Timing for the Spring 2017 GS1 Global Healthcare Conference could not have been better. The semi-annual event, held this April in Berlin, coincided with the long-awaited vote by the European Parliament to adopt its own version of the unique device identification (UDI) regulation. Attendees heard from the European Commission (EC), as well as manufacturers and providers, on what the new requirements mean for the industry.
There was overwhelming support in Parliament for two regulations that included the UDI requirements: one for medical devices and the other for in vitro diagnostics (IVDs). They are expected to be published in Official Journal of the European Union (OJ) on May 5. Twenty days after publication, the clock starts ticking toward the compliance deadlines: three years later for medical devices, five for IVDs. The UDI regulations include similar requirements as the U.S. for manufacturers: assigning and labelling products with UDIs and publishing product data, this time to the European Database of Medical Devices (EUDAMED) managed by the European Commission. Like the U.S. FDA’s Global UDI Database (GUDID), much of the data in Eudamed will be made available to the public.
The European UDI regulation also requires hospital and healthcare systems to store the UDIs for implantable devices in patient records. This is similar to U.S. regulations for Meaningful Use Stage 3 from the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid Services (CMS). The ONC regulation requires electronic health record vendors to be able to hold and manage UDIs and related data for implantable devices, and the CMS rule requires healthcare providers to share the UDIs as part of the Common Clinical Data set with other providers.
The UDI regulations in Europe were prompted by high profile failures of medical devices, most prominently the PIP breast implants, which contained industrial grade silicone and were five times more likely to rupture than similar products on the market. The failed implants were implicated in several deaths, but by the time the products were fully recalled, the French manufacturer had gone defunct. The European rule requires a manufacturer to ensure that it has the financial ability to quickly and effectively compensate victims should its products fail, even if the company were to go bankrupt.
Also at the meeting, Melissa Finocchio of bioMerieux, a French-based IVD supplier, provided some insights into just how challenging UDI compliance can be for a manufacturer. When the UDI regulation first came out in the U.S., Melissa’s boss assigned it to her, thinking “How hard could it be?”. With just two products covered by the first deadline, it was easy. But when the deadline for Class II products approached, Finocchio quickly discovered that the 250 or so covered products were manufactured on a line with thousands of other products, and any changes made would impact all of them.
What started as a small project soon required millions in funding. For example, Finocchio had to convince the company that they needed to change out the entire packaging and printing systems for a line of products because the materials used were too shiny and the dot matrix printers were too imprecise, which made it hard for the company’s customers to read the barcodes. The company also discovered that when it changed its barcodes to accommodate external parties, its internal systems could no longer effectively scan them. It took further changes — and further expense — to create barcodes that could be scanned by both.
These are just a couple of examples from bioMerieux’s 19 different worldwide manufacturing sites, each with 19 different processes, different technology systems and different data in different formats, some of it manual. There was no way to centralize or synchronize the data. Finnochio said bioMerieux has to implement a master data management program before it can effectively use the Global Data Synchronization Network (GDSN).
Gathering the data elements for UDI compliance has been among the most challenging aspects fo UDI compliance for most manufacturers. This is compounded, they say, by increasing customer requests for data outside the UDI requirements. bioMerieux and others all said they want to meet their customers’ needs, but some question whether their customers are ready to consume all of the data elements they request. Some hospitals I have spoken to have also admitted that they are not always ready to consume data provided by manufacturers, even when they have asked for it. This sentiment was borne out in a presentation by University Hospital Schleswig-Holstein in Germany. Hajo Reissmann, MD, noted that his research could only find five hospitals in all of Germany with a master data management (MDM) program. Hospitals need both MDM and technology systems to effectively capture and share various product attributes, which will vary depending upon what they are trying to do with a product, e.g., source it, procure it, use it, evaluate it, etc. Many hospitals, in Europe and elsewhere, do not yet have the systems in place to effectively manage their data. The one bright spot, according to Dr. Reissmann, was that after hearing Finnochio’s presentation, he realized hospitals are not the only ones with these challenges.