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 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 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 IEEE 11073, DICOM, HL7, IHE, Continua, HITSP, 80001-1, ASTM F29, IEEE 802.11, 802.3, Zigbee, Bluetooth, WMTS, USB, RS-232, ICD, LOINC, SNOMED, UCUM

Barriers: 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”

Safely, 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

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 requirements Vendor salespeople wouldn’t be able to blow as much smoke Imaging devices as an example

Cultural 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? 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!

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 vendors.

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 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 Process

Showcase 2007 Welch Allyn ConnexTM GE Philips LiveData Draeger Management System Vital Signs Monitor GE Aware Gateway Patient Monitor, Ventilator Philips Intellivue Information Center Emergency Care Intensive Care LiveData OR-DashBoard Centricity® Periop Anesthesia Draeger Innovian® Solution Suite Anesthesia Sys B. Braun DoseTracTM Infusion Software Infusion Devices Perioperative Care Intellivue Clinical Portfolio

Showcase 2008

Hospital Bed, BIS Monitor Hospital Bed, VS Monitor Showcase 2009 Enterprise GE Centricity® Enterprise PDQ/PAM Server Time Server Alarm Client Polycom Wireless Phone DOC AC Patient Patient Patient Patient OR ICU 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 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 17

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 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

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

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 Don’t forget to look ahead – what is being developed, what is the upgrade path? 21

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 Proposals Due 9/25 User handbook Join the technical workgroups Join us at the Face to Face meetings Oct 5-9

All Aboard!

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.

My 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