DEV Domain F2F Sep 2025 FDA

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Meeting Week: Sept 8-12, 2025 Agenda Dates: Sept 9-11, 2025

N.B. DRAFT - INCOMPLETE

Meeting Objectives

This is a special meeting held in parallel with the IEEE 11073 PoCD and PHD WGs.
The final day (Thursday 9/11) will be a joint plenary with invited guests.
These face-to-face meetings have a number of objectives depending on the programs and committees involved:
  • DEV Domain level Discussions
  • DEV PCD Program Discussion
  • DEV PCH Program Discussion
  • DEV DPi Program Discussion
Planning Committee: Review, plan and initiate PCD activities; contribute to planning of the HIMSS Interoperability Showcase and other Showcases and events; recruit vendors and users.
Technical Committee: Review and adopt brief profile proposals; contribute to Connectathon test tools, tests, and procedures.

Location & General Schedule

Meeting Location:
FDA Headquarters Address: FDA White Oak Campus
10903 New Hampshire Avenue, Silver Spring, MD 20993
Special access information: All foreign visitors without a green card must provide information to Isabel Tejero and Kostas Makrodimitris to submit 10 days prior to the meeting, the information is linked to the IEEE agenda. Visitor Information
Directions to FDA -Google map
the route to the visitor's parking from hotel
Plan about 30 min to get to FDA from hotel , visitor parking is near security building, about a 5 min walk from there to building 1.
Need to be at building 1 security by 7:45 to allow time to get to meeting rooms.
Suggested Hotels
Hotel information for the Joint PoCD/PHD Meeting that will be in held at FDA Headquarters in


Meeting Dates
  • Tuesday, Sept 9: IHE Session 1: Point-of-Care Identity Management - IHE Session 2: Pump Meeting (FDA Building 2 – Room 2053)
  • Tuesday, Sept 9: PHD Session 1:
  • Tuesday, Sept 9: POCD Session 1:
  • Wednesday, Sept 10 : IHE Session 1: PCD Planning Committee & PCD Technical Committee IHE Session 2: Joint DEV Domain meeting (PCD+DPi+PCH) (FDA Building 2 – Room 2053)
  • Wednesday, Sept 10 : PHD Session 1:
  • Wednesday, Sept 10 : POCD Session 1:
  • Thursday, Sept 11 : Plenary (FDA Room 2047 -Auditorium)
The schedule is proposed; actual meeting times may change during the week.
Daily Schedule - All times Eastern Daylight Savings Time
  • 08:00 - 12:00 Session #1
  • 1:00 - 5:00 Session #2

Agenda Suggestions

Please submit suggestions for agenda topics here or through emails to the committee co-chairs.

Teams Meeting Information

Topic: IHE DEV Domain Sept 2025 F2F - Tuesday, Sept 9

All times are in US Eastern Time
8:00am – 12:00am: PCIM Workgroup
1:30pm – 5:00pm: Pump Workgroup
Join Teams meeting
Meeting ID: 292 339 385 743 8
Passcode: qF2VQ6DW


Topic: IHE DEV Domain Sept 2025 F2F - Wednesday, Sept 10

All times are in US Eastern Time
8:00am – 12:00pm: PCD/DEV Technical & Planning Committees
Join Teams meeting
Meeting ID: 292 339 385 743 8
Passcode: qF2VQ6DW
1:30pm – 5:00pm: IHE Devices/IEEE Joint Meeting
IEEE agenda and meeting links


Topic: IEEE/IHE Plenary Sept 2025 F2F - Thursday, Sept 11

IEEE agenda and meeting links

Attachments / Materials

Documents related to the meeting when available will be found at the [2025-09 DEV F2F Devices Google Drive] unless otherwise noted. Documents are available without a password.

Schedule/Deadlines: Patient Care Device and Domain Milestones

PCD PC Action Items PCD Planning Committee Action Items. Significant changes, other than dates, will be in bold.

PCD TC Action Items PCD Technical Committee Action Items. Significant changes, other than dates, will be in bold.

CoChairs

PCD Work Program Co-Chairs:
  • DEV Planning Committee Co-Chair: Kurt Elliason (ICU Medical), [Rob Wilder (Spok)]
  • DEV Technical Committee Co-chair [Tom Kowalczyk, (BBraun Medical)] and [Lisa Diggett (Becton Dickenson)]
PCH Work Program Co-Chairs:
  • DEV Planning Committee Co-Chair: [TBD]
  • DEV Technical Committee Co-chair [Javier Espina (Philips)]
Device Point-of-Care Interoperability Program Co-Chairs:

Participants

Tuesday, Sept 9

PCD PCIM WG
Chair: Eldon Metz
Participants:
Onsite:
Online:
PCD Pump WG
Chair: Kurt Elliason
Participants:
Onsite:
Online:


Wednesday, Sept 10

PCD/DEV Planning and Technical
Chair: Kurt Elliason
Participants:
Onsite:
Online:


Meeting notes

Tuesday, Sept 9, 2024 (IHE Pump & PCIM Workgroups)

Date Hours Committees Agenda Items
Tuesday Pt. 1 08:00 - 10:00 PCIMWG Meeting
Tuesday Pt. 2 10:15 - 12:00 PCIMWG Meeting



