Implementing the HL7 XML Annotated
ECG Waveform Standard for submission
to the Food and Drug Administration
AMPS FDAEcg Suite
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AMPS developed the XMLFDA Full
Functional Viewer, a product that was
designed by AMPS to help the FDA officials
for the viewing and validation of the XML
HL7 aECG files until October 2005, before
the release of the FDA Warehouse
software.
Background
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For his contribution Dr. Fabio
Badilini, Chief Scientist at
AMPS, received an Award by
the FDA for: “development of
a format for regulatory
submission of annotated
electrocardiographic
waveform data to meet FDA’s
needs in assessing the
proarrhythmic potential of
drugs”.
Achievements
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AMPS and Mortara Instruments agreed in August 2006 to
cooperate in aligning the HL7 XML validation checks in a future
version of the AMPS XMLFDA Viewer with those implemented
by Mortara in the E-Scribe ECG Warehouse.
The AMPS FDAEcg Suite, the successor of the Full Functional
Viewer, includes the development based on this agreement.
Completely re-designed the FDAEcg Suite provides, under the
same easy-to-use common interface, 3 main features:
O Display of HL7 XML ECG traces
O Validation of HL7 XML ECG traces
O Scoring of HL7 ECG traces
The FDAEcg Suite
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Display of HL7 XML
ECG Traces
The Suite allows to
display annotated ECGs
saved in the FDA XML
format and includes an
extensive set of
additional tools,
allowing to view
multiple XML files
simultaneously
The FDAEcg Suite: Display
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The FDAEcg Suite has a
validation algorithm
which verifies the
structure of the XML files
at three separate levels,
and produce a consistent
set of syntactical
warnings and error
messages, during the
validation phase prior to
the submission to the
FDA Warehouse.
The FDAEcg Suite: Validation
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Three level validation
Level 1: syntax checks for well-formed
XML document and HL7 schema
validation
Level 2 : Implementation Guide
Level 3 : FDA Warehouse
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Three level validation - 1
Level one: Well-form XML and against HL7
Schema
A "Well Formed" XML document is a document that
conforms to the XML syntax rules
A valid XML document is a "Well Formed" XML document
which also conforms to the rules of a Document Type
Definition (DTD or Schema). The purpose of a DTD is to
define the building blocks of an XML document, and its
structure through a list of legal elements. This level
checks if all used elements conform to the HL7 Schema
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Three level validation - 2
Level two: Implementation Guide
The IG Level (Implementation Guide Level) checks all
aspects of the HL7 format described in the Implementation
Guide.
Even though the HL7 aECG standard was created in
response to the FDA's need to have ECG waveforms and
annotations in a standard format, it does not exclude that it
can be used for other purposes. The standard is flexible
and allows additional uses.
This level checks that the ECG object complies with the
specific IG requirements of the HL7 aECG format.
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Three level validation - 3
Level three: FDA-Warehouse (1/2)
This level is specifically aimed to address all issues related
with the submission of the aECG files into the FDA
warehouse, and that are NOT specified at the level of the
HL7 schema, or at the level of the IG.
This level checks can be ignored for aECG files aimed for
other purposes than the submission to the FDA.
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Three level validation -
Level three: FDA-Warehouse (2/2)
The alignment with the Mortara Warehouse insures that all
requirements embodied in the HL7 Schema and the HL7
Implementation Guide are interpreted and flagged by the
two products in the same fashion, thus giving a consistent
interpretation of the HL7 annotated ECG standard
requirements.
AMPS shall continue to maintain and update this validation
level in coordination with the maintainers of the FDA
warehouse software to guarantee that aECG files cleared
through this level will be accepted when submitted to the
FDA Warehouse.
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AMPS guarantees that files successfully
validated with the FDAEcg Suite are fully
compliant with the HL7 XML standard and
the XML Implementation Guide, and will be
accepted when submitted to the FDA
Warehouse
The AMPS guarantee
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It is possible to score the ECGs quality through the use
of predefined algorithms for the computation of high and
low frequency noise according to non-parametric
algorithms.
The FDAEcg Suite comes with an open user interface
whereby it is possible to add new metrics criteria
without the need of AMPS to be involved in the process.
An intuitive user interface gives the distribution of noise
within the study ECG data-set, then the user can review
and visualize the tracings of the scored ECGs.
The FDAEcg Suite: Scoring - 1
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The FDAEcg Suite: Scoring - 2
Example of HF noise on a set of 2000 ECGs
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The FDAEcg Suite: Scoring - 3
Example of ECGs revision
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For questions, additional information, or a price proposition
please contact:
E-mail: Marketing@amps-llc.com
Web: www.amps-llc.com
418 Central Park West suite 21 - 10025 - New York - New York
Via Paolo VI, 34 - 25018 - Montichiari (BS) - Italy
127 rue de la Glaciere - 75013 - Paris - France
AMPS LLC
