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CEN/ISO/IEEE 11073 Standards: Overview of Point-of-Care Device Communication

This article provides an overview of the CEN/ISO/IEEE 11073 Standards for point-of-care device communication, discussing the requirements, interoperability, history, and content standards. It highlights the need for standardization in point-of-care communication and explores the benefits and challenges of implementing these standards. The article also discusses the architecture, context, and structure of the standards.

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CEN/ISO/IEEE 11073 Standards: Overview of Point-of-Care Device Communication

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  1. CEN/ISO/IEEE 11073 Standards for point-of-care device communication: Overview SCATA, London, 5th May, 2005 Melvin Reynolds, AMS Consulting, Ross-on-Wye, UKChair CEN TC251 WGIV Health informatics – Technologies for interoperability, Chair ISO TC215 WG2 Health informatics – Messages and communications; Past-chair ISO TC215 WG2.1 Health informatics – Device communications, Co-chair IEEE1073 Medical device communications. with thanks to: Thomas Norgall, Fraunhofer Institute, Erlangen, andTodd Cooper, Breakthrough Solutions, San Diego

  2. CEN/ISO/IEEE 11073 Standards Overview • Requirements • Interoperability • History • The (content) standards • Conclusions • Discussion

  3. CEN/ISO/IEEE 11073 Standards Point-of-care: the need About 20% of an ICU nurse’s time can be redeployed if charting is automated, eliminating transcription error & false recording; as well a providing more rapid feedback. Different benefits apply in other care situations.

  4. Data Processing System / PDMS CEN/ISO/IEEE 11073 Standards Point-of-care: all change Fixed configuration, e.g. anaesthesia Syringe Pumps and Infusors Patient Monitor Respirator Additional Pump – but changing periodically, and evolving over time Additional Monitor

  5. CEN/ISO/IEEE 11073 Standards Point-of-care: all change Variable configuration, e.g. intensive care Data Processing System / PDMS Many Syringe Pumps and Infusors Respirator Patient Monitor - changing frequently and within minutes

  6. CEN/ISO/IEEE 11073 Standards Interoperability Interoperability: ability of two or more systems or components to exchange information and to use the information that has been exchanged source: IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries, IEEE, 1990 Functional interoperability: Shared Architectures, Methods & Frameworks Semantic interoperability: Shared Data types, Terminologies, Codings

  7. CEN/ISO/IEEE 11073 Standards Interoperability Point-of-care medical device communication (IEEE1073) Charter: • Provide real-time plug-and-play interoperability for patient-connected medical devices • Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-of-care, in all health care environments … Leveraging off-the-shelf technologies, scaling across a wide range of system complexities, and supporting commercially viable implementations.

  8. CEN/ISO/IEEE 11073 Standards Context Health informatics: Generally interpreted as being in ISO/OSI Level 7 Medical device communication: Works at all ISO/OSI Levels, Directly in ISO/OSI Levels 7 – 5 In Levels 1 – 4, chiefly by reference to other standards (such as IrDA or 802.11)

  9. CEN/ISO/IEEE 11073 Standards Architecture Requirements: • True interoperability across all 7-layers - from the ‘connector’ to the end application • Mechanisms to support the strong quality of service requirements placed on regulated medical devices • Maintainability as communications technology and applications change

  10. CEN/ISO/IEEE 11073 Standards Series title (National, e.g. BS) EN ISO/IEEE 11073-xyyzz Health informatics - Point-of-care medical device communication - x partition (general): yy subsection (group) - zz detail (specialised)

  11. Data & Information Definitions 11073.1xxxx 11073.2xxxx Application Profiles Transport & Physical Layers 11073.3xxxx Internetworking Support 11073.5xxxx Application Gateways 11073.6xxxx Related – some shared concepts 11073.9xxxx CEN/ISO/IEEE 11073 Standards Series structure

  12. CEN/ISO/IEEE 11073 Standards 11073-1xxxx content 11073.1xxxx Data & Information Definitions Semantics needed to communicate a device’sapplication data, status and control information. Three main components: • Nomenclature: 11073.10101 • Domain Information Model (DIM): 11073.10201 • Device Specialisations: 11073.103xx

  13. CEN/ISO/IEEE 11073 Standards 11073-10101 content Nomenclature: A set of numeric codes that identify every item that is communicated between systems.

