessagesMany producers: msgs arrive in Q at onceMany consumers: msg removed from Q and copy to many worker threadsAnOpenTestBedforMedicalDeviceIntegrationand一種用于醫(yī)療設(shè)備集成的開放式測(cè)試床31OR equipped withAnesthesia machine with integrated ventilator, ECG, and blood pressure cuffLarge “heads-up” displays (render data)Transformer (s