DEV Domain F2F May 2023 Alexandria

Meeting Week: May 22-26, 2023 Agenda Dates: May 23-25, 2023

N.B. DRAFT - INCOMPLETE

Meeting Objectives

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:

Spok Holdings, Inc

5911 Kingstowne Village Pkwy 6th floor

Alexandria, VA 22315

The office is about 20 mins from the Reagan airport so that is the best place to fly into.

Suggested Hotels

SpringHill Suites by Marriott

6065 Richmond Hwy

Alexandria, Virginia, 22303

571-481-4441

HOLIDAY INN EXPRESS & SUITES ALEXANDRIA - FORT BELVOIR

6055 Richmond Highway

Alexandria, VA 22303

Meeting Dates

• Tuesday, May 23 : Session 1: Point-of-Care Identity Management - Session 2: Pump Meeting
• Wednesday, May 24 : PCD Planning Committee & PCD Technical Committee
• Thursday, May 25 : Joint DEV Domain meeting (PCD+DPi+PCH)(9am to 1pm Eastern)

The schedule is proposed; actual meeting times may change during the week.

Daily Schedule - All times Eastern Daylight Savings Time

• 08:30 - 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 Information

Topic: IHE DEV Domain May 2023 F2F - Tuesday, May 23

PCIM WG 8:30-11:30 ET

Meeting ID: 221 600 368 866

Passcode: bJiSM8

Pump WG 12:30-5:30 ET

Meeting ID: 277 703 337 131

Passcode: yZ99tk

Topic: IHE DEV Domain May 2023 F2F - Wednesday, May 24

Joint PCD Planning and Technical Committee 9:00-5:00 ET

Meeting ID: 235 383 111 368

Passcode: DJmYWL

Topic: IHE DEV Domain May 2023 F2F - Thursday, May 25

Devices Domain Planning and Technical Committee 9:00-5:00

Meeting ID: 210 648 052 100

Passcode: cEoKPz

Attachments / Materials

Documents related to the meeting when available will be found at the [2023-05 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:

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

Participants

Tuesday, May 23

PCD Pump WG

Chair: Kurt Elliason

Participants:

On site: Brendan Burke, Kurt Elliason, William Haralson, Roan Horning, Tom Kowalczyk, Eldon Metz, Paul Schluter, Rob Wilder, Brian Witkowski

Online:

PCD PCIM WG

Chair: Kurt Elliason

Participants:

On site: Brendan Burke, Kurt Elliason, William Haralson, Roan Horning, Tom Kowalczyk, Eldon Metz, Paul Schluter, Rob Wilder, Brian Witkowski

Online:

Wednesday, May 24

PCD Planning and Technical

Chair: Kurt Elliason

Participants:

On site: Brendan Burke, Kurt Elliason, Ken Fuchs, William Haralson, Tom Kowalczyk, Eldon Metz, Paul Schluter, Rob Wilder, Brian Witkowski

Online:

Thursday, May 25

DEV Planning and Technical

Chair:

Participants:

On site:

Online:

Meeting notes

Tuesday, May 23, 2023 (Pump & PCIM Workgroups)

Date	Hours	Committees	Topics
Tuesday Pt. 1	08:30 - 11:30	PCIMWG Meeting	Introductions - Eldon/Tom Agenda review - Eldon/Tom IHE IP Management Process - Eldon/Tom - 30 min - 25 min - 30 min - 25 min Break (9:50-10:00) - 30 min - 30 min 11:00 Review action items
Lunch	11:30 - 12:30 PM		Walk to local restaurant
Tuesday Pt. 2	12:30 - 5:00	Pump WG Meeting	Introductions - Kurt Agenda review - Kurt IHE IP Management Process - Kurt Reporting intermediate volumes - reset of volume at shift change- 60 min, Al E. PCD03 example CP 20 min, Brian W. Flush use case discussion, Michael W. Next steps: white paper, implementation notes, TF updates? - 20 min Syringe flush reporting/Auto Program new terms needed? - 20 min Break (2:30-2:45) Multi-step infusions 30-60 min Expand PCD03 Error codes see latest draft. Define/review categories - 30 min Group existing codes into categories - 30 min Review vendors specific custom error codes, identify duplicates - 30 min Revisit mgPE unit request? - xx min 5:30 Review action items

Wednesday May 24, 2023 (PCD Work Program committee)

Date	Hours	Committees	Topics
Wednesday Pt. 1	09:00 - 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) - MEM DMC (Monroe P) - MEM LS (Monroe P) MEM DMC and MEM LS to FT status - WCM (Paul Schluter) - IDCO (Paul Schluter) - RTM (Paul Schluter) - Vent (Paul Schluter) - Pump (Kurt) - IPEC (Kurt) - PIV (Kurt) - PCIM (Eldon, John R or Tom) - Physio monitor (John R) No updates, not active at this time - DEC - DCM Pulse Oximetry No updates, currently waiting for someone to take it to FT. - General update PCD TF (John R) Break 10:30-10:45 Standards Coordination -45min IEEE 11073 Device nomenclature standards (Paul S) HL7 - RTMMS V2 - 30min (Michael F.)
Lunch	12:00 - 1:00 PM		Walk to local restaurant
Wednesday Pt. 2	1:00 PM - 3:00 PM	Continue PCD Planning and Technical Committee	Device containment models (Paul S) Marketing/Recruitment of PCD Globally Discuss ways to promote PCD profiles outside the US EU Connectathon topic Proposals - PC&TC Action item review - Complete DEV Domain Action Items PC&TC Meeting Wrap up and Adjournment (Kurt & Tom) Break 2:45-3:00 Additional PCIM CP working session

Thursday May 25, 2023 (Devices Domain)

Quarter	Time	Committees	Agenda Items
Thursday Pt. 1	09:00 AM - 12:00 PM	DEV Planning and Technical Committee Meeting	9:00 > IHE IP Management Process (Kurt) - Introductions and Agenda Review (Kurt) - Welcome 9:10 > Last Dev Joint Meeting DEV Joint 2023-04-26 9:15 IHE International Board - DEV Town Hall (Todd/Ken) 9:40 Program Summary Reports (20 minutes each) DPI (9:40) PCD (10:00) PCH (10:20) 10:45 - 11:00 Break 11:00 Discussion on consistent “branding” of DEV supplements
Lunch	12:00 - 01:00 PM		Walk to local restaurant
Thursday Pt. 2	1:00 PM - 5:00 PM	DEV PC & TC Continued	Afternoon (01:00) Artificial Intelligence/Machine Learning-Enabled Medical Devices (Isabel T.) Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Discussion of how to manage DEV content other than DPI in HL7 Github in conformance with HL7 Github policies NA Connectathon 2024? 3:00 - 3:15 Break 3:15 DEV Domain Roster cleanup/update (20 minutes) - Complete DEV Domain Action Items > Next steps and wrap up Location, Dates of the DEV Fall 2023 F2F 2023 joint in person meet 11073 IEEE, AAMI headqs Sept 26-28 F2F Action Review (from this week) Adjourn Joint DEV Meeting Archive 2023 5:00 > Meeting Adjournment

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:

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