1. Patient Care Devices Infusion Pump Modeling Overview 2009.05.19 – San Diego Todd Cooper Breakthrough Solutions Foundry, Inc. Board, IHE International Co-chair, IHE PCD Technical Committee

2. 2 X73 Background… PCD TF: Standards & Profiles 11073-10301 Infusion Pump Specialization MDCIG Demo II Document Whats on?

3. 3 ISO/IEEE 11073 Purpose (classic): Provide real-time plug-and-play interoperability for patient-connected medical devices and Facilitate the efficient exchange of vital signs and medical device data, acquired at or near 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. ISO/IEEE 11073 Background

4. 4 ISO/IEEE 11073 Purpose (2009.04): Standardization in the application of Information and Communications Technologies (ICT) to health device informatics and device interoperability in support of medicine, health care, and wellness. ISO/IEEE 11073 Background

5. 5 Multi-layered Integration Profiles Device Interface Profile Device Semantics & Services Terminology & Data Models Services Events Application Services (security, QoS) Transport Technologies (WiFi … Ethernet, simple serial…Bluetooth…) Device integration involves many levels… Standards-based interoperability profiles must support all levels… From transmitter to abstract semantics!

6. 6 11073-10201 Domain Info Model Object Model One Model – Multiple Packages/ Subject Areas: System Level Medical & Alert Info Patient Info …

7. 7 11073-10201 Domain Info Model Notes: MDS can nest Device Context Mechanical System Architecture

8. 8 11073-10201 Domain Info Model Strict Containment Channels provide primary parameter aggregation Waveforms Persistence - Buffers

9. 9 11073-10201 Domain Info Model Primary Alert Object Used Information reported by Alert Scanner

10. 10 Baxter Colleague (MDCIG II)

11. 11 X73 Background… PCD TF: Standards & Profiles 11073-10301 Infusion Pump Specialization MDCIG Demo II Document Whats on?

12. 12 IHE PCD Profile: DPI Device Point-of-Care Integration Discovery and Association (PnP) Discovery and Association (PnP) Real-Time Data Reporting Real-Time Data Reporting Bi-Directional / Symmetric Bi-Directional / Symmetric External Control External Control Enterprise Integration Semantic Interoperability Monitored Parameters Alarms & Limits Waveforms (Real-Time) Control Parameters Semantic Interoperability Monitored Parameters Alarms & Limits Waveforms (Real-Time) Control Parameters Device Reporting, Management & Control Real-Time Clinical Decision Support Point-of-Care Applications Real-Time Closed / Open Loop Control DPI Manager / Enterprise Gateway

13. 13 Need for Semantic Profiles Migrating Toward True PCD Semantic Interoperability

14. 14 Measurement Context is Dynamic

15. 15 IEEE 11073 Domain Information Model Defines Device Context 1 0..n0..n

16. 16 Mapping preserves measurement context

17. 17 Role of IHE PCD Infusion Pump WG: Extend and develop content for next version of the ISO/IEEE 11073-10301 Infusion Pump Device Specialization standard. ISO/IEEE 11073 & IHE PCD (According to … Todd…!!!)

18. 18 X73 Background… PCD TF: Standards & Profiles 11073-10301 Infusion Pump Specialization MDCIG Demo II Document Whats on?

19. 19 ISO/IEEE 11073-10101 Infusion Pump Device Specialization Standards… Select between multiple general model implementation options Present basic concepts per modality Device Types… Single & Multiple Channels Simple to complex infusion protocols Fixed vs. dynamically configurable

20. 20 ISO/IEEE 11073-10101 Infusion Pump MDSs, VMDs vs. Channels… Mechanical device architecture Mechanical fluid line configurations Infusion protocol complexity management Pre- & Post- Terminology coordination

21. 21 ISO/IEEE 11073-10101 Infusion Pump Unfinished Topics… Terminology & Attribute Gaps Text Labels (externally settable) Infusion Protocol Programs …

22. 22 X73 Background… PCD TF: Standards & Profiles 11073-10301 Infusion Pump Specialization MDCIG Demo II Document Whats on?

23. 23 MDCIG Demo II Document IEEE ISTO MDCIG IEEE Industry Standards & Technology Organization (ISTO) – Medical Device Communications Industry Group (MDCIG) information modeldynamic modelmessage examples Documents pump & vent specializations from information model to dynamic model to message examples NIST X73 Tooling Basis for NIST X73 Tooling

24. 24 Todd Cooper President Breakthrough Solutions Foundry, Inc. San Diego Americas Finest City (e) t.cooper@ieee.org (v) +1 858.435.0729 (s) ToddCooperX73 Q & A

26. 26 Extra Slides

27. 27 IHE PCD 09 ShowcaseGE 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

28. 28 IHE PCD Profile: PIV

29. 29 IHE PCD Profile: DEC w/ SPD

30. 30