patient care devices presentation for the clinical engineering association of illinois april 25,...
TRANSCRIPT
Patient Care Devicespresentation for thepresentation for the
Clinical Engineering Association of IllinoisClinical Engineering Association of Illinois
April 25, 2009April 25, 2009
Paul Schluter, Ph.D.Paul Schluter, Ph.D. GE Healthcare (Milwaukee, WI)GE Healthcare (Milwaukee, WI)IHE Patient Care Devices DomainIHE 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
What is IHE?
IHEIHEIntegrating the Healthcare EnterpriseIntegrating the Healthcare Enterprise
In a nutshell:– IHE identifies real-world interoperability problems– Brings people together to design, test and demonstrate
solutions using existing standards.
IHE International
IHE International is …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.
IHE International
PCD Domain Overview
IHE PCD DomainIHE PCD Domain
Patient Care DevicesPatient Care Devices
PCD Domain Overview
A Brief History of PCDA 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 CharterIHE PCD Charter
The Patient Care Devices Domain is concerned with Use Cases in which at least one actor is a regulated patient care regulated patient care devicedevice. The PCD coordinates with other IHE clinical specialty based domains such as cardiology, pharmacy, laboratory and medical imaging.
PCD Domain Overview
IHE PCD MissionIHE PCD Mission
The IHE Patient Care Devices Domain will apply the proven, use case drivenuse case driven IHE processes to:
– DeliverDeliver the technical frameworktechnical framework for the IHE-PCD domain profiles;
– ValidateValidate IHE-PCD profile implementations via ConnectathonsConnectathons; and
– Demonstrate Demonstrate marketable solutions at public trade public trade showsshows.
PCD Domain Overview
• 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
PCD Profile Value Objectives:PCD Profile Value Objectives:
IHE PCD Profiles and Objectives
PCD Technical Frameworks for 2007/2008PCD 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 2008/2009PCD Technical Frameworks for 2008/2009• Rosetta Terminology Management Project (RTM)• Alarm Communication Management (ACM)• Infusion Pump Integration - Drug Administration (PIV)
Key Objectives 2009 and beyondKey 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 ProfileDEC Profile
Device to Enterprise CommunicationDevice to Enterprise Communication
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.
Mapping preserves measurement context
Medical Device System (MDS)
Virtual Medical Device (VMD)
Channel (Chan)
Numeric
Enumeration
1
*
1
*
1
*
1
0..*
Metric
