Conceptual Design and Resources for a General-Purpose Safety and Performance Verification and Validation Toolkit (V2T) for Life-Critical Wireless Medical Device Networks (WMDN)

Wireless medical device network (WMDN) deployment is occurring to facilitate ambulatory patient care, increase safer and more intelligent diagnostic and therapeutic capabilities, and improve flexible patient bed configuration that matches census requirements. Patient safety risks exist from delayed or lost WMDN alarm and data streams, however, and non-proprietary verification and validation (V2) techniques do not exist. Single-vendor and heterogeneous multi-vendor deployment must be considered, as well as safe and reliable coexistence with other IS technologies sharing similar network components. V2 of even a homogeneous single vendor, single device WMDNS is very complex for several reasons including: absence of industry standards or regulations, unconstrained mobility of patients and devices, and rapid changes in the underlying wireless network modalities. This project will evaluate and recommend appropriate best V2 practices from fields like software and systems engineering to improve a hospital´s ability to properly implement and manage the emerging WMDN opportunities and to prevent patient injuries or other serious problems