Now that the comment period for FDA’s proposed unique device identification (UDI) rule is closed, many manufacturers are in a holding pattern, waiting to see what FDA will include in the final rule, which could be out as early as this June. But if you talk to industry experts, now is the time for orthopaedic OEMs to get busy, as they will be among the first to be impacted by the regulation. FDA, meanwhile, is hard at work sorting through hundreds of comments submitted on the proposed rule. Those comments address myriad topics, from the compliance timeline to requirements for direct part marking of implantable devices. But when it is all said, read and done, the biggest challenges for manufacturers are bound to be all about the data.
First, here’s a little background on UDI. The proposed rule, which was published in the Federal Register in July 2012, is the result of language included in the FDA Amendment Acts of 2007, requiring medical device labels to bear a unique identifier that “shall adequately identify the device through distribution and use, and may include information on the lot or serial number.” However, as with any regulation, it’s more complicated than that. In addition to assigning a code that is part of the ISO 15459 series of standards to each of their products, OEMs must make sure the label displays the code in both human- and machine-readable formats. However, the highest regulatory hurdle appears to be the requirement to populate an FDA Global UDI Database (GUDID) with specified data about those products. While the data elements that OEMs need to submit to the GUDID have likely been included in one regulatory filing or another, they are owned and managed by different business functions that have historically not worked closely together.
Locating, harvesting and aggregating the data can be quite challenging, says Mike Gillespie of GHX Business Solutions, who advises manufacturers on how to prepare for UDI. The data elements exist in a variety of places and formats, some not even electronic. It’s even harder for suppliers that have gone through mergers and acquisitions, Gillespie adds. One division might keep a certain attribute in an ERP system, while another division might keep the same attribute in an entirely different place.
While not final, FDA has listed these attributes to date for inclusion in the Global UDI database.
• Issuing Agency
• Primary Device ID Number
• DUNS Number
• Brand Name
• Model/Version Number
• GMDN Code
• FDA Premarket Authorization Number
• FDA Listing Number
• Device Size (dimension type and value)
• Device Sterility
• Device Contains Latex?
• Device is sold as a Kit?
• Device is a Combination Product?
• Device Production Identifiers
• Device Package Configuration
Developing a sustainable process for publishing data to the GUDID requires a cross functional business process involving a wide variety of stakeholders, including but not limited to:
- Process engineering
- Supply chain
- Labeling and barcoding
- Information technology
- Marketing and sales
Getting all of these players together is an exercise in change management, but it is absolutely critical to manage highly-dynamic data. Gillespie says on average 30 percent of products sold in the U.S. have some kind of change in their associated data elements each year. As many of the manufacturers pointed out in their comments, FDA is not expected to fully define the required attributes until the final rule is issued, and unless things change, manufacturers of Class III orthopaedic devices would only have one year to prepare to populate the GUDID.
Overall, the comments received came from a wide range of organizations, including suppliers, healthcare delivery organizations and physicians. In general and not surprisingly, suppliers asked for delays in timelines and more product exemptions, while hospital groups called for faster timelines and fewer exemptions.
Surprisingly, one of the more contentious issues arising from direct part marketing was an area in which many provider, supplier and physician groups agreed. Under the proposed rule, products that are implanted in the body for more than 30 days and products that must be re-sterilized before reuse would be required to carry the UDI on the product itself as well as on the label. Comments from representatives of all three stakeholder groups argued that direct part marking of implants was unnecessary, ineffective and potentially dangerous. For example, they stated that once an implant is in the body, the direct part marking would be unreadable. More importantly, the American Academy of Orthopaedic Surgeons pointed to studies in which etching on implantable devices led to early weakening and failure. Finally, it was argued that as long as the UDI can be read on the label and captured in various systems such as the electronic health record (EHR) and implant log, there is no need to try to capture it again in the sterile field during a procedure. Therein lies another challenge. Will providers have the technology and make the necessary process change to ensure UDIs are captured in patient records? Today, without UDIs in EHRs, surgeons preparing for a revision case often do not know exactly which implants a patient has. Something as small as not knowing who manufactured the screws in an orthopaedic case can require the surgeon to have multiple instruments on hand, given that screws designed by different manufacturers often have different heads.
“UDI compliance is more than a labeling exercise,” says Jackie Elkin, Global Process Owner, Standard Product Identification, for Medtronic. “FDA plans to make UDI the ‘key’ for master data management within the Center for Devices and Radiological Health, and as manufacturers, we need to think similarly within our own organizations.” According to the proposed rule, FDA intends to integrate UDI into the Code of Federal Regulations (CFR) in order to improve the visibility and consistency of product identification across its multiple applications. “By using the UDI as the foundation for their regulatory master data, manufacturers can achieve a more consolidated view of product data within their own organizations that they can use for different regulatory submissions,” Elkin says.While regulatory pundits predict that requirements around direct part marking will be greatly reduced in the final rule, there are a wide variety of other issues that must be addressed to make UDI both feasible and effective.
Given the wide range of implications of the rule on orthopaedic OEMs, UDI will sit center stage at OMTEC this June in Chicago. You can get involved now in helping to shape the UDI conversation. Submit your thoughts on topics and questions to explore by emailing Karen Conway.
As Executive Director of Industry Relations for GHX, Karen Conway works with industry associations, standards bodies, government agencies, analyst firms, academic institutions and the media to identify opportunities for hospitals and suppliers to improve business and clinical performance. Conway serves on the board of directors of AHRMM, the supply chain organization for the American Hospital Association; the leadership council of the ASU Health Sector Supply Chain Research Consortium and as co-chair of the HIMSS Supply Chain Special Interest Group. You can reach her at firstname.lastname@example.org.