With the deadline approaching for Class II medical devices to comply with unique device identifier regulations, the Food and Drug Administration is focused on ensuring that its infrastructure can support the sharp uptick in volume of devices reported to the Global Unique Device Identification Database.
The database, launched just a year ago, allows hospitals and others to download information about a device by entering its unique device identifier. The UDI consists of two parts, device identifier and a production identifier.
Manufacturers began submitting DIs for the highest-risk devices, Class III, in September 2014, followed by implantable devices a year later. The deadline for reporting UDIs for Class II products — those bearing low to moderate risk — is Sept. 24. Class I devices (tongue depressors, medical gloves, etc.) come into compliance in 2018.
The initial deadlines are for UDIs on packaging and labeling. Manufacturers have another two years to put UDIs on the devices themselves, and the FDA is still working on guidance on just how that should be done.
In the meantime, performance and load testing is ongoing, both internally and with eternal stakeholders to ensure the FDA can handle the anticipated high volume of Class II device GUDID submissions, says agency spokeswoman Deborah Kotz. The National Library of Medicine, which hosts the AccessGUDID portal, is also taking steps to ensure that the public-facing system will support the additional volume.
Jay Crowley, vice president of UDI services and solutions at USDM Life Sciences in Santa Barbara, CA, and the architect of the FDA’s UDI system, says its hard to know just how many Class II devices there are, given the many versions and packaging of a particular 510(k) — a device that is substantially equivalent to one already approved for marketing — that may exist.
Currently, there are about 150,000 records in the GUDID, “and that number will continue to grow significantly,” Crowley said
But while Class II device makers are mostly prepared to report their UDIs, there are major issues that exist around implementation. Chief among those is understanding what just qualifies as a regulated medical device.
“You can look at an IV catheter in a pack and say, sure, that’s a medical device,” says Crowley. “When we get to other systems and systems of devices, it becomes much less obvious where you draw the line.”
It is clear, for example, that an x-ray system is a medical device, but what about all of the bits and pieces that go into making up that system? Are service parts and spare parts medical devices? And what about the pump motor for a ventilator, or the castors that roll it along? What about the software that interfaces between different devices?
“That’s a big issue I think we will continue to struggle with as we move into the Class II space and particularly as we move into the Class I space,” Crowley says. “No one has ever had to deal with things at this level of granularity.”
Other challenges to UDI implementation include understanding where the line is drawn between pharmaceutical and device regulation of combination products and understanding the roles and responsibilities of contract manufacturers.
The FDA is currently working on finalizing three draft guidance documents on UDI direct marking, convenience kits and enforcement policy for NDC (National Drug Code) and NHRIC (National Heath Related Items Code) numbers assigned to devices. Also in the works is draft guidance to define the form and content of the UDI.
Direct marking is a particular concern for makers of non-sterile orthopedic implants, who must apply UDIs to their products by September. “You have orthopedic sets that have dozens to hundreds of implants … all sorts of screws and sizes and types, some of them very small,” Crowley says. “But managing what specific implants go into a patient, it’s not known until you’re in there putting things back together that you need two of these, four of those, six of that.”
Figuring out how to put tools and processes in place to know that a particular rod and plate were used in a certain patient who underwent ankle reconstructive surgery at a UDI level is a significant challenge, Crowley says.
Kotz says the FDA has made finalizing the direct marking guidance a “high priority for this year.”
The UDI final rule allows companies three years to exhaust inventories of devices that were labeled before the final rule took effect. Moreover, products that are consigned or on loan to hospitals and healthcare facilities or that have an expected use life beyond that time may remain in use even after the three-year exception expires, Kotz notes, adding the FDA did not believe it would serve the UDI program goals to require those products to comply.
Because implementation is being phased in over several years and the requirements do not apply to devices already in commercial distribution, it is too early to see any real impact on public health. But that should change as more devices come into compliance, says Crowley.
“From a very basic post-market surveillance perspective, we can start to do things like adverse event reporting better. We can start to aggregate data in a way that we can’t today," he says. "Recalls, of course, would be much more efficient."
“Our ability to provide information, get back information, all of this starts to grow and evolve, and I think we will see an enormous paradigm shift in the same way that we’ve seen with what happened in the retail space,” Crowley adds. “You’ll have visibility that you can leverage for all sorts of activities.”
There is also pressure to get UDIs into electronic health records and claims forms. In March, Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) urged the FDA and CMS to include implant IDs on Medicare claims forms saying this could save taxpayers billions of dollars.
The senators cited a letter from HHS Office of Inspector General noting that recalls of defective devices have triggered numerous claims for monitoring, replacement, and follow-up care. Beneficiaries who receive defective implants also face possible adverse effects and unnecessary expenses.
The senators noted that CMS has opposed adding UDI to Medicare claims forms because of the technological challenges, but said they should be incorporated when the claims form is updated.
Kotz tells Healthcare Dive that the FDA, CMS and Office of the National Coordinator for Health IT “are working closely” to include UDIs in EHRs. “FDA and CMS also support the recommendation by the National Committee on Vital and Health Statistics to consider conducting voluntary pilot tests of the benefits, costs and feasibility of UDIs in claims reporting,” she adds.
But doing that will not be easy, Crowley says. “Changing the claim form, and then changing and updating all the systems to capture that information, is not a trivial undertaking. And the benefits that accrue may not necessarily be to CMS.”