The roots of Unique Device Identification date back at least to 1999 when the Institute of Medicine published its report, “To Err is Human.” Fast forward to 2013, FDA released a final rule establishing the inclusion of a unique device identifier (UDI) on labels and packages. When any new initiative is proposed, questions arise. They did during that fourteen year gap and they continue today. What will we need to do to comply? How will it be enforced? How can we find ROI in the regulation? Now that the UDI regulations are mostly upon us, the second two questions remain unanswered.
So, how exactly does FDA plan to enforce these regulations? When I spoke with Jerry Brown, he had serious doubts that the Agency has the resources to consistently crack down on companies that are non-compliant. (Mr. Brown is the former Vice President of Global Supply Chain for X-Spine, and is now a consultant.)
During an email exchange with FDA, I specifically asked, “How will these UDI regulations be enforced?” The response received was, “FDA’s main focus is getting the UDI system implemented correctly and actively helping companies comply with system requirements. However, we expect industry will be able to comply according to specific timetables. If an entity is not in compliance with applicable UDI regulations within the stated timeframe for implementation, FDA may take necessary enforcement action.”
Setting compliance and unknown enforcement aside, then, the question isn’t how UDI will alter your business, because it has already done so. The question is, how can your business benefit from the changes you’ve made, and how will the healthcare system as a whole benefit from UDI, if at all?
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FDA, for what it’s worth, has repeatedly said that the UDI system should allow industry to more rapidly review and aggregate adverse event reports, identify problems relating to a particular device, more rapidly take corrective action, and reduce medical errors. The Agency also believes that UDI could enhance analysis of devices on the market, provide a more robust postmarket surveillance system and lay the foundation for a more secure, global distribution chain.
The GUDID Database
Whether or not those goals have been achieved is debatable. I spoke with Brad Steger, the Global Project Manager, UDI for Zimmer Biomet. He said that when the rule was first published, it felt like government overreach or another regulation without a useful purpose, a sentiment shared throughout the industry. Steger says he now sees the benefit of successful UDI implementation.
Specifically, Steger called out the possibilities associated with the Global Unique Device Identification Database or GUDID.
“It’s a well–put-together system in which, provided you get good data into the system, the end-users will benefit, be they hospitals looking for reimbursement aid or patients looking for more information on what’s been implanted in them,” he says.
For Zimmer Biomet, the GUDID spurred a clean-up of internal databases and ensured global alignment of all data. Steger also says that the company developed controls for Global Trade Item Number (GTIN) assignment, leading to better supply chain visibility.
GUDID asks inputters to include information like whether or not an instrument or implantable is single-use, whether it uses latex, whether there are human cells in the product, etc. Zimmer Biomet can now direct customers to the GUDID for more information on their products, or even use the database as a type of marketing tool with more than 54,000 devices uploaded to the GUDID.
Steger had previously served as an MRI compatibility expert for Zimmer Biomet, fielding phone calls from providers, payors and even patients seeking to uncover the MRI compatibility of implants. With the GUDID, all of those parties, including patients, can visit the site, plug in implant information and find out if it is compatible with an MRI. There’s an immediate time-savings for a portion of the staff at Zimmer Biomet.
For manufacturers, the database does provide some interesting intelligence on competitor products. You should be able to easily compare notes on MRI compatibility, package sterility and inclusion of human cells or tissue, as well as understand the device description and status. If you’re so inclined, the GUDID provides weekly downloadable data reports that detail each device that has been plugged in to the system.