1. 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

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. 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

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. 4

5. IHE International

6. PCD Domain Overview
IHE PCD Domain
Patient Care Devices 6

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
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
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.

10. 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

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 12

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 11073 Domain Information Model Defines Device Context

18. Mapping preserves measurement context

19. Example PCD-01 Message IEEE EUI-64 OBX-4 ‘Heart Rate’ ‘/min’ UOM
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]}^UCUM|||||R
OBX-4
‘Heart Rate’
‘/min’ UOM

20. PCD - Published Profiles
PIB Profile
Patient Identity Binding 20

21. Patient Identity Binding

22. 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

23. PCD - Published Profiles
SPD Profile
Subscribe to Patient Data 23

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

25. DEC - Subscribe to Patient Data

26. PCD – Rosetta Terminology Mapping
RTM Profile
Rosetta Terminology Mapping 26

27. Rosetta for Semantic Interoperability

28. Rosetta for Semantic Interoperability28

29. 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

30. 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
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
NOTE: Respiratory / Ventilator terms are a major area. See

31. 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
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. Alarm Communication Management
PCD - New Profiles
ACM Profile
Alarm Communication Management 32

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) 33

34. 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

35. 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

36. 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

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

38. 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

39. 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

40. 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

41. PIV Actors

42. 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

43. IHE PCD Profile: MEM

44. PCD - Emerging Profiles44

45. PCD - Testing
Test Tooling Support 45

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 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…
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 ), Sandra Martinez, Maria Cherkaoui (guest researcher), and Richard Theimer (contractor)
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.

47. 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 Personal Health Device WG
IEEE 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.

48. Test Tool Support – HL7 v2 48

49. 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

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

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 !! 54

55. 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

56. PCD at HIMSS 2008 (Labor, Cardiac)

57. Hospital Bed, BIS Monitor Hospital Bed, VS Monitor
PCD at HIMSS (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

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

59. PCD at HIMSS 2008 Showcase 59

60. HIMSS Showcase 2008 – ER & OR 60

61. HIMSS Showcase 2008 – ICU 61

62. PCD Resources and Contacts62

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 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

65. 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)

66. PCD Contacts http://www.IHE.net/pcd PCD CoChairs:
Todd Cooper
Ken Fuchs
Ray Zambuto
PCD Technical Project Manager:
Manny Furst
IHE (International) Strategic Development Committee Co-Chair:
Elliot Sloane
Rosetta Terminology Mapping Working Group Co-Chair:
Paul Schluter

67. Q & A
Questions? 67