1. Medical Device Integration
Steve Merritt
Infrastructure Engineer
Baystate Health

2. 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

3. 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

4. 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

5. Standards Smorgasbord
IEEE 11073, DICOM, HL7, IHE, Continua, HITSP, , ASTM F29, IEEE , 802.3, Zigbee, Bluetooth, WMTS, USB, RS-232, ICD, LOINC, SNOMED, UCUM

6. 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”

7. 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

8. 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

9. 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

10. 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

11. IHE PCD: Simplify Specs!

12. 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.

13. 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

14. IHE Process

15. 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

16. Showcase 2008

17. 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

18. 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 / xx (PHD Device specialization) nomenclature
ICE-PAC: Collaboration with CIMIT
NIST: Test tooling

19. 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

20. 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

21. 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

22. 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.”

23. 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

24. All Aboard!

25. 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.

26. 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