30 Day Trial

ORTHOKNOW content is posted to these pages in real time.

Monthly compilations are available in PDF form.

Current & Critical

Unique Device Identification: Start Preparing Now

By Karen Conway, GHX

With the final rule for FDA’s proposed unique device identification (UDI) expected for release this summer, orthopaedic manufacturers are focusing upon what they need to do to comply with the regulation.

OEMs will be among the first to be impacted, with the final rule expected to require manufacturers of Class III devices to be in compliance one year after publication. Data will be a large challenge, but those companies that take a more holistic approach to UDI have an opportunity to reap benefits beyond just checking the regulatory box.

First, 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.”

But 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 (e.g. GS1’s GTIN or HIBCC’s LIC), OEMs must make sure the label displays the code in both human- and machine-readable formats. But the highest hurdle might be the requirement to populate the FDA Global UDI Database (GUDID) with specified data about those products.

“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) to improve the visibility and consistency of product identification across multiple applications. By using 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.

Many of the data elements that manufacturers need to submit to the GUDID have likely been included in one regulatory filing or another, but are often owned and managed by different business functions that have historically not worked closely together. (See GUDID Attributes.)

GUDID Attributes

These attributes will likely be required in the Global UDI database.

• Primary Device Identifier (DI)
• DI Issuing Agency
• DUNS Number
• Brand Name
• Model/Version Number
• GMDN Code
• FDA Premarket Authorization Number
• FDA Listing Number
• Device Size (dimension type/value)
• Device Sterility
• Device Contains Latex?
• Device is sold as a Kit?
• Device is a Combination Product?
• Device Production Identifiers (e.g., controlled by lot or batch number, serial number, manufacturing date, expiration date)
• Device Package Configuration
Locating, harvesting and aggregating the data can be quite challenging. 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. One division might keep a certain attribute in an ERP system, while another might keep the same attribute in an entirely different place.

Developing a sustainable process for publishing data to the GUDID requires a cross-functional business process, involving a variety of stakeholders, including but not limited to:

• Regulatory
• Legal
• 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 is absolutely critical to manage highly dynamic data. (On average, 30 percent of products sold in the U.S. have some kind of change in their associated data elements each year.)

FDA has said the final rule will mirror much of what is in the proposed rule, giving manufacturers a good place to start preparing now (See Questions to consider), but some critical areas of uncertainty remain, including:

• Which products will require direct part marking (DPM) and when?
• How to label kits and combo products?
• Which finished products will be exempt, e.g., those in manufacturer warehouses or on consignment, or only those already purchased?

Questions to consider in preparation for UDI

• Which products will be covered by UDI, and when?
• Is production manual or automated?
• Where are those products produced?
• Into which markets are they sold?
• Will the label artwork have enough space to accommodate the UDI?
• Do you need to add printing capabilities to accommodate dynamic (production) data? If so, how will that impact space and layout on the production floor?
• How will you handle validation of new IT equipment and processes?
• Do you have kits or combo products? If so, you do label each of them late-stage, and then combine?
• Do you have multipacks? Will secondary or tertiary labeling be required?
• Do you have any products that are implanted longer than 30 days or that must be re-sterilized before reuse and may require direct part marking?
• Will you need to add a contingent workforce to prepare for UDI?

Let’s look briefly at the critical areas of uncertainty.

Under the proposed rule, products that are implanted in the body for more than 30 days and those that must be re-sterilized before reuse, such as instruments, would be required to carry the UDI on the product itself as well as on the label. DPM was the target of many of the comments submitted to FDA on the proposed rule, but interestingly, it was also an area where some manufacturers, hospitals and healthcare systems and physicians agreed, at least on how implantable devices should be treated.

Representatives from all three stakeholder groups argued that direct part marking implants themselves 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 electronic health records (EHR) and implant logs, there is no need to capture it again in the sterile field during a procedure.

Therein lies another challenge. Providers must have the technology and make the necessary process changes to ensure that UDIs are captured in patient records, a key to delivering on their intended value. Today, without UDIs in EHRs, a surgeon preparing for a revision case often does not know exactly which implant the patient has.

Something as small as not knowing the original manufacturer for screws for an orthopaedic implant can require that multiple instruments are on hand for a single case, given that screws designed by different manufacturers often have different heads.

Myriad parts used in orthopaedic and spine cases make the second issue, regarding kits and combo products, a concern for orthopaedic manufacturers. For example, if FDA treats orthopaedic trays as kits, will it require that each individual component (e.g., screws and plates) have its own UDI, as well as the kit itself? Given the large amount of orthopaedic products sold on consignment or handled as trunk stock and the extremely low inventory turns, the third matter regarding finished goods is also problematic.

FDA faced this same question when the pharmaceutical barcode rule took effect in 2006, and it is possible that FDA will adopt a similar solution, providing manufacturers with a grace period for finished but not yet sold or used goods.

These are all legitimate concerns, but should not stop a manufacturer from thinking now about how to achieve compliance, and if possible, added value. Global manufacturers should also consider how their compliance efforts in the U.S. will relate to UDI regulations in other parts of the world.

The European Commission has already issued draft regulations referencing UDI, as well as a vision for a common UDI framework, and countries ranging from Korea to Canada are considering their next steps around UDI as well.

When it comes to UDI, manufacturers are encouraged to think globally and holistically to minimize the compliance challenges and to leverage those efforts for additional efficiencies across multiple functions and regions.

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 Ms. Conway at kconway@ghx.com.