Tihs presentation was delivered at the 2013 AAMI Conference in Long Beach, California, USA by Dr. Terenzio Facchinetti of UL LLC. The subject matter of interoperability for medical devices is a very important subject and has implications for Healthcare Quality, Healthcare Costs Containmnet and Sustaining the Healthcare industry. UL is working with AAMI to develop a series of standards that address interoperability of medical devices.

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Tackling Interoperability
What ´s being done?
Efforts, Working together, Impact
AAMI Conference
1-2 June , 2013
Long Beach - CA - USA
Dr. Terenzio Facchinetti
Underwriters Laboratories

2. 2
Digital System / PnP System of Systems
digitization
integration
INTEGRATION driven future Who integrates the best wins !
I N T E R O P E R A B I L I T Y
Improvement of HC Quality – HC Costs Containement – Sustaining HC Industry
TerenzioFacchinetti:adaptedfromShahidN.Shah
Stand Alone MD
UL and the UL logo are trademarks of UL LLC © 2013

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Medical Device engineering is evolving
3Dr. Terenzio Facchinetti
S A F E T Y

4. UL and the UL logo are trademarks of UL LLC © 2013
Healthcare is going digital
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Dr.TerenzioFacchinetti
4
S
A
F
E
T
Y
THE
TOMORROW HEALTHCARE
S
E
C
U
R
I
T
Y
R E G U L A T O R Y
Improvement of HC Quality – HC Costs Containement – Sustaining HC Industry

5. UL and the UL logo are trademarks of UL LLC © 2013
INTEROPERABILITY
• The ability of two or more systems or components to
exchange information and to use the information that has
been exchanged (IEEE)
• Being able to accomplish end-user applications using
different types of computer systems, operating systems,
and application software, interconnected by different types
of local and wide area networks (O`Brien & Marakas)
• The capability to communicate, execute programs, or
transfer data among various functional units in a manner
that requires the user to have little or no knowledge of the
unique characteristics of those units (ISO/IEC 2382-01)
• Ability of medical devices, clinical systems, or their
components to communicate in order to safely fulfill an
intended purpose (AAMI-HITI)
5
Dr.TerenzioFacchinetti

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CONTRIBUTING TO SOLUTIONS
6Dr. Terenzio Facchinetti
AAMI-UL 2800
Underwriters Laboratories Copyrights

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PRIORITIES
7Dr. Terenzio Facchinetti
• Need for standardization
• Align incentives, expectations, roles and responsibilities.
• Drive Patient safety with systems approach to design and
implementation
• Focus on human behavior first
• Improve regulatory clarity
• Streamline clinical workflow to improve return on investment
• Remove barriers with shared continuous learning

8. UL and the UL logo are trademarks of UL LLC © 2013
INTEROPERABILITY focus
• The technology of interoperability
- Architecture, Interfaces & Infrastructure
- Interoperability technical specification and communication standards
• Safety & safety standards for interoperable scenarios
• Security and Privacy
8Dr. Terenzio Facchinetti
Level INTEROPERABILITY
0 No Interoperability
1 Technical Interoperability
2 Syntactic Interoperability
3 Semantic Interoperability
4 Pragmatic Interoperability
5 Dynamic Interoperability
6 Conceptual Interoperability
*Turnitsa 2005

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Safety
Finding The Weakest Links & Emerging Properties
AAMI-UL 2800
9Dr. Terenzio Facchinetti
SAFETY: freedom from unacceptable risk [ISO 14971: 2007]
SYSTEMCollection
of parts
behaviour
Safety System Approach
Underwriters Laboratories Copyrights

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AAMI-UL 2800 in the “big picture”
10Dr. Terenzio Facchinetti
Clinical
Scenario
Interoperable
Scenario
System Safety /
Interoperability
Connectivity /
Interoperability (HL7, IEEE.
Continua, etc…)
Enabling Technologies (Wi-Fi,
Bluetooth, Zigbee, Ethernet,
etc…)
AAMI-UL 2800

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THE CLINICAL ENVIRONMENT
11Dr. Terenzio Facchinetti
ICE Supervisor
Ext.
Interface
NC
Network Controller
Data
Logger
Interface
MD
Interface
MD
APP APP APP
INTERFACE
Adaptation from ASTM 2761-09

12. AAMI/UL 2800
UPFRONT RECOMMENDATIONS
• Focus on SAFETY
• Avoid duplication of efforts
• Recognize Work and Intellectual efforts
a. Make use of case studies & devices
b. On-going federally funded projects
• Provide Quality of work: „Useful & Usable“
Focus
Trust
Cooperation
UL and the UL logo are trademarks of UL LLC © 2013

13. UL and the UL logo are trademarks of UL LLC © 2013
BENEFITS of having a MD Interoperability
Safety Standard
13Dr. Terenzio Facchinetti
MANUFACTURERS
•Safety Std of reference
•Mitigate R&D investments
•Reference for regulatory
•Overall risks mitigation
•Exclude unfair market entry
of „cheap but unsafe“
producs
REGULATORY
•Reference of criteria and
rules for MD safety review
•Reference and guidance for
manufacturers
•Support for product
clearance submissions
•Reference for Users and HC
providers
PATIENTS, HC
PROVIDERS,
INSURANCE,
MARKET
•Assurance of safety
•Reference for procurement
•Support in selection of quality
products
•Risks mitigation
Trust
Security
Safety

14. THANK YOU
Dr. Terenzio Facchinetti
Underwriters Laboratories
terenzio.facchinetti@ul.com
phone +49 162 262 1912
SAFETY
Finding The Weakest Link & Emerging Properties
AAMI / UL 2800
UL and the UL logo are trademarks of UL LLC © 2013