The Healthcare Hub

European Medical Device Regulation Heats Up

posted by: Ed Palferman
Wednesday, February 27, 2013

This week marks one year since the Poly Implant Prothese (PIP) breast implant scandal that rocked the European medical device supply chain. The resulting set of proposals to toughen European regulations on medical devices, published in September 2012, has started a debate around the benefits of differing approaches, which is recently summarized by Ben Hirschler of Reuters.

The discussion started by the EU Commission’s draft proposals mirrors the process we have just been through in the U.S. that culminated with the recent FDA proposals (read more in a previous Healthcare Hub post). Our view is that key to the success of any regulations will be an enhanced ability for manufacturers and healthcare delivery organizations to identify and quickly recall potentially faulty products. This requires the use of Unique Device Identifiers (UDI) and global data standards (e.g. GS1).

This view was reinforced this week, when I met with colleagues at the Medicines and Healthcare products Regulatory Agency (MHRA), the UK agency responsible for regulating medical devices in the supply chain. While the organizations (and acronyms!) are different on either side of the Atlantic, it is interesting to hear that many of the challenges are the same. All proposals for the track and trace of medical devices are merely theoretical until the industry (manufacturers) adopts global standards and consumers of these devices (healthcare providers) invest to be able to record more detailed product information, including LOT and Batch numbers, through the use of GTINs or equivalent global data standards.

We are currently working with providers and suppliers in Germany, France, Spain, the Netherlands, Switzerland and the UK to help with the transition to global data standards – whether GS1/GTIN, HIBC or any other – and to ensure that inventory and materials management systems in hospitals are capable of reading any of these barcodes. Uniform global standards, their application through commonly used barcodes and the ability of all players in the supply chain to read and record the information contained within these barcodes, is essential to the success of track and trace initiatives and, as a result, the ability for greater savings.

To catch up on the U.S. FDA’s proposed rule, check out the various posts on UDI and a UDI readiness video series on the Healthcare Hub.