2023-10-02 LIDR WG Meeting Notes

Hung Luu - regrets

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

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 LOINC 2823-3 Potassium [Moles/volume] in Serum or Plasma mili equivalents /mL - can be interchanged with millimoles/mL

Looking at the FDA webpages:

510(k) Premarket Notification

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

10/9 - UDI presentation

10/16 - LOINC travel? - Riki to send email to find out how many impacted

10/23 - SCT business meeting - Riki to send email to find out how many impacted

Adjourned

9:48 AM ET