Lunch 12:00 - 1:30 PM
Tuesday Pt. 3 1:30 PM - 3:15 PM Pump WG Meeting
  • pcd-15 containment for pumps - 30 min
  • pcd-03 error codes - 30 min
  • pcd-03 for PCA pumps - 30 min
Multiple delivery types, multiple RXG examples
  • - 30 min
  • Break - 15 min
  • Review TF vol2 Table M.1.2.1-4 Clinical Scenarios - 30 min
switching from a library based infusion to non library pg. 262
Tuesday Pt. 4 3:30 PM - 5:00 PM Pump WG Meeting

Tuesday Sept 9, 2024 (IEEE 11073 PHD and POCD WG Sessions)

https://sagroups.ieee.org/11073/meeting/annual-joint-ieee11073-phd-and-pocd-with-ihe-devices-in-person-meeting-fdawhiteoaksilverspringusa/

Wednesday Sept 10, 2024 (IHE PCD Work Program committee and DEV Domain Committee)

Date Hours Committees Agenda Items


Wednesday Pt. 1 8:00 AM - 10:00 AM DEV Planning and Technical Committee
- Introductions and Agenda Review (Kurt)
- Welcome
If you are interested in receiving Domain updates, Ballot invitations and meeting notices etc. for the Devices Domain please click this link to join the DevPC-TC Google group.
  • 8:05 IHE International Board - DEV Town Hall (Kurt/Ken)
  • 8:15 Program Summary Reports (15 minutes each)
Early Oct. (5-9?)
Location: TBD
Planned profiles to test
  • HIMSS'26 Showcase
March 9-12
Location: Las Vegas
  • 8:55 Marketing/Recruitment of DEV Globally
The IHE Marketing and Communications Committee has been working to revamp the IHE Newsletter; one area of focus has been to highlight important milestones within IHE Domains.
- IHE Newsletter Signup
- IHE Canada Webinar: Sept 18,2025
  • 9:00 IHE DEV OID extensions
Wednesday Pt. 2 10:30 - 12:00 PCD Program Planning and Technical Committee (PC&TC)
  • Introduction
- IHE IP Management Process (5 minutes)(Kurt)
- Review & Approve PCD Agenda (Kurt)
  • General PCD Work Program Review (statuses, plans, and technical discussion):
- ACM (Rob W) ACM+MEM
- PCMC (Point of Care Monitored Communication)
New profile proposal (Peter K)
- MEM DMC (Monroe P)
- MEM LS (Monroe P)
- Pump (Kurt) (Pump WG update presentation)
- IPEC (Kurt)
- PIV (Kurt)
- PCIM (Eldon /Tom) (PCIM update presentation)
- Physio monitor ()
No updates, not active at this time
- DEC
- DCM Pulse Oximetry
No updates, currently waiting for someone to take it to FT.
- WCM (Paul Schluter)
- Vent (Paul Schluter)
- General update PCD TF (Co-Chairs)
Co-chairs reviewing last update, plan to have a 2024 update complete for publication by end of the year.
  • Standards Coordination - 5min (Summary only, details to be covered in joint afternoon session)
*2024 DEV Domain Roster cleanup/update
Please review the roster and update for your organization. List of member organizations is available here
  • Proposed Location, Dates of the DEV Spring 2026 F2F
HIMSS in March, HL7/IEEE meetings in May. Will plan a time in April.
West coast option at ?, East coast possibly ?
  • PC&TC Meeting Wrap up and Adjournment (Kurt & Tom)
  • PC&TC Action item review
- Complete DEV Domain Action Items::
Lunch 12:00 - 1:30 PM
Wednesday afternoon 1:30 PM - 5:00 PM Joint PoCD/PHD/IHE DEV meeting

Wednesday Sept 10, 2025 (IEEE 11073 PHD and POCD WG Sessions)

https://sagroups.ieee.org/11073/meeting/annual-joint-ieee11073-phd-and-pocd-with-ihe-devices-in-person-meeting-fdawhiteoaksilverspringusa/

Thursday Sept 11, 2025 (IEEE11073/IHE DEVICES JOINT WORKGROUP MEETING ON INTEROPERABILITY STANDARDS)

https://sagroups.ieee.org/11073/meeting/annual-joint-ieee11073-phd-and-pocd-with-ihe-devices-in-person-meeting-fdawhiteoaksilverspringusa/

Goal:
Facilitate the standard development lifecycle of interoperability standards, profiles and use cases of the three Workgroups (IEEE11073/POCD/PHD and IHE/DEV).
Coordinate interoperability standards, profiles and use cases, understand domains amongst workgroups and other in the interoperability space, collaborate on promotion of standards, optimize :standards for regulatory purposes, plan for conformity assessment, evaluate the adoption of standards and harmonize these standards globally.

Action Items - PC

The Action Items that follow and approved in subsequent committee meetings will be added to the committee Action Item page.


Next Meetings

Technical Committee:

Planning Committee:

- Next DEV Joint Meeting DEV Joint 2025-09-24
- Next PCD TC-PC Meeting PCD TC-PC 2025-10-08


DEV Home Page

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