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Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America

Patient Care Devices. Overview & Update HIMSS Webinar – 3 August. Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare. IHE Patient Care Devices - Overview and Update. Devices and Interoperability

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Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America

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  1. Patient Care Devices Overview & UpdateHIMSS Webinar – 3 August Todd Cooper, Breakthrough Solutions Foundry Ken Fuchs, Mindray North America Steve Merritt, Baystate Health John Rhoads, Philips Healthcare

  2. IHE Patient Care Devices - Overview and Update • Devices and Interoperability • Medical Devices - Not a Simple Problem!! • IHE PCD – Overview • IHE PCD – Profiles • IHE PCD – Testing and Demonstrations • Getting to Yes!! • Questions & Answers

  3. 2009 – Obama vows to continue the HIT Plan begun by President Bush • President Barack Obama announces an audacious plan: Computerize all health records within five years. - January 12, 2009 • February 17, 2009 – the American Reinvestment and Recovery Act (ARRA) is signed into law • HITECH Act component of ARRA provides a $19 billion program to stimulate the adoption and use of HIT, with a focus on meaningful use of certified EHR-S

  4. What about Device Connectivity? Download HITSP/TN905 @ www.HITSP.org

  5. HITSP/TN905 Roadmap

  6. The Dream! Heterogeneity Multiple manufacturers + multiple device & application modalities coexisting & interoperating over a shared infrastructure Enables… “Best of Breed” Selection Ability to base product acquisition on most appropriate technology without requiring HIT re-engineering. Semantic Comparability Harmonized semantics (terminology & models) enable next generation applications, incl. real-time CDSS. Comprehensive, Real-time Availability Timely health care decisions based on richer, more complete information. Medical Device HIT:No longer a “nice to have”

  7. The Benefits! Integration – Provider value propositions… • Integrity of data – automatic population of all information systems – reducing medical errors • Automated systems saves time for clinicians • Improved agility of enterprises to meet varied patient loads • Improved life-cycle cost of ownership • Automated clinical data capture for EHR • Access to patient data across devices and systems so custom communication interfaces can be eliminated. • Allows for best of breed selection

  8. IHE Patient Care Devices - Overview and Update • Devices and Interoperability • Medical Devices - Not a Simple Problem!! • IHE PCD – Overview • IHE PCD – Profiles • IHE PCD – Testing and Demonstrations • Getting to Yes!! • Questions & Answers

  9. Multiple Care Contexts (Jan Wittenber, Philips Medical, HITSP/TN905)

  10. Device Integration for Multiple Applications (Jan Wittenber, Philips Medical, HITSP/TN905)

  11. Medication Administration It’s not just interfacing the infusion pumps! Many clinical systems must be integrated – from many vendors – using many technologies! (Erin Sparnon, ECRI Institute, IHE-PCD Infusion Pump Summit, 2010.02.16, wiki.ihe.net)

  12. Example: CDSS & Multi Data Sources (John Zaleski, Nuvon, HITSP/TN905)

  13. IHE Patient Care Devices - Overview and Update • Devices and Interoperability • Medical Devices - Not a Simple Problem!! • IHE PCD – Overview • IHE PCD – Profiles • IHE PCD – Testing and Demonstrations • Getting to Yes!! • Questions & Answers

  14. IHE Patient Care Devices IHE-PCD Charter The Patient Care Device Domain is concerned with use cases in which at least one actor is a patient-centric point-of-care medical device. The PCD coordinates with other IHE clinical specialty based domains such as medical imaging and lab to ensure consistency of medical device integration solutions across all IHE technical frameworks. • NOTE: Formed in 2005 & sponsored by HIMSS & ACCE

  15. IHE PCD Overview Information Consumers: (HIS, PhIS, eMAR, EMR) Physiological and Operational Data (PCD) ADT,Orders Technical Framework Physiological and Operational Data (PCD) Physiological and Operational Data (PCD) Server/Gateway ADT, Orders ADT, Orders Information Reporters:Standalone Medical Devices Information Reporters:Medical Devices with Server/Gateway

