DEV Domain F2F May 2023 Alexandria: Difference between revisions

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'''Agenda Dates''': May 23-25, 2023
'''Agenda Dates''': May 23-25, 2023


== '''N.B. DRAFT - INCOMPLETE ==
== '''N.B. DRAFT - INCOMPLETE ''' ==




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:* '''DEV DPi 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.
:: 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; Adjourn Joint PC&TC meeting. contribute to Connectathon test tools, tests, and procedures.
:: Technical Committee:  Review and adopt brief profile proposals; contribute to Connectathon test tools, tests, and procedures.


== Location & General Schedule ==
== Location & General Schedule ==


: '''Meeting Location''':  
: '''Meeting Location''':
:Spok Holdings, Inc  
:Spok Holdings, Inc
:5911 Kingstowne Village Pkwy 6th floor  
:5911 Kingstowne Village Pkwy 6th floor
:Alexandria, VA 22315
:Alexandria, VA 22315


Line 25: Line 25:
:
:


: '''Suggested Hotel'''  
: '''Suggested Hotels'''
:The Westin Alexandria Old Town
:400 Courthouse Square
:Alexandria, VA 22314


::'''[https://www.marriott.com/en-us/hotels/wasax-springhill-suites-alexandria/overview/?scid=f2ae0541-1279-4f24-b197-a979c79310b0 SpringHill Suites by Marriott]'''
:::6065 Richmond Hwy
:::Alexandria, Virginia, 22303
:::571-481-4441
:
:


::Phone: +1 TBD
::'''[https://www.ihg.com/holidayinnexpress/hotels/us/en/alexandria/axexs/hoteldetail? HOLIDAY INN EXPRESS & SUITES ALEXANDRIA - FORT BELVOIR]'''
:: Booking link: TBD
:::6055 Richmond Highway
:::Alexandria, VA 22303
:: Instructions on how to make reservation to receive the group rate.
:::1. TBD
:::2. Code: SP3
::
:::OR
::
:::Call the hotel reservationist direct at


:


: '''Tentative Dates'''  
: '''Meeting Dates'''


::* Tuesday, May 23 : Joint DEV Domain meeting (PCD+DPi+PCH)(9am to 1pm Eastern)
::* Tuesday, May 23 : Session 1: Point-of-Care Identity Management - Session 2: Pump Meeting
::* Wednesday, May 24 : PCD Planning Committee & PCD Technical Committee
::* Wednesday, May 24 : PCD Planning Committee & PCD Technical Committee
::* Thursday, May 25 : Session 1: Pump Meeting - Session 2: Point-of-Care Identity Management
::* 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.
:: The schedule is proposed; actual meeting times may change during the week.
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: '''Daily Schedule''' - All times Eastern Daylight Savings Time
: '''Daily Schedule''' - All times Eastern Daylight Savings Time


:* 08:00 - 12:00    Session #1
:* 08:30 - 12:00    Session #1


:* 1:00 - 5:00    Session #2
:* 1:00 - 5:00    Session #2
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Topic: IHE DEV Domain May 2023 F2F - '''Tuesday, May 23'''
Topic: IHE DEV Domain May 2023 F2F - '''Tuesday, May 23'''


[https://teams.microsoft.com/ Join Teams Meeting]  
:[https://teams.microsoft.com/l/meetup-join/19*3ameeting_MDI0MTBkZmQtNGE1Zi00YTU5LTllNzAtMTA4ODFjM2JhYjEw*40thread.v2/0?context=*7b*22Tid*22*3a*2202a9376b-a4f9-4a63-a240-52c43ebf9a89*22*2c*22Oid*22*3a*226459fea4-110a-4d17-85f0-00587211a0c0*22*7d__;JSUlJSUlJSUlJSUlJSUl!!OKmB4xE!4ncMbnoZon-2iyZxUQawriZOQ0equupedRMIOj2Jo6zO066hupDV6cBk2xICUb585tIH2mbMVKuE4e_b4OJWkCA$ PCIM WG 8:30-11:30 ET]


Meeting ID:
:Meeting ID: 221 600 368 866
:Passcode: bJiSM8


Passcode:  
:[https://www.microsoft.com/en-us/microsoft-teams/join-a-meeting?rtc=1 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'''
Topic: IHE DEV Domain May 2023 F2F - '''Wednesday, May 24'''


