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Medical Device IntegrationMedical Device Integration
Steve MerrittInfrastructure Engineer
Baystate Health
Steve MerrittInfrastructure Engineer
Baystate Health
Why Are We Here?Why Are We Here?
• Background• Barriers to adoption• Momentum moving us forward• How IHE is breaking down these barriers• Lets get to work!• Panel discussion
• Background• Barriers to adoption• Momentum moving us forward• How IHE is breaking down these barriers• Lets get to work!• Panel discussion
Key Benefits of Point of Care Medical Device Interoperability
Key Benefits of Point of Care Medical Device Interoperability
• More accurate data (10 to 20% errors introduced with data transcription)– Improved patient safety and care outcomes– Improved discharge decisions– Improved Case Management, Infection Prevention and QA
• More “real time” data available to MD, clinicians and care managers – More clinically sound diagnosis and orders– Earlier initiative of appropriate interventions and therapies– Prevention of undetected patient deterioration (“failure to rescue”)– More “proactive” patient management (LOS, reimbursement)– Better outcomes
• Increased MD productivity and satisfaction• Increased Nursing productivity and satisfaction
– 1 to 1.5 hrs day savings per RN or CAN• Outcomes data warehousing
• More accurate data (10 to 20% errors introduced with data transcription)– Improved patient safety and care outcomes– Improved discharge decisions– Improved Case Management, Infection Prevention and QA
• More “real time” data available to MD, clinicians and care managers – More clinically sound diagnosis and orders– Earlier initiative of appropriate interventions and therapies– Prevention of undetected patient deterioration (“failure to rescue”)– More “proactive” patient management (LOS, reimbursement)– Better outcomes
• Increased MD productivity and satisfaction• Increased Nursing productivity and satisfaction
– 1 to 1.5 hrs day savings per RN or CAN• Outcomes data warehousing
Interoperability: A Brief History of Time
Interoperability: A Brief History of Time
• Pre 1990’s – analog outputs (e.g. 0-3V)• 1990’s
– DICOM: Imaging devices– HL7: Healthcare informatics, ADT, orders, results– ISO/IEEE 11073: Medical devices
• 2000’s– IHE– HITSP– Continua– ASTM F29
• Pre 1990’s – analog outputs (e.g. 0-3V)• 1990’s
– DICOM: Imaging devices– HL7: Healthcare informatics, ADT, orders, results– ISO/IEEE 11073: Medical devices
• 2000’s– IHE– HITSP– Continua– ASTM F29
Standards SmorgasbordStandards Smorgasbord
Barriers: Market ForcesBarriers: Market Forces
• Healthcare organization financial priorities– Where is the ROI for medical device
interoperability?– Each solution must be justified financially– Reimbursement drivers– Are you willing to pay more for standards?
• Would anyone buy an ultrasound without “DICOM”• Vendors marketing one-size-fits-all
– Do they really make financial sense?– Don’t listen to these marketing or sales guys
• Talk to people who have actually implemented• “Sure, we can interface these widgets to your EMR”
• Healthcare organization financial priorities– Where is the ROI for medical device
interoperability?– Each solution must be justified financially– Reimbursement drivers– Are you willing to pay more for standards?
• Would anyone buy an ultrasound without “DICOM”• Vendors marketing one-size-fits-all
– Do they really make financial sense?– Don’t listen to these marketing or sales guys
• Talk to people who have actually implemented• “Sure, we can interface these widgets to your EMR”
Safely, EffectivelySafely, Effectively
• Rigorous validation, verification, and testing of medical devices is required
• This slows development to market timelines
• We’re creating complex systems of systems requiring analysis
• Rigorous validation, verification, and testing of medical devices is required
• This slows development to market timelines
• We’re creating complex systems of systems requiring analysis
Complex ProblemsComplex Problems
• Most healthcare organizations do not have the staff to understand requirements of medical device interoperability– Sure it “interfaces” does to your EMR but what
does that mean?
