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Patient Care Devices presentation for the Clinical Engineering Association of Illinois April 25, 2009 Paul Schluter, Ph.D. GE Healthcare (Milwaukee, WI)

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Presentation on theme: "Patient Care Devices presentation for the Clinical Engineering Association of Illinois April 25, 2009 Paul Schluter, Ph.D. GE Healthcare (Milwaukee, WI)"— Presentation transcript:

1 Patient Care Devices presentation for the Clinical Engineering Association of Illinois April 25, 2009 Paul Schluter, Ph.D. GE Healthcare (Milwaukee, WI) IHE Patient Care Devices Domain

2 Agenda IHE Overview PCD Domain Overview Published Profiles: DEC, PIB & SPD New Profiles: RTM, ACM, PIV Emerging Profiles: IDCO, WCM, MEM, PNP,... Test Tooling Connectathon Showcase Demonstrations Summary and Contact Information Q & A

3 What is IHE? IHE Integrating the Healthcare Enterprise In a nutshell: –IHE identifies real-world interoperability problems –Brings people together to design, test and demonstrate solutions using existing standards.

4 IHE International IHE International is … An international umbrella organization sponsored by RSNA, HIMSS and others… Voluntary, non-profit, operating in public view –Largely manufacturers, users, regulators An initiative by healthcare professionals and industry to improve the way computer systems share information.

5 IHE International

6 PCD Domain Overview IHE PCD Domain Patient Care Devices

7 PCD Domain Overview A Brief History of PCD Established in 2005 when the charter was awarded to the ACCE Jointly sponsored by ACCE and HIMSS as of July 1, 2006 Technical Framework developed to communicate patient data (asynchronous) Successful demonstration at the 2007 & 2008 Connectathons and HIMSS Interoperability Showcases

8 PCD Domain Overview IHE PCD Charter regulated patient care device The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated patient care device. The PCD coordinates with other IHE clinical specialty based domains such as cardiology, pharmacy, laboratory and medical imaging.

9 PCD Domain Overview IHE PCD Mission use case driven The IHE Patient Care Devices Domain will apply the proven, use case driven IHE processes to: –Delivertechnical framework –Deliver the technical framework for the IHE-PCD domain profiles; –Validate Connectathons –Validate IHE-PCD profile implementations via Connectathons; and –Demonstrate public trade shows –Demonstrate marketable solutions at public trade shows.

10 PCD Domain Overview Heterogeneity – … coexistence in a multi-vendor and multi-modality world, leveraging shared infrastructure Semantic Interoperability – … from the sensor to the EHR Real-time Availability – … facilitating more timely clinical decisions PCD Profile Value Objectives:

11 IHE PCD Profiles and Objectives PCD Technical Frameworks for 2007/2008 Device Enterprise Communication (of device data) (DEC, PCD-01) Patient Identity Binding to Device Data (PIB) Subscribe to Patient Data (SPD) PCD Technical Frameworks for 2008/2009 Rosetta Terminology Management Project (RTM) Alarm Communication Management (ACM) Infusion Pump Integration - Drug Administration (PIV) Key Objectives 2009 and beyond Implanted Cardiac Devices (IDCO) Waveform Communication Management (WCM) Medical Equipment Management (MEM) Device Point-of-Care Integration (DPI, a multiyear effort) Real-time data archiving and communication Mobile, enterprise-wide, reliable vital signs monitoring … many more! Initial device classes… vital sign monitors, bedside monitors, infusion pumps and ventilators

12 PCD - Published Profiles DEC Profile Device to Enterprise Communication

13 Device Enterprise Communication (DEC) - Year 1

14 IHE PCD DEC: Simplify Specs!

15 DEC Profile Mapping Model ISO/IEEE Domain Information Model and Nomenclature mapped to HL7 (v2.5) Observation Report ISO/IEEE Data Types mapped to HL7 Data Types Mapping preserves measurement context for complex devices.

