Slide 1 IHE

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					Medical Device Integration

         Steve Merritt
    Infrastructure Engineer
        Baystate Health
         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
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
   –   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
• 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 Smorgasbord
        Barriers: Market Forces

• Healthcare organization financial priorities
   – Where is the ROI for medical device
   – 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, Effectively

• Rigorous validation, verification, and
  testing of medical devices is required
• This slows development to market
• We’re creating complex systems of
  systems requiring analysis
         Complex 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
  – Vendor salespeople wouldn’t be able to blow as
    much smoke
• Imaging devices as an example

• Clinical Engineering and
  Information Systems have
  traditionally worked in
• Clinical Systems Engineer
  – A Hybrid employee
• Trend is partnering CE
  with IT
  – Neither one can do this
   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
      • 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!
                  PCD 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
                         PCD 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

•    [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.“

IHE Process
                              Showcase 2007
Emergency Care   Intensive Care                                         Perioperative Care

                                          Philips                         LiveData                    GE

                                     Intellivue Clinical                                         Centricity®
                                        Information                     OR-DashBoard               Periop
                                          Portfolio                                              Anesthesia

 Welch Allyn           GE                Philips            B. Braun                Draeger
   ConnexTM                                                DoseTracTM
    Data             Aware              Intellivue           Infusion               Innovian®
 Management         Gateway            Information         Management             Solution Suite
   System                                 Center            Software

   Vital Signs    Patient Monitor,     Patient Monitor,      Infusion              Patient Monitor,
     Monitor         Ventilator           Ventilator         Devices               Anesthesia Sys
Showcase 2008
                                                           Showcase 2009
                PDQ/PAM                          Time                                                          Centricity®                                                 Alarm                      Polycom
                                                                                                               Enterprise                                                                              Wireless
                 Server                         Server                                                                                                                     Client                       Phone

Patient                                                     Patient                                                                       Patient                                                                           Patient
                                      OR                                                                     ICU                                                                            Step-Down

               GE                             SIS                                                         Philips                                                                           LiveData
    Centricity®                              Periop
   Periop Anes.                                                                                            Emergin                                                                          Alert Manager
     DOC                                                  DOC                                                  AM                                                                                AM

                                                                              Cerner                                     Philips                         Draeger                                              Cerner
                               LiveData                                                                                   IntelliVue                Innovian® Web
                                 OR –                                                                                      Clinical
                              DashBoardTM                                   CareMobileTM                                Info Portfolio                                                                       CareMobileTM
                                     DOC   AR                                 IOP                  DOC                   DOC       DOR,                                    DOC                                IOP        DOC

               DOR,                                                          DOR,                             DOR,                                              DOR,                               DOR,                      DOR,
               AR                                DOR, AR                     AR              IOC              AR                     DOR                        AR                IOC              AR                        AR

                                                                                                                                                    B. Braun
   B. Braun


                                                                 B. Braun




                                        Draeger                                                                                 GE                                                           Cerner                  Philips
                                                                                                         Capsule              Aware                                                                                  IntelliVue
                                           Gateway                                                       DataCaptor          Gateway                                                        CareAwareTM             Info. Center

              Infusion                 Patient Monitor,                     Infusion                 Hospital Bed,          Patient Monitor,                   Infusion                      Hospital Bed,
                                                                                                                                                                                                                    Patient Monitor
              Devices                  Anesthesia Sys                       Devices                   BIS Monitor              Ventilator                      Devices                        VS Monitor
       IHE 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
         Leveraging IHE for
• 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
• Enables you to efficiently manage the array of integrated
  information systems necessary to support effective
• 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
• IHE Profiles come with initial unit testing done
            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
   – Adopt very specific language
            Sample 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.”
   Help Break Down Barriers

• IHE PCD Call for Work Item
  – Due 9/25
• User handbook
• Join the technical
• Join us at the Face to Face
  – Oct 5-9
All Aboard!
•   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 Background

• Past Position: Clinical Engineering, IT Specialist
• M.S. Biomedical Engineering, University of
   – Focus on Clinical Engineering
• Co-chair IHE Patient Care Devices Planning
• 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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