Example PCD-01 Message
MSH|^~\&|HL7^080019FFFF4F6AC0^EUI-64|MMS|||20070118133700||ORU^R01|a4e2e3:11036b5cdbb:-|P|2.5|20070118133700||NE|AL||8859/1PID|||GE101^^^DefaultDomai||JACKSON^IRWIN^^^^^LPV1||E|3WICU^305^305OBR|1|080019FFFF4F6AFE200701|080019FFFF4F6AC0200701|126.3.3.1^2000^MDC|||20070118133700OBX|1|NM|147842^MDC_ECG_HEART_RATE^MDC|1.6.1.1|80|/min^/min^UCUM|||||ROBX|2|NM|148065^MDC_ECG_V_P_C_CNT^MDC|1.6.1.2|0|/min^/min^UCUM|||||ROBX|3|NM|150035^MDC_PRESS_BLD_ART_MEAN^MDC|1.3.1.1|96|{mm[Hg]}^{mm[Hg]}^UCUM|||||ROBX|4|NM|150033^MDC_PRESS_BLD_ART_SYS^MDC|1.3.1.2|120|{mm[Hg]}^{mm[Hg]}^UCUM|||||ROBX|5|NM|150034^MDC_PRESS_BLD_ART_DIA^MDC|1.3.1.3|80|{mm[Hg]}^{mm[Hg]}^UCUM|||||ROBX|6|NM|149522^MDC_BLD_PULS_RATE_INV^MDC|1.2.1.1|80|/min^/min^UCUM|||||ROBX|7|NM|150047^MDC_PRESS_BLD_ART_PULM_MEAN^MDC|1.4.2.1|15|{mm[Hg]}^{mm[Hg]}^UCUM|||||ROBX|8|NM|150045^MDC_PRESS_BLD_ART_PULM_SYS^MDC|1.4.2.2|24|{mm[Hg]}^{mm[Hg]}^UCUM|||||ROBX|9|NM|150046^MDC_PRESS_BLD_ART_PULM_DIA^MDC|1.4.2.3|10|{mm[Hg]}^{mm[Hg]}^UCUM|||||ROBX|10|NM|150344^MDC_TEMP^MDC|1.10.1.1|26.4|cel^cel^UCUM|||||ROBX|11|NM|150344^MDC_TEMP^MDC|1.10.1.2|37.4|cel^cel^UCUM|||||ROBX|12|NM|151610^MDC_VENT_CO2_RESP_RATE^MDC|1.5.1.1|12|{{breath}/min}^{{breath}/min}UCUM|||||ROBX|13|NM|151804^MDC_PRESS_AWAY_END_EXP_POS^MDC|1.5.1.2|4|{cm[H20]}^{cm[H20]}^UCUM|||||ROBX|14|NM|152008^MDC_VENT_VOL_MINUTE_AWAY^MDC|1.5.1.3|0.0|l/min^l/min^UCUM|||||ROBX|15|NM|151920^MDC_VENT_CONC_AWAY_O2_INSP^MDC|1.5.1.4|21|%^%^UCUM|||||ROBX|16|NM|151980^MDC_VENT_VOL_TIDAL^MDC|1.5.1.5|920|ml^ml^UCUM|||||ROBX|17|NM|151957^MDC_VENT_PRESS_MAX^MDC|1.5.1.6|17|{cm[H20]}^{cm[H20]}^UCUM|||||ROBX|18|NM|151784^MDC_PRESS_RESP_PLAT^MDC|1.5.1.7|31|{cm[H20]}^{cm[H20]}^UCUM|||||ROBX|19|NM|151792^MDC_PRESS_AWAY^MDC|1.5.1.8|36|{cm[H20]}^{cm[H20]}^UCUM|||||ROBX|20|NM|151808^MDC_PRESS_AWAY_END_EXP_POS_INTRINSIC^MDC|1.5.1.9|1|{cm[H20]}^{cm[H20]}^UCUM|||||R
‘Heart Rate’ ‘/min’ UOM
IEEE EUI-64
OBX-4
PCD - Published Profiles
PIB ProfilePIB Profile
Patient Identity BindingPatient Identity Binding
Patient Identity Binding
Patient Identity Binding
• 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)
DEC-PIB profile…DEC-PIB profile…
PCD - Published Profiles
SPD ProfileSPD Profile
Subscribe to Patient DataSubscribe to Patient Data
Note: SPD is a DEC Profile option.
DEC - Subscribe to Patient Data
DEC - Subscribe to Patient Data
PCD – Rosetta Terminology Mapping
RTM ProfileRTM Profile
Rosetta Terminology MappingRosetta Terminology Mapping
Rosetta for Semantic Interoperability
Rosetta for Semantic Interoperability
Migrating Toward True PCD Semantic Interoperability
Today HIMSS ’09!
