Content Comparison

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

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