Clinical Engineering Association of Illinois 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

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

Integrating the Healthcare Enterprise 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. 3

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. 4

IHE International

PCD Domain Overview IHE PCD Domain Patient Care Devices 6

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 2006-7 developed to communicate patient data (asynchronous) Successful demonstration at the 2007 & 2008 Connectathons and HIMSS Interoperability Showcases

PCD Domain Overview IHE PCD Charter 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.

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

PCD Profile Value Objectives: PCD Domain Overview PCD Profile Value Objectives: 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

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

PCD - Published Profiles DEC Profile Device to Enterprise Communication 12

Device Enterprise Communication (DEC) - Year 1

IHE PCD DEC: Simplify Specs!

DEC Profile Mapping Model ISO/IEEE 11073 Domain Information Model and Nomenclature mapped to HL7 (v2.5) Observation Report ISO/IEEE 11073 Data Types mapped to HL7 Data Types Mapping preserves measurement context for complex devices.

Measurement Context is Dynamic

IEEE 11073 Domain Information Model Defines Device Context

Mapping preserves measurement context

Example PCD-01 Message IEEE EUI-64 OBX-4 ‘Heart Rate’ ‘/min’ UOM MSH|^~\&|HL7^080019FFFF4F6AC0^EUI-64|MMS|||20070118133700||ORU^R01|a4e2e3:11036b5cdbb:-|P|2.5|20070118133700||NE|AL||8859/1 PID|||GE101^^^DefaultDomai||JACKSON^IRWIN^^^^^L PV1||E|3WICU^305^305 OBR|1|080019FFFF4F6AFE200701|080019FFFF4F6AC0200701|126.3.3.1^2000^MDC|||20070118133700 OBX|1|NM|147842^MDC_ECG_HEART_RATE^MDC|1.6.1.1|80|/min^/min^UCUM|||||R OBX|2|NM|148065^MDC_ECG_V_P_C_CNT^MDC|1.6.1.2|0|/min^/min^UCUM|||||R OBX|3|NM|150035^MDC_PRESS_BLD_ART_MEAN^MDC|1.3.1.1|96|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|4|NM|150033^MDC_PRESS_BLD_ART_SYS^MDC|1.3.1.2|120|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|5|NM|150034^MDC_PRESS_BLD_ART_DIA^MDC|1.3.1.3|80|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|6|NM|149522^MDC_BLD_PULS_RATE_INV^MDC|1.2.1.1|80|/min^/min^UCUM|||||R OBX|7|NM|150047^MDC_PRESS_BLD_ART_PULM_MEAN^MDC|1.4.2.1|15|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|8|NM|150045^MDC_PRESS_BLD_ART_PULM_SYS^MDC|1.4.2.2|24|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|9|NM|150046^MDC_PRESS_BLD_ART_PULM_DIA^MDC|1.4.2.3|10|{mm[Hg]}^{mm[Hg]}^UCUM|||||R OBX|10|NM|150344^MDC_TEMP^MDC|1.10.1.1|26.4|cel^cel^UCUM|||||R OBX|11|NM|150344^MDC_TEMP^MDC|1.10.1.2|37.4|cel^cel^UCUM|||||R OBX|12|NM|151610^MDC_VENT_CO2_RESP_RATE^MDC|1.5.1.1|12|{{breath}/min}^{{breath}/min}UCUM|||||R OBX|13|NM|151804^MDC_PRESS_AWAY_END_EXP_POS^MDC|1.5.1.2|4|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX|14|NM|152008^MDC_VENT_VOL_MINUTE_AWAY^MDC|1.5.1.3|0.0|l/min^l/min^UCUM|||||R OBX|15|NM|151920^MDC_VENT_CONC_AWAY_O2_INSP^MDC|1.5.1.4|21|%^%^UCUM|||||R OBX|16|NM|151980^MDC_VENT_VOL_TIDAL^MDC|1.5.1.5|920|ml^ml^UCUM|||||R OBX|17|NM|151957^MDC_VENT_PRESS_MAX^MDC|1.5.1.6|17|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX|18|NM|151784^MDC_PRESS_RESP_PLAT^MDC|1.5.1.7|31|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX|19|NM|151792^MDC_PRESS_AWAY^MDC|1.5.1.8|36|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX|20|NM|151808^MDC_PRESS_AWAY_END_EXP_POS_INTRINSIC^MDC|1.5.1.9|1|{cm[H20]}^{cm[H20]}^UCUM|||||R OBX-4 ‘Heart Rate’ ‘/min’ UOM