ISO/IEEE 11073Semantic Standards
Vendor Semantics
IHE PCD TF Content
Vendor A
Vendor C
Vendor B
RosettaMappingTables(RTM)
11073PnP Comm
HL7 v3CDA/CCD
HL7 v2Messages
RTM Cardiovascular (multiple vendors)
Group REFERENCE_ID Vendor_Description
CODEVendor
A Vendor
BVendor
C
CVS_ECG_HR MDC_ECG_CARD_BEAT_RATE Heart Rate (DBR 326) 16770 HR HR HR
CVS_ECG_HR MDC_ECG_CARD_BEAT_RATE_BTB Beat-to-Beat Rate 16778 btbHR
CVS_ECG_HR MDC_ECG_HEART_RATE Heart Rate (DBR 2178) 16770 HR HR HR
CVS_ECG_HR MDC_ECG_PACED_BEAT_RATE %PACED 16554 %PACED
CVS_ECG_HR MDC_ECG_TIME_PD_RR_GL R to R Interval 16168 rr_time rr_time rr_time
CVS_ECG_QT MDC_ECG_TIME_PD_QT_GL QT interval 16160 QT
CVS_ECG_QT MDC_ECG_TIME_PD_QTc QT interval (corrected) 16164 QTc
CVS_ECG_RHY MDC_ECG_ARRHY Arrhythmia 4410 ARR
CVS_ECG_RHY MDC_ECG_V_P_C_CNT PVC rate. 16993 PVC/min PVC PVC
CVS_ECG_ST MDC_ECG_AMPL_ST ST generic label 768 ST ST
CVS_ECG_ST MDC_ECG_AMPL_ST_AVF ST lead aVF 832 STaVF ST-AVF ST-aVF
CVS_ECG_ST MDC_ECG_AMPL_ST_AVL ST lead aVL 831 STaVL ST-AVL ST-aVL
CVS_ECG_ST MDC_ECG_AMPL_ST_AVR ST lead aVR 830 STaVR ST-AVR ST-aVR
RTM Goals for 2009/10
• ExpandExpand the number of numeric parameters supported by PCD-01 from 40 today to nearly 300, providing a more comprehensive set.
• HarmonizeHarmonize the use of existing nomenclature terms defined by ISO/IEEE 11073-10101.
• Specify the units-of-measureunits-of-measure and enumerated enumerated valuesvalues associated with each numeric parameter.
• Identify and add new nomenclature termsIdentify 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_Ventilatorhttp://wiki.ihe.net/index.php?title=PCD_RTM_Ventilator
PCD - New Profiles
ACM ProfileACM Profile
Alarm Communication ManagementAlarm Communication Management
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)
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)
AlarmSource
AlarmAggregator
AlarmReceiver
AlarmCoordinator
AlarmDisseminator
AlarmCommunication
AlarmEndpoint
AlarmCommunication
(AC)
AlarmCommunication
(AC)
AlarmManagement
(AM)
AlarmManagement
(AM)
AlarmReporter
(AR)
AlarmReporter
(AR)
AlarmReporter
AlarmCache
Alarm
Query
(AQAQ)
Alarm
Query
(AQAQ)
Communication detailed in ACM profileCommunication detailed in ACM profile
Communication not detailed in ACM profileCommunication not detailed in ACM profile
.
.
.
.
.
.......
PCD Inputs(PM, NC, Resp,
Pump, etc.)
PCD Inputs(PM, NC, Resp,
Pump, etc.)
Output Devices(Marquee Sign, Pager,
Wi-Fi Phone or Badge, etc.)
Output Devices(Marquee Sign, Pager,
Wi-Fi Phone or Badge, etc.)
HIS, EMRHIS, EMROptionalOptional
ACM Actors
PCD - New Profiles
PIV ProfilePIV Profile
Point-of-Care Infusion VerificationPoint-of-Care Infusion Verification
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.
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.
PIV Statement
PIV will reduce errorsreduce errors by eliminating keystroke errors and by increasing the use of automaticdosage checking facilitated by onboard drug libraries.
Supports the ‘Five+ Rights’ of Medication Administration:
Right Patient, Drug, Dose, Route, Time and Pump.
PIV will reduce errorsreduce errors by eliminating keystroke errors and by increasing the use of automaticdosage checking facilitated by onboard drug libraries.
Supports the ‘Five+ Rights’ of Medication Administration:
Right Patient, Drug, Dose, Route, Time and Pump.
