PCD PC 2008-09-10 Webex

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Patient Care Device Domain

Meeting Purpose

Regularly scheduled meeting of the PCD Planning Committee

WebEx Information

Topic: PCD Committee Tcons

Date: Wednesday, September 10, 2008

Time: 11:00 am, Eastern Time (New York )

Duration: 60 Minutes

Proposed Agenda

1 Review of minutes of August 27, 2008
2 Update Action Items
3 Find date to reschedule Sept. 17, 24
4 Plan the F2F meeting
5 Update on Brief Profile Proposals:
6 Connectathon and Showcase Planning
7 AHIC "Common Device Connectivity" Public Feedback discussion
8 HITSP RMON Update
9 IHE International
10 New Business

Minutes and Action Items from Previous Meetings

Minutes from previous meetings for review/approval:

Minutes from August 27, http://wiki.ihe.net/index.php?title=PCD_PC_2008-08-27_Webex

Action Items from the previous meeting:

No. Action Item Owner Participants Due Open/Closed Description/Update
41 Monitor FDA actions on Universal Device ID Jeff Secunda October 1, 2008 Open FDA announced that nothing will happen before the election.
44 Define relationship between IEEE standards and IHE profiles; the role of the PCD in determining this relationship. Todd Cooper October 1, 2008 Open Elliot arranged for Didi to forward the current HL7 draft to IEEE for review as a template. That one is complete and signatures added. This MOU addresses intellectual property exchanges. Change date to Oct. 1.
66 Analysis of Survey Results Ray September 10, 2008 Open
69 Recruit Champions for development of Profiles, e.g., document transfer Ken October 1, 2008 Open Extensions to ACM, waveform segments, MEM, PnP likely.
70 Coordinate 12 lead ECG effort with Cardiology domain Ray None Open Depends upon Cardiology Domain's success in finding sponsors. Defer until Cardiology Domain has updated its workplan and additional action is required.
71 Recruit clinicians; develop novel ways, attend to their priorities and schedules Ken, Manny None Open A few replies were recieved from Ken's email indicating nurses would not be able to participate in PC. Todd indicated that RTM ventilator WG has successfully recruited physicians. Profile development may be a reasonable initial focus for involvement and perhaps lead to further involvement in PCD. Paul had earlier suggested a booth at at ACC, other meetings. Liase with standards groups such as ASTM, professional societies.
72 Press releases as recruiting tool Manny September 10, 2008 Open Manny requested suggestions for publications (email and print) to send press releases. Ray suggested developing a feed to the new CE/IT community. Steve Campbell (AAMI), Joyce and Chirstel Anderson (HIMSS), Steve Grimes and Ray (ACCE). Manny will draft a release for the Trial Implementation versions. This item and item 71 will be coordinated.
73 How to accommodate participation of non-members Cochairs September 10, 2008 Open Questions remain about IP aspect of IHE membership. PCD needs to find a way for public participation in developing profile proposals and to clarify how to go beyond that in developing supplements. Need to schedule a webinar with Didi, Chris, IHE's IP attorney. PCD Cochairs to continue discussion. Ray to call Didi, Chris to follow up. Ken will address at next cochairs webex, Aug. 19.
74 Mapping PCD into v3 CDA with relevance to RTM Todd Peter Hendler September 10, 2008 Open Todd: VA was planning to move forward about use of CDA. He will talk with James McCain. Peter: Kaiser and VA working to trade documents as part of NHIN project.
Goal is to assure the appropriate set of medical device semantic components is included in the appropriate location in CDA/CCD documents and HL7 v3 nessages.
Todd will Quesry the VA as to whether there is still any interest in this project.
Todd will schedule a webex the end of August/early September to discuss the status of the profile proposal and identify what needs to happen to move it forward in this next cycle.
Will be addressed in Vancouver meeting.
75 Continua/IHE Communication: Learn who the point-of-contact is, what the process is. Ray September 10, 2008 Open Continua memorandum of understanding has been signed and Joyce Sensmeier is the IHE point of contact. Ray will ensure that coordination between Continua and the PCD is on the agenda for the first official coordination meeting between the groups. Todd suggested that discussion of RMON be coordinated through Joyce.
76 Test Tooling, NIST and MWB John Garguilo Al Engelbert, Todd Cooper, Robert Flanders, John Garguilo, John Rhoads, Peter Rontey, Paul Schluter September 10, 2008 Open Rob Snellick is working on this, will likely work with Pete Rontey to update the MWB and develop a strategy for testing PCD-01 RTM conformance in the 2009 Connectathon. Manny will survey participants, set up conference call with Pete for mid-August.
77 Develop PCD Cycle 4 Profile Proposals Ray Zambuto, Ken Fuchs IHE PCD October 31, 2008 Open Todd will update PCD_Profiles and related Wiki pages for use in the profile development process.

