Medical Device Integration Steve Merritt Infrastructure Engineer Baystate Health Steve Merritt Infrastructure Engineer Baystate Health.

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

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ira

Ca

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Ca

rdin

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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

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Patient Monitor,Anesthesia Sys

DOR, AR

DraegerDraeger InfinityInfinityGatewayGateway

DOR,AR

InfusionDevices

B.

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B.

Bra

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Ho

sp

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Ho

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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