PIV Benefits
PIV as part of overall workflow…
Nurse
Review
MAR Entry
Pharmacist reviews
order detail
(Pharmacy
System)
eMAR updated
Medication
DispensedNurse removes
Medication
from Dispensing
Unit or Med Room
Nurse Confirms 5
Rights:
Right Patient,
Medication,
Dose, Time, Route
AT THE BEDSIDE
Medication
Administered
Physician reviews
data and places
Orders
Nurse
Review
eMAR Entry
Pharmacist reviews
order detail
(Pharmacy
System)
eMAR updated
Medication
DispensedNurse removes
Medication
from Dispensing
Unit or Med Room
Nurse Confirms 5 Rights
Right Patient,
Medication,Dose, Time, Route
AT THE BEDSIDE
Medication
Administered
Physician reviews
data and places
Orders
PIV Actors
PCD – Emerging Profiles
Emerging ProfilesEmerging 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!
IHE PCD Profile: MEM
DEVICE MANAGEMENT
REPORTER
Patch ManagementPending patchesPatch history
Location ServicesCurrent locationPrevious locations (Trending)Boundary controls (Alarm when
device leaves area)
Device Configuration Management
Recall ManagementUnique device identificationHardware configuration (serial numbers, etc)Software configuration (revision numbers, etc)
Device ReconfigurationUse profiles (NICU vs. CICU)
Operational Status and Monitoring
Is the device currently in useUsage historyAlarms – which are active, what the trigger
levels, how long has the alarm been on
Day/time of last self check and its resultEvent log recordingPreventative Maintanence
Last PMNext scheduled PMLast repair time/date
Battery ManagementOn A/C or D/C? Charge level (% of full)/Est.
operating time left. Charging / Discharging historyBattery type and installation date Est. battery life
IHE
PC
D
Sta
nd
ard
s b
ase
d
Tra
ns
act
ion
s
DEVICE MANAGEMENT
CONSUMER
DPIDECACM
Risk ManagementRisk analysisRisk evaluationVerification of risk control measuresResidual risks
PCD - Testing
Test Tooling SupportTest Tooling Support
Test Tooling Support - NIST
• NIST Test Tools– ICSGeneratorICSGenerator
• Medical Device Profiles (specializations)• Implementation Conformance Statements
– ValidatePDUValidatePDU • X73 Application Layer Message Syntax and Semantic Validation
• NIST Medical Device Standards Work– ISO/IEEE 11073 Standard (X73): Medical Device Communication
• XML SchemaXML 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 & V3HL7 V2 & V3)– PHD X73 profile and message testing (ContinuaContinua)– X73 Java Class LibraryX73 Java Class Library
• NIST Team Members– John Garguilo ([email protected] 301-975-5248), Sandra Martinez,
Maria Cherkaoui (guest researcher), and Richard Theimer (contractor)
http://www.nist.gov/medicaldeviceshttp://www.nist.gov/medicaldevices
PCD - Showcase
ConnectathonConnectathon
Where we prove that it really works !!Where we prove that it really works !!
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 …Now that we have connectivity … … … demonstrate clinical workflows !!demonstrate clinical workflows !!
Welch AllynWelch AllynConnexConnexTMTM
DataDataManagementManagement
SystemSystem
Vital Signs Monitor
GEGE
AwareAwareGatewayGateway
Patient Monitor, Ventilator
PhilipsPhilips
IntellivueIntellivueInformationInformation
CenterCenter
Patient Monitor, Ventilator
Emergency Care Intensive Care
LiveDataLiveData
OR-DashBoardOR-DashBoard
GE GE
CentricityCentricity®®
PeriopPeriopAnesthesiaAnesthesia
DraegerDraeger
InnovianInnovian®®
Solution SuiteSolution Suite
Patient Monitor, Anesthesia Sys
B. BraunB. BraunDoseTracDoseTracTMTM
InfusionInfusionManagementManagement
SoftwareSoftware
InfusionDevices
Perioperative Care
PhilipsPhilips
Intellivue ClinicalIntellivue ClinicalInformationInformation
PortfolioPortfolio
PCD at HIMSS 2007 (Cardiac, Bypass)
PCD at HIMSS 2008 (Labor, Cardiac)
GE GE CentricityCentricity®®
Periop Anes.Periop Anes.
