Workshop with FDA

Following the meetings of the IEEE 11073 Point-of-Care-Devices Working Group, which took place three times a year, representatives of OR.NET e.V. took the opportunity for a technical exchange with the responsible liaison officer of the U.S. Food and Drug Administration (FDA), Dr. Konstantinos Makrodimitris. In the USA, the FDA is responsible for the approval of medical devices and the recognition of standards in medical technology. On the premises of the Helmholtz Institute for Biomedical Engineering at the RWTH Aachen University, Dr. Makrodimitris was able to learn about the practical implementation of manufacturer-independent medical device networking on the basis of the new IEEE 11073 SDC standards using an extensive demonstrator (see photo). On the basis of real application cases the technical solutions were presented and questions of risk management and approval were discussed.

Furthermore, the current research projects, MoVE (Modular Validation Environment), funded by the Federal Ministry of Education and Research (BMBF), and ZiMT (Zertifizierbare integrierte Medizintechnik), funded by the European Regional Development Fund (EFRE) and the State of North Rhine-Westphalia, and the general concept of modular risk analysis and approval of SDC-based networked medical devices were presented and discussed.The successful workshop is another milestone in the constructive cooperation between OR.NET e.V. and FDA in the areas of standardization, risk management and approval and thus a success for the international establishment of IEEE 11073 SDC as the standard series for interoperability in the operating room.