Evangeline Loh and Sage Farrar The Rosetta St

Evangeline Loh and Sage Farrar

The Rosetta Stone, an ancient Egyptian artifact created in 196 B.C., was inscribed with three different scripts: Greek, Hieroglyphic and Demotic. By virtue of its trilingual inscription, distinct members of Egyptian society—rulers, pharaohs, clergy and government officials—could read the stone. The discovery of the Rosetta Stone in 1799 was revolutionary not only because of the antiquity of the artifact, but also because it culminated in the decipherment and understanding of ancient Egypt’s hieroglyphic texts that previously had been unintelligible. Today, the Rosetta Stone is housed within the European Union, on display at the British Museum, where it has been since 1802.

While harmonized information on medical devices unlikely will be as momentous as the discovery of the Rosetta Stone, there are undeniable advantages to such a concept. In fact, multilingual device nomenclature, as well as shared data on incidents and device-related issues throughout the European Union, certainly would help regulatory authorities, manufacturers and users alike.

Along these lines, in last month’s column, we covered vigilance in Europe. In particular, various efforts, both at national and international levels, to improve incident reporting were discussed. The topic of the European Commission’s creation of a central databank, Eudamed, which would help unify vigilance measures throughout the EU, also was addressed in the May issue of MPO.

This column will elaborate on Eudamed and its practical implications. It also discusses the Global Medical Device Nomenclature (GMDN) and its current transformation.