PCD - Published Profiles PIB Profile Patient Identity Binding 20

Patient Identity Binding

Patient Identity Binding DEC-PIB profile… 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) 22

PCD - Published Profiles SPD Profile Subscribe to Patient Data 23

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

DEC - Subscribe to Patient Data

PCD – Rosetta Terminology Mapping RTM Profile Rosetta Terminology Mapping 26

Rosetta for Semantic Interoperability

Rosetta for Semantic Interoperability 28

RTM Cardiovascular (multiple vendors) Group REFERENCE_ID Vendor_ Description CODE Vendor A Vendor B Vendor C CVS_ECG_HR MDC_ECG_CARD_BEAT_RATE Heart Rate  (DBR 326) 16770 HR  MDC_ECG_CARD_BEAT_RATE_BTB Beat-to-Beat Rate 16778 btbHR  MDC_ECG_HEART_RATE Heart Rate  (DBR 2178) MDC_ECG_PACED_BEAT_RATE %PACED  16554 %PACED MDC_ECG_TIME_PD_RR_GL R to R Interval  16168 rr_time  CVS_ECG_QT MDC_ECG_TIME_PD_QT_GL QT interval  16160 QT  MDC_ECG_TIME_PD_QTc QT interval (corrected) 16164 QTc  CVS_ECG_RHY MDC_ECG_ARRHY Arrhythmia  4410 ARR  MDC_ECG_V_P_C_CNT PVC rate. 16993 PVC/min  PVC  CVS_ECG_ST MDC_ECG_AMPL_ST ST generic label  768 ST  MDC_ECG_AMPL_ST_AVF ST lead aVF  832 STaVF  ST-AVF  ST-aVF  MDC_ECG_AMPL_ST_AVL ST lead aVL  831 STaVL  ST-AVL  ST-aVL  MDC_ECG_AMPL_ST_AVR ST lead aVR  830 STaVR ST-AVR ST-aVR

RTM Goals for 2009/10 Expand the number of numeric parameters supported by PCD-01 from 40 today to nearly 300, providing a more comprehensive set. Harmonize the use of existing nomenclature terms defined by ISO/IEEE 11073-10101. Specify the units-of-measure and enumerated values associated with each numeric parameter. Identify and add new nomenclature terms that are currently missing from ISO/IEEE 11073-10101. NOTE: Respiratory / Ventilator terms are a major area. See http://wiki.ihe.net/index.php?title=PCD_RTM_Ventilator

RTM Technical Steps Create the Rosetta Terminology Mapping Table Current draft (1k) has over 930 rows submitted by six vendors. Identify implementation differences and resolve. Resolve differences in interpretation. Pre- or post-coordinated measurement site location(s). Identify missing terms and propose new terms to standards organizations. IHE PCD – need to add 40+ terms to ISO/IEEE 11073. Continua – need to add 100+ terms to ISO/IEEE 11073. Generate final set of terms, units-of-measure and enumerations for testing. Working with NIST for HL7 test and validation tooling Wiki: http://wiki.ihe.net/index.php?title=PCD_Profile_Rosetta_Terminology_Mapping

Alarm Communication Management PCD - New Profiles ACM Profile Alarm Communication Management 32

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) 33

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

What Actor does What? 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 35

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

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

PIV Statement 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. 38

PIV Benefits 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. 39

PIV as part of overall workflow… Nurse Review MAR Entry Pharmacist reviews order detail (Pharmacy System) eMAR updated Medication Dispensed Nurse removes from Dispensing Unit or Med Room Nurse Confirms 5 Rights: Right Patient, Medication, Dose, Time, Route AT THE BEDSIDE Administered Physician reviews data and places Orders eMAR Entry Nurse Confirms 5 Rights

PIV Actors

PCD – 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! 42

IHE PCD Profile: MEM

PCD - Emerging Profiles 44

PCD - Testing Test Tooling Support 45

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 11073 Standard (X73): Medical Device Communication XML Schema: NIST P11073-10202 Domain Information Model Collaborations Integrating Health Enterprise - Patient Care Devices (IHE-PCD) IEEE 11073 Personal Health Devices (PHD) Working Group (WG) ISO/IEEE 11073 WG On-going Work and Future Direction… IHE-PCD profile and message generation and testing (includes enterprise – e.g., HL7 V2 & V3) PHD X73 profile and message testing (Continua) X73 Java Class Library NIST Team Members John Garguilo (john.garguilo@nist.gov 301-975-5248), Sandra Martinez, Maria Cherkaoui (guest researcher), and Richard Theimer (contractor) http://www.nist.gov/medicaldevices In today’s presentation I will provide with an update of the NIST Test tools including the DIM Schema and some open issues related to the DIM.

