For many manufacturers, compliance with the U.S. Food and Drug Administration (FDA) unique device identification rule is just another regulation in an already highly regulated world. But for others, the rule creates an opportunity to get closer to their customers.
For those not familiar with the now three-year-old regulation, it requires manufacturers of medical devices to assign and label their products with a unique device identifier (UDI) and to provide additional information about those products to the FDA’s Global UDI Database (GUDID). The FDA is phasing in compliance based on product risk class. So far, all Class III products, all implantable devices and all products considered life-sustaining or life-saving, have had to comply. This September, the largest class of products - Class II, representing more than 40 percent of medical devices sold in the U.S. - must be in compliance. By then, there will be well over three million medical devices in the GUDID, a number high enough that healthcare delivery organizations and others might just be able to do something with the data.
To help move things along, the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid (CMS) have issued their own rules. By 2018, electronic health record vendors need to be able to hold a list of a patient’s UDIs, parse the UDI into the device identifier and the production identifier and pull data from the GUDID, while providers need to share UDIs for their patients’ implantable devices with other providers caring for the same patient as part of the common clinical data set. In other words, UDI is not just for manufacturers any more. This also changes the game for manufacturers and how they comply with the rule.
At GHX, we have seen the full gamut of approaches by manufacturers. Some are doing just the bare minimum to comply, and others, as surprising as it might be, are just getting started. But others have embraced it fully, seeing it as the chance they have been waiting for to build a business case for investment in master data management (MDM). I’d like to spend a few minutes talking about the latter and why it makes sense for more manufacturers to take that approach.
Take the case of a large global manufacturer that began working with GHX and PTC almost as soon as the rule was published. The firm saw it has a chance to create a full catalog of the products it sells and to begin using the same identifier across multiple internal functions: billing, rebates, e-commerce, inventory management, etc. As a result, the manufacturer was one of the first suppliers to use the PTC Windchill solution to successfully submit its data to the GUDID.
The manufacturer also decided to take an enterprise wide approach to compliance. Rather than work piecemeal on products as the relevant deadlines approached, it worked on the data for all of its products at the same time. Not only did that avoid scalability issues down the road, but it also positioned the company to deliver value both internally and externally more quickly.
The manufacturer has eliminated redundant work and potential version control issues that come with managing multiple databases. It’s also made it possible to provide customers with accurate, up-to-date and standardized information about its products. More importantly, the manufacturer is helping customers do just what it did: use the same product identifier no matter what they are doing with the product: sourcing it, buying it, storing it, using it, paying for it, or evaluating its performance. It’s also the key to realizing the value of UDI.
The FDA developed the UDI rule primarily to promote patient safety and have better visibility to adverse events. But along the way, regulators and industry have realized, there are a multitude of benefits from UDI adoption, from supply chain efficiencies to understanding what products, and more importantly, which clinically relevant attributes work best on which patients. In other words, it’s not just about knowing when something goes wrong, but also about what works in the real world, which can help providers source the right products and manufacturers design and market products.
It’s one thing to comply with UDI, but it’s another to do so in a manner that works for healthcare. A review of the data provided so far by manufacturers to the GUDID shows a wide range of usability. For example, some manufacturers have provided 510K product descriptions, which deliver no value to end users. Others have only published required data, ignoring fields like clinically relevant size or catalog number.
One of the challenges that manufacturers face is that the FDA is not the only one asking for their data. Suppliers receive multiple requests, from their customers, their customers’ business partners, and soon an increasing number of regulatory bodies. In June, the European Union released the text for its own UDI regulation, which is expected to become final later this year or early next. To streamline how they meet multiple needs, suppliers provide GHX with a super spec of their product data. GHX then works with PTC Windchill to publish to the GUDID, while making other data available in the formats different users want, e.g., clinicians need different data attributes than supply chain and group purchasing organizations. In the end, it’s all about making it as easy as possible for manufacturers to live in a material and a regulated world, and most importantly making UDI work the way it was intended and not become just another cost and regulatory burden.
Learn more about how PTC Windchill is delivering Product Lifecycle Management (PLM) for medical device manufacturers with its Medical Device Industry Value-Ready Deployment solution.