16 Measurement Context is Dynamic

17 IEEE Domain Information Model Defines Device Context n

18 Mapping preserves measurement context

19 Example PCD-01 Message MSH|^~\&|HL7^080019FFFF4F6AC0^EUI-64|MMS||| ||ORU^R01|a4e2e3:11036b5cdbb:- |P|2.5| ||NE|AL||8859/1 PID|||GE101^^^DefaultDomai||JACKSON^IRWIN^^^^^L PV1||E|3WICU^305^305 OBR|1|080019FFFF4F6AFE200701|080019FFFF4F6AC | ^2000^MDC||| OBX|1|NM|147842^MDC_ECG_HEART_RATE^MDC| |80|/min^/min^UCUM|||||R OBX|2|NM|148065^MDC_ECG_V_P_C_CNT^MDC| |0|/min^/min^UCUM|||||R OBX|3|NM|150035^MDC_PRESS_BLD_ART_MEAN^MDC| |96|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|4|NM|150033^MDC_PRESS_BLD_ART_SYS^MDC| |120|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|5|NM|150034^MDC_PRESS_BLD_ART_DIA^MDC| |80|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|6|NM|149522^MDC_BLD_PULS_RATE_INV^MDC| |80|/min^/min^UCUM|||||R OBX|7|NM|150047^MDC_PRESS_BLD_ART_PULM_MEAN^MDC| |15|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|8|NM|150045^MDC_PRESS_BLD_ART_PULM_SYS^MDC| |24|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|9|NM|150046^MDC_PRESS_BLD_ART_PULM_DIA^MDC| |10|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|10|NM|150344^MDC_TEMP^MDC| |26.4|cel^cel^UCUM|||||R OBX|11|NM|150344^MDC_TEMP^MDC| |37.4|cel^cel^UCUM|||||R OBX|12|NM|151610^MDC_VENT_CO2_RESP_RATE^MDC| |12|{{breath}/min}^{{breath}/min}UCUM|||||R OBX|13|NM|151804^MDC_PRESS_AWAY_END_EXP_POS^MDC| |4|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX|14|NM|152008^MDC_VENT_VOL_MINUTE_AWAY^MDC| |0.0|l/min^l/min^UCUM|||||R OBX|15|NM|151920^MDC_VENT_CONC_AWAY_O2_INSP^MDC| |21|%^%^UCUM|||||R OBX|16|NM|151980^MDC_VENT_VOL_TIDAL^MDC| |920|ml^ml^UCUM|||||R OBX|17|NM|151957^MDC_VENT_PRESS_MAX^MDC| |17|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX|18|NM|151784^MDC_PRESS_RESP_PLAT^MDC| |31|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX|19|NM|151792^MDC_PRESS_AWAY^MDC| |36|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX|20|NM|151808^MDC_PRESS_AWAY_END_EXP_POS_INTRINSIC^MDC| |1|{cm[H20]}^{cm[H20]}^UC UM|||||R Heart Rate/min UOM IEEE EUI-64 OBX-4

20 PCD - Published Profiles PIB Profile Patient Identity Binding

21

22 Automates identity association / authentication process using standard ITI profiles. Option for the DEC Profile Async identity access using ITI-21 Patient Demographics Query (PDQ) Sync identity acquisition using ITI-30 Patient Admin Management / Patient Identity Feed (PAM) DEC-PIB profile…

23 PCD - Published Profiles SPD Profile Subscribe to Patient Data

24 Note: SPD is a DEC Profile option. DEC - Subscribe to Patient Data

25

26 PCD – Rosetta Terminology Mapping RTM Profile Rosetta Terminology Mapping

27 Rosetta for Semantic Interoperability

28

29 RTM Cardiovascular (multiple vendors) GroupREFERENCE_ID Vendor_ Description CODE Vendor A Vendor B Vendor C CVS_ECG_HRMDC_ECG_CARD_BEAT_RATEHeart Rate (DBR 326)16770HR CVS_ECG_HRMDC_ECG_CARD_BEAT_RATE_BTBBeat-to-Beat Rate16778btbHR CVS_ECG_HRMDC_ECG_HEART_RATEHeart Rate (DBR 2178)16770HR CVS_ECG_HRMDC_ECG_PACED_BEAT_RATE%PACED 16554%PACED CVS_ECG_HRMDC_ECG_TIME_PD_RR_GLR to R Interval 16168rr_time CVS_ECG_QTMDC_ECG_TIME_PD_QT_GLQT interval 16160QT CVS_ECG_QTMDC_ECG_TIME_PD_QTcQT interval (corrected)16164QTc CVS_ECG_RHYMDC_ECG_ARRHYArrhythmia 4410ARR CVS_ECG_RHYMDC_ECG_V_P_C_CNTPVC rate.16993PVC/min PVC CVS_ECG_STMDC_ECG_AMPL_STST generic label 768ST CVS_ECG_STMDC_ECG_AMPL_ST_AVFST lead aVF 832STaVF ST-AVF ST-aVF CVS_ECG_STMDC_ECG_AMPL_ST_AVLST lead aVL 831STaVL ST-AVL ST-aVL CVS_ECG_STMDC_ECG_AMPL_ST_AVRST lead aVR 830STaVRST-AVRST-aVR

