Transcript 11073 POC-MDC standards

CEN/ISO/IEEE 11073 Standards for
point-of-care device communication:
Overview
SCATA,
London, 5th May, 2005
Melvin Reynolds, AMS Consulting, Ross-on-Wye, UK
Chair CEN TC251 WGIV Health informatics – Technologies for interoperability,
Chair ISO TC215 WG2 Health informatics – Messages and communications; Past-chair ISO TC215 WG2.1 Health informatics – Device communications,
Co-chair IEEE1073 Medical device communications.
with thanks to:
Thomas Norgall, Fraunhofer Institute, Erlangen,
Todd Cooper, Breakthrough Solutions, San Diego
and
CEN/ISO/IEEE 11073 Standards
Overview
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Requirements
Interoperability
History
The (content) standards
Conclusions
Discussion
CEN/ISO/IEEE 11073 Standards
Point-of-care: the need
About 20% of an
ICU nurse’s time
can be redeployed
if charting is
automated,
eliminating
transcription error
& false recording;
as well a
providing more
rapid feedback.
Different benefits
apply in other
care situations.
CEN/ISO/IEEE 11073 Standards
Point-of-care: all change
Fixed configuration, e.g. anaesthesia
Data Processing
System / PDMS
Patient Monitor
Syringe Pumps and Infusors
Respirator
Additional Pump
Additional Monitor
– but changing
periodically, and
evolving over time
CEN/ISO/IEEE 11073 Standards
Point-of-care: all change
Variable configuration, e.g. intensive care
Data Processing
System / PDMS
Patient Monitor
Many Syringe Pumps and Infusors
Respirator
- changing
frequently and
within minutes
CEN/ISO/IEEE 11073 Standards
Interoperability
Interoperability:
ability of two or more systems or components to
exchange information and to use the
information that has been exchanged
source: IEEE Standard Computer Dictionary: A Compilation of
IEEE Standard Computer Glossaries, IEEE, 1990
Functional interoperability:
Shared Architectures, Methods & Frameworks
Semantic interoperability:
Shared Data types, Terminologies, Codings
CEN/ISO/IEEE 11073 Standards
Interoperability
Point-of-care medical device communication
(IEEE1073) Charter:
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Provide real-time plug-and-play interoperability for
patient-connected medical devices
Facilitate the efficient exchange of vital signs and
medical device data, acquired at the point-of-care,
in all health care environments
… Leveraging off-the-shelf technologies, scaling across
a wide range of system complexities, and supporting
commercially viable implementations.
CEN/ISO/IEEE 11073 Standards
Context
Health informatics:
Generally interpreted as being
in ISO/OSI Level 7
Medical device communication:
Works at all ISO/OSI Levels,
Directly in ISO/OSI Levels 7 – 5
In Levels 1 – 4, chiefly by
reference to other standards
(such as IrDA or 802.11)
ISO/OSI Level 7:
Application
ISO/OSI Level 6:
Presentation
ISO/OSI Level 5:
Session
ISO/OSI Level 4:
Transport
ISO/OSI Level 3:
Network
ISO/OSI Level 2:
Datalink
ISO/OSI Level 1:
Physical
CEN/ISO/IEEE 11073 Standards
Architecture
Requirements:
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True interoperability across all 7-layers from the ‘connector’ to the end application
Mechanisms to support the strong quality of
service requirements placed on regulated
medical devices
Maintainability as communications
technology and applications change
CEN/ISO/IEEE 11073 Standards
Series title
(National, e.g. BS) EN ISO/IEEE
11073-xyyzz
Health informatics Point-of-care medical device
communication x partition (general):
yy subsection (group) zz detail (specialised)
CEN/ISO/IEEE 11073 Standards
Series structure
11073.1xxxx
Data & Information Definitions
11073.2xxxx
Application Profiles
11073.3xxxx
Transport & Physical Layers
11073.5xxxx
Internetworking Support
11073.6xxxx
Application Gateways
11073.9xxxx
Related – some shared concepts
CEN/ISO/IEEE 11073 Standards
11073-1xxxx content
11073.1xxxx
Data & Information Definitions
Semantics needed to communicate a device’s
application data, status and control
information.
Three main components:
 Nomenclature: 11073.10101
 Domain Information Model (DIM): 11073.10201
 Device Specialisations: 11073.103xx
CEN/ISO/IEEE 11073 Standards
11073-10101 content
Nomenclature:
A set of numeric
codes that
identify every
item that is
communicated
between systems.