[https://teams.microsoft.com/ Join Teams Meeting]
:[https://www.microsoft.com/en-us/microsoft-teams/join-a-meeting?rtc=1 Joint PCD Planning and Technical Committee 9:00-5:00 ET]


Meeting ID:
:Meeting ID: 235 383 111 368
:Passcode: DJmYWL


Passcode:




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


[https://teams.microsoft.com/ Join Teams Meeting]  
:[https://www.microsoft.com/en-us/microsoft-teams/join-a-meeting?rtc=1 Devices Domain Planning and Technical Committee 9:00-5:00]


Meeting ID:
:Meeting ID: 210 648 052 100
 
:Passcode: cEoKPz
Passcode:  


== Attachments / Materials ==
== Attachments / Materials ==


Documents related to the meeting '''when available '''will be found at the [[https://drive.google.com/drive/folders/1jKMF6gVkmR6G-ezr8OuK-C6cCV6vyiKG?usp=sharing 2022-10 DEV F2F Devices Google Drive]] unless otherwise noted. Documents are available without a password.
Documents related to the meeting '''when available '''will be found at the [[https://drive.google.com/drive/folders/1JA38YlejAGoueIVbMJXUcUbxDF7raZsL?usp=share_link 2023-05 DEV F2F Devices Google Drive]] unless otherwise noted. Documents are available without a password.


Schedule/Deadlines: [[Patient Care Device]] and [[Domain Milestones]]
Schedule/Deadlines: [[Patient Care Device]] and [[Domain Milestones]]
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PCD TC Action Items [[PCD Technical 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 ==  
==  CoChairs ==
:PCD Work Program Co-Chairs:
:PCD Work Program Co-Chairs:
::* DEV Planning Committee Co-Chair:  [mailto:kurt.elliason@icumed.com| Kurt Elliason (ICU Medical)], [Rob Wilder (Spok)]
::* DEV Planning Committee Co-Chair:  [mailto:kurt.elliason@icumed.com| Kurt Elliason (ICU Medical)], [Rob Wilder (Spok)]
Line 115: Line 115:


'''Tuesday, May 23'''
'''Tuesday, May 23'''
:'''PCD PCIM WG '''
:'''Chair:''' Kurt Elliason
:'''Participants:'''
::: On site: Brendan Burke, Kurt Elliason, Al Englebert, William Haralson, Roan Horning, Tom Kowalczyk, Eldon Metz, Monroe Pattillo, Paul Schluter, Rob Wilder, Brian Witkowski
::: Online:  Lisa Diggett, Ben Elliot, Ben Fascelli, Michael Faughn, Thomas Joseph, Ali Nakoulima, Steven Nichols, Marufur Rahman, Andrea Roberts, Jesus Santana, Brugu Sirimalla, Isabel Tejero, Michael Workman
:'''PCD Pump WG '''
:'''PCD Pump WG '''
:'''Chair:''' ''
:'''Participants:''' 
:: On site:


:: Online:  
:'''Chair:''' Kurt Elliason
 
:'''Participants:'''


:'''PCD PCIM WG '''
::: Online:  Adam Bunton, Shantanu Chawla, Lisa Diggett, Ben Elliot, Ben Fascelli, Thomas Joseph, Martin Kasparik, Chris Mathes, Ali Nakoulima, Steven Nichols, Jeff Rinda, Brugu Sirimalla, Isabel Tejero
:'''Chair:''' ''
:'''Participants:'''  
:: On site:


:: Online:


'''Wednesday, May 24'''
'''Wednesday, May 24'''
:'''PCD Planning and Technical '''
:'''PCD Planning and Technical '''
:'''Chair:''' '' 
:'''Participants:''' 


:: On site:
:'''Chair:''' Kurt Elliason


:: Online:  
:'''Participants:'''
 
::: On site: Brendan Burke, Kurt Elliason, Al Englebert, Ken Fuchs, William Haralson, Tom Kowalczyk, Eldon Metz, Monroe Pattillo, Paul Schluter, Rob Wilder, Brian Witkowski
 
::: Online: Ben Fascelli, John Garguilo, Brian Sullivan




'''Thursday, May 25'''
'''Thursday, May 25'''
:'''DEV Planning and Technical '''
:'''DEV Planning and Technical '''
:'''Chair:''' ''  
:'''Chair:''' ''
:'''Participants:'''
:'''Participants:'''


