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Kelle O'Neal

Thanks for joining our data conversation! This blog is an opportunity to share the real life challenges, opportunities and approaches to improving the quality and value of data in your organization. We will write about everything data related from translating "data" speak into "business" speak, to governance models, to the real differences among the myriad software tools available. But there's one catch: we all have to agree to toss out the fluff. That's right, no 30,000 foot, theoretical strategies that leave you wondering how to execute and actually improve performance. Visit regularly to learn from peers and partners on how they are managing and improving data, and we hope you'll also share your views and experiences.

About the author >

As Founder and Managing Partner of First San Francisco Partners, Kelle O’Neal manages specialist data governance and data management consulting services to complex organizations that deliver faster time to results. Kelle can be reached at kelle@firstsanfranciscopartners.com or through the First San Francisco Partners website.

Follow First San Francisco Partners on Twitter at @1stSanFrancsico.

Editor's Note: Find more articles and resources in Kelle's BeyeNETWORK Expert Channel. Be sure to visit today!

In the wake of on-going medical device fraud, negligence and harm occurring in the U.S. and abroad, pressure had been mounting to tighten device tracking and monitoring regulations. In UPC barcode_smallthe U.S., Congress responded to that pressure along with other medical and healthcare needs by signing into law the FDA Amendments Act of 2007 (FDAAA). For medical devices, FDAAA required the FDA to establish a unique device identifier (UDI) system to improve adverse event reporting and traceability for devices distributed within the U.S. The system would also facilitate faster and easier device recalls and enable improved detection of and response to counterfeit products, with the ultimate goal of improving patient safety. 

Specifically, under FDAAA, UDI regulations require:
  • The label of a device to bear a unique identifier that enables device identification through distribution and use, unless an alternative location is specified by the FDA or unless an exception is made for a particular device or group of devices
  • The unique identifier to include a lot or serial number
All medical devices manufacturers distributing devices in the U.S. will be required to comply with these regulations, and each manufacturer will have one year to comply, although priority for compliance will fall to those devices that are implantable or life sustaining.

On its most fundamental level, the UDI would be a coded number registered with standards organizations that would incorporate information including, but not limited to:
  • Device manufacturer
  • Device make and model
  • Device expiry date
  • Any special attributes that the device may possess
Currently, the FDA is building the IT infrastructure to support the system. This includes the creation of a UDI database that will serve as the authoritative source for all UDIs and UDI-related information. In effect, they are creating a "UDI Master of all Masters," populated by the feeds provided by the different medical device companies.

UDI regulation is driving the need for medical device companies to revisit their own data management approaches to ensure that they can provide the FDA with a clean submission of unique identifiers for their own device data. I previously wrote a blog post--Leveraging MDM for UDI Compliance--on how Master Data Management, specifically Product Master Data Management or Product Information Management (PIM), can help medical device companies organize their device data in a way that facilitates their submissions to the FDA. Data Governance is also an important competency that organizations need to develop in order to ensure that changes made to their data management practices to address UDI do not add complexity to their infrastructure or create a short-term "stop-gap" solution that creates rework down the road.

If you are part of a medical device organization, how are you preparing to comply with UDI regulation?

Posted July 19, 2013 5:30 AM
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