• We need to simplify the integration requirements– Vendor salespeople wouldn’t be able to blow as
much smoke
• Imaging devices as an example
• Most healthcare organizations do not have the staff to understand requirements of medical device interoperability– Sure it “interfaces” does to your EMR but what
does that mean?
• We need to simplify the integration requirements– Vendor salespeople wouldn’t be able to blow as
much smoke
• Imaging devices as an example
CulturalCultural
• Clinical Engineering and Information Systems have traditionally worked in silo’s
• Clinical Systems Engineer– A Hybrid employee
• Trend is partnering CE with IT– Neither one can do this
alone • AAMI-ACCE-HIMSS CE-IT
Community
• Clinical Engineering and Information Systems have traditionally worked in silo’s
• Clinical Systems Engineer– A Hybrid employee
• Trend is partnering CE with IT– Neither one can do this
alone • AAMI-ACCE-HIMSS CE-IT
Community
What Is Driving Us Today?What Is Driving Us Today?
• Trend to organizations and government initiatives to move this forward.
• These are not Standards Delivery Organizations (SDO’s)
– HITSP (Healthcare Information Technology Standards Panel)
• Wide focus on harmonizing and integrating standards across healthcare
– Continua• Focus on Personal Health Devices
– IHE• Patient Care Devices Domain• Where at least one actor is a regulated point-of-care
medical device
• Trend to organizations and government initiatives to move this forward.
• These are not Standards Delivery Organizations (SDO’s)
– HITSP (Healthcare Information Technology Standards Panel)
• Wide focus on harmonizing and integrating standards across healthcare
– Continua• Focus on Personal Health Devices
– IHE• Patient Care Devices Domain• Where at least one actor is a regulated point-of-care
medical device
IHE PCD: Simplify Specs!IHE PCD: Simplify Specs!
PCD OverviewPCD Overview• Sponsored by HIMSS and ACCE
• The IHE Patient Care Device Domain, working with regional and national deployment committees, will apply the proven, Use Case driven IHE processes to:– Deliver the technical framework for the IHE-PCD; – Test conformance with published IHE-PCD profiles using test
plans, tools and scripts at Connectathons; and – Demonstrate marketable solutions at public trade shows.
• IHE-PCD profiles:– Improve patient safety and clinical efficacy,– Reduce healthcare delivery cost by improving efficiency,
reliability, and operational flexibility for healthcare providers,– Enable innovative patient care capabilities, and– Expand the international marketplace for patient care device
vendors.
• Sponsored by HIMSS and ACCE
• The IHE Patient Care Device Domain, working with regional and national deployment committees, will apply the proven, Use Case driven IHE processes to:– Deliver the technical framework for the IHE-PCD; – Test conformance with published IHE-PCD profiles using test
plans, tools and scripts at Connectathons; and – Demonstrate marketable solutions at public trade shows.
• IHE-PCD profiles:– Improve patient safety and clinical efficacy,– Reduce healthcare delivery cost by improving efficiency,
reliability, and operational flexibility for healthcare providers,– Enable innovative patient care capabilities, and– Expand the international marketplace for patient care device
vendors.
PCD StatusPCD Status
• [ACM] Alarm Communication Management enables the remote communication of point-of-care medical device alarm conditions ensuring the right alarm with the right priority to the right individuals with the right content (e.g., evidentiary data).
• [DEC] Device Enterprise Communication supports publication of information acquired from point-of-care medical devices to applications such as clinical information systems and electronic health record systems, using a consistent messaging format and device semantic content.
• [PIV] Point-of-care Infusion Verification supports communication of a 5-Rights validated medication delivery / infusion order from a BCMA system to an infusion pump or pump management system, thus "closing the loop.“
• DPI, MEM, WCM, IDCO
• [ACM] Alarm Communication Management enables the remote communication of point-of-care medical device alarm conditions ensuring the right alarm with the right priority to the right individuals with the right content (e.g., evidentiary data).