:: On site:  
:: On site:


:: Online:
:: Online:
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=== Tuesday, May 23, 2023 (Devices Domain) ===
=== Tuesday, May 23, 2023 (Pump & PCIM Workgroups) ===




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! width="10%"  align="center" |Date
! width="10%"  align="center" |Date
! width="10%"  align="center" |Hours
! width="10%"  align="center" |Hours
! width="20%"  align="center"   |Committees
! width="20%"  align="center" |Committees
!              align="center"   |Topics
!              align="center" |Topics
 


|-
|-
| align="center" | '''Breakfast'''  
| align="center" | '''Tuesday Pt. 1'''
| align="center" | 8:30 - 9:00 AM
| align="center" | 08:30 - 11:30
| align="center" | PCIMWG Meeting
|
|
|
::* Introductions - Eldon/Tom
|-
::* Agenda review - Eldon/Tom
| align="center" | '''Tuesday Pt. 1'''
::* [[Patent_Disclosure_Process | IHE IP Management Process]] - Eldon/Tom
| align="center" | 09:00 - 12:00
:::
:::  - 30 min
:::  - 25 min
:::  - 30 min
:::  - 25 min
::
:: Break (9:50-10:00)
 
:::
::: - 30 min
::: - 30 min
:::
:: 11:00 Review action items




| Joint IHE Devices Meeting
|
:* 9:00 > [[Patent_Disclosure_Process | IHE IP Management Process]] (Kurt)
::: - Introductions and Agenda Review (Kurt)
::: - Welcome
:* 9:10 > IHE International Board - DEV Town Hall (Todd)
:* 9:40 Program Summary Reports (20 minutes each)
::* DPI (9:40)
::* [https://docs.google.com/presentation/d/1350jHoml2I80k04pPPxOSn9X1_gBg_O5/edit?usp=sharing&ouid=108127959796856836161&rtpof=true&sd=true PCD] (10:00)
::* PCH (10:20)
:* 10:40 - 10:50 Break
::
:* 10:50 [https://docs.google.com/spreadsheets/d/1PfPBVMoraBTBlHNUkOq8kJQs7n81hi2N/edit?usp=sharing&ouid=108127959796856836161&rtpof=true&sd=true DEV Domain Roster] cleanup/update (20 minutes)
:* 11:00 [https://docs.google.com/document/d/1BKO5xvzDinb9IZg7AhViwSCD7uJLdbVQ/edit?usp=sharing&ouid=108127959796856836161&rtpof=true&sd=true Domain board report draft] (30 minutes)
:* 11:10 NA Connectathon 2023
::> Next steps and wrap up
::* Location, Dates of the DEV Spring 2023 F2F
::* F2F Action Review (from this week)
:* 11:15 > Adjourn Joint DEV Meeting Archive 2022
|-
|-
| align="center" | '''Lunch'''  
| align="center" | '''Lunch'''
| align="center" | 12:00 - 1:00 PM
| align="center" | 11:30 - 12:30 PM
|
|
|
|
: Walk to local restaurant
|-
|-
| align="center" | '''Tuesday Pt. 2'''
| align="center" | '''Tuesday Pt. 2'''
| align="center" | 01:00 - 4:00
| align="center" | 12:30 - 5:00
| align="center" | Pump WG Meeting
|
|
|
::* Introductions - Kurt
:* 1:00 > Start PCIM WG
::* Agenda review - Kurt
:
::* [[Patent_Disclosure_Process | IHE IP Management Process]] - Kurt
:* 2:30-2:45 > Break
:::
:
 
:* 4:00 PM >
:::* Reporting intermediate volumes - reset of volume at shift change- 60 min,  Al E.
:::: Add 4 new terms to 10101b, follow-up call on Wed next week at 3ET to finalize
:::: MDC_VOL_FLUID_DELIV_SINCE_COUNTER_RESET - volume delivered since last reset
:::: MDC_DOSE_DRUG_DELIV_SINCE_COUNTER_RESET - drug amount delivered since last reset
:::: MDC_TIME_PD_SINCE_COUNTER_RESET - Elapsed time since last volume and/or drug amount balancing reset
:::: MDC_TIME_COUNTER_RESET - time of last reset
 