  14. CEN/ISO/IEEE 11073 Standards 11073-10201 content Domain Information Model: An object oriented data model that specifies objects, attributes, attribute groups, event reports, and services that may be used to communicate device data and to control / configure the reporting of information . . . • Medical Devices and Functionalities • Measured Data and Settings • Alert Information • Remote Control • Patient Information • Communication

  15. CEN/ISO/IEEE 11073 Standards Domain Information Model

  16. ‘On-the-Wire’ Format Abstract Syntax (ASN.1) Transfer Syntax (MDER) CEN/ISO/IEEE 11073 Standards Development Process Domain Information Model

  17. CEN/ISO/IEEE 11073 Standards 11073-6xxxx content 11073.6xxxx Application Gateways Objectives: Interoperability between different application-layer protocols + Bi-directional transparency 11073 11073.3xxxx 11073.3 /.5xxxx System non-VITAL 11073.6xxxx Gateway Application (Agent/ Transport Transport Manager) Example: HL7 / 11073 Gateway: 11073.60101 HL7 - Observation Reporting Interface

  18. CEN/ISO/IEEE 11073 Standards 11073-60101 content HL7 - Observation Reporting Interface Objective: To ensure that … information … from devices using … 11073 standards is conveyed with appropriate … identification of source device system, medical device, channel and metric (… with required annotation …). For traceability, and to enable safe computation from data, the 11073… nomenclature is retained … payload of the HL7 message/document that carries the information to the target information system.

  19. CEN/ISO/IEEE 11073 Standards 11073-60101 HL7 ORI Example HL7 v2.6 message:MSH|||^~\&|Vendor_name||NUR||200312021203||ORU^R01|02110212073000458038 |P|2.3| ||||||PID|||999-99-9999 ||Smith^John^L |||||||||||||999-99-9999 ||||||||||||PV1|||CU1^^BED1||||^^^|||||||||||||||||||||||||||||||||||||||||||||OBR|||||||20031202120235|||||||||||||||||||||||||||||||||||||OBX||SN|147842^MDC_ECG_HEART_RATE^MDC^^HR^local||=^83|264864^MDC_DIM_BEAT_PER_MIN^MDC^^beat/min^local|||||R|||20031202120235|||OBX||SN|134276^MDC_EVT_ECG_V_P_C^MDC^^PVC rate^local||=^0|264864^MDC_DIM_BEAT_PER_MIN^MDC^^beat/min^local|||||R|||20031202120235|||OBX||SN|131841^MDC_ECG_AMPL_ST_LEAD_I^MDC^^ST elev lead I^local||=^0.01|266418^MDC_DIM_X_VOLT^MDC^^mV^local|||||R|||20031202120235|||OBX||SN|131842^MDC_ECG_AMPL_ST LEAD_II^MDC^^ST elev lead II^local||=^0.01|266418^MDC_DIM_X_VOLT^MDC^^mV^local|||||R|||20031202120235|||OBX||SN|131901^MDC_ECG_AMPL_ST_LEAD_III^MDC^^ST elev lead III^local||=^0.01|266418^MDC_DIM_X_VOLT^MDC^^mV^local|||||R|||20031202120235|||OBX||SN|150324^MDC_SAT_O2_ART^MDC^^SPO2^local||=^97|262688^MDC_DIM_PERCENT^MDC^^%sat^local|||||R|||20031202120235|||||460230^MDC_UPEXT_FINGER^MDC^Finger NOS^local^^1OBX||SN|149538^MDC_PLETH_PULS_RATE^MDC^^Pulse rate^local||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^Pulse/min^local|||||R|||20031202120235|||||460230^MDC_UPEXT_FINGER^MDC^Finger NOS^local^^1OBX||ST|150302^MDC_PRESS_CUFF_DIA^MDC^^NIBPdia^local||=^80|266016^MDC_DIM_MMHG^MDC^^mmHg^local|||||R|||20031202120030|||||458572^MDC_UPEXT_ARM_UPPER^MDC^Upper arm^local^^1OBX||ST|150303^MDC_PRESS_CUFF_MEAN^MDC^^NIBP mean^local||=^93|266016^MDC_DIM_MMHG^MDC^^mmHg^local|||||R|||20031202120030|||||458572^MDC_UPEXT_ARM_UPPER^MDC^Upper arm^local^^1OBX||ST|150301^MDC_PRESS_CUFF_SYS^MDC^^NIBP sys^local||=^120|266016^MDC_DIM_MMHG^MDC^^mmHg^local|||||R|||20031202120030|||||458572^MDC_UPEXT_ARM_UPPER^MDC^Upper arm^local^^1OBX||ST|149546^MDC_PULS_RATE_NON_INV^MDC^^Pulse rate^local||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^Pulse/min^local|||||R|||20031202120030|||||458572^MDC_UPEXT_ARM_UPPER^MDC^Upper arm^local^^1