  16. PCD Domain Overview PCD Profile Primary Objectives: • Heterogeneity – … coexistence in a multi-vendor & multi-modality world, leveraging shared infrastructure • Semantic Interoperability – … from the sensor to the EHR • Real-time Availability – … facilitating more timely clinical decisions Ultimately providing improved – … safety, quality of care & workflow efficiency

  17. Profiles Simplify Development All implementation detail!

  18. IHE PCD Profiles • Current Profiles: • Enterprise sharing of Patient Care Data (DEC) • Subscribe to Patient Data (SPD) • Rosetta Stone Terminology Project (RTM) • PCD Alarm Communication Management (ACM) • Point-of-care Infusion Verification (PIV) • Work in Process: • Device Point-of-care Integration (DPI) • Waveform Communication Management (WCM) • Event Communication (EVT) • Medical Equipment Management (MEM) • Patient – Device Association (PDA) • Initial device classes… vital signs / physiological monitors, infusion pumpsandventilators

  19. IHE PCD – Profile Overview Physiologic Monitoring System CPOE/ Pharmacy System Clinical Decision Support System Ventilation/AnesthesiaSystem ACM, DEC, WCM ACM, DEC, WCM ACM, DEC, WCM Barcode Medication Administration System EMR/EHR Infusion Pump Implantable Device ACM, DEC PIV IDCO CIS ACM, MEM DEC ACM, DEC, WCM EquipmentManagement System Home Based System Other Devices ACM: Alarm Communication Management DEC: Device Enterprise Communication IDCO: Implantable Device – Cardiac – Observation MEM: Medical Equipment Management PIV: Point-of-Care Infusion Verification WCM: Waveform Communication Management CurrentPCD FuturePCD Future Non- PCD

  20. IHE Patient Care Devices • 2009 White Paper Proposals • Device Point-of-care Integration (DPI) • Medical Equipment Management (MEM) – Complete! • Medical Device Semantic Architecture • Regulatory Considerations in Deploying Systems Incorporating IHE PCD Profiles • IHE PCD Users Handbook • What is & is not specified in PCD Profiles • How to assess PCD profile support • System verification & validation testing considerations

  21. IHE Patient Care Devices - Overview and Update • Devices and Interoperability • Medical Devices - Not a Simple Problem!! • IHE PCD – Overview • IHE PCD – Profiles • IHE PCD – Testing and Demonstrations • Getting to Yes!! • Questions & Answers

  22. PCD Published Profiles DEC Profile Device to Enterprise Communication Trial Implementation

  23. DEC Profiles • PCD DEC profile supports the communication of patient clinical data from devices. • This data can include: • Vital Signs (profile available) • Alarm information (2008/2009 profile) • Waveform information (emerging profile) • Device configuration information (MEM) • Etc.

  24. Device to Enterprise Comm. (DEC) The Device to Enterprise Communication (DEC) profile allows a consuming device to receive patient clinical information including vitals, settings, demographics and location from a reporting device.

