Medical Product Information Project Meeting Minutes

Teleconference

May 6, 2010

Attendees:

Name / Affiliation / E-mail Address
Richard Brandt / Quark /
Jay Crowley / FDA /
Bill Friggle / Sanofi-Aventis /
Jackie Elkin / Medtronic /
Myron Finseth / Medtronic /
Michael Mlodzik / Boehringer Ingelheim Vetmedica, Inc. /
Janine Bridgeford / GE Healthcare /
Andrea Poteat / Baxter Healthcare /
Terrie Reed / FDA /
Anie Mathews / FDA /
Steve Ryan / Genzyme /
Jean Kirkeleit-Davis / Hospira /
Jeff Secunda / AdvaMed /
Joe Jenkins / Oberon Technologies /
Gabriele Fischer / Pfizer /
Beth Thompson / Medline /
Sue Santamaria / Veterinary Medical Informatics Laboratory /
Andy Martin / GHX
Reina Kalish / Baxter Healthcare /
Gunther Schadow / Pragmatic Data /

Agenda:

I.  Medical Product Information (SPL r5) project overview

·  Medical Product Information (SPLr5) teleconference call is the beginning of bi-weekly meetings that have been setup specifically to discuss the new project as it goes through the balloting process (May 2011). Agendas will vary. Today’s agenda provided an overview of the standard, balloting process, and give opportunities for questions.

·  Link to Microsoft Live Meeting was not working for most attendees. Myron will look into getting a more reliable link sent out to all on the List Serve before the next meeting.

·  The SPLr5 project was started during the January HL7 WGM in Phoenix AZ. SPLr5 adds structures that will help support medical devices and substances. Since the January WGM, there have been three meetings in the SPL Technical Team telecons. During these meetings, Terrie Reed, CDRH, gave a presentation on CDRH Informatics and the UDI project, Gunther Schadow, SPL and CPM modeler, gave a Discussion paper on SPL and CPM – describing how the standards are structured.

·  This separate telecon for the SPLr5 project was formed so that we could get interested parties engaged in the standard development. Since few device companies have been participating in the RCRIM WG, some special efforts have been made to get participation from device companies.

II.  Changes from SPL R4 to SPL R5

Discussed similarities and differences between SPL R4 and R5 and how SPL relates to other HL7 standards (RPS, ICSR, etc.). The supporting slides have been posted to the project wiki page:

http://wiki.hl7.org/images/8/8d/SPLr4_to_SPL(r5)_presentation_04062010.pdf

III.  HL7 organization, project wiki page

Reviewed the new SPLr5 Project wiki page that is setup under the RCRIM Working Group wiki. Looked the major sections of the page (project scope, meeting information, minutes, working documents, HL7 ballot materials, voting guides).

http://wiki.hl7.org/index.php?title=Medical_Product_Information_(SPLr5)

IV.  Review ballot website

Looked at the SPLr5 and Common Product Model (CPM) ballot material on the HL7 Ballot website. Gunther gave a brief overview of the CPM Domain Message Information Model diagram and pointed out the main areas of the model.

http://www.hl7.org/v3ballot/html/welcome/environment/index.htm

V.  Other

The meetings are scheduled for every other Thursdays at 10:30 eastern. The next meeting (May 20th) will be cancelled due to the HL7 Working Group Meeting in Rio de Janeiro. The next project telecon will be Thursday, June 3rd.

Everyone is encouraged to send in agenda items and suggestions for future meetings.

Medical Product Information (SPLr5) Meeting Minutes May 6, 2010 Page 1 of 2