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An Open Test Bed for Medical Device Integration and Coordination Zahid Mian November 7, 2012 Andrew King, Sam Procter, Dan Andersen, John Hatcliff, Steve.

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Presentation on theme: "An Open Test Bed for Medical Device Integration and Coordination Zahid Mian November 7, 2012 Andrew King, Sam Procter, Dan Andersen, John Hatcliff, Steve."— Presentation transcript:

1 An Open Test Bed for Medical Device Integration and Coordination Zahid Mian November 7, 2012 Andrew King, Sam Procter, Dan Andersen, John Hatcliff, Steve Warren (Kansas State Univerty) William Spees, Raoul Jetley, Paul Jones, Sandy Weininger (US FDA)

2 Worcester Polytechnic Institute 2 Introduction Lack of Medical Device Integration V & V Techniques for Single Systems Developers More Focused on Firmware Dev Not formal QA Techniques Most Devices Have Connectivity, But Not Well Integrated Many Commercial Companies Are Producing Integrated ProductsSomewhat Dangerous

3 Worcester Polytechnic Institute 3 Challenges Choosing Middleware & Integration Architectures to Support Integration Choosing Programming Models for V&V, Certification, RAD, etc. Appropriate V & V Techniques Can Existing Regulatory Guidelines be Extended Innovation of New TechnologySafe/Effective Interoperability & Security

4 Worcester Polytechnic Institute 4 Medical Device Coordination Framework (MDCF) Three Contexts –Clinical (Room-Oriented) –Alarm Integration and Forwarding –Critical Care Flexible Pub/Sub middleware architecture using JMS Model-Based Programming

5 Worcester Polytechnic Institute 5 Clinical (Room Oriented) Intensive Care Ward –Several Stand Alone Devices, Each Having its Own Logging/Monitoring Tools (EHR, Billing, etc.) –Inefficiencies: different interfaces (confusion) physically separated different roles/views separate logs

6 Worcester Polytechnic Institute 6 Clinical – Integration Solution EHR DB is Single Consumer –aggregates device data into one place Heads Up Displayinfo from multiple devices displayed on Monitor(s) near patient bed Eg: CareWare uses IBMs Eclipse Framework –Define view(s) based on device

7 Clinical – Integration Solution Worcester Polytechnic Institute 7

8 8 Clinical – Implementation Requirements –Support different data amounts/rates Pulse oximeterupdated every 10 seconds Electronic stethoscope8 kilosamples/second –Integration of Data Transformations Filters, aggregations, etc. –Allow definition of producers, consumers, transformers –Provide facilitates for validation and auditing –Single Server or Server/Room?

9 Worcester Polytechnic Institute 9 Clinical – V&V and Regulatory Performance –Unacceptable Latencies and Jitter? –Impact of Heightened Activity in Another Room Security –Private data, unobservable, unalterable Safety –Redisplay must be faithful to the precision & presentation of original

10 Worcester Polytechnic Institute 10 Alarm Integration & Forwarding Devices Produce Alarms –IEC 60601-1-8 Standarddistributed alarm system Problem of False Positives –Smart Alarms – Fuzzy Logic (reasoning) –Consider: patient body type, weight, history Eg: pulse oximeter and respiratory monitor Solution: –Priority/source of alarm –Information signals from monitoring devices –Programmable support to correlate data from many sources

11 Worcester Polytechnic Institute 11 Critical Care Device Coordination Not just unidirectional flow Automated Agent Control to Communicate Between Devices Eg: X-ray/Ventilator –Acquiring chest x-rays from patients on ventilators –Doctors must turn off Ventilator – Human Error –Automatically Coordinate Ventilator can identify full inhalation/exhalation Capture x-ray at optimal point Eg: Smart Pumps (fluid infusion)

12 Worcester Polytechnic Institute 12 Critical Care Device Coordination Integration Solution –Network capable devices (MAC based ID) –DB for scripts written by experts –Allow clinician to choose appropriate script –Script selects necessary devices –Script may run uninterrupted or stop for input Issues –Coordination comps as simple automata –Support rigorous validation for regulatory oversight –Server per Room (too critical)

13 Critical Care Device Coordination Worcester Polytechnic Institute 13

14 Worcester Polytechnic Institute 14 Goals of MDCF Provide middleware to enable integration of devices from different vendors with minimal effort Support for common data formats Enable transformation of data streams Support realistic device integration contexts Performance/programmability scales Options for guaranteed delivery, logs/audits, message persistence Script programming from building blocks Infra should be freely available and open source

15 Worcester Polytechnic Institute 15 Goals of MDCF Standards-based Framework for enterprise-level Support real and simulated devices

16 Worcester Polytechnic Institute 16 MOM Foundation Messaging-Oriented-Middleware –Based on JMS Meets the Goals of MDCF –Flexible messaging, open source, enterprise-level, etc.

