aami conference presentation - "tackling interoperability - what's being done?"
DESCRIPTION
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.TRANSCRIPT
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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
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
Tere
nzio
Facchin
etti: a
dapte
d fro
m S
hahid
N.
Shah
Stand Alone MD
UL and the UL logo are trademarks of UL LLC © 2013
UL and the UL logo are trademarks of UL LLC © 2013
Medical Device engineering is evolving
3 Dr. Terenzio Facchinetti
S A F E T Y
UL and the UL logo are trademarks of UL LLC © 2013
Healthcare is going digital
4
Dr.
Tere
nzio
Facchin
etti
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
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.
Tere
nzio
Facchin
etti
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CONTRIBUTING TO SOLUTIONS
6 Dr. Terenzio Facchinetti
AAMI-UL 2800
Underwriters Laboratories Copyrights
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PRIORITIES
7 Dr. 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
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INTEROPERABILITY focus
• The technology of interoperability
- Architecture, Interfaces & Infrastructure
- Interoperability technical specification and communication standards
• Safety & safety standards for interoperable scenarios
• Security and Privacy
8 Dr. 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
9 Dr. Terenzio Facchinetti
SAFETY: freedom from unacceptable risk [ISO 14971: 2007]
SYSTEM
Collection
of parts
behaviour
Safety System Approach
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AAMI-UL 2800 in the “big picture”
10 Dr. 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
11 Dr. Terenzio Facchinetti
ICE Supervisor
Ext.
Interface
NC
Network Controller
Data
Logger
Interface
MD
Interface
MD
APP APP APP
INTERFACE
Adaptation from ASTM 2761-09
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
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UL and the UL logo are trademarks of UL LLC © 2013
BENEFITS of having a MD Interoperability
Safety Standard
13 Dr. 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
THANK YOU
Dr. Terenzio Facchinetti
Underwriters Laboratories
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