CEN/ISO/IEEE 11073 Standards
11073-10201 content
Domain Information Model:
An object oriented data model that specifies
objects, attributes, attribute groups, event reports,
and services that may be used to communicate
device data and to control / configure the reporting
of information . . .
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Medical Devices and
Functionalities
Measured Data and
Settings
Alert Information
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Remote Control
Patient Information
Communication
CEN/ISO/IEEE 11073 Standards
Domain Information Model
VMO
Session-Test
(from Archival)
MDS
(from System)
0..1
0..n
1
VMD
0..1
1
0..n
Channel
0..1
1
0..n
0..n
0..n
Metric
0..n
PM-Store
0..n
1
1..n
Numeric
Time-SA
Sample Array
Distribution-SA
0..n
Enumeration
RealTime-SA
Complex Metric
0..n
0..n
PM-Segment
CEN/ISO/IEEE 11073 Standards
Development Process
Domain
Information
Model
‘On-the-Wire’
Format
Abstract
Syntax
(ASN.1)
Transfer
Syntax
(MDER)
CEN/ISO/IEEE 11073 Standards
11073-6xxxx content
11073.6xxxx
Application Gateways
Objectives: Interoperability between different
application-layer protocols
+
Bi-directional transparency
11073
System
(Agent/
Manager)
11073.3xxxx
11073.6xxxx Gateway
Transport
11073.3 /.5xxxx non-VITAL
Application
Transport
Example: HL7 / 11073 Gateway: 11073.60101
HL7 - Observation Reporting Interface
CEN/ISO/IEEE 11073 Standards
11073-60101 content
HL7 - Observation Reporting Interface
Objective: To ensure that … information … from devices using …
11073 standards is conveyed with appropriate …
identification of source device system, medical device,
channel and metric (… with required annotation …). For
traceability, and to enable safe computation from data,
the 11073… nomenclature is retained … payload of the
HL7 message/document that carries the information to
the target information system.
BP
HL7 QRY
11073
SpO2
11073
Glucose
POCT
HL7?
Manual
Data Manager
providing 11073
Application
gateway ORI
Services
HL7 MF info
HL7 ADT
HL7 OML
HL7 ORU
HL7 ESU
CIS
CEN/ISO/IEEE 11073 Standards
11073-60101 HL7 ORI
Example HL7 v2.6 message:
MSH|||^~\&|Vendor_name||NUR||200312021203||ORU^R01|02110212073000458038 |P|2.3| ||||||
PID|||999-99-9999 ||Smith^John^L |||||||||||||999-99-9999 ||||||||||||
PV1|||CU1^^BED1||||^^^|||||||||||||||||||||||||||||||||||||||||||||
OBR|||||||20031202120235|||||||||||||||||||||||||||||||||||||
OBX||SN|147842^MDC_ECG_HEART_RATE^MDC^^HR^local||=^83|264864^MDC_DIM_BEAT_PER_MIN^MDC^^beat/min^local|||||R|||20031202120235| ||
OBX||SN|134276^MDC_EVT_ECG_V_P_C^MDC^^PVC
rate^local||=^0|264864^MDC_DIM_BEAT_PER_MIN^MDC^^beat/min^local|||||R|||20031202120235|||
OBX||SN|131841^MDC_ECG_AMPL_ST_LEAD_I^MDC^^ST elev lead
I^local||=^0.01|266418^MDC_DIM_X_VOLT^MDC^^mV^local|||||R|||20031202120235|||
OBX||SN|131842^MDC_ECG_AMPL_ST LEAD_II^MDC^^ST elev lead
II^local||=^0.01|266418^MDC_DIM_X_VOLT^MDC^^mV^local|||||R|||20031202120235|||
OBX||SN|131901^MDC_ECG_AMPL_ST_LEAD_III^MDC^^ST elev lead
III^local||=^0.01|266418^MDC_DIM_X_VOLT^MDC^^mV^local|||||R|||20031202120235|||
OBX||SN|150324^MDC_SAT_O2_ART^MDC^^SPO2^local||=^97|262688^MDC_DIM_PERCENT^MDC^^%sat^local|||||R|||20031202120235|||||460230^ MDC
_UPEXT_FINGER^MDC^Finger NOS^local^^1
