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.

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. 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. Manny requested suggestions for additional publications.
  • #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.
  • #78: No change.

Decisions/Issues:

Action(s):

4 Announcements
- Jeff Secunda
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 AHIC Public Comment Period for Common Device Connectivity
- Todd
Status/Discussion:
  • Public comment period open until September 16.
  • Comments will be discussed in October.
  • Considers both push and pull to/from EHR.
  • Steve Dain noted that there is a need to edit erroneous data, e.g. artifact from sensors, as the data directly becomes part of the medical record.
  • A meeting to develop the PCD comments will take place later this week. A survey will establish the time.

Decisions/Issues:

Action(s):

  • Manny will set up the meeting.
6 Profiles for the Next Cycle
- Profile Champions
Status/Discussion:
  • ACM - Possible focus could be -
AM actors for smart alarming and evidentiary data; these are out of scope this year.
AM will eventually be powerful, but is limited this year.
Additional effor on Alarm Query/Archiver in this year's TI - nobody has volunteered to implement.
Ken noted that the archival function is broader than ACM and volunteered to review previous suggestions offered by Jack Harrington and develop a brief profile [note: http://wiki.ihe.net/index.php?title=PCD_Brief_Profile_Proposal_2008_WCM was posted later]
  • PIV - Jeff Rinda suggested that syringe pumps and PCD pumps are good possibilities for extensions.
  • Device Point-of-Care Integration - Todd led one meeting, a second is scheduled for Friday. Discussion will continue in Vancouver and then via Webex the following week.
  • RTM - Detailed discussion will continue in a meeting following this meeting.

Decisions/Issues:

Action(s):

  • Ken to provide a proposal for archiving functionality, Jeff for extensions to PIV
7 HITSP RMON
- Paul
Status/Discussion:
  • Paul attended a HITSP meeting in Chicago last week. There seems to be agreement with HITSP and Continua to use RTM for coding parameters and units of measure.
  • Some participants prefer PCD-01 with its ability to handle more complex devices.
  • The issue will be included in the next public review cycle.

Decisions/Issues:

Action(s):


Next Meeting

The next meeting was originally scheduled for September 24. That meeting is cancelled. A Joint PC/TC meeting will take place September 22 at a time to be determined. Please refer to that meeting page http://wiki.ihe.net/index.php?title=PCD_PC%26TC_2008-09-22_Webex for the meeting time.


Minutes approved October 8 PCD PC 2008-10-08 Webex


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