30 RTM Goals for 2009/10 ExpandExpand the number of numeric parameters supported by PCD-01 from 40 today to nearly 300, providing a more comprehensive set. HarmonizeHarmonize the use of existing nomenclature terms defined by ISO/IEEE units-of-measureenumerated valuesSpecify the units-of-measure and enumerated values associated with each numeric parameter. Identify and add new nomenclature termsIdentify and add new nomenclature terms that are currently missing from ISO/IEEE NOTE: Respiratory / Ventilator terms are a major area. See

31 RTM Technical Steps 1.Create the Rosetta Terminology Mapping Table Current draft (1k) has over 930 rows submitted by six vendors. 2.Identify implementation differences and resolve. Resolve differences in interpretation. Pre- or post-coordinated measurement site location(s). 3.Identify missing terms and propose new terms to standards organizations. IHE PCD – need to add 40+ terms to ISO/IEEE Continua – need to add 100+ terms to ISO/IEEE Generate final set of terms, units-of-measure and enumerations for testing. Working with NIST for HL7 test and validation tooling Wiki:

32 PCD - New Profiles ACM Profile Alarm Communication Management

33 ACM Statement Alarm Communication Management enables systems to deliver the right alarms, with the right priority, to the right individuals, via devices with the right content, escalating to other individuals via devices (based on system configuration)

34 Alarm Source Alarm Aggregator Alarm Receiver Alarm Coordinator Alarm Disseminator Alarm Communication Alarm Endpoint Alarm Communication (AC) Alarm Communication (AC) Alarm Management (AM) Alarm Management (AM) Alarm Reporter (AR) Alarm Reporter (AR) Alarm Reporter Alarm Cache Alarm Query AQ (AQ) Alarm Query AQ (AQ) Communication detailed in ACM profile Communication not detailed in ACM profile PCD Inputs (PM, NC, Resp, Pump, etc.) PCD Inputs (PM, NC, Resp, Pump, etc.) Output Devices (Marquee Sign, Pager, Wi-Fi Phone or Badge, etc.) Output Devices (Marquee Sign, Pager, Wi-Fi Phone or Badge, etc.) HIS, EMR Optional ACM Actors

35 AR – knows originating alarm, ultimately responsible for clearing it, knows how to get the alarm to the AM AM – a giant offloading engine, dumb or intelligent, dispatching, escalation, filtering, assignments, content harmonization, knows how to communicate with multiple, potentially proprietary, AC actors, may know end device distinctions, may gather RTLS samples at alarm time AC – data communication gateway to the endpoint device, understands how to communicate to end devices across things like Wi-Fi and WANs, knows device specific characteristics, and concepts like presence, read, read receipt, accept, cancel, etc. and how to communicate those back to the AM, might also know how to bridge to telephony and web based systems for things like callbacks and hyperlinks AQ – standalone optional subscriber and query source for gathering ad-hoc or long term information AR – knows originating alarm, ultimately responsible for clearing it, knows how to get the alarm to the AM AM – a giant offloading engine, dumb or intelligent, dispatching, escalation, filtering, assignments, content harmonization, knows how to communicate with multiple, potentially proprietary, AC actors, may know end device distinctions, may gather RTLS samples at alarm time AC – data communication gateway to the endpoint device, understands how to communicate to end devices across things like Wi-Fi and WANs, knows device specific characteristics, and concepts like presence, read, read receipt, accept, cancel, etc. and how to communicate those back to the AM, might also know how to bridge to telephony and web based systems for things like callbacks and hyperlinks AQ – standalone optional subscriber and query source for gathering ad-hoc or long term information What Actor does What?

