Ensuring patient safety in wireless medical device networks

WMDNs provide many alarms and related clinical data that are life-critical. To avoid exposing patients to serious injuries or death, these systems must be protected from data delays, distortions, loss, or other erratic delivery problems. Despite the careful planning, procurement, installation, and management that goes into selecting and deploying WMDN systems, by nature many intentional and unintentional ad hoc changes will occur throughout these systems´ life cycle. Clearly, delayed or lost WMDN alarm and data streams can cause serious patient safety risks, but, to date, nonproprietary WMDN verification and validation (V2) techniques do not exist. Further, because the implementation of decision-support-system capabilities for life-critical analyses like ECG arrhythmias or drug interactions varies by manufacturer, model, and user configuration, no single proprietary V2 strategy can, by itself, universally assure safe and reliable WMDN systems. Based on the belief that a formal-methods-based approach could help to verify and validate heterogeneous, wireless, patient-care-device networks, we propose developing a prototype verification and validation toolkit (V2T) that clinical biomedical engineering and IS departments can use to ensure safe and reliable WMDN operation.