:::* PCD03 example CP 20 min, Brian W.
:::: Reviewed CP and TF.  Identified sections related to AppAck optionality that can be removed.  Brian will rework CP and send out for review
:::*  [https://docs.google.com/document/d/19x4K0tXV5ZLd-dAmxF7OihlyEO0ngLkq/edit?usp=sharing&ouid=108127959796856836161&rtpof=true&sd=true Flush use case] discussion, Michael W.
::::  Next steps: white paper, implementation notes, TF updates? - 20 min
::::: Review use cases with EMR vendors. - Review/cleanup latest draft and schedule meetings.  Lisa will work on this.
::::: White paper from use cases?  Do we want Connectathon tests specific to Flush?
::::: Identify TF updates related to ordering flushes.
 
::::  Syringe flush reporting/Auto Program new terms needed? - 20 min
::::: Terms exist for reporting but no terms for programming.
::::: How do EMRs order flushes now, want to order them in the future.  As step in multi-step infusion or as a separate order?
::::: Do customers want drug and flush in the same order?  Can it be done with two linked orders?  Every med/bag/syringe should be scanned.
 
:: Break (2:30-2:45)
:::* Multi-step infusions  30-60 min
:::: A short section exists in the TF.  No one has really tried to use it yet.  This is another topic to discuss with EMR vendors to support this, more edits may need to be made when multi-step is supported.  Common scenario would be a loading dose followed by a maintenance dose. 
 
:::* Expand PCD03 Error codes [https://docs.google.com/spreadsheets/d/1G2TU873iFMjxW4GX0AXHIXJMJoDvq1VO/edit?usp=drive_link&ouid=108127959796856836161&rtpof=true&sd=true 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
:::: Decided to use segment 7 (Diagnostic Information) to communicate category.
:::: ERR|||207^Application internal error^^^^^^^207\S\Application internal error: Unable to match medication to drug library|E|9010^Unable to match medication to drug library||Category1~Category2
 
::
:::* Revisit mgPE unit request?
:::: EMR vendors get something in LOINC?  Work with Regenstrief?  Can pump vendors do anything?
:::: Can FDA help?
:: 5:30 Review action items
 
|-
|-
|}
|}


=== Wednesday May 24, 2023 ===
=== Wednesday May 24, 2023 (PCD Work Program committee) ===
 
 


:{|class="wikitable"
:{|class="wikitable"
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! width="10%"  align="center" |Date
! width="10%"  align="center" |Date
! width="10%"  align="center" |Hours
! width="10%"  align="center" |Hours
! width="20%"  align="center"   |Committees
! width="20%"  align="center" |Committees
!              align="center"   |Topics
!              align="center" |Topics
 


|-
| align="center" | '''Breakfast'''
| align="center" | 7:30 - 8:00 AM
|
|
|-
|-
| align="center" | '''Wednesday Pt. 1'''
| align="center" | '''Wednesday Pt. 1'''
| align="center" | 08:00 - 12:00
| align="center" | 09:00 - 12:00
| PCD Program Planning and Technical Committee (PC&TC)
| PCD Program Planning and Technical Committee (PC&TC)
|
|
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:: '''General PCD Work Program Review''' (statuses, plans, and technical discussion):
:: '''General PCD Work Program Review''' (statuses, plans, and technical discussion):
::- ACM (Rob W or Monroe P)
::- ACM (Rob W)
::: CP Ballot
::- MEM DMC (Monroe P)
::- MEM DMC (Monroe P)
::: Ballot for update to MEMDMC TI
::- MEM LS (Monroe P)
::- MEM LS (Monroe P)
::: Ballot for update to MEMLS TI
:::: MEM DMC and MEM LS to FT status
::- WCM (Paul Schluter)
::- WCM (Paul Schluter)
::- IDCO (Paul Schluter)
::- IDCO (Paul Schluter)
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::- Physio monitor (John R)
::- Physio monitor (John R)
::: No updates, not active at this time
::: No updates, not active at this time
::- DEC  
::- DEC
::- DCM Pulse Oximetry
::- DCM Pulse Oximetry
::: No updates, currently waiting for someone to take it to FT.
::: No updates, currently waiting for someone to take it to FT.
::- General update PCD TF (John R)
::- General update PCD TF (John R)
:
:
:* Break 10:10-10:20
:* Break 10:30-10:45
:
:
 
:* Standards Coordination -45min
:* Device nomenclature standards (Paul S)
:: IEEE 11073
 
::: Device nomenclature standards (Paul S)
:* Standards Coordination
:: IEEE 11073
:: HL7
:: HL7
:
:
::- RTMMS V2 (Michael F.)
::- RTMMS V2 - 30min (Michael F.)
 