What is NIST doing? Test Tools! ICSGenerator ValidatePDU 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 Who’s 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 11073 Personal Health Device WG IEEE 11073 WG ICSGenerator To support interoperability of applications and systems, an implementation based on the X73 standard shall provide specific details about the way that the definitions of the standard are applied. These specifications have to be provided in form of a set of implementation conformance statements (ICSs). An ICS is a form of data sheet that discloses details of a specific implementation and specifies which features are provided. Specific applications or functional communication profiles that are based on the X73 standard shall define more specific conformance requirements in addition to or as a replacement of the ICS defined.

Test Tool Support – HL7 v2 48

Test Tool Support – R-T PnP IHE-PCD Point-of-Care, Plug-n-Play, Real-Time Profile Medical Device Profiles and Implementation Conformance Statements (ICS) are generated using ICSGenerator according to X73 Standard Device Profiles are used to configure medical devices (Agent/Manager) which, in turn, exchange X73 data X73 messages are captured and validated against X73 standard and profile (from ICSGenerator) using ValidatePDU

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

Connectathon 2008 – at the Hyatt in Chicago

Connectathon 2008 – signing off!

Connectathon 2008 – everyone passed!

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

PCD at HIMSS 2007 (Cardiac, Bypass) Emergency Care Intensive Care Perioperative Care Philips Intellivue Clinical Information Portfolio LiveData OR-DashBoard GE Centricity® Periop Anesthesia Welch Allyn ConnexTM Data Management System GE Aware Gateway Philips Intellivue Information Center B. Braun DoseTracTM Infusion Management Software Draeger Innovian® Solution Suite Vital Signs Monitor Patient Monitor, Ventilator Patient Monitor, Ventilator Infusion Devices Patient Monitor, Anesthesia Sys

PCD at HIMSS 2008 (Labor, Cardiac)

Hospital Bed, BIS Monitor Hospital Bed, VS Monitor PCD at HIMSS 2009 (infusors, alarms) Enterprise GE Centricity® Enterprise PDQ/PAM Server Time Server Alarm Client Polycom Wireless Phone DOC AC Patient Patient ICU Patient Patient OR Step-Down GE Centricity® Periop Anes. SIS Periop Solution Philips Emergin LiveData Alert Manager DOC DOC AM AM Cerner CareMobileTM Philips IntelliVue Clinical Info Portfolio DOC Draeger Innovian® Web Capsule Cerner CareMobileTM DOC IOP LiveData OR – DashBoardTM DOC AR IOP DOC DOC DOR, AR Can we find a way to spell out VSM, CIS, GW, perhaps as a footnote? Make orange and type larger, perhaps making the blocks a little smaller. Need to show the VSM is in the ER and not ICU Two of the logos will be HIMSS and IHE DOR, AR Infusion Devices B. Braun Hospira Cardinal DOR, AR Infusion Devices IOC B. Braun Hospira Cardinal Hospital Bed, BIS Monitor Capsule DataCaptor DOR, AR Patient Monitor, Ventilator DOR GE Aware Gateway DOR, AR Infusion Devices IOC B. Braun Hospira Cardinal DOR, AR Hospital Bed, VS Monitor Cerner CareAwareTM Patient Monitor DOR, AR Philips IntelliVue Info. Center DOR, AR Capsule Draeger Infinity Gateway Patient Monitor, Anesthesia Sys DOR = Device Observation Reporter IOP = Infusion Order Programmer DOC = Device Observation Consumer IOC = Infusion Order Consumer AR = Alarm Reporter / AM = Alarm Manager 57

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

PCD at HIMSS 2008 Showcase 59

HIMSS Showcase 2008 – ER & OR 60

HIMSS Showcase 2008 – ICU 61

PCD Resources and Contacts 62

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

PCD Profile Development 2009 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 Handbook What is and is not specified in PCD Profiles How to assess PCD profile support System verification & validation testing considerations

Why use IHE PCD profiles? PCD profiles will enable… 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 Contacts http://www.IHE.net/pcd PCD CoChairs: Todd Cooper t.cooper@ieee.org Ken Fuchs ken.fuchs@draeger.com Ray Zambuto ray.zambuto@techmed.lincfs.com PCD Technical Project Manager: Manny Furst efurst@imp-tech.com IHE (International) Strategic Development Committee Co-Chair: Elliot Sloane ebsloane@villanova.edu Rosetta Terminology Mapping Working Group Co-Chair: Paul Schluter Paul.Schluter@med.ge.com http://www.IHE.net/pcd

Q & A Questions? 67