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FDB recently interviewed Jay Crowley to get his expert perspective on the Unique Device Identification (UDI) system. Crowley developed the framework and authored key requirements for the Food and Drug Administration’s UDI system while working as the Senior Advisor for Patient Safety in the FDA’s Center for Devices and Radiological Health. This is the first of a two-part blog series where Crowley offers his thoughts on the evolution and future of this emerging identification system. Read Part 2 here.
What has been most surprising to you about the advent of unique device identifiers (UDIs) and how the healthcare industry has reacted to it?
At first, it was difficult getting the various stakeholders on board with the idea of a standardized device identification scheme. Eventually, clinicians, healthcare provider organizations, payers and patients really saw that there could be tremendous benefits. So, there was significant momentum for the regulation.
What’s surprising, though, is that we haven’t seen the enthusiasm for implementation that we saw for the development of the rule. Before the regulation passed, all the provider constituents were saying “We need this. Let’s get this done.” And, now that the regulation is in play, I hear crickets. A few progressive organizations are trying to drive some adoption but more broadly, we just have not really seen the uptake that I thought we would.
Why has adoption been less than what you expected?
Healthcare organizations have many distributed and disconnected processes and systems in place that are very ingrained in their organizations and that have evolved over time to serve very specific needs or solve very specific problems. So, when turning that on its head and telling organizations that they must replace the internal numbering concepts that they have been using for years and use the UDIs in the future, everyone just throws their arms up and says, "Oh, that's too hard."
Can you describe the ideal scenario for UDI adoption?
The low hanging fruit has always been with supply chain logistics and materials management. Managing supply chain at a UDI level is a straightforward and idealized use case for standardized identification. The legislation that created the mandate for UDI talks about distribution and use. Congress was concerned not just with the point-of-use activities and patient safety but also with supply chain and having visibility into the movement and distribution of medical devices. Managing the devices that have been ordered, received and distributed throughout healthcare organizations ─ that's the ideal starting point for UDI.
From there, organizations can move toward the point of clinical encounter and use the UDI to gain visibility into device use with specific patients, making it possible to know what products are used on what patients in case of recalls or other problems. Then, moving forward, organizations can use the UDI to accrue data that can be used for cost analytics or more broadly for public health surveillance. Eventually, organizations can arrive at a set of population-based data that provides insight into the long-term safety and effectiveness of devices.
What uses of UDIs will provide the earliest benefits and what uses will provide the greatest benefits, both to patient safety and business operations?
The earliest and easiest benefits are on the supply management end in terms of knowing what a provider has in stock, what they have received, how much of it, and better management of that entire process. That has obvious business implications, but also patient safety implications when it comes to recalls or responding to emergencies. As organizations and the industry start to create longitudinal data, then there’s better visibility into the safety and effectiveness of devices and the ability to identify problems earlier. Creating that post-market surveillance capability makes it possible to connect the dots earlier. That is the reason that FDA was so adamant about the development of UDIs.
What initiatives are you familiar with that are underway with the use of UDI and its associated data?
FDA has a program called the Medical Device Epidemiologic Network, or MDEpiNet, and has also sponsored a couple of projects for better visibility into device use -- and these are driving some registry-related activities.
Some of the big integrated delivery networks are also working on UDI implementation ─ trying to capture certain products as they come into an organization, so they can have better visibility. These pockets of activity are usually focused on some area of concern, where there's a particular problem or issue or use case or business case that they're trying to solve.
Do you see these initiatives helping with recall, magnetic resonance imaging (MRI) safety, or the need for additional clinical attributes?
Organizations are starting to capture information about what they're actually ordering and receiving, and that could certainly help with recalls. They may not know where a device is located but they know whether they possess it or not, and that's often the biggest challenge. We're not quite there yet with MRI safety. There are some organizations that are starting to scan at the bedside, looking for allergens and such as they do for pharmaceutical products – but it is not commonly adopted.
There is a need for additional clinical attributes. For example, I was involved with an FDA demonstration project focused on cardiovascular stents, capturing UDIs and data about devices to gain better visibility. And, it became very clear that the researchers needed certain information that wouldn't necessarily be needed in a day-to-day sense. For example, they needed detailed information about the actual size and materials of the implant. There were half dozen or so additional clinical data attributes that the researchers needed to answer certain questions from an epidemiological perspective, not from a "What product am I ordering?" or "What is this thing?" perspective. I think that those clinical attributes be added, as external partners start to use the UDI data for various purposes.
Jay Crowley is Vice President of the Unique Device Identification Services and Solutions at USDM Life Sciences where he focuses exclusively on providing business process, technology and compliance solutions for the regulated life science industry. Jay held a variety of positions over his nearly 27 years at FDA, including work with design control regulations to reduce the chance of human errors with medical devices, patient safety and adverse event reporting. Jay also worked in the Office of the Commissioner of FDA, and the Office of Compliance at FDA.