:* '''Five year plan'''
::: No current plan
:::- [https://docs.google.com/spreadsheets/d/1VnZqO685xFd9KQrw_YcewwchQYY12cpm/edit?usp=sharing&ouid=108127959796856836161&rtpof=true&sd=true 2020 Roadmap]
:::- and [https://drive.google.com/file/d/1HB7hpxh59E84Yjg8Kvj-W1SnJg8Wtrkm/view?usp=sharing 2011 Plan Notes]
::
::
::
::
|-
|-
| align="center" | '''Lunch'''  
| align="center" | '''Lunch'''
| align="center" | 12:00 - 1:00 PM
| align="center" | 12:20 - 1:20 PM
|
|
|
|
: Walk to local restaurant
|-
|-
| align="center" | '''Wednesday Pt. 2'''
| align="center" | '''Wednesday Pt. 2'''
| align="center" | 1:00 PM - 4:00 PM
| align="center" | 1:20 PM - 3:00 PM
|  PCD wrap-up and PCIM Working Group
|  Continue PCD Planning and Technical Committee
|  
|
:* Device containment models (Paul S)
 
:* Marketing/Recruitment of PCD Globally
:* Marketing/Recruitment of PCD Globally
:: Discuss ways to promote PCD profiles outside the US
:: Discuss ways to promote PCD profiles outside the US
::
::
:* Proposals -  
:* EU Connectathon topic
:* Proposals -
::
::
:* PC&TC Action item review
:* PC&TC Action item review
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:* PC&TC Meeting Wrap up and Adjournment (Kurt & Tom)
:* PC&TC Meeting Wrap up and Adjournment (Kurt & Tom)
:
:
:* Break 2:45-3:00
:
:
:* Break 2:50-3:00
:* Additional PCIM CP working session
:
: Begin PCIM WG meeting
:
:
: CPs & Profile updates
: Connectathon tests
|}
|}


=== Thursday May 25, 2023 (Pump & PCIM Workgroups) ===
=== Thursday May 25, 2023 (Devices Domain) ===




:{|class="wikitable"  
:{|class="wikitable"
|-
|-
! width="10%"  align="center" |Quarter
! width="10%"  align="center" |Quarter
! width="10%"  align="center" |Time
! width="10%"  align="center" |Time
! width="20%"  align="center" |Lead
! width="20%"  align="center" |Committees
!              align="center" |Agenda Items
!              align="center" |Agenda Items


|-
| align="center" | '''Breakfast'''
| align="center" | 7:30 - 8:00 AM
|
|
|-
|-
| align="center" | '''Thursday Pt. 1'''
| align="center" | '''Thursday Pt. 1'''
| align="center" | 08:00 - 10:00 AM
| align="center" | 09:00 AM - 12:00 PM
| align="center" | PCIM workgroup
| align="center" | DEV Planning and Technical Committee Meeting
|
|
:* 9:00 > [[Patent_Disclosure_Process | 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)
::* [https://docs.google.com/presentation/d/1jr8KXjPxO1NWkg3kbt0ACH1JN4cWFL37/edit?usp=drive_link&ouid=108127959796856836161&rtpof=true&sd=true PCD] (10:00)
::* PCH (10:20)
:* 10:45 - 11:00 Break
::
::
: Morning (08:00)
::
::* Agenda review - TBD
:* 10:00 Discussion on consistent “branding” of DEV supplements
::* [[Patent_Disclosure_Process | IHE IP Management Process]] - TBD
:* 10:30 Marketing/Recruitment of DEV Globally
:
:* 11:00
:
:* Artificial Intelligence/Machine Learning-Enabled Medical Devices (Isabel T.)
: CPs & Profile updates
:: [https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-issues-draft-guidance-predetermined-change-control-plans-artificial-intelligencemachine Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices]
: Connectathon tests
:
: 10:00-12:00 Break  - Falcon 9 launch at 10:45 
::https://www.spacelaunchschedule.com/launch/falcon-9-block-5-starlink-group-4-36/
::https://everydayastronaut.com/starlink-group-4-36-falcon-9-block-5
:
:
:: [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions]
::
:::[https://drive.google.com/file/d/1Ma4GsWtxCoDH5BPB1_SQ87af4mT61uZk/view?usp=sharing Webinar-AIML-Draft-Guidance-Slides.pdf]
:::[https://drive.google.com/file/d/1YKib7EQEHh2fg1b8wxuT-Mp3PoJH3LTH/view?usp=sharing CDRHWebinar-AI-ML-Draft-Guidance-transcript.pdf]
::
:: Youtube webinar recording: [https://www.youtube.com/watch?v=J26TfajAeSo Predetermined Change Control Plan, AI/ML-Enabled Device Software Functions, Draft G’dnce - 4/13/2023 ]