  20. CEN/ISO/IEEE 11073 Standards 11073-60101 HL7 ORI Example HL7 v2.6 message 11073 payload: OBX||SN|147842^MDC_ECG_HEART_RATE^MDC^^HR^local||=^83|264864^MDC_DIM_BEAT_PER_MIN^MDC^^beat/min^local|||||R|||20031202120235|||||OBX||SN|134276^MDC_EVT_ECG_V_P_C^MDC^^PVC rate^local||=^0| 264864^MDC_DIM_BEAT_PER_MIN^MDC^^beat/min^local|||||R|||20031202120235|||||OBX||SN|131841^MDC_ECG_AMPL_ST_LEAD_I^MDC^^ST elev lead I^local||=^0.01|266418^MDC_DIM_X_VOLT^MDC^^mV^local|||||R|||20031202120235|||||… OBX||SN|150324^MDC_SAT_O2_ART^MDC^^SPO2^local||=^97| 262688^MDC_DIM_PERCENT^MDC ^^%sat^local|||||R|||20031202120235|||||460230^MDC_UPEXT_FINGER^MDC^Finger NOS^local^^1OBX||SN|149538^MDC_PLETH_PULS_RATE^MDC^^Pulse rate^local||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^Pulse/min^local|||||R|||20031202120235|||| |460230^MDC_UPEXT_FINGER^MDC^Finger NOS^local^^1… OBX||ST|150301^MDC_PRESS_CUFF_SYS^MDC^^NIBP sys^local||=^120|266016^MDC_DIM_MMHG^MDC^^mmHg^local|||||R|||20031202120030|||||458572^MDC_UPEXT_ARM_UPPER^MDC^Upper arm^local^^1OBX||ST|149546^MDC_PULS_RATE_NON_INV^MDC^^Pulse rate^local||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^Pulse/min^local|||||R|||20031202120030|||| |458572^MDC_UPEXT_ARM_UPPER^MDC^Upper arm^local^^1

  21. CEN/ISO/IEEE 11073 Standards Conclusions • 11073 is a comprehensive system of point-of-care medical device communication standards • 11073 device types range from real-time-operating medical equipment to point-of-care test • 11073 supports wired, wireless IR (and hopefully future wireless RF) network technologies • 11073 provides plug-and-play, internetworking and application gateway capabilities

  22. CEN/ISO/IEEE 11073 Standards Conclusions • 11073 is used to a greater or lesser extent by the biggest companies in the business – often not declared! • 11073 provides an open way of accessing: device networks data for real time decision support • 11073 is being requested by health care providers & management organisations, e.g NHS NPfIT, US DHHS, as they seek point-of-care to record transparency of information

  23. CEN/ISO/IEEE 11073 Standards Contact details Thank you for your attention. Melvin ReynoldsAMS Consulting Ashcote, Walford Road, Ross-on-Wye, HR9 5PQ, UKmelvinr@ams-consulting.co.ukwww.ieee1073.org

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