DEV Domain F2F Sep 2025 FDA

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

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

• Hotel Name: Residence Inn Silver Spring
• Hotel Website: https://www.marriott.com/en-us/hotels/waslv-residence-inn-silver-spring/overview/
• Hotel Address: 12000 Plum Orchard Drive, Silver Spring, Maryland, USA, 20904
• Room Rate:

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)]

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:

• DEV Planning Committee Co-Chair: Ken Fuchs
• DEV Technical Committee Co-chair David.Gregorczyk (OR.NET)

Participants

Tuesday, Sept 9

PCD PCIM WG

Chair: Eldon Metz

Participants:

Onsite:

Al Engelbert (B. Braun Medical), Amy Rowe (B. Braun Medical), Brendan Burke (B. Braun Medical Inc.), David Eguren (FDA), Eldon Metz (InnoVision Medical Technologies), Kurt Elliason (ICU Medical), Tom Kowalczyk (B. Braun Medical)

Remote:

Brian Witkowski (Baxter), Debaditya Ghosh(GE Healthcare), Jeff Gaetano (BD), Jacob Braschler(Epic), Michael Workman (BD), Monroe Pattillo (Practical Health Interoperability LLC), Tim Chant (Connexall)

PCD Pump WG

Chair: Kurt Elliason

Participants:

Onsite:

Al Engelbert (B. Braun Medical), Amy Rowe (B. Braun Medical), Brendan Burke (B. Braun Medical Inc.), David Eguren (FDA), Eldon Metz (InnoVision Medical Technologies), Paul Schluter (Paul Schluter Consulting), Tom Kowalczyk (B. Braun Medical),

Remote:

Brian Sullivan (BD), Brian Witkowski (Baxter), Debaditya Ghosh(GE Healthcare), Jeff Gaetano (BD), Michael Workman (BD), Tim Chant (Connexall), Shawntanu (BD)

Wednesday, Sept 10

PCD/DEV Planning and Technical

Chair: Kurt Elliason

Participants:

Onsite:

Al Engelbert (B. Braun Medical), Amy Rowe (B. Braun Medical), Brendan Burke (B. Braun Medical Inc.), David Eguren (FDA), Eldon Metz (InnoVision Medical Technologies), Javier Espina (Philips), Ken Fuchs (Red*Fox Consulting), Michael Faughn (NIST), Todd AFC! Cooper (OR.NET), Tom Kowalczyk (B. Braun Medical),

Remote:

Brian Witkowski (Baxter), Jeff Gaetano (BD), Michael Workman (BD), Monroe Pattillo (Practical Health Interoperability LLC), Rob Wilder (Spok), Tim Chant (Connexall)

Meeting notes

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

Date	Hours	Committees	Agenda Items
Tuesday Pt. 1	08:00 - 10:00	PCIMWG Meeting	Introductions - Eldon/Tom Agenda review - Eldon/Tom IHE IP Management Process - Eldon/Tom
Tuesday Pt. 2	10:15 - 12:00	PCIMWG Meeting
Lunch	12:00 - 1:30 PM
Tuesday Pt. 3	1:30 PM - 5:00 PM	Pump WG Meeting	Introductions - Kurt Agenda review - Kurt IHE IP Management Process - Kurt 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 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 Review comments in Standardized Identification Whitepaper - 30 min - 30 min
Tuesday Pt. 4	5:00 PM - 5:30 PM	Group Dinner

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/

The draft minutes of the Sep 9, 2025 meeting are at https://ieee-sa.imeetcentral.com/p/aQAAAAAFL6L-.

Presented materials on that day are stored at https://ieee-sa.imeetcentral.com/p/ZgAAAAABJ4tK and linked from the minutes.

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	8:00 > IHE IP Management Process (Kurt) - 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) - All IHE meetings have switched over to use IHE Google Meet account instead of HIMSS Teams account. - Elections Treasurer Board Co-chair B General Membership voting in process for (though Sept 15) Board Member At-large C&D Emeritus Domain Co-chair B MarComm Chair - Acknowledgment of the IHE "Project Z" V 1.0 was approved through offline voting working on formal name and public launch Pilot project in EU 8:15 NA Connectathon 2026 link to be updated IHE-NA Early Oct. (5-9?) Location: TBD Planned profiles to test IHE-EU: March 23 - 26, 2026, Brussels Belgium HIMSS'26 Showcase March 9-12 Location: Las Vegas 8:25 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 8:30 Program Summary Reports (15 minutes each) DPI (8:35) PCD (8:40) PCD-update PCH (8:45) 9:00 IHE DEV OID extensions https://wiki.ihe.net/index.php/PCD_OID_Management SDPi-specific discussion that Todd just mentioned, listing the missing "OID categories": https://github.com/IHE/DEV.SDPi/issues/449 Add OIDs · Issue #449 · IHE/DEV.SDPi 9:30 Complete DEV Domain Action Items 9:40 GitHub/AsciiDoc publishing update Considerations Start with all three volumes or just Vol2 or the smaller v1 and 3? Use one repo for TF, IHE\DEV? Separate Repo for tools\code extensions in Java, Javascript, Ruby? Tools: IntelliJ, VS Code, other Consider shared CSS for consistency across DEV publications Adjourn Joint DEV Meeting Archive 2025
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	IHE/PoCD/PHD Agenda

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

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