While it followed the U.S. UDI rule by nearly four years, the European regulation that requires manufacturers to label their products with unique device identifiers (UDIs) may broaden the value received from the U.S. Food and Drug Administration (FDA) UDI rule. That’s because the European regulation that covers both medical devices and in vitro diagnostics (MDR/IVDR) includes language requiring capture and storage (preferably electronically) of the UDIs for implantable devices, as well as increasing requirements related to generation of real world evidence (RWE) on the performance of medical devices. The U.S. has similar mandates related to UDI capture, but they were not part of the original UDI rule; instead, they were included in subsequent regulations by the Office of the National Coordinator for Health IT (ONC) and the Center for Medicare and Medicaid Services (CMS) and only went into effect this year. The European regulations also foresee benefits in both purchasing and inventory management, topics rarely if ever referenced in medical device regulation in the United States. Given that European and U.S. regulators work closely together through organizations like the International Medical Device Regulatory Forum, which strives for global harmonization in UDI and other regulations, it will be interesting to watch if U.S. public policy makers start paying more attention to the medical device supply chain. Meanwhile, regulators in other regions of the world, including China, South Korea, Saudi Arabia and India, are also working on their own versions of UDI, some of which further expand the use of UDI to areas such as import control and reimbursement. All of this expanded activity could impact how UDI is seen and used in the United States, if not by government bodies, then certainly by hospitals, clinicians and commercial payors.
Like the U.S., the European regulation is based on guidelines first published by the Global Harmonisation Task Force and further advanced by the International Medical Device Regulatory Forum. It requires manufacturers to assign UDIs to their devices at each packaging level, to label their products with the UDIs, and to publish additional data attributes about those products to a regulatory database. While the U.S. rule focuses on “identify[ing]… [a} device through distribution and use,” the European regulation goes beyond identification to “facilitate the traceability of medical devices.” Certainly, assigning UDIs to devices is foundational to a traceability system, but the European regulations expanded requirements demonstrates the critical role that hospitals play in making UDI a success. In other words, if hospitals don’t capture UDIs, all of the other benefits — from adverse event reporting and recall management to improved supply chain efficiencies and post market surveillance — will be difficult if not impossible to achieve.
Another notable difference between the U.S. and European regulations are the latter’s additional requirements on generating clinical evidence on medical devices across their entire lifecycle. Manufacturers who want to sell their products in Europe are required to work with what are called “notified bodies,” organizations that are designated by European countries to certify that the device makers are in conformance with various regulatory requirements. This includes expanded requirements in the MDR/IVDR “to continuously generate, collect, analyze and assess the clinical data pertaining to a device in order to verify the safety and performance, including the clinical benefits, of the device when used as intended by the manufacturer.” The MDR/IVDR intends for this data to be collected using the UDIs, at least for implantable devices, although the European Commission has stated the “capture and storage” requirements could extend in the future to other devices. But even if the regulation does not require more than implantable devices. In the U.S., Franciscan Missionaries of Our Lady Health System in Louisiana, used the UDI regulations as the impetus to adopt the technology and process changes to capture data on all of the products used in the perioperative environment to identify variation and track the true cost of delivery care. If you have to capture data on one class of products, why not do so for all products?
Many experts expect the expanded RWE requirements and the evidence generated will only increase the demand not only for data on safety and performance, but also on the economic value of medical devices, i.e., does a medical device deliver commensurate value for the cost (including) price to use? It’s not hard to imagine the value of this kind of data to value analysis professionals in healthcare delivery organizations, commercial payors, and organizations developing predictive and prescriptive analytics tools.
The reason why regulatory bodies want UDI to be globally harmonized goes beyond making it easier for manufacturers who have to comply with regulations in many different countries. When the regulations are similar, it can ease the regulatory burden. But using a common approach to product identification provides important downstream benefits for regulators, providers and patients as well. Given that many devices sold around the world are similar if not the same across various countries, the data generated on a device in one part of the world can be relevant for data consumers elsewhere. After all, the initial evidence that there were problems with metal-on-metal hip implants came from registries in the United Kingdom. Had that data been visible sooner to manufacturers, regulators, clinicians and patients, more could possibly have been done to minimize the negative consequences for all involved.
As for the supply chain benefits, it will be interesting to watch both the UDI regulation along with another standards-driven medical device initiative in (what is still) Europe. The U.S. FDA has been following the progress of the Scan4Safety program in the United Kingdom, which uses GS1 barcodes to track medical devices from the point of manufacturer through to patient use; the GS1 standard for product identification, the Global Product Item Number (GTIN), is one of the UDI compliant codes in both the US and Europe. In fact, the FDA will lead a panel discussion with those involved with Scan4Safety, as well as the UDI regulations in both the UK and Europe, at the 2018 GHX Healthcare Supply Chain Summit in May. To date, Scan4Safety has achieved benefits in a wide variety of areas, including:
- Better supply chain controls (less waste)
- Improvement recall management
- Patient and equipment location
- Reduction in medical errors
- Improved operational efficiencies
But Andrew Crosbie, manager of post market surveillance strategy for the Medicines and Healthcare Products Regulatory Agency (MHRA)- the equivalent of the U.S. FDA in the U.K. — sees tremendous opportunities for Scan4Safety, as well as the MDR and IVDR regulations. to significantly increase the quantity, quality and availability of real world data on product performance.
The important point here is that there are a variety of purposes for RWE, from regulatory to purchasing, value analysis, and comparative effectiveness research. The more that data can be collected in a standardized manner the more data will be available to meet the needs of multiple stakeholders across healthcare. That’s not only good standard practice, it’s more efficient and effective healthcare. hpn