• [DEC] Device Enterprise Communication supports publication of information acquired from point-of-care medical devices to applications such as clinical information systems and electronic health record systems, using a consistent messaging format and device semantic content.
• [PIV] Point-of-care Infusion Verification supports communication of a 5-Rights validated medication delivery / infusion order from a BCMA system to an infusion pump or pump management system, thus "closing the loop.“
• DPI, MEM, WCM, IDCO
IHE ProcessIHE Process
Showcase 2007Showcase 2007
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
Showcase 2008Showcase 2008
GE GE CentricityCentricity®®
Periop Anes.Periop Anes.
Enterprise
DOC
DOC
Patient Patient
LiveDataLiveDataOR –OR –
DashBoardDashBoardTMTM
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
Showcase 2009
IHE PCD CollaborationIHE PCD Collaboration
• Helping to harmonize standards
• IHE PCD and Continua team up– HITSP IS77 Remote Monitoring– Content - HL7 v2.6 messages using IHE PCD-01
Vocabulary - Constrained to IEEE/ISO 11073-20601/11073-104xx (PHD Device specialization) nomenclature
• ICE-PAC: Collaboration with CIMIT
• NIST: Test tooling
• Helping to harmonize standards
• IHE PCD and Continua team up– HITSP IS77 Remote Monitoring– Content - HL7 v2.6 messages using IHE PCD-01
Vocabulary - Constrained to IEEE/ISO 11073-20601/11073-104xx (PHD Device specialization) nomenclature
• ICE-PAC: Collaboration with CIMIT
• NIST: Test tooling
Leveraging IHE for purchasingLeveraging IHE for purchasing
• How do you get IHE Integration Profiles? – Specify IHE capabilities as requirements – State in the RFP which IHE Actors and Integration
Profiles you want.
• What do IHE Integration Profiles cost?– Nothing in most cases– Any cost should be a fraction of the overall
• How do you get IHE Integration Profiles? – Specify IHE capabilities as requirements – State in the RFP which IHE Actors and Integration
Profiles you want.
• What do IHE Integration Profiles cost?– Nothing in most cases– Any cost should be a fraction of the overall
The business case for implementing IHE Profiles
The business case for implementing IHE Profiles
• Enables you to efficiently manage the array of integrated information systems necessary to support effective healthcare
• The alternative– Building site-specific interfaces
• More expensive• Requires maintaining these custom interfaces for the life
of the system involved. • Integration via IHE is less costly at the start and makes
future acquisitions easier to plan and execute• IHE Profiles give clear definitions of how the pieces fit
together • IHE Profiles come with initial unit testing done
• Enables you to efficiently manage the array of integrated information systems necessary to support effective healthcare
• The alternative– Building site-specific interfaces
• More expensive• Requires maintaining these custom interfaces for the life
of the system involved. • Integration via IHE is less costly at the start and makes
future acquisitions easier to plan and execute• IHE Profiles give clear definitions of how the pieces fit
together • IHE Profiles come with initial unit testing done
What Can You Do?What Can You Do?
• Plan, Evaluate, Purchase IHE Conforming Devices
• In continuing discussions with vendors – at all levels– Push IHE Interoperability
• Refer to lower deployment, maintenance costs– Encourage vendors’ active IHE participation
• Lower development, installation, support costs– Refer to profiles
• Leverage public and objective commitments
• In RFPs– Refer to profiles, Conformance Statements– Use Conformance Statements to “nail down” vendor’s
representations– Adopt very specific language
• Plan, Evaluate, Purchase IHE Conforming Devices
• In continuing discussions with vendors – at all levels– Push IHE Interoperability
• Refer to lower deployment, maintenance costs– Encourage vendors’ active IHE participation
• Lower development, installation, support costs– Refer to profiles
• Leverage public and objective commitments
• In RFPs– Refer to profiles, Conformance Statements– Use Conformance Statements to “nail down” vendor’s
representations– Adopt very specific language
Sample languageSample language
• “The device shall support the IHE Device Enterprise Communication (DEC) Integration Profile as the Device Observation Reporter (DOR) Actor.”