17 JMS Primary Objects Client uses JNDI to get Connection Factory Create Active Connection Exception Listener monitors problems If Conn is good, client creates a JMS Session Session is Single Threaded (serial delivery) Worcester Polytechnic Institute 17

18 JMS Primary Objects Worcester Polytechnic Institute 18

19 JMS Destinations Dest is abstract entity (to/from, pub/sub) Session creates MessageProducers/Consumers Client requests a Message, updates it, and sends it using MessageProducer Clients can add filter expressions Supports diff message formats: text (eg. HL7) and objects (eg. DICOM images) Worcester Polytechnic Institute 19

20 JMS Destinations Worcester Polytechnic Institute 20

21 JMS Message Format Worcester Polytechnic Institute 21 Key-value pairs

22 MDFC Modules Device Connection Manager –Listens on JMS channel for desired connections –Assumes every device has JVM –JVM-capable adapter available for non-JVM device HHSQL (stores device, driver info) Consoles –Maintenance (allow installation/updates) –Monitoring (flow of events) –Clinician (data visuals, invocation of scripts) Scenario Manager (manages life-cycle of objects within a script, teardown of objects) Worcester Polytechnic Institute 22

23 Programming Model Component-Based Programming –Abstract details of lower-level system –Rapid assembly of integration scenarios Supports typed input/output event ports Supports multiple categories of comps –Data producers, data transformers, data consumers Worcester Polytechnic Institute 23

24 Cadena Framework IDE Component-based meta-modeling Cadena generates –Component interface editor … define comp types –System scenario editor … allocate/connect comps –Builds executable system Active Typing: checks for type correctness Worcester Polytechnic Institute 24

25 ICU Scenario Components Worcester Polytechnic Institute 25

26 OR Scenario Components Worcester Polytechnic Institute 26

27 CORBA Component Model Generates Java Skeleton/Container Has all logic required for framework Code Business Logic Only Analyzes scenario model; gen xml spec file –details of the scenario model –location of class files Reduces Programming errors Worcester Polytechnic Institute 27

28 Experiments Baseline –Simple producer/consumer; measure raw perf Clinical –Asses ability to support typical usage modes Categories of Data –Device data –Alarm events –Medial informatics (patient, images, drug, etc.) Parameter settings (rates set to worst-case) Worcester Polytechnic Institute 28

29 Baseline Configurations Simple Event Notifications –No payload (10 bytes) HL7 –313-byte (vaccine) –2227-byte (adverse reactions to vaccine) –4312-byte (additional vaccine events) DICOM –Chest (379 kb), knee (130 kb), shoulder (70 kb) Connection Topologies –Likely real world setup Worcester Polytechnic Institute 29

30 Baseline Experimental Results Worcester Polytechnic Institute 30 Throughput (messages) Producers to Consumers

31 Baseline Experimental Results Message Size + Topology Affect TP Larger Message reduces TP rate (marshalling) Greatly affected by Topology Increasing Producers; limited impact Increasing Consumers; high impact Possibly due to Queue sharing Messages –Many producers: msgs arrive in Q at once –Many consumers: msg removed from Q and copy to many worker threads Worcester Polytechnic Institute 31

32 Critical Care Device Coordination OR equipped with –Anesthesia machine with integrated ventilator, ECG, and blood pressure cuff –Large heads-up displays (render data) –Transformer (software) preprocessor for ECG –Results (latency) –shows the framework can support coordinated activities Worcester Polytechnic Institute 32 Why so high?

33 Integrated Displays and Alarms Large ICU ward with multiple rooms –Equipped with blood pressure cuff, cardiac monitor, intravenous medicator, pulse oximeter, and ventilator. –device produces data/alarm –room has monitor to render data –room has a nurses station display (subs to alarms) Worcester Polytechnic Institute 33

34 Integrated Results Worcester Polytechnic Institute 34 Scales to 20 rooms Max latency 4 sec Max latency 3 sec

35 Conclusions The Good –Provides scalability –Enterprise-Level architecture –Solid performance with open source –Loosely coupled component-model programming The Bad –Unacceptable performance with persistence More Work –Expand list of devices –Include wearable, ambulatory sensor-based devices Worcester Polytechnic Institute 35

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