June 28, 2016 UDI Project Meeting

Agenda - Unique Device Identifier Implementation Guidance Project Meeting, June 28, 2016

Contents

1. Attendees
2. Meeting Minutes - Next meeting
3. Meeting Discussion

• Review Schedule for Summer/Fall leading to January 2017 Ballot Cycle
• Review Status DAM/Conceptual Model Ballot Document
• New Project Team member/author from the FDA
• UDI for Adverse Events

Meeting Minutes:

Last minutes ready later this week. Will review both next meeting

Meeting Discussion:

• Review Schedule:

• 6/30/2016 Add new primary author for DAM
• 7/26/2016 Next project meeting - Status DAM
• 8/30/2016 Project meeting - Status DAM, Any issues for WGM
• 9/17-23/2016 Baltimore WGM and Plenary
• 10/2/2016 Announcement of peer review which starts 10/23
• 10/23/2016-11/6/2016 2 week peer review
• 11/6/2016 Final Day for submission of peer review comments
• 11/8/2016 Project meeting, Reconciliation of peer review comments
• 11/13/2016 Ballot submission - initial content
• 11/15/2016 Possible project meeting if reconciliation not complete on 11/8
• 11/21/2016 Start of 2 weeks for changes to DAM doc to address reconciled issues from peer review
• 11/29/2016 Project Meeting - Final document approval
• 12/4/2016 Ballot submission – final content

• Review Status DAM/Conceptual Model Ballot Document

Not making tremendous progress. Turning over primary authorship on 6/30 after previous author completes current thoughts

• New Project Team member/author from the FDA

Not really a new member to the project team; he's been here for a number of weeks. However, turnover of primary authorship of DAM document from Patrick to Bob later this week (6/30/2016).

• UDI for Adverse Events
• bring up the possibility of using a UDI element in the 201609 FHIR Connectathon for the Device Integration track. We could easily fit it in ... assuming it isn't being taken care of elsewhere.

For example, an adverse drug event scenario where you have a CDS system that identifies a patient having an ADE that ultimately generates an ICSR with the UDI of the device(s) in use. Or we could include a supply chain example or just device management & use.

Parking Lot

• Add to Parking lot: how to fix an incorrect identifier
• Add to Parking lot: supply chain
• Add to Parking lot: directives in Europe to check identifier, before implantation

Next Meeting:

• Tuesday, July 26, 2016, Noon - 1:00PM EDT
• Phone: +1 770-657-9270, Passcode: 398652
• WebEx: https://fda.webex.com/fda/j.php?MTID=m40a6a072d9e4b354bb99222e7b0a04af
  • Meeting number: 741 298 577
  • Meeting password: 123456