• “The pump shall support the IHE Point-of-Care Infusion Verification (PIV) Integration Profile as the Infusion Order Consumer (IOC) Actor.”
• “The device shall support the IHE Alarm Communication Management (ACM) Integration Profile as the Alarm Reporter (AR) Actor.”
• “The device shall support the IHE Device Enterprise Communication (DEC) Integration Profile as the Device Observation Reporter (DOR) Actor.”
• “The pump shall support the IHE Point-of-Care Infusion Verification (PIV) Integration Profile as the Infusion Order Consumer (IOC) Actor.”
• “The device shall support the IHE Alarm Communication Management (ACM) Integration Profile as the Alarm Reporter (AR) Actor.”
Help Break Down BarriersHelp Break Down Barriers
• IHE PCD Call for Work Item Proposals– Due 9/25
• User handbook• Join the technical
workgroups• Join us at the Face to Face
meetings– Oct 5-9
• IHE PCD Call for Work Item Proposals– Due 9/25
• User handbook• Join the technical
workgroups• Join us at the Face to Face
meetings– Oct 5-9
All Aboard!All Aboard!
PANEL DISCUSSION: INDUSTRY STANDARDS WHICH STANDARDS WILL BE ADOPTED AND
WHY?
PANEL DISCUSSION: INDUSTRY STANDARDS WHICH STANDARDS WILL BE ADOPTED AND
WHY?
• 5 minutes each followed by audience questions
• Julian M. Goldman, MD, Medical Director of Biomedical Engineering, Partners HealthCare System, Director, CIMIT Program on Interoperability and Medical Device Plug-and-Play Interoperability Program, Massachusetts General Hospital
• John Harrington, Vice President Research and Development, Hill-Rom IT Solutions
• Sudheer Matta, Product Manager, Wireless Networking Business Unit, Cisco
• Dick Moberg, President, Moberg Research, Inc.
• Bridget Moorman, CCE, President, BMoorman Consulting, LLC
• Robert Rinck, Manager, Clinical Engineering, Spectrum Health
• Vaughan Zakian, Founder & CTO, Nuvon, Inc.
• 5 minutes each followed by audience questions
• Julian M. Goldman, MD, Medical Director of Biomedical Engineering, Partners HealthCare System, Director, CIMIT Program on Interoperability and Medical Device Plug-and-Play Interoperability Program, Massachusetts General Hospital
• John Harrington, Vice President Research and Development, Hill-Rom IT Solutions
• Sudheer Matta, Product Manager, Wireless Networking Business Unit, Cisco
• Dick Moberg, President, Moberg Research, Inc.
• Bridget Moorman, CCE, President, BMoorman Consulting, LLC
• Robert Rinck, Manager, Clinical Engineering, Spectrum Health
• Vaughan Zakian, Founder & CTO, Nuvon, Inc.
My BackgroundMy Background
• Past Position: Clinical Engineering, IT Specialist• M.S. Biomedical Engineering, University of
Connecticut– Focus on Clinical Engineering
• Co-chair IHE Patient Care Devices Planning Committee
• 2 years in Desktop and Server Support• 5 years in Clinical Engineering• 4 years as Hybrid CE-IT role• I’m not a standards guy, I would just love to see
more of them
• Past Position: Clinical Engineering, IT Specialist• M.S. Biomedical Engineering, University of
Connecticut– Focus on Clinical Engineering
• Co-chair IHE Patient Care Devices Planning Committee
• 2 years in Desktop and Server Support• 5 years in Clinical Engineering• 4 years as Hybrid CE-IT role• I’m not a standards guy, I would just love to see
more of them
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