Todd and Ken will determine whether ITI and possibly PCC have any interest in RTLS profiling.

78 2009 Survey Development Ray Zambuto January 1, 2009 Open Ray will add a question or two regarding the need to support web services and other service oriented architectures.



Participants

Chair/Host: Ken Fuchs, Draeger
Alex Beechie, Steve Borchers, Todd Cooper, Steve Dain, Bikram Day, Al Engelbert, Robert Flanders, John Garguilo, Colin FX Garstka, John Hotchkiss, Steve Merritt, Monroe Pattillo, John Rhoads, Jeff Rinda, Paul Schluter, Jeff Secunda, Manny Furst

Discussion

Item Topic Discussion
1 Introductions & Agenda Review
- Chair 		Status/Discussion:

Decisions/Issues:

Action(s):

2 Approval of Minutes
- Chair 		Status/Discussion:

Decisions/Issues: Minutes of August 27 were approved.

Action(s):

3 Action Items Review
- Chair 		Status/Discussion:
  • #41: Jeff Secunda reported that the FDA issued an RFP for a pilot project for implanted devices. It is addressed to (a) ___________ and (b) reduce errors due to using the wrong device for a clinical application. While a preliminary rule may be issued, it is unlikely that a final rule will issue in 2009. Change to January 1.
  • #44: IEEE MOU - a response from IEEE is expected in a week. Change to October 1.
  • #66: No change.
  • #69: Ken will review Jack's documents.
  • #70, 71: No change.
  • #72: Press releases were sent to several publications. ACCE has posted one to their web site. 24X7 has expressed interest. Jeff will submit to AdvaMed.
  • #73: Transfer to Cochairs.
  • #74: CDA - Will be discussed in Vancouver. Change date to October 1.
  • #75: Continua/IHE - Close.
  • #76: Test Tooling - John Garguilo sent Peter Rontey information about last year's PCD profiles. Robert will post MWB files on a Wiki page. After review and update following the Technical Framework public comment period, this will be updated on the MWB.
Peter will provide training on the MWB in early October. A new version will be issued before that.
  • #77: Cycle 4 Profiles - Change date to October 1.


Decisions/Issues:

Action(s):

4 Announcements
- Chair 		Status/Discussion:
  • The FDA is making an effort to publicize their regulation of MDDSs.
  • The ISO 215/CEN 251 Istanbul Risk Management meetings will address software and attempt to address regulatory differences among countries.

Decisions/Issues:

Action(s):

5 xyz
- <lead> 		Status/Discussion:
  • ...

Decisions/Issues:

Action(s):

6 xyz
- <lead> 		Status/Discussion:
  • ...

Decisions/Issues:

Action(s):

7 xyz
- <lead> 		Status/Discussion:
  • ...

Decisions/Issues:

Action(s):

8 xyz
- <lead> 		Status/Discussion:
  • ...

Decisions/Issues:

Action(s):

9 xyz
- <lead> 		Status/Discussion:
  • ...

Decisions/Issues:

Action(s):

n Next Meeting
- Chair 		Status/Discussion:

Decisions/Issues:

Action(s):


Next Meeting

September, 24, 2008: http://wiki.ihe.net/index.php?title=PCD_PC_2008-09-24_Webex

<Add review line here when minutes are approved; e.g., "(Reviewed & approved by PCD RTM Vent TG 2008-04-16)">


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