The latest deadline passed this week for medical-device makers to comply with federal rules requiring them to mark their products with unique identifiers that allow the industry and the government to track device safety and efficacy.
As the U.S. Food and Drug Administration's Unique Device Identification (UDI) system begins to take shape, the onus for compliance will shift from manufacturers to healthcare providers, who will be charged with collecting, processing, storing and tracking the new data.
Makers of Class III medical devices such as implanted pacemakers and heart valves were the first device makers required to include UDI on their products, beginning in September 2014. On Thursday the UDI labeling requirement was extended to all implantable, life-supporting, or life-sustaining devices, regardless of class. All devices are required to carry UDI labeling by 2020.
The success of the identifiers will ultimately depend on how well hospitals and health systems are able to integrate UDI with their electronic health-record systems. Adoption of the identification system could be slow because there is no mandate for providers to use it.
“The FDA has built the system so that this information will be widely available for anyone who needs it,” said Dr. Josh Rising, director of health care programs for the Pew Charitable Trusts. “So now that products are appearing with these new codes, it is kind of incumbent on the healthcare system to realize a lot of the benefits that are out there for having these new codes.”
Rising co-authored a recent Pew report (PDF) that looked at ways to help healthcare providers adopt the UDI system and realize its potential.
Experts hope the identifiers will help providers reduce costs with more efficient medical-supply management, and improve patient safety with better reporting and tracking of faulty products and adverse events. The FDA has estimated that approximately 50,000 serious adverse events related to medical devices are reported each year, resulting in some 3,000 deaths.
“Right now there are some fundamental questions about devices that we don't have a great ability to answer,” Rising said. “For example, in a specific population, what's the right hip replacement or defibrillator to be using? UDI should be a way to help answer some of those questions.”
The Pew report detailed results from a 2012 pilot project conducted by Missouri-based Mercy health system, which incorporated UDI within its supply chain and electronic health-records systems, as part of inventory management within its cardiac catheterization labs. The project took six months to implement at an initial cost of $2 million, but it helped the system reduce its inventory and generated approximately $400,000 in cost savings in its first few months of usage.
The UDI system was established under a provision of the 2012 Food and Drug Administration Safety and Innovation Act. The agency issued a final rule in 2013 requiring devicemakers to include a unique device identifier on device labels and packages.
Some critics have voiced concerns about the FDA's efforts to incorporate UDI into medical claims because the administrative burdens and information-technology challenges could dampen providers' willingness to participate.
“Adding the UDI to the claim would require changes to the standards used for billing, updating even more administrative systems, connecting them to the supply chain and clinical systems, and maintaining them each and every time FDA adds a new device or removes an existing one,” the American Hospital Association said in a fact sheet published in March. “Given that clinical systems are most important for patient safety benefits, the rationale for including the UDI directly in the health claim is not clear.”