OR.NET e.V. and FDA held joint workshop
Following the trient-annual IEEE 11073 Point-of-Care Devices working group meeting this May in Cologne, representatives of the OR.NET association met with Konstantinos Makrodimitris who serves as the FDA liaison officer to the working group. At the RWTH Aachen University’s Helmholtz-Institute for Biomedical Engineering, Dr. Makrodimitris seized the opportunity to examine prototypical implementations of IEEE 11073 SDC-connected medical devices from multiple vendors in a hands-on session at the extensive demonstrator environment (photo). Based on real-world use cases, technical solutions were discussed with respect to risk management and regulatory issues. Finally, current research projects, MoVE (Modular Validation Environment), funded by the German Federal Ministry for Education and Research (BMBF), und ZiMT (Zertifizierbare integrierte Medizintechnik), funded by the European Regional Development Fund (EFRE) and the federal state of North Rhine-Westphalia, were presented in addition to the novel modular risk management and approval strategy for SDC-based device connectivity.
The successful workshop marks another major milestone in the continuing constructive cooperation of OR.NET e.V. and FDA on standardisation, risk management, and regulatory issues and thereby for establishing SDC as the international standard series for interoperability of devices in the OR.