  25. PCD-01 Message Example MSH|^~\&|INFO_SRC_PHILIPS^ACDE48234567ABCD^EUI-64||||20061215153500||ORU^R01^ORU_R01|PMS116621490051| P|2.5|||NE|AL||8859/1 PID|||AB60001^^^Philips Medical^PI||Brooks^Albert^^^^^L||19610101|M PV1||I|UNIT_1^^Bed1 OBR|1|PMS116621490051^INFO_SRC_PHILIPS^ACDE48234567ABCD^EUI-64| PMS116621490051^INFO_SRC_PHILIPS^ACDE48234567ABCD^EUI-64| 69837^MDC_DEV_METER_PHYSIO_MULTI_PARAM_MDS^MDC|||20061215153500 OBX|1|ST|184326^MDC_ECG_STAT_ECT^MDC|1.5130.1.184326|""||||||F OBX|2|ST|184327^MDC_ECG_STAT_RHY^MDC|1.5130.1.184327|Sinus Rhythm||||||F OBX|3|NM|150456^MDC_PULS_OXIM_SAT_O2^MDC|1.5238.1.150456|99|262688^MDC_DIM_PERCENT^MDC|||||F OBX|4|NM|147842^MDC_ECG_HEART_RATE^MDC|1.5130.1.147842|81|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|5|NM|150037^MDC_PRESS_BLD_ART_ABP_SYS^MDC|1.5190.1.150036|126|266016^MDC_DIM_MMHG^MDC|||||F OBX|6|NM|150038^MDC_PRESS_BLD_ART_ABP_DIA^MDC|1.5190.1.150036|76|266016^MDC_DIM_MMHG^MDC|||||F OBX|7|NM|150039^MDC_PRESS_BLD_ART_ABP_MEAN^MDC|1.5190.1.150036|92|266016^MDC_DIM_MMHG^MDC|||||F OBX|8|NM|148065^MDC_ECG_V_P_C_CNT^MDC|1.5130.1.148065|0|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|9|NM|150045^MDC_PRESS_BLD_ART_PULM_SYS^MDC|1.5190.1.150044|26|266016^MDC_DIM_MMHG^MDC|||||F OBX|10|NM|150046^MDC_PRESS_BLD_ART_PULM_DIA^MDC|1.5190.1.150044|9|266016^MDC_DIM_MMHG^MDC|||||F OBX|11|NM|150047^MDC_PRESS_BLD_ART_PULM_MEAN^MDC|1.5190.1.150044|14|266016^MDC_DIM_MMHG^MDC|||||F OBX|12|NM|149538^MDC_PLETH_PULS_RATE^MDC|1.5238.1.149538|55|264864^MDC_DIM_BEAT_PER_MIN^MDC|||||F OBX|13|NM|150067^MDC_PRESS_BLD_ATR_LEFT_MEAN^MDC|1.5190.1.150064|4|266016^MDC_DIM_MMHG^MDC|||||F OBX|14|NM|150087^MDC_PRESS_BLD_VEN_CENT_MEAN^MDC|1.5190.1.150084|12|266016^MDC_DIM_MMHG^MDC|||||F Note: Extensive message examples on the PCD FTP Site: ftp://ftp.ihe.net/Patient_Care_Devices/ConnectathonsIncludingProcessAndTesting

  26. Subscribe to Patient Data (SPD)

  27. PCD Published Profiles ACM Profile Alarm Communication Management Trial Implementation

  28. Alarm Communication Management (ACM) 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)

  29. ACM Data Flows 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 *Disseminate Alarm Report Alarm  Dissemination Status* Alarm Source Alarm Aggregator Alarm Receiver Alarm Coordinator Alarm Disseminator Alarm Communication Alarm Endpoint Alarm Status* Subscribe to Alarm* Alarm Reporter . . . . . . Gap! Alarm Cache Report Alarm Subscribe to Alarm * Communication detailed in ACM profile Alarm Archiver AA HIS, EMR Communication not detailed in ACM profile *Note: Implementation TBD

  30. ACM Status Update • Fill Gap: Alarm Manager (AM) to Alarm Communicator (AC) • Define alarm identifier codes (RTM for alarms) • Extend implementation of actors & transactions • Expand to additional IHE domains

  31. PCD Published Profiles PIV Profile Point-of-Care Infusion Verification Trial Implementation

  32. PIV Objective 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.

  33. PIV Workflow Context This is the focus of PIV … only! Nurse Nurse Pharmacist reviews Pharmacist reviews Review Review order detail order detail (Pharmacy (Pharmacy eMAR Entry System) System) Physician reviews Physician reviews eMAR updated eMAR updated data and places data and places Orders Orders Nurse Confirms 5 Nurse Confirms 5 Rights: Rights: Right Patient, Right Patient, Medication, Medication, Medication Medication Medication Medication Nurse removes Nurse removes Dose, Time, Route Dose, Time, Route Dispensed Dispensed Administered Administered Medication Medication AT THE BEDSIDE AT THE BEDSIDE from Dispensing from Dispensing Unit or Med Room Unit or Med Room

  34. PIV Actors & Data Flows DEC!

  35. PCD Published Profiles IDCO Profile Implantable Device – Cardiac – Observation Trial Implementation

  36. IDCO Objective • IDCO specifies the creation, transmission, and processing of discrete data elements and report attachments associated with implantable cardiac device interrogations (observations) or messages.