36 AlarmCommunication(AC)AlarmCommunication(AC)AlarmManagement(AM)AlarmManagement(AM)AlarmReporter(AR)AlarmReporter(AR) AlarmQuery(AQ)AlarmQuery(AQ) Alarm Status [ACM-02]* Disseminate Alarm [ACM-03] Dissemination Status [ACM-04] Subscribe to Alarm Cache [ACM-06]* Query for Alarm [ACM-07]* Subscribe to Alarm [ACM-05]* Report Alarm [ACM-01] Inputs Outputs Historical Capture and Reporting Historical Capture and Reporting Optional Report Alarm [ACM-01] * Not planned for implementation in 2008/09 ACM Data Flows

37 PCD - New Profiles PIV Profile Point-of-Care Infusion Verification

38 Point-of-Care Infusion Verification supports the electronic transfer of infusion parameters from a Barcode Point of Care (BPOC) system, also known as a Bar Code Medication Administration (BCMA) system, to an infusion pump. PIV Statement

39 reduce errors PIV will reduce errors by eliminating keystroke errors and by increasing the use of automatic dosage checking facilitated by onboard drug libraries. Supports the Five+ Rights of Medication Administration: Right Patient, Drug, Dose, Route, Time and Pump. reduce errors PIV will reduce errors by eliminating keystroke errors and by increasing the use of automatic dosage checking facilitated by onboard drug libraries. Supports the Five+ Rights of Medication Administration: Right Patient, Drug, Dose, Route, Time and Pump. PIV Benefits

40 PIV as part of overall workflow…

41 PIV Actors

42 PCD – Emerging Profiles Emerging Profiles Implanted Cardiac Devices (IDCO) Waveform Communication Management (WCM) Medical Equipment Management (MEM) Device Point-of-Care Integration (DPI, a multiyear effort) Real-time data archiving and communication Mobile, enterprise-wide, reliable vital signs monitoring … many more!

43 IHE PCD Profile: MEM

44 PCD - Emerging Profiles

45 PCD - Testing Test Tooling Support

46 Test Tooling Support - NIST NIST Test Tools –ICSGenerator Medical Device Profiles (specializations) Implementation Conformance Statements –ValidatePDU X73 Application Layer Message Syntax and Semantic Validation NIST Medical Device Standards Work –ISO/IEEE Standard (X73): Medical Device Communication XML SchemaXML Schema : NIST P Domain Information Model Collaborations –Integrating Health Enterprise - Patient Care Devices (IHE-PCD) –IEEE Personal Health Devices (PHD) Working Group (WG) –ISO/IEEE WG On-going Work and Future Direction… HL7 V2 & V3 –IHE-PCD profile and message generation and testing (includes enterprise – e.g., HL7 V2 & V3) Continua –PHD X73 profile and message testing (Continua) –X73 Java Class Library NIST Team Members –John Garguilo ), Sandra Martinez, Maria Cherkaoui (guest researcher), and Richard Theimer

47 What is NIST doing? Test Tools! Test ToolsICSGeneratorValidatePDU What is it?Implementation Conformance Statement Generator, Profile builder X73 Message validation: profile and standard Why?Easy to use interface Based on standard Promote Interoperability Whos using it?Most major medial device manufacturers –IHE-PCD participants (pre-connectathon, connectathon, HIMSS) –PHD participants (smaller devices - Continua effort) A few small manufactures have expressed interest Countries participating: US, Europe, Japan, Korea, Canada How is it being used? As a requirement to standard (ICSs) Early stage interoperability Help produce more accurate standards documentation IHE-PCD profile validation Message validation Who are we working with? IHE-Patient Care Domain IEEE Personal Health Device WG IEEE WG

