***National Electrical Manufacturers Association***

*1300 North 17th Street, Suite 1847, Rosslyn, VA 22209*

*www.nema.org tel: 703-841-3200 fax: 703-841-5900*

> May 23, 2003
>
> Submitted by e-mail to:
>
> [mailto:fdadockets@oc.fda.gov](mailto:fdadockets@oc.fda.gov)

Dockets Management Branch

HFA-305

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852

**Re: Docket Number 03N-0158**

**Specification for Annotated Electrocardiographic Waveform Data in
Electronic Format; Request for Comments.**

To Whom It May Concern:

On behalf of the Diagnostic Imaging and Therapy Systems Division of
NEMA, I am pleased to submit comments in response to the subject
request. NEMA, the National Electrical Manufacturers Association, is the
nation's largest trade association representing the electro-industry.
NEMA's Diagnostic Imaging and Therapy Systems Division represents the
majority of the nation's manufacturers of X-ray imaging, computed
tomography, diagnostic ultrasound, radiation therapy, magnetic resonance
imaging, and nuclear imaging equipment. In addition, the division
represents manufacturers of picture archiving and communications systems
some of which manufacture cardiology IT systems that handle ECG data and
images.

[**1.** **This is the right action **]{.underline}

NEMA unequivocally supports the FDA effort to provide for the submission
of the subject data in electronic format to provide the benefits of
computer-supported analysis and review.

[**2.** **Pilot project to prove process before companies make
investments**]{.underline}

NEMA is very keen on ensuring rapid transition from today's paper-based
system to an electronic submission process in order to reduce the
overhead of a dual process.

For this electronic submission of ECG waveform data process to become
operational on full scale, however, FDA will have to have in place a
suitable infrastructure, both hardware and software, to receive and
process the data. Further, the standards used in the process for
communication and formatting of data must also be tested in actual
clinical use. Such testing has not been done to date.

For the foregoing reasons NEMA strongly urges FDA to conduct a pilot
electronic submission program to confirm suitability of standards and
infrastructure. This pilot project should coincide with the issuance of
the draft guidance so that the comments on the draft guidance can
include the experiences learned in the pilot program. This will
significantly strengthen the knowledge base for the preparation of the
Final Guidance.

[**3.** **The process is for clinical trial data submission only -
clarification**]{.underline}

NEMA believes that FDA's intent with this guidance is to utilize this
process for ECG waveform data of clinical trials. NEMA agrees with this
intent. While the current notice specifies this limited use in the
amplified "Background" section, the "Summary" section of the notice is
ambiguous in this regard. It is so, we believe because of the inherent
required brevity of a "Summary".

However, NEMA is concerned that the broad clinical use of ECG exchange
(beyond clinical trials) has critical requirements that are simply not
addressed in this proposal. NEMA therefore requests the FDA to specify,
in every form of communication on the subject, that the intent is
limited to regulated entity submission of clinical trials ECG, even if
at the expense of brevity.

**[4. Immediate source of data cannot be specified for ECG devices -
clarification]{.underline}**

The current notice speaks of annotated ECG waveform data "from the full
spectrum of ECG devices, including 12-lead standard ECG, holter
monitors, and implanted devices." In current and expected future
technologies there are IT systems connected to ECG devices that have a
function in the handling of data and are better suited to export the
annotated ECGs. While we believe it was not FDA's intent to exclude
these other systems employed, we believe the relevant language in the
forthcoming guidance should not imply that devices are the immediate
source of the ECGs formatted per this rule. This guidance should leave
the specific technical solutions open to the decision of users and
vendors and leave open development of new data handling technologies.

**[5. Comments on FDA's Specific Questions]{.underline}**

> [5.1 Does the proposed message capture the appropriate level of detail
> about ECGs for assessment?]{.underline}
>
> The best answer to this question will be generated in the course of
> the above recommended pilot program for the electronic submission of
> ECG waveform clinical trials data.

[5.2 Are there additions needed to the proposed controlled
terminology?]{.underline}

> NEMA's members have contributed to the proposed terminology and feel
> confident of its quality.

[5.3 What are the issues concerning the creation of the HL7
message?]{.underline}

> [5.3.1 Do not use HL7 Version 3 Messaging]{.underline}

###### NEMA is concerned with the use of an HL7 informative standard/chapter as technical reference for the communication function in this process. It relies on HL7 v3 messaging, which is complex and not yet in a final approved stage with no proven implementations at this time. 

###### 

###### The use of HL7 v3 methodology for the data modeling is an excellent choice for developing the content of the ECG submission data. In fact, NEMA's many years of standards development teaches that the most important part of standardization is of the semantic content and nomenclature; the specific encoding utilized for the data is of secondary importance. 

###### In order to maximize the probability of success in a predictable timeframe NEMA advises FDA to consider a simpler XML based technology as an encoding format. NEMA is willing to help in selecting a more practical approach to the FDA\'s needs.

> [5.3.2 Specify method of encapsulation]{.underline}

The electronically formatted ECG data will most likely be stored in a
file in order to be submitted on commonly available media such as CDs.
In order to achieve completeness, the forthcoming FDA Guidance should
specify the method for encapsulation of the format in a file. This is
needed because the HL7 documents do not define this. (Specifically:
specify how to put the XML string in the file; where to start and where
to end.)

NEMA is pleased to submit these comments and looks forward to working
with the agency.

> ![](media/image3.bmp)Sincerely yours,

Robert G. Britain

![](media/image4.wmf) Vice President - Medical Products

Stephen A. Vastagh

Industry Manager -- Medical Products

Cc: Norman Stockbridge, CDER

[mailto:stockbridgen@cder.fda.gov](mailto:stockbridgen@cder.fda.gov)