Enterprise
DOC
DOC
Patient Patient
LiveDataLiveDataOR –OR –
DashBoardDashBoardTMTM
DOR = Device Observation Reporter IOP = Infusion Order Programmer
DOC = Device Observation Consumer IOC = Infusion Order Consumer
AR = Alarm Reporter / AM = Alarm Manager
PDQ/PAMServer
PhilipsPhilipsIntelliVueIntelliVue ClinicalClinical
Info PortfolioInfo Portfolio
DOC DOC
DraegerDraegerInnovianInnovian® ® WebWeb
CapsuleCapsule
GE GE CentricityCentricity®®
EnterpriseEnterprise
DOC
LiveData LiveData Alert ManagerAlert Manager
PhilipsPhilipsEmerginEmergin
AM
OR
TimeServer
Step-DownICU
AM
Hospital Bed,BIS Monitor
CapsuleCapsuleDataCaptorDataCaptor
DOR,AR
Patient Monitor
DOR,AR
PhilipsPhilipsIntelliVueIntelliVue
Info. CenterInfo. Center
AR DOR,AR
CernerCerner
CareMobileCareMobileTMTM
DOCIOP
AC
DOR,AR
Hospital Bed,VS Monitor
CernerCerner
CareAwareCareAwareTMTM
DOR,AR
InfusionDevices
IOC
B.
Bra
un
B.
Bra
un
Ho
sp
ira
Ho
sp
ira
Ca
rdin
al
Ca
rdin
al
Patient Monitor,Ventilator
DOR
GEGEAwareAware
GatewayGateway
DOR,AR
InfusionDevices
IOC
B.
Bra
un
B.
Bra
un
Ho
sp
ira
Ho
sp
ira
Ca
rdin
al
Ca
rdin
al
Patient Monitor,Anesthesia Sys
DOR, AR
DraegerDraeger InfinityInfinityGatewayGateway
DOR,AR
InfusionDevices
B.
Bra
un
B.
Bra
un
Ho
sp
ira
Ho
sp
ira
Ca
rdin
al
Ca
rdin
al
Patient Patient
PolycomPolycomWirelessWirelessPhonePhone
AlarmClient
CapsuleCapsule
SISSISPeriopPeriop
SolutionSolutionDOC
CernerCerner
CareMobileCareMobileTMTM
DOCIOP
PCD at HIMSS 2009 (infusors, alarms)
PCD – IHE Showcase at HIMSS
HIMSS ShowcaseHIMSS Showcase
Where we get to show it off !!Where we get to show it off !!
PCD at HIMSS 2008 Showcase
HIMSS Showcase 2008 – ER & OR
HIMSS Showcase 2008 – ICU
PCD Resources …
PCD ResourcesPCD Resourcesand Contactsand Contacts
IHE PCD Profiles and Objectives (Recap)
PCD Technical Frameworks for 2007/2008PCD 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 2008/2009PCD Technical Frameworks for 2008/2009• Rosetta Terminology Management Project (RTM)• Alarm Communication Management (ACM)• Infusion Pump Integration - Drug Administration (PIV)
Key Objectives 2009 and beyondKey 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 Proposals2009 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 HandbookIHE 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?
• 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 profiles will enable…PCD profiles will enable…
PCD Contacts
PCD CoChairs:– Todd Cooper [email protected] – Ken Fuchs [email protected] – Ray Zambuto [email protected]
• PCD Technical Project Manager:– Manny Furst [email protected]
• IHE (International) Strategic Development Committee Co-Chair:– Elliot Sloane [email protected]
• Rosetta Terminology Mapping Working Group Co-Chair:– Paul Schluter [email protected]
http://www.IHE.net/pcd
Q & A
Questions?Questions?