  37. Implantable Cardiac Devices Implantable Cardiac Device Leads for Sensing or Delivering Electrical Therapy

  38. IDCO Profile Context • Device is interrogated via inductive or wireless telemetry in clinic or home environment using vendor proprietary equipment • Information is transferred to clinic system as structured HL7 v2.6 ORU message using IEEE 11073 IDC nomenclature [PCD-09]

  39. PCD Published Profiles RTM Profile Rosetta Terminology Mapping Trial Implementation

  40. Rosetta for Semantic Interoperability

  41. Rosetta for Semantic Interoperability ISO/IEEE 11073Semantic Standards VendorTerms RTM 1400 rows HarmonizedTerms hRTM 440 terms VendorSemantics IHE PCD Technical Framework Content HL7 V2 Messages Vendor A HL7 V3 CDA/CCD Vendor B 11073PnP Comm Vendor C • Open consensus process • Observation identifiers and co-constraints • New terms incorporated into standards • hRTM used for conformance testing

  42. Harmonized Rosetta (hRTM) Specifies for each IEEE 11073 REFID observation identifier: • the 11073 MDC and UCUM units-of-measure • includes dimensional analysis to ensure correct ‘units-math’ • enumerated values and measurement sites • numericcodes, where appropriate An extract from the hRTM is shown below: http://wiki.ihe.net/index.php?title=PCD_Profile_Rosetta_Terminology_Mapping

  43. RTM & hRTM Highlights • Unified semantics and semantic model are essential prerequisites for safe and effective interoperability between devices and systems. • The hRTM rigorously defineswhat may be sent and informs recipients of what they may expect to receive. For each observation identifier, the hRTM specifies the units-of-measure, enumerated values, measurement sites and other co-constraints. • The hRTM is based on the ISO/IEEE 11073 standards and leverages and extends that work by using an open consensus process. • The hRTM is publicly available for IHE PCD clinical devices and will be available shortly for IEEE 11073 personal health devices. • The hRTM supports message conformance testing frameworks that can be used for both clinical and personalhealth devices.

  44. PCD Emerging Profiles Emerging Profiles • Waveform Communication Management (WCM) • Medical Equipment Management (MEM) • Event Communication • Device Point-of-Care Integration (DPI) • Real Time Location Tracking • Real-time data archiving and communication • Mobile, enterprise-wide, reliable vital signs monitoring • … many more!

  45. PCD Emerging Profiles Device Point-of-Care Integration [DPI]

  46. Device Point-of-Care Integration • DPI: Scope – Device Point-of-care Integration (DPI) is concerned with use cases that include care contexts that fall within the stated charter of the IHE PCD, namely where "at leastone actor is a regulated patient centric point-of-care medical device," and that requiredevice-to-device communication.

  47. Device Point-of-Care Integration Enterprise Integration Real-Time Clinical Decision Support Point-of-Care Applications Real-Time Closed / Open Loop Control Device Point-of-Care Integration • Discovery and Association (PnP) • Real-Time Data Reporting • Bi-Directional / Symmetric • External Control Device Reporting, Management & Control Semantic Interoperability Monitored Parameters Alarms & Limits Waveforms (Real-Time) Control Parameters DPI Manager / Enterprise Gateway

  48. PCD Emerging Profiles Medical Equipment Management [MEM] Imagine … What if I.T. & device vendors gave me EVERYTHING I ever wanted?!

  49. MEM (Medical Equipment Management)

  50. MEM Status • 2009 – White Paper • Ongoing work • Cycle 5 Brief Profile Proposal • Real Time Location Tracking • Location Boundary Alarms • Battery Management • Semantic Content Requirements

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