PCD PC 2012-03-14 Webex

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Patient Care Device Domain

Meeting Purpose

PC Regularly Scheduled Meeting

WebEx Information

Topic: PCD Planning Committee Meeting

Regularly Scheduled Meeting Time

Date: Wednesday, March 14, 2012

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

Duration: 60 Minutes

Proposed Agenda

1. Agenda Approval
2. Review Discussion Summaries: PCD PC&TC 2012-02-29 Webex
3. Profile/Supplement Development
- Timetable: Patient Care Device
4. Recruiting EHR Companies: Feb. 7 Webex
5. HIMSS12
6. AAMI Mini-Showcase
7. Action Item Review (previous review to 116)
8. Next and Recent Meetings
9. Additional Business

Action Items from Previous Meetings

See PCD Planning Committee Action Items.

Significant changes, other than dates, will be in bold.


Chair: Ken Fuchs
Paul Elletson, Al Engelbert, Ken Fuchs, John Garguilo, Monroe Pattillo, John Rhoads, Jeff Rinda, Ioana Singureanu, Erin Sparnon, Manny Furst


Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Item Topic Discussion
1 Introductions & Agenda Review
- Chair


Agenda approved.


2 Discussion Summary or Approval of Minutes
- Chair
Discussion Summary of previous meeting was accepted



3 Agenda Items
- As Noted

3. Profile Supplements:

- MEM Cybersecurity will begin meeting on Fridays at 1 pm ET starting the 23rd. John Rhoads agreed with Ken’s assessment that users are very interested in this subject. This will be included in the F2F.
- Prototype FDA Submission: Ken described an effort to learn what the FDA will want from manufacturers who claim interoperability.
- Pulse Oximeter Profile: John Rhoads described a series of lively meetings with good representation by clinicians.
- ACM: Monroe reported that the document is being revised in preparation for the day long F2F in April.
- ADQ: The intention is to have a draft ready for the F2F.

4. Recruiting EHR companies: Manny to ask Charles Parisot what PCD can do to follow up.

5. HIMSS12: Manny indicated that extensive comments about the PCD experience were received from vendors and a few docents. The summary was submitted to Sandy, John Donnelly and Elli.

6. AAMI12: Manny described the current status: He will develop a budget and other documents. Monroe indicated he has several posters from last year and is willing to bring them. Manny will develop a list of potential posters and these will be reviewed to determine if they need to be updated. The WG will meet again in two weeks. Ken suggested including some reference to MDFire in the User Handbook and elsewhere following a request from Dr. Goldman. John Rhoads indicated that the MDFire website refers to other efforts. This could be included in the AAMI12 handout. Manny will ask Dr. Goldman if he’d like to submit a poster.

8. Next meetings:

- TC March 7 then alternating.
- F2F April 24 – 27, with an alarm meeting Monday April 26 in San Diego at CareFusion.
- Pump meeting March 27 – 29 in San Diego at CareFusion.
- WHIT meeting will take place in Denmark.



4 Announcements
- As Noted

FDA Meeting last Friday on Interoperability:

Ken summarized the meeting. The goal is to move interoperability forward, help the FDA identify priorities for their resources related to these standards. The meeting started with the legal framework for public/private collaboration and what the FDA can participate in. It isn’t clear how this will affect the process. Each organization then described its role in interoperability and offered suggested major goals. This included:
- Overview of role of each SDO to identify overlaps and gaps. It will begin with a collection of use cases.
- Develop a value document. West Wireless offered its work as a starting point.
- Develop metrics to measure progress, e.g. the adoption curve.
- Consider how to market interoperability and how to structure the FDA/SDO effort.
John Garguilo asked how this will lead to use of existing standards rather than duplicative standards. Ken responded that the FDA will not take this role, but rather help bring visibility to the role of the SDOs. E.g., how will UL proceed – use existing standards or develop their own. Ken remarked that the most likely overlap for PCD will be Continua’s developments that may include hospital devices and Dr. Goldman’s work.

FDA/AAMI Annual Regulatory Meeting (end of March):

- Ken was asked to sit on a panel with Dr. Goldman in this annual meeting.



Next Meetings

The next meetings are:

PC March 28, 2012 PCD PC 2012-03-28 Webex

TC March 21, 2012 PCD TC 2012-03-21 Webex

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