OBX||SN|149538^MDC_PLETH_PULS_RATE^MDC^^Pulse
rate^local||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^Pulse/min^local|||||R|||20031202120235|||||460230^MDC_UPEXT_FINGER^MDC^Fing er
NOS^local^^1
OBX||ST|150302^MDC_PRESS_CUFF_DIA^MDC^^NIBP
dia^local||=^80|266016^MDC_DIM_MMHG^MDC^^mmHg^local|||||R|||20031202120030|||||458572^MDC_UPEXT_ARM_UPPER^MDC^Upper arm^local^^1
OBX||ST|150303^MDC_PRESS_CUFF_MEAN^MDC^^NIBP
mean^local||=^93|266016^MDC_DIM_MMHG^MDC^^mmHg^local|||||R|||20031202120030|||||458572^MDC_UPEXT_ARM_UPPER^MDC^Upper
arm^local^^1
OBX||ST|150301^MDC_PRESS_CUFF_SYS^MDC^^NIBP
sys^local||=^120|266016^MDC_DIM_MMHG^MDC^^mmHg^local|||||R|||20031202120030|||||458572^MDC_UPEXT_ARM_UPPER^MDC^Upper
arm^local^^1
OBX||ST|149546^MDC_PULS_RATE_NON_INV^MDC^^Pulse
rate^local||=^83|264896^MDC_DIM_PULS_PER_MIN^MDC^^Pulse/min^local|||||R|||20031202120030|||||458572^MDC_UPEXT_ARM_UPPER^MDC^U pper
arm^local^^1
CEN/ISO/IEEE 11073 Standards
11073-60101 HL7 ORI
Example HL7 v2.6 message 11073 payload:
OBX||SN|147842^MDC_ECG_HEART_RATE^MDC^^HR^local||=^83|
264864^MDC_DIM_BEAT_PER_MIN^MDC^^beat/min^local|||||R|||20031202120235|||||
OBX||SN|134276^MDC_EVT_ECG_V_P_C^MDC^^PVC rate^local||=^0|
264864^MDC_DIM_BEAT_PER_MIN^MDC^^beat/min^local|||||R|||20031202120235|||||
OBX||SN|131841^MDC_ECG_AMPL_ST_LEAD_I^MDC^^ST elev lead I^local||=^0.01|
266418^MDC_DIM_X_VOLT^MDC^^mV^local|||||R|||20031202120235|||||
…
OBX||SN|150324^MDC_SAT_O2_ART^MDC^^SPO2^local||=^97|
262688^MDC_DIM_PERCENT^MDC ^^%sat^local|||||R|||20031202120235|||||
460230^MDC_UPEXT_FINGER^MDC^Finger NOS^local^^1
OBX||SN|149538^MDC_PLETH_PULS_RATE^MDC^^Pulse rate^local||=^83|
264896^MDC_DIM_PULS_PER_MIN^MDC^^Pulse/min^local|||||R|||20031202120235||||
|460230^MDC_UPEXT_FINGER^MDC^Finger NOS^local^^1
…
OBX||ST|150301^MDC_PRESS_CUFF_SYS^MDC^^NIBP sys^local||=^120|
266016^MDC_DIM_MMHG^MDC^^mmHg^local|||||R|||20031202120030|||||
458572^MDC_UPEXT_ARM_UPPER^MDC^Upper arm^local^^1
OBX||ST|149546^MDC_PULS_RATE_NON_INV^MDC^^Pulse rate^local||=^83|
264896^MDC_DIM_PULS_PER_MIN^MDC^^Pulse/min^local|||||R|||20031202120030||||
|458572^MDC_UPEXT_ARM_UPPER^MDC^Upper arm^local^^1
CEN/ISO/IEEE 11073 Standards
Conclusions
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11073 is a comprehensive system of point-of-care
medical device communication standards
11073 device types range from real-time-operating
medical equipment to point-of-care test
11073 supports wired, wireless IR (and hopefully
future wireless RF) network technologies
11073 provides plug-and-play, internetworking and
application gateway capabilities
CEN/ISO/IEEE 11073 Standards
Conclusions
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11073 is used to a greater or lesser extent by the
biggest companies in the business – often not
declared!
11073 provides an open way of accessing:
device networks
data for real time decision support
11073 is being requested by health care providers
& management organisations, e.g NHS NPfIT, US
DHHS, as they seek point-of-care to record
transparency of information
CEN/ISO/IEEE 11073 Standards
Contact details
Thank you for your attention.
Melvin Reynolds
AMS Consulting
Ashcote, Walford Road,
Ross-on-Wye, HR9 5PQ, UK
[email protected]
www.ieee1073.org