OR.NET - Approaches for Risk Analysis and Measures of Dynamically Interconnected Medical Devices

Abstract

Nowadays, it lacks an open, standardized and dynamic interconnection of medical devices.  All existing combinations of medical devices consist of isolated solutions with proprietary interfaces, as no common standards for networking and the exchange of data of medical devices exist. This situation leads to confusing operating rooms and inefficient operations. Thus, new strategies need to be developed for the authorization of dynamically interconnected medical devices. Primarily, those concern of an acquisition and methodical adaption of new requirements and risks resulting from this way of interconnection.
The approach is to develop a method for a risk analysis for interconnected medical devices, which is structured modular and consists of a risk assessment of the standalone device and a risk analysis for the interconnection considering the risks involved in the transfer of functions. When interconnecting the medical devices the risk analysis of each of the devices is taken and they are compared by a gap analysis. Through this strategy it will be possible to realize a standard-compliant dynamic interconnection of medical products, which would be advantageous both for clinic operators and producers. This paper presents the current situation of the authorization of combined medical devices and proposes a strategy for the risk management of dynamically interconnected medical devices as a substantial part of the authorization.