UDI Conference Takeaways

In addition to announcing and explaining the final UDI rule, presenters at the conference offered a wealth of advice for medical device manufacturers preparing to comply with the regulation. For those of you who were unable to attend the conference, we’ve selected some highlights for you:

Terrie Reid, Associate Director for Informatics, who has worked incredibly hard to create the infrastructure for the Global Unique Device Identifier Database (GUDID, pronounced, “Good-ID”), cited these keys to UDI implementation:

1. Act now – the sooner implementation begins, the lower the overall costs are likely to be.
2. Advocate for change – know the benefits of UDI and share them widely among colleagues.
3. Build a great team – this will ensure that implementation goes smoothly.
4. Partner with all key stakeholders – and communicate constantly and clearly with all of them.

In his presentation, Ken Koldan, co-chair of the AIM North America UDI Committee and CEO of FLEXcon, laid out five simple steps to UDI compliance:

1. Identify which accredited issuing agency from whom you are going to acquire codes (GS1, HIBCC and ICCBA are the only accredited agencies)
2. Reformat your Product Identifier (PI) to match UDI requirement.
3. Mark your products with you Automatic Identification Code (AIDC) technology
4. Register the device with the FDA Database
5. Ship out the device

We’re grateful to all of the presenters for sharing their thoughts about UDI. We’d also like to commend the UDI team on their exceptional work to create a regulation that will have such a positive impact on public health. We look forward to providing AIDC and data submission solutions to manufacturers as they work to implement these important changes.