High-Risk Medical Devices Part III: UDI Usage in Implant Recall Events

December 27, 2019

2-minute read.

Implantable device recalls increased 304% from 2015 to 2018

This blog post is the third in a series where we’ll be sharing statistics around medical device recalls, adverse events, and reported product problems to explore what kinds of analysis one can do by linking different medical device data sources.

Part I: Top 20 Adverse Events

Part II: Top 20 Recalls

With implantable medical device recall events occurring more frequently, has UDI adoption in recall notices increased to easily identify products in inventory and notify affected patients?

To continue exploring the topic of reported product problems we analyzed both the volume of implant recall events and the adoption of UDI standards in the event notices.

Given the challenges in identifying recalled medical devices discussed in Part II, we wanted to investigate the adoption of UDI standards in implantable medical device recalls.

While the FDA still does not have a separate data field for UDI in recall notices, we parsed out all UDIs or UDI-DIs in the available free text fields submitted by the manufacturer. It should be noted that this is not a simple algorithm to program and by not having a separate field, there cannot be any automated data validation completed by the FDA upon receipt.

Since we have a complete mapping where possible to UDI-DIs, discussed in Part II, we compared AccessGUDID identifier published dates to the manufacturer published recall dates to see how many recall notices for implants could've included some form of UDI standards but did not.

77% of implantable device recalls could have included UDI in 2018 and 2019 but only 24% did

Data Sources used in analysis as of December 2019: FDA Weekly Enforcement Report, FDA Medical Device Recalls Database, OpenFDA Device, Acccess GUDID

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