2023-11-06 Meeting notes

Date

06 Nov 2023

Attendees

Bolded names were present

Name	Organization
Hung Luu	Children’s
Riki Merrick	Vernetzt, APHL
Andrea Pitkus	UW
Pam Banning	3M
Xavier Gansel	Biomerieux
Amy McCormick	Epic
Dan Rutz	Epic
Rob Rae	CAP
Sandy Jones	CDC
Stan Huff	Graphite
Ed Heierman	Abbott / IICC
Andrew Quinn
Laurent Lardin	Biomerieux
Anthony Killeen	UMN
Craig Collom
Marti Velezis	Sonrisa / FDA
Walter Sujansky	FDA
Susan Downer	JMC
Ralf Herzog	Roche
Cornelia Felder	Roche
Daniel Golson	JMC
Andrea Prada	JMC
Maria Sagat

Agenda and Notes

Topic	Notes
Reviewing minutes from the last call - Action Item Follow up	Pull out the definitions from LIVD for test kit and equipment and put here: SHIELD Glossary UDI presentation: Planned for Oct 9 Outreach to Dr. DeBaca Hung will check for more info and maybe see, if she could participate in SHIELD Hung is still working on the examples Waiting for response from Ed
Call time	Tried to move, but all on the call agree to leave call as is (easier for west coast folks to be on early than for Europeans to be on that late)
How can we start doing some actual work?	Have LIVD File Repository Requirements Have draft budget (for setting up a web-based database and yearly maintenance): https://aphlinformatics.atlassian.net/wiki/download/attachments/915407143/LIDR - Budget.xlsx?api=v2 Use the LIVD on FHIR as prototype (still need to add in value sets for specimen) - need to also add category for method (should be kept out and reported separately) Create example LIVD file for these types of tests: harmonized (i.e. results are interchangeable between instruments) Electrolytes serum potassium not harmonized blood potassium? Keep out timed tests and calculations for now Next step review FDA 510k webpage to find all the instruments that can do serum potassium https://loinc.org/2823-3 mili equivalents /mL - can be interchanged with millimoles/mL Looking at the FDA webpages: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm - this one seems to get us closest to what we may need - in decision summary for each instrument
Next Steps	Set up googlesheet to collect the data: Potassium Analyzers Riki to reach out to FDA to see, if they can provide the IFU for all approved serum electrolyte instruments - if not provide tutorial on how best to search for them Pam to reach out to SHIELD participating vendors to see, if we can get their LIVD files - these were the vendors contacted: Roche Abbott Hologic Siemens BD Thermo Fisher Cepheid BioMerieux stated during the meeting they didn’t provide K analyzers
Next calls
Adjourned

Chat:

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