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 regulation. Attendees heard from the European Commission (EC), as well as manufacturers and providers, on the 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 the Official Journal of the European Union (OJ). 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 US for manufacturers: assigning and labelling products with unique device identifiers (UDIs) and publishing product data, this time to the European Database of Medical Devices (EUDAMED) managed by the European Commission. Like the US 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 US regulations for Meaningful Use Stage 3 from the Office of the National Coordinator for Health IT (ONC) and the Centre 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 company had gone defunct. The European rule requires a manufacturer 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.
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