48 Test Tool Support – HL7 v2

49 Test Tool Support – R-T PnP

50 PCD - Showcase Connectathon Where we prove that it really works !!

51 Connectathon 2008 – at the Hyatt in Chicago

52 Connectathon 2008 – signing off!

53 Connectathon 2008 – everyone passed!

54 PCD – Preparing for HIMSS Showcase Now that we have connectivity … … demonstrate clinical workflows !!

55 Welch Allyn Connex TM DataManagementSystem Vital Signs Monitor GEAwareGateway Patient Monitor, Ventilator PhilipsIntellivueInformationCenter Patient Monitor, Ventilator Emergency CareIntensive Care LiveDataOR-DashBoardGE Centricity ® Periop Anesthesia Draeger Innovian ® Solution Suite Patient Monitor, Anesthesia Sys B. Braun DoseTrac TM InfusionManagementSoftware Infusion Devices Perioperative Care Philips Intellivue Clinical InformationPortfolio PCD at HIMSS 2007 (Cardiac, Bypass)

56 PCD at HIMSS 2008 (Labor, Cardiac)

57 GE Centricity ® Periop Anes. Enterprise DOC Patient LiveData OR – DashBoard TM DOR = Device Observation Reporter IOP = Infusion Order Programmer DOC = Device Observation Consumer IOC = Infusion Order Consumer AR = Alarm Reporter / AM = Alarm Manager PDQ/PAM Server Philips IntelliVue Clinical Clinical Info Portfolio DOC Draeger Innovian ® Web Capsule GE Centricity ® Enterprise DOC LiveData Alert Manager Philips Emergin AM OR Time Server Step-DownICU AM Hospital Bed, BIS Monitor Capsule DataCaptor DOR, AR Patient Monitor DOR, AR Philips IntelliVue Info. Center AR DOR, AR Cerner CareMobile TM DOCIOP AC DOR, AR Hospital Bed, VS Monitor Cerner CareAware TM DOR, AR Infusion Devices IOC B. Braun HospiraCardinal Patient Monitor, Ventilator DOR GE Aware Gateway DOR, AR Infusion Devices IOC B. Braun HospiraCardinal Patient Monitor, Anesthesia Sys DOR, AR Draeger Infinity Gateway DOR, AR Infusion Devices B. Braun HospiraCardinal Patient Polycom Wireless Phone Alarm Client Capsule SIS Periop Solution DOC Cerner CareMobile TM DOCIOP PCD at HIMSS 2009 (infusors, alarms)

58 PCD – IHE Showcase at HIMSS HIMSS Showcase Where we get to show it off !!

59 PCD at HIMSS 2008 Showcase

60 HIMSS Showcase 2008 – ER & OR

61 HIMSS Showcase 2008 – ICU

62 PCD Resources … PCD Resources and Contacts

63 IHE PCD Profiles and Objectives (Recap) PCD Technical Frameworks for 2007/2008 Device Enterprise Communication (of device data) (DEC, PCD-01) Patient Identity Binding to Device Data (PIB) Subscribe to Patient Data (SPD) PCD Technical Frameworks for 2008/2009 Rosetta Terminology Management Project (RTM) Alarm Communication Management (ACM) Infusion Pump Integration - Drug Administration (PIV) Key Objectives 2009 and beyond Implanted Cardiac Devices (IDCO) Waveform Communication Management (WCM) Medical Equipment Management (MEM) Device Point-of-Care Integration (DPI, a multiyear effort) Real-time data archiving and communication Mobile, enterprise-wide, reliable vital signs monitoring … many more! Initial device classes… vital sign monitors, bedside monitors, infusion pumps and ventilators

64 PCD Profile Development 2009 White Paper Proposals2009 White Paper Proposals –Device Point-of-care Integration (DPI) –Medical Equipment Management (MEM) –Medical Device Semantic Architecture –Regulatory Considerations in Deploying Systems Incorporating IHE PCD Profiles IHE PCD Users HandbookIHE PCD Users Handbook –What is and is not specified in PCD Profiles –How to assess PCD profile support –System verification & validation testing considerations

65 Why use IHE PCD profiles? Simplified standards-based integration of point-of-care device info & services Multi-vendor product integration and testing at Connectathons Visibility of products with care providers and peer technology organizations in Showcases Path to programs such as the U.S. National Health Information Network (NHIN) PCD profiles will enable…

66 PCD Contacts PCD CoChairs: –Todd Cooper –Ken –Ray Zambuto PCD Technical Project Manager: –Manny IHE (International) Strategic Development Committee Co-Chair: –Elliot Rosetta Terminology Mapping Working Group Co-Chair: –Paul

67 Q & A Questions?

68


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