|-
|-
| align="center" | '''Lunch'''  
| align="center" | '''Lunch'''
| align="center" | 12:00 - 01:00 PM
| align="center" | 12:00 - 01:00 PM
|
|
|  
|
: Walk to local restaurant
 
|-
|-
| align="center" | '''Thursday Pt. 2'''  
| align="center" | '''Thursday Pt. 2'''
| align="center" | 1:00 PM - 5:00 PM
| align="center" | 1:00 PM - 5:00 PM
| align="center" | Pump workgroup
| align="center" | DEV PC & TC Continued
|
|
: Afternoon (01:00)
: Afternoon (01:00)
::* Introductions - Kurt
 
::* Agenda review - Kurt
:* Discussion of how to manage DEV content other than DPI in IHE Github in conformance with HL7 Github policies
::* [[Patent_Disclosure_Process | IHE IP Management Process]] - Kurt
:* NA Connectathon 2024
:::
:: Date, assuming January for planning TI/TF publishing deadlines
:::  [https://docs.google.com/document/d/19x4K0tXV5ZLd-dAmxF7OihlyEO0ngLkq/edit?usp=sharing&ouid=108127959796856836161&rtpof=true&sd=true Flush use case] discussion - 30 min
:: Location
::: - 25 min
::: Syringe flush Auto Program Requests - 30 min
::: Revisit mgPE unit request - 25 min
::
::
:: Break (3:00-3:10)
:* [https://docs.google.com/spreadsheets/d/1PfPBVMoraBTBlHNUkOq8kJQs7n81hi2N/edit?usp=sharing&ouid=108127959796856836161&rtpof=true&sd=true DEV Domain Roster] cleanup/update (20 minutes)
 
:- [[Complete DEV Domain Action Items]]
::: Expand PCD03 Error codes
:> Next steps and wrap up
:::: Define/review categories - 30 min
:* Location, Dates of the DEV Fall 2023 F2F
:::: Group existing codes into categories - 30 min
::2023 joint in person meet 11073 IEEE, AAMI headqs Sept 26-28
:::: Review vendors specific custom codes, identify duplicates - 30 min
:* F2F Action Review (from this week)
:::
:* Adjourn Joint DEV Meeting Archive 2023
:: 4:40 Review action items
: 5:00 > Meeting Adjournment
: 5:00 > Meeting Adjournment
|-
|-
|-
|-
| align="center" | '''Thursday Pt. 3'''
|
| align="center" | 6:00 PM - 8:00 PM
| Pump/PCIM WG Dinner for those still in town  Location TBD
|  




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== Next Meetings ==
== Next Meetings ==


Technical Committee:  
Technical Committee:


Planning Committee:  
Planning Committee:




Line 390: Line 418:
[[Devices | DEV Home Page]]
[[Devices | DEV Home Page]]


[[Category:DEV Meeting]]
[[Category:PCD Meeting Archive 2023]]
[[Category:PCD Meeting]]
[[Category:DEV Meeting Archive 2023]]

Latest revision as of 15:15, 26 April 2024

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:

Participants

Tuesday, May 23

PCD PCIM WG
Chair: Kurt Elliason
Participants:
On site: Brendan Burke, Kurt Elliason, Al Englebert, William Haralson, Roan Horning, Tom Kowalczyk, Eldon Metz, Monroe Pattillo, Paul Schluter, Rob Wilder, Brian Witkowski
Online: Lisa Diggett, Ben Elliot, Ben Fascelli, Michael Faughn, Thomas Joseph, Ali Nakoulima, Steven Nichols, Marufur Rahman, Andrea Roberts, Jesus Santana, Brugu Sirimalla, Isabel Tejero, Michael Workman


PCD Pump WG
Chair: Kurt Elliason
Participants:
Online: Adam Bunton, Shantanu Chawla, Lisa Diggett, Ben Elliot, Ben Fascelli, Thomas Joseph, Martin Kasparik, Chris Mathes, Ali Nakoulima, Steven Nichols, Jeff Rinda, Brugu Sirimalla, Isabel Tejero


Wednesday, May 24

PCD Planning and Technical
Chair: Kurt Elliason
Participants:
On site: Brendan Burke, Kurt Elliason, Al Englebert, Ken Fuchs, William Haralson, Tom Kowalczyk, Eldon Metz, Monroe Pattillo, Paul Schluter, Rob Wilder, Brian Witkowski
Online: Ben Fascelli, John Garguilo, Brian Sullivan


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
- 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
  • Reporting intermediate volumes - reset of volume at shift change- 60 min, Al E.
Add 4 new terms to 10101b, follow-up call on Wed next week at 3ET to finalize
MDC_VOL_FLUID_DELIV_SINCE_COUNTER_RESET - volume delivered since last reset
MDC_DOSE_DRUG_DELIV_SINCE_COUNTER_RESET - drug amount delivered since last reset
MDC_TIME_PD_SINCE_COUNTER_RESET - Elapsed time since last volume and/or drug amount balancing reset
MDC_TIME_COUNTER_RESET - time of last reset
  • PCD03 example CP 20 min, Brian W.
Reviewed CP and TF. Identified sections related to AppAck optionality that can be removed. Brian will rework CP and send out for review
Next steps: white paper, implementation notes, TF updates? - 20 min
Review use cases with EMR vendors. - Review/cleanup latest draft and schedule meetings. Lisa will work on this.
White paper from use cases? Do we want Connectathon tests specific to Flush?
Identify TF updates related to ordering flushes.


Syringe flush reporting/Auto Program new terms needed? - 20 min
Terms exist for reporting but no terms for programming.
How do EMRs order flushes now, want to order them in the future. As step in multi-step infusion or as a separate order?
Do customers want drug and flush in the same order? Can it be done with two linked orders? Every med/bag/syringe should be scanned.
Break (2:30-2:45)
  • Multi-step infusions 30-60 min
A short section exists in the TF. No one has really tried to use it yet. This is another topic to discuss with EMR vendors to support this, more edits may need to be made when multi-step is supported. Common scenario would be a loading dose followed by a maintenance dose.


Define/review categories - 30 min
Group existing codes into categories - 30 min
Review vendors specific custom error codes, identify duplicates - 30 min
Decided to use segment 7 (Diagnostic Information) to communicate category.
ERR|||207^Application internal error^^^^^^^207\S\Application internal error: Unable to match medication to drug library|E|9010^Unable to match medication to drug library||Category1~Category2
  • Revisit mgPE unit request?
EMR vendors get something in LOINC? Work with Regenstrief? Can pump vendors do anything?
Can FDA help?
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 12:20 - 1:20 PM
Walk to local restaurant
Wednesday Pt. 2 1:20 PM - 3:00 PM Continue PCD Planning and Technical Committee
  • 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
- 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
  • 10:00 Discussion on consistent “branding” of DEV supplements
  • 10:30 Marketing/Recruitment of DEV Globally
  • 11:00
  • 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
Webinar-AIML-Draft-Guidance-Slides.pdf
CDRHWebinar-AI-ML-Draft-Guidance-transcript.pdf
Youtube webinar recording: Predetermined Change Control Plan, AI/ML-Enabled Device Software Functions, Draft G’dnce - 4/13/2023
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)
  • Discussion of how to manage DEV content other than DPI in IHE Github in conformance with HL7 Github policies
  • NA Connectathon 2024
Date, assuming January for planning TI/TF publishing deadlines
